cyrilzakka/clinical-trials huggingface dataset:
Evaluation Of The Pillcam™ Colon Capsule Endoscopy (Pcce-2) In Pediatric Ulcerative Colitis

This prospective pilot study of 30 pediatric subjects, that are indicated for standard colonoscopy due to follow-up of ulcerative colitis (UC), examines the Given Diagnostic System and the PillCam Colon Capsule in comparison to standard colonoscopy.

This study aims

1. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis.
2. To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.


Eligibility Criteria:
ELIGIBILITY Ages Eligible for Study: 6-18 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Inclusion criteria:

Subjects must meet one the following inclusion criteria to be eligible for enrollment into this proposed study:

* diagnosis of UC made at least 3 months before the enrolment;
* subject was referred for standard colonoscopy and endoscopic follow-up in Ulcerative colitis
* signed informed consent. Exclusion criteria

The presence of any of the following will exclude a subject from study enrollment:

* Subject has dysphagia
* Subject has renal insufficiency
* Subject is known or suspected structuring CD.
* Subject has a cardiac pacemaker or other implanted electro medical devices.
* Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
* Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
Cross-Sectional Survey on the Use of Tobacco Products - Germany

The main purpose of the research study is to estimate the prevalence of tobacco product use and describe the tobacco use patterns in adults in Germany.

The aim of the survey is to describe the current and past patterns of use of tobacco products in the general adult population of Germany and in adult IQOS users registered in the IQOS user database of Philip Morris GmbH (Germany IQOS User Database), and explore their association with key independent variables. More specifically, the objectives are:

1. Estimate the prevalence of current tobacco use status in the study population.
2. Describe the past tobacco use status (cigarette, IQOS and other innovative products, including e-cigarettes) in the study population (i.e. never-use, initiation, product use transition, cessation, re-initiation, and relapse).
3. Explore the association between self-reported health status and use of tobacco products in the study population.
4. Explore the association between patterns of use (including misuse) with motivation to use, perceived quality attributes of IQOS (e.g. risk and self-reported changes since switching to the product, in a number of relevant domains where IQOS may have potential benefits), and consumer's satisfaction in the population of IQOS users in Germany registered in the Germany IQOS User Database.

Eligibility Criteria:
Inclusion Criteria (all participants, including IQOS users):

* Legally permitted to buy tobacco products in Germany (≥18 years of age).
* Currently residing in Germany.
* Able to read, write and understand German.
* Consent to participate in the survey

Inclusion Criteria (IQOS users only):

* Has used more than 100 HEETS tobacco sticks in his or her lifetime.
* Is currently using IQOS.
* Has access to the internet.
* Is not currently employed by Philip Morris International or any of its affiliates

Exclusion Criteria:

* Not meeting the inclusion criteria
Phenylbutyrate Response as a Biomarker for Alpha-synuclein Clearance From the Brain

This is a Phase I clinical trial of the FDA approved drug Glycerol Phenylbutyrate to see if phenylbutyrate can increase the removal of alpha-synuclein from the brain into the bloodstream. Alpha-synuclein forms abnormal protein deposits in dopamine neurons and is believed to cause the death of brain cells, leading to Parkinson's Disease.

This is a Phase I clinical trial of phenylbutyrate in 20 Parkinson patients and 20 age- and sex-matched normal control subjects to see if phenylbutyrate can increase the removal of alpha-synuclein from the brain into the bloodstream. All subjects will receive 20 grams/day of phenylbutyrate in the liquid form phenylbutyrate-triglyceride taken as one teaspoonful three times per day with meals. Blood will be drawn on two days prior to starting phenylbutyrate to measure alpha-synuclein concentrations. Phenylbutyrate-triglyceride will then be started and the change in plasma alpha-synuclein will be measured on day 1, 7, 14, and 21 days while taking phenylbutyrate. After 21 days, the drug will be stopped and a final blood sample will be measured at 28 days to see if plasma alpha-synuclein has fallen to its pre-phenylbutyrate level. No effects on Parkinson symptoms are expected during this short trial. Please note that although taking any type of Parkinson's drugs for symptomatic treatment disqualifies you, if you and your neurologist are willing and able to have you off Parkinson medication for six weeks before and during the trial, you may be eligible to participate.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease with mild symptoms;
* May be on treatment with dopamine agonists provided that the treating neurologist agrees:

