cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Interleukin-2 (IL-2) Plus Anti-HIV Therapy in HIV-Positive Patients

The purpose of this study is to find out if the immune systems of HIV-positive patients can be improved by treatment with anti-HIV medications plus interleukin-2 (IL-2) in the early stages of HIV infection.

IL-2 is a protein found naturally in the blood that can help boost the immune system. HIV spreads throughout the body by invading CD4 cells, which are cells of the immune system that fight infection. Doctors hope that adding IL-2 to a current anti-HIV drug combination can help restore the CD4 cell count and the immune functions. This study will look at how the HIV virus acts during the early stages of HIV infection, how the immune system responds to HIV, and what impact early treatment with anti-HIV medications has on the course of HIV infection.

At the time of initial HIV infection, CD4 cells are susceptible to infection, and the virus infects many T cells during the first 4 to 6 weeks. Many of these infected cells subsequently maintain the virus in a latent state. Immune reconstitution with daily low-dose IL-2 therapy is intended to correct or improve the deficiency in CD4 cells, while maintaining a high frequency of CD8+ HIV-specific CTL and increasing natural killer (NK) cells. After a year of HAART plus IL-2, it may be possible to discontinue HAART while maintaining IL-2 stimulatory therapy, and the immune reactivity repaired and stimulated by IL-2 should be able to contain the virus and maintain latency.

Patients are randomized to add IL-2 to their current HAART regimen or simply to remain on their current HAART regimen. IL-2 therapy is initiated at Month 3 of HAART. IL-2 is injected subcutaneously daily for 9 months, in addition to HAART. After completion of this 1-year treatment period, patients are evaluated for discontinuation of HAART. Patients with a viral load below 50 copies/ml throughout HAART plus IL-2, a CD4 count of at least 500 cells/mm3, and no onset of opportunistic infections may have HAART discontinued and IL-2 continued as monotherapy for an additional 6 months. After completing 6 months of IL-2 monotherapy, eligible patients may have IL-2 therapy discontinued.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* HIV-infected.
* Viral load of 5,000 copies/ml or less within 3 months.
* Completed at least 3 months of anti-HIV medications.
* Have a refrigerator to store the needles for IL-2 shots.

Exclusion Criteria

* Glucocorticoids or other drugs that affect the immune system such as INF-alpha, G-CSF, or GM-CSF.
Improving Hand Use in Multiple Sclerosis

This study will compare two different kinds of physical therapy to improve use of the hands in individuals with multiple sclerosis (MS). One treatment will be Constraint-Induced Movement therapy (CI therapy), the other will be a set of Complementary and Alternative Medicine (CAM) treatments (yoga, relaxation exercises, aquatherapy, massage). The study will determine which of the two forms of treatment is more successful for improving hand use.

Multiple Sclerosis (MS) frequently causes reduced use of one of the hands, and as a result, much of daily living activities are conducted only by the other hand, leaving the person effective one-handed. Nonetheless, reduced hand use can be improved for extended amounts of time with specific forms of physical therapy, as long as persons with MS have the ability to perform the training tasks.

This study will randomize persons with MS who have relatively reduced use of one of the hands to either CI therapy or CAM treatments. Treatment in either program will be for 2 consecutive weeks, 3.5 hours per day (Monday-Friday), under the direct supervision of a specially trained therapist. Before starting, participants will also undergo comprehensive medical and physical exam screening and brain MRI scan. The same evaluations will be performed after treatment to learn whether any of these have changed as a result of treatment.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of non-relapsing multiple sclerosis (primary progressive MS, secondary progressive MS)
* reduced use of one of the hands because of MS
* ability to pick up and release a small object with the more-affected hand when requested
* can travel to the treatment program at the University of Alabama at Birmingham (UAB)
* can undergo treatment for 2 weeks (Monday-Friday), 3.5 hours per day
* can undergo MRI scan
* any kind of medication used for MS is allowed except spasticity medicine

Exclusion Criteria:

* disease relapse in the past 3 months
* pregnancy
* marked pain with arm movement
* severe uncontrolled medical illness
* simultaneous treatment with another form of physical therapy
New Alternative Formats vs Standard of SoF Tables. Non-inferiority Controlled Trial

