cyrilzakka/clinical-trials huggingface dataset:
Platelet Dysfunction in Blood Donors

Platelets are circulating blood cells. They bind to each other and to the damaged vessel wall to prevent excessive bllod loss. Unlike quantitative platelet defects, there is no automated, simple test to diagnose qualitative platelets defects. However, these defects expose to bleeding in a surgical situation and could explain the transfusion inefficiency of some platelet concentrates.

In recent decades, considerable progress has been made in understanding qualitative platelet disorders.

In this project, we propose to submit blood donors to a standardized hemorrhagic diathesis questionnaire and to compare the prevalence of platelet function abnormalities in blood donors with and without hemorrhagic diathesis.

Primary objective specify the prevalence of qualitative platelet disorders in blood donors with i) a clinical history of bleeding diathesis collected through a standardized and validated questionnaire ii) and / or a hematoma (more than 4 cm) that occurred during blood donation.

Secondary objectives to obtain the prevalence of other defects of hemostasis

Eligibility Criteria:
Inclusion Criteria:

- Any male or female volunteer eligible for the blood donation

Exclusion Criteria:

* Subject with contraindications to blood donation:
* weight \<50 kg;
* severe fatigue,
* anemia,
* insulin-dependent diabetes;
* subject treated for epileptic seizures or having followed a treatment whose arrest is less than 14 days old.
* active pregnancy or childbirth less than 6 months old.
* viral disease (eg influenza, gastroenteritis ...) active less than two weeks after the end of symptoms.
* waiting period not respected after certain acts of daily life according to the regulatory criteria set by the EFS
* HIV infection, hepatitis B, hepatitis C
Cerebellar Alterations in Individuals With a Cannabis Use Disorder

The purpose of this study is to investigate if individuals with a cannabis use disorder have an impaired cerebellar function by assessing possible alterations to their implicit adaptation during a visuomotor rotation task.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with a Cannabis use disorder following Diagnostic and Statistical Manual (DSM-V) criteria.
* Patients screen positive to cannabis in the urine analysis performed a week prior to assessment.
* Right-handed patients.
* Patients provide a signed consent.

Exclusion Criteria:

* Patients with another current substance use disorder (with the exception of tobacco).
* Patients with a visual impairment that has not been corrected.
* Patients with a cognitive impairment such as mental retardation.
* Patients with psychotic disorders.
Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway

With the development of the Intubation Surfactant Extubation technic, in which surfactant is administered during a brief intubation followed by immediate extubation, surfactant therapy can be given during nasal continuous positive airway pressure treatment further reducing need for mechanical ventilation. Preterm newborn babies until eight hours of life, with respiratory distress syndrome, will be randomized to standard delivery of surfactant via endotracheal tube airway inserted after premedication for pain with midazolam and remifentanil or to surfactant delivery via Proseal laryngeal mask airway size 1. The intent is to is to compare efficacy and safety of surfactant administration via two different airways and ventilatory approaches.


Eligibility Criteria:
Inclusion Criteria:

* Birthweight more than 1000 grams
* Gestational age more than 28 weeks and less than 35 weeks
* Chronologic age less than 8 hours
* Diagnosis of RDS by clinical and radiographic criteria
* Treated with nasal continuous positive airway pressure and supplemental oxygen more than 30%
* Parental consent

Exclusion Criteria:

* Birthweight less than 1000 grams
* Gestational age more than 28 weeks and less than 35 weeks
* Chronologic age more than 8 hours
* Maternal fever or premature rupture of fetal membranes less than 18 hours
* Diagnosis other than respiratory distress syndrome
* Babies who require or have already had endotracheal intubation
* Analgesia and or sedation during the first six hours of life
* Apgar 5 minute score less than three
* Babies with congenital anomalies or signs of acute circulatory failure
Early Versus Late Interval Postpartum Copper Intrauterine Device Insertion

The optimal interval between pregnancies is debated, but a duration greater than 11-18 months has been suggested as reducing complications in the subsequent pregnancy. Improved birth spacing can be a key benefit use of long-acting reversible contraception, but delay to initiation can still be problematic.So women who have recently given birth can be cost-effectively targeted for family planning education and engagement because often they are already connected with health professionals


Eligibility Criteria:
Inclusion Criteria:

Delivered (vaginal or Cesarean) a singleton living baby ≥28weeks gestation. Women desire birth spacing for one year or more. Women who will accept to participate in the study and follow up.

Exclusion Criteria:

1. Known uterine anomalies.
2. Women with previous ectopic pregnancy.
3. Presence of postpartum pyrexia.
4. Women with history of postpartum hemorrhage in the last delivery either primary or secondary.
5. Retained products of conception.
6. History of previous uterine perforation.
7. Anticipation of difficulty of subsequent follow-up with the women.
8. Women with uncontrolled diabetes and hypertension.
9. Women who wish to use other contraceptive methods.
Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer

Active Surveillance manages selected men with prostate cancer expectantly with curative intent. This means men are carefully selected and subsequently actively observed in order to have the possibility to offer them curative treatment once the tumor seems to progress.

