cyrilzakka/clinical-trials huggingface dataset:
Electrically Evoked Compound Action Potentials Human Observation Medtronic System Study (ECHO-MDT)

This is a prospective, multi-center, non-significant risk IDE study of evoked waveforms resulting from stimulation of the dorsal column using a closed-loop system. comprised of Medtronic hardware or off the shelf hardware, which uses recorded waveforms to adjust stimulation amplitude.


Eligibility Criteria:
Inclusion Criteria:

1. 22 years of age or older
2. Candidate for or undergoing Medtronic SCS device trial for labeled indication\*
3. Willing and able to provide signed and dated informed consent
4. Capable of comprehending and consenting in English
5. Willing and able to comply with all study procedures and visits \*Candidate for or undergoing Medtronic SCS device trial for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic SCS trialing to treat the patient's chronic pain. This decision is to be made prior to discussing with the patient whether to enroll in the study.

Exclusion Criteria:

1. Implanted electrical cardiac device (e.g., pacemaker, defibrillator)
2. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee)
3. Currently diagnosed with a disease that may confound ability to evoke compound action potentials, e.g. multiple sclerosis, as determined by the investigator
4. Pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
5. Has untreated major psychiatric comorbidity, as determined by the investigator or designee
6. Trialed with a permanent implant lead and extension ("buried lead trial")
Treatment of Dentin Hypersensitivity Using Different Desensitizing Agents

Treatment of Dentin Hypersensitivity Using Theobromine , Remin Pro , and Combination of Both Materials


Eligibility Criteria:
Inclusion Criteria:

* Patients that aged 18-50 years.
* Patients in good general health.
* Patients that have accessible teeth demonstrating signs of sensitivity.

Exclusion Criteria:

* • Any chronic debilitating disease that could influence study outcomes.

  * Partial dentures, orthodontic appliances, implants or restorations in a poor state of repair that could influence study outcomes.
  * Intolerance or hypersensitivity to the study desensitizing agents or their ingredients.
  * Desensitising treatment or tooth bleaching within 8 weeks of screening.
  * Daily use of medications that might influence the perception of pain.(
Phase 1 Study of Multiple-Dose Pharmacokinetics of Cenicriviroc in Subjects With Mild and Moderate Hepatic Impairment

To determine whether CVC exposures are altered in subjects with impaired hepatic function, compared to subjects with normal hepatic function. The results will help guide the clinical use of CVC in patients with hepatic impairment, determine the extent of PK changes, if any, and identify the potential need for dose adjustments of CVC in this population.


Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant, non-lactating females aged 18-65
* Weight ≥ 50.0 kg
* BMI 18.0 - 40.0 kg/m2
* Able to participate, and willing to give written informed consent and to comply with the study restrictions
* Subjects with hepatic impairment will have stable liver disease (Child Pugh A or Child Pugh B)

Exclusion Criteria:

* Pregnant or lactating women and male partners of women who are pregnant or lactating
* Uncontrolled treated or untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg)
* QTcF \> 450 msec for males and \> 470 msec for females at Screening or Day -1
* Donation or loss of blood over 350 mL within 60 days prior to screening
* Any evidence of progressive liver disease within the last 4 weeks for subjects with hepatic impairment
Overview of the Mental Health of Adolescents in Therapeutci, Educational and Pedagogical Facilities in France

Assess the prevalence of various psychiatric disorders in adolescents aged 12 to 16 receiving support from therapeutic, educational and pedagogical institutes.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent aged 12 to 16
* In a DITEP for at least 15 days
* Minor who has been informed and has not objected to the research (according to his/her capacity)
* At least one person exercising parental authority who has read and understood the information note and has not objected to the research OR
* For a minor under guardianship: legal representative who has read and understood the information note and has not objected to the research.

Exclusion Criteria:

* Minor and/or person(s) exercising parental authority who do not understand French
* Holder of parental authority opposed to the search
* Minor opposed to search
Early Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones

The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones.

Endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy (LC) is a commonly performed treatment modality for concomitant common bile duct stones (CBDs) and gallbladder stones. There has been a debate about the appropriate timing of laparoscopic cholecystectomy after ERCP. The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones adding new parameters like Nassar scale.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent laparoscopic cholecystectomy after clearance of CBDs by ERCP

Exclusion Criteria:

* advanced liver cirrhosis, pancreatitis, acute cholangitis, suspected malignancy, severe malnutrition, and pregnancy.
Efficiency of the Imaging Strategy for the Management of Suspected Covid-19

Emergency departments have been placed at the heart of the patient triage strategy during the COVID-19 epidemic. In the absence of scientific knowledge on the most efficient strategy to put in place in emergency structures, the centers have proposed very heterogeneous protocols resulting from collaboration with local radiology and virology teams. While the pandemic in France appears to be currently under control, it is important to assess the sorting strategies put in place to deal with a new epidemic.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years old)
* Subject treated in the emergency rooms of participating centers for suspicion of COVID-19 presenting with fever\> 38 ° and / or respiratory signs (dyspnea, cough, sputum) and / or other symptoms suggestive of COVID-19 (diarrhea , confusion ...) and / or people over 85 or living in an institution during the study period from March 9 to May 8, 2020
* Subject affiliated to a social health insurance protection scheme
* Subject not having expressed their opposition, after information, to the reuse of their data for the purposes of this research

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice
Voluntary Surgical Terminations of Pregnancy: Comparison of the Hemorrhagic Risk Depending on the Term

Voluntary termination of pregnancy (abortion) is a major current societal issue. This is a very common situation, around 225,000 abortions are carried out every year in France. The legislation has recently been amended, with the law of March 2, 2022 aimed at strengthening the right to abortion (no. 2022-295) which extended the legal period for voluntary termination of pregnancy from 14 to 16 weeks amenorrhea (AS).

The National College of French Obstetrician Gynecologists (CNGOF), in a press release published on October 12, 2020 in response to the proposed law adopted by the National Assembly, wishes to draw attention to the fact that the procedure of surgical abortion between 14 and 16 AS changes nature. He states that additional procedures are necessary beyond 14 weeks, which could be a source of complications. In addition, the practice recommendations have not been updated following this extension of time, the centers performing abortions are therefore free regarding the protocol for carrying out these so-called late abortions (between 14 and 16 weeks).

There are two pregnancy termination techniques practiced in France: medical or surgical.

Due to the recent nature of these late abortions, practitioners still have little experience of the consequences of these procedures and this compromises the quality of the information provided to patients. It is necessary to have quality studies to improve knowledge about late-term abortions, in order to be able to correctly inform patients and allow them to make an informed choice regarding the method used.

This study follows the modification of the legislation extending the legal period for abortion, with the aim of providing arguments regarding the safety of carrying out surgical abortions at these more advanced stages of pregnancy.

In addition, abortion often generates anxiety, the term at which it is carried out could influence the experience of patients. This study would therefore also improve knowledge about the experience of abortion, in order to better support patients throughout their journey.


Eligibility Criteria:
Inclusion Criteria:

* Woman treated for the performance of a surgical abortion between 10 and 16 weeks (dating by ultrasound)
* Singleton pregnancy

Exclusion Criteria:

* Protected adult patient (guardianship, curatorship, safeguard of justice)
* Refusal to participate expressed by the patient
Safety and Efficacy of an Amino Acid Blend on Muscle and Gut Functionality in ICU Patients

Assessment of the Safety and efficacy of an amino acid blend on muscle and gut functionality in Intensive Care Unit (ICU) patients.

Since this was a proof of concept, exploratory trial, we assessed different primary outcomes without hierarchy.

This monocentric trial was a parallel, randomized, double-blind, controlled study. Patients hospitalized in the ICU for sepsis or ARDS were enrolled.

The treatment group (n=15) was administered the study product (amino acid blend) and the negative control group (=15) was administrated maltodextrin only. The mode of administration was nasogastric probe.

The treatment period was 21 days. Subject were followed during stay in High care and intermediate care units up to 2 months or after hospital discharge with a follow up until 12 months.

Recruitment stopped when 30 patients (15 in each group) reached V4.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 and over
2. Sepsis or ARDS patients: expected to stay at least 21 days in ICU (or midcare), to the opinion of the investigator
3. Informed consent signed by the patient or/and by his/her representative

Exclusion Criteria:

1. Patient with muscle mass loss due to previous hospitalization
2. Intolerance to enteral feeding
3. Patients using parenteral feeding
4. Chronic renal failure to the opinion of the investigator
5. Chronic liver disease to the opinion of the investigator
6. Cachectic patients
7. Current treatment with paralyzing drugs
8. No pacemaker or metal implants interacting with MRI and magnetic stimulation
9. Pregnant woman (known)
10. Persons without social security
11. Under guardianship
12. Currently participating or having participated in another clinical trial within 4 weeks prior to trial start
13. Patient who is expected not to comply with the study procedures, to the opinion of the investigator
Comparisons of iv Ibuprofen and iv Paracetamol During Bariatric Surgery

The aim of this study is to evaluate and to compare the effectiveness of iv ibuprofen and iv paracetamol during bariatric surgery.

