cyrilzakka/clinical-trials huggingface dataset:
Early MRI Prediction of Crohns

The investigators plan a prospective study designed to optimize and translate noncontrast, novel Magnetic Resonance Imaging (MRI) techniques for detecting and measuring intestinal inflammation as well as for allowing early prediction of response to medical therapy in small bowel Crohn's Disease (CD).

The investigators plan to evaluate novel MRI techniques to measure: 1) mesenteric/intestinal blood flow using phase-contrast cine MRI, 2) intestinal motility (peristalsis) using dynamic cine MRI, and 3) bowel wall perfusion and molecular water diffusion. Precise objective measurements of diseased bowel blood flow (in ml/min) and bowel motility (in contractions per minute) are not currently used in the clinical care of CD patients, while diffusion-weighted imaging is typically used in a qualitative manner. None of these techniques have been evaluated for predicting eventual response to therapy or correlated with endoscopic mucosal healing in pediatric or adult CD.

Eligibility Criteria:
Inclusion Criteria:

Healthy Control Group

-Be able to tolerate up to 45 minutes in an MRI scanner

Newly Diagnosed Crohns Group

* Newly diagnosed, pathology-confirmed diagnosis of small bowel Crohn's disease,
* Expected to receive infliximab (Remicade; Janssen Biotech, Inc.) or other anti-Tumor Necrosis Factor (anti-TNF) medical therapy,
* Between 11 to 25 years of age and able to assent/consent,
* Be available for follow-up MRI at 4-weeks and 6-months after the initiation of treatment,
* Be able to tolerate up to 45 minutes in an MRI scanner.

Exclusion Criteria:

Healthy Control Group

* Inability to obtain assent/consent,
* Inability to tolerate 45 minutes in an MRI scanner,
* Contraindication to MRI (e.g., MRI incompatible implant or support device),
* Previous (remote) diagnosis or treatment of inflammatory bowel disease or other intestinal disease,
* History of intra-abdominal surgery, including surgery on the intestine,
* Pregnancy. Point-of-care urine pregnancy testing will be performed on all female study participants of reproductive potential (pediatric and adult) prior to each research MRI exam.

Newly Diagnosed Crohns Group

* Inability to obtain assent/consent,
* Inability to tolerate 45 minutes in an MRI scanner,
* Contraindication to MRI (e.g., MRI incompatible implant or support device),
* Previous (remote) diagnosis or treatment of inflammatory bowel disease,
* History of intra-abdominal surgery, including surgery on the intestine,
* Known bleeding disorder/coagulopathy (contraindication for adult subjects, as this may increase the risk of research colonoscopy),
* Pregnancy. Point-of-care urine pregnancy testing will be performed on all female study participants of reproductive potential (pediatric and adult) prior to each research MRI exam.
Congenital Uterine Anomalies & Pregnancy in Polycystic Ovarian Syndrome

Prospective research in which patients who applied to UUTF Gynecology and Obstetrics ART center for the treatment of infertility (inability to conceive despite one year of unprotected sexual intercourse), who will undergo IVF due to PCOS and unexplained infertility

As of 01/10/2020, IVF cycles of patients with PCOS (n = 105) and unexplained infertility (n = 105) who have applied to Bursa Uludag University Gynecology and Obstetrics Department, Reproductive Treatments Center, will be included in the study. Demographic data of all patients (age, BMI, smoking), presence of hyperandrogenism findings such as systemic diseases, hirsutism, alopecia, FSH, LH, LH/FSH ratio, estradiol levels, pregestational serum AMH levels, uterine anomalies detected by transvaginal USG or hysterosalpingography, controlled ovarian hyperstimulation protocols and doses; Besides, DHEA-S, Free Testosterone, 17-OH Progesterone levels will be recorded in patients diagnosed with PCOS. All these data are routine laboratory and imaging parameters of patients who underwent in vitro fertilization in our UYTE center. Pregnancy results of the patients (biochemical pregnancy, anembryonic pregnancy, abortion, clinical pregnancy, live birth), perinatal results and complications during clinical pregnancy, delivery ways, and newborn APGAR scores will be recorded. Results will be compared with patients in the control group diagnosed with unexplained infertility.

