cyrilzakka/clinical-trials huggingface dataset:
ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis

The protocols including ciclosporin A （CsA）+methotrexate (MTX) +mycophenolate Mofetil(MMF) have been widely used for graft-versus-host disease (GVHD) prophylaxis in allogeneic hematopoietic stem cell transplantation from HLA-matched sibling donor (MSD). Nevertheless, severe chronic graft-versus-host disease (cGVHD) remains an obstacle for MSD HSCT. A growing body of studies have suggested antithymocyte globulin (ATG) could reduce the incidence of cGVHD. This study is aim to evaluate the efficacy of a protocol that includes CsA, MTX, MMF and ATG in recipients of MSD HSCT.


Eligibility Criteria:
Inclusion Criteria:

1. A patient age of 18-65 years
2. MSD transplant recipient
3. Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

1. Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
2. Patients with any conditions not suitable for the trial (investigators' decision)
The Benefits of Individualized Follow-up with a Sport-Health Professional in the Care of Patients with Chronic Respiratory Diseases

Pulmonary rehabilitation is an integral part of care for patients with chronic respiratory diseases. It improves patients' physical capacities, quality of life and symptoms, at least in the short term.

The hypothesis that patients receiving personalized support from a professional following pulmonary rehabilitation will maintain long-term benefits.

This study concerns patients with a diagnosis of one or more chronic respiratory diseases.

It is a multicenter, blinded, randomized controlled superiority trial in 2 parallel arms:

* a group comparing follow-up and personalized support after a pulmonary rehabilitation program (experimental group)
* a control group receiving only usual care

Pulmonary rehabilitation is an integral part of care for patients with chronic respiratory diseases. It improves patients' physical capacities, quality of life and symptoms, at least in the short term.

The hypothesis that patients receiving personalized support from a professional following pulmonary rehabilitation will maintain long-term benefits.

This study concerns patients with a diagnosis of one or more chronic respiratory diseases.

It is a multicenter, blinded, randomized controlled superiority trial in 2 parallel arms:

* a group comparing follow-up and personalized support after a pulmonary rehabilitation program (experimental group)
* a control group receiving only usual care

Each patient is followed up for 24 months with a visit every 6 months. A total of 352 subjects will be recruited

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of one or more chronic respiratory diseases (asthma, chronic obstructive pulmonary disease, diffuse interstitial lung disease, bronchiectasis, obstructive sleep apnea syndrome, etc.).
* Participation in a respiratory pulmonary program
* Have given consent
* Patient of legal age
* Patient affiliated to Social Security

Exclusion Criteria:

* Any medical contraindication to the practice of adapted physical activity in rehabilitation
* Patient refusal
* Patients under guardianship or curatorship
* Patients deprived of their liberty
* Minors
* Patients over 80 years of age at the time of inclusion.
Improving Diabetes Outcomes for Persons With Severe Mental Illness

Persons with severe mental illness are at great risk for developing type 2 diabetes (T2DM). Unfortunately, persons with mental illness and T2DM are less likely to receive recommended diabetes monitoring and are more likely to have poorly controlled diabetes, which leads to microvascular and macrovascular complications later in life. Evidence-based diabetes self-management education and support interventions have yet to be adapted for persons with mental illness and there have been no randomized controlled trials (RCTs) to examine their feasibility and efficacy. The purpose of this study is to assess the feasibility of conducting a RCT of a diabetes self-management intervention for persons with severe mental illness and T2DM.


Eligibility Criteria:
Inclusion Criteria: Type 2 diabetes plus severe mental illness -

Exclusion Criteria: None

-
Vaccine Responses in Cancer

The investigators are conducting a prospective unblinded study of individuals diagnosed with cancer who will receive one or more of the following: influenza, SARS-CoV2 and shingles.

Vaccinations are indicated for all adults, but the immunogenicity of vaccination has not been assessed in all situations. In particular, immune responses following vaccination have not been studied in the setting of cancer and in the context of various anti-tumor treatments. In this study, the investigators will look at the immune response of subjects receiving vaccination.

Eligibility Criteria:
Inclusion Criteria:

* adults over age 18 who are able to provide consent, who have a diagnosis of cancer, and are willing to receive the influenza, recombinant shingles, and/or SARS-CoV-2 vaccines.