  1. that the drugs can be stopped for at least three weeks prior to participating in the phenylbutyrate study, and
  2. for the 4-week duration of the study.
* Age and sex matched normal control subjects from spouses and the general population;
* In good general health;
* Controlled hypertension, or
* Controlled hypercholesterolemia with medication.

Exclusion Criteria:

* Pregnant women;
* Current treatment with:

  1. L-3,4-dihydroxyphenylalanine (L-DOPA);
  2. monoamine oxidase (MAO) inhibitors,
  3. catechol-O-methyl transferase (COMT) inhibitors;
  4. histone deacetylase (HDAC) inhibitors;
  5. prednisone or other corticosteroids, or
  6. probenecid.
* Severe cardiopulmonary disease such as:

  1. congestive heart failure, or
  2. emphysema requiring supplemental oxygen;
* Renal disease with serum creatinine greater than 2.5;
* History of:

  1. depression in the prior year;
  2. epilepsy;
  3. stroke;
  4. prior brain surgery;
  5. dementia, or
  6. psychosis.
Semi-closed Loop Automated Insulin Therapy in the Pediatric Population Aged 2-6 Years With Type 1 Diabetes: Impact on Quality of Life and Glycemic Control

The incidence of type 1 diabetes is increasing, with an incidence of +4% per year in France today.

The treatment for type 1 diabetes is insulin therapy. In recent years, new systems have emerged, so-called "semi-closed loop" systems, also called automated insulin therapy, which have proven their superiority in terms of quality of life and glycemic balance in adults and children over 6 years old.

Since January 24, 2024, the HAS now recognizes the indication of the semi-closed loop for the YPSOPUMP model in children aged 2 to 6 years. This is the first reimbursement in France of a closed loop system for the 2-6 year old age group. There are currently few studies comparing the quality of life of children in semi-closed loop versus other treatments (open loop or injections). Regarding quality of life, the studies found mainly concern the contribution for parents and the improvement of adolescents' sleep as in the study by Erin C Cobry et al from 2020 (6).

Our study therefore aims to demonstrate an improvement in quality of life but also in diabetes balance in type 1 diabetic patients on a closed loop insulin pump versus open loop or injections in the pediatric population aged 2-6 years.


Eligibility Criteria:
Inclusion Criteria:

* -Patients aged 2 to 6 years inclusive
* Presenting type 1 diabetes on insulin therapy
* Social security affiliates
* Patient initiating semi-closed loop treatment
* Family (at least one parent or representative of parental authority) agreeing to follow the training necessary for continuous measurement of glucose in real time.
* collection of non-opposition from one of the two parents or the representative of parental authority agreement

Exclusion Criteria:

* Opposition to participation in research involving humans or opposition to the use of data or samples and associated data (withdrawal of non-opposition).
Yuva Sath: A Peer-led Behavioral Intervention to Support Substance Use Treatment and HIV Prevention Among Young People Who Inject Drugs in India

The goal of this pilot randomized controlled trial is to learn if Yuva Sath, a youth-tailored peer-led behavioral intervention, can support substance use treatment engagement and HIV prevention among young people who inject drugs in India. The main questions it aims to answer are:

* Is Yuva Sath feasible and is it acceptable to young people who inject drugs in India ?
* Can Yuva Sath improve engagement in substance use treatment, increase use of HIV prevention services and decrease substance use and risk behaviors among young people who inject drugs in India ?

Researchers will compare participants who receive the Yuva Sath behavioral intervention to participants who do not to see if the behavioral intervention improves substance use treatment engagement and HIV prevention.

