cyrilzakka/clinical-trials huggingface dataset:
C2P - Phase III: MPowerment and Community Promise

One of the objectives of the C2P coalition is the successful delivery of a CDC-endorsed community-level HIV prevention program aimed at changing the risk profiles of youth. This protocol (ATN 041) describes the program, Community PROMISE (Peers Reaching Out and Modeling Intervention Strategies) or MPowerment, and plans for adapting and implementing it. There are a total of 4 interventions that a community can implement.

Community Promise: Role model stories comprise the "heart" of printed materials distributed throughout the target community. The role model stories are brief publications that depict personal accounts from individuals in the population of focus who have made or are planning to make a risk-reducing behavioral change. The messages in the role model stories are reinforced by interpersonal communication with trained peer advocates.

MPowerment: is a community level HIV/STD prevention program that relies on peer advocates from the community to lead outreach activities including discussion groups (M-groups), venue-based outreach, social events and a publicity campaign. Sites will adapt MPowerment for local use remaining faithful to the core elements.

Eligibility Criteria:
Community Promise:

Inclusion Criteria

1. Adolescents and young adults who provide verbal confirmation that their age is within
2. the range of 12 through 24 years, inclusive.
3. Gender will reflect that of the population of focus.
4. Must report having engaged in voluntary sexual activity within the past 12 months (vaginal, anal and/or oral sex).
5. Ability to understand and willingness to provide informed consent/assent.

Exclusion Criteria

1. Visibly distraught and/or visibly emotionally unstable (e.g., depressive mood, or exhibiting manic, suicidal, or violent behavior).
2. Visibly intoxicated or under the influence of psychoactive agents
3. Clinically presents as acutely ill.

MPowerment:

Inclusion Criteria

1. Male adolescents and young adults who provide verbal confirmation that their age is within the range of 12 through 24 years, inclusive.
2. Must report having engaged in voluntary sexual activity within the past 12 months (anal and/or oral sex) with a man.
3. Ability to understand and willingness to provide informed consent/assent.

Exclusion Criteria

1. Visibly distraught and/or visibly emotionally unstable (i.e., depressive mood,
2. or exhibiting manic, suicidal, or violent behavior, etc.).
3. Visibly intoxicated or under the influence of psychoactive agents.
4. Clinically presents as acutely ill.
Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.

A comparison of the rate of surgical site infections after cesarean section depending on the type of suture used for subcutaneous closure-continuous versus interrupted.

Patients at term that are candidates for elective cesarean section will receive an explanation regarding the study and sign informed consent. Patients will then be divided randomly to one of 2 treatment groups based on the type of subcutaneous tissue closure:

1. Interrupted sutures.
2. Continuous sutures. Information regarding medical and obstetric history will be collected for each patient.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women undergoing elective cesarean section.
* Subcutaneous tissue layer\>2 centimeter according to ultrasound.

Exclusion Criteria:

* Non-elective CS.
* Fever during the 48 hours prior to surgery.
* Antibiotic treatment during the 48 hours prior to surgery.
* Inability to give informed consent.
* Preterm delivery (\< 37 weeks' gestation).
* Fetal death.
* Known fetal anomalies or placental abnormalities.
* Immunosuppressive conditions.
Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury

This study will examine the use brief prolonged exposure (Brief PE) therapy compared to standard clinical care to reduce posttraumatic distress among people who have had a spinal cord injury and are receiving rehabilitation in an inpatient setting.

This is a prospective randomized controlled trial examining the efficacy of brief Prolonged Exposure Therapy (Brief PE) delivered in an inpatient rehabilitation setting post-SCI to reduce PTSD symptoms. The overall goal of this project is to test a Brief PE (three 60-minute sessions) to reduce psychological distress after SCI and to mitigate long-term post-SCI distress including PTSD as well as secondary health outcomes (including depression and general anxiety) at 1, 3, and 6 months from baseline. The intervention group (Brief PE) will be compared to standard clinical care with treatment as usual (TAU).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Admitted to the inpatient rehabilitation hospital diagnosed with a SCI following a traumatic event

Exclusion Criteria:

* Patients in police custody
* Not fluent in the English language
* Severe cognitive impairment
* Patients who are acutely suicidal
* Patients with active psychosis
Intravenous Versus Intraperitoneal Instillation of Ondansetron for Decreasing Incidence of Nausea and Vomiting After Laparoscopic Gynecological Surgeries.

Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic surgeries.

Laparoscopic surgeries have many advantages e.g., decreasing postoperative pain, better cosmetic, rapid recovery, and better recovery but also, it has side effects e.g., pain, postoperative nausea and vomiting.

There are many risk factors that cause PONV either patient related factors or anesthesia related factors (opioids, inhalational anesthetics, Nitrous oxide and duration of anesthesia) and surgery related factors (intraabdominal, laparoscopic, postoperative pain).

