cyrilzakka/clinical-trials huggingface dataset:
Detection of Significant Coronary Artery Disease by Promising Biomarker: A2A Adenosine Receptor (A2AR) Assays

Transversal, national, multi-center study with progressive recruitment designed to assess the diagnostic accuracy of A2AR expression for the identification of significant obstructive CAD (FFR\<0.8) of patients suspected of CCS compared to the gold standard.

1. To assess the diagnostic accuracy of the A2AR profile (i.e. KD/EC50) for identifying myocardial ischemia in patients with suspected CCS compared to the gold standard inducible myocardial ischemia.
2. To determine the best threshold value for A2AR expression for identifying significant obstructive CAD (FFR\<0,8) in patients with CCS, and to estimate the diagnostic performances associated with the identified threshold
3. To determine the best threshold value for A2AR profile (i.e. KD/EC50) for identifying myocardial ischemia (See annex 2) in patients with CCS and to estimate the diagnostic performances associated with the identified threshold.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged ≥18 and \<90 years old;
* Must not be of child-bearing potential (≥1 year post-menopausal, contraceptive, or surgically sterile);
* Symptoms suggestive of CCS and intermediate PTP (15-85%) according to the Diamond classification (2);
* Undergone at least one stress imaging test (annex 3) or an abnormal coronary Computed Tomography Angiography (CTA) with the recommendation to perform ICA with FFR in all intermediate lesions;
* Non-contributive ECG (resting 18-lead);
* Normal echocardiography with left ventricular ejection fraction (LVEF) \>50%;
* Cardiac troponin level \<99th percentile;
* Intended for an invasive strategy for CCS;
* Affiliated to or beneficiary of, a social security system;
* Signed written informed consent.

Exclusion Criteria:

Persons referred in articles L.1121-5 to L.1121-8 and L.1122-2 of the Public Health Code:

* Pregnant, parturient or breastfeeding woman
* Person deprived of liberty for judicial or administrative decision
* Person under psychiatric care
* Minor person (non-emancipated)

  * History of CAD or known CAD
  * Suspected acute coronary syndrome (ACS: annex 4)
  * Inability to undergo adenosine testing
  * Allergy to iodinated contrast media
  * Bleeding diathesis
  * Known significant bleeding risk according to physician judgment
  * Severe hepatic failure (ASAT, ALAT\>3ULN)
  * Ischemic stroke within 1 month or a history of hemorrhagic stroke
  * Bradycardia
  * Platelet count \<100 G/L
  * Hemoglobin \<10g/dl
  * Major surgery or trauma within 10 days
  * Life expectancy \<1 year
  * Pre-test Probability \<15% or \>85%
  * History and clinical examination suggesting non-cardiac chest pain
  * Contraindication to coronary angiography
  * Thyroid disorder
  * Refusal to participate
Renal Transplantation and Raltegravir in HIV-Infected Patients

The aim of this study is to evaluate the incidence of acute renal graft rejection 6 months after transplantation in HIV-infected patients under three antiretroviral drugs regimen including Raltegravir.

Antiretroviral treatment of HIV-1 Infection might interact with immunosuppressive treatments which increase rejection of renal graft incidence.

In addition HIV infection may be modified together with cardiovascular risk. Patients participating to this study will receive after transplantation antiretroviral regimen including Raltegravir.

Raltegravir treatment does not interact with immunosuppressive drugs and thus seems to be the treatment of choice to be associated with immunosuppressive drugs.

Eligibility Criteria:
Inclusion Criteria:

* Registration on the French national renal transplantation waiting list (Biomedicines Agency) for a living or cadaveric donor organ
* HIV-1-infected patients treated by a three-drug ARV regimen
* Immuno-virologic criteria at renal transplantation: undetectable viral load (\<50 copies/mL) and CD4 \>200/mm3 for at least three months on stable ARV
* Age \>18 years and \<70 years
* Effective contraception for women
* Written informed consent
* Patient with social security coverage

Exclusion Criteria:

* Permanent:

  * Hepatic cirrhosis
  * Serious psychiatric illness history
  * EBV or HHV8 lymphoproliferation (lymphoma, systemic Kaposi's sarcoma or multifocal Castleman's disease)
  * History of PML
  * HTLV-1 seropositivity
  * Severe pulmonary or cardiovascular disease with poor short-term vital prognosis
  * Patient with AgHBs+
  * History of cryptosporidiosis
  * History of fungal infection with multi resistant fungi not likely to respond to oral antifungal therapy
  * Impossibility or refusal of Raltegravir switch, decision made by doctor or patient
* Temporary:

  * Recent malignancy (between 2 and 5 years according to type)
  * HPV-related cervical or anal disease: carcinoma in situ, AIN III, CIN III in remission for less than three years
  * Active infection
  * HCV infection (PCR-positive)
The Biophysical Impact of Transcutaneous Spinal Cord Stimulation Within a Single Session

To determine the biophysical impact of biophysical Impact of Transcutaneous Spinal Cord Stimulation (TSCS) within a single session. We hypothesize that subjects will demonstrate increased volitional muscle strength with TSCS. This will be assessed by isokinetic strength testing of post-injury dominant-side knee extension. Subjects will be tested in both Transcutaneous Spinal Cord Stimulation and sham conditions.

The investigators will conduct isokinetic strength testing (via the Biodex) of post-injury, dominant-side knee extension before, during, and after TSCS and a sham condition. Transcutaneous Spinal Cord Stimulation will be applied (via the Vectra Neo) using a 5cm x10cm oval electrode placed midline on the skin between spinous process T11 -T12 as a cathode and two 7.5cm x 13cm rectangular electrodes placed symmetrically on the skin over the lower abdomen as anodes. A symmetrical biphasic rectangular waveform, at 50Hz and 1millisecond, will be used to provide 30 continuous minutes of stimulation. As sham procedures for this intervention have not been established, the investigators will follow sham procedures well documented in Transcranial DC Stimulation (tDCS). Electrodes will be placed as they are in the Transcutaneous Spinal Cord Stimulation condition. Stimulation will be applied at subject's maximum intensity for 30 seconds and then discontinued. Subjects will participate in two testing sessions, each approximately one hour in length, separated by at least 24 hours.

Subject's starting condition will be randomized. Subjects will be informed that two stimulation conditions are being tested, but will not be told which is the experimental condition.

Eligibility Criteria:
Inclusion Criteria:

* \> 1 year post spinal cord injury
* Non-progressive spinal cord injury
* Neurological level above T10
* Tolerates upright position for \>30 minutes
* Medically stable (no hospitalizations in last 3 months)
* Unilateral knee extension strength \>/= 1/5 MMT
* Able to comply with procedures and follow up
* Are legally able to make their own health care decisions

Exclusion Criteria:

* Progressive SCI/D (MS, ALS, ADEM, etc.)
* Opens wounds at stimulation site
* Pregnant women
* ROM limits of \>10 degree of knee flexion or extension
* Cardiac pacemaker/defibrillator
* Active cancer diagnosis
* Currently receiving TSCS
* Evidence of uncontrolled autonomic dysreflexia
* Non- English speaking
Impact Evaluation of WFP's Fresh Food Voucher Pilot Programme in Ethiopia

To assess the impact of WFP's Fresh Food Voucher Pilot Programme in Ethiopia on children's and mother's diets

Rationale: Infants, young children and adult women in rural Ethiopia consume one of the least diversified diets in the world. The World Food Programme's Fresh Food Voucher (FFV) Pilot Programme aims to improve dietary diversity among infants and young children and their mothers. The focus on these demographic groups is based on the now well-established theory on the importance of the 'first 1,000 days'. This period, spanning the pregnancy and the first 2 years of child's life, is considered critical for child's physical growth and cognitive development. The beneficiary households receive a voucher that can be used to purchase fresh foods (fruits, vegetables and certain animal source foods).

Objective: The main objectives of the evaluation are to assess and report on the performance and results of the FFV programme to help WFP present high-quality and credible evidence of actual impact to its donors. In addition, the evaluation will determine the reasons why certain results occurred (or not) to draw lessons, derive good practices and pointers for learning.