Participants will:

* Receive a total of 6 one-on-one sessions, and weekly phone text check-ins from peer counselors over a course of 6 months.
* Complete monthly random urine drug screens
* Complete in-person study questionnaires every 3 months
* Report substance use and risk behaviors weekly to peer counselors through a brief phone text message survey


Eligibility Criteria:
Inclusion Criteria:

* Age 18-29 years;
* Receiving medications for opioid use disorder (MOUD) for at least 3 months and receipt frequency \< 2 times a week

Exclusion Criteria:

* Receiving medications for opioid use disorder (MOUD) for less than 3 months and receipt frequency \>= 2 times a week
* Requiring urgent medical attention
* Inability to provide informed consent
Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation)

This survey will be conducted to investigate the status of occurrence of the safety specifications set for "Safety specification" in patients who received Ondexxya Intravenous Injection 200 mg. In addition, this survey will be implemented to understand the followings by collecting safety and effectiveness information under actual use conditions.

This survey will be conducted to investigate the status of occurrence of the safety specifications set for "Safety specification" in patients who received Ondexxya Intravenous Injection 200 mg. In addition, this survey will be implemented to understand the followings by collecting safety and effectiveness information under actual use conditions.

1. Detection of unknown adverse drug reactions
2. Incidence of adverse drug reactions under actual use conditions of the drug
3. Factors that may affect the safety or effectiveness

"Safety specification" Thrombotic events, Infusion reaction, re-bleeding

Eligibility Criteria:
Inclusion Criteria:

* All patients treated with this drug to neutralize the anticoagulant effect of a FXa inhibitor (apixaban, rivaroxaban, or edoxaban) at onset of a life-threatening bleeding episode or a unarrestable bleeding episode.

Exclusion Criteria:

* N/A
REBIRTH Active School 2.0 . a School Based Physical Activity Program

Rebirth active SCHOOL 2.0 is a physical activity intervention program and about to be realised at 40 primary schools in Lower Saxony Germany.

Half of all schools will be assigned to the intervention program or to wait for one year before starting with the movement program. After one and two years, the follow up will take place. After completing baseline examinations (i.e. physical and cognitive functions, physical activity questionnaires) the intervention program will start for one year.

The intervention program is going to be designed with the goal of implementing physical activity of 60 minutes per day. For the main module of movement impulses, the pupils will perform a 5-minute exercise in every lesson, realised by the teachers.


Eligibility Criteria:
Inclusion Criteria:

* First and second grade pupils at primary schools (District Hannover/Wolfsburg/Helmstedt/Gifhorn/Hildesheim; Lower-Saxony, Germany),

Exclusion Criteria:

* none, if no medical contraindications against intensive physical activity/tests excist.
Efficiency of Combined Rehabilitation Programs Including Resistance and Endurance Exercises on Functional Capacities, Quality of Life and Daily Level of Activities in Hemodialysis Patients

Hemodialysis patients display among the lowest level of daily activities and decline of functional abilities is highly correlated with mortality. Perdialytic exercise during hemodialysis procedure is now part of the patients' routine care and appears to be a solution to struggle against the functional skills decrease. Our team was able to demonstrate that beyond muscle mass, muscle strength and physical activity were essential determinants of morbidity and mortality of dialysis patients. The AIDER Santé medical team has set up an assessment of physical activities and muscle strength in the Montpellier and Nimes centers. In order to rehabilitate muscle strength and endurance, perdialytic exercise may be prescribed. Its effectiveness can be appreciated by measuring the SPPB score (Short Physical Performance Battery). Recent studies established that combined training including resistance and endurance exercises was the most effective to improve functional performance. In AIDER Santé dialysis centers, the two mainly used exercise approaches are distinguished by the time distribution of the two types of exercise: the first plans to practice both types of exercise at each session (continuous program), the second plans to alternate a week of resistance exercise with a week of endurance exercise (discontinuous program). It is established that the rehabilitation of the hemodialysis patient must include both resistance and endurance exercises, but the combination of these exercises during the same session is potentially at the origin of an interference phenomenon, limiting neuromuscular adaptations specific to each effort. Therefore, the main hypothesis of the project is that the temporal separation of resistance and endurance exercises in a discontinuous program could optimize the functional gains of combined rehabilitation and therefore be more effective than a continuous program generating a phenomenon of interference.


