cyrilzakka/clinical-trials huggingface dataset:
Auricular VNS Following Subarachnoid Hemorrhage

This study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following spontaneous subarachnoid hemorrhage.

Vagal nerve stimulation (VNS) has been studied in several inflammatory conditions, and has been implemented in animal models of subarachnoid hemorrhage (SAH) with promising results. The purpose of the proposed study is to determine how applying auricular VNS in patients presenting with spontaneous SAH impacts their expression of inflammatory markers in their blood and cerebrospinal fluid (CSF), and how it impacts their clinical course and outcomes.

This study will involve randomizing patients to stimulation with VNS, or sham stimulation. Blood and CSF will be collected on admission, and serially throughout the patient's admission. Clinical events tracked during the hospital stay include development of cerebral vasospasm, need for CSF diversion via a shunt, stress-induced cardiomyopathy, and development of stroke or global cerebral ischemia. Outcomes following admission will include functional scores at discharge, and at follow-up visits for up to 2 years after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous subarachnoid hemorrhage

Exclusion Criteria:

* Trauma-induced subarachnoid hemorrhage
* Ongoing chemotherapy
* Taking immunosuppressive medications for other medical illnesses
* Presence of a pacemaker
* Prolonged bradycardia at time of admission
An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed

The purpose of this study is to determine whether BMS-986299 both by itself and in combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced solid tumors. In addition, the ability of study drugs to stimulate an immune response against cancer will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced/metastatic solid tumor and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
* IO therapy resistant or insensitive tumors
* Have at least 2 tumor lesions accessible for biopsy
* Eastern Cooperative Oncology Group Performance Status of 0 or 1

Exclusion Criteria:

* Primary CNS malignancy
* Participants with other active malignancy requiring concurrent intervention
* Uncontrolled or significant cardiovascular disease

Other protocol-defined inclusion/exclusion criteria apply
Add-on to Thiazolidinedione (TZD) Failures

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on TZD alone. The safety of this treatment will also be studied


Eligibility Criteria:
Inclusion Criteria:

* Males and females, ≥ 18 years old, with type 2 diabetes and with inadequate glycemic control
* All subjects must have central laboratory pre-randomization A1C ≥ 7.0 and ≤ 10.5%
* C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
* Body Mass Index ≤ 45.0 kg/m²

Exclusion Criteria:

* AST and /or ALT \> 2.5 times the upper limit of normal
* Serum total bilirubin \> 2 mg/dL (34.2 µmol/L)
* Creatinine kinase \> 3.0 times the upper limit of normal
* Symptoms of severely uncontrolled diabetes
* Serum creatinine ≥ 2.0 mg/dL
* Calculated Cr-Clearance \< 50 ml/min (calculated by Cockroft-Gault formula)
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Study to Assess the Efficacy and Safety of Meloxicam vs. Diclofenac SR in Patients With Osteoarthritis of the Knee

To assess the efficacy and safety of meloxicam 7.5mg once daily compared with diclofenac 100mg SR once daily over a treatment period of 8 weeks


Eligibility Criteria:
Inclusion Criteria:

- Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (NSAIDs)

Exclusion Criteria:

- none
Evaluation of Oesogastroduodenoscopy With Vision to 245 ° (Full Spectrum Endoscopy) to View the Main Disc and Accessory

The monitoring and prognosis of patients with familial polyposis adenomatous rests on analysis of the transitional mucosa at the anal margin and especially on the tracking, characterization and resection of lesions of dysplasia type of high grade at the duodenal level, after total proctocolectomy. Currently, endoscopes with axial or lateral vision are used. The FUSE technology allows the simplification or even the improvement of patient surveillance with a 245° vision (versus150° in case of classical gastroscope). The use of a second screen to enlarge the field of view may allow both analysis of duodenum and the main and accessory papilla with one single endoscope and to decrease the number of omitted lesions .


Eligibility Criteria:
Inclusion Criteria:

* Patient eligible to any upper gastrointestinal endoscopy diagnostic

Exclusion Criteria:

* History of duodenal or gastric surgery
Personal KinetiGraph® Clinical Validation Study

The purpose of this study is to clinically validate new measures of the Personal KinetiGraph® (PKG®).