Study design: This is a mixed methods evaluation that combines a Randomized Controlled Trial (RCT) with Focus Group Discussions (FGDs) with caregivers and food traders. The RCT contains three arms. The first treatment arm receives a smaller voucher (roughly $12-17) and social behavioural change communication (SBCC). The second treatment arm receives a larger voucher (roughly $21-23) and SBCC. Households in the third study arm (control) receive SBCC but do not receive vouchers. A cluster in this impact evaluation is defined as a village (got in Amharic) and these clusters of are randomly allocated to the different arms of the trial. Within a cluster, all eligible households will receive the same treatment.

Study population: All households with a child between 6-17 months at the baseline in December 2017 were eligible to be included in the quantitative sample.

Main study parameters/endpoints: The main outcomes of interest are minimum acceptable diet score for children 6- 23 months (World Health Organization, 2008) and minimum diet diversity for women of reproductive age (FAO \& FHI-360, 2016).

Eligibility Criteria:
Inclusion Criteria:

Households with young children aged 6-17 months age at the baseline in December 2017.
Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal

This study is designed to evaluate dexmedetomidine as adjunctive therapy of severe alcohol withdrawal of medical ICU patients. Specifically, this study will assess whether adjunctive dexmedetomidine reduces the doses of conventional agents used for alcohol withdrawal while maintaining patient comfort and safety and will explore if dexmedetomidine exhibits a dose-dependent profile of action when it is used for this indication. In addition, this study will assess the relationships between alcohol withdrawal, therapy with dexmedetomidine, and potential serum biomarkers of alcohol withdrawal.

The objectives of this randomized, double-blind, placebo controlled, dose escalation study are a) to determine if adding dexmedetomidine to symptom-triggered, standard therapy of severe alcohol withdrawal reduces the dose requirements of conventional sedatives, analgesics, and neuroleptics; maintains patient comfort and safety; and prevents and shortens tracheal intubation; b) to explore whether dexmedetomidine acts in a dose-dependent manner to reduce the dose requirements of conventional sedatives, analgesics, and neuroleptics while maintaining patient comfort; and c) determine the association between alcohol withdrawal and potential serum biomarkers of alcohol withdrawal and assess whether these are expressed differently when dexmedetomidine is used as adjunctive therapy. Dexmedetomidine will be added to existing sedative therapies in an effort to decrease the use of these agents while maintaining patient comfort. The study will randomize twenty-four patients in a double-blind manner to receive placebo or dexmedetomidine at doses of 0.4 or 1.2 µg/kg per hour for a maximum duration of five days. All patients will be managed using an existing institution-specific, symptom-triggered alcohol withdrawal protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Severe alcohol withdrawal defined by a CIWA score ≥ 15 and the need for at least 16 mg of lorazepam over a four-hour period. All lorazepam doses, whether oral or intravenous, will contribute to the cumulative amount.
2. Patients receiving standard therapy for severe alcohol withdrawal according to a symptom-triggered alcohol withdrawal protocol. Lorazepam is the preferred benzodiazepine agent for patients requiring ICU admission due to alcohol withdrawal.
3. Informed consent within 36 hours of qualifying for the study.

Exclusion Criteria:

1. Patients \< 18 years of age or \> 85 years of age.
2. Patients receiving benzodiazepine therapy for purposes other than alcohol withdrawal (e.g. sedation).
3. Patients with alcohol withdrawal not requiring ICU admission.
4. Patients receiving epidural administration of medication(s).
5. Comatose patients by metabolic or neurologic affectation.
6. Patients with active myocardial ischemia or second- or third-degree heart block.
7. Moribund state with planned withdrawal of life support.
8. Patients with known or suspected severe adverse reactions to dexmedetomidine (or clonidine).
9. Pregnant females or females suspected of being pregnant
A Study of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma

This is a multicenter, single-arm phase II study to evaluate the efficacy and safety of CS1001 monotherapy for relapsed/refractory classical Hodgkin Lymphoma (rr-cHL)

Eligible subjects with rr-cHL who failed at least two prior lines of therapies are planned to receive CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn or death.The primary endpoint of this trial is objective response rate (ORR), as assessed by independent radiological review committee (IRRC) based on Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with histologically confirmed cHL at study site.
2. Relapsed or refractory cHL that failed at least two lines of systemic therapy.
3. ECOG PS of 0-2.
4. Subjects with at least one measurable lesion at baseline.
5. Subjects treated by prior anti-cancer therapy whose toxicity resolved to baseline or =\< Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
6. Subjects who agree to use highly effective contraception.

