cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers

CDX-301 is a protein that stimulates the growth of bone marrow stem cells and certain immune cells. This study is testing CDX-301 in healthy volunteers who will be monitored for safety and biological response for approximately one month or more.

A total of seven cohorts of healthy volunteers are planned with doses of CDX-301 (rhuFlt3L) ranging between 1 and 75 μg/kg and dosing durations between 5 and 10 days.

Volunteers will be admitted to an inpatient unit during the Treatment Period. Blood samples will be collected periodically to assess the effect of CDX-301. Volunteers will be followed for safety for 28 days following the last dose. Any volunteer who develops anti-CDX-301 antibodies will be followed monthly until the antibody response is below the limit of detection. In general, the total duration of the study will be between approximately 33-38 days.

Eligibility Criteria:
Inclusion Criteria:

Among other criteria, volunteers must meet the following conditions to be eligible for the study:

1. Ages 18 - 55
2. Body Weight ≤ 120 kg
3. Generally good health and without significant medical conditions
4. Willing to use effective method of contraception
5. Abstinence from alcohol for 72 hours prior to study drug administration and throughout the study
6. Negative screening test for HIV, hepatitis B, and hepatitis C
7. Provide written informed consent

Exclusion Criteria:

Among other criteria, volunteers who meet the following conditions are NOT eligible for the study:

1. Drug or alcohol abuse within 12 months
2. Positive drug screen
3. Receipt of certain types of experimental drugs or other treatments, or certain medications
4. Use of systemic immunosuppressive agents (excluding topical steroids) within 12 months
5. History of certain diseases including syphilis, herpes zoster, primary or secondary immunodeficiency
6. Diagnosis with or family history of significant autoimmunity (ex: type I diabetes, multiple sclerosis, rheumatoid arthritis, scleroderma)
7. Any history of cancer, excluding adequately treated and cured basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ within 2 years
8. History of asthma requiring any use of inhaled or oral medication within 5 years
9. Herpes zoster within 3 months
10. Donation of blood within 8 weeks, and donation of plasma within 2 weeks
Effect of Repetitive Transcranial Magnetic Stimulation on Neurological Recovery in Patients With Ischaemic Stroke

The goal of this clinical trial is to learn if transcranial magnetic stimulation(rTMS) can improve neurological rehabilitation in patients with acute ischemic stroke. The main questions it aims to answer are:

Can rTMS Promote Recovery of Limb Impairment in Patients with Acute Ischemia? Can rTMS Cause Changes in the Functional Connections of Brain Networks in Patients?

Researchers will compare rTMS therapy to non-stimulation therapy to see if rTMS is effective in promoting neurological recovery from ischemic stroke.

Participants will:

Receive rTMS or sham stimulation with LF-rTMS on the contralateral M1 of the brain lesion for 20 minutes, 1200 pulses, 120% RMT, and a treatment period of 5 days； Be evaluated on a scale before and after treatment


Eligibility Criteria:
Inclusion Criteria:

1. The age range is 18\~75 years old
2. Meet the diagnostic criteria of China Acute Ischaemic Stroke Diagnosis and Treatment Guidelines 2018 and confirmed by head CT or MRI scanning
3. Acute stage of the disease \&lt;14 days and stable condition
4. Stroke patients with only unilateral limb involvement (without bilateral cerebrovascular lesions)
5. Patients with upper limb muscle strength ≥ grade 3, able to perform fNIRS tasks with the patient.
6. Subjects were right-handed
7. Participants give their informed consent and sign an informed consent form

Exclusion Criteria:

1. Those who have metal implants or any electronic devices in their body
2. Those with previous epilepsy or mental abnormality.
3. Combined with serious heart, liver, lung and other important organ failure
4. Those who have brain haemorrhage or bleeding tendency.
5. Deteriorating condition, new cerebral infarction or secondary cerebral haemorrhage.
6. Patients with history of craniocerebral trauma and craniocerebral surgery.
7. Those with severe cognitive and communication disorders who are unable to cooperate -
Anterior Shoulder Dislocation at Emergency Department

In this study, investigator will analyze the demographic characteristics of patients presenting to emergency department with Anterior Shoulder Dislocation. Investigators will document the mechanism of injury, orthopedic classification of shoulder dislocation, associated treatments, pre-procedural pain scoring, post-procedural pain scoring, as well as the duration of emergency department stay related to the preferred treatment, orthopedic consultation, and patient outcomes (discharge, admission to ward or intensive care unit, mortality). Aim of the study to investigate whether the current treatments used provide any superiority in emergency department outcomes for patients

Intravenous analgesia (Paracetamol, NSAIDs, opioids) is preferred for patients during the treatment and reduction stages of anterior shoulder dislocation. Additionally, patients may receive regional anesthesia and analgesia (lidocaine, bupivacaine). The route and dosage of analgesic administration are chosen by the attending physician managing the patient. In this study, investigators plan to observationally evaluate the analgesic management of patients without intervening in the method and dosage chosen by the primary treating physician.

