cyrilzakka/clinical-trials huggingface dataset:
Pepped on Pre-exposure Prophylaxis (PrEP): A Counseling and Problem-Solving PrEP Adherence Intervention for Stimulant Using Men Who Have Sex With Men (MSM).

Pepped on PrEP is an innovative pilot RCT designed by an interdisciplinary team to develop a counseling and problem-solving PrEP adherence intervention with a Behavioral Activation (BA) approach that aims to re-engage participants in safe but pleasurable activities in life and addresses stimulant-abuse as well as associated factors including depression, as barriers to optimal PrEP adherence.

Enrolled participants will receive a referral to the Miriam Hospital for standard of care PrEP treatment. Once prescribed PrEP through the Miriam Hospital, the study participants will be randomly assigned to one of two treatment conditions. In the intervention condition, participants will receive a two-stepped intervention which could include up to 10 free BA and risk reduction (RR) counseling sessions. Participants assigned to the comparison condition will receive the standard of care for PrEP treatment at the Miriam Hospital, which includes information about PrEP and how to obtain it, assistance from medical staff in obtaining health insurance for study participants, and information regarding local community resources.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 years or older
2. Sex: assigned male sex at birth
3. Self-reports having sex with another man in the past month while using stimulants
4. Self-reports behavioral risk for HIV infection (consistent with the Center for Disease Control guidelines) for prescribing PrEP: condomless anal intercourse with at least one HIV-infected or unknown serostatus partner in the preceding six months)
5. Not currently prescribed PrEP at initial visit
6. Able to speak and understand English (for consenting and counseling)
7. Lives in New England

Exclusion Criteria:

1.) Potential participants unable to provide informed consent, including people with severe mental illness requiring immediate treatment or with mental illness limiting their ability to participate.
PHILOS Augmented - a Multicenter Randomized Controlled Trial

The primary objective is to compare the mechanical failure risks in the first year after treatment.

Biomechanical tests have shown that augmentation of screws or nails with polymethylmethacrylate (PMMA) leads to increased mechanical properties of the bone-implant complex, leading to the assumption that augmentation could reduce mechanical failures in patients. While a few clinical studies have already been performed with augmented trochanteric nails in proximal femur fractures, no clinical studies exist with the use of Proximal Humerus Internal Locking System (PHILOS) and (PMMA) augmentation for the treatment of fractures in the proximal humerus.

In this study a new standardized technique for augmentation of screw tips using high viscous PMMA cement (Traumacem V+) with the PHILOS plate will be applied. Fracture treatment with PHILOS Screw Augmentation will be compared with treatment with PHILOS without augmentation.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* Low energy trauma (e.g. fall from standing height)
* Radiologically confirmed closed fracture (≤ 10 days) of the proximal humerus
* Any displaced or unstable 3- or 4-part fracture of the proximal humerus (i.e. segment dis-placement \> 0.5 cm or angulated \> 45°) except isolated displaced fractures of the greater or lesser tuberosity
* Primary fracture treatment with a PHILOS plate
* Ability to understand the content of the patient information / informed consent form
* Willingness and ability to participate in the clinical investigation including imaging and fol-low-up procedures
* Signed informed consent

Preoperative Exclusion Criteria:

* Bilateral or previous proximal humerus fractures on either side
* Splitting fracture of the humeral head or humeral head impression fracture
* Cuff-arthropathy of the contra- or ipsilateral proximal humerus
* Associated nerve or vessel injury
* Any known clotting disorders, severe cardiac and/or pulmonary insufficiency
* Known hypersensitivity or allergy to any of the components of Traumacem V+ Cement Kit
* Any severe systemic disease: class 4 - 6 of the American Society of Anesthesiologists (ASA) physical status classification
* Any not medically managed severe systemic disease: class 3 of the ASA physical status classification
* Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
* Prisoner
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Intraoperative Exclusion Criteria:

* Intraoperative decision to use implants other than PHILOS/PHILOS Screw Augmentation
Native Kidney Denervation in Patients With End Stage Renal Disease

To investigate the utility of renal denervation in the treatment of patients with End Stage Renal Disease (ESRD).


Eligibility Criteria:
Inclusion Criteria:

* adult \>= 18 years of age
* end stage renal disease, undergoing concurrent dialysis treatment
* poorly controlled blood pressure on at least 2 antihypertensive drugs
* agrees to have the study procedure(s) performed and additional procedures and evaluations, including interventions and follow up visits
* competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria:

* renal arterial abnormalities
* myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within six (6) months
* hemodynamically significant valvular heart disease
* implantable cardioverter defibrillator (ICD) or pacemaker
* respiratory support.
* pregnant, nursing or planning to be pregnant
* other
Correction of Nonsense Mutations in Cystic Fibrosis

The presence of a nonsense mutation leads to the rapid degradation of the carrier mRNA mutation by a mechanism called NMD (nonsense-mediated mRNA decay) \[6, 13\]. There are currently 3 main strategies at least for correcting nonsense mutations: exon skipping, inhibition of NMD and nonsense mutation readthrough.

