cyrilzakka/clinical-trials huggingface dataset:
The Influences of Single Chamber Vs. Multi-chamber Blood Flow Restriction Cuffs with Bicep Curls

The purpose of this study is to investigate the use of single (SC) and multi-chamber (MC) blood flow restriction (BFR) cuff bicep exercise on indices of arterial stiffness, muscle morphology, and participant perception.

Twenty six adults aged 18-40 years old will undergo three treatment sessions (control (no BFR), SC BFR, and MC BFR) in a randomized order separated by one week. A familiarization session will also occur one week before starting the treatment period. Each subject will undergo a series of tests including anthropometry, ultrasonography of the carotid artery, applanation tonometry, ultrasonography of the vastus lateralis, blood pressure acquisition, body composition, and maximal strength assessments (1RM). The exercise trial will consist of sets of dumbbell bicep curls performed to failure with a 2-seconds concentric and 2-seconds eccentric cadence, at 20% of their 1RM using 60% of the supine limb occlusion pressure (LOP) with 1-minute rest intervals. Assessments will be performed immediately before and after the exercise bout during each treatment session. Two-way ANOVAs will be used to examine the main effects of treatment and treatment-order interaction on pulse wave velocity, muscle cross-sectional area, and perceptual response.

Eligibility Criteria:
Inclusion Criteria:

1. Physically active (\> 1,000 MET/min/wk) for at least six months.
2. Weight stable for previous 6 months (+/-2.5 kg)
3. Female subjects only- reported regular menstrual cycles for the last 2 years

Exclusion Criteria:

1. BP\>140/90 mmHg
2. BMI\>40 kg/m2
3. Diabetes
4. Familial hypercholesterolemia
5. Past or current history of CHD, stroke or major CVD events. Respiratory diseases (not including asthma), endocrine or metabolic, neurological, or hematological disorders that would compromise the study or the health of the subject.
6. Women must not be pregnant, plan to become pregnant during the study, or be nursing
7. Active renal or liver disease
8. All medications and supplements that influence dependent variables\*
9. Recent surgery \< 2 months
10. Alcohol abuse
11. Sleep apnea
12. Claustrophobia
Study on Left Atrial Function of Paroxysmal Supraventricular Tachycardia After Radiofrequency Ablation

This study to investigate the effects of RF ablation on left atrial systolic function in patients with atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular tachycardia (AVRT).

A total of 100 patients with persistent，in whom successful RF ablation of slow pathway or accessory pathway was performed. Patients with atrial fibrillation, structural heart disease, ventricular arrhythmias, impaired left ventricular systolic function or on antiarrhythmics were excluded. All the patients had echocardiographic study before ablation 、1 day and 1 months after ablation. Left atrial systolic function was assessed using atrial ejection force (AEF) according to Manning's formula (AEF = 0.5 x ρ x MA x A(2), r: blood density = 1.06 g/cm(3), MA: mitral orifice area \[cm(2)\], A: A wave velocity). The following left atrial dimensions were assessed: antero-posterior (LA-AP), infero-superior (LA-IS, long axis), medio-lateral (LA-ML, short axis). The correlations between AEF and electrophysiological parameters were analysed (VA - ventriculo-atrial conduction, VA/CL - tachycardia cycle length).

Eligibility Criteria:
Inclusion Criteria:

Patients with paroxysmal supraventricular tachycardia,includes atrioventricular reentrant tachycardia and atrioventricular nodal reentrant tachycardia， Age is \>14 years

Exclusion Criteria:

Atrial fibrillation, Atrial tachycardia， Structural heart disease, Ventricular arrhythmias, Patients with impaired left ventricular systolic function or on antiarrhythmics
Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers

The objective of this investigation is to demonstrate the effectiveness and safety of Biatain Ibu non-adhesive foam dressing compared to Biatain non-adhesive foam dressing.


Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years of age
* Chronic venous leg ulcer on the lower leg
* Ulcer duration \>= 8 weeks
* Pain intensity in study ulcer at least 4 on an 11-point numerical box scale (NBS): 0= no pain, 10= worst possible pain
* Exudate level moderate to high
* Ulcer size min 1.6 cm and max 11 cm in any direction
* Ankle/brachial index \>= 0.8
* Treated with moist wound healing during the past 2 weeks prior to inclusion
* Adequate compression therapy during the past 2 weeks prior to inclusion
* The patient is cognitive capable of evaluating his/her pain relief and pain intensity
* The patient is able to understand the treatment and is willing to comply with the treatment regimen.
* The patient is able to complete the patient diary
* The patient is willing and able to give written informed consent

Exclusion Criteria:

* Painful ulcers that have been treatment resistant to analgesics for the past 6 months or more
* Pregnant or lactating women
* Known and verified hypersensitivity to any content of the products used in this investigation
* Local infection (bacterial imbalanced wound) in the study ulcer
* Clinical infection in the study ulcer
* Diseases: Vasculitis, erysipelas and cellulitis of the peri-ulcer skin
* The investigator considers the patient not eligible
* Diseases and conditions where ibuprofen or other analgesics are contraindicated (including known hypersensitivity to Aspirin (acetylsalicylic acid) or other analgesics, especially associated with a history of asthma, rhinitis or urticaria)
* Diabetes
* Use of per need medication for the past 3 days
* Concomitant treatment with systemic antibiotics other than nitrofurantoin
* Concomitant treatment with systemic corticosteroids (more than 10 mg/day prednisolon or equivalent) or other immunosuppressants within 1 month prior to inclusion
* Concomitant treatment with cancer chemotherapeutics
* Concomitant participation in other studies
* Previous participation in this study
Management of RPOC After Induced Abortion

Randomized trial comparing expectant management and medical management in women diagnosed with retained products of conception after first trimester induced abortion

An open label randomized controlled trial (RCT) of all women diagnosed with retained product of conception (RPOC) after first trimester medical TOP in a single university affiliated medical center. All consecutive women who underwent medical TOP by mifepristone and misoprostol at gestational age under 63 days from last menstrual period and were diagnosed with RPOC in a routine 3-week ultrasound follow-up are offered to participate. RPOC is defined as thick irregular endometrium (over 12 mm) with positive Doppler flow. Following recruitment, patients are randomized into either expectant arm or medical arm (800 mcg misoprostol). The primary outcome measure is RPOC rate in repeat ultrasound scan performed 5 weeks after randomization.

Eligibility Criteria:
Inclusion Criteria:

* 18 \< age \< 45 year old
* Thick irregular endometrium \>12 mm on trans-vaginal ultrasound

Exclusion Criteria:

* Endometritis
* Cervical opening \> 1 cm
* Uterine abnormalities
* Contraindication to Misoprostol treatment
Economic Analyses of the REDUCE Trial

The objective of this project is to conduct a retrospective economic analysis of the use of dutasteride for the prevention of prostate cancer based on data from the REDUCE clinical trial. REDUCE is a 4-year, phase 3, randomized, double-blind, parallel assignment clinical trial of the use of dutasteride compared with no chemopreventive treatment.

The REDUCE trial was a four-year, international, multicenter, randomized, double-blind, placebo-controlled, parallel group study. There were 790 investigators in 42 countries.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 50 to 75 years
* serum prostate-specific antigen (PSA) ≥2.5 ng per milliliter and ≤10 ng per milliliter (men aged 50-60 years) or ≥3.0 ng per milliliter and ≤10 ng per milliliter (men aged \>60 years)
* single, negative prostate biopsy (6-12 cores) within 6 months prior to enrollment (independent of the study)

Exclusion Criteria:

* Principal exclusion criteria were more than one prior prostate biopsy
* high-grade intraepithelial neoplasia (HG-PIN) or atypical small acinar proliferation (ASAP) on the pre-entry prostate biopsy
* a prostate volume \>80 ml, previous prostate surgery
* International Prostate Symptom Score (IPSS) ≥25 or ≥20 if already on alpha-blocker therapy for BPH
Gene Therapy of Pancreatic Ductal Adenocarcinoma

