cyrilzakka/clinical-trials huggingface dataset:
Prospective, Multicenter Observational Study Evaluating the Long Term Safety of the Custombone Implant

A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™

The patients will be included as soon as they are implanted and follow-up for 2 years. It is observational so no specific exam is planned.

The explantation rate will be measured, that is to say the number of patients whose prosthesis will be removed (with or without any relationship with the implant or the procedure).


Eligibility Criteria:
Inclusion Criteria:

* Patient planning to have a cranioplasty and be implanted with the Custombone™ medical device
* Patient who agrees to take part in the study, or agreement of a representative of the patient in case of patient inability, after being informed by the investigator and having received an information letter

Exclusion criteria:

- Patient who does not accept to take part in the study after being informed
Evaluation of PillCam® Express Capsule Endoscopy Delivery System

The purpose of this study is to evaluate the safety and efficacy of a trans-endoscopic capsule placement Capsule Endoscopy Delivery System.

Natural ingestion of a wireless capsule endoscope (e.g. PillCam™ SB) is contraindicated in subjects with oropharyngeal or mechanical dysphagia, gastroparesis and known or suspected anatomical abnormalities. In addition, ingestion of a wireless capsule endoscope may be challenging in the pediatric population. The PillCam® Express Capsule Endoscopy Delivery System is intended to provide physicians with the capability to place capsules in the proximal duodenum using the accessory channel of a standard endoscope.

The PillCam™ SB capsule to be used in this study was cleared by the FDA in August 2001 for small bowel evaluation. It has been ingested to date by more than 1,000,000 people worldwide and is well accepted by subjects and physicians as well as the professional societies.

Further details of the PillCam®Express Capsule Endoscopy Delivery System can be found in the device description section.

This study is designed to evaluate the performance and safety of the Capsule Endoscopy Delivery System in subjects indicated to undergo a standard Esophagogastroduodenoscopy (EGD) endoscopy

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 2 years
* Subject scheduled for EGD endoscopy with a 2.8 mm (or greater) working channel

Exclusion criteria:

* Subject is known or is suspected to suffer from bowel obstruction or bowel perforation at the time of presentation
* Subject has history of UGI tract surgery (e.g., Billroth I, Billroth II, esophagectomy, gastrectomy, bariatric procedure)
* Presence of an electro-medical device (pacemaker or internal cardiac defibrillator)
* Subject is pregnant
* Subject is expected to undergo a MRI examination within 7 days after ingestion of the capsule
* Subject has known allergy to conscious sedation medications
* Subject or legal guardian is not able to provide written informed consent
Features Emotional Responses in Adults With Autism: Comparison With Bipolar Disorder (REMBAU)

The objective of this study is to identify the specific characteristics of Autism Spectrum Disorder (ASD) in emotional response profiles and shared with Bipolar Disorder (BD) characteristics.


Eligibility Criteria:
Inclusion Criteria:

* For all participants:

  * Age between 18 and 50 years
  * Normal vision (or corrected)
  * Absence of neurological disorder (epilepsy , head trauma, ... )
  * Ability to understand information about the protocol
  * Informed and signed consent
  * normal mood (euthymia)
  * normal or high intelligence
* Subjects with ASD:

  * Subjects with an autism spectrum disorder according to the DSM-5
  * The diagnosis is confirmed by diagnostic interviews: ADI- R (Autism Diagnostic Interview-Revised) and / or ADOS (Autism Diagnostic Observation Schedule ) .
* Subjects with bipolar disorder:

  * Diagnosis of bipolar disorder according to DSM-IV-TR or DSM -5
  * The diagnosis is confirmed by the MINI 6.0 (The Mini-International Neuropsychiatric Interview) .
* Healthy volunteers:

  * Inclusion after checking the national register of healthy volunteers
  * No history of disease of the central nervous system or psychiatric disorder
  * No family history of ASD or BD in the first degree
  * Lack of psychotropic medication or current cardiotropic
  * Lack of psychiatric disorder on Axis I MINI 6.0
  * AQ Score \< 32
Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula

Anal abscess-fistula disease is of common occurrence and has a significant impact on the quality of life of affected individuals. The course of abscess-fistula disease as well as its treatment modalities may affect anal continence. The present cohort study investigates the results of anal fistula plug surgery. In particular, this study focus on the impact of anal fistula plug surgery on fistula healing, quality of life, and anal continence. Fifty patients will be included and followed up at 6 weeks and 6 months after surgery in the clinic of participating surgeons.