The goal of this study is to validate the treatment option Active Surveillance in men with localized, well differentiated prostate cancer, in order to limit the amount of overtreatment. A number of key points will be studied, such as the pathological findings in radical prostatectomy specimens, and the effect of expectancy on the quality of life.

Objectives:

Primary

- To evaluate the equivalence of the time on active surveillance before an active treatment between group Epstein + and the expanded active surveillance group (Epstein -)

Secondary

* To evaluate the role of diffusion-weighted MRI (DW-MRI) in the initial diagnosis and the follow-up of patients under active surveillance
* To evaluate the role of BCAR-1 to predict the clinical outcome of localized prostate cancer
* To evaluate the proportion of patients who discontinued active surveillance
* To evaluate the mortality at 10, 15 and 20 years from the inclusion in the study
* To evaluate the time to radical treatment
* To evaluate the time to metastatic disease
* To evaluate patients quality of life

Eligibility Criteria:
Inclusion Criteria:

* Localized adenocarcinoma of the prostate with a Gleason score of 3+3 (group I patients) or 3+4 (group II patients)
* Percentage of tumor biopsy invasion \<50% and/or with a size of maximum 8 mm
* With a number of positive tumor biopsies ≤3 (group I patients) or ≤ 5 (group II patients)
* TNM stage T1-2a N0 M0 (group I patients); TNM stage T1-2c N0 M0 (group II patients)
* PSA level at diagnosis \< 10 ng/ml for group I patients; \< 15 ng/ml for group II patients
* Tumor volume negative (group I patients); positive (group II patients)
* Absence of extra-capsular extension
* Life expectancy \> 10 years
* Signed informed consent
* Patient has elected active surveillance as preferred management plan for the prostate cancer

Exclusion Criteria:

* Previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery or chemotherapy)
* Patients with hypogonadism
The Optimization of Haploidentical Hematopoietic Stem Cell Transplantation

The goal of this observational study is to compare the incidence of relapse in G-CSF/ATG based and PT-Cy based haploidentical transplantation\] in \[patients aged 18 to 55 years with a diagnosis of hematological malignancies who unmanipulated haplo-HSCT with myeloablative conditioning\]. The main question it aims to answer are:

Primary objective: To compare the incidence of relapse in G-CSF/ATG based and PT-Cy based haploidentical transplantation and illustrate the possible immune mechanism.

Secondary objectives: To compare CMV infection, GVHD and survival outcomes, and to observe the dynamic immune reconstitution of G-CSF/ATG based or PT-Cy based model.

Exploratory objectives: To compare the long-term quality of life among recipients who receive G-CSF/ATG based or PT-Cy based protocol.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects diagnosed as acute leukemia with transplant indications in ≤ CR2;
2. Lack of available, HLA-identical, related sibling or unrelated donor;
3. Female or male, age: 18-55 years old;
4. ECOG performance status 0-2;
5. Adequate organ function as defined by the following criteria:

   Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤2.5× upper limit of normal (ULN), or AST and ALT ≤5× ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin≤1.5× ULN Serum creatinine≤2.5× ULN
6. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment;
7. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

1. Uncontrollable active infection;
2. Severe organic impairment: hepatic and renal impairment;
3. Any of the following within 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, congestive heart failure, or cerebrovascular accident including transient ischemic attack;
4. Pregnancy or breastfeeding;
5. Psychiatric disorders;
6. Don't sign the informed consent;
7. Prior/concurrent clinical study experience;
8. Other conditions:

   * Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
   * Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with section 1.61 of the ICH-GCP Ordinance E6)
   * Any specific situation during study implementation/course that may rise ethics considerations
   * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 Acute Respiratory Distress Syndrome

Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patients on mechanical ventilation.

Post-hospitalization follow-up for 6 and 12-months of survival and end-organ dysfunction (lung, heart, kidney, neuropsychological), plus quality of life and return to work of those previously working

Eligibility Criteria:
Exclusion Criteria:

* Pregnancy

Inclusion Criteria:

* Diagnosis of SARS-CoV-2 with first positive test within 14 days, and,
* Diagnosis of ARDS by the Berlin Criteria (2012):

  1. Onset: \< 7 days
  2. Chest x-ray: Bilateral Patchy Opacities, Infiltrates
  3. Mechanical Vent Support: PEEP or CPAP Support \>= 5 cm H2O
  4. Pulmonary Edema: Not fully explained by cardiogenic etiology
  5. Hypoxia: PaO2/FIO2 Ratio \< 300, or O2Sat/FIO2 Ratio \< 315
Exploratory Study of Respiratory Bacterial Infections or Superinfections and Colonizations in Patients With Spinal Muscular Atrophy Under NIV

