cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain

Clinical study to determine the responder rate of the TheraNova Migraine Treatment System to that of a sham control treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18-100 years, inclusive
* Diagnosis of episodic migraine with and without aura per International Headache Society diagnostic criteria
* 4-14 migraine days per month
* Ability to provide informed consent
* Demonstrates no contraindication to the use of electrical nerve stimulation
* Capable and willing to follow all study-related procedures

Exclusion Criteria:

* Currently pregnant or breastfeeding, pregnant within the past 6 months or intends to become pregnant during the enrollment period
* Diagnosis of chronic migraine or other forms of primary or secondary headache disorders, including medication overuse headache per International Headache Society diagnostic criteria
* Any medical condition that would, in the opinion of the investigator, make the subject ineligible
* Has received botulinum toxin injections within the past 3 months
* Is currently implanted with an electrical and/or neurostimulator devic, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, sacral stimulator, bone growth stimulator, or cochlear implant
* Use of investigational drug/device therapy within the past 4 weeks
* Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination (including bleeding disorders, anticoagulant medications and peripheral neuropathy)
* No changes in preventive medications (or other medications determined to potentially interfere with the study) in the previous 30 days and no intent to change it during the study
On-Pump vs. Off-Pump CABG in High-Risk Patients (EuroSCORE 6+)

Previous studies comparing on-pump and off-pump operating strategy did only partially demonstrate benefits of the off-pump myocardial revascularisation.In primary end-points (MI, death, renal failure, and so on) there was no significant difference, but in secondary end-points we observed benefits resulting for patients. We would like to show the benefit of the method without extracorporeal circulation in patients with higher and hight operation risk, coming from EuroSCORE classification system (6 points and more).


Eligibility Criteria:
Inclusion Criteria:

* stable form of ischemic heart disease
* unstable angina pectoris
* acute myocardial infarction
* additive EuroSCORE 6 and more
* informed approval of the patient

Exclusion Criteria:

* significant heart valve disease, requesting surgery
* aortic aneurysm requesting surgery
Effects of Bromelain and Boswellia Serrata Casperome With Centella Asiatica and Vitamins on Edema, Paresthesia and Postoperative Pain After Quadrantectomy With or Without Sentinel Lymph Node Biopsy.

Aim: to investigate the effects of dietary supplements on postoperative edema and pain in patients undergoing quadrantectomy for breast cancer.

Methods: 120 patients will be randomized into 3 groups: A, treated with Bromelain/Boswellia Serrata Casperome and Centella Asiatica with Vitamins for 30 days; B, treated with Bromelain/Bosswellia Serrata and placebo for 30 days; C, treated with 2 placebos. Inclusion criteria: adult (\>18 years) patients with breast cancer undergoing quadrantectomy with or without sentinel lymph node biopsy. Exclusion criteria: diabetic neuropathy, previous breast/chest surgeries, allergies to studied drugs, severe kidney failure, alcohol and toxics addiction, axillary lymphadenectomy. Patients will be studied through ultrasound examination for edema and collections, VAS and DN4 for pain, during 30 postoperative days. Patients will also be studied through psychological and physiatric evaluations. Wilcoxon, T student, Chi-Squared tests will be used to evaluate the outcomes. STATA 14 (StataCorp LP, College Station, Tex, USA) will be used for the analysis. P\<0.05 will be statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years) with breast cancer undergoing quadrantectomy with or without sentinel lymph node biopsy

Exclusion Criteria:

* Diabetical neuropathy
* Previous breast/chest surgery
* Allergies to studied drugs
* Severe kidney failure
* Alcohol and toxics addiction
* Axillary lymphadenectomy
HFS in the Assessement and Management of Severe Asthma Attack Among Fifth Year Medical School Students

Bedside clinical case learning, such for respiratory distress, represent a challenge for medical teachers, especially in critical conditions. In fact, this kind of learning implicate the presence of an appropriate case (the patient itself), framework and may be time consuming which could compromise the patient's safety and wellbeing.

New pedagogic tools have emerged to strengthen the medical reasoning and the acquisition of knowledge. in recent years, the development of medical simulation has found a growing interest in the medical teaching field. Contextualization, reproducibility and reliability are the characteristics of high-fidelity simulation (HFS) which guarantee a lifetime experience of clinical conditions without putting at risk patient's safety and comfort.

The aim of this study is to assess the impact of HFS on fifth year medical students learning skills in the assessement and management of an acute asthma attack in the emergency room, and to compares it to other modern teaching tools such as "video-case"


Eligibility Criteria:
Inclusion Criteria:

* all fifth year medical students allocated to the one month internship period in the emergency departement.

Exclusion Criteria:

* students refusing to participate in the protocol.
A Repeat Dose Study With GSK1018921 to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics in Healthy Volunteers and Patients With Schizophrenia and to Evaluate Its Effect on PK of Midazolam.

