cyrilzakka/clinical-trials huggingface dataset:
Study of Recovery of Intestinal CD4+ and Th17 T Cells in HIV-infected Individuals on Short-term Antiretroviral Therapy

HIV infection is associated with a state of chronic, generalized immune activation that has been shown in many studies to be a key predictor of progression to AIDS. The molecular, cellular, and pathophysiological mechanisms underlying the HIV-associated immune activation are complex and still poorly studied. There is, however, growing consensus that both viral and host factors contribute to this phenotype, with emphasis on the role played by the mucosal immune dysfunction (and consequent microbial translocation). Moreover if it is known that in HIV-infected individuals, a severe depletion of intestinal cluster of differentiation 4 (CD4+) T-cells, is associated with loss of epithelium integrity, microbial translocation and systemic immune activation, the kinetics of intestinal CD4+ T-cell reconstitution under combined antiretroviral therapy (cART) remains poorly understood.

This study sought to evaluate the reconstitution of intestinal CD4+ T-cells, including Th1 and Th17, in blood and colon samples collected from HIV-infected individuals before and after a short term cART.


Eligibility Criteria:
Inclusion Criteria:

* naïve for antiretroviral treatment
* met the criteria to start cART according to International Guidelines
* written informed consent signed

Exclusion Criteria:

* treatment with glucocorticosteroids and any immune modulating medication for more than seven days in the previous month
* any past or current systemic malignancy, history of inflammatory diseases of the small or large intestine
* pregnancy
* anemia, use of anticoagulants, and any contraindications to phlebotomy or colonoscopy.
Prophylactic Ilioinguinal Neurectomy During Open Tension-Free Inguinal Hernia Repair

postoperative chronic inguinal pain is a common postoperative complication after open inguinal hernia repair.

Chronic inguinal pain is a common complication following open inguinal hernia repair. Ilioinguinal nerve entrapment is a common cause of this chronic pain which may adversely affect the patients' life. Ilioinguinal neurectomy seems to be beneficial in preventing such pain, but it carries the risk for numbness and hypoesthesia.


Eligibility Criteria:
Inclusion Criteria:

- the study included all adult patients operated on for unilateral inguinal hernia by Lichtenstein tension-free mesh hernioplasty with or without ilioinguinal neurectomy.

Exclusion Criteria:

* patients with recurrent inguinal hernia, bilateral inguinal hernia repair, or huge inguinoscrotal hernia were excluded. Diabetic patients as well as, patients with suspected inguinal hernia recurrence at the time of the questionnaire were excluded.
IV PAPAVERINE Prior to Propess for Labor Induction

We aim to evaluate the effect of administering papaverine prior to PGE2 (propess) insertion on changes in Bishop-scores and on the induction-to-delivery interval.

More than 22% of all pregnant women undergo induction of labor. Induction of labor is usually medically indicated for maternal and fetal related conditions; however, elective induction has become more common since the ARRIVE trial. Women with an unfavourable cervix, according to Bishop-score (\<6), are prone to higher induction failure rates and are candidates for cervical ripening.

The cervix is composed of connective tissue and smooth-muscle located mainly beneath the internal os. Papaverine is an antispasmodic-musculotropic drug that targets smooth-muscle, resulting in decreased muscle spasm and subsequent smooth-muscle relaxation. The half-life of the drug is in the range of 0.5-2 hours, and its action starts 10 minutes after administration. Short-term use of papaverine during the first trimester has been reported as safe. However, outcome data are lacking of the use of mucosotropic-agents prior to PGE2 (propess) insertion. We will investigate this in a trial in which the co-primary outcomes were the change in Bishop-score after PGE2 extraction and the PGE2 insertion-to-delivery interval

Eligibility Criteria:
Inclusion Criteria:

* singleton term pregnancy
* bishop score
* need for labor induction with PGE2
* vertex presentation
* viable fetus

Exclusion Criteria:

* Prelabour rupture of membrane
* Twins pregnancy
* previous cesarean section
* allergy to the study medication
* fetal anomaly contraindications for vaginal delivery
* maternal supraventricular tachicardia
Study in Healthy Volunteers to Assess Effect of Omeprazole and Ranitidine on the Pharmacokinetics of Vandetanib

Study in healthy volunteers to assess effect of omeprazole and ranitidine on the pharmacokinetics of vandetanib

A Phase I, Randomized, Open-label, Single-center Study to Assess the Pharmacokinetics of Vandetanib (CAPRELSA) in Healthy Subjects when a Single Oral Dose of Vandetanib 300 mg is Administered Alone and in Combination with Omeprazole or Ranitidine

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study-specific procedures
* Volunteers must be males or females aged 18 to 50 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2
* Inclusive Females must have a negative pregnancy test at screening and on admission to the study center
* Females must not be lactating and must be of non childbearing potential defined as postmenopausal or documentation of irreversible surgical sterilization.

Exclusion Criteria:

* History of any clinically significant disease or disorder such as gastrointestinal, hepatic, renal or skin disease.
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
* Volunteers who smoke more than 5 cigarettes per day or are unable to refrain from smoking while resident in the study center
* Screening blood pressure of greater than 140/90 mmHg and/or a resting heart rate of less than 45 beats per minute (repeat test allowed at the Investigator's discretion
* Clinically significant abnormal12-lead ECG as assessed by the Investigator
* QTcF interval greater than 450 ms Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody
* Human immunodeficiency virus (HIV), or positive screen for drugs of abuse.
VA Genetic Tissue Banking

This project is a program-wide genetic tissue databank for the Department of Veterans Affairs Cooperative Studies Program (CSP). The genetic tissue bank has four components: a central repository for DNA and other genetic tissue specimens; a Scientific Advisory Committee of individuals with expertise in the genetics and epidemiology of diseases with special importance to the VA (including cardiovascular, neurologic, respiratory, psychological and other disorders); an Ethics Oversight Committee of individuals with expertise in bioethics and the law, as they apply to the collection and use of genetic tissue, and a Coordinating Center that administers the tissue bank, coordinates the scientific and ethics oversight committees, maintains central access to clinical study data linked to the tissue bank, and provides statistical analysis.

Intervention: No intervention.

Primary Hypothesis: It is feasible and cost-effective to create a CSP-wide facility for banking genetic tissue in CSP studies.

Study Abstract: This is a program-wide genetic tissue databank for the Department of Veterans Affairs Cooperative Studies Program (CSP). The study has five components: a central repository for DNA and other genetic tissue specimens; a Scientific Advisory Committee of individuals with expertise in the genetics and epidemiology of diseases with special importance to the VA (including cardiovascular, neurologic, respiratory, psychological and other disorders); an Ethical Oversight Committee of individuals with expertise in bioethics and the law, as they apply to the collection and use of genetic tissue, A Veteran's Advisory Group, and a Coordinating Center administers the tissue bank, coordinates the three oversight committees, maintains central access to clinical study data linked to the tissue bank, and provides statistical analysis.

Eligibility Criteria:
This DNA Banking substudy piggybacks on VA Cooperative Studies Clinical Trials. All participants who are randomized to selected CSP clinical trials are eligible to participate in the Banking Initiative.
Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy

This application proposes a prospective clinical trial to evaluate the impact of adding a focused physical therapy (PT) intervention to the preoperative regimen of individuals diagnosed with a malignancy of the lower extremity (LE). The primary aim will be to determine if individuals diagnosed with a malignancy of the LE can participate in a 10 week preoperative strengthening, stretching, and aerobic exercise regimen.

The intervention group will receive PT 3 times per week for 60 minutes each session. The therapy sessions will include endurance, strengthening, and stretching exercises. Endurance exercises will consist of ambulating with assistive devices as needed, using the upper extremity (UE) ergometer, and/or playing the Wii. Strengthening exercises will involve both UE's and LE's. For UE's, bicep curls, triceps curls, shoulder flexion, and/or press-ups from the therapy mat or wheelchair will be included. For the LE's, bridging, long arc quads, hamstring curls, calf raises in standing, single LE squats, and/or dorsiflexion (DF) in supine will be performed on the uninvolved extremity. Resistance and exercise time will be increased depending upon participant's tolerance. Stretching will consist of ankle stretch into DF in supine or long sitting, hamstring stretch in supine with hip flexed to 90 degrees, and trunk extension in sitting.