This is a prospective, observational research study of the Personal KinetiGraph (PKG) System. The PKG System is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia. This study aims to clinically validate new PKG assessments such as walking, Device Assisted Therapy readiness, Percent Time Bradykinesia, Percent Time Dyskinesia, fall prediction, disease progression and non-motor. The clinical validation will require enrollment of both subjects with a diagnosis of movement disorder, such as Parkinson's disease, and healthy control subjects who do not a neurological disorder.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to sign a written informed consent for study participation
* Existing diagnosis of a movement disorder or a healthy control subject without diagnosis of a movement disorder

Exclusion Criteria:

* Bedridden, wheelchair confined, or requires the regular use of an assistive gait device (e.g., walker, cane, etc.)
* Occupation that involves repetitive movement or complete immobility (e.g., janitor, construction, or sedentary with no/limited arm movements such as a taxi driver)
* In the investigator's or sponsor's opinion, subject has any unstable or clinically significant condition that would impair the participant's ability to complete the required PKG watch wear (e.g., subject unable to complete PKG wear instructions per Patient Instruction Manual), complete required assessments or interfere with data collection.
Follow-up of Osteo-articular Biomarkers After Spa Therapy in a Population With Knee Osteoarthritis and Their Correlation With the Clinical Evolution

Spa therapy is used in the treatment of various diseases and mainly osteoarthritis. Knee osteoarthritis is a very common rheumatic disease whose prevalence increases with longer life span and is a public health problem.

The Forestier and al. study highlighted the actual benefit and confirmed the improvement of the quality of life and pain of the knee osteoarthritis patients from 6 months of spa treatment.\[1\] A significant decrease of 30% in the rate of Serum Hyaluronic Acid at 6 months after the end of the spa therapy was also highlighted in the Canteloup et al study.\[6\] This study aims to measure different osteoarticular biomarkers (hyaluronic acid, coll2-1 and CTX1) before, at the end of the spa therapy and 6 months after the spa therapy and correlate with the clinical evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Patient with knee osteoarthritis defined according to the recommendations of the American College of Rheumatology (ACR):

  * painful articulation and at least one of the following three criteria: age \> 50 years and/or articular crepitation and/or morning stiffness less than 30min
  * and radiographic sign of gonarthrosis with osteophyte (on X-rays of less than 3 years).
* Patient can come to the final visit at 6 months and living within a perimeter of 30km around Dax.
* Patient affiliated to a social security scheme.

Exclusion Criteria:

* Osteoarthritis limited to patellofemoral joint.
* A previous spa therapy of less than 6 months.
* Spa therapies with double indication rheumatology and phlebology.
* Patient with osteoporosis.
* A known hepatocellular failure or known acute or end-stage renal failure.
* Severe depressive syndrome, psychotic syndrome, immune deficiency, cardiopathy, evolutive neoplasia or infection.
* Infiltration and/or viscosupplementation \< 6 months.
* Change in anti-osteoarthritis treatment of less than 3 months.
* Patient under tutorship or curatorship.
Autologous Prefabrication of Body Surface Tissues/ Organs(e.g. Joint)

The purpose of this study is to observe the feasibility and its application of autologous prefabrication for body surface tissues/oranges

In the field of tissue regeneration techniques, the in vitro processes and other exogenous factors still have many uncertainties. These uncertainties have hampered road to the clinical application. As the importance of in vivo environment has aroused more awareness, the investigators validated the hypothesis that the feasibility of self-regeneration prefabricated unaided by any in vitro culture process or exogenous elements.

Eligibility Criteria:
Inclusion Criteria:

* With body surface tissue or organ defects (e.g., ear, nose, bone and joint) requiring reconstruction.

Exclusion Criteria:

* evidence of infection, ischemia, ulcer or other pathological changes within the prefabricated area which defined as not suitable for tissues regeneration
* history of delayed healing, radiational therapy;
* significant renal, cardiovascular, hepatic and psychiatric diseases;
* significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV);
* BMI \>30;
* history of any hematological disease, including leukopenia, thrombocytopenia, or thrombocytosis;
* Evidence of malignant diseases
* unwillingness to participate.
ExAblate Blood-Brain Barrier Opening for Treatment of Alzheimer's Disease

The purpose of this study is to evaluate the safety and efficacy of the ExAblate® Model 4000 Type 2.0 system as a tool to open the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).

This study is a prospective, open label, single-arm, non-randomized, phase IIa trial to evaluate the feasibility, safety and efficacy of repeated, BBB opening using the ExAblate® Model Type 2.0 (220 kHz) system. Patients with diagnosis of Probable Alzheimer's Disease may qualify for a clinical trial to have three serial ExAblate BBB disruption procedures in specific areas in the brain.This study will be conducted at a single center in Canada and will enroll up to 30 patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female between 50-85 years of age
2. Probable Alzheimer's Disease (AD)
3. If taking concurrent Alzheimer's medication, has been on the medication for at least 2 months with a stable dose for at least 3 months
4. Able to communicate sensations during the ExAblate MRgFUS procedure
5. Ambulatory

Exclusion Criteria:

1. MRI Findings
2. Presence of unknown or MR unsafe devices anywhere in the body
3. Significant cardiac disease or unstable hemodynamic status
4. Relative contraindications to ultrasound contrast agent or PET amyloid tracer
5. History of a bleeding disorder
6. History of liver disease
7. Known cerebral or systemic vasculopathy
8. Significant depression and at potential risk of suicide
9. Any contraindications to MRI scanning
10. Any contraindication to lumbar puncture for collection of cerebral spinal fluid
11. Untreated, uncontrolled sleep apnea
12. History of seizure disorder or epilepsy
13. Severely Impaired renal function
14. Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research
15. Chronic pulmonary disorders
16. Positive human immunodeficiency virus (HIV)
17. Known apolipoprotein E allele (ApoE4) homozygosity
The Role of Zamzam Water in Idiopathic Oligohydramnios

The aim of this study is to evaluate the efficacy of drinking zamzam water versus tap water in increasing the AF index in women with oligohydramnios.

Oligohydramnios refers to decrease in amniotic fluid and it is defined as a deepest fluid pocket of less than 2 cm or an amniotic fluid index of 5 cm or less. Oligohydramnios complicates 0.5% to 8% of pregnancies, and 12 % if postdates When it occurs in first half of pregnancy it is associated with birth defects while in second half it causes poor fetal growth, malpresentations , FHR decelerations , MAS , Fetal suicidal syndrome and increases cesarean section and management and prognosis depend on gestational age

Eligibility Criteria:
Inclusion Criteria:

* pregnant female with idiopathic oligohydramnios

Exclusion Criteria:

* patients with medical disorder
* congenital anomalies
* premature rupture of membrane
* Patient refuse to participate
A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery

Evaluation of efficacy and safety on the use of rotigotine in patients suffering from Parkinson's Disease during and after surgery requiring general anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Subject has idiopathic Parkinson's disease (early- or advanced-stage), as defined by the cardinal sign bradykinesia, plus the presence of at least one of the following: resting tremor, rigidity, or postural instability and is without any other known or suspected cause of Parkinsonism.
* Subject is scheduled for an operation requiring general anesthesia.

Exclusion Criteria:

* Subject has previously been treated with rotigotine.
* Subject has a history of significant skin hypersensitivity to adhesives or other transdermals or recent unresolved contact dermatitis or has a known allergy or hypersensitivity to rotigotine or to other components of the patch.
* Subject is scheduled for a surgical procedure (surgery per protocol(SPP)) that requires magnetic resonance imaging or cardioversion.
* Subject has a high probability to require extended postoperative ventilation (\> 24 hours).
* Subject has any medical condition that, in the opinion of the investigator, could jeopardize or compromise the subject's ability to participate in this trial.
Definitive (Chemo)Radiotherapy for Patients With Esophageal Cancer - 3JECROG R-01

The aim of this observational study is to retrospectively collect survival data for 3000 primary esophageal cancer patients from multicenter between January 2000 to present. Based on a Cox model, we want to develope a nomogram that predicts local recurrence, distant metastases, and survival for patients treated with radiotherapy or chemoradiotherapy with or without chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma, adenocarcinoma of the esophageal or esophagogastric junction Unresectable or potentially resectable tumor (cT3-4N0-1M0-M1b, without visceral metastasis, according to AJCC 6th) based on standard primary staging by EUS and CT
* Age\>18 years
* No distant metastasis other than supraclavicular lymph nodes
* No prior history of thoracic radiation
* Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits

Exclusion Criteria:

* Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer during 5 years before diagnosis of esophageal cancer
* Pregnant or lactating females
* Contraindication for radiotherapy or chemotherapy
Development of a Risk Prediction Algorithm Through the Investigation of Genetic Risk Factors and the Complexity of Coronary Artery Disease to Estimate Future Risk of Cardiovascular Events: Angiographic (SYNTAX Score), Clinical and Pharmacogenetic Analysis.

The purpose of the research project is to investigate the potential association of 207 genetic polymorphisms with the complexity and the severity of coronary artery disease (SYNTAX score), along with the patients' response to clopidogrel and statin therapy. The aim of the study is to combine genetic, pharmacogenetic, clinical and laboratory data in order to create an algorithm (GEnetic Syntax Score-GESS) that will enable an individualized therapeutic patient approach.