Near 85% of patients with pancreatic adenocarcinoma are diagnosed with a locally advanced and/or metastatic unresectable tumor. In these patients chemotherapy (such as gemcitabine) is given as a palliative therapy. Aim of the present study is to evaluate the feasibility, tolerance and antitumor effect of repeated intratumoral injection of a gene therapy product (with antitumor and chemo sensitizing effects) combined with gemcitabine in patients with unresectable pancreatic carcinoma.

This is a gene therapy open non randomized phase I trial for advanced and/or metastatic pancreatic cancer patients. The protocol is based on the administration of increasing doses of a plasmid DNA pre-complexed to PEI (polyethylenimine - non-viral vector) that encodes two genes (somatostatin receptor subtype 2 named sst2 and deoxycitidine kinase :: uridylmonophosphate kinase named dck::umk) which exhibit complementary therapeutic effects. Both transgenes induce an antitumor bystander effect and render gemcitabine treatment more efficient. Intratumor injections of the gene therapy product (CYL-02) will be performed by transgastric or transduodenal route under endoscopic ultrasound guidance. Each injection will be followed standard gemcitabine IV administration every week (1000 mg/m2). Two intratumor injections of a same dose of CYL-02 will be administered at one month interval. Four increasing doses (125 µg, 250 µg, 500 µg and 1 mg) will be tested by group of 6 patients. The primary objectives are: evaluation of local pancreatic and general tolerance; the secondary objectives are: possible tumor volume regression, secondary respectability, evaluation of transgene biodistribution.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a pancreatic adenocarcinoma histologically proven and/or a solid pancreatic mass associated with on or multiple metastatis from pancreatic origin (histologically proven)
* Patient with a non resectable pancreatic adenocarcinoma (on preoperative CT-scan and/or endoscopic ultrasound evaluation)
* Pancreatic tumor that could be evaluated by endoscopic ultrasound (no digestive stenosis, no gastrectomy)
* Patient with no contraindication to général anaesthesia.
* Karnofsky index \>= 70%
* Written informed consent given

Exclusion Criteria:

* - Exclusion period for another clinical trial or research protocol.
* Patient unable to read or understand information/consent formula or unable to decide alone for his participation to the trial
* Patient under tutelage
* Pregnant woman or able to procreate without contraception.
* Patient with pancreatic cystic tumor or pancreatic pseudocyst.
* Patient with pancreatic tumor different from adenocarcinoma (endocrine, metastasis).
* Patient contraindication to Gemzar® :

  * Hypersensitivity to Gemcitabine.
  * Decision of radiotherapy
  * Granulocytes \< 1000/mm3
  * Thrombocytes \< 100 000/mm3
* Patient not efficiently treated for jaundice (biliary stent or bypass) if present at time of diagnosis
* Contraindication for fine needle aspiration biopsy under endoscopic ultrasound (hemostasis trouble).
Fenofibrate in Primary Biliary Cholangitis: a Real World Study

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination with Ursodeoxycholic Acid in Subjects with Primary Biliary Cholangitis (PBC)


Eligibility Criteria:
Inclusion Criteria:

1. Must have given written informed consent (signed and dated)
2. Completed in a PBC study with fenofibrate(NCT05749822,NCT06174402)
3. ALP\> 1\*ULN
4. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose

Exclusion Criteria:

1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results
Hospital Mortality in Patients Submitted to Pharmacoinvasive Strategy With Tenecteplase (TNK)

This study has the following objective:

To identify related factors to hospital mortality in patients with ST-segment elevation acute myocardial infarction submitted to pharmacoinvasive strategy within a structured healthcare network.

Primary percutaneous coronary intervention is the main therapy for patients with ST-segment elevation acute myocardial infarction. However, a significant portion of these patients won't receive optimal treatment due to the small number of tertiary centers with interventional laboratories available for 24 hours a day, 7 days a week.