The purpose of this study is to understand safety and tolerability of the drug GSK1018921 after 14 days of dosing in healthy volunteers and then in patient volunteers.

This is a four part, parallel group, randomised, study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effects of repeat doses of GSK1018921 in healthy volunteers and stable patients with schizophrenia and to evaluate its effect on pharmacokinetics of midazolam. Part A will evaluate 14 days repeat BID dosing in at least three cohorts of healthy volunteers, to assess safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK1018921. Part B will study the potential drug interaction of GSK1018921 (Maximum Tolerated Dose from Part A) with midazolam with 14 days repeat BID dosing in healthy volunteers and therefore will assess the PK, safety and tolerability. Part C will be a single dose study in healthy volunteers and will include CSF sampling to assess the concentration of GSK1018921 and glycine in CSF with two doses (80 and 200 mg). Part D will study stable patients with schizophrenia, to assess safety, tolerability, PK and PD following 28 days of repeat BID dosing.

Safety assessments will include physical examination, 12-lead ECGs, holter monitoring, vital signs, orthostatic vital signs, visual assessments, and clinical lab test. Tolerability will be assessed by collecting Adverse Events.

PD assessments will include glycine in red blood cells, plasma and CSF, as well as CogState Battery test, Visual Assessment Scale, Positive And Negative Symptom Scores (PANSS) and Clinical Global Impression scales of change.

Eligibility Criteria:
All subjects (Healthy and Patients)

Exclusion Criteria:

* History of drug or alcohol abuse.
* Consumption of drug, food or drink affecting the CYP450 metabolism pathway.
* Has received investigational drug within 30 days to 5 half lives or twice the duration of the biological effect of any drug (which ever is the longer).
* Donation of blood in excess of 500mL within a 56 day period.

Patients eligibility

- Stable patients with schizophrenia.
Characterizing Guideline Adoption and Treatment Quality in Clinical Routine of German HFrEF Care

This is a multicenter, non-randomized, non-interventional cohort study with prospective and retrospective collection of primary data on heart failure with reduced ejection fraction (HFrEF) patient treatment and care following a decompensation event in different types of Heart Failure Unit (HFU) or non-HFU centers across Germany.

This study aims to describe quality of care of HFrEF patients following a decompensation event in different center types (=settings) utilizing the quality indicators for the care and outcomes of adults with heart failure as specified by the Heart Failure Association in 2022.

No strict visit schedule will be imposed on participants to avoid interference with routine clinical care. HFrEF patients will be treated according to the local routine in terms of medication, visit frequency and types of assessments performed and only these data will be collected as part of the study from patient files.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who provide written informed consent to participate in the study
2. Male or female patients ≥ 18 years of age
3. Patients with diagnosis of heart failure with reduced ejection fraction (HFrEF) and HF treatment according to the summaries of product characteristics (SmPCs)
4. Decompensation event up to three months prior to inclusion

Exclusion Criteria:

1. Simultaneous or planned participation in an interventional research study
2. Participation in this study at another site e.g. in a HFU network
3. Patients incapable of understanding and signing the informed consent form
Philips Intracardiac Echocardiography (ICE) Clinical Registry

The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.

This is a prospective, multi-center, observational, single-arm registry intended to gather real-world data to report VeriSight ICE catheter performance and safety. It will be conducted in the United States under the approval of one or more recognized institutional review boards and in compliance with Good Clinical Practice guidelines defined in International Standards Organization:14155;2011, the Declaration of Helsinki, and all applicable federal and local laws and regulations. Only on label uses of the VeriSight ICE catheter will be allowed. No specific claims are being validated during this registry, though data analyzed from this protocol are intended to inform of future claims regarding the performance and safety of the VeriSight catheter.

Enrolled patients will be imaged with VeriSight for various types of percutaneous cardiac interventional procedures. Enrolled subjects will be followed until discharge or ≤48 hrs post-procedure. The registry has a planned duration of approximately 24-36 months with interim analysis planned at 100 patients before further enrollment will be considered. Statistical hypotheses are not intended for this registry and descriptive analysis will be conducted. Data from all clinical sites are intended to be pooled for analysis. It is possible that sub-analyses may be conducted to demonstrate VeriSight guidance for target intervention types in structural heart and electrophysiology procedures.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age and willing to provide written, dated and signed, informed consent
2. Scheduled for a procedure that is within the scope of clinical indication for VeriSight per Instructions for Use (IFU)

Exclusion Criteria:

1. Contraindicated for ICE catheter placement or patient considerations that make placement of VeriSight not technically feasible
2. If alternate access (as needed instead of femoral) is not viable
3. Known contraindicated conditions include sepsis, major coagulation abnormalities, presence of any intracardiac thrombus, presence of class IV angina or heart failure, deep vein thrombosis, or significant peripheral vascular disease.
Investigation of Pectoralis Muscle Strength in Elderly With Interstitial Lung Disease

Interstitial lung disease (ILD) is a restrictive lung disease characterized by impaired lung function, exercise limitation and skeletal muscle dysfunction. There is limited data on skeletal muscle function in ILD, most of which are focused on the lower limb muscles. The aim of this study were to evaluated the change of pectoralis muscle strength and relationship of pulmonary function with pectoralis muscle strength.

