cyrilzakka/clinical-trials huggingface dataset:
NEWPROMRI-PATHWAY - A New Prostate Magnetic Resonance Imaging (MRI) Pathway

Prostate cancer is the second most common cancer in men worldwide. The demand for magnetic resonance imaging (MRI) to diagnose and manage prostate cancer is continually growing. There is, however, a severe global shortage of radiologists who review and make decisions on prostate scans. This shortage causes compromises that are inefficient and negatively affect care provision, patient outcomes, and patient experiences. Two key examples of these compromises are that every patient receives a gadolinium contrast injection during a prostate MRI scan and patients often require multiple imaging appointments. If radiologists' knowledge of making prostate MRI decisions around these compromises could be harnessed and passed to radiographers (who are trained to acquire the MRIs but currently do not review them) with a computerised system to support clinical decision-making, this would have enormous potential to improve the diagnosing and managing prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* MRI radiographers in University Hospitals of North Midlands (UHNM) and or University Hospitals of Derby and Burton (UHDB) with over 5 years' experience in MRI of the prostate.
* Radiographers from UHNM or UHDB who have completed an online and hands on study specific training materials before the testing phase.
* Retrospective data of 800 patients each from UHNM and UHDB who have had mpMRI and went on to have a biopsy.

Exclusion Criteria:

* Non-MRI radiographers.
* Radiographers who did not completed an online and hands on study specific training materials before the testing phase.
* Non-mpMRI.
Relationship Between Parameters of VOT Using NIRS and Clinical Outcomes in Pediatric Cardiac Surgery

The purpose of this study is to evaluate the ability of vascular occlusion test (VOT) during cardiac surgery to predict postoperative outcomes in pediatric patients.

After induction of anesthesia, pediatric SomaSensor for INVOS 5100C is attached at calf muscle and non-invasive blood pressure cuff is applied to ipsilateral thigh. VOT is performed as: after baseline oxygen saturation value is recorded, cuff pressure is rapidly increased to 30 mmHg over than systolic blood pressure. After 3 minutes of ischemic time, cuff pressure is rapidly decreased. It is performed at 3 time periods : before start of operation, during cardiopulmonary bypass, and after weaning from cardiopulmonary bypass. Postoperative outcome variables are recorded after surgery : major adverse event, use of inotropic and vasoactive drugs, duration of mechanical ventilation and ICU stay. The relationship between the results of VOT and postoperative outcome will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged under 8 years old who are scheduled for cardiac surgery

Exclusion Criteria:

* Skin disease
* Skin preparation involving thigh
* Peripheral vascular disease
Ambulation as a Factor on Oscillating Thermometry

This research study aims to better understand how the plantar temperature data collected by the Podimetrics RTM System corresponds to physical activity level in subjects.

Subjects with prescription for monitoring with Podimetrics RTM System will be assigned activity monitors to track physical activity. Data from the Podimetrics RTM System and the activity monitor will be assessed after one month of use to determine any correlation between the two data sets and adherence to the use of activity monitor.

Eligibility Criteria:
Inclusion Criteria: Study subjects must

* Be at least 18 years old
* Not be pregnant
* Provide informed consent
* Have a prescription for monitoring with Podimetrics Remote Temperature Monitoring System

Exclusion Criteria:

* Be younger than 18 years old
* Unable to understand English
* Unable to provide consent
* At the discretion of the investigator
TAP vs QLB in Patients After Cesarean Delivery

Comparison of two types of analgesia after cesarean section All patients will be anesthetized with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will be measured with visual-analog scale (VAS). 1, 2, 6 months after surgery each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).

Written consent will be obtained before the cesarean section. Only subarachnoidally anesthetized patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.

At the end of surgery ultrasound-guided regional block will be performed. Each patient will be randomly allocated to one of the treated group: transversus abdominis plane block (TAP) or quadratus lumborum (QL). Patients receive 0.2 mL of local anesthetic solution (0.375 % ropivacaine) on each side.

Postoperative pain will be measured with VAS (visual-analog scale) 2, 4, 8, 12 and 24 hours after the end of the operation.

Paracetamol, metamizole, ketoprofen may be given as required. Whenever pain exceeds 40 (VAS) 5 mg of morphine will be given intravenously (maximum two dosages per day).

1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.

Eligibility Criteria:
Inclusion Criteria:

* obtained consent
* singleton pregnancy
* subarachnoid anesthesia

Exclusion Criteria:

* coagulopathy
* allergy to local anesthetics
* depression, antidepressant drugs treatment
* epilepsy
* usage of painkiller before surgery
* addiction to alcohol or recreational drugs
Angio-Seal Interventional Radiology (IR) Registry

The purpose of this study is to collect data on the standard of care use of the St. Jude Medical (SJM) Angio Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in diagnostic and/or interventional radiology patient populations.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is undergoing a diagnostic and/or interventional radiology procedure via femoral arterial access and the investigator performing the procedure would use Angio-Seal for closure as part of his/her routine care of the patient. Angio-Seal deployment will follow the standard of care for vascular closure device use and the Instructions for Use (IFU) for the device.
2. Sheath angiography prior to Angio-Seal deployment reveals appropriate anatomy and puncture location for vascular closure device deployment.

