cyrilzakka/clinical-trials huggingface dataset:
Sublingual Misoprostol for Induction of Labor

The purpose of this study is to compare effectiveness and safety of a sublingual misoprostol 12,5 mcg with vaginal misoprostol 25 mcg for induction of labour with an alive and term fetus.

Several methods for induction of labour are available. However, the most effective and with less frequency of adverse effects is still unknown. Vaginal misoprostol has been used frequently to induce labour but other routes of administrations have been proposed, such as oral and sublingual. The purpose of this study is to compare effectiveness and safety of sublingual misoprostol 12,5 mcg with vaginal misoprostol 25 mcg administration for induction of labour with an alive and term fetus. A randomized controlled double-blind trial will be carried in two hospitals: Instituto de Medicina Integral Prof. Fernando Figueira and Universidade Federal do Ceará and Instituto de Saúde Elpídio de Almeida, from July 2014 to November 2016. A total of 150 patients must be enrolled. Inclusion criteria are: a) indication for labour induction; b) term pregnancy with alive fetus; Bishop score less than six. Exclusion criteria are: a) previous uterine scar; b) nonvertex presentation; c) non-reassuring fetal status; d) fetal anomalies; e) fetal growth restriction; f) genital bleeding; g) tumors, malformations and/or ulcers of vulva, perineum or vagina. They will be randomized to receive a sublingual misoprostol 12,5 mcg with vaginal placebo tablet or sublingual placebo with vaginal misoprostol 25 mcg tablet. Vaginal tablets will have 25mcg of misoprostol or placebo. Sublingual tablet will have 12,5mcg or placebo. Vaginal misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 200mcg or eight tablets. Primary outcome will be the frequency of tachysystole. Secondary outcomes will be vaginal delivery within 24 hours, hyperstimulation syndrome, cesarean section, severe neonatal morbidity or perinatal death, serious maternal morbidity or maternal death, need of oxytocin for augmentation of labour, number of misoprostol doses needed to bring on labour, interval from first dose to labour and first dose to delivery, failed induction, uterine rupture, need of labour analgesia, instrumental delivery, side effects, maternal death, meconium, non-reassuring fetal heart rate, Apgar scores less than seven at 1st and 5th minutes, admission at neonatal intensive care unit, neonatal encephalopaty, perinatal death and women not satisfied.

Eligibility Criteria:
Inclusion Criteria:

* Indication for labour induction
* Term pregnancy with alive fetus
* Bishop score less than six

Exclusion Criteria:

* Previous uterine scar
* Nonvertex presentation
* Non-reassuring fetal status
* Fetal anomalies
* Fetal growth restriction
* Genital bleeding
* Tumors, malformations and/or ulcers of vulva, perineum or vagina
Advanced Cardiovascular Imaging Consortium

The ACIC is a Collaborative Quality Improvement (CQI) program involving the collection of data related to: indications for Coronary Computed Tomography (CCTA), patient health characteristics, acquisition techniques of CCTA scans, physician interpretation of results and short-term outcomes over a 90 day period.

This study is a collaborative quality assurance initiative organized by Blue Cross Blue Shield of Michigan and Blue Cross Network (BCBSM/BCN) for initiation of insurance coverage of coronary artery CT scanning (CCTA), a relatively new procedure that can provide non-invasive coronary angiograms. While this procedure has promise in that it can rapidly diagnose patients with unknown chest pain and reduce the cost of medical care, there is substantial potential for abuse and excess cost and inappropriate care if not appropriately used.

The Consortium's objectives are to educate participating sites of the clinical uses of CCTA as well as other best-practice recommendations; to create a database (Registry) to develop evidence of the best-practice utilization of CCTA; to provide a feedback mechanism to the sites about the positive or negative evidence of best-practice utilization of CCTA; to develop strategies to improve the utilization of CCTA; to monitor the CQI process of the individual participating sites; to reduce cost and improve safety and efficiency in in the care of patients with acute chest pain, indeterminate stress tests results, and to assess coronary bypass graft patency.

Eligibility Criteria:
Inclusion Criteria:

(Patient must meet one criteria)

* Patient has had a CCTA examination ordered by a referring physician at a participating site.
* Patient is a self referral.

Exclusion Criteria:

Clinical contraindications to CCTA are present as determined by attending physician or staff, including but not limited to:

* Pregnancy or potential pregnancy.
* Renal failure or dysfunction.
* Inability to receive beta blockers.
* Allergy to iodinated contrast without prior premedication.
* Unwillingness to participate.
* Inability to read or understand Patient Information Sheet.
* Age less than 18 years without parent or guardian's evaluation of Patient Information Sheet. Underage and other vulnerable populations are included as the CQI process is intended to detect and correct adverse consequences of CCTA, e.g., excessive radiation, and protect such patients.
Effects of Water-soluble Olive Extract Supplementation

Six weeks of supplementation of an olive extract will:

* Improve antioxidant status
* Reduce inflammation
* Reduce muscle damage
* Improve exercise performance
* Improve exercise recovery as compared to a placebo.