PRIMARY OBJECTIVE

To determine if individuals diagnosed with a malignancy of the LE can participate in a 10 week preoperative strengthening, stretching, and aerobic exercise regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patient being treated at St. Jude Children's Research Hospital
* Permission from participant's physician
* Participants must be between the ages of 6 and 30 years of age
* Patient is newly diagnosed with LE malignancy as shown by biopsy. Diagnoses include: osteosarcoma, Ewing's sarcoma, rhabdomyosarcoma, synovial sarcoma, malignant peripheral nerve sheath sarcoma, malignant fibrous histiocytoma of the bone and chondrosarcoma of the bone, or any other LE malignancy that requires surgical intervention.
* Patient has Karnofsky score ≥ 50 or WHO/ECOG ≤ 2 if ≥ 16 years of age
* Lansky score ≥ 50 for patients age \< 16
* Surgical intervention is planned primary mechanism of local control
* Negative pregnancy test
* All patients and/or their parents or legal guardians must sign a written informed consent

Exclusion Criteria:

* Patients with serious, non-healing wound, ulcer or bone fracture (other than pathologic fracture)
* Pre-morbid condition that prevents patient from ambulating
* Patients who do not have at least 10 weeks before receiving local control
The Effects of Basic Body Awareness Therapy on Balance, Jumping Performance and Sports Injury Anxiety in American Football Players

This study aims to investigate the effects of Basic Body Awareness Therapy (BBAT) on balance, jump performance and sports injury anxiety in American football players. Participants were divided into two groups, Body Awareness Therapy Treatment Group (n=22) and a Control group(n=22), by computer-based randomization.

This study aims to investigate the effects of Basic Body Awareness Therapy (BBAT) on balance, jump performance and sports injury anxiety in American football players. Participants were divided into two groups, Body Awareness Therapy Treatment Group (n=22) and a Control group(n=22), by computer-based randomization. Before starting the study, all participants were given detailed information about the content of the study and filled out a voluntary consent form. All participants in both groups were evaluated under the same conditions and surveys were conducted. The intervention group was given BBAT exercises by a physiotherapist who had received BBTA training 2 days a week for 6 weeks. All participants continued their team training during this period. At the end of the 6 weeks, all participants were given the same conditions and the surveys were repeated.

Eligibility Criteria:
Inclusion Criteria:

* Being a licensed American football player
* Playing in the university league
* Continue training for at least 1 year
* To be between the ages of 18-25
* Volunteering to participate in the study
* No disabilities for assessment tests

Exclusion Criteria:

* Orthopedic injury in the last 6 months
* Having undergone lower extremity surgery in the last 1 year
* Loss of vision and hearing
* Presence of a neurological defect- The athlete (if female) is not pregnant
Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks

In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Osmotic dilators are the method currently used in our institution, and are placed 24 hours prior to abortion. The primary outcome will be the length of the procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure, participant's assessment of discomfort before mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff.


Eligibility Criteria:
Inclusion Criteria:

* Women 18-50 years of age undergoing surgical termination of pregnancy
* English or Spanish speaking
* Gestational age between 15 and 18 weeks gestation on day of abortion (inclusive), by ultrasound dating
* Eligible for a dilation and evacuation abortion with local anesthesia and sedation
* Ultrasound for dating purposes done within the last two weeks

Exclusion Criteria:

* Intrauterine infection
* Fetal demise
* Ruptured membranes
* Multiple gestation
* Uterine anomaly or significant distortion of the uterus with fibroids
* BMI greater than 45
* Inability to place osmotic dilators
* Active substance abuse or intoxication
* Adrenal failure, chronic corticosteroid use, anticoagulant usage
* Severe cervicitis, until treated and resolved
* Prior Cesarean section
Foot Neuromodulation for Nocturnal Enuresis