Exclusion Criteria:

1. Nodular lymphocyte predominant Hodgkin lymphoma or grey zone lymphoma.
2. Primary site in central nervous system (CNS) or CNS involvement.
3. Subjects currently participating in other clinical studies or use of any investigational drug within 4 weeks prior to the first dose of CS1001.
4. Subjects who had systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of CS1001.
5. Subject who had chemotherapy, immune therapy or biological therapy as systemic anti-cancer treatment within 28 days prior to the first dose of CS1001.
6. Receipt of traditional medicinal herbal preparations within 7 days prior to the first dose of CS1001.
7. Known history of human immunodefiency virus (HIV) infection and/or acquired immune deficiency syndrome.
8. Subjects with active Hepatitis B or C infection.
9. Subjects with active tuberculosis infection.
10. Subjects who received prior therapy with anti-PD-1, anti-PD-L1 or anti CTLA-4 monoclonal antibody.
11. Female subjects who are pregnant or breast-feeding.

For more information regarding trial participation, please contact at cstonera@cstonepharma.com
The Impact of High Fidelity Simulation on Stress Level in Medical Students.

High fidelity simulation (HFS) is an established method of training in various fields of medicine, especially emergency medicine, anesthesiology and intensive therapy. One of the benefits of HFS as an educational tool is the protective environment, where the risk of error do not bring harm to the patients.

It is proven that HFS is successful in acquisition of new knowledge and skills and may facilitate positive behavioral change in medical students. However, this education method may cause elevated stress levels as well as other physiological reactions. Other than sympathetic nervous system reactions such as heart rate and blood pressure, there are a few laboratory stress level markers such as cortisol, alpha-amylase, testosterone and secretory immunoglobulin A. Our aim was to evaluate the change of stress level induced by high-fidelity simulation in medical students.


Eligibility Criteria:
Inclusion Criteria:

* willingness to take part in the study

Exclusion Criteria:

* pregnancy,
* active infections
* diseases of immune system
* metabolic or endocrine disturbances
* current use of any medication (except for oral contraceptives)
Clinical Study of Manpixiao in the Treatment of Chronic Atrophic Gastritis

To explore the efficacy and safety of "Manpixiao" in the treatment of Chronic Atrophic Gastritis.


Eligibility Criteria:
Inclusion Criteria:

* The age is 18-75 years old, regardless of gender;
* Before treatment, the patients were diagnosed as chronic atrophic gastritis (with intestinal metaplasia and dysplasia) by gastroscopy and pathological examination, which met the criteria of the Chinese consensus on chronic gastritis (2017, Shanghai);
* Sign the informed consent form.

Exclusion Criteria:

* Patients with autoimmune gastritis (chronic atrophic gastritis type A), peptic ulcer (a1-h2), reflux esophagitis, gastric polyps, hypertrophic gastritis and other diseases;
* Patients with high-grade intraepithelial neoplasia of gastric mucosa, suspected malignant change of gastrointestinal mucosal lesions, and gastrointestinal tumors;
* Patients with malignant tumors who have undergone surgery, radiotherapy and chemotherapy in recent 5 years;
* Patients with primary diseases such as heart, brain, lung, hematopoietic system and malignant tumors, and subjects with severe diabetes;
* Patients with chronic liver and kidney dysfunction before treatment, including ALT \> 1.5 times the upper limit of normal value, blood creatinine (CR) \> 1.5 times the upper limit of normal value, and platelets lower than 1.5 times the lower limit of normal value;
* Disabled subjects specified by law (blind, deaf, dumb, intellectual, mental, physical disabilities);
* The description of self symptoms is unclear or the investigation is not the author;
* Have a history of alcohol abuse;
* Allergic constitution or a history of allergy to multiple drugs (more than two or known ingredients in the drug);
* Pregnant or lactating women;
* According to the judgment of the researcher, other reasons should not be selected.
Mesh Augmentation and Panniculectomy for the Treatment of Post-partum Abdominal Wall Insufficiency

The aim of this study is to evaluate this multidisciplinary surgical approach of PPAWI (one-step procedure a panniculectomy by a plastic surgeon was performed together with a mesh augmentation of the abdominal wall by a general surgeon) at least 1 year post-operatively. Evaluation of the PPAWI approach by clinical examination with Quality of Life questionnaire and by ultrasound examination.