The investigators will conduct a parallel two-armed, non-inferiority randomized trial comparing new alternative formats of summary of findings tables (SoF) tables with current formats. The investigators will contact Cochrane review users by email and will ask them to fill a questionnaire developed using the "Survey Monkey" online system. The survey will include questions about baseline information (demographic characteristics, background, number of visits to the Cochrane Library, familiarity with the GRADE system, etc.). Then, participants will be stratified (health professional, guideline developer, researcher) and randomly assigned to one of the two SoF table formats, either the alternative (Table A) or the current one (Table C). Participants will be asked to answer questions to determine understanding, accessibility, and satisfaction with the formats to which they were randomized. Finally, the investigators will show them the table format to which they were not initially allocated in order to test their preference for either one.


Eligibility Criteria:
Inclusion Criteria:

* Cochrane review users
* Authors of systematic reviews
* Health professionals
* Guideline developers
* Researchers

Exclusion Criteria:

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Depakote ER in Borderline Personality Disorder

This study examines the effect of Depakote ER versus placebo in a randomized trial of borderline personality disorder. Patients all participate in DBT therapy and those who are not responsive are assigned to either Depakote ER or placebo for up to 12 weeks. Borderline Personality Symtoms are measured and side-effects are assessed.


Eligibility Criteria:
Inclusion Criteria:Male or female patients with the diagnosis of borderline personality disorder between the ages of 21 adn 55 years old. Must be in good physical health -

Exclusion Criteria:Major psychiatric illness on Axis I - schizophrenia or bipolar disorder. May not have current MDD. May not be dependent on illicit substances or alcohol.

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Determination of COVID-19 Related Virus in Central Nervous System

Coronavirus disease 2019 (COVID-19) is a highly infectious pandemic disease caused by SARS-CoV-2 virus. Central Nervous System (CNS) complications associated with COVID-19 might be secondary sequelae due to exuberant systemic innate-mediated hyper-inflammation, which may impair neurovascular endothelial function, disrupt blood brain barrier (BBB), activates CNS innate immune signaling pathways, and induces parainfectious autoimmunity, potentially contributing to the CNS manifestations. Although the predominant clinical manifestation of SARS-CoV-2 is characterized by dyspnea, unremitting fever and hypoxemic respiratory failure, neurologic manifestations do occur in most hospitalized SARS-CoV-2 patients and include non-specific encephalopathy, psychosis, meningitis/encephalitis, myelitis, cerebrovascular events, Guillain-Barre' syndrome, and cranial or peripheral neuropathies, such as anosmia and ageusia. To date, data about primary CNS involvement due to neurotropism and direct neuroinvasion are still lacking.

Determination of SARS-CoV-2 presence in central nervous system

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Patients candidate for CNS surgery
* Patients who have been tested for nasopharyngeal swab for SARS-CoV-2
* Patients who have been tested for serology test for anti SARS-CoV-2 immunoglobulinG (IgG) and immunoglobulinM (IgM) antibodies
* Patients able to sign informed consent

Exclusion Criteria:

* Patients not meeting inclusion criteria
Time at VO2max During High-Intensity Interval Training

The project titled "Time at VO2max During High-Intensity Interval Training Manipulating Work and Rest" aims to investigate how different high-intensity interval training (HIIT) protocols influence the time athletes spend at or above 90% of their VO2max. By adjusting the work-to-rest ratios in the HIIT formats, the study seeks to determine which configurations maximize the time spent in this high-intensity zone, contributing to more effective endurance training strategies. The findings could help optimize training protocols for athletes targeting improvements in aerobic capacity and performance.


Eligibility Criteria:
Inclusion Criteria:

* Middle and long distance track and field athletes

Exclusion Criteria:

* Injured athletes
Short-term Cognitive Training in Late-life Depression

The purpose of this study is to examine the effects of the alternative uses training (AUT) and word association training (WAT) on cognitive functions and mood symptoms in late-life depression (LLD).