In the laboratory, we developed a strategy for correcting nonsense mutations combining inhibition of NMD and activation of translecture. For this purpose, we have constructed screening systems to identify NMD-inhibiting and/or readthrough enhancers. The molecules thus identified are then tested on cell lines and in murine models carrying a nonsense mutation.

One of our goals is to select a set of molecules that can correct effectively nonsense mutations. For this we have to test these molecules on a great diversity of nonsense mutations.

This work will:

* determine if we can correct all the nonsense mutations tested with at least one of our molecules
* determine what is common within a group of mutations corrected by a given molecule
* be able to assign the parameters that make one mutation is corrected by one molecule and not or little by another.

This study will therefore improve our theoretical knowledge on the recognition of premature stop codons but also to propose therapeutic approaches for the correction of nonsense mutations of the CFTR gene in cystic fibrosis in a targeted way for a patient.


Eligibility Criteria:
Inclusion Criteria:

* Male / female adults and minors aged 8 years and over
* Patients with cystic fibrosis and carry a nonsense mutation on the 2 alleles of the gene coding for the CFTR channel.
* Patients whose genotype of patients concerning the CFTR gene is known.
* Patients with social security
* Major patients who have given their consent
* Minor patients with parental authorization

Exclusion Criteria:

* Patients who have a mutation other than nonsense in the CFTR gene
* Patients whose CFTR gene was not sequenced on the 2 alleles
* Patients not wishing to participate in this study or persons not giving or not able to give consent.
* Pregnant or lactating women
* Patients under curatorship or guardianship
China 3T MRI Study

The purpose of the China CIED 3.0T MRI Performance Study is to confirm safety of SureScan CIED in the clinical 3.0T MRI environment when subjects receive MRI scans. ll subjects will have required follow-up visits at baseline, MRI visit, 1-month post-MRI. The MRI scans will occur at the MRI visit. The MRI scan region will be determined by investigator according to the subject's clinical condition.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who were implanted an SureScan system CIED over 6 weeks at the time of signing ICF.
* Subjects who are able and willing to undergo elective MRI scanning without sedation.
* Subjects who were implanted an SureScan system CIED in the pectoral region.
* Subjects who are geographically stable and available for follow-up at the study site for the length of the study.
* Subjects who are at least 18 years of age (or older, if required by local law).

Exclusion Criteria:

* Subjects who require a legally authorized representative to obtain informed consent.
* Subjects with abandoned or capped leads.
* Subjects who require an indicated MRI scan, other than those specifically described in the China CIED 3.0T MRI performance study, before the 1-month post-MRI follow-up.
* Subjects with a non-MRI compatible device (such as neurostimulators) or material implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys).
* Subjects with medical conditions that preclude the testing required by the CIP or limit study participation.
* Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the SureScan study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
* Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within seven (7) days prior to device implant.
To Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent

to evaluate safety and efficacy of CGBIO stent(DES) compared to Biomatrix flex stent(DES)

A Multicenter, subject-blinded, randomized study to evaluate safety and efficacy of CGBIO stent compared to Biomatrix Flex stent in patients undergoing drug-eluting stent procedure after coronary angiography

Eligibility Criteria:
Inclusion Criteria:

* At least one lesion with a diameter stenosis \>50%
* suitable for coronary stent implantation in a vessel with a reference diameter ranging from 2.5 mm to 4.0 mm;
* Gr 1 ≤TIMI flow

Exclusion Criteria:

* ST-segment elevation MI
* Bifurcation lesion
* Chronic total occulusion
* Restenosis lesion
* Graft vessel lesion
* Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated or in which patient will not be able to comply with dual antiplatelet therapy for at least 1 year
* Cardiogenic shock or hemodynamic compromise
* Existing impairment in liver and kidney.
Noise Impact in the Post-anesthesia Care Unit

World health organization recommends noise level should be less than 30db in hospital. However many analysis conclude to an average of 67dB in the post anesthesia care unit. No many studies were reported about noise impact in a post-anesthesia care unit. Only one was published by B.Allaouchiche in 2002. However, noise is a complaint reported by patients and it could be responsible for physiological and psychological troubles. In this prospective study, the main objective is to determine patients' satisfaction in the post anesthesia care unit, before and after installation of a noise warning device. Between the two parts, a short training about noise consequences on health will be presented to nurses. Improvement off anti-noise actions on patient's satisfaction will analysed.

