cyrilzakka/clinical-trials huggingface dataset:
Ear Acupuncture for Neuropathic Pain

The purpose of this study is to gather information on the effectiveness of auricular acupuncture (i.e., the placement of acupuncture needles in specific points on the ear) in reducing pain and improving quality of life among patients experiencing neuropathic pain in the acute inpatient rehabilitation setting.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have acute or chronic neuropathic pain of any etiology (traumatic, non-traumatic, central, peripheral, and mixed cases).
* Ability to provide informed consent.
* Ability to speak English and complete all aspects of this trial.
* At least 18 years of age.
* Patients will have stable neuropathic pain medication dosing for 3 days prior to enrollment to include gabapentin, pre-gabalin, TCAs, duloxetine, carbamazepine, oxcarbazepine, and venlafaxine).

Exclusion Criteria:

* Patients with platelet count \<50,000 or known bleeding disorder.
* Patients in a severe immunocompromised state.
* Pregnant women. All patients who meet the criteria will have their medical records reviewed to ensure they are not pregnant.
* Allergy to gold.
* Use of non-FDA approved herbal supplements. Their effect on enhancing or blunting effect of acupuncture is not known. Patients using medical marijuana with an approved prescription from a state issuing such prescriptions will not be excluded.
* Current infection of the skin or cartilage of the ear.
* Patients already using adjuvant modalities such as chiropractic, massage, yoga, tai chi, massage will not be excluded, but those who add in these modalities during the course of the intervention and observation period will be excluded.
* Patients not anticipated to stay for a minimum of 7 days after enrollment.
* Patient without mental capacity to participate in the consent process and the questionnaire responses.
* Fear of needles or no interest in acupuncture.
Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

The purpose of this study is to determine the effectiveness of behavioral treatment, drug treatment, and combined treatment for children with Attention Deficit Hyperactivity Disorder (ADHD). This study will also examine the interactions between different levels of behavioral and drug treatments.

Participants attend a summer treatment program each Monday-Friday for 9 weeks. They participate in group recreational and classroom activities, with 12 children and 5 staff per group. Three behavioral conditions (no behavioral modification, low-intensity behavioral modification, and high-intensity behavioral modification) are delivered in random order, with each condition lasting 3 weeks. Along with the behavioral treatment conditions, children receive 1 of 4 medication doses (placebo, 0.15 mg/kg methylphenidate, 0.3 mg/kg methylphenidate, or 0.6 mg/kg methylphenidate) in random order, with each dose varied daily and repeated 3 or 4 times within each behavioral treatment condition.

Measures include frequency counts of positive and negative behaviors, academic productivity and accuracy in the classroom, and counselor, parent, and teacher ratings of benefits and side effects. Parents attend training sessions and implement behavioral programs at home.

Eligibility Criteria:
Inclusion Criteria:

* Attention Deficit Hyperactivity Disorder
* IQ \>= 80

Exclusion Criteria:

* History of seizures or other neurological problems
* Medical history that would involve considerable risk in taking stimulant medication
* History or concurrent diagnosis of any of the following disorders: pervasive developmental disorder, schizophrenia or other psychotic disorders, sexual disorder, organic mental disorder, or eating disorder
Usefulness of DORNASE in COVID-19 on HFNO

COVID-19 pneumonia manifests among others with a thick bronhial secretion. It contains an increased number of neutrophil extracellular traps (NETs), formed during netosis. DNA is a major component in NETs. DNAse alfa (Pulmozyme®, Roche) is a recombinant human enzyme, registered for inhalations in patients with Cystic fibrosis, in which NETs are also a typical characteristic. DNAse alfa inhalations are typically well tolerated and with no major side effects. Some initial reports exist of using DNAse alfa inhalations in COVID-19 patients, that had benefitial effects. There are some trials registered with ClinicalTrials, investigating the usufulness of DNAse alfa in intubated patients, but the investigators have no knowledge of a trial, investigating the usufulness of this drug in patients receiving High Flow Nasal Oxygen therapy.


Eligibility Criteria:
Inclusion Criteria:

* Positive SARS-CoV-2 RNA PCR swab
* inflamatory phase of infection
* HFNO

Exclusion Criteria:

* pregnancy
* previous treatment with DNAse alfa
A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients

This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as "add-on" therapy for prostate cancer patients with hot flashes following surgical or medical castration. All prostate cancer therapy must be stable for at least 45 days before entering the study and must remain stable throughout this 12-week study. Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period.

