cyrilzakka/clinical-trials huggingface dataset:
Community-based, Peer-delivered PrEP for Female Sex Workers in Rural Uganda: The Peers for PrEP (P4P) Study

The overall goal of the P4P: Peers for PrEP (pre-exposure prophylaxis) study is to pilot test a peer-led and delivered intervention for biomedical HIV prevention that is tailored to women who engage in sex work in southwestern Uganda. This study will evaluate whether this intervention is feasible, acceptable, and increases uptake of biomedical prevention.

The investigators have collaborated with key stakeholders to develop a community-based, peer-led intervention to provide biomedical prevention products (e.g. pre-exposure prophylaxis \[PrEP\] and post-exposure prophylaxis \[PEP\]) for women who engage in sex work in southwestern Uganda. A single-arm pilot trial will evaluate the feasibility, acceptability, and preliminary effectiveness of the intervention. The intervention is designed to reduce stigma associated with attending clinics (via community-based delivery by peers), leverage peer support to foster adherence, and reduce barriers to prevention services (through access to PrEP, HIV self-testing, and PEP from trusted peers).

Eligibility Criteria:
Inclusion Criteria:

* Female sex at birth
* Self-identified as commercial sex worker; exchange of sex for goods or money in last 3 months; or work or live in setting associated with sex work
* Age \>=18 years (or mature minor \>=15 years)
* HIV-negative by country-standard rapid testing algorithm

Exclusion Criteria:

* Contraindication to country-recommended PrEP regimen per national guidelines
* Unable or unwilling to provide informed consent
* Participation in another HIV prevention study
Contact Lens Adaptation in Neophytes

Eye care professionals prescribe contact lenses to new wearers on a daily basis, and it is common practice for practitioners to educate their patients to gradually increase their contact lens wear time over their first few days of use; however, there is no scientific basis in the literature for this practice. This study will compare the ocular health and comfort of new contact lens wearers who are randomly assigned to begin contact lens wear with increasing wearing time versus those who immediately start full-time wear (eight hours or more/day). The increasing wearing time group will wear daily wear contact lenses (Acuvue Oasys) for two, four, six, eight, and eight or more hours on the first, second, third, fourth, and fifth days, respectively. The other group will be instructed to wear the same contact lenses for eight or more hours per day, starting with the first day of wear. Both groups of subjects will have their eye health and comfort evaluated at baseline, one, and two weeks with a lighted-microscope and eye comfort surveys. Subjects will also keep a daily log of eye comfort with a visual analog scale survey at home. All subjects will learn how to wear and take care of contact lenses. They will also receive a prescription for contact lenses at the conclusion if they wish to continue wearing the study contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Has had a completed comprehensive eye exam within the past 6 months
* Able to wear spherical senofilcon A contact lenses
* Able to use Opti-Free PureMoist contact lens solution

Exclusion Criteria:

* Any prior contact lens use
* Topical eye drops within the last two hours of the study visit
* Known systemic health conditions known to alter tear film physiology
* History of severe ocular trauma
* Active ocular infection
* Active ocular inflammation
* Known hypersensitivity to diagnostic eye drops
* Pregnant or breast feeding
A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity

The main purpose of this study is to determine if combining tirzepatide with mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 74 weeks and may include up to 19 visits.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) of ≥30 kilogram/square meter (kg/m²) and ≤40 kg/m²
* Willing to learn how to self-inject study intervention (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject the study intervention; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the study intervention)
* Male or female contraceptive use by participant should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

* Have a history of diabetes mellitus, including Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma
* Have a self-reported change (increase or decrease) in body weight \>5 kilogram (kg) within 3 months prior to screening
* Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2
* Have acute or chronic hepatitis
* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
Effect of Early Postoperative Drinking Water on Postoperative Recovery Quality of Patients With Thyroid Surgery

This study is a single-center, prospective and randomized controlled study to investigate the effects of early recovery of oral intake (E) and late recovery of oral intake (L) on postoperative recovery quality and satisfaction of patients undergoing thyroid surgery. The study's primary outcome is quality of recovery-15 scale (Qor-15).