Exclusion Criteria:

* allergic to influenza, shingles, and/or SARS-CoV-2 vaccination; have HIV infection; have a history of solid organ or bone marrow transplant.
Study on Improvement of Blood Glucose Control in Patients With Diabetes Type 2 Using SMBG

This clinical study is to determine if the use of structured testing, which is a blood glucose monitoring, via the Accu-Chek 360° View blood glucose analysis tool has a positive effect on the subjects overall glycemic control.


Eligibility Criteria:
Inclusion Criteria:

1. Age:= and \>20 years. 2. Intend to paticipate in this study after education of structured testing. 3.HbA1c:= and \>7.5% in the recect 2 months.

Exclusion Criteria:

1.Pregancy. 2. Heavy complication 3. judged unsuitable by doctor
Managing Adolescent Obesity at Local Level by Combining Primary and Secondary Intervention

The objective of the project is to develop, implement and evaluate a prevention program for obesity among adolescents in Brazil combining the primary care health system implemented in the country in recent decades with primary prevention at schools.

The study will combine primary prevention activities at the school level with secondary prevention at the household level, both focusing on behavior strategies such as mindfulness, reduction of eating rate; eating with others at a dinning table; healthy eating, increasing physical activity and reducing sedentary lifestyle habits.

Eligibility Criteria:
Inclusion Criteria:

* Both prevention programs
* 5th and 6th grades students
* consent form signed by parents/tutors
* Secondary prevention program
* Overweight and obese children

Exclusion Criteria:

* pregnant girls
Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study

Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks

The process is based on obtaining plasma from patients recovered from COVID-19 in Colombia, and through a donation of plasma from the recovered, the subsequent transfusion of this to patients infected with coronavirus disease (COVID-19). Our group has reviewed the scientific evidence regarding the application of convalescent plasma for emergency viral outbreaks and has recommended the following protocol

Eligibility Criteria:
Inclusion Criteria:Fulfilling all the following criteria

1. Olerder than 18.
2. Hospitalized participants with diagnosis of COVID 19 by Real Time - Polymerase Chain Reaction.
3. Severe cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 7)".
4. Sequential Organ Failure Assessment score (SOFA) \< 6.
5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding.
2. Patients with prior allergic reactions to transfusions.
3. Critical ill patients in intensive care units with requierment of Invasive Mechanical Venitlation.
4. Patients with surgical procedures in the last 30 days.
5. Patients with active treatment for cancer (Radiotherapy or Chemotherapy).
6. HIV diagnosed patients with viral failure (detectable viral load\> 1000 copies / ml persistent, two consecutive viral load measurements within a 3 month interval, with medication adherence between measurements after at least 6 months of starting a new regimen antiretrovirals).
7. Demonstrated coinfection that explains the patient's symptoms
8. End-stage chronic kidney disease (Glomerular Filtration Rate \<15 ml / min / 1.73 m2).
9. Child Pugh C stage liver cirrhosis.
10. High cardiac output diseases.
11. Autoimmune diseases or Immunoglobulin A nephropathy.
12. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.
Randomized Control Trial Copper Intrauterine Device and Depo-medroxyprogesterone Acetate (DMPA) of HIV+ Women in Malawi

The IUD is an extremely effective method of contraception yet few women use it worldwide. Considered safe to use in HIV+ women, few studies have evaluated its use among those using antiretroviral therapy. The only prior randomized trial looking at the IUD compared to hormonal contraception noted a high rate of IUD discontinuations. Understanding IUD acceptability and continuation is critical to improve utilization.

* Objective 1: Determine WHO medical eligibility and the willingness for IUD placement
* Objective 2: Compare method-related side effects and adverse events
* Objective 3: Assess the 1-year acceptability and continuation rates

Methods: To address our objectives the investigators have designed a two Phase Study:

* A cross-sectional screening to evaluate contraceptive medical eligibility and desirability
* A randomized controlled trial that will compare acceptability and adherence to DMPA compared to the Copper IUD: enrolling 200 women stable on antiretroviral therapy to follow for 1 year


Eligibility Criteria:
Inclusion Criteria:

* Can provide informed consent
* Women ages 18-45
* Known HIV + status on antiretroviral therapy for at least 6 months
* Not currently pregnant
* Willing to initiate either DMPA or CuT380A-IUD. Women currently using DMPA or CuT380A-IUD will be excluded
* Do not desire to become pregnant within next 12 months
* Intend to stay in Lilongwe region for the duration of the study
* No known uterine anomalies based upon history
* Greater than or equal to 4 weeks post partum
* No known or suspected genital tract cancer
* No evidence of current pelvic inflammatory disease or cervicitis. Women with cervicitis at the time of examination will be treated with antibiotics and eligibility will be reassessed at a follow-up visit at least 7 days after treatment
* No pelvic inflammatory disease within prior 3 months
* No contraindications to DMPA or the CuT380A-IUD per the WHO medical eligibility criteria or Malawi National Reproductive Health Service Delivery Guidelines, 2007
* Based on clinical assessment, no condition that would preclude start of study intervention

Exclusion Criteria:

* Women ages younger than18 or older than 45
* Known HIV + status on antiretroviral therapy less than 6 months or not on antiretroviral therapy
* Pregnant
* Uterine anomaly
* Less than 4 weeks post partum
* Suspected genital tract cancer

Inclusion Criteria:

•Current STI or PID
Impact of Educational Intervention Protocol on the Level of Knowledge, Clinical Control and Lung Function of People With Asthma

The goal of this randomized controlled clinical trial is to evaluate the effects of a proposed educational intervention on people with asthma. The main question it aims to contribute to a better understanding of the effectiveness of educational intervention strategies in people with asthma.

Participants allocated to the control group will receive standard follow-up according to the clinic routine. Participants allocated to the experimental group will undergo an educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024).

People with asthma will participate in the study, from the Pulmonary Function Clinic of the Department of Physiotherapy at Federal University of Paraíba - UFPB. Spirometry data, knowledge about asthma and correct control over inhalation therapy, clinical control of the disease using the Asthma Control Test (ACT) and C-ACT questionnaire, number of asthma attacks, amount of medication used, hospitalizations and visit to the emergency room in the last 4 weeks will be assessed. Assessments will be carried out at the first contact (baseline) and twelve weeks after the first contact.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of asthma
* Assisted by the Pulmonary Function Clinic
* Ventilatory dysfunction assessed by spirometry

Exclusion Criteria:

* Obesity
* Treatment with systemic corticosteroids
* Previous chest surgery
* Unable to perform any of the proposed assessment steps
Implantation Rate of Vitrified-warmed Collapsed Blastocysts

In our centre, the implantation rate of frozen blastocysts (cryopreserved using vitrification)was 20,3% (Van Landuyt et al. 2011). This implantation rate is lower when compared to data from other observational studies. Retrospective studies have shown that artificial shrinkage of the blastocoelic cavity (also called collapse) and dehydration of the blastocyst just before vitrification can have a positive effect on the survival after warming. This collapse can be induced by using a laser. The study of Iwayama et al. 2010 has shown a similar survival rate but an increase in the implantation rate of collapsed blastocysts compared to non-collapsed blastocysts.

The aim of the study is to investigate the effect of artificial shrinkage by laser-induced collapse on the implantation potential of vitrified-warmed day 5 or day 6 blastocyst stage embryos in a prospective randomised controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* female age \<39 years
* at least 1 blastocyst available for cryopreservation

Exclusion Criteria:

* sperm origin: testicular or epididymal sperm extraction
* IVM (in-vitro maturation) cycles
* PGD cycles (preimplantation genetic diagnosis)
An Extension Study for Patients Previously Treated With ARQ 501

To provide ongoing treatment with ARQ 501 for patients who have benefited from prior treatment with ARQ 501


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Has previous participated in a clinical trial with ARQ 501 and is eligible for continued treatment

Exclusion Criteria:

* Have not received previous treatment with ARQ 501 under a treatment protocol
* Uncontrolled intercurrent illness, uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects

The main purpose of the trial is to compare the bioavailability (extent of drug absorption into the circulation) of insulin degludec and liraglutide as part of a combination product insulin degludec/liraglutide compared to the corresponding doses of single, separate injections of insulin degludec and liraglutide. Participants will receive all three test substances. The order of trial administration will be allocated by chance. During the trial period, serials of blood samples will be collected from the participants at three dosing periods, in order to determine the concentration of insulin degludec and liraglutide. The total volume of blood taken throughout the whole trial period will be less than 400 mL. Participants will be asked to stay on daytime and overnight in the trial sites on some predefined days. For other outpatient days, participants need to attend the trial site as required for drug administration or required assessments.