This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as "add-on" therapy for prostate cancer in patients with mild to moderate vasomotor symptoms (hot flashes) following surgical or medical castration. All prostate cancer therapy must be stable for at least 45 days before entering the study and must remain stable throughout this 12-week study. To be eligible for this study prostate cancer patients must have undergone bilateral orchiectomy or medical castration utilizing LHRH analogues (LHRH agonists or LHRH antagonists) with or without additional antiandrogen therapy. Patients must have at least 21 moderate to severe hot flashes weekly.

Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period. In addition, a brief physical evaluation will be done, diaries will be reviewed and any adverse events will be recorded at each follow-up evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer patients who have undergone chemical or surgical castration
* History of hot flashes for at least 30 days
* Stable prostate cancer therapy for at least 45 days

Exclusion Criteria:

* Uncontrolled diabetes or severe COPD
* History of thromboembolic disease
* Liver or kidney dysfunction
* History or presence of cancer other than prostate cancer within the last 5 years
* Surgery within the last 3 months
Lipid Characterisation of Plasma Microparticles in a Large Population of Healthy Donors

Extracellular vesicles (EVs) are membrane structures containing numerous mediators categorised according to their size and mode of production. Among them, microparticles (MPs) are EVs between 100 nm and 1 μm in size that are produced by budding at the plasma membrane of different cell types following different mechanisms of cell activation or death. MPs include a large pool of bioactive molecules, such as lipids, proteins or nucleic acids. This makes them important mediators of intercellular communication, increasingly recognised for their role in various biological processes such as inflammation, coagulation, immune response and tumour progression. Their ability to transmit molecular signals between cells may have implications for disease pathogenesis and cellular interactions in pathological microenvironments. These MPs therefore appear to be an innovative biomarker, potentially useful in the early management of disease, both in terms of diagnosis and as a therapeutic target.

The main techniques used to analyse these MPs include flow cytometry, which enables surface markers to be quantified and determined, and electron microscopy, which provides a direct view of their morphology and structure. Molecular biology, such as the quantitative PCR technique, is also an approach used by several teams, notably to search for RNA or DNA fragments involved in various biological processes. However, few studies have focused on the lipid composition of these MPs. Since MPs are membrane vesicles, they are a major lipid reservoir. In addition, lipids represent a significant population of molecules with extensive properties, whether in inflammation, cell proliferation, energy metabolism, etc.

The aim of this project is to develop a reliable and robust method for analysing plasma MP concentration, phenotype and lipid composition in a population of healthy volunteers. These parameters will subsequently provide a comparator for studying MPs in populations of patients suffering from cardiovascular and/or inflammatory diseases.


Eligibility Criteria:
Inclusion Criteria:

* Person who has given his/her non-opposition
* All healthy volunteers are eligible to donate according to EFS criteria.

Exclusion Criteria:

* Person subject to a legal protection measure (curatorship, guardianship, etc)
* Pregnant, parturient or breast-feeding women
* Adults who are incapable or unable to give their consent
* Minors
* Person not eligible to donate according to EFS criteria.
Oral Care Study of Postoperative Infections

Reduce the incidence of post-operative infections after ENT surgery and flap reconstruction by performing preoperative oral and dental care

Reduce the incidence of post-operative infections after ENT surgery and flap reconstruction by performing preoperative oral and dental care

Eligibility Criteria:
Inclusion Criteria:

* ENT surgery with free flap reconstruction

Exclusion Criteria:

* Allergy to chlorhexidine
Cryopneumatic Device After Shoulder Surgeries

This study randomize patients to receive either a cryopneumatic device or standard care (ice and ice packs) following open or arthroscopic shoulder surgeries. The primary objective is to determine the impact of the cryopneumatic device on post-surgery pain management, while secondary objectives are to detemine the effect on pain, patient eperience, quality of life, narcotic consumption and time to stop narcotic usage. Patients who do not wish to participate in the randomized portion of the trial will be invited to participate in an observational cohort who will all receive the cryopneumatic device. Patients who wish to enter this cohort will not have the device provided to them for free, and will either use their insurance or pay for the device, in order to determine if patients who pay demonstrate different outcomes from the patients receiving the device for free in the RCT.


Eligibility Criteria:
Inclusion Criteria:

1. men or women aged 18 years and older;
2. undergoing a unilateral primary or revision shoulder surgery (total shoulder replacement or arthroscopic surgery \[rotator cuff repair, subacromial decompression, Bankart repair, Latarjet repair, debridement\]).

Exclusion Criteria:

1. patients undergoing bilateral surgery;
2. patients who are pregnant or nursing;
3. patients that do not believe they can comply with the study protocol;
4. patients generally unfit for surgery;
5. patients with specific treatment preferences;
6. patients who are unable to complete questionnaires due to language barriers, decreased mental capacity, neuro-psychological problems;
7. social factors precluding follow-up; 8) inability or unwillingness to provide informed consent.
Analgesic Self-medication for Acute Pain by Patients Awaiting a Consultation With a General Practitioner

What are the terms of use of analgesics for acute pain on an outpatient basis before a consultation with a general practitioner? Descriptive epidemiological study of patients in general practice in Rhône-Alpes


Eligibility Criteria:
Inclusion Criteria:

* adult patient
* without cognitive impairment
* having acute pain for less than 3 months
* Consultant to the practices participating to the study.