Intraperitoneal instillation of drugs can be used for instillation of LA, opoids, ketamine and antiemetics to provide analgesia and manage side effects of laparoscopic surgery. The mechanism of action of ondansetron is inhibition of presynaptic 5-HT3 receptors that located in the peripheral nervous. Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from the patient.
* Age: 21-60 years old.
* female patients
* Physical status: ASA 1\& II.
* BMI = ≤ 35 kg/m2).
* Type of operation: elective laparoscopic gynecological surgeries.

Exclusion Criteria:

* Altered mental state.
* Patients with known history of allergy to the study drugs.
* hepatic, renal impairment or disease , cardiovascular, and respiratory diseases.
* Patients with chronic pain received NSAID or opioid during previous two weeks.
* Patients with history of PONV or motion sickness and patients received antiemetic therapy 24 h before the surgery.
Multi-device Testing for Autonomic Nervous System Stimulation

The Vagus nerve (VN) serve as an "unconscious inner brain" that integrates messages from the body and provides metabolic homeostatic regulation to various organs.In this study the investigators want to compare different ways to stimulate the vagus nerve to assess their respective effects compared to a sham stimulation.

Each participant will be exposed in a random way to 7 different ways to stimulate the VN:

* Manual Head Massage
* Mechanical Head Massager (BREO Inc. Helmet)
* Low laser Therapy (LLT)
* Sham LLT
* Transcutaneous Electrical Nervous Stimulation (TENS) ear stimulation (as testing phase prototype device)
* Deep and slow breathing (as testing intervention based on video app)
* Relaxed reading time (as control situation)

Therefore, within the same design the investigators want to conduct two separate studies that should lead to two separate publications:

* Study 1: comparison of manual head massage to mechanical Helmet massager and relaxed reading
* Study 2: comparison of LLT with sham LLT and relaxed reading

The two other interventions: TENS ear stimulation and Deep and Slow breathing are purely observational to gain knowledge in context of a convenient design.

OBJECTIVES Overall objective is to assess the respective effects of the different ways to stimulate the Vagus Nerve on the Heart Rate Variability (HRV) parameters: High Frequency (HF), Low Frequency (LF), Total Power (TP), Heart rate (HR), and blood pressure (BP).

Specific objectives:

* Comparison of Manual Head Massage to Mechanical Head Massager to Control situation
* Comparison of Low Laser Therapy (LLT) to sham LLT to control situation
* Effects of TENS ear stimulation (descriptive)
* Effects of Deep and Slow breathing (descriptive)

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged 20 to 40 in normal context

Exclusion Criteria:

* To have work night shift the night before
* To use certain drugs that affect the ANS (beta blockers, beta stimulant, hypnotic, for instance)
* To be in situation of unusual life stress
* To have a chronic disease that require some daily treatment
* Not to stay in Beijing for the duration of the investigation
Impact of External Drainage of the Lumbar Cistern in Patients With Hydrocephalus Following Meningioma Surgery and Its Influence on Patient Satisfaction

This study aims to investigate the effect of external lumbar cistern drainage in preventing postoperative hydrocephalus in patients who have undergone meningioma surgery and its impact on patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of meningiomas based on established diagnostic criteria and pathological confirmation
* postoperative development of hydrocephalus, specifically communicating hydrocephalus
* absence of other intracranial tumours or contraindications for surgery

Exclusion Criteria:

* concurrent mental disorders, coagulation dysfunction or organic diseases affecting other areas
* hematologic diseases, severe liver or kidney dysfunction
* patients discontinuing treatment or transferring to a higher-level hospital
* a history of hydrocephalus, such as obstructive hydrocephalus
Impact on Risk Stratification of Overlap Syndrome Phenotype in Patients With E1784K Mutation in SCN5A

In patients expressing the SCN5A-E1784K mutation (Glu1784Lys), cardiovascular risk is difficult to define as the stratification of these patients is challenging. From our experience, major cardiovascular events (MCE) tend to occur more frequently in patients expressing overlap syndrome phenotype (Brugada syndrome and Long QT syndrome type 3)than in patients expressing a single phenotype (whether Brugada syndrome or Long QT syndrome type 3). This trials is led on the impact on Risk Stratification of Overlap Syndrome Phenotype in Patients With E1784K Mutation in SCN5A ( RISKOVER )

Study design: This study will compare the occurrence of MCE between patients with overlap syndrome phenotype and patients with a single phenotype (whether Brugada syndrome or Long QT syndrome type 3) in a cohort of patients 12 years of age and older with the SCN5A-E1784K mutation. Eligible patients will be identified nationwide and included retrospectively and prospectively. Occurrence of MCE between the group " overlap syndrome " and the group " single phenotype " will be compared.