Eligibility Criteria:
Inclusion Criteria:

* Being in the age range of 20-40
* Need for an assisted reproductive method due to PCOS or unexplained infertility

Exclusion Criteria:

* \<20 years or \>40 years
* Detecting a cause for infertility other than PCOS
RC48-ADC in Breast Cancer

To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) in patients with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed breast cancer;
* Prior or current use of Disitamab vedotin (RC48-ADC);

Exclusion Criteria:

* Participating in clinical trials involving Disitamab vedotin (RC48-ADC) or not.
Assessing the Impact of Isokinetic Muscular Strengthening in Eccentric Mode in the Medical Treatment of Knee Osteoarthritis

Knee osteoarthritis (O.A. from now on) is associated to muscular weakness of inferior limbs, especially the quadriceps; leading to disease progression. Advantages of muscular strength training for the treatment of this kind of O.A. is now well established. In this therapeutic field, isokinetic exercises seem to have a better efficiency than other, more frequently used, kinds of exercises such as isometric or isotonic exercises.

Functional impairment caused by knee O.A. is mainly affecting walking. Walking induces muscles to work in eccentric mode.

The hypothesis of this study is that muscular strengthening using isokinetic exercises in eccentric mode would have a more important benefit than isokinetic exercises in concentric mode. Such an hypothesis, if verified, could lead to a better management of rehabilitative knee exercises in the treatment of knee O.A.

Knee osteoarthritis (O.A. from now on) is associated to muscular weakness of inferior limbs, especially the quadriceps; leading to disease progression. Advantages of muscular strength training for the treatment of this kind of O.A. is now well established. In this therapeutic field, isokinetic exercises seem to have a better efficiency than other, more frequently used, kinds of exercises such as isometric or isotonic exercises.

Functional impairment caused by knee O.A. is mainly affecting walking. Walking induces muscles to work in eccentric mode.

The hypothesis of this study is that muscular strengthening using isokinetic exercises in eccentric mode would have a more important benefit than isokinetic exercises in concentric mode. Such an hypothesis, if verified, could lead to a better management of rehabilitative knee exercises in the treatment of knee O.A.

Eligibility Criteria:
Inclusion Criteria:

* Patient male or female, age ranging from 40 to 70 years old
* Patient suffering from one-sided knee O.A. regarding criteria of the American College of Rheumatology (A.C.R.), with radiologic score ranging from 2 to 3 according to the Kellgren \& Lawrence classification.
* Patient receiving medical support
* Patient that did not receive any infiltration on knee within two months before randomisation.
* Patient free from any disease that could be a contraindication to the study treatment
* Patient able to understand the protocol and willing to comply with its rules.
* Patient willing to give consent.
* Patient affiliated to the french social secu

Exclusion Criteria:

* Patient carrying prosthesis.
* Patient suffering from inflammatory arthritis, or flare of arthritis.
* Patient suffering from symptomatic patellofemoral osteoarthritis.
* Patient suffering from cardio-vascular or pneumologic disease that could a contraindication to the study treatment.
* Patient suffering from any pathology that could cause muscular weakness (myopathy, neuropathy, hemiplegia...)
The Effects of an Acute Bout of Exercise on Alcohol and Cocaine Craving - an fNIRS Study

The study is a crossover randomised controlled trial. Alcohol or cocaine dependent participants will be recruited from inpatient and outpatient psychiatric treatment centres, on the approval of their treating physician. A healthy control group will be recruited using online advertising. All participants will undergo each of three conditions in a randomised order; 1) 20 minutes of cycle ergometry at 50-60% of maximum heart rate; 2) 20 minutes of exercise at 70-80% of maximum heart rate; 3) 20 minutes of quiet reading. Immediately before and after each condition, participants will be asked to complete a computerised Stroop test, watch a film containing substance-related images, and self-report craving levels. During the Stroop test and film viewing, participants' neural activity will be measured via functional near-infrared spectroscopy

The aim of this study is to examine whether, following acute exercise bouts at moderate and high intensities, reduced craving and increased inhibitory control can be observed in alcohol or cocaine dependent individuals. As the focus of this study is the potential of exercise to be integrated into treatment, individuals in treatment for their dependence, who have been abstinent for a short period, will be recruited.