Evaluation of effectiveness of iv ibuprofen and iv paracetamol on postoperative pain, opioid consumption, and side effects in morbidly obese patients undergoing bariatric laparoscopic surgery

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic sleeve gastrectomy and gastric by-pass surgery

Exclusion Criteria:

* Hepatic disfunction,
* Renal failure (creatinine \> 3 mg/dL,creatinin clearance \< 60 mL/dk or urine out-put \< 500 mL/day ) or a history of dialysis 28 days before surgery,
* A history of gastrointestinal bleeding or bleeding diathesis 6 weeks before surgery, therapeutic dose of anticoagulation therapy (except subcutaneous heparin prophylactic dose),
* Angiotensin converting enzymes inhibitor or antihypertensive combination with furosemide,
* A history of opioid addiction or opioid tolerance
* Allergy to study drugs,
* Noncooperative patients for pain assessments
The Effects of Body Contouring: Abdominoplasty and Liposuction

The data regarding the effects of aesthetic body contouring is insufficient. Poor results may related to preoperative psychological distress. Studies regarding eating disorder symptoms are lacking. Therefore studies using standardized and validated are needed. We decided to prospectively study quality of life, psychological distress, and eating disorder symptoms in body contouring (abdominoplasty or liposuction) patient populations. Used questionnaires are 15D quality of life, Raitasalo's modification of the Beck Inventory, and the Eating Disorder Inventory. We hypothesize that aesthetic body contouring plastic surgery has notable quality of life effects.


Eligibility Criteria:
Inclusion Criteria:

* patients requesting body contouring surgery

Exclusion Criteria:

* previous abdominal aesthetic surgery, simultaneous other aesthetic surgery at the same time
BHV-7000 Acute Treatment of Bipolar Mania

The purpose of this study is to determine whether BHV-7000 is a safe and effective acute treatment for manic episodes in bipolar disorder I.


Eligibility Criteria:
Key Inclusion Criteria:

1. Participant must be voluntarily hospitalized for a current manic episode.
2. Male and female participants 18 years to 75 years of age at the time of the screening visit.
3. Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m2.
4. Meets DSM-5 criteria for bipolar disorder type I, with or without mixed features, as confirmed by MINI interview with at least one well- defined prior mood episode (in addition to the current episode). The most recent prior manic episode must have occurred in the last 2 years.
5. Episode of mania must not exceed 12 weeks in duration.
6. Participants must be able and willing to discontinue all other psychotropic medications during the Screening Phase (e.g., antidepressant, antimanic, antipsychotic medications).

Key Exclusion Criteria:

1. Rapid cycling is excluded as defined herein by subjects who have experienced ≥ 6 distinct mood episodes in a year. Consecutive mood episodes must be demarcated either by a partial or full remission of at least 2 months' duration or by a switch to an episode of opposite polarity. Each manic or mixed episode must have lasted at least 1 week, and each hypomanic episode must have lasted at least 4 days.
2. Participants with a confirmed lifetime history of schizophrenia, psychotic disorders, dementia, delirium, amnesia, neurodegenerative disease, traumatic brain injury with clinically significant sequalae, seizure disorder, or other neurocognitive disorder. Previous diagnosis of psychotic spectrum disorders are allowable if the Investigator deems the diagnosis to be describing symptoms related to bipolar disorder.
3. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
Drainless Robot-assisted Minimally Invasive Esophagectomy

The aim of this study is the evaluation of two different chest drain management strategies in patients undergoing robot-assisted minimally invasive esophagectomy (RAMIE) for esophageal cancer with regard to perioperative complications until discharge.The primary objective of the study is to investigate whether the intensity of postoperative pain can be significantly reduced by avoiding thoracic drains after RAMIE. We assume that this will influence secondary endpoints such as early recovery and length of hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective RAMIE for esophageal cancer with intrathoracic esophagogastrostomy (Ivor-Lewis)
* American Society of Anesthesiologists (ASA) score ≤ III
* Eastern Cooperative of Oncology Group (ECOG) status ≤ II
* Patient suitable for both surgical techniques
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent

Exclusion Criteria:

* Open esophagectomy (either abdominal or during the thoracic part)
* Emergency operations
* ASA IV
* ECOG \> II
* Chronic pain syndromes requiring routine analgesics
* Simultaneous lung resection
* Presence of contraindications to the use of epidural anesthesia (e.g. coagulopathies, anticoagulation or allergies)
* Participation in an interventional trial, which interferes with the outcome
* Impaired mental state
Biological Therapy in Treating Patients at High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies

The purpose of this phase I/II trial is to study the side effects and best dose of biological therapy to treat patients at high-risk or with Epstein-Barr virus-associated lymphoma or lymphoproliferative disease.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically documented EBV antigen positive lymphoproliferative disease, lymphoma, or other EBV-associated malignancy OR
* Severely immunocompromised patients who develop blood levels of EBV DNA exceeding 500 copies/ml DNA, and are therefore at high risk for developing an EBV LPD

It is expected that five types of patients afflicted with EBV-associated lymphomas or lymphoproliferative diseases will be referred and will consent to participate in this trial. These are:

1. Patients developing or at risk for EBV lymphomas or lymphoproliferative disorders following an allogeneic marrow transplant.
2. Patients developing or at risk for EBV lymphomas or lymphoproliferative disorders following an allogeneic organ transplant.
3. Patients with AIDS developing EBV lymphomas or lymphoproliferative diseases as a consequence of the profound acquired immunodeficiency induced by HIV.
4. Patients who develop EBV lymphomas or lymphoproliferative diseases as a consequence of profound immunodeficiencies associated with a congenital immune deficit or acquired as a sequela of anti-neoplastic or immunosuppressive therapy.
5. Patients who develop other EBV-associated malignancies without pre-existing immune deficiency, including: EBV+ Hodgkin's and Non- Hodgkin's disease, EBV+ nasopharyngeal carcinoma, EBV+ hemophagocytic lymphohistiocytosis, or EBV+ leiomyosarcoma.

Exclusion Criteria:

The following patients will be excluded from this study:

* Moribund patients who, by virtue of heart, kidney, liver, lung, or neurologic dysfunction not related to lymphoma, are unlikely to survive the 6-8 weeks required for in vitro generation and expansion of the EBV-specific T cells to be used for therapy and the subsequent 3 weeks required to achieve an initial assessment of the effects of infusions of EBV-specific T cells.
* Pregnancy does not constitute a contraindication to infusions of EBV-specific T cells.
Can Imagination Change Upsetting Memories of Trauma?

Research suggests that imagination is a powerful tool to change images inside our heads (e.g. memories) and make them less upsetting. It is thought that this occurs through changing the meaning attached to the memory (e.g. I am weak), therefore making it less upsetting to remember.

Research has also linked some people's experience of psychosis to distressing trauma memories. Despite this, little is known about whether using imagination to change memories is helpful for people with psychosis. This project will look at whether a talking therapy that uses imagination to change trauma memories helps people with psychosis. This project will specifically look at whether this therapy helps; change the meaning linked to memory, make the memory less upsetting and frequent, and increase sense of control over the memory.

This project will recruit six to twelve people with psychosis. Participants will be recruited from services within South London and the Maudsley NHS Foundation Trust's Psychosis Clinical Academic Group. Participants will first be interviewed about their posttraumatic stress difficulties, experiences of psychosis, mental health, and wellbeing. In this appointment, participants will also identify a traumatic memory to focus on during the talking therapy. Four questions about the trauma memory will be asked every day for the remainder of the project.

Participants will then wait between one to three weeks before they receive three therapy sessions. Comparing participants to themselves for different periods of time makes sure that their memories do not become less upsetting over time, without therapy.

After therapy, participants will continue daily measures for two weeks, with an appointment in the middle (i.e. one week post therapy). This appointment will include questions about posttraumatic stress difficulties, wellbeing and satisfaction with therapy. Participation will last between 6-8 weeks. Participants will be reimbursed for their time


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a Schizophrenia-spectrum disorder or mood disorder with psychotic features
* Able to identify an intrusive traumatic memory occurring at least twice in the past week, as assessed by the Post Traumatic Stress Diagnostic Scale.
* Sufficient English to participate in the project

Exclusion Criteria:

* Concurrent trauma-focused psychological therapy
* Primary diagnosis of learning disability, substance use or organic disorder
* Acute suicide risk
* Lack of capacity to provide informed consent