The hypotheses are:

1. post-training cognitive performance will be superior to pre-training cognitive performance
2. post-training depressive symptomatology will be less severe as compared with pre-training clinical severity and
3. AUT group will show better post-training cognitive performance and improved mood symptoms when compared with the WAT group.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age \>=55
* Proficiency in English
* Current depressive episode and meet criteria for DSM-IV major depressive disorder
* Hamilton Depression Rating Scale score \>=15
* Able to give informed consent
* Stable medication dosages during the training period

Exclusion Criteria:

* Other DSM-IV Axis I psychiatric disorders, except for anxiety disorders due to high comorbidity with mood disorders
* Mini-Mental State Examination score of \<26
* Diagnosis of dementia
* Neurological and medical conditions known to affect cognition (e.g., stroke, head injury, previous chemotherapy for cancer)
* Unstable medical illnesses requiring active treatment
* Vision or hearing impairment affecting ability to participate in training
Optimizing Continuous-flow Left Ventricular Assist Device Settings and Identification of Pump Malfunction - A Comparative Study of Echocardiography and Invasive Hemodynamics

The purpose of the trial is to identify factors which can be used as guidance when optimizing continuous-flow left ventricular assist device (CF-LVAD) settings.

The hypothesis of the study is that pulmonary capillary wedge pressure (PCWP) will change independently of left ventricular end diastolic diameter (LVEDD) when increasing pump speed ie ΔPCWP/RPM ≠ ΔLVEDD/RPM.

The primary combined endpoint of the study is correlation between ΔPCWP and LVEDD slope under ramp testing in a cohort of "continuous-flow left ventricular assist device" heart failure patients.


Eligibility Criteria:
Inclusion Criteria:

* Heart failure patients with HeartMate II (HM II) followed as outpatients at The Heart Centre at University Hospital of Copenhagen, Rigshospitalet.
* Age \> 18 years.
* Heart failure in stable phase without the need for intravenous inotropic therapy.
* Ischemic or non-ischemic cardiomyopathy.
* Signed informed consent.

Exclusion Criteria:

* Unstable patients with the need for intravenous inotropic therapy.
* Current hospitalization.
* Implantation of HM II less than one month ago.
Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment

The purpose of this study is to compare the efficacy of body iron storage replenishment between low dose intravenous iron and oral iron in late pregnancy.

Despite routine antenatal oral iron supplementation, the prevalence of iron deficiency anemia (IDA) in the 3rd trimester of pregnancy in developing countries remains high. Apparently, intravenous iron sucrose appears to be safe and efficient in treating within a short period. From literature review, no study of intravenous iron for IDA treatment has been carried out in the third trimester of pregnancy. This research aims to compare the efficacy of body iron storage replenishment at 3 weeks as labor may take place at this point in some women. In this study,500 mg intravenous iron has been given weekly instead of every other day for the sake of patient's convenience in the hope that parenteral iron may become another alternative for treatment of pregnant women with iron deficiency anemia who have difficulties or failures with oral iron.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-45 years old
2. Singleton pregnancy at 32 weeks gestation
3. Having anemia in the third trimester according to World Health Organization, namely, with a hemoglobin level of \< 11 g/dL or hematocrit of \< 33%
4. Having no underlying disease such as hypertension, gestational diabetes mellitus, heart disease, peptic ulcer, etc.
5. Having no history of allergy to iron containing medication
6. Having no history or other allergic conditions or asthma
7. Having no thalassemia disease, for examples: B thalassemia major, hemoglobin E/ B thalassemia, homozygous hemoglobin E, Hemoglobin H, AE Bart disease, and EF Bart disease. Pregnant women who have iron deficiency anemia and are thalassemia carriers such as A-thalassemia 1, B-thalassemia, or less severe Hb E/ B thalassemia are able to enter the study.
8. Having no history of bleeding tendency
9. Having no history of blood transfusion within the prior 120 days
10. Having no history of delivery before 36 weeks gestation
11. Giving consent and having signed the consent form for this study

Exclusion Criteria:

1. Stool exam revealed parasitic infestation
2. C-reactive protein \> 3 mg/L
3. Serum ferritin \> 15 mcg/L
Endometrium Microbiome Alterations in Cesarean Section Diverticula Before and After Transvaginal Repair Surgery

The study compares the microbiome differences in the endometrium between normal people and patients with uterine diverticula after cesarean section and aims to discover the essential microbes and their metabolites that highly associate with the repair of myometrium through metagenomics and metabolomics. It verifies that flora disorder in the endometrium is the important cause of poor uterine repair after cesarean section. Then these patients with uterine diverticula receive the transvaginal repair surgery. Through the follow-up with them, we gain the microbiome differences of the endometrium before and after the surgery and show the validity of transvaginal repair surgery in the level of microbiome and metabolism.


