cyrilzakka/clinical-trials huggingface dataset:
Kaposi Sarcoma Chemotherapy and Research (KS-CARE)

This prospective, nonrandomized, open-label, single-arm, cohort study examines the effects of chemotherapy provided under local standard of care in patients with pathologically confirmed HIV-associated Kaposi Sarcoma (HIV-KS). Previous HIV-KS studies demonstrated significant variability in clinical outcomes based on differences in gender or baseline KSHV DNA levels in patients with HIV-KS.

Patients will receive chemotherapy according to local site treatment guidelines and standard of care. Chemotherapy regimen for two treatments that are used locally based on physician's choice namely intravenous (IV) Paclitaxel (PTX) or the combination of Bleomycin and Vincristine (BV). In addition, all histologically proven HIV-KS could be enrolled, irrespective of their prior length of combination anti-retroviral treatment (cART). This enrolment strategy will reflect a more realistic picture of HIV-KS management.

This study result could trigger treatment alteration of HIV-KS. The treatment approaches to HIV-KS can be individualized if clinically relevant subsets and novel prognostic markers are defined. In that case, newer and potentially more expensive agents can be selectively applied to those patients most likely to benefit, especially if prolonged treatment is needed.


Eligibility Criteria:
Inclusion Criteria:

Participants meeting all the inclusion criteria listed below will be eligible for screening.

* Histologically confirmed T1 KS presenting to TBH combined Kaposi Sarcoma clinic with or without visceral disease. no evidence of improvement in human immunodeficiency virus (HIV)-associated Kaposi Sarcoma (HIV-KS) in the 4 weeks immediately prior; and a clinical indication for systemic chemotherapy treatment
* Known HIV-1 infection status, as documented by any nationally approved, licensed HIV rapid test and confirmed at any time point prior by the local standard of care assay.
* On ART or not on ART.
* Age ≥18 years.
* Participants able to understand and provide written informed consent in English, Afrikaans, or isiXhosa.

Exclusion Criteria:

Failure to meet the inclusion criteria listed above.

* Specifically, pregnancy and breastfeeding are not exclusion criteria given the observational nature of the study with diagnostic and treatment interventions administered according to local standards of care.
* Specifically, the absence of skin lesions is not an exclusion criterion if recorded evidence of
* visceral or nodal disease is present in the form of a radiology or endoscopy report.
* Participants who have had prior chemotherapy or radiotherapy for human immunodeficiency virus (HIV)-associated Kaposi Sarcoma.
* Specifically, patients who have had prior cART will not be excluded.
* Participants who are receiving any other investigational agents.
Acceptance and Commitment Therapy (ACT) in Groups for Obsessive Compulsive Disorder: A Clinical Trial in Brazil

The goal of this clinical trial is to learn if Acceptance and Commitment Therapy (ACT) + Exposure and Response Prevention (ERP) in Group is effective to Obsessive Compulsive Disorder (OCD) in adults.

Researchers will compare intervention to control group to see if those who attend the group therapy have better results than control group.

Participants will go through a 16-week group therapy based on a protocol designed by Michael Twohig (Twohig et al, 2018).

* Participants will not have any medication adjustment during therapy
* Participants will be assessed 3 times throughout the therapy, plus an assessment in a 6-month follow-up.

The goal of this clinical trial is to learn if Acceptance and Commitment Therapy (ACT) + Exposure and Response Prevention (ERP) in Group is effective to Obsessive Compulsive Disorder (OCD) in adults. The main questions it aims to answer are:

* Can ACT in groups help decrease the severity of OCD symptoms?
* Can ACT in groups help increase psychological flexibility in this group?
* Can ACT in groups help increase quality of life in this group?

Researchers will compare intervention (n=16) to control group (n=8) to see if those who attend the group therapy have better results than control group.

We will perform an unequal randomization in a 2:1 ratio, in blocks of 6, for allocation to each group. The assessor of the outcomes of interest will be blinded to the group to which the participant was assigned

Participants will go through a 16-week group therapy based on a protocol designed by Michael Twohig (Twohig et al, 2018).

* Participants will not have any medication adjustment during therapy
* Participants will be assessed 3 times throughout the therapy, plus an assessment in a 6-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* OCD diagnosis according to DMS-5/ Minimum score of 20 in YBOCS

Exclusion Criteria:

* Psychotic disorder, maniac episode, intellectual disability, Chemical dependency, Suicidal risk, another current psychotherapy
Pharmacokinetics and Safety Study of ME1111 in Moderate to Severe Onychomycosis Patients

This study is Randomized, Double-Blind, Vehicle-Controlled, Multiple-Dose Study.

The purpose is to determine the safety, tolerability, systemic exposure and pharmacokinetics of ME1111 after repeated daily topical application of ME1111 in a maximal