Although the post- anesthesia care unit can be noisy, the effect of noise on patients recovering from anesthesia is unknown. Indeed, many studies are achieved in reanimation or ICU. That's why this prospective study is about patients' satisfaction after their stay in the post-anesthesia care unit. In a first part, noise is just measured with a sound level meter and patients are asked about their experience. Before the second part, during few days, nurses will be informed about noise consequences on heath. With some precaution, a decrease of the sound level in a room (ex: decrease scope alarms, speaking quietly, not slamming the drawer, noise warning device...) will be expected. The main objective is to determine the patient's satisfaction in the post-anesthesia care unit before and after installation of a noise warning device.

Eligibility Criteria:
inclusion criteria :

* patient who have a scheduled surgery in University hospital of Reims
* patient who stay in the post-anesthesia care unit
* patient consenting to participate to the study
* patient older than 18 years

exclusion criteria :

* Emergency surgery
* Patients who have been hearing disorders (notice in the preoperative consultation)
* Patients who have cognitive disorders (notice in the preoperative consultation)
* Patients who have a medical history of ear/cerebral surgery
Postoperative Dexamethasone on Post-Cesarean Pain

Investigating if giving post-operative dexamethasone to patients with a history of opioid use disorder on medication assisted treatment during pregnancy improves their pain scores and decreases their opioid use after cesarean section.

For this study, the researchers are most interested in an option that would be able to be administered consistently (same time/same way): that labor nurses could give and without requiring the patient to have had an epidural placement. Further, Gabapentin, clonidine and ketamine are associated with CNS effects like sedation or confusion that could make health care providers less likely to be comfortable giving these women additional oxycodone due to possible worsened sedation or respiratory depression. Lastly, the researchers wanted to give a drug that both obstetricians and pediatricians were comfortable with from extensive use in our maternal population. Thus, a single administration IV dexamethasone was chosen for this study. Dexamethasone has been used as an adjunct for post-operative pain management in many types of surgeries. Although no large randomized trials exist, several small trials suggest an analgesic and opioid sparing effect of dexamethasone post-operatively for both pregnant and non-pregnanat patients; however these studies excluded patients on MAT

Eligibility Criteria:
Inclusion Criteria:

* English-speaking,
* History of opioid use disorder with current use of MAT during pregnancy,
* Scheduled for cesarean delivery for their current pregnancy for any indication \[examples of elective c-section (decision made for c-section to be performed prior to onset of labor): fetal malpresentation, suspected macrosomia, prior c-section, abnormal placentation, patient preference\],
* Negative toxicology screen upon admission to the hospital for their cesarean section, no prior administration of betamethasone for fetal lung maturity within 24h of their scheduled cesarean delivery

Exclusion Criteria:

* non-english speaking,
* screen positive for illicit substance(s) on their admission toxicology screen,
* require general anesthesia for their cesarean section due to maternal/fetal indication for non-anticipated urgency (thus no longer 'elective') or failure of adequate intra- operative pain control with spinal anesthesia,
* medical history including known cardiovascular disease, heart failure, uncontrolled hypertension, uncontrolled gestational diabetes or uncontrolled pregestational diabetes, active GI bleed or untreated peptic ulcer,
* untreated infectious diseases including tuberculosis, systemic candida
Impact of Bariatric Surgery in Obese Patients With and Without Obstructive Sleep Apnea Syndrome

It has been shown to date that obesity is associated with increased mortality and that weight loss significantly improves cardiovascular risk factors. Among patients receiving bariatric surgery, 30-90% have moderate to severe obstructive sleep apnea (OSA) syndrome. Given the strong associations between OSA and cardiometabolic comorbidities, this project is based on the hypothesis of a lower improvement of cardiovascular risk factors and a higher number of post-surgical complications in OSAS patients.

It has been shown to date that obesity is associated with increased mortality and that weight loss significantly improves cardiovascular risk factors.