Exclusion Criteria:

1. Patients who are unable to provide written informed consent.
Mirror Therapy Rehabilitation for Motor Functional Neurological Disorders.

Motor functional neurological disorders (FND) correspond to motor symptoms that are unexplained by an organic lesion but are due to cerebral dysfunction. Patients with these disorders have high rates of disability and health care utilization, and their quality of life is as impaired as that of patients with an "organic" disease. Accompanying these patients in their often-complex health journey represents a socio-economic and human challenge that demands interdisciplinary collaboration. Rehabilitation is seen as an important part of the therapy for motor FND. However, further research is needed to refine appropriate interventions and to create evidence-based recommendations. In this study, patients suffering from a functional neurological motor disorder of the upper limb will be included in a novel rehabilitation protocol that includes computerized mirror therapy. The study will used a multiple baseline, across subjects, single-case experimental design (SCED). In this type of design, each subject is his own control, with individual parameters being repeatedly measured in the presence and absence of the intervention of interest (computerized mirror therapy). Computerized mirror therapy could restore the coherence between the motor program and its execution. The investigators hypothesize that this process could re-normalize upper-limb motor activity and that this will have a beneficial impact on manual dexterity, quality of life, and mental representation capacities of the upper limb.

The objective of this project is to use the single case experimental design method to investigate the efficacy of rehabilitation with computerized mirror therapy for patients suffering from motor neurological disorders (FND) of the upper limb.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old,
* Included in the PULSES program (University Program of Liaison and Care for Somatoform Etiologies),
* Announcement and explanation of the diagnosis already given to the patient,
* Motivated to participate in the project,
* Diagnosed with any type of motor functional neurological disorder : partial or complete deficits and abnormal movements,
* With a lateralized disorder (limited to one hemi-body) involving at least the upper limb,
* Disorder must primarily involve the distal part of the upper-limb (fingers, wrist),
* Admitted to the day hospital at Henry Gabrielle Hospital during the study,
* Given free, informed consent in writing after being informed orally and in writing of how the study will proceed.

Exclusion Criteria:

* Patients with visual disorders such as uncorrected diplopia, blindness or low visual acuity (corrected or uncorrected),
* Pregnant, parturient and breastfeeding women,
* Patients under a legal protection measure such as guardianship or curatorship
* Patients not affiliated to a social security scheme (French Social Security) or beneficiaries of a similar scheme.
Unicirc Adolescent 12-15 Year Old Boys

This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged 12 to 15 years.

Boys are healthy, without severe anatomic abnormalities complicating circumcision. Boys with moderate phimosis and tight frenulum were included. Informed assent was obtained.

Eligibility Criteria:
Inclusion Criteria:

* healthy boys desiring circumcision

Exclusion Criteria:

* current illness
* bleeding disorder
* reaction to local anaesthetic
* infection
* any penile abnormality potentially complicating circumcision
Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With COVID-19

Observational pilot single-center study aiming to determine the microbiota of critically ill patients infected with SARS-CoV-2. COVID-19 patients will be compared to historical critically ill controls with no SARS-CoV-2 infection.

Observational pilot single-center study aiming to determine the microbiota of critically ill patients infected with SARS-CoV-2. COVID-19 patients will be compared to historical critically ill controls with no SARS-CoV-2 infection.

Respiratory and fecal microbiota (microbial and fungal) will be determined in COVID-19 patients on bronchoalveolar lavage and rectal swab.

Inflammatory biomarkers will also be measured in COVID-19 patients.

Characteristics of study patients will be collected at ICU admission and during ICU stay.

Eligibility Criteria:
Inclusion Criteria:

For the Covid-19 Group: with a confirmed severe lung infection with CoV2-SARS-Cov2 admitted to the ICU.

For the Control Group:

* Historic cohort of non SARS -CoV2-infected adults admitted to the ICU (between March and October 2019),
* that was investigated for fecal microbiota in a previous study (control patients in a fecal microbiota study in patients included in the SEAT study).