Eligibility Criteria:
Inclusion Criteria:

For alcohol or cocaine dependent participants:

* meeting three or more of the DSM-IV criteria for substance dependence (as determined by treating physician);
* minimum of 20 days and maximum of 40 days abstinence from substance of dependence;
* able to understand and complete the informed consent;
* able to travel to study site independently, as confirmed by the treating psychiatrist;
* assessed for physical and mental fitness by treating physician and cleared to take part in the study;
* fewer than 3 hours of physical exercise or sport per week;

For healthy controls:

* fewer than 3 hours of physical exercise or sport per week;
* no history of problematic alcohol or illicit drug consumption.

Exclusion Criteria:

* Pregnancy
* Questionable findings during resting ECG screen
Blue Star Cares: Innovative Approaches to Helping Military-Connected Caregivers

The purpose of this project is to evaluate an interactive training program for military-connected caregivers (MCCs) of wounded warriors. The program leverages existing resources and incorporates evidence-based training and peer-based support networks to enhance continuity of care. The program consists of an educational Toolkit (workbook) and an avatar training interaction where an MCC can practice skills learned from the toolkit training with the avatar (how to navigate difficult conversations). This is an educational training evaluation to determine whether or not avatar interaction can effectively improve health outcomes in MCCs.

The purpose of this project is to evaluate an interactive training program for military-connected caregivers (MCCs) of wounded warriors. The program leverages existing resources and incorporates evidence-based training and peer-based support networks to enhance continuity of care. The program consists of an educational Toolkit (workbook) and an avatar training interaction where an MCC can practice skills learned from the toolkit training with the avatar (how to navigate difficult conversations). This is an educational training evaluation to determine whether or not avatar interaction can effectively improve health outcomes in MCCs.

The investigators will implement a pre-post design looking at a group of caregivers across multiple time points examining differences in outcomes from baseline (before engaging in the training/intervention) to after completing the training, including follow-ups at 3- and 6-months to evaluate longer-term outcomes.Those enrolled in the intervention will receive the complete training program (toolkit and avatar).

Project participants (i.e., MCCs who engage in the training and follow-up activities) will receive the (a) training toolkit workshop and will engage with the avatar to practice the knowledge and skills described in the workshop or will receive only the (b) training toolkit workshop (control).

Comparing the time differences will enable us to determine if the training program, specifically the avatar interaction, is associated with improved health and quality of life in caregivers of wounded warriors, enhanced caregiver social support and networks, improved patient (wounded warrior) experience of care, and reduced per capita costs of care for both the wounded warrior and caregiver.

Follow-up focus groups and interviews will be conducted to assess caregiver participant perspectives on what worked, what did not work, what they would like to see in the future, how the avatar interaction impacted them, and how the program could be improved in the future, as well as to clarify findings

Eligibility Criteria:
Inclusion Criteria:

* Participants must be a military-connected caregiver over the age of 18.

Exclusion Criteria:

* Participants under the age of 18 or not a military-connected caregiver. Active duty military personnel are unable to participate in this project.
Effect of Fentanyl on Coughing and Recovery After Anesthesia With an LMA Laryngeal Mask Airway)for Airway Management

The purpose of this research is to evaluate the effectiveness of fentanyl for reducing coughing during the perioperative period (i.e., insertion of an LMA \[Laryngeal Mask Airway\] device, maintenance period during surgery, and awakening \[emergence\] from general anesthesia) for ambulatory surgery procedures. Also to assess the effects of fentanyl on the postoperative outcomes, (e.g., pain, postoperative nausea and vomiting, return of bowel function \[constipation\], resumption of normal activities of daily living).