Eligibility Criteria:
Inclusion criteria:

* Hemodialysis started since at least 3 months
* Medical prescription of perdialytic combined exercise
* Age \< 85
* Life expectancy \> 6 months

Exclusion criteria:

* Ischemic and valvular cardiopathies
* Lower-extremity arterial disease (stade III and IV)
* Knee or hip amputation/prothesis
* Severe respiratory disease
* BMI \> 35
* Pacemaker
Non-invasive Nerve Stimulation for PTSD and Sleep

In this study, our objective is to determine the effect of two different nerve stimulation types in changing sleep architecture.

Persons suffering from PTSD or mild TBI may suffer from sleep deprivation. The purpose of this study is to explore options to improve sleep quality.

Eligibility Criteria:
Inclusion Criteria:

* veterans with history of PTSD with and without history of mild TBI

Exclusion Criteria with:

* history of severe psychiatric illness unrelated to PTSD or TBI
* other medical conditions of severity that may impair cognition
* current illicit or prescription drug abuse
* breathing disorder requiring constant use of oxygen
Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)

To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).


Eligibility Criteria:
Inclusion Criteria:

* Male or female Chinese subjects, ages ≥18 at screening
* Subjects with symptoms of neuropathic pain associated with postherpetic neuralgia (PHN). Subjects must have pain present for ﹥3 months after healing of the acute herpes zoster skin rash
* At screening (V1), subjects must have a score ≥40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)
* At randomization (V2), subjects must have a score ≥40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)
* At randomization (V2), subjects must have completed at least 5 daily pain diaries (DPRS, see Appendix 2) and have an average daily pain score ≥4 over the past 7 days

Exclusion Criteria:

* Subjects who demonstrate a high response to placebo, with 30% decrease on the Pain Visual Analog Scale (VAS) at randomization as compared to screening
* Subjects who have a high variability in pain scores during the 1 week screening period, with any difference between two scores ﹥3
Prostate Delineation: High Quality Volume CT

This study will look at how feasible it is to use a certain type of Computed Tomography (CT) to scan prostate cancer, called a high quality volume CT scan. It is hoped that this technique will help doctors provide a higher-quality image of the prostate cancer, making it easier to plan the area that will be treated. Using this type of CT scan will also lessen the amount of time patients spend in the scanner.

This study will not offer patients a different treatment for their prostate cancer. Patients will receive the most appropriate standard treatment whether or not they are in this study.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old
2. Subjects undergoing radical external beam radiotherapy for prostate cancer
3. Ability to provide written informed consent

Exclusion Criteria:

1. Age ≤ 18 years
2. Subjects not suitable for MRI scanning
3. 3 usable image sets not obtained during treatment planning scans.
Middle School Parent Module for a Brief Bullying Intervention Program

This study evaluates the feasibility and short-term outcomes of a parent training designed as a companion module to a bullying bystander intervention (STAC) for middle school students in rural communities. The aim of this project is to provide a brief, low-cost intervention that can be easily disseminated as part of a school-based bullying prevention program to address this important public health problem.


Eligibility Criteria:
Inclusion Criteria:

1. Being a parent of an adolescent enrolled in grades 6, 7, or 8 in a participating middle school in Idaho.
2. Speaks and reads English.
3. Consents to participate.