Exclusion Criteria:

* For the Covid-19 group:
* Lack of coverage Patients who received antibiotic therapy within 6 weeks prior to Covid-19 symptomatology,
* Pregnant women,
* Severe immunosuppression: Neutropenia \< 0.5 G/L, Chemotherapy \< 6 months, Bone marrow transplant recipients, HIV with CD4+ lymphocytes \< 0.4 G/L
* Impossible to perform bronchoalveolar lavage,
* Non-socially insured,
* Refusal to participate in the social study
Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents

The study aims to investigate possible effects of per os Crocus Kozanis administration in children and adolescents with obesity


Eligibility Criteria:
Inclusion Criteria:

* Age above 10 year-old
* Diagnosis of Obesity according to International Obesity Task Force Criteria
* Presence of impaired glucose tolerance and/or impaired fasting glucose

Exclusion Criteria:

* Overt diabetes (any type)
* Diagnosis of any chronic disease
* Previous use of dietary supplement with Crocus or Crocus Sativus
* Administration of chronic medication
Residual Renal Function Preservation in Peritoneal Dialysis Patients

Aldosterone blockade is useful in preserving residual renal function in patients on PD.The long term efficacy of dual blockade of the RAAS is better than monotherapy.

Residual renal function has been proven to contribute to improved survival and quality of life of dialysis patients. It is now recognized as an important factor in the prognosis of PD.The RAAS system is involved in the development of renal diseases. Angiotensin II and aldosterone are vital in this process. The beneficial effect of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker on residual renal function has been demonstrated in peritoneal dialysis patients. Unfortunately, neither ACE inhibition nor angiotensin receptor blocker fully supprsses aldosterone production. Now much focus has been placed on aldosterone antagonist.

Eligibility Criteria:
Inclusion Criteria:

* Patients who having been on PD continuously for one month, urine volume\>600 ml/d, residual renal function\>2ml/min/1.73m2, blood pressure\>120/70mmHg, serum potassium levels\<5.5mmol/l, stable clinical condition.

Exclusion Criteria:

* Patients with infectious systemic disease, peritonitis during the preceding 1 month, who had taken ACEI/ARBs in the 3 preceding months, spirolactone in the 2 preceding weeks, intolerance to ACEI/ARBs, CHF, MI, malignant hypertension and stroke within the preceding 6 months.
Gut-brain Axis, Brain Function, and Behaviour.

The aim is to test if dietary supplementation with prebiotics reduces measures of anxiety in healthy human participants with high self-reported levels of anxiety. Study will test for an effect on behavioural, neuroendocrine and brain imaging markers of anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Trait anxiety levels \> 40 on STAI trait inventory
* Participant is willing and able to give informed consent for participation in the study
* Not currently taking any psychoactive medications

Exclusion Criteria:

* Pregnant participants
* No contraindications to prebiotic administration
* Antibiotic, probiotics and/or prebiotic treatment in at least the two previous months.
* Participants who are taking any other food supplements that, in the opinion of the Investigators, may affect the results.
* Participants who are taking any medications that, in the opinion of the Investigators, may affect the results.
* Any significant change in diet which, at the discretion of the Investigators, may affect the results.
* Participants who have recently participated in another research trial which, at the discretion of the Investigators, may affect the results.
* A history of dementia, traumatic brain injury or stroke.
* Anyone who is unable to perform the behavioural tasks.
* Current use of any psychoactive medication.
* Current use of psychological treatment.
* Anyone who does not have adequate understanding of English, sufficient to give informed consent.
* Any person who has a history of drug abuse or a previous history of a neurological, or has a history of neurosurgical procedure is excluded as they may be at increased risk of epilepsy and data collected may be influenced by their condition.
* Anyone with any metal implants or implantable device would be excluded from any brain imaging studies as indicated by the MRI safety screening form.
Chinese Medicine Zhengyi Prescription Tea Bag

Chinese herbal tea bags can adjust physiological functions, help protect power, and give positive energy to the body. This prescription not only focuses on regulating the patient's physical function, but also helps to enhance physical strength.

In Taiwan ,acoording to the TCM theories and viewpoints, Chinese herbal medicine plays an important role in clinical drug application.TCM compound combinations for different diseases, emphasizing the complementarity and balance of ingredients, natural gentleness, uniqueness and efficacy are widely accepted by the public.

Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 20, those who have no chronic respiratory disease or those who have been diagnosed as nasal and sinusitis by a doctor, whose clinical diagnosis includes subjects with allergic rhinitis.

Exclusion Criteria:

1. Patient characteristics: age, gender, weight, education level, race, pregnancy and breastfeeding status, smoking, drinking, caffeine, alcohol or drug poisoning, diet and nutritional status, physical limitations, genetic history, etc. Exclude women under the age of 20, unable to order their behavior, pregnant or breast-feeding women
2. Disease characteristics: Subjects who have been diagnosis of mental illness by doctors, as well as long-term diarrhea or long-term use of Chinese medicine.
3. Environmental characteristics: other conditions that make patients unable to cooperate. Such as unsuitability after screening, not signing the subject consent form, etc.
Dual Mobility Total Joint Prosthesis (Touch) for Thumb Carpometacarpal Joint Osteoarthritis

The dual mobility concept currently represents the newest generation of thumb carpometacarpal prostheses. The aim of this study was to evaluate the outcomes of TOUCH® prosthesis. From September 2019 to December 2023,a minimum of 100 prosthesis shall be implanted in patients suffering from symptomatic stage III osteoarthritis. All included patients will follow a systematic follow-up regimen (4, 8, 16 weeks, 6, and 12 months as well as 24 months postoperatively).