Eligibility Criteria:
Inclusion Criteria:

* Recreational exerciser
* BMI \<= 30
* Non-smoker

Exclusion Criteria:

* Blood pressure over 140/90
* Type I or Type II diabetes
* Renal, hepatic or cardiac disease
* Current infectious disease
Screening for Postpartum Depression and Associated Risk Factors Among Women Who Deliver in Four Hospital in France During the COVID-19 Epidemic

Postpartum depression (PPD) represent around 15% of birth in developed countries. The context of the COVID-19 epidemy represents a possible source of additional emotional distress. The objective of this study is to determine the screening prevalence and risk factors of postpartum depression, among women who deliver in fourth hospital in the North of France in the context of the COVID epidemy.


Eligibility Criteria:
Inclusion Criteria:

* Single baby delivery
* alive new born child without admission in neonatal intensive care unit
* French-speaking mother
* mother older than 18 years old

Exclusion Criteria:

* Patients who refuses the inclusion
Study Evaluating Pharmacovigilance Of Refacto AF

The purpose of this observational study is to describe the incidence of adverse events among patients treated with Refacto AF in usual health care settings in Germany and Austria.

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility Criteria:
Inclusion Criteria:

* Patients with hemophilia A of any severity already receiving or starting treatment with ReFacto AF.

Exclusion Criteria:

* Patients with Hemophilia A treated with a product other than Refacto AF.
Study Evaluating the Safety, Tolerability, PK, and Activity of Topical ATx201 Gel in Outpatients With Impetigo

This is a Phase 2 study evaluating the safety, tolerability, systemic exposure, and activity of topical ATx201 GEL (2% and 4%) treatment for 1, 2, or 5 days in outpatients with primary nonbullous or bullous impetigo.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of primary nonbullous or bullous impetigo
* affected area comprising 1 to 100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area.
* target area has total SIRS score of at least 3, including pus/exudate of at least 1
* normally active and otherwise in good health by medical history and physical examination

Exclusion Criteria:

* has a pre-existing skin condition or skin trauma with clinical evidence of secondary infection
* has an infection that could not be appropriately treated with a topical antibiotic or severe manifestation of impetigo warranting systemic therapy
* clinically significant mental illness
* pregnant or breast-feeding
* recent history, or strong potential for, alcohol or substance abuse.
* skin condition that may interfere with the placement of study treatment or impede clinical evaluations
* receipt of systemic drugs that affect the immune system within the past 3 months
* receipt of any topical medication on the regions to be treated or topical antibiotics used for nasal decolonization within the past 24 hours
Acute Efficacy of Exercises Applied With Xbox and Biodex Devices in Pes Planus"

.Pes planus; It can be defined as the valgus of the hindfoot while loading the foot, the disappearance of the medial longitudinal arch in the midfoot, and the supination of the forefoot relative to the hindfoot. It may also occur due to the fact that the medial longitudinal arch in the foot is lower than the required height according to the anatomical position. The parts of the foot that touch the ground are anatomically healthy in a person; They are the heads of the calcaneus tuberositas calcanei on the back of the foot and the 5 metatarsal bones on the front of the foot. In the standing position, 25% of our body weight is on the tuber calcanei, while 25% is on the 5 metatarsal bones. In individuals with pes planus, convergence of the sole of the midfoot to the ground may even result in the sole of the midfoot touching the ground at its advanced levels. It is one of the common foot deformities.

pes planus can cause symptoms and dysfunction that are symptomatic or severe enough to limit patients' quality of life. Degeneration of the posterior tibial tendon may occur due to trauma, neuroarthropathy, neuromuscular disease and inflammatory arthritis. Among these, the most common cause of pes planus is the degeneration of the posterior tibial tendon.

The highest arch of the foot, the medical longitudinal arch calcaneus, talus, navicular, cuneiform and 1-2-3. It is formed by metatarsals. It is effective in the distribution of the load on the feet. Plantar ligaments are important in protecting the dome of the foot.

They used many definitions known as pes planus, that is, flat feet in the literature. Weak foot, relaxed foot, pes valgus, congenital hypermobile flat foot, hypermobile flat foot, flaccid flat food, talipes calcaneovalgus, compensated talipes equinus can be given as examples.