Exclusion Criteria:

* Patients who do not understand French
* Patients protected by law
Latarjet Procedure: Comparative Outcomes Study of Arthroscopic Versus Mini-open Approach With Minimum 2-year Follow-up

To date, use of arthroscopic procedure to perform Latarjet procedure is still technically demanding. The benefits of arthroscopic procedure need to be evaluated compared to the mini-invasive approach. The aim of this study was to assess postoperative pain during the first week, and the positioning of coracoid bone block at the anterior aspect of the glenoid. At minimum 2 years follow-up, the recurrence of shoulder instability and functional evaluation of patients according to the Western Ontario Score Index (WOSI) were assessed.

This prospective comparative study was performed at two centers in 2012. Each center performed one procedure so this study was observational. All patients with a chronic anterior instability requiring bone grafting (Instability Severity Index Score\>3) were included. The Latarjet procedure was performed by mini-open approach (set Arthrex, Naples, FL) in the first group, and by arthroscopic approach (set Depuy-Mitek, Raynham, MA) in the second group. The analgesic postoperative protocol was standardized (paracetamol, non-steroidal anti-inflammatory, tramadol).

Eligibility Criteria:
Inclusion Criteria:

* chronic anterior instability requiring bone grafting (Instability Severity Index Score\>3)

Exclusion Criteria:

* Patient refusal
A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study

The purpose of this study is to evaluate the long-term safety and efficacy of ASP015K in subjects with Rheumatoid Arthritis (RA) who have completed a preceding Phase 2 ASP015K RA study.

This study is comprised of a 104 week treatment period beginning on Day 1 of study drug administration and a 30-day follow-up period or permanent termination of clinical development of the product, whichever is earlier.

Eligibility Criteria:
Inclusion Criteria:

* Subject completed the week 12 visit in one of the Phase 2, ASP015K Rheumatoid Arthritis studies within the previous 14 days.
* Male and Female subjects must be willing to comply with contraception requirements as well as restrictions regarding egg and sperm donation

Exclusion Criteria:

* Subject has any condition considered by the Principal Investigator or Medical Monitor to preclude adequate evaluation of drug safety
* Subject is scheduled to receive any investigational drug other than ASP015K during the course of the study
* Subject is scheduled to receive a prohibited medication
* Subject has a planned major surgery
* Subject discontinued study drug due to meeting study drug discontinuation criteria prior to completion of the Week 12 visit in the preceding study or fulfills study drug discontinuation criteria at the final study visit of the preceding study
* Subject has out of range laboratory values within 14 days of the Day 1 study dosing
* Absolute lymphocyte count (ALC) \< 500/mm3
* Creatine Phosphokinase (CPK) \> 1.5 x upper limit of normal unless the level has been stable for at least 2 consecutive blood draws (at least 7 days apart), and subject does not have symptoms of muscle aching, weakness, or severe unusual muscle cramps
Brachial Artery Ultrasound Imaging: A Repeatability Study

The objective of the study is to define the analytical repeatability of quantifying flow-mediated dilation of the brachial artery using brachial artery ultrasound imaging using upper arm cuff occlusion.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, ≥18 years old
2. Eastern Cooperative Oncology Group/Zubrod score performance status of 0, 1, or 2, determined within 7 days prior to FMD testing on Study Day 1 (Visit 1)
3. Written informed consent understood and signed; understanding of study procedures and ability to comply with them for the length of the study

Exclusion Criteria:

1. Body mass index (BMI) \>50 kg/m2
2. Mid-upper arm circumference of arm selected for FMD testing \<17 cm or \>42 cm
3. Sinus arrhythmia (RR intervals vary by \>50%), atrial fibrillation, atrial flutter, multifocal atrial tachycardia, frequent (\>1 per 10-sec strip) premature atrial or ventricular contractions (isolated, non-isolated, or alternating), documented by 12-lead ECG with rhythm strip at the time of subject screening.
4. Clinical signs and/or symptoms of active viral or bacterial infections
5. Resting tremor or inability to remain still for the duration of the testing period
6. Systolic blood pressure (SBP) at rest of \>170 mmHg or diastolic blood pressure (DBP) at rest of ≥110 mmHg.
7. Diabetic subjects - Type I or II
8. Previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff
A Study to Assess Change in How Oral Icalcaprant With Itraconazole Moves Through the Body in Healthy Adult Participants

This study is to assess the change of itraconazole, a strong CYP3A inhibitor, on the pharmacokinetics, safety, and tolerability of a single dose of icalcaprant in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion Criteria:

* History of any clinically significant sensitivity or allergy to any medication or food.
* Exposure to icalcaprant within the past 90 days.
* History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].
Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix

Post-marketing surveillance study to demonstrate the silent rupture rate and satisfaction of patients who underwent a primary and revision breast augmentation surgery with Motiva Implants®, 3 to 10 years before enrollment.