Patients receiving analgesia will be chosen according to preffered treatment at emergency department. The study population will consist of patients presenting to the emergency department with shoulder dislocation who receive analgesia and fall into the following 4 treatment groups.

These 4 group will consist in:

1. ketamine group
2. interscalene nerve block group
3. suprascapular nerve block group
4. intraarticular lidocaine injection group. The study will compare these 4 treatment methods in terms of analgesia management, reduction time, comfort, and length of hospital stay for patients presenting to the emergency department with shoulder dislocation and receiving analgesia. The researcher will not interfere with the treatment decision made by the responsible physician or the treatment process

Eligibility Criteria:
Inclusion Criteria:

Patients aged 18 years and older

Exclusion Criteria:

Patients who are not conscious at the time of admission and do not consent to participate in the study.

Patients who do not have follow-up in our healthcare system or cannot be followed up.

Patients with allergies to opioids or local anesthetics. Patients presenting to the emergency department with suspicion of multiple fractures and dislocations involving ≥2 different types of injuries will also be excluded from the study.

Forensic cases
Evaluation of PET-CT Scanner Performances to Detect Infra-centimetric Lesions in Patients With Cancer

Prospective, monocentric study aiming to evaluate the PET-CT (Positron Emission Tomography - Computed Tomography) scanner performances to detect infra-centimetric lesions in two groups of patients with cancer and of different BMI (Body Mass Index) classes (BMI ≤ 25 and BMI \> 25).

For each patient, two consecutive PET-CT scanner will be performed using the "Discovery MI" and "Discovery IQ" PET-CT scanner systems.

Virtual lesions will then be created on images obtained. Images will be interpreted by two independent observers.

The study participation of each patient will be a maximum of 24 hours.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old.
2. A patient with a cancer for which a FDG-PET (fluorodeoxyglucose-positron emission tomography) must be performed according to the standard practices
3. OMS ≤ 1, Karnofsky Index \> 70.
4. Negative pregnancy test at inclusion.
5. Patient able to maintain a lying position in a strict supine position twice.
6. Patient affiliated to a Social Health Insurance in France.
7. Patient who has signed informed consent prior inclusion in the study and before any specific procedures for the study.

Exclusion Criteria:

1. Patient with unbalanced diabetic
2. Patient with a formal contraindication usual for certain imaging procedures (severe claustrophobia, wearing a heart valve, pacemaker, etc.)
3. Pregnant or breastfeeding woman
4. Any psychological, family, geographical or sociological condition that does not allow medical follow-up and/or procedures provided for in the study protocol to be respected
5. Patient protected by law
Preoxygenation Using NIV in Hypoxemic Patients

Critically ill patients are predisposed to oxyhaemoglobin desaturation during intubation. For the intubation of hypoxemic patients, preoxygenation using non invasive ventilation (NIV) is more effective at reducing arterial oxyhaemoglobin desaturation than standard method.

Objectives: To find out whether NIV, as a preoxygenation method, is more effective at reducing the degree of organ dysfunction/failure than standard preoxygenation during the week following endotracheal intubation.

During the inclusion period (at least 10 min and maximum 30 min), the patients ware a high FiO2 mask, driven by 10-15L/min oxygen and are randomly assigned to control or NIV group. Preoxygenation is then performed for a 3 minute period prior to a standardized rapid sequence intubation. For the control group, preoxygenation use a non-re-breather bag-valve mask driven by 15L/min oxygen. Patients allow to breath spontaneously with occasional assists (usual preoxygenation method). For the NIV group, pressure support mode is delivered by an ICU ventilator through a face mask adjusted to obtain an expired tidal volume of 7 to 10 mL/kg. The fraction of inspired oxygen (FiO2) was 100% and we used a PEEP level of 5 cmH2O.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients with acute respiratory failure requiring intubation

Exclusion Criteria:

* Encephalopathy or coma, cardiac resuscitation
Effect of a Physical Exercise Intervention Based on the Transtheoretical Model on Blood Pressure