Eligibility Criteria:
Inclusion Criteria:

* Having mild and moderate pes planus,
* Volunteering of individuals,
* Being between the age group of 18-25,
* Having experienced at least one inflammatory symptom (pain, swelling, etc.)
* Not having any systemic, locomotor and foot related diseases, sensory loss, diabetic and peripheral neuropathy.

Exclusion Criteria:

* Having had a serious lower extremity injury in the last 6 months,
* Getting a full score from the balance test,
* Having ligament rupture in the ankle.
The Indian POLYCAP Study (TIPS)

STUDY TITLE A randomized double-blind controlled trial of the efficacy and safety of the POLYCAP® versus its components in subjects aged 45 to 80 years of age with at least one additional cardiovascular risk factor.

STUDY OBJECTIVES This study is designed to assess the efficacy and safety of the POLYCAP®, a fixed dose combinationcontaining 5 drugs (an antiplatelet drug; 3 blood pressure lowering agents, a beta blocker, an ACE inhibitor, a diuretic and a statin.

STUDY DESIGN

Randomized controlled double-blind trial of the POLYCAP® versus its components in eight formulations.

STUDY POPULATION Subjects between 45 and 80 years of age, with at least one additional CVD risk factor.

INVESTIGATIONAL PRODUCTS Composition POLYCAP® and its comparators FOLLOW UP The total duration of follow up will be 4 months, from the start of study medication.. Subjects will take study medication for 3 months. There will be a final follow up visit 1 month after stopping the study medication.

There will be five follow up visits, the first 7 - 10 days after starting study medication and thereafter monthly visits for 4 months. Subjects taking any of the study medications prior to enrolment will have one or more additional visits during a defined wash out and before enrolment.

OUTCOME MEASURES Mean difference of change in BP, LDL and urinary thromboxane at the end of the three month period.

STATISTICAL ISSUES Non-inferiority evaluation of the POLYCAP in modifying BP, lipids and platelet activity \[as measured by urinary thromboxane\] when compared with its different components in eight different formulations.


Eligibility Criteria:
Inclusion Criteria:

* Age between 45 and 80 years
* At least any one of the following CVD risk factors:

  * Stable type 2 diabetes mellitus or
  * Hypertension or
  * Current smoker or
  * A waist to hip ratio \> 0.85 for women and \>0.9 for men or
  * Elevated lipids.
* Informed consent.

Exclusion Criteria:

* On any of the study medications,
* Uncontrolled blood pressure,
* Symptomatic hypotension,
* Any clear indication or a contraindication to the use of any of the study medications,
* History of coronary/cerebrovascular events,
* Pregnancy or lactating or women of child-bearing potential with inadequate contraception and / or an inability to attend follow up visits.
Survey of Tourniquet Use in a Combat Support Hospital

Data will be collected on the type of tourniquet and circumstances of its use. Patients with penetrating extremity injury will have clinical and pre-clinical hospital data collected.

This is a performance improvement project that is a prospective observational cohort design with subgroup analyses. This project meets the criteria of research with its intent to publish. No data is generated and only existing data are used. No interventions are made and the comparisons will be with within subgroups in the cohort.

Aim 1. Describe the number of tourniquets which were appropriately used (wound required a tourniquet and tourniquet was placed properly) as assessed by treating physician

Aim 2 \&3. Describe if limbs wounds with tourniquets were bleeding upon admission, resuscitation, and following tourniquet removal

Aim 4. Describe if mortality for the cohort of patients with tourniquets is different than the mortality predicted by various injury scoring systems

Aim 5. Compare patient outcomes between those in which a tourniquet was indicated but not used and those for whom a tourniquet was indicated and used

Aim 6. Determine if patients that received tourniquets for an extended time period exhibit any known tourniquet complications

Eligibility Criteria:
Inclusion Criteria:

* penetrating extremity injury with tourniquet use

Exclusion Criteria:

* non penetrating extremity injury
Effects of Black Soy Peptide Supplementation on Blood Pressure

Black soy peptides have been shown to possess properties that may decrease blood pressure. To examine the effects of black soy peptides supplementation on blood pressure and oxidative stress in subjects with pre-hypertension or stage I hypertension.

Trial participants included men and women aged 30 to 65 years who had an average systolic blood pressure (SBP) between 130 to 159 mmHg, average diastolic blood pressure (DBP) between 80 to 99 mmHg, or both, based on an average of six measurements during two screening visits. Participants were supplied with 84 pouches of placebo (casein) or black soy peptide (3 pouches/day) at 0-week and at 4-week visits. Test group subjects received pouches containing black soy peptides (4.5 g/day total soy peptides for 8 weeks). The control group received pouches containing casein that had a similar appearance to the black soy peptide tablet. During the intervention, we instructed study participants to continue their current food intake patterns and lifestyles so that total energy intake and energy expenditure would be constant during the course of trial. Participants brought back unconsumed pouches at their 4- and 8-week follow-up visits. The dietitian counted the number of returned pouches, and we used this to assess the participants' adherence to their assigned intervention.