Fentanyl is one of the most common used anesthetic adjuncts for ambulatory surgery because of its anesthetic-sparing effects and alleged ability to reduce coughing during instrumentation of the patient's airway.

This research study is designed to evaluate the effects of fentanyl when administered as an adjuvant to standard anesthetic and analgesic drugs on coughing (during insertion of an LMA device, during maintenance and emergence from general anesthesia) and on the postoperative adverse outcomes (i.e., side effects).

All patients will receive local anesthetics and commonly used non-opioid pain relieving medications during surgery.

Eligibility Criteria:
Inclusion Criteria

* Patients scheduled to undergo outpatient arthroscopic surgery procedures
* Willingness and ability to sign an informed consent document
* No allergies to anesthetic or analgesic medications
* 18 - 80 years of age
* American Society of Anesthesiologists (ASA) Class I - III adults of either sex
* Women of childbearing potential must be currently practicing an acceptable form of birth control, and have a negative urine pregnancy test

Exclusion Criteria

* Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications
* Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases, peptic ulcer disease or bleeding disorders
* Pregnant or lactating women
* Subjects with a history of alcohol or drug abuse within the past 3 months
* Any other conditions or use of any medication which may interfere with the conduct of the study (e.g., asthmatic patients history of asthma, chronic cough, or upper respiratory tract infection during the previous 2 wk or recent treatment with angiotensin-converting enzyme inhibitors, bronchodilators, or steroids.
Gait Parameters Analysis in Post-stroke Patients and in Elderly Fallers

A large proportion of falls in older people occurs when walking. Most studies have recently demonstrated correlation between the variations in spatiotemporal gait parameters and fall risk in elderly and in several diseases. The investigators objective is to analyse this parameters in population with gait stability disorders (post-stroke patients and fallers) to identify the most valuable and to develop/test a conglomerate stability score.

Temporal-spatial gait parameters will be recorded in subjects aged 65-80 years : 30 healthy people, 30 patients at least one year post-stroke, and 30 fallers while walking on an electronic walkway GAITRite® at self-selected speed.

Eligibility Criteria:
1. For healthy subjects

   * Aged 65 to 80 years (included) ;
   * Patient has been informed and has signed the consent form.
2. For post-stroke patients

   * Aged 65 to 80 years (included) ;
   * Stroke patients who had only one cerebrovascular accident, at least one year before inclusion ;
   * Able to walk without using assisting devices or ambulatory aids ;
   * No cardiovascular contraindication ;
   * No history of neurological diseases with influence on walking capacities (excepted stroke) ;
   * No history of vestibular or orthopaedic (lower limb) disorders ;
   * No amblyopia ;
   * Patient has been informed and has signed the consent form.
3. For fallers

   * Aged 65 to 80 years (included) ;
   * Reported 2 or more falls within 6 months prior to the beginning of the study ;
   * Able to walk without using assisting devices or ambulatory aids ;
   * No cardiovascular contraindication ;
   * No history of neurological diseases with influence on walking capacities ;
   * No history of vestibular or orthopaedic (lower limb) disorders ;
   * No amblyopia ;
   * Patient has been informed and has signed the consent form.
Test@Work Study: Evaluation of Attitudes and Uptake Within Employee Health Checks in the Construction Industry

This project is called Test@Work. In this project the investigators will offer general health checks and tailored health advice to up to 650 employees in the construction industry at sites across the East Midlands. The investigators will assess reach and uptake, and evaluate the views and perceptions of employees, managers and the delivery team. Health checks will include Body Mass Index (BMI; weight/height), waist-to-hip ratio, blood pressure, mental health screen, sexual health consultation and an opt-in rapid screening test for human immunodeficiency virus (HIV). Employees will be provided with a resource pack with information and signposting around physical activity, diabetes risk, diet, and musculoskeletal health. A digital resource providing information and signposting about workplace health screening and HIV testing will be developed and provided to managers at the participating worksites 2 weeks before their health check event.