Specially in large urban centers and rural areas, where tertiary care hospitals are restricted to a specific region, alternative approaches must be developed. The pharmacoinvasive strategy has emerged as an alternative for patients admitted to primary care centers. It is based in up-front intravenous thrombolytic therapy and transfer to a tertiary center where early, systematic, coronary intervention will be performed between 3 to 24 hours after the administration of thrombolytic drugs, even in cases in which successful reperfusion was obtained.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ST-segment elevation acute myocardial infarction submitted to pharmacoinvasive strategy with tenecteplase.

Exclusion Criteria:

* Absence of obstructive coronary disease
* Surgical reference
* Did not undergo catheterization
The Association of Marital Status With Kidney Cancer Surgery Morbidity

Retrospective cohort study

Data source and study cohort:

We conducted a retrospective cohort study using the Premier Healthcare Database (PHD, Premier Inc., Charlotte, NC), an extensive, US hospital-based, all-payer database representing approximately 20% of annual United States inpatient discharges at community and academic centers. The International Classification of Diseases, ninth revision (ICD-9), and tenth revision (ICD-10) procedure codes were used to identify patients who had undergone elective kidney cancer surgery between the 15 years of study from 2003 to 2017. The cohort was then restricted based on appropriate ICD-9 and ICD-10 diagnosis codes to ensure that surgery was performed for a kidney mass. The study cohort was also limited to adult patients (age \>= 18 years), "elective" cases based on administrative codes, as well as surgery on hospital day zero or one to minimize outlier patients who could skew the surgical outcomes.

Outcomes:

The primary outcome of this study was the 90-day complication rate. Complication rates were based on the Clavien-Dindo classification of surgical complications and divided into four categories: no complications, minor complications (Clavien grades 1, 2), and non-fatal major complications (Clavien grades 3, 4), and mortality (Clavien grade 5). Clinical systems also categorized complications (bleeding, cardiac, endocrine, gastrointestinal, infection, neurology, pulmonary, renal, soft tissue, urologic, venous thromboembolism) using Health Care Cost and Utilization Project Clinical Classification Software Level II or III designations; of note, the category for "surgical" complications was excluded given that all complications captured in this analysis are considered surgical complications. Secondary outcomes included patient disposition, length of hospital stay, and readmission rate.

Eligibility Criteria:
Inclusion Criteria:

1. Surgery was performed for a kidney mass.
2. age \>= 18 years
3. "elective" cases
4. Surgery was performed on the day0 or day1 after administration.

Exclusion Criteria:

1. ICD codes are not available.
2. Missing value of the primary outcomes and exposure.
Pilot Clinical Trial of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy

Pilot clinical trial on the efficacy and safety of IDRACARE® in moderate to severe symptoms of vulvovaginal atrophy. To assess the efficacy and safety of Idracare® in the treatment of symptoms of AVV (dryness and / or dyspareunia) associated with menopause.

Pilot clinical trial on the efficacy and safety of IDRACARE® in moderate to severe symptoms of vulvovaginal atrophy. To assess the efficacy and safety of Idracare® in the treatment of symptoms of AVV (dryness and / or dyspareunia) associated with menopause.

Open study with only one arm. The study has a total duration per patient of 3 months: initial visit (V1), a follow-up visit (V2) after 4 weeks of treatment and a final visit (V3) after 12 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Women who attend medical centers, either for a visit related to vulvovaginal atrophy (VVA) or for any other reason for consultation, with symptoms of VVA (dryness and / or dyspareunia) of moderate or severe intensity (score 2-3 on the Likert scale).
* Women between the ages of 40 and 65, inclusive, in the peri- or postmenopausal period.
* Women are able to understand and sign the informed consent after the nature of the study has been fully explained to them.