To determine the effects of electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children

Nocturnal Enuresis is a very common and difficult to treat problem in the pediatric population which can have significant negative impact on a child's quality of life. Apart from medications which can have significant side effects limiting their use, there is a lack of effective and safe treatment options for children with frequent nocturnal enuresis. If foot stimulation prior to bed does indeed improve the frequency of nocturnal enuresis, it may provide a safe and non-invasive therapeutic option.

Eligibility Criteria:
Inclusion Criteria:

1. Children ages 5 to 16 years old without any specific neurological disorder or urinary tract infection, clinically diagnosed as having nocturnal enuresis AT LEAST 4 episodes per month by history
2. Currently having no daytime overactive bladder symptoms, i.e. urinary frequency, urgency, or daytime incontinence
3. Having been assessed for and treated if applicable for behavioral etiologies of nocturnal enuresis - consuming excess fluids or specific bladder irritants
4. Having been assessed for and treated if applicable for constipation

Exclusion Criteria:

1. Children with known neurological disorders which may be contributing to nocturnal enuresis episodes
2. Children found through history to have significant behavioral causes of nocturnal enuresis including consumption of excessive fluids or known bladder irritants
3. Children with chronic constipation who are non-compliant with previous pharmacologic efforts to treat.
4. Children who are not adequately potty trained
5. Children with significant daytime symptoms of overactive bladder including frequency, urgency, and daytime incontinence

5. Children who do not tolerate initial stimulation training session in the urology clinic upon enrollment

6. Children with any implantable medical devices such as a pacemaker will be excluded from the study

Note: Any patient currently taking medication such as an anti-muscarinic or a tricyclic antidepressant for overactive bladder at time of enrollment will be eligible to participate and will be continued on their usual medication and dosage throughout the study.
Drug Eluting Balloon in peripherAl inTErvention SFA

The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.


Eligibility Criteria:
Inclusion Criteria:

* age\>18 years
* intermittent claudication(Fontane III or IV)
* angiographic stenosis\>50% or occlusion of superficial femoral-popliteal artery\>40mm
* at least one below-knee vessel to the ankle

Exclusion Criteria:

* allergy to Paclitaxel
* contraindication for combined antiplatelet treatment
* life expectancy \<1 year
* hypersensitivity or contraindication to one of the study drugs
* lack of consent
The Effect of Iloprost on Capillary Recruitment and Insulin Sensitivity in Type 2 Diabetes

This study examines the effects of iloprost - a stable prostacyclin analogue - on insulin-mediated muscle capillary recruitment and whole-body glucose uptake in a cross-over design.

In type 2 diabetes impaired insulin-mediated muscle perfusion is thought to contribute to reduced whole-body glucose uptake. This study aims to identify iloprost - a stable prostacyclin analogue - as a possible therapeutic option to increase whole-body glucose uptake via enhancement of muscle perfusion.

All participants will be subjected to two hyperinsulinemic-euglycemic clamps; one with and one without simultaneous iloprost infusion in a randomized cross-over design. Microvascular blood volume will be measured by means of contrast-enhanced ultrasonography.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Male or female (post-menopausal)
* Age above 45 years and below 70 years
* BMI \>30 kg/m2
* HbA1c \< 80 mmol/mol or \< 8,6% Subjects must use metformin
* Stable medication use
* Stable tension regulation (with or without medication)
* Subjects should be able to give informed consent

Exclusion Criteria:

* A history of cardiovascular event (Cerebrovascular event, myocardial infarction or pacemaker implantation)
* Severe-very severe lung emphysema (GOLD stage III-IV)
* Use of any antibiotics or proton pump inhibitor (PPI) in the past three months
* Use of any other antidiabetic medication besides metformin (e.g. SU-derivates, insulin)
* Use of a platelet inhibitor or cumarin derivate during
* Subjects participated in a lifestyle programme in the past 6 months (diet or exercise)
Hormone Therapy Effects on CVD Risk Factors

To conduct extended analysis of the Postmenopausal Estrogen/Progestins Intervention PEPI trial database to address questions related to cardiovascular disease risk factor response and the possible determinants of this response.