PPAWI (post partum abdominal wall insufficiency) is an acronym first introduced during Congress of the European Hernia Society in 2013. It is a pathological condition induced by abdominal distension during pregnancy. General laxity of the anterior abdominal wall develops because of diastasis of the rectus abdominis muscles and excess of skin and panniculus. This has important repercussion on abdominal wall function and its aesthetics. This diastasis is induced by abdominal distension and hormonal influences.

To evaluate diastasis of the rectus abdominis the inter-recti distance (IRD) is measured by ultrasound. When it is 3cm or more, it is defined as diastasis of recti abdominis.

An operation is indicated when there is an aesthetic problem and/or the abdominal wall function is impaired e.g. by loss of integrity of myofascial system and altered angle of attachment, which results in loss of abdominal muscle strength and endurance and loss of pelvic stabilization.

Since September 2013, 11 patients underwent an one-step procedure in which a panniculectomy/ abdominoplasty performed by a plastic surgeon was combined by a mesh augmentation of the abdominal wall with a Parietex Progrip Self Fixating Mesh performed by a general surgeon in the Maria Middelares hospital, Ghent, Belgium.

The study will be conducted in the department of surgery in the Maria Middelares hospital, Ghent, Belgium. Dr. Filip Muysoms (general surgeon) selected all patient that have previous been operated together with Dr. Rudolf Vertriest (plastic surgeon) with PPAWI technique. Ultrasound will be performed by Dr. Beckers subsequently pre- and postoperative. Pictures to evaluate the esthetic result will be taken by Dr. Vertriest pre- and postoperative.

The aim of this study is to evaluate this multidisciplinary surgical approach of PPAWI at least one year post-operatively by clinical and radiological examination.

Eligibility Criteria:
Inclusion Criteria:

* Adult female patients who underwent an abdominal wall repair and an abdominoplasty in one-step technique

Exclusion Criteria:

* Pregnancy
* No Informed Consent
Efficacy of a Lipolytic Cream in an Overweight and Obesity Treatment

The coadyouvant efficacy of a combination of cosmetics ingredients in the form of a lipolytic cream with hypocaloric diet and physical activity were assessed and compared with with hypocaloric diet and physical activity for overweight and obesity treatment in patients.

The coadyouvant efficacy and safety of a combination of cosmetics ingredients in the form of a lipolytic cream with hypocaloric diet and physical activity were assessed and compared with with hypocaloric diet and physical activity for overweight and obesity treatment in patients of both gender and different age groups. DESIGN: In a monocenter, open-label, randomized, parallel-group study of 102 patients that consulted for overweight and obesity treatment were analyzed in perimeters and body composition for 12 consecutive weeks that were medically prescribed a weekly hypocaloric diet and physical activity for one group of 51 patients, and hypocaloric diet, physical activity and the lypolitic cream at least twice per day for the other group of 51 patients. Efficacy was evaluated by comparing intial and final of all values in both groups. Safety was monitored by the incidence of adverse events. Patients also assessed the acceptability of the cream presentation.

Eligibility Criteria:
Inclusion Criteria:

* Overweight and obesity treatment voluntary assistance

Exclusion Criteria:

* Hearth disease
Questionnaires and Cognitive Assessments Following Mammography

This pilot research trial studies how well questionnaires and cognitive assessments work in tracking patient symptoms following mammography. Gathering information over time through questionnaires and cognitive tests about symptoms patients may experience after a mammogram may help doctors understand the cause of these symptoms.

PRIMARY OBJECTIVES:

I. To determine the feasibility of Internet-based cognitive assessments as preliminary data prior to larger clinical trial.

OUTLINE:

Patients complete questionnaires and cognitive assessments over 45-60 minutes within 3 weeks following mammography and at about 3 months in patients for whom biopsy is not required, before biopsy and at about 3 months in patients for whom biopsy is required, and at 4-6 weeks after first chemotherapy infusion in patients receiving chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Mammography Breast Imaging Reporting and Data System (BI-RAD) 4-5; or BI-RAD 1-2
* Fluent in English
* Access to Internet
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Prior abnormal mammography
* Prior cancer diagnosis
* Prior treatment with chemotherapy