Exclusion Criteria:

* Pregnant or immediate postpartum patients (up to 40 days).
* Formal contraindication for the use of the product, such as hypersensitivity to any of the components of the study treatment.
* Use of any other experimental drug or device during the 30 days prior to screening.
* Use of topical antibiotics or antifungals applied vaginally in the two weeks prior to the initial visit.
* Use of contraceptives for vaginal application.
* Decompensated chronic diseases (diabetes, epilepsy, high blood pressure, etc.)
* Undiagnosed abnormal genital bleeding or presence of vaginal lesion.
* Active genitourinary infections at the time of inclusion or in the 15 days prior to inclusion in the study.
* Impossibility, at the discretion of the researcher, to comply with the requirements of the study, either due to follow-up problems, or due to their psychophysical characteristics.
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 1 of 4)

The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.

A randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenously administered PRT064445 after dosing to steady state with one of four direct/indirect fXa inhibitors in healthy volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women between the ages of 18 and 45 years old

Exclusion Criteria:

* History (including family history) or symptoms of, or risk factors for bleeding
* History (including family history) of or risk factors for a hypercoagulable or thrombotic condition
* Absolute/relative contraindication to anticoagulation or treatment with specific anticoagulants
* History of major surgery, severe trauma or bone fracture within 3 months prior to dosing; or planned surgery within 1 month after dosing.
In Vivo IGF-1R Molecular Imaging Using [68Ga]- Labelling Anti-IGF-1R Affibody Molecule

The investigators developed \[68Ga\]-labelling Anti-IGF-1R Affibody Molecule as a targeted molecular imaging agent for noninvasive and repeatable detecting IGF-1R expression status.

The goals of investigators are to evaluate the use of \[68Ga\]-labelling Anti-IGF-1R Affibody Molecule as a novel PET/CT radiotracer to monitor IGF-1R expression status. The investigators want to evaluate the use of \[68Ga\]-labelling Anti-IGF-1R Affibody Molecule in IGF-1R expression cancer imaging in adult cancer patients （colon cancer 、NSCLC、gliomas cancer patients）with different IGF-1R expression status.

Eligibility Criteria:
Inclusion Criteria:

1. Colon cancer, NSCLC and gliomas patients with pathological and gene detection results and did not receive any treatment
2. More than 18 years old
3. A life expectancy of at least 12 weeks
4. Presence of a malignant lesion within the chest of at least 0.5 cm diameter as measured by computed tomography (CT)
5. Written informed consent

Exclusion Criteria:

1. Could not get pathological and gene detection results
2. Pregnancy
3. do not want to write informed consent。
Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD

This study will be conducted in order to determine safety and efficacy esomeprazole, lansoprazole and pantoprazole control stomach acid by measuring the stomach acid in men and women of Hispanic origin who have GERD.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Males and females ages 18-69 who are of Hispanic origin
* Symptoms of GERD, defined as heartburn at least 2 times a week on average over the last 3 months

Exclusion Criteria:

* Female patients who are pregnant or breastfeeding
* Known intolerance or lack of response to Proton Pump Inhibitors (PPIs) such as Nexium, Prevacid, or Protonix
* Current or relevant history of non-healed ulcers, stomach surgery, or esophageal surgery
High Dose Donor Hematopoietic Stem Cell Infusion for Relapsed/Refractory AML

The purpose of this study is to evaluate the safety and efficiency of high dose allogeneic mismatched hematopoietic stem cells infusions after normal chemotherapy in patients with relapsed/refractory acute myeloid leukemia（AML）.

The relapsed/refractory AML patients will receive IA/DA/MA(I,Idamycin，D，Daunorubicin，M，Mitoxantrone，A，cytosine arabinoside) chemotherapy followed by infusion of high dose allogeneic mismatched hematopoietic stem cells.

no graft-versus-host disease (GVHD) prevention will be conducted before transplantation. Cytokine storm,GVHD snd donor graft will be detected post-transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patient with relapsed and/or refractory AML
* Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

* Previous treatment with investigational gene or cell therapy medicine products
* Any uncontrolled active medical disorder that would preclude participation as outlined