Eligibility Criteria:
Inclusion Criteria:

* genotype E1784K (glu1784lys) in SCN5A gene

Exclusion Criteria:

* none
Bioenergetic Phenotypes and Cardiometabolic Health

This research study is about how daily activities, behaviors, and fitness affect the health and function of blood cells and their mitochondria, which are the powerhouses of the cells. These small mitochondria inside the cells make energy, and are very important for the health of the body.

Determine the impact of physical activity and obesity status on circulating cells mitochondrial function (e.g., fat vs. carbohydrates combustion capacity, total oxidative capacity, mitochondrial number and proton leak).

Eligibility Criteria:
Inclusion Criteria:

Ages 8-10 years Boys and girls All ethnicity All BMI

Exclusion Criteria:

severe persistent asthma exercise induced asthma autism spectrum disorder attention deficit hyperactivity disorder attention deficit disorder

* Opposition defiant disorder
* conduct disorder
* epilepsy
* chronic kidney disease
* hormonal disease
* autoimmune diseases
* bleeding disorders
* chronic infections
* mental health disorder
* Type 2 and Type 1 diabetes
* Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest
Evaluating A Drug Testing and Graduated Sanctions Program in Delaware

The objective of this three year project funded by the National Institute of Justice is to conduct a program evaluation of the "Decide Your Time" program at the Hares Corner Office of the Delaware Department of Probation and Parole. The program is intended to provide an alternative to incarceration by monitoring chronic drug offenders through increased, regularly scheduled, known urinalysis testing, coupled with increasing sanctions and referral to treatment for positive tests. The program was designed and is being implemented by the Delaware Department of Probation and Parole. Offenders will become eligible for the program when they test positive for drugs at their initial probation intake at the Hare's Corner Probation Office in New Castle, Delaware or are moved from standard probation to intensive supervision due to failed urine tests. Due to budgetary constraints, the office lacks sufficient resources to place all eligible offenders into the program. The Department of Probation thus intends to randomly assign eligible offenders to either intensive supervision probation (ISP)(n=400) or the Decide Your Time program(n=400). Those in ISP will receive the normal intensive supervision requirements, including weekly visits and random urinalysis. Those in the enhanced condition will receive regularly scheduled urinalysis coupled with referral to treatment, if required, and a program of graduated sanctions. The Center for Drug and Alcohol Studies is conducting an evaluation of the program that involves examining data on effectiveness, and collecting and examining data on program implementation, and probation officer and client perspectives of how the program worked. It is hypothesized that those randomized to the Decide Your Time program will have fewer arrests, violations and positive urine screens upon program completion than those randomized to the control condition.


Eligibility Criteria:
Inclusion Criteria:

* sentenced to intensive supervision and fails a urine drug screen at the HAres Corner Probation office in Delaware

Exclusion Criteria:

* Clinical Diagnosis of DSM-IV Mental Illness
* Judge ordered Zero Tolerance program
* Sex Offender
* Less than sixty days on probation
Effects of Core Strengthening on Pelvic Tilt, Dynamic Balance and Agility in Lower Cross Syndrome: a Quasi-experimental Study

This study is a quasi experimental study and the purpose of this study is to determine the effects of core strengthening on pelvic tilt, dynamic balance and agilty in lower cross syndrome.

Participants will be recruited into the study using the criteria of lower crossed syndrome which is assessed using te following tests:

Prone hip extension test Trunk flexion strength test Tightness in erector spinae Modified Thomas test

Eligibility Criteria:
Inclusion Criteria:

* Age 19-35 years
* Both genders
* Positive modified Thomas test
* Positive prone hip extension strength test
* Positive trunk flexion strength test
* Tight erector spinae
* Asia pacific BMI normal (18.5-24.9 Kg/m2)
* Local intermittent lumbar pain
* moderate pain (NPRS 3-7)
* Painless movement and activity
* Pain only produced by sustained loading in relevant position, which is then relieved on moving from that pos

Exclusion criteria:

* Acute flare of LBP
* Centralization and peripheralization of pain
* Signs of stenosis(leg symptoms when walking that are eased upon flexion)
* Pain due to repetitive movements
* Paresthesia/Numbness
* Structual deformity(Kyphosis, spondylosis, spondylolisthesis,scoliosis and joint contractures)
* Curve reversal
* Pregnancy
* Post surgery
* Degenerative and inflammatory spine diseases
Screening for COVID-19 and Monitoring of Serological Responses to SARS-CoV-2 in Healthcare Workers

The main objectives of this study are 1) to establish the prevalence of SARS-CoV-2 in asymptomatic healthcare workers (HCWs) in an early phase of community spread as well as 2) to monitor the future spread of the disease by assessing serological responses to SARS-CoV-2 in symptomatic and asymptomatic HCWs over time and 3) to improve the assessment of the immune response and its protective effect as well as the assessment of infectivity of affected HCWs and 4) to evaluate the value and significance of antibody formation and serological antibody tests and 5) to be able to evaluate possible future preventive and / or therapeutic approaches against SARS-CoV-2, e.g. to assess vaccination effects

This study aims to collect information on staff working at the Greifswald University hospital.