Bariatric surgery is now the most effective intervention for the long-term treatment of obesity and its complications. Among patients receiving bariatric surgery, 30-90% have moderate to severe obstructive sleep apnea (OSA) syndrome. The progressive loss of weight contributes to the regression of the symptoms related to OSA. Observational studies have shown that bariatric surgery can rapidly improve glycemic control and cardiovascular risk factors with a significantly higher remission rate of hypertension and dyslipidemias than in the non-surgical group. Given the strong associations between OSA and cardiometabolic comorbidities, this project is based on the hypothesis of a lower improvement of cardiovascular risk factors and a higher number of post-surgical complications in OSAS patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, aged over 18
* Patient in preparation for bariatric surgery (ring, Sleeve gastrectomy or Bypass) in the center CELIOBE.
* Patient affiliated with social security or beneficiary of such a scheme
* Patient having signed the free and informed consent

Exclusion Criteria:

* Patient who has already had bariatric surgery (ring, sleeve gastrectomy or bypass).
* Patient already receiving CPAP treatment for sleep apnea syndrome.
* Patients with pathology indicating the use of CPAP in self-guided mode (heart failure with altered ejection fraction) for patients diagnosed with OSAS
* Patient likely, in the opinion of the investigator, not to be cooperative or respectful of the obligations inherent to participation in the study
* Patient suffering from mental pathology does not make possible the collection of a consent.
* Protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, lactating or parturient woman
* Patient hospitalized without consent
Computerized Health Education to Promote Physical Activity

This study will test the efficacy of providing primary care physicians and their patients with computer-tailored information, based on patients' responses to survey questions. The health education messages are designed to encourage patients to become physically active and to encourage physicians to counsel their patients about exercise.

The main objective of this study is to determine, via a 6-month randomized controlled study, the efficacy of providing tailored physical activity computer reports to patients and physicians. The primary outcome is minutes of physical activity measured by the 7-Day Physical Activity Recall interview at 6 months. The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription. The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.

Eligibility Criteria:
Inclusion Criteria:

* Ability to speak and read English
* Current patient of a physician participating in this study (if selecting a new physician, may deliberately select one that is involved in the study, in order to participate)
* Ability to complete all written surveys
* Accessible for follow-up telephone surveys
* Ability to undergo exercise testing

Exclusion Criteria:

* Currently participating in another research study
* Planning to move out of the Philadelphia area
* Unable to walk without pain
* Pregnant or planning to become pregnant in the year following study entry
* Excessive drinking
* Coronary heart disease
* Congestive heart failure
* Peripheral vascular disease
* Cerebrovascular disease
* Chronic obstructive pulmonary disease
* Arrhythmia
* Recurrent seizures
* Dizziness
* Balance problems
* Psychoses
Multi-dimensional Investigations of Negative Emotions and Drug-resistant Auditory Verbal Hallucinations in Psychosis

Auditory verbal hallucinations (AVH) are commonly reported as source of distress, disability and mortality in schizophrenia. Despite proven efficacy of antipsychotics, many patients still experience drug-refractory AVH. It has been postulated that AVH is maintained by negative emotions. Yet, little is known about the temporal relationship and underlying mechanisms between negative affect and AVH. Utilizing both an ecologically-validated method and brain imaging technique, this study aims to uncover the role of emotions in the maintenance of psychotic symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 65 years
* Clinical diagnosis of schizophrenia spectrum disorder
* Present hallucinations

Exclusion Criteria:

* Left-handedness
* Intellectual disability
* Organic psychosis
Safety and Pharmacokinetic Study of Hepalatide(L47) in Healthy Volunteers

To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical pharmacokinetics in healthy volunteers.

This is a randomized, double-blinded, dose escalating, phase Ia trial, which will be conducted in No. 302 Hospital of China. There are seven cohorts at dose of 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. The first cohort with 0.21mg is an open test with no placebo as control. All other healthy volunteers will be randomized into Hepalatide or placebo group at 4:1 rate, and will be received drug by abdominal subcutaneous injection and will be observed for 8 days.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 18 and 45 years
* BMI Index between 19 and 25 (BMI=weight/height2)
* Normal previous history and physical exam
* No drug and alcohol abuse
* No illness in 4 weeks and no drug therapy in 2 weeks
* No blood donation or subject not sampled in 3 months
* Consistent and correct use of recommended methods of birth control for men and women
* Good compliance with study protocol
* Understand and agree to sign a consent form

Exclusion Criteria:

* Infection with HAV, HBV, HCV, HEV, HIV, EBV or CMV
* Abnormal and clinical significance test of physical examination, vital signs, blood routines, urine routines, liver and kidney functions, coagulation indicator, electrolyte, glucose, blood lipid, thyroid functions, chest X-Ray, ECG, B ultrasound of gallbladder, spleen and kidney, AFP ,and CEA
* Positive for anti-Pre-S1 antibody
* Women being pregnant or nursing, or with abnormal sex hormones, B ultrasound of ovaries/uterus proliferative diseases or breast mass
* Unable to quit smoking in trial
* Subject with little chance of enrollment (i.e. the weak)
* Subject not suitable to join the trial under other circumstances judged by investigator.