BACKGROUND:

Cardiovascular disease is the leading cause of death among postmenopausal women. Growing evidence exists that hormone replacement therapy (HRT) may reduce cardiovascular disease and mortality. This has led to the use of postmenopausal HRT for primary prevention of heart disease, however it remains unresolved which women are likely to benefit most from this clinical approach. This is a complicated question because many potential mechanisms are involved by which hormone therapy (HRT) may confer cardioprotection. The Postmenopausal Estrogen/Progestins Intervention (PEPI) trial examined the relative impact of four regimens of hormone therapy on a range of cardiovascular disease risk factors (e.g. lipids, blood pressure, insulin/glucose, hemostasis factors). The trial was well conducted; its data have been thoroughly edited and have yielded a series of important publications. To date, however, publications have focused on average effects without a thorough exploration of the range of, and interplay among, the various effects across the 875 enrolled in the trial.

DESIGN NARRATIVE:

The study extended the analysis of PEPI data by: 1) characterizing the distributions of responses to hormone therapy with respect to risk factors for cardiovascular disease (lipids/lipoproteins, blood pressure, insulin/glucose, hemostasis factors); 2) examining the multivariate patterns of treatment effects among these cardiovascular risk factors and on other outcomes (symptomatology, bone, endometrial); 3) examining clinical and demographic factors that may affect these relationships and, in doing so, characterizing women who may vary with respect to their "sensitivity" to the separate effects of estrogen and progestin therapy; 4) examining closely patterns of adherence and their relationship to response. An experienced team of statisticians/epidemiologists conducted and planned to publish results from these analyses.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

Although many phase III clinical trials evaluate the quality of life as a secondary endpoint, male sexuality remains a neglected topic in oncology research. In light of the long-term efficacy of new-generation anticancer treatments for ANSCLC (i.e. targeted therapies and immunotherapy), there is a paucity of data about any detrimental effect on fertility and sexuality that could complicate the therapy proposal, especially in young patients.

The aim of this trial is to assess incidence of endocrine toxicity and sexual dysfuction in male patients receiving active treatment for ANSCLC


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced/metastatic NSCLC
* To be candidate to active treatment
* Aged ≥ 18 anni (up to 75 years old)
* To be sexually active in last 30 days before treatment start
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Written informed consent

Exclusion Criteria:

* History of endocrine disorders, excepting for controlled hypothyroidism (surgical or non-surgical) treated with replacement levothyroxine since at least 2 years
* Any cancer-related or medical condition that would interfere with the patient reported outcomes or laboratory assessment. Examples include, but are not limited to:
* Cancer-related conditions that may preclude/undermine sexual activity (e.g. leptomeningeal carcinomatosis, pathological vertebral fractures, gonadic metastases, unstable spinal cord compression, uncontrolled neurological symptoms, surgical complications):

  * History of chronic liver disease or hormonal replacement therapy (e.g. ADT for prostatic cancer)
  * Participants who not adequately recovered from previous confirmed chemotherapy-induced gonadotoxicity (e.g. cisplatin)
  * Chronic use of drugs with known effect on male sexuality, including opiates, anxiolytics, antidepressants, mood stabilizers, beta blockers (e.g. atenolol) and high dose diuretics
  * Psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
  * Major psychological disorder and/or high distress level that would interfere with sexual function and the participant's ability to cooperate with the requirements of the study
Acute Clinical Outcomes of Hemorrhagic Myocardial Infarction

Acute clinical outcomes 1. Mortality 2. Arrhythmia 3. Readmission 4. CVA 5. ADHF


Eligibility Criteria:
Inclusion Criteria:

1. 18-85 years of age
2. Primary PCI
3. Post-PCI cardiac biomarker labs