Eligibility Criteria:
Inclusion Criteria:

* Average systolic blood pressure (SBP) between 130 to 159 mmHg
* Average diastolic blood pressure (DBP) between 80 to 99 mmHg, or both, based on an average of six measurements during two screening visits

Exclusion Criteria:

* Previous diagnosed clinical hypertension
* Self-reported use of anti-hypertensive medication
* Abnormal liver or renal function
* History of cardiovascular disease, cancer, thyroid or pituitary disease, or any other serious life-threatening illness that required regular medical treatment
Prostate Cancer Diagnosis Through NMR Spectroscopy of Semen and Prostatic Secretions

To develop the hypothesis that quantitative NMR spectroscopy of human semen can be used to diagnose prostate cancer.

Any willing subject who meets the male gender requirements, who is competent, agrees to participate, and is able to understand the consent form.

Eligibility Criteria:
Inclusion Criteria:

* Any willing subject who meets the male gender requirements, who is competent, agrees to participate, and is able to understand the consent form.

Exclusion Criteria:

* Not sepcified.
Study of Nivolumab in Subjects With Relapsed or Refractory Follicular Lymphoma (FL) (CheckMate 140)

The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating agent.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Grade 1, 2, or 3a FL without pathologic evidence of transformation
* Male and female, ages 18 and above, with relapsed or refractory FL lymphoma after \> or =2 prior treatment lines; each of the 2 prior treatment lines must include at least CD20 antibody and/or an alkylating agent
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1

Exclusion Criteria:

* Known central nervous system lymphoma
* History of interstitial lung disease
* Subjects with active, known or suspected autoimmune disease
* Prior allogeneic stem cell transplant
* Prior autologous stem cell transplant ≤12 weeks prior to first dose of study drug
Adherence Through Home Education and Nursing Assessment, Indonesia

Adherence to antiretroviral therapy (ART) drops sharply after prison release. Effective medication adherence training immediately before and after prison release may improve health outcomes and limit transmission of Human Immunodeficiency Virus (HIV). ATHENA (Adherence Through Home Education and Nursing Assessment) is an evidence-based medication adherence intervention, which is delivered in the patient's home by nurses and peer educators working in teams. In this study, researchers will examine the acceptability and feasibility of the ATHENA intervention through a 2-arm randomized controlled trial conducted with HIV-infected prisoners in Indonesia. Eligible subjects will be \>18 years of age, HIV-infected, and may be treatment-experienced or treatment-naive. Subjects randomized to the intervention arm will participate in monthly medication adherence counseling sessions within prison and home visits up to four months after prison release. Subjects randomized to the control arm will receive standard care, which includes a referral for HIV care after prison release. The primary endpoint is the proportion of subjects demonstrating ART adherence \>90% at 3 months after prison release. Secondary endpoints are: 1) retention in HIV care, 2) ART initiation, 3) HIV- RNA viral load, 4) CD4+ T-cell count, 5) quality of life, 6) hospitalization, 6) substance use and sexual risk behaviors at 3 months after prison release.

The acceptability and feasibility of the adapted ATHENA intervention will be assessed through a 2-arm randomized controlled trial conducted in two phases with HIV-infected prisoners recruited from 2 correctional facilities in Jakarta, Indonesia.

Phase 1: HIV+ prisoners who are already aware of their status will be recruited through prison clinics and randomized to receive either the adapted ATHENA intervention or standard care as a control. Uniform data collection at baseline will include measures of ART adherence, HIV stigma, and drug dependence and CD4+ T-cell and viral load testing.

Phase 2: Subjects receiving the ATHENA intervention will participate in monthly medication adherence counseling sessions within prison, and home visits up to four months after prison release, during which intervention staff (nurses and peer educators working in teams) will deliver individualized medication adherence counseling based on the Freirian educational model.

Phase 3: Participants in both groups will be followed for 12 months after prison release, and asked to complete monthly study visits to evaluate primary and secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection documented by a rapid HIV test or any licensed ELISA test; and confirmed by another test using a different method, including but not limited to rapid HIV tests, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry; and aware of HIV status
* age ≥ 18 years
* Karnofsky performance score \>40
* conversant in Bahasa Indonesia

Exclusion Criteria:

* none