SMA (Spinal Muscular Atrophy) is a rare neuromuscular disease characterized by motoneuron damage. Symptoms consist of respiratory involvement with numerous respiratory infections and eventually respiratory failure, for which NIV (Non Invasive Ventilation) is often used. Ventilation machines are in close contact with the respiratory tract of patients. They contain heated water to humidify the circuit. These humid and warm environments are conducive to the development of bacteria such as Pseudomonas aeruginosa. In this context, it is interesting to look for the presence or absence of bacteria, in comparison with the respiratory ecology of the patients. The aim is to highlight the microbiological role of NIV on the occurrence of respiratory bacterial infections or secondary infections in patients with SMA. To do this, samples are taken from the machines, and ECBCs are performed on patients during respiratory physiotherapy sessions.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AMS (previous diagnosis or new diagnosis during the inclusion period)
* Age from 0 to 12 years old
* Nusinersen treatment
* Benefiting from a NIV
* Current monitoring at the University Hospital of Amiens

Exclusion Criteria:

* Invasive ventilation on tracheotomy
* No ventilation
* Other treatment than Nusinersen or no treatment
* Parental refusal to participate in the study
Iron Status in Women of Reproductive Age Reproductive Age

Analyzed iron status, HFE mutations and ethnicity for women in five primary care centers in the United States and Canada using de-identified data from the HEIRS study.

HEIRS included a cross-sectional screening study of 101,168 patients, 25 years of age or older, in the primary care setting. Participants were recruited from four centers in the U.S .and one in Canada from February 2001 to February 2003. We will evaluate results for women aged 25-44 years of age who are self-reported as Asian, Black, Hispanic or White. The lower detection limit for the serum ferritin (SF) assay in the HEIRS study was 15 μg/L and therefore the definition of iron deficiency will be SF concentration ≤ 15 μg/L. Elevated SF concentrations, possibly indicative of elevated iron stores, will be classified by two definitions: 1) SF concentration \> 300 μg/L and 2) SF \>200 μg/L in combination with TSAT \>45%. Proportions will be compared by Pearson's chi-square. Logistic regression models will be used to identify independent associations with measures of iron deficiency and elevated iron stores.

Eligibility Criteria:
Inclusion Criteria:

1. primary care women included in the HEIRS study with in the age range of this study
2. Self designation as Asian American, African American, Hispanic American or White.

Exclusion Criteria:

1. Age \>44 years
2. Self-described ethnicity other in than inclusion criterion 2.
Kanglaite Injection Phase I Study

The Kanglaite Injection (KLT)is a novel broad spectrum anti-cancer injection produced from traditional Chinese medicinal herbs (the Coix Seed). It was approved in China in 1995 and has become the most popular anti-cancer drug in China. In June of 2001, the Phase I study of KLT commenced at the Huntsman Cancer Institute in Salt Lake City, Utah, with the objectives of 1) To determine the maximum tolerated dose (MTD) and the safety profile of KLT in patients with refractory solid tumors; 2) To determine the pharmacokinetics of KLT in patients with refractory solid tumors; and 3) To gather preliminary efficacy data. The method of testing is open-label, sequential cohort, dose-escalation study.


Eligibility Criteria:
* Patients with histological evidence of malignancy that has become refractory to standard therapy, or for whom effective standard therapy does not exist.
* Patients with an estimated life-expectancy of at least 3 months
* Patients with a Karnofsky Performance Score of at least 60%
* Patients with no history of congestive heart failure (CHF), and normal ejection fraction by echocardiography
* Patients with adequate renal and hepatic function
* Patients with adequate bone marrow status
A Observational Study to Evaluate Deucravacitinib in Patients With Moderate Plaque Psoriasis in China

The purpose of this study is to collect and evaluate real-world data on the effectiveness of deucravacitinib treatment in adults with moderate plaque psoriasis in China.


Eligibility Criteria:
Inclusion Criteria:

* Participant aged 18 years or older
* Physician-reported (dermatologist) diagnosis of moderate plaque psoriasis with Body Surface Area ≥ 3% and \< 10%
* Participant newly initiated deucravacitinib according to the label
* Provided written informed consent to participate in the study

Exclusion Criteria:

* Participating in or planning to participate in an interventional clinical trial
* Concomitant use of other systemic treatments for psoriasis at baseline
* Prior treatment of deucravacitinib
The Long-term Safety and Efficacy of CDP6038 (Olokizumab) With Active Rheumatoid Arthritis

The purpose of this study is to evaluate the long-term safety and tolerability of CDP6038 (olokizumab) treatment in adult subjects with active rheumatoid arthritis (RA) who completed study RA0083 \[NCT01463059\].