Eligibility Criteria:
Inclusion criteria:

* Male and female Chinese subjects, who are considered to be generally healthy, based on assessment of medical history, physical examination, and clinical laboratory data, as judged by the investigator
* Age between 18 to 45 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 19.0 and 24.0 kg/sqm (both inclusive)
* Body weight at least 50.0 kg
* Fasting plasma glucose less than 6.1 mmol/L (110 mg/dL)

Exclusion criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive methods throughout the trial including follow-up period. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or barrier methods
* Donation of any blood or plasma in the past month or in excess of 400 mL within the 90 days preceding screening or surgery or trauma with more than 400 mL blood loss within the 90 days preceding screening
* History or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes and recurrent hypoglycaemia), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the trial result, as judged by the investigator
* Use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (mega-dose vitamin therapy not allowed, dose judged by the investigator) within 2 weeks prior to screening
Effects of Compression Stockings on Obstructive Sleep Apnea in Patients Under Hemodialysis

To study the effects of compression stockings on sleep apnea in hemodialysis patients with diagnosed obstructive sleep apnea. The rationale of this study consists in the fluid shift theory, which consists in the nocturnal rostral fluid shift from legs, which causes upper airways edema.

The aim of this study is to evaluate if compression stockings could improve such nocturnal volume redistribution and, therefore, improve obstructive sleep apnea.

Investigators will apply the following methods:

* Sleep study, performed through polysomnography
* Fluid redistribution, by bioimpedance analysis
* Autonomic nervous system evaluation, by spectral heart rate variability analysis.

The study protocol comprises two moments: baseline evaluation (in patients with diagnosed sleep apnea) and after using compression stockings for a one-week period.

Eligibility Criteria:
Inclusion Criteria:

* Patients under hemodialysis
* Patients with diagnosed obstructive sleep apnea

Exclusion Criteria:

* Congestive heart failure
* Urine output \> 500 ml/day
* non-sinusal cardiac rhythm
* refusal to give written consent
Changes in Stem Cells of the Colon in Response to Increased Risk of Colorectal Cancer

Colorectal cancer is a common disease worldwide. Increasing evidence is demonstrating that colorectal cancers arise from 'cancer stem cells.' Stem cells in the colon reside at the bottom of thousands of microscopic crypts throughout the wall of the colon. They create all the cells lining the bowel wall. These cells are created in the base of the crypt and ascend to the top acquiring the characteristics of mature cells of the bowel wall as they ascend.

It is now thought that colorectal cancer cells arise from stem cells where the genetic material regulating growth and division of the stem cell has become defective. This leads to unregulated production of cells which in turn have defective genetic information and cancer formation.

Prior studies have demonstrated that the earliest changes before a cancer develops are changes in cellular proliferation. Now that reliable markers to identify stem cells have been found, the researchers aim to investigate stem cell numbers and changes in distribution in those at normal risk of colorectal cancer and those at higher risk. The researchers hypothesise that changes in cellular proliferation at the top of the crypt in individuals at higher risk of colorectal cancer are due to a change in the number of stem cells in the crypt base.


Eligibility Criteria:
Inclusion Criteria:

* Referred for endoscopy at participating centre

Exclusion Criteria:

* Age \<16 or \>85
* Familial polyposis syndrome
* Lynch syndrome
* Known colorectal tumour
* Previous colorectal resection
* Pregnancy
* Chemotherapy in last 6 months
* Therapy with aspirin/other nonsteroidal anti-inflammatory drug (NSAID)
* Other immunosuppressive medication
* Incomplete left sided examination
* Colorectal carcinoma found at endoscopy
* Iatrogenic perforation at endoscopy
* Colorectal cancer on histology
* Microscopic colitis on histology

For the colitis group

* Simple clinical colitis activity index (SCCAI) score \> 5
Negative ER Expression Assessed by 18F-FES PET/CT in the MBC With ER-positive Primary Tumor

To investigate the treatment pattern and efficacy of patients with positive primary ER lesion but negative ER expression in MBC using a novel convenient way of 18F-fluoroestradiol positron emission tomography/computed tomography (18F-FES PET/CT).


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with breast cancer (according to International Classification of Diseases 10th Revision) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
* MBC patients who underwent 18F-FES PET/CT at the Fudan University Shanghai Cancer Center between 2010 and 2022
* Patients diagnosed with primary ER-positive tumor and who were yet to receive any systemic therapy during the advanced stage

Exclusion Criteria:

* Patients with incomplete medical records and those diagnosed with secondary primary tumors