Eligibility Criteria:
Inclusion Criteria:

have one cesarean delivery, have intermenstrual spotting after the cesarean section or Residual muscle thickness was less than 3.0 mm at the preoperative stage underwent magnetic resonance imaging and transvaginalultrasound to evaluate the size of the defect and the Residual muscle thickness before surgery have vaginal repair of Cesarean Section Diverticula write consent for operation.

Exclusion Criteria:

have a history of endocrine disorders have coagulation disorders use of intrauterine devices have sub-mucous myoma have endometrial diseases have endometrial cysts, uterine fibroids, and adenomyosis
Possible Differences in HCC Course Depending on DAA Treatment

BACKGROUND It is estimated that around 71 milion people live with chronic hepatitis C virus (HCV) infection. This may lead to the development of liver cirrhosis and hepatocellular carcinoma (HCC). Liver cirrhosis is considered as one of the most common risk factors of hepatocellular carcinoma (HCC). HCC is seventh most common cancer worldwide. The treatment of HCV with direct-acting antivirals (DAAs) has led to the increase of sustained virological response (SVR) rates to more than 90%. It is suggested that the virus eradication reduces, but not eliminates the risk of HCC. This concerns especially patients with liver cirrhosis or previous HCC history. There are reports of early occurrence of HCC after the DAA treatment. Therefore, patients undergoing successful HCV treatment should be monitored for the possibility of hepatoccelular carcinoma occurrence.

AIM OF THE STUDY In this study the investigators aimed to assess the occurrence of HCC after direct acting antiviral HCV treatment and evaluate whether the course of HCC and liver function differ among the population of patients treated with DAAs and those who were not receiving the therapy with DAA.

MATERIAL AND METHODS This is the observative, cohort, retrospective study which will be performed in several clinical centres in Poland. The inclusion criteria are: hepatocellular carcinoma diagnosis, age \>18 years old.

The investigators will collect both epidemiological (age, gender, comorbidities, alcohol abuse) and clinical data (serum bilirubin, alanine, aspartate aminotransferase, platelets, gammaglutamyltransferase, alkaline phosphatase and alpha-fetoprotein level, Child-Pugh and MELD score, imaging tests, liver biopsy and elastography, if performed).

In all patients, the HCV infection and co-infections will be assessed. In those who underwent the DAA treatment, the composition of the therapy and response to the treatment will be evaluated.

Statistical analysis will be performed in subgroups of patients undergoing DAA treatment and without the therapy. The distribution of continuous variables will be analysed by the Shapiro-Wilk test. Quantitative data will be analysed using the Mann-Whitney U test or Kruskal-Wallis ANOVA when appropriate. Qualitative data will be compared using the χ² test or the Fisher exact test. Correlations between quantitative variables will be assessed using the Spearman correlation coefficient. P value will be set at \<0.05.

FUNDING:

No remuneration is provided for participation in the study


Eligibility Criteria:
Inclusion Criteria:

* hepatocellular carcinoma diagnosis
* age \>18 years old

Exclusion Criteria:

* age \<18 years old
Warm Pads Applied to the Breast During Episiotomy Repair

H1-1 Hypothesis: Warm pads applied to the breast during episiotomy repair in the intervention group will have an effect on increasing milk production compared with the control group.

H1-2 Hypothesis: Warm pads applied to the breast of the intervention group during episiotomy repair will have an effect on increasing breastfeeding motivation compared to the control group.

H1-3 Hypothesis: Warm pads applied to the breast of the intervention group during episiotomy repair will have an effect on reducing the mother's perception of insufficient milk compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* First pregnancy,
* Those who are 18 years or older,
* Can speak Turkish and express themselves in Turkish,
* Do not have any disability (such as sight, hearing),
* Gave birth after \>37 weeks of pregnancy,
* Who have had a normal birth and have had an episiotomy,
* There is no open wound on the breast,
* A singleton pregnancy,
* Women who are open to communication and mentally and emotionally healthy.