Anal abscess-fistula disease is of common occurrence and has a significant impact on the quality of life of affected individuals. The clinical course of abscess-fistula disease as well as its treatment modalities may affect anal continence. Anal fistula plug surgery is an Health Canada and FDA approved surgical treatment that has demonstrated promising results in terms of fistula healing and minimal patients' burden. The present cohort study prospectively investigates the results of anal fistula plug surgery performed in teaching hospitals affiliated to the University of Toronto. In particular, this study focus on the impact of anal fistula plug surgery on health-related quality of life, and its 2 major determinants anal continence and fistula healing. Fifty patients will be included and followed up at 6 weeks and 6 months after surgery in the clinic of participating surgeons. Quality of life and anal continence will be measured with the validated Short Form-36 Health Survey (SF-36 v2) and Fecal Incontinence Score Index (FISI) questionnaires, respectively. It is expected that the present study will provide objective information on the results and generalizability of anal fistula surgery, as well as on its impact on health-related quality of life and anal continence.

Eligibility Criteria:
Inclusion Criteria:

Complex anal fistula as defined by

* high transsphincteric fistula
* extrasphincteric fistula
* suprasphincteric fistula
* recurrent fistula
* multiple fistula openings, including horseshoe fistula
* imperfect continence- jeopardized anal continence (anterior transsphincteric fistula, prior anal surgery)

Exclusion Criteria:

* Uncomplicated fistula curable by simple fistulotomy
* History of inflammatory bowel disease
* Chronic immunosuppressive treatment (ie, systemic steroids for \>3 days)
* Clinical heart failure as defined by a CCS angina severity class ≥ III
* Untreated cancer or cancer diagnosed/treated (all modalities) within 6 months
* Estimated life expectancy inferior to 6 months
* Incompetent subject
* Pregnancy
Psychological and Physiological Effects of Different Objects of Breath Meditation

The goal of this research is to test whether certain areas of focus in breath meditation are connected with certain mental health outcomes. The main question to be addressed is whether attention placed on the breath in the belly versus the nostrils during meditation results in differences in subjective experience, respiration and heart rate.

Participants will:

* complete surveys
* have heart rate and respiration measured
* practice focused breathing

Participants can expect the study visit to last for one hour.

An online prescreen will determine eligibility. Participants that 1) are under 18, 2) are not students currently enrolled at UW-Madison 3) have previous mediation experience 4) obtain a high PROMIS depression or anxiety score, or 5) have been diagnosed with one or more psychiatric disorders by a healthcare professional that will be listed in the pre-screen survey will be excluded.

Participants deemed eligible following prescreen will schedule a lab visit. At the beginning of the lab visit, participants will be provided a consent document and time to ask questions. After signing the consent form, researchers will place ECG leads and a respiration belt on participants, and then complete the baseline survey battery. Participants will then sit at rest for 5 minutes of baseline heart rate and respiration data collection. Next, participants will be randomly assigned in a counterbalanced order to nostril focus first or belly focus first and asked to follow a brief (\~5 minute) guided practice. After the practice, participants will complete a second battery of self-reports and then have a 10-minute period of rest/recovery. They will then complete the second practice (\~5 minutes) followed by a final survey. The entire session will take about an hour.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* student at UW Madison
* no major history of meditation practice

Exclusion Criteria:

* under 18 years of age
* not currently enrolled at UW Madison
* have previous meditation experience
* Self-reports a mental health diagnosis
Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery

The aim of this clinical trial is to evaluate the efficacy and safety of two intravenous administrations of ilofotase alfa in patients at risk for renal damage following open heart surgery.

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, 2-arm parallel group design trial in patients at risk for renal damage following open heart surgery. After screening and baseline assessments, eligible patients will be randomized 1:1 to either 2 doses of 128 mg ilofotase alfa, or 2 doses of placebo control. Randomization will be stratified by baseline eGFR and type of surgery. The patient will be treated with the investigational product (ilofotase alfa or placebo) at the same day before and after the surgery (Day 1). Follow-up clinic visits will be performed daily up to Day 5 for efficacy, safety, and pharmocokinetics assessments. A safety follow-up can be performed by telephone at Day 28. At Day 61, an end of trial visit will be done at site for efficacy, safety, and anti-drug antibodies assessments.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Planned for one of the following types of open chest cardiovascular surgery with the use of cardiopulmonary bypass pump (CPB):

   1. 1. combined valve and CABG surgery; 2. aortic valve plus aortic root and/or ascending aorta (excluding aortic arch)
   2. CABG with 3 or more distal anastomoses
3. Screening eGFR ≥25 mL/min/1.73m2 and ≤65 mL/min/1.73m2
4. Female patients of childbearing potential agreeing to use effective contraception within IP treatment and 14 days thereafter

   Post-menopausal females do not require contraception during the trial.
5. Male patients agreeing to refrain from donating sperm, use a male condom when having sexual intercourse and in case their partner is of childbearing potential they must agree to use adequate and effective contraception method (see inclusion criterion 4) within IP treatment and 14 days thereafter

The five most important Exclusion Criteria:

1. Body weight ≤55 kg
2. Known or suspected glomerulonephritis (other than diabetic kidney disease) or other systemic vasculitis
3. Confirmed or treated endocarditis requiring antimicrobial or antiviral treatment within 30 days prior to surgery or other current active infection requiring antimicrobial or antiviral treatment within 14 days prior to surgery
4. Known chronic liver disorder with Child-Pugh C classification
5. Current planned (or scheduled) surgical intervention under conditions of circulatory arrest, including planned deep hypothermic circulatory arrest
Comparison of Eligible TAVI-valves - Cohort B

The study performs head-to-head comparison of two TAVI-valves: Sapien and Myval.