The subjects of this study are patients who will receive thyroid surgery in Peking Union Medical College Hospital. After the patient is included in the experiment, when the patient meets the exit criteria of the PACU, the patient will be randomly assigned to early resumption of oral intake group and late resumption of oral intake group to receive different treatments. Finally, researchers will collecte and evaluate the different outcome indicators of the two groups of patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. ASA Physical Status I-II
3. Body mass index 18.5-29.9kg/m2
4. First operation on operation day
5. Thyroid surgery

Exclusion Criteria:

1. Patients or family members cannot understand the conditions and objectives of this study
2. Preoperative patients with acute pharyngitis, hoarseness, cough, dysphagia, and high risk of aspiration
3. The surgeons or anesthesiologists point out that the patient is not suitable for early postoperative drinking (such as considering the injury of recurrent laryngeal nerve or lymphatic vessels during the operation)
4. Exclusion criteria of QoR-15\* (\*QoR-15 exclusion criteria: 1. Unable to understand words and language; 2. Difficult to cooperate due to mental disorders; 3. History of alcohol or drug abuse; 4. Any serious pre-existing medical condition that can limit the objective evaluation after surgery; 5. Any life-threatening complications; 6. Emergency surgery)
Isokinetic Fatigue Index in a Population of Triathletes

The aim of this study is to evaluate the relevance of carrying out a measure of muscular fatigability by isokinetism, in the search for factors favouring micro-traumatic lesions of the lower limbs in a population of triathletes.

This is a prospective monocentric pilot study of the before/after type in which the patient is his or her own control, in high-level triathletes practising an endurance sport, who have had more than 7 consecutive days off running due to a musculoskeletal injury during the previous sporting year.


Eligibility Criteria:
Inclusion Criteria:

* Having had a practical running break of more than 7 consecutive days due to a musculoskeletal injury of a lower limb during the previous sport year
* Willing to comply with all study procedures
* Having given written consent
* Socially insured

Exclusion Criteria:

* Pain that does not allow an isokinetic test to be performed
* Knee joint amplitude less than 100° of flexion or flessum greater than 5°.
* History of rupture or ligamentoplasty of the anterior cruciate ligament less than 2 years ago
* History of knee surgery less than 2 years
A Cross-sectional Study of Congenital Cytomegalovirus Infection in Newborns in China

The primary objectives of this study were to evaluate the incidence of congenital CMV infection in neonates, and assess the concordance of detecting congenital cytomegalovirus (CMV) infection in neonatal saliva and urine samples.

This Cross-sectional study was conducted to recruit neonates less than 14 days old delivered in Maternal and Child Health Hospitals (MCHHs) of Xinmi City, Jiaxian County, Zhongmu County and Huli District Xiamen City, in China, from June 2015 to June 2016. The aim of this study is to enroll \~1800 neonates, and collect their saliva and urine samples which will be tested the CMV DNA by using real-time PCR.

Eligibility Criteria:
Inclusion Criteria:

* Neonates aged 0 to 14 days
* Neonates delivered in MCHHs of Xinmi City, Jiaxian County, Zhongmu County and Huli District Xiamen City

Exclusion Criteria:

* the parents of neonates not comply with our study
Effects of Dapagliflozin on the Incretin Sensitivity of the Pancreatic Beta Cell

To investigate the effect of dapagliflozin on the incretin sensitivity of the pancreatic beta cell.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for dapagliflozin arm
* Normal glucose tolerance (fasting plasma glucose \<100 mgd/l, HbA1c \<6.0%) for normal glucose tolerance arm
* Age 18 to 75 years
* BMI \<35 kg/m2
* For type 2 diabetes patients, at least 3 months of treatment period and HbA1c 7.5 to 11.0% and treatment with lifestyle modification and/or metformin or sulfonylurea

Exclusion Criteria:

* Who is allergic to dapagliflozin
* Type 1 diabetes
* Patients with history of diabetic ketoacidosis
* Reduced renal function (eGFR \<60ml/min/1.73m2)
* Taking loop diuretics or dehydrated patient
* History of hypotension when taking hypertensive medication
* Diagnosed with heart failure
* Diagnosed with cerebral infarction
* Taking insulin, DPP-4 inhibitor, GLP-1 analogue, pioglitazone, alpha-glucosidase inhibitor
* Above upper limit of normal hematocrit range (male 39-52%, female 36-48%)
* Pregnant or breastfeeding women
* History of recurrent genitourinary infection
* AST/ALT more than two fold increased above normal upper limit
* Hemolytic disorder
Simvastatin Effect on Radiation Therapy of Brain Metastases

The purpose of the study is to evaluate the effect of simvastatin in combination with radiotherapy on the clinical outcomes of patients with brain metastases.

Despite current advances in therapies, the outcome for patients with brain metastases is fatal. New therapeutic approaches, such as radiosensitizing agents, are needed to provide a significant survival advantage for those patients. Statins have been reported to enhance the efficacy of radiotherapy in addition to a neuroprotective effect. The aim of the study is to evaluate the effect of simvastatin on the efficacy and safety of radiation therapy in patients with brain metastases and on improving patients' quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with measurable brain metastases
* Age more than 18 years old
* Patients should be planned for radiation therapy

Exclusion Criteria:

* Renal dysfunction (more than 1 upper normal level)
* Hepatic dysfunction (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>3 times the upper normal level )
* Pregnancy or lactation.
* Known hypersensitivity to simvastatin
Analysis of the Mechanisms of Actions of Heat Shock Protein (Hsp27) Responsible of the Androgen-independent Evolution in Prostate Cancer

Prostate cancer (PC) represents one of the most common cancers in industrialized countries. Patients with localized disease may be treated with surgery or radiation, while androgen ablation is used as first-line therapy in patients with metastatic disease. While most patients initially respond well to this hormonal therapy, they most ultimately become unresponsive and recur within 2 years as androgen-independent prostate cancer (AIPC). Recently, docetaxel-based regimens have demonstrated improved survival in men with AIPC in two different, large, phase III studies. However, the median overall survival was prolonged for only 2 or 3 months. Androgen independent (AI) progression involves variable combinations of clonal selection, adaptive up-regulation of anti-apoptotic genes, ligand-independent androgen receptor (AR) activation, alternative growth factor pathways, and immune system escape. Additional therapeutic strategies targeting molecular mechanisms mediating resistance, combined with immunotherapy must be developed. One strategy to improve therapies in advanced PC involves targeting genes that are activated by androgen withdrawal, either to delay or prevent the emergence of the resistant AI phenotype. Recently, a scientist,identified Heat Shock Protein (Hsp27) as a highly over-expressed gene in AIPC. Hsp27 knockdown using antisens oligonucleotides (ASO) and small interfering RNA (siRNA) increased apoptotic rates and enhanced hormone- and chemo-therapy in PC. She developed and patented a 2nd generation ASO targeting Hsp27 that has been licensed (investigational drug called OGX-427) and clinical trials phase I/II is currently in process in PC. Despite OGX-427 efficiency, the functional role of stress induced Hsp27 in castration or chemotherapy-induced apoptosis remains undefined. The purpose of this study is to elucidate the pathways leading to Hsp27 action in androgen-independent prostate cancer in order to 1/ Increase the pharmacological safety of OGX-427 and 2/find new specific therapeutic targets and treatment strategy for androgen-independent prostate cancer .


Eligibility Criteria:
Inclusion Criteria:

* Prostate adenocarcinoma
* Patient \> 18 years old
* Patient affiliated to a social security system or benefiting from such a system
* Signed consent to participate

Exclusion Criteria:

* Patient in emergency situation, major person being the object of a legal protective measure or unable to express its consent
Prognostic Score in Covid-19

The aim of the study is to define the clinical and biochemical parameters that characterize COVID-19 patients with a negative prognostic evolution. Our clinical score will be capable to recognize patient with favorable prognosis or patient with poor prognosis by statistical data analysis.