Single-arm, multicenter study with a minimum of 160 subjects who underwent Breast Implant surgery from 3-10 years postoperatively.

Following IRB / EC approval - and if applicable Competent Authority approval - Magnetic Resonance Imaging (MRI) and Patient-Reported Outcome (PRO) with the validated BREAST-Q will be collected at a single time point for all enrolled subjects.

MRI data will be used for the analysis of silent rupture, and BREAST-Q Postoperative Augmentation module scales to record patients for satisfaction.

Two styles of Motiva Implants® will be used for this study:

* Motiva Implants® Silicone Gel-Filled Breast Implants, SmoothSilk® Round (referred to as "Motiva Implants® Round ProgressiveGel® Plus", or "Round")
* Motiva Implants® Silicone Gel-Filled Breast Implants, SmoothSilk® Round Ergonomix® (referred to as "Motiva Implants® Ergonomix® Round ProgressiveGel® Ultima®", or "Round Ergonomix").

Henceforth, these devices will generally be referenced as "Motiva Implants®."

Eligibility Criteria:
Inclusion Criteria:

* Cisgender women.
* The subject has undergone primary or revision augmentation surgery with Motiva Implants® Round or Round Ergonomix®, which are still implanted before enrolling in the study.
* The subject underwent breast implant surgery at least three (3) years or more before enrolling in the study.
* The subject has undergone an MRI to evaluate implant rupture in the last 3 years before enrolling in the study or is willing to undergo an MRI evaluation.
* The subject is willing to follow all study requirements (signing informed consent, completing questionnaires, attending a baseline visit, and allowing access to previous MRI images or having new MRI images for the study).

Exclusion Criteria:

* The subject had undergone fat grafting, needle biopsy, or any procedures that might have caused an iatrogenic rupture.
* The Subject or Investigator are aware of a possible ruptured device that has not been removed.
* The subject is pregnant or nursing.
* The subject has any condition that impedes the use of Magnetic Resonance Imaging (MRI), including implanted metal devices, claustrophobia, or other conditions that would prohibit MRI scans.
Impact of LPV During OFA on Postoperative Oxygen Saturation.

Observational study comparing patients with lung protective ventilation (LPV) following the consensus guidelines by Young C with patients getting routine lung ventilation, both during opioid free anesthesia (OFA).

The paper by C Young et al describes the essential steps in protecting the lungs and preventing post operative pulmonary complications (PPC) like alveolar collapse.

Alveolar collapse can be measured by oxygen saturation drop when no oxygen therapy is given, when full neuromuscular block (NMB) reversal and no opioid is given intra and postoperative.

LPV means:

tidal volume of 6 ml/kg, inspiratory-expiratory (I/E) ratio of 1/1, positive end expiratory pressure (PEEP) minimum 5 cmH20 and higher during laparoscopy in obese patients, Inspiratory oxygen concentration (FIO2) max 80% during induction and max 40 % during maintenance and extubation. Extubation in an awake, full NMB reversed patient getting no opioids while giving continuous positive airway pressure (CPAP) during withdrawal of the tube. Lung recruitment maneuver (LRM) when lung compliance decreases below 40 milliliter per centimeter water. (ml/cmH2O)

Eligibility Criteria:
Inclusion Criteria:

* bariatric surgery
* morbid obesity ( BMI \> 35)

Exclusion Criteria:

* patients with pre existing severe cardio-pulmonary diseases having oxygen saturation without oxygen below 94%.
Evaluation of Coagulopathy in Critically Ill COVID-19 Patients.

Novel coronavirus disease 19 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), this pneumonia was first emerged in December 2019 in Wuhan, China and rapidly spread around the world .

Coagulopathy is one of the most significant prognostic factors in patients with COVID-19 and is associated with increased mortality and admission to critical care. Most observed coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is characterized by increased D-dimer and fibrinogen levels. 71% of patients who did not survive hospitalization reported to have developed disseminated intravascular coagulation


Eligibility Criteria:
Inclusion Criteria:

* COVID 19 critically ill patients

Exclusion Criteria:

* any critical illness not related to COVID 19