The purpose of the present study is to ensure a continuous comparison of the TAVI-valves implanted, and to monitor long-term valve performances.

Purpose: To randomize between two TAVI-valve types in patients who according to a heart team conference is found eligible for treatment with more than one valve.

Hypotheses:

1. There is no difference in the combined endpoint (death, stroke, moderate/severe para-valvular leakage, moderate/severe device stenosis) between the two valves to be compared.
2. There is no difference between valves in secondary endpoints: death, stroke, moderate/major paravalvular leakage, moderate/severe aortic device stenosis, new pacemaker implantation, readmission for congestive heart failure, 6-minute walk test, and degeneration of the valve as evaluated by computerized tomography (HCT), transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), or MRI.

Design: Randomized controlled trial with clinical national registry follow-up.

Centers eligible for inclusion: Scandinavian and European centers who fulfill the above mentioned criteria.

Randomization:

Before randomizing patients, the center decides which two valves the patient is found eligible for, and enters these valves in the electronic randomization form (TrialPartner). Randomization is then performed between these two valves. A patient is only randomized if a dedicated technical TAVI conference has found the patient eligible for treatment with both valves.

Consecutive cohorts are established.

In the current study we plan to initiate the following cohorts:

Cohort B: Patients randomized to the Sapien or the Myval TAVI valve.

Operator requirements:

Any procedure requires that the physician has performed at least 15 implantations with the valve in use. Otherwise the procedure is performed according to the routine of the institution.

Eligibility Criteria:
Inclusion Criteria:

1. Patient more than 18 years of age.
2. Patient eligible for at least 2 valves being implanted routinely at the participating center, according to a TAVI heart team conference.
3. The center experience for each of the valves considered should be more than 15 cases a year, and at least 15 valves implanted before a valve can be used in the trial.
4. The center volume should be more than 75 cases a year.
5. The patient has given signed informed consent.
6. TAVI performed via the femoral artery.

Exclusion Criteria:

1. Not able to give written inform consent
Mind-body Interventions in Cardiac Patients

This study is investigating whether a series of psychological exercises, called positive psychology, provides benefit to patients who have been hospitalized for heart disease (an 'acute coronary syndrome' or heart failure).

In this study, subjects are randomly assigned to complete 8 positive psychology exercises over 8 weeks, or to complete different exercises in control groups.

We hypothesize that patients who are assigned to the positive psychology tasks will be able to complete the exercises at a high rate, will feel that the exercises were easy to perform, and will have greater improvements of optimism, anxiety, mood, and health-related quality of life than subjects in the control conditions.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalization at Massachusetts General Hospital for an acute coronary syndrome or congestive heart failure
* Able to read/write in English
* Have working home or cellular phone

Exclusion Criteria:

* Cognitive disorder
* Medical condition likely to lead to death within 6 months
* Illness leading to inabilty to consent or complete study exercises
* Current or prior participation in positive psychology interventions
A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)

This single center study will monitor the developmental progress of PPHN patients who received iv sildenafil in study A1481276. Two visits will be conducted, at 12 and 24 months following the end of study drug infusion.

This study will monitor developmental progress of PPHN patients for 2 years following study treatment, using Bayley III and Hammersmith tools. Data will be explored with descriptive statistics.

Eligibility Criteria:
Inclusion Criteria:

* Any subject who received sildenafil treatment in study A1481276.
* Signed and dated informed consent document by legal guardian.

Exclusion Criteria:

* Any subject who did not receive sildenafil treatment during study A1481276.
Reduction of Microembolism After the Intervention Surgery of Intracranial Aneurysms by Administration of Tirofiban

The goal of this clinical trial is to investigate whether intravenous injection of tilofiban can reduce microembolism in patients with unruptured intracranial aneurysms after Stent-Assisted Coil Embolization.The main questions it aims to answer are:

* Is it safe to inject tirofiban intravenously during interventional treatment of intracranial aneurysms？
* What dose of tirofiban is safe and effective?

We aim to reduce microembolism in patients with unruptured intracranial aneurysms after Stent-Assisted Coil Embolization.

Eligibility Criteria:
Inclusion Criteria:

* Age was between 18 and 75 years old;
* Unruptured aneurysm with surgical indications;
* Stent assisted coil embolization treatment was received ;
* The patient was willing to receive intervention treatment.