Eligibility Criteria:
Inclusion Criteria:

* patients over 18 and symptomatic and positive for COVID-19 by polymerase chain reaction assay for rhino-pharingeal swab

Exclusion Criteria:

* Under 18
Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function

To evaluate the effect of renal impairment on the pharmacokinetics (PK) of teduglutide following subcutaneous (SC) administration of 10 mg teduglutide.

Secondary objectives are to assess the safety and tolerability of 10 mg teduglutide. A further objective is the description of the PK of teduglutide following SC administration of 10 mg teduglutide in elderly (≥ 65 years) healthy subjects compared to non elderly healthy subjects.

Pharmacokinetic study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with moderate, severe and end stage renal failure and matched healthy controls.
Figure-of-Eight Hand, Volumetric Measurements and Reliability in Clinic With Hand Injured Patients

This study determined the intra-rater and inter-rater reliability of the Figure-of-Eight method on healthy hands, and compared the figure-of-eight measurements to the gold standard volumetric measurements. Part B of the study conducted in a clinic, assessed the intra-rater reliability and inter-rater reliability on both hands of patients with hand injuries.

Edema is the retention of fluid in the intracellular spaces, which is common in inflammatory condition such as traumatic injury and post surgical conditions. Edema in the hand and wrist can result in detrimental physiological changes which decrease the range of motion of joint and limit the overall functional capacity and dexterity of the hand. The gold standard Volumetric measurements are reliable for measuring edema changes in upper extremity. Using volumeters can be cumbersome in a busy clinic. Figure-of-eight measurements using a tape measure on the wrist and hand is an easy way to measure edema and can capture the accumulation in the dorsal hand that circumferential tape measurements do not capture. This study was performed in two parts. Part A determined the intra-rater and inter-rater reliability of the Figure-of-Eight method on healthy hands, and compared the figure-of-eight measurements to the gold standard volumetric measurements. No study other study has compared right and left hands. Part B of the study was conducted in a clinic to assess the intra-rater reliability and inter-rater reliability on both hands of patients with hand injuries.

Eligibility Criteria:
Inclusion Criteria

* Healthy-part A
* Recent history of hand or wrist injury with swelling -part B

Exclusion Criteria

* Open wounds-part A
* Current swelling-part A
* History of injury in either upper extremity-part A
* Diabetes mellitus-part A
* Raynaud's Syndrome-part A
* Pregnant women-part A \& B
* Could not speak English-part A \& B
* Could not consent for oneself-part A \& B
Comparison of Image Quality of Coronary Computed Tomography Angiography bEtweeN High concenTRATion and Low concEntration Contrast Agents(CONCENTRATE Trial)

According to CT technology development, cardiac CT is very useful examination as noninvasive examination and the accuracy in locating lesions has increased to 95%. Specifically, cardiac CT has been performing a gateway role in reducing invasive cardiac angiography implemented solely for the purpose of diagnosis because of the invasive testing of makeshift cardiac angiography. However, cardiac CT also comes with the disadvantage that patients cannot avoid being exposed to radiation, so there has been much effort in appealing to reduce exposed radiation dose. Of these methods, the most effective is the method of repeatedly reconstitution by way of synchronized prospective ECG while using low tube-based potential. According to recent studies, the SNR(Signal Noise Ratio) and CNR(Contrast Noise Ratio) values representing image quality have been higher compared to the combined method of image reconstruction by makeshift filtered back projection and condition of image acquisition by patient BMI. Also, the administered amount of contrast agent can be reduced for achieving the same contrast effect due to the advantage of the increased effect of contrast enhancement by using low tube voltage. Therefore, the efficacy studies of using low concentration of contrast agents in conditions of using low tube voltage are being processed.

This study intends to prove that image quality does not deteriorate by suitable image reconstruction method with low concentration contrast agent compared to the combined method of the makeshift filtered back projection image reconstruction method and the conditions of image acquisition according to BMI with general amount of contrast agent.