Exclusion Criteria:

* Those who do not agree to work
* Those who want to leave for any reason during the application process
* Having postpartum haemorrhage,
* Women who develop any postpartum complications,
* Women whose babies are admitted to the neonatal intensive care unit.
A Single Dose Pharmacokinetics (PK) Study of GSK2434735 in Healthy Male Volunteers

An exploratory First Time in Human (FTIH) study investigating the pharmacokinetics, immunogenicity, safety and tolerability of GSK2434735 administered as a single low dose in healthy male subjects

Interleukin-13 (IL-13) and IL-4 are mediators in the pathogenesis of established asthmatic disease. GSK2434735 is a bispecific antibody to IL-13 and IL-4. The purpose of this open label, sequential cohort, exploratory First Time in Human (FTIH) study is to evaluate the pharmacokinetics (PK) profile of GSK2434735 after a single low intravenous or subcutaneous dose in healthy male volunteers, and to assess if the pharmacokinetics (PK) parameters can be scaled from monkey to man. In addition, the safety and tolerability will be monitored and the study will assess if antibodies are generated to GSK2434735.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers between 18 and 65 years of age
* Negative for pre-existing antibodies to GSK2434735.
* Body weight greater than and equal to 50 kg
* BMI 19 - 29.9 kg/m2.
* Lifelong non-smokers or ex-smokers of greater than 6 months

Exclusion Criteria:

* Clinically significant abnormalities.
* Current or past history of significant cardiac, respiratory, metabolic, renal, hepatic, neurological or gastrointestinal conditions.
* Current evidence or recent history of an infective illness.
* Vaccination within 3 weeks of screening
* History of severe allergic reactions, angio-oedema, anaphylaxis or immunodeficiency
Non-Invasive Measurement of Pulmonary Dysfunction in Children with Cerebral Palsy

This proposal addresses pulmonary dysfunction in severe cerebral palsy by using a novel non-invasive respiratory sensor. The two aims of the project are to 1) provide a screening tool to detect respiratory distress and 2) Find a correlation between the degree of pulmonary dysfunction and scoliosis in children with cerebral palsy.

This project proposes the utilization of a novel non-invasive real-time breathing sensor - pneuRIP- to measure pulmonary function (PF) in children with high-level cerebral palsy. Currently the standard measures of PF such as spirometry and peak flow meters are too strenuous for children and those with severe CP, as a result they have low compliance rates. The pneuRIP does not require active user participation and can passively measure PF. It consists of two inductive bands worn around the chest and abdomen that measure and differentiate diaphragmatic and chest breathing through Respiratory Inductance Plethysmography (RIP). Readings are recorded and analyzed on a small chest-worn unit and wirelessly transmitted to an iPad. The pneuRIP yields indices of work of breathing (WOB) which includes the phase angle between the chest and abdomen; percentage breathing through the ribcage; respiratory rate; and labored breathing index. This sensor takes little time to set up and readings are provided instantaneously.

The WOB indices provide a screening tool for pulmonary diagnosis and treatment, decrease the risk for pneumonia and respiratory illness, and has the potential to act as a marker for scoliosis in children with high-level CP.

The impact on the field will be to have a simple and fast way to measure pulmonary function in children and adults with severe CP and correlate this to measures of function and scoliosis severity as the effects of scoliosis, which is common in CP, on pulmonary function is unclear. Measures of motor function are classified by the Gross Motor Functional Classification System (GMFCS), ranking from I to V, with worsening disability from near normal gait in Type I to complete wheelchair use in Type V. This project will address GMFCS levels IV and V which includes people using wheelchairs. The two specific aims are a) Measure WOB indices non-invasively using the pneuRIP sensor in children with CP who use a wheelchair (GMFCS level IV, V) and validate the use of WOB indices as a screening test for pulmonary dysfunction., 2) Determine the correlation between WOB indices and the degree of scoliosis using the pneuRIP sensor in 250 children with CP who use a wheelchair (GMFCS level IV, V).

Eligibility Criteria:
Inclusion Criteria:

* Subjects should have cerebral palsy a GMFCS levels IV, V

Exclusion Criteria:

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