Background: Hypertension is a public health problem; the World Health Organization (WHO) estimates that more than 1280 million people suffer it. The treatment of said condition is pharmacological and non-pharmacological. Physical activity is part of the treatment, but unfortunately few adults can be classified as physically active. There is evidence that performing physical exercise reduces systolic blood pressure by up to 5 mm Hg, which has associated with reduced heart disease by up to 9%, ictus up to 14% and all-cause mortality by 4%. Lifestyle changing interventions, among them promoting exercise marked by a theory of behavior change, have shown positive results. Objective: To evaluate the effect of an intervention promoting the performance of physical exercise, with specific recommendations, based on the Transtheoretical Model, on systolic blood pressure and on the amount of exercise performed (minutes/week) in patients with hypertension aged 40 to 70 years, users of primary care in the Mexican Institute for Social Security (IMSS) in Aguascalientes. Material and methods: Randomized clinical trial, in which 442 patients with hypertension will participate. The control group will receive conventional care and recommendations for physical exercise and diet. The intervention group, in addition, will attend 6 workshops, one a month, which will promote performing physical exercise, with access given to videos of physical exercise routines, designed to gradually increase the exercise performed. At the start and end of the study, blood pressure, anthropometric measurements will be taken, through a questionnaire asking about sociodemographic data, performance of physical exercise, psychosocial factors regarding physical exercise, diet and adherence to pharmacological treatment. The characteristics of the study population by group will be described, and changes between baseline and final measurements compared, intra and intergroup, in the systolic blood pressure and minutes/week of physical exercise.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertension.
* Patients from 40 to 70 years old.
* IMSS primary care users at UMF No. 1, in Aguascalientes.
* Patients who agree to participate in the study.

Exclusion Criteria:

* Patients with hypertension that have a medical contraindication for performing physical exercise, or whose health status suggests an individualized, supervised exercise plan (angina, arrhythmia, chronic kidney disease, lupus erythematosus).
* Patients who have some mental alteration that impedes answering the questionnaires or adequately following the established strategy.
The Association of Gut Microbiota With Urinary Tract Infection in Infants

This prospective case-control study will compare the gut microbiota between the infants with febrile urinary tract infection and healthy infants.

The investigators hypothesize that the gut environment reflected by intestinal microbiota influences the risk of urinary tract infection. This prospective case-control study will compare the gut microbiota between the infants with febrile urinary tract infection and healthy infants. The investigators will sequence the V3-V4 of the bacterial 16SrRNA genes from the feces and analyze the sequencing data by QIIME2.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of febrile urinary tract infection.
* Infants

Exclusion Criteria:

* Congenital kidney disease
* Congenital heart disease
* Other metabolic disease
Prenatal Multi-micronutrient Supplementation and Pregnancy Outcome

Prenatal maternal micronutrient supplementation has been suggested as a means to reduce the proportion of low birth weight babies in low-income countries. The effects of prenatal multi-micronutrient supplements on birth weight and perinatal mortality were studied in a randomised controlled trial among 2100 pregnant women in Guinea-Bissau. Women up to 37 weeks pregnant were individually randomised to daily supplements until delivery of A) Iron + folic acid or multi-micronutrients in B) One or C) Two recommended dietary allowances. Secondary outcomes were infant growth and maternal haemoglobin eight weeks after delivery.

Prenatal maternal micronutrient supplementation has been suggested as a means to reduce the proportion of low birth weight babies in low-income countries. The effects of prenatal multi-micronutrient supplements on birth weight and perinatal mortality were studied in a randomised controlled trial among 2100 pregnant women in Guinea-Bissau. Women up to 37 weeks pregnant were individually randomised to daily supplements until delivery of identically looking tablets containing 1) Iron (60 mg) + folate (400 µg), 2) One recommended dietary allowance (RDA) of 5 minerals and 10 vitamins, including iron (30 mg) and folate (400 µg), or 3) Two RDA's of 5 minerals and 10 vitamins, including iron (30 mg) and folate (800 µg). Supplements were provided in known excess at fortnightly home visits until delivery. Compliance was assessed by tablet count.

Women were interviewed about age, civil status, obstetric history and socio-economic status at enrolment. Maternal anthropometry was measured at enrolment, at delivery, and eight weeks after delivery. Maternal malaria parasitaemia and haemoglobin were measured at enrolment and eight weeks after delivery. Maternal status of a wide range of micronutrients was assessed at enrolment and eight weeks after delivery in a sub-cohort of 600 women. Further, survival of the infants will be followed until 3 years of age, within the routines of the Bandim Health Project surveillance system.

Women were provided impregnated bed nets and weekly malaria prophylaxis until delivery. Women with high malaria parasitaemia at enrolment were in addition given a full treatment at enrolment.

Sample size considerations: A sample size of 638 women in each treatment group will be required to detect a reduction in perinatal mortality from 9% to 5% or less in a treatment group using 80% power and a 5% significance level. With an expected loss to follow up of 10%, 2100 women are required. With a sample size of 2100 the study will be able to detect at least 75 g difference, i.e. a 2.5% change in birth weight.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women

Exclusion Criteria:

* \>37 weeks of gestational at enrollment
Study To Evaluate Safety and Efficacy of Vesatolimod for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Participants

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod in participants with chronic hepatitis B (CHB) infection currently being treated with oral antivirals (OAV).