Male and female subjects were randomized in a multi-center, open-label, follow-up study to assess the long-term safety and efficacy of a subcutaneous dose of 120 mg CDP6038 (olokizumab), every 2 weeks (q2w), for the treatment of active RA.

Eligibility Criteria:
Inclusion Criteria:

* Completed the RA0083 \[NCT01463059\] study (Week 12 Visit)
* Must have maintained their stable dose (and route) of methotrexate (MTX) between 6 to 16 mg/week in Japan or 7.5 to 20 mg/week in Korea and Taiwan in RA0083 \[NCT01463059\], and plan to maintain this same dose and route of administration for at least 12 weeks
* Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing 2 acceptable methods of contraception

Exclusion Criteria:

* Have an ongoing SAE from the RA0083 \[NCT01463059\] study
* Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks
* Have evidence of active or latent tuberculosis (TB)
* Subject is receiving any biologic response modifier or synthetic disease-modifying antirheumatic drug (DMARD) other than MTX
* Subject has planned surgery during the first 12 weeks of the study
* Subjects who tested positive for hepatitis B core antibody (HBcAb) and/or hepatitis B surface antibody (HBsAb) at Screening in RA0083 \[NCT01463059\] and who subsequently test positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) at Week 12 of RA0083 \[NCT01463059\]
The Initial Effect of Training on Mitochondrial Function in Patients With Intermittent Claudication

The hypothesis of this study is that one bout of leg exercise gives acute qualitative changes in mitochondrial function in claudication. Final purpose is to determine the optimal exercise frequency in treatment of claudication.


Eligibility Criteria:
Inclusion Criteria:

* A history of any type of uni- or bilateral exertion leg pain.
* A maximal claudication distance that is less than 300 meter
* Diagnosed with intermittent claudication secondary to vascular insufficiency
* An ankle-brachial index between 0.4 and 0.9.
* Lives in Trondheim

Exclusion Criteria:

* Diagnosed with critical limb ischemia
* ankle-brachial index \> 0.90 or \< 0.4
* Limited exercise tolerance
* Warfarin or heparin usage
* Diabetes mellitus
* Underwent a vascular intervention in the last 3 months
* Active cancer, renal- or liver disease.
DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening

Based on the previous study of NCT03961191 and NCT03960879, we performed this trial to further confirm the accuracy of host DNA PAX1 and JAM3 methylation for cervical cancer screening. This study would provide profound basis for the approval of assay kit of DNA methylation in China for cervical screening. Three hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA PAX1 and JAM3 methylation, and the results will compared with the cervical histological pathology, which is achieved after collection of cervical cytology, by surgeries including loop electrosurgical excision procedure, cervical conization, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The retrospective and prospective parts will enroll at least 120 patients and at least 339 patients, respectively.


Eligibility Criteria:
Inclusion Criteria:

* With uterine cervix intact
* Aged 18 years or older
* With accessible histological results of cervix
* Signed an approved informed consents
* With accessible cervical cytology before harvesting cervical histology

Exclusion Criteria:

* Not meeting all of the inclusion criteria
A Study of the Efficacy and Safety of Efsubaglutide Alfa in Overweight or Obesity Patients

This is a study to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of Efsubaglutide Alfa at difference dose range once-weekly in patients with Overweight or Obesity.

This study will look at the adverse events and the change in participants' body weight from the start of the study to the end. Weight loss in participants taking Efsubaglutide Alfa will be compared to weight loss in participants taking placebo.

Eligibility Criteria:
Inclusion Criteria:

* Fully understood the study, signed the informed consent.
* Male or female patients aged from 18 to 75 years at the time of signing informed consent.
* Body mass index (BMI) greater than or equal to 28 kg/sqm or greater than or equal to 24 kg/sqm with the presence of at least one of the following weight-related comorbidities: prediabetic state, hypertension, dyslipidemia, non-alcoholic steatohepatitis (NASH), obstructive sleep apnea or cardiovascular disease.
* A self-reported change in body weight less than 5% within 90 days before screening irrespective.

Exclusion Criteria:

* Glycated hemoglobin (HbA1c) greater than or equal to 6.5%, or previously diagnosed with type 1 diabetes or type 2 diabetes.
* Have history of clinically significant abnormal gastric emptying, severe chronic gastrointestinal diseases, long-term use of medications that directly affect gastrointestinal peristalsis, or gastrointestinal surgery within 6 months prior to screening, and deemed unsuitable for participation by the investigator.
* Have history of hyperthyroidism or hypothyroidism, or a thyroid-stimulating hormone (TSH) level below the lower limit or above 1.5 times the upper limit of the normal range.
* Calcitonin greater than or equal to 50 ng/L, or have history of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) type 2A or 2B syndrome, or a related family history.
* Any other condition that, in the judgment of the researchers, may affect the patient's ability to provide informed consent or comply with the trial protocol.