Eligibility Criteria:
Inclusion Criteria:

* Adults at least 20 years old
* Subject who had requested a coronary CT angiography as per a clinical disease

Exclusion Criteria:

* Subject suspected as having myocardial infarction, unstable angina pectoris, coronary artery disease
* Subject with heart attack within 40 days prior to the CT scan
* Subject with diagnosed complicated heart anomaly
* BMI (body mass index) \> 35kg/m2
* Serum creatinine ≥1.5mg/dl of renal insufficiency
* Subject with pregnancy or unknown pregnancy
* Subject with history of hypersensitivity reaction of contrast agents
* Subject has contraindication of using nitroglycerine
* Subject has plan to participate or enrolled in other randomized clinical trial for cardiovascular disease.
* Subject has contraindication of using adenosine (e.g. bronchial asthma, 2-3 degree AV block, sick sinus syndrome, SBP (systolic blood pressure) less than 90mmHg, recent prescribed history of dipyridamole, hypersensitivity of adenosine)
The Effects of Enoximone in Acute Exacerbation COPD

Introduction:

The pharmacodynamic properties of enoximone could be beneficial for patients with an Acute Exacerbation COPD (AE-COPD). This research will focus on patients suffering of a severe AE-COPD and the bronchodilatory and inotropic effects of lower doses of enoximone. The main objective of the pilot study is to investigate if there is a bronchodilatory effect of enoximone in patients with AE-COPD. Secondary objective is to investigate a dose responsiveness in a range between 0.5 and 1.5 mg/kg enoximone.

Methods:

The study design is a prospective interventional non-randomized clinical series study involving patients admitted and intubated at the Intensive Care Unit (ICU) with an AE-COPD. Patients will receive three times a dose of 0.5 mg/kg enoximone with a one-hour-interval. The primary objective is a reduction in auto-positive end-expiratory pressure (PEEP) after enoximone compared to baseline. A dose-titration will test for dose dependency. Secondary objectives are a reduction in ventilator pressures, a reduction in pulmonary artery pressures and an increase in cardiac output.

Ventilator will be set during the study period at Volume Controle, 6 ml/kg, 5 PEEP and a respiratory rate of 15 bpm with an I:E-ratio of 1:2.

Salbutamol/ipratropium bromide and magnesium sulphate will be administered at baseline (t=0h) and measurements will be made for an hour.

At T=1h the first dose of 0.5 mg/kg enoximone will be administered and will be repeated at T=2h and T=3h. Ventilator derived variables will be obtained every fifteen minutes and echocardiography, arterial and central venous bloodgas analyses every hour until t=6h.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an AE-COPD for which intubation occurred within 24 hours before enrolment.

Exclusion Criteria:

* Patients with known asthma or interstitial lung disease (ILD)
* Known neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Guillain-Barre and Dementia
* Hypertrophic obstructive cardiomyopathy (HOCM)
* Severe aortic stenosis with aortic valve area \< 1cm2
* Known ventricular arrhythmias
* Severe kidney disorders with Glomerular Filtration Rate (GFR) \< 30
* Severe liver insufficiency with spontaneous PT/INR \> 1.5
* Pregnancy
* Lactation
* High dose-diuretics use (daily dose of \>480 mg furosemide)
Anticoagulant Utilization Pattern

This study plans to describe utilization patterns for oral anticoagulants over time in patients with non-valvular atrial fibrillation at risk for stroke using electronic claims data from a United States commercial insurance database.


Eligibility Criteria:
Inclusion criteria:

* A recorded diagnosis of atrial fibrillation
* Initiation of oral anticoagulant medication
* Congestive Heart Failure, Hypertension, Age \> 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease, Age 65-74, Sex Category (CHA2DS2-VASc) Score \>=1
* At least 18 years of age on the date of anticoagulant initiation

Exclusion criteria:

* Patients with missing or ambiguous age or sex information
* Patients with documented evidence of valvular disease
* Patients with less than 12 months enrolment in the UnitedHealth Research Database preceding the first dispensing
* Patients with prior use of any oral anticoagulant