Participants will be randomized in 3 sequential cohorts (Cohorts A, B, and C). Within each cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of the doses of vesatolimod (1, 2, or 4 mg).


Eligibility Criteria:
Key Inclusion Criteria:

* Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
* Documented evidence of CHB infection (eg, hepatitis B surface antigen \[HBsAg\] positive for more than 6 months) with detectable HBsAg levels at screening
* Have been on approved HBV OAV treatment for ≥ 1 year prior to screening, with HBV DNA below lower limit of quantitation (LLOQ), measured at least once, 6 or more months prior to screening, and HBV DNA \< 20 IU/mL at screening
* Currently taking an approved HBV OAV (tenofovir, entecavir, adefovir, lamivudine, or telbivudine, either as single agents or in combination) with no change in regimen for 3 months prior to screening
* Willing to provide blood sample for toll-like receptor 7 (TLR-7) and interleukin 28 B (IL28B) single-nucleotide polymorphism (SNP) assessment
* Must be willing and able to comply with all study requirements

Key Exclusion Criteria:

* Extensive bridging fibrosis or cirrhosis
* Laboratory parameters not within defined thresholds for neutropenia, anemia, thrombocytopenia, leukopenia, or other evidence of inadequate liver function
* Coinfection with hepatitis C virus (HCV), HIV, or hepatitis D virus (HDV)
* Evidence of hepatocellular carcinoma
* Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.). Participants under evaluation for possible malignancy are not eligible.
* Significant cardiovascular, pulmonary, or neurological disease
* Any of the following conditions that may worsen in response to interferon (IFN):

  * Autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, moderate or severe psoriasis)
  * Poorly controlled diabetes mellitus
  * Significant psychiatric disorders
  * Thyroid disorder (unless controlled under treatment)
  * Significant pulmonary diseases (eg, chronic obstructive pulmonary disease)
  * Retinal disease
  * Immunodeficiency disorders
* Received solid organ or bone marrow transplant
* Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal Ab, interferon) within 3 months of screening
* Use of another investigational agents within 3 months of screening
* Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
* Females who are pregnant or may wish to become pregnant during the study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Application of Two Different Synthetic Sequential Media for the Human IVF-Embryo Transfer (IVF-ET) Program

Quality-controlled commercial media have been used in many in-vitro fertilization (IVF) laboratories. However, commercial media are costly and difficult to compare directly because their exact compositions are not clearly indicated. Although commercially available media have commonly been used in most IVF programs worldwide, there are several advantages to the use of in-house synthetic sequential media at IVF laboratories. First, the results of quality control should be reliable due to a stringent protocol setting-up. Second, any direct supplementations or deletions of specific components are feasible to obtain good quality embryos and high pregnancy rates since those components can be defined. Finally, dependence on commercially available media diminishes so that the laboratory can more easily accommodate unexpected situations or problems, such as a sudden increase in IVF patients. Therefore, the present study was conducted to compare the efficacy of in-house MRC media in the human IVF-embryo transfer (ET) program to that of commercially available media.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing IVF treatment in our clinic during study period

Exclusion Criteria:

* Females older than 40 years
* Patients showed fertilization failure
* Patients with less than two 2PN embryos
Urinary Tract Infections Rates Using 50% Dextrose Plus Washout Versus Normal Saline as Cystoscopy Fluid

Our study will compare the rates of postoperative urinary tract infections (UTI) between patients who undergo cystoscopy using 50% dextrose injection plus bladder washout versus normal saline after hysterectomy for benign indications. Primary outcome will be rates of urinary tract infections at 6-9 days post-operatively. This will be defined as a urine culture yielding greater than 100,000 gram-negative colony-forming units per milliliter.

This will be a prospective cohort study of the rate of UTIs after cystoscopic distention media of normal saline with maximum injection of 40 cc of 50% dextrose plus 300 cc of normal saline washout versus normal saline after hysterectomy for benign indications.

A pre-operative urine culture will be obtained via mid-stream clean catch prior to administration of routine pre-operative prophylactic antibiotics.

At 6-9 days post-operatively, a repeat urine culture will be obtained via mid-stream clean catch. Appropriate treatment will be administered if the urine culture is positive.Primary outcome will be rates of urinary tract infections at 6-9 days post-operatively. This will be defined as a urine culture yielding greater than 100,000 gram-negative colony-forming units per milliliter.

Eligibility Criteria:
Inclusion Criteria:

* Preoperative scheduling CPT codes for hysterectomy

Exclusion Criteria:

* Discharged home with indwelling foley catheter
* Indwelling foley catheter \> 24 hours
* Ureteral injury
* Chronic immunosuppression
* History of diabetes
* Recurrent UTIs (≥2 infections in six months or ≥3 infections in one year)
* Reported Chronic Kidney Disease
* Renal anomalies