Employees will be offered an additional text messaging service involving receipt of a series of messages with advice around HIV and testing alongside general health information. Employees will complete post-health check exit questionnaires and an exit interview. Managers will complete a post-event evaluation questionnaire and post-event interview. Mixed-methods evaluation will include assessment of reach, uptake, and intervention implementation processes.

The investigators will collect evaluation data with employees and company representatives.

Employees: will complete exit-questionnaires and be invited to a brief exit interview.

The investigators will collect by anonymous questionnaire: age, gender, country of birth, ethnicity, postcode, sexual orientation, employment status (FT/PT, permanent, agency, contract worker), reasons for attending, health perceptions, prior HIV testing history, influence of work on health, perceptions of employers provision for health and wellbeing, perceptions towards HIV testing in the workplace, range of tests undertaken, views about the workplace health check and future health intentions. Personal identifiers will not be collected and questionnaire data will not be provided to employers. Those employees who agree to be interviewed after the health check will be invited to a brief independent confidential interview with the project researcher.

Company representatives: will complete brief post-event questionnaire and be invited to post-event interview

The investigators will ask about the organisational/employee profile, their perceptions of company provision for health and wellbeing, perceptions towards the usefulness of the implementation toolkit and towards HIV testing in the workplace, method of delivery and their confidence to support employees who disclose a positive test outcome, views about the workplace health check and future implementation intentions.

Eligibility Criteria:
Inclusion Criteria:

* employee of a company in construction or related industries
* provides informed consent

Exclusion Criteria:

* does not speak English
Neurologic Deficits and Recovery in Chronic Subdural Hematoma

Chronic subdural hematoma (cSDH) is one of the most common problems treated by neurosurgeons, particularly as the population ages. While often dismissed as a benign problem, it has become clear that cSDH is associated with worse long term functional and cognitive outcomes compared to matched controls. Though surgical techniques for treatment of cSDH are becoming more effective and safe, a persisting problem of fluctuating, stroke-like neurological deficits has re-emerged. Such deficits are not always directly related to hematoma mass effect and not always relieved with surgical decompression, but can result in prolonged hospital course, additional workup, and sometimes even additional invasive treatments. While the cause of such events is unknown, we recently documented for the first time that massive waves of spreading depolarization can occur in these patients and were closely linked to such neurologic deficits in some patients. In the current study, we plan to expand on these preliminary findings with rigorous, standardized application of post operative subdural electrocorticography monitoring, pioneered at our institution to detect SD. We also plan to build on our large retrospective analysis estimating the overall incidence of such deficits in cSDH patients by assessing multiple proposed risk factors for SD. In addition, for the first time, we will assess the short- and long-term consequences of cSDH and SD with detailed functional, cognitive, and headache related outcome measurement. These assessments are based on several remarkable cases we have observed with time-locked neurologic deterioration associated with recurrent SD. This study qualifies as a mechanistic clinical trial in that we will be prospectively assigning patients to the intervention of SD monitoring and assessing outcomes related to the occurrence of SD. This constitutes the application of a novel measure of brain signaling and assessing biomarkers of these physiologic processes of SD. These studies will provide critically needed information on this novel mechanism for neurologic deficits and worse outcomes after cSDH evacuation. Upon successful completion, we would identify a targetable mechanism for poor outcomes that occur commonly in patients with cSDH. This overall strategy offers the opportunity to radically improve the care of patients with cSDH by focusing on clinical trials of pharmacologic therapies for neurologic deficits in patients with cSDH.


Eligibility Criteria:
Inclusion Criteria:

* chronic/ subacute subdural hematoma deemed necessary for surgical evacuation,
* Ability to consent or have LAR consent

Exclusion Criteria:

* emergent need for evacuation,
* acute traumatic subdural hematoma, and
* severe baseline disability (mRS\>2) (modified Rankin Scale)