Radiographics, ROM, VAS, DASH and Pinch grip are measured. Aim of the study is to compare clinical outcome of dual mobility prosthesis with common results of CMC I Prosthesis in literature.

The dual mobility concept currently represents the newest generation of thumb carpometacarpal prostheses. The aim of this study was to evaluate the outcomes of TOUCH® prosthesis. From September 2019 to December 2023,a minimum of 100 prosthesis shall be implanted in patients suffering from symptomatic stage III osteoarthritis. All included patients will follow a systematic follow-up regimen (4, 8, 16 weeks, 6, and 12 months as well as 24 months postoperatively).

Radiographics, ROM, VAS, DASH and Pinch grip are measured. Aim of the study is to compare clinical outcome of dual mobility prosthesis with common results of CMC I Prosthesis in literature.

The Study is designed to give clinical results after one year, 2 years and also long time results in the future.

Eligibility Criteria:
Inclusion Criteria:

* CMC I Osteoarthritis /Stage III)

Exclusion Criteria:

* CMC I (osteoarthritis / Other Stage than III)
* Anticoagulation
A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone

This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).


Eligibility Criteria:
Inclusion Criteria:

* Participants had given written informed consent to participate in the study in accordance with local regulations
* Adult participants 18 years and older with a diagnosis of T1DM made at least 1 year prior to informed consent
* Participants were being treated with insulin or insulin analog
* Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the study diary as required per protocol
* At the Screening Visit, A1C was between 7.0% to 11.0%
* Females of childbearing potential used an adequate method of contraception and had a negative pregnancy test

Exclusion Criteria:

* Use of antidiabetic agent other than insulin or insulin analog at the time of screening
* Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening
* Chronic systemic corticosteroid use
* Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator
A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer

The purpose of this study is to determine maximum tolerated dose (MTD), dose limiting toxicities (DLT) and recommend a proper dose for our phase II study of S-1 when combined with radiation therapy for locally advanced or recurrent gastric cancer.

This is a Phase I trial of S-1 given in treatment days with an oral dose from 30mg/m2/d to 80mg/m2/d, concurrently with radiation in patients with locally advanced or locally recurrent gastric cancer. Patients will be treated with external beam radiation therapy in a standard manner. S-1 will be administered for 6 dose levels,30/40/50/60/70/80mg/m2/d. Patients will be assessed for acute toxicities according to Common Toxicity Criteria for Adverse Effects (CTCAE)3.0.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients undergoing R0, R1, R2 resection, or with unresectable or locoregional recurrent disease
* Any prior chemotherapy is allowed in this protocol.
* No distant metastasis in liver,lung,,bone,central nervous system(CNS),no peritoneal transplantation
* No prior abdominal or pelvic radiotherapy.
* Karnofsky performance status(KPS)≥ 70,predictive life span no less than 6 months
* Patients must have normal organ and marrow function as defined below:

  * Leukocytes greater than or equal to 3,000 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
  * Informed consent
* Without any serious complications,such as hypertension,coronary artery disease,psychiatric history.

Exclusion Criteria:

* Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
* With any distant metastasis in liver,lung,,bone,CNS,or peritoneal transplantation
* History of allergic reactions attributed to similar chemical or biologic complex to S-1
* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
* History of prior radiation to the abdomen
* Pregnant or lactating females
Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19

This study is a multi-center randomized, controlled, and blinded clinical trial study that will be performed in four medical-educational centers. In this study, the samples will be selected from among patients with SARS-CoV-2 as easy access and based on entry criteria and will be randomly divided into two groups, including a control group and an intervention group. The study will be conducted in four medical centers. From each center, 56 definitive Corona patients will be selected, who will be randomly divided into two groups of 28, for a total of 224 patients will enter the study. In the intervention group, in addition to receiving the test spray, Patients will also receive standard treatment


Eligibility Criteria:
Inclusion Criteria:

* Conscious consent to participate in the study
* Patients 18 to 75 years of age with COVID-19 who have been diagnosed with PCR.
* Strong clinical suspicion of covid 19 with positive findings in CT Scan
* Shortness of breath

Exclusion Criteria:

* Patients with HIV
* Patients with cancer undergoing chemotherapy
* Patients receiving Immune Mediators
* Patients need hospitalization in the intensive care unit
* Patients with uncontrolled heart, kidney or liver failure
* Pregnant or lactating women
* Intolerance to the drugs used in this study (symptoms such as diarrhea, nausea, vomiting and respiratory problems)