Regarding Greece, this is the first prospectively enrolling medical database of this magnitude. Clinical and genetic patient information are systematically collected in a fashion that will enable also future retrospective evaluation of clinical and genetic details from each patient. This study is a discrete arm of a series of research projects that focus on the development of personalized medical therapy and share a common purpose: predicting future risk of cardiovascular events, assessing the severity and complexity of coronary artery disease by incorporating genetic information into the SYNTAX score and providing personalized therapeutic guidance to patients. The ultimate goal of the study would be to identify, design and develop a panel of genetic markers that in combination with clinical and angiographic information will be a reliable tool for predicting cardiovascular risk for future adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Patients giving voluntary written consent to participate in the study
2. Male or female patients between 18 years to 90 years at entry
3. Patients without previous history of CAD
4. Patients who are admitted in the Department of Cardiology in the AHEPA University General Hospital of Thessaloniki and undergo coronary angiography for clinical purposes

Exclusion Criteria:

1. Patients \< 18 years old and \> 90 years old at time of coronary angiography
2. Patients with a previous history of CAD
3. Cardiac Arrest at admission
4. Patients with serious concurrent disease and life expectancy of \< 1 year
5. Patients who refuse to give written consent for participation in the study
Dyadic Mindfulness for People with Parkinson's Disease and Their Caregivers

The proposed two-arm randomized waitlist-controlled trial will use a mixed-methods design to investigate the effects of dyadic mindfulness on physio-psycho-spiritual outcomes in people with Parkinson's Disease (PwPD) and their family caregivers. One hundred Chinese patient-caregiver dyads will be randomized to receive eight weekly 90-minute dyadic mindfulness sessions or usual care. Outcome measures include negative emotions (primary outcome), patient-caregiver relationship, mindfulness, HRQOL, gut microbiome, PD-related symptoms, and caregiving burden. An actor-partner interdependence model will be used to explore the interactions of treatment effects within the dyads. The dyads will be assessed at baseline(T0), post-intervention(T1), and 4-months post-intervention(T2). The investigators will also invite 25 dyads to attend in-depth interviews exploring their experiences, perceived changes, and factors attributable to the effectiveness/ineffectiveness of the intervention. Generalized linear mixed-effects (GLME) with intention-to-treat analysis will be used to compare the changes in outcomes over time within and between the two arms. The findings will be triangulated to provide a comprehensive evaluation of the intervention's effectiveness. This study will generate rigorous scientific evidence to inform the application of dyadic mindfulness as a public health practice preventing the progression of psychological distress in PwPD and caregivers to clinically severe levels. Its self-help nature also enriches the primary care for this clinical cohort.


Eligibility Criteria:
Inclusion Criteria of PwPD:

* Chinese patients with idiopathic mild-moderate PD (as indicated by the Hoehn and Yahr Scale stages I-III: those with unilateral/bilateral symptoms, with/without postural instability who are able to walk/stand unassisted)
* Aged 50-80
* Experience at least mild negative emotions (as indicated by the 21-item Depression, Anxiety and Stress Scale \[DASS21\] score of Depression subscale ≥10, Anxiety subscale ≥8, or Stress subscale ≥15)

Inclusion Criteria of caregivers of PwPD:

- Self-identified as the primary caregivers of their patient

Both need to be able to communicate in Cantonese and provide written consent.

Exclusion Criteria:

* Engage in regular supervised mind-body practices such as Tai Chi, yoga, or other forms of mindfulness training (\>2 times per week)
* Have a pre-existing acute psychotic disease
* Currently participating in any other behavioral or pharmacological trial
* Have significant cognitive impairment, as indicated by an Abbreviated Mental Test score≤ 6
* Have other contraindications that may limit their full participation (e.g., severe hearing/vision impairment)
Standard Treatment Compliance of Participants, Effectiveness and Prognosis in Acute Respiratory Distress Syndrome

The Acute Respiratory Distress Syndrome (ARDS) is one of common clinical critically diseases. In the United States, the incidence of ARDS reaches 31%, which is one of the main causes of death in patients. There is no unified treatment process for ARDS currently and the treatment measures are not yet standardized, so the standardization of ARDS treatment processes is needed to reduce mortality in patients. Following the evidence-based medicine principles and six-step treatment standards of ARDS, this study uses the method of multi-center randomized controlled clinical trials to evaluate the standardized treatment process of ARDS, which provides the basis for the standardized treatment of ARDS.


Eligibility Criteria:
Inclusion Criteria:

* aged ≥ 18 years
* admitted to the ICU
* according to the diagnostic criteria of ARDS Berlin definition，admit patients with severe ARDS

Exclusion Criteria:

* age \<18 years old
* be expected to die within 24 hours
* end-stage malignancies
* be participating in other studies, which may affect the results of this study
* DNI (do not intubation) and DNR (do not recovery) patients
* family members do not agree to sign an informed consent
Study Evaluating Sirolimus in Kidney Transplant Recipients in India

To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing surveillance setting.


Eligibility Criteria:
Inclusion Criteria:

* Patients in End Stage Renal Disease who are above 13 years of age and weigh more than 40 kilograms.
* Patients scheduled to receive a kidney from a cadaveric donor, from a living unrelated donor or from a living related donor.

Exclusion Criteria:

* Evidence of major infections at the time of sirolimus administration
* Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the treatment phase.
* Females who are pregnant, breast feeding or in reproductive age group and not using a medically acceptable form of contraception