Exclusion Criteria:

* Complicated with hemorrhagic cerebrovascular diseases such as cerebral vascular malformations and moyamoya disease or their medical history;
* Recent (within 1 year) bleeding symptoms such as gastrointestinal bleeding, clinically significant urinary/reproductive tract bleeding, and skin blueness;
* Dissecting aneurysm, pseudoaneurysm, and bullous aneurysm;
* A known history of coagulation disorders, platelet abnormalities, or thrombocytopenia; 5. Platelet count less than 150 × 109/L；
* A history of major surgical procedures or severe physical trauma within one month;
* Severe uncontrolled hypertension (systolic blood pressure\>160mmHg and/or diastolic blood pressure\>100mmHg);
* Hemorrhagic retinopathy;
* Chronic hemodialysis;
* Renal insufficiency.
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BI 10773 in Type II Diabetes Patients With Different Degrees of Renal Impairment

Assessment of the effect of normal and impaired kidney function on the pharmacokinetics, pharmacodynamics and safety of BI 10773


Eligibility Criteria:
Inclusion criteria:

1. Male and female subjects with type 2 diabetes
2. Renally impaired male or female subjects
3. Age 18 - 75 years
4. BMI 18 - 34 kg/m2, at least 45 kg for females (Body Mass Index)
5. Signed and dated written informed consent

Exclusion criteria:

1. Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders as judged by the investigator.
2. Relevant gastrointestinal tract surgery
3. Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or relevant neurological disorders
4. History of relevant orthostatic hypotension, fainting spells or blackouts; systolic blood pressure \< 100 or \> 160 mm Hg, diastolic blood pressure \< 60 or \> 100 mm Hg, pulse rate \< 50 or \> 100 1/min
5. Chronic or relevant acute infections
6. History of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the trial as judged by the investigator
7. Use within 10 days prior to administration or during the trial of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation. Co medication known to inhibit or induce P-glycoprotein or CYP3A is not allowed. Inhibitors of P-glycoprotein or CYP3A (cytochrom P3A) are e.g.

   * protease inhibitors, (e.g. ritonavir, lopinavir nelfinavir)
   * azole antimycotics, (itraconazole, ketoconazole, miconazole)
   * macrolid antibiotics, (clarithromycin, erythromycin)
   * amiodarone, cimetidine, diltiazem, fluvoxamine, mibefradil, nefazodone, verapamil, tacrolimus, quinidine, reserpine, cyclosporine A Inducers of P-gp or CYP3A are e.g. carbamazepine, phenobarbital, phenytoin, rifabutin, ri-fampin, St. John's wort, troglitazone. In dubious cases, a case by case decision will be made after consultation with the sponsor.
The Effects of Core Stability Training in Chronic Stroke Patients

The purpose of this study is to assess effects of core stability training on functional ability, balance, gait, motor functions, quality of lite and core muscle thickness of chronic stroke patients.

After being informed about the study all the patients giving written informed consent were assessed. At the beginning the eligible patients were randomized into two groups: core stability and conventional therapy group. The therapy programs were performed 5 times a week for 45 min over a period of 3 weeks. Patients were assessed twice: before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* First onset
* Stroke duration from 6 months to 2 years
* With ability to cooperate
* Independent ambulation or ambulation with assistive device

Exclusion Criteria:

* Uncooperative
* Neglect syndrome
* Surgical history of abdominal and hip region
* Drugs that affect neuromuscular control
* Other neurological disorders
* Serious diseases, unstable medical condition
* BMI ≥ 35
COVID-19 Respiratory Distress and Antithrombotic Drugs in Subject's Habits

Current management of VID-19 consists of oxygen support without specific treatment. Hospitalization may suddenly require delayed resuscitation. This evolution corresponds to an atypical acute respiratory distress syndrome (ARDS), the mechanism of which is poorly understood and difficult to predict. The general pathophysiology of ARDS, the vascular tropism of SARS-Cov2, the description of coagulopathy and numerous pulmonary artery thromboses in resuscitation and the encouraging investigation of antithrombotics in general ARDS


Eligibility Criteria:
Inclusion Criteria:

* Major Subject (≥18 years)
* Subject hospitalised in HUS or GHRMSA for COVID-19
* The diagnosis COVID-19 confirmed by smear or evoked by CT scan or chest X-ray without a differential diagnosis retained in the medical record
* Subjects who, after being informed, do not wish to have their data reused for the purposes of this research

Exclusion Criteria:

* Subject who expressed opposition to participating in the study
* Subject under guardianship or trusteeship
* Subject under safeguard of justice
* Patient hospitalized in a geriatric service or in a ward not labeled COVID (surgery, oncology,...) or in a short-term hospitalization unit without transfer to another service.
* Serious patient on admission to the emergency room and recused from resuscitation.