This study consisted of intervention and control groups. Thirty one patients with ILD were included in the patient's group and 37 healthy volunteers in the control group. All participants were selected from the geriatric population. Demographic and cardiopulmonary physiotherapy assessment of all participants were performed. Lung function test, maximal inspiratory and expiratory pressure and pectoralis muscle strength were measured in participants of both groups. All measurements were performed once.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ILD by a multidisciplinary team according to the 2011 ATS/ERS guidelines for ILD
* Aged 65-85

Exclusion Criteria:

* Uncontrolled/active cardiovascular, metabolic, systemic or cancerous disease
* Significant orthopedic, neurologic or musculoskeletal comorbidity that limited functional independence
* No being able to cooperate
* Refuse to participate in the current study
An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Assessment of Bare Spots

This study will assess the distribution of a microbicidal gel in the vagina and confirm the presence of bare spots. MRIs will be done with and without the addition of the MRI contrast Gadolinium to the microbicide in order to determine whether the bare spots are an artifact of the MRI technique.


Eligibility Criteria:
Inclusion Criteria:

* 18 -45 year old women
* normal Pap smear
* not pregnant

Exclusion Criteria:

* abnormal pelvic exam
* history of claustrophobia
* allergy to product formulation
* pregnant or breastfeeding
Rg3 in Combination With TACE in Hepatocellular Carcinoma Patients With High Expression of Notch1

In order to provide a new option for clinical anti-angiogenesis therapy in hepatoma, a randomized controlled study is planed to confirm the effect of Rg3 in combination with TACE on angiogenesis and tumor treatment in advanced hepatocellular carcinoma patients with high expression of Notch1.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed hepatocellular carcinoma.
2. High expression of Notch1 in tumor tissues.

Exclusion Criteria:

no pathological evidence of HCC
Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.

SOGUG-PRINCIS is a retrospective (regarding patient inclusion) and prospective follow-up, epidemiological, non-interventional, non-blinded, non-randomized, multicenter, national observational study with drugs. This study will collect data from patients with genitourinary tumors to analyze the effectiveness under routine clinical practice conditions of drugs recently approved for funding in the Spanish National Health System.

In all cases, the decision to start treatment will be made prior to and independently of participation in the study, which will be limited to subsequently collecting the data necessary to assess the objectives of the study.

This study will serve as a registry for genitourinary cancers. Every time a new drug will be authorized, a new subproject with a primary endpoint will be opened to recruitment. The substudy will try to validate with real-world data the endpoints reported in the phase III clinical trials that led to the marketin authorization.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old.
* Patients granting the ICF unless exemption or exceptions mentioned below.
* Histological diagnosis of malignant neoplasia originating in the genitourinary system: kidney, renal pelvis, ureter, bladder, prostate, testicle and germinal tissue of other locations, urethra, penis, or seminal vesicles.
* Patients have started treatment with medications whose positive resolution of financing by the Spanish National Health System for the aforementioned tumors has been after January 1, 2023.
* Patients have started treatment after the official publication of the positive resolution of financing of the drug under study by the National Health System. This restriction is intended to avoid interference of the study with the marketing authorization processes by the European Medicines Agency, and price and reimbursement negotiations by the Spanish health authorities.
* Patients have received treatment at the participating center.

Exclusion Criteria:

* Patients previously treated at another centre who have subsequently been referred to one of the participating centres. In this case, the patient will be included in the centre where treatment was started, or in the second centre if the first is not part of this study.
* Patients who do not meet any of the inclusion criteria.
* Evidence of an express objection by the subject or his/her legal representative to participate in the study.
An Early Childhood Internet-based and Family-based Intervention Study

The poverty rate among children under 18 years old in Hong Kong in 2015 was 18% after social welfare intervention. James Heckman, a Nobel Prize winner in Economics, advocates early childhood investment to enhance social mobility, given its lifelong impact of on child development. However, few randomized control trails have been used to examine the effectiveness of early childhood intervention in promoting social mobility through child development in Hong Kong. To fill these gaps, we propose an interdisciplinary intervention study involving academics from economics, sociology, social work, gerontology, education, and psychology to investigate methods to promote the social mobility of children living in poverty through early intervention.