Over a 5 year period, a maximum of 12 study visits per participant are planned. At each visit, nasal/throat swabs (for PCR testing) and/or blood samples (to assess immunological responses, e.g. for SARS-CoV-2 antibody testing) will be collected. This will help to gain a better understanding of viral load and immunological responses, e.g. antibody development and their effects over time.

At study visit 2 - 12, participants will also be asked to fill in a questionnaire (asking for SARS-CoV-2 risk factors, perceived risk, impact of the pandemic on their quality of life, their interest in getting a SARS-CoV-2 vaccine/their SARS-CoV-2 vaccination status and vaccination side effects).

The remaining blood samples will be stored in a repository for future research.

The study is part of a modular SARS-CoV-2-research programme of the University Medicine Greifswald.

Eligibility Criteria:
Inclusion Criteria:

1. \>= 18 years of age
2. Willing and able to complete a written consent form
3. Willing to have blood samples stored for future research
4. Healthcare worker employed at Greifswald University Hospital

Exclusion Criteria:

1. \< 18 years of age
2. Decline to participate
A Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of PF-03654764 In Combination With Fexofenadine In Healthy Subjects

The purpose of this study in heathy people is to investigate the safety, toleration and time course of PF-03654764 in the blood, following multiple doses given by mouth together with fexofenadine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
Therapeutic Yoga to Improve Function in Parkinson's Disease

This is a single blind, randomized, wait-list controlled, phase II exploratory pilot study.

This is a single blind, randomized, wait-list controlled, phase II exploratory pilot study utilizing an after-trial embedded mixed methods approach that will examine the efficacy of therapeutic yoga as a rehabilitation strategy for individuals with PD to improve balance and reduce fear of falling (FoF). Potential participants will have a FoF in order to enter the study. An after-trial embedded mixed methods design will be employed in this study and will include the collection of qualitative data to assist in the overall interpretation of the more heavily weighted quantitative trial data. Adding qualitative methods will serve as a post-hoc analysis capturing participant perceptions of the relationships between the yoga intervention and various outcomes. More specifically, the qualitative data will aide in explaining the link between the various yoga techniques and mechanisms that participants attribute to improved balance, reduced FoF, and other bio-psychosocial outcomes and experiences. Qualitative data will be collected using focus group interviews with participants in the yoga group at the end of the class in week 8.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's Disease with a rating of 1.5-4 on the Modified Hoehn and Yahr Scale of Parkinson's Disease Progression
* Endorsement of FoF,44 able to stand and walk 10 meters with or without an assistive device
* \>18 years old; able to speak English
* Score \>4 out of 6 on the short Mini Mental Status Exam
* Able and willing to attend twice weekly sessions for 8 weeks

Exclusion Criteria:

* People with self-reported life expectancy \<12 months
* Inability to attend sessions due to transportation issues
* Current involvement with other physical activity (including yoga), rehabilitation, or other intervention studies
* Inability or refusal to provide informed consent
Prevision® PMCF Study

Monocentric, non-interventional Post-Market Clinical Follow-Up (PMCF) Study on past implantations of the Prevision® prosthesis; the survival rate of the Prevision® prosthesis shall be evaluated and compared to literature results on comparable Revision stems.


Eligibility Criteria:
Inclusion:

* Patient received a Prevision® Hip Stem (curved or straight) between 2002 an 2012
* Patient gave his written consent for study participation

Exclusion:

- none
Study PIEB vs PIEB: the Dose is it Variable According to the Patients

the main objective of this study is to compare the effectiveness of three groups of epidurals with three different programmed intermittent epidural bolus (PIEB)settings.

In a PIEB, the concentration of local anesthetics administered is standardized in the services according to the recommendations. What is left to the judgement of the clinician, taking care of the patient during the work, is the administered dose. This often varies according to clinician deductions that take notice of height, weight, previous pregnancies In the CHU of Rennes, three dosages are used in common practice. The objective by comparing these three dosages is to show if there is a significant difference between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old.
* Pregnant patient, during labor, live fetus, for whom a PIEB is desired / programmed.
* Patient not objecting to their participation in the study.

Exclusion Criteria:

* Hemostasis disorder contraindicated the epidural
* Eclampsia
* Caesarean section straightaway
* Patient under legal protection (guardianship, curatorship, safeguard of justice).