Exclusion Criteria:

1. Speaks and reads only a language other than English.
2. Does not consent for participation.
A Study Of PF-05190457 In Healthy Volunteers And Type-2 Diabetic Patients

The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of multiple doses to healthy volunteers and Type 2 diabetic patients and to evaluate the plasma drug concentrations after multiple doses.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females of non-childbearing potential between ages of 18 and 55 years, BMI of 18.5 to 30.5 kg/m\^2, and weight between 50 and 100 kg, inclusive.
* Type 2 diabetic males and females of non-childbearing potential between ages of 18 and 55 years, BMI of 18.5 to 40.0 kg/m\^2, weight between 50 and 150 kg, and HbA1c of 7.0-10.0%, inclusive.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Additionally, type 2 diabetic patients who have history of diabetic complications with significant end-organ damage or pharmacologic treatment for diabetes in addition to metformin.
Intracervical Anasthesia in Outpatient Hystroscopy, Can Procedure be Completed Diagnostic and Therapeutic With no Need to General Anaesthesia

Single blind randomized controlled study in which 80 patients coming for hystroscopy due to multiple indication as infertility, AUB and missed IUD were assigned for our study. Both Sample size and randomization were done by a computer program. Patients were classified into 2 groups, group 1 study group was subjected to intracervical injection of 5 mi of mepivacaine hydrochloride at position 3 and 9 of the vaginal portion of the cervix, and at least 5 minutes post injection before procedure done. The control group received NSAI injection 15 minutes before procedure and 5 ml of saline was injected in each side of cervix at 3 9 positions. Hystroscopy was done if an abnormality is detected an intervention was done. A descriptive scale of pain was done into mild, moderate or severe (that lead to interruption of the procedures).

Procedures:

All patients were subjected to:

1. History taking
2. Verbal consent to participate in our study
3. Patient put in lithotomy position
4. Casco speculum was applied exposing the cervix
5. Betadine sterilization of the cervix then properly washed with saline as heavy metals of disinfectant may cause irritation with injection
6. Multiple toothed volselum was used just to fix cervix
7. 3 cartridges of mepivacaine hydrochloride was filled in 10 mi syringe
8. Do aspiration to exclude and avoid intravascular injection then infilterate slowly intracervical at both 3 and 9 positions
9. Instruments are removed and at least 5 minutes later procedure started.
10. Hystroscopy (rigid , 2.9 mm sheath) was introduced gently throw vaginoscopy exploring vagina , cervix and uterine cavity
11. Patient was monitored for pain all through the procedure by descriptive scale, mild, moderate and severe. ( moderate who needed to take rest then continue , severe that necessitated interruption of the procedure
12. All patients were monitored for signs of vaso vagal attack as sings (low blood pressure and bradycardia) before and if needed during. Occurrence of symptoms as pallor , sweet and fainting
13. All patients were monitored post procedure for persistence of colicky pain

Eligibility Criteria:
Inclusion Criteria:

1. must be under 40 years
2. must be no history of renal or hepatic disease
3. must be no known hypersensitivity to local anaesthetic agents
4. must be no significant vaginal or cervical infection.

Exclusion Criteria:

* All patients with history of sever vasovagal attack during any gynecological procedures.
Italian Study for Congenital Platelet Disorders

Inherited platelet disorders (IPD) are a heterogeneous group of rare bleeding diseases associated with a reduction of platelet number and/or function and with a bleeding tendency ranging from mild to severe. The frequency of inherited thrombocytopenias has been estimated to be 2.7/100,000 while the prevalence of inherited platelet function disorders is unknown, partly because they are frequently overlooked due to their difficult diagnosis.

This a no-profit national multicenter ambispectic (retrospective and prospective) observational study.

After collection of informed consent form each patient, each center will enroll the patient and will collect general, laboratory and clinical data on an electronic CRF on a REDCAP platform. Each patient will receive a unique identification number. All clinical events will be reported in the data base.

Eligibility Criteria:
Inclusion Criteria:

* All patients with established diagnosis of inherited number or function platelet disorder (IPN and IPD, respectively), on the basis of internationally established clinical, laboratory and genetic criteria will be enrolled.
* For patients \<18 ys, consensus will be signed by parents or legal responsible

Exclusion Criteria:

* No written consent
* Undocumented or uncertain diagnosis