The overall objective is to enhance the developmental outcomes of children in poverty by utilizing parental resources within a family system, technological resources available in modern metropolis and the human resources enjoyed by the elderly in Hong Kong.

The primary objective is to evaluate an internet- and family-based intervention to promote the development of children in poverty aged 24 months to three years. The examined outcome will be the developmental well-being of participating children, with the long-term goal of promoting their social mobility to break the cycle of poverty. In the long run, we aim to establish the proposed intervention in policy to promote the development of disadvantaged children.

The secondary objective is to identify intergenerational volunteerism as a means for productive aging through a mentoring program using older adults as mentors to participating parents.

The proposed research consists of three phases. The first phase will be a cross-sectional survey with a sample of 1,000 cases from 60 nurseries cum kindergartens to explore the family demographics and developmental profiles of low-income children in comparison to others. The second phase will be a randomized control trail implementing a 24-month internet-based intervention with 200 toddler-parents dyads from 20 to 30 of the original 60 nurseries. Interventions will be delivered by older mentors professionally trained by the research team. All children, parents and elderly mentors will be evaluated through a set of outcome measurements to assess the effectiveness of the program. The last phase will involve the dissemination of research information that may become building blocks for policies on internet-based early childhood education, poverty alleviation and social mobility enhancement, as well as productive aging.

Eligibility Criteria:
Inclusion Criteria:

* Parents who have children aged 24 months to 3 years

Exclusion Criteria:

* Parents who have children beyond the above age range
Cerebellum - Cognitive Outcome and Functional Connectivity

Aim: To investigate the effect of cerebellar tumor surgery on the resting state functional connectivity level in higher order cognition networks known to interact with the cerebellum. Furthermore, to correlate the connectivity level of these networks with the neuropsychological performance and functional outcome of the patients.

The investigator's hypothesis is that the functional connectivity of various cognition networks in the cerebrum as assessed by resting-state functional magnetic resonance imaging can be impaired after cerebellar tumor surgery and can be correlated with the neuropsychological performance. The effect of surgery on the cognition networks and the neuropsychological performance is dependent on the tumor location within the cerebellum. Such a correlation seems feasible as functional connectivity analysis could be correlated with the neuropsychological impairment in various neuropsychiatric disorders. Furthermore, investigators were able to depict the maturation of the functional connectivity networks in parallel to the neurocognitive development in childhood


Eligibility Criteria:
Inclusion Criteria:

* • Male or female patients aged \> 15 yrs

  * Age at surgery between 1 yrs - 12 yrs
  * Compliance (the patients have to be able to lay motionless in a 3 Tesla MR scanner and to cooperate with the examiner during the examination)
  * Signed informed consent from the patient and/or the parents

Exclusion Criteria:

* • Patients with Neurofibromatosis 1

  * Severe visual or auditory impairment
  * Cerebrospinal fluid shunt device
  * Prior radiotherapy or chemotherapy
  * Contraindications to MRI
RAD 1801: Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy

This study offers focal therapy for prostate cancer by using an intra-urethral radiotransponder temporarily placed during radiotherapy. The study aims to improve the risk-benefit ratio of therapy for early prostate cancer and potentially lessen symptom burden over time.

This study offers focal stereotactic body radiotherapy for prostate cancer by using an intra-urethral radiotransponder placed temporarily during each of the 5 radiotherapy treatments. The study aims to improve the risk-benefit ratio of therapy for early prostate cancer and potentially lessen symptom burden over time while also accessing early efficacy, late toxicity, and overall quality of life post-treatment. Patients will be followed for 24 months (2 years) with follow-up appointments at 3, 6, 9, 12, 18, and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have histologically confirmed adenocarcinoma of the prostate, with biopsies obtained within 12 months of registration

  * Gleason score 3+3 or 3+4
  * PSA \<10 ng/mL within 3 months of enrollment
  * Clinical stage T1a-T2a by digital rectal exam
  * Up to 2 intraprostatic nodules visible on MRI, with combined volume \<50% of the total prostate volume
* Karnofsky Performance Status (KPS) \>70%.
* Life expectancy \>10 years
* Age ≥ 19 years
* Subjects given written informed consent

Exclusion Criteria:

* \>2 MRI defined nodules representing prostate cancer
* Total volume of MRI nodules exceeding 50% of total prostate volume
* Positive biopsy core in sextant region without MRI defined nodule (i.e. biopsy proven MRI occult prostate cancer)
* American Urological Association (AUA) urinary score ≥ 18.
* History of inflammatory bowel disease.
* Prior pelvic surgery
* Prior treatment for prostate cancer
* Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids is not considered an exclusion criteria.
* Platelet count \< 70,000/µL
* Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. Use of aspirin is not an exclusion criteria.
* Contraindication to MRI such as implanted devices.
* Metallic pelvic implants resulting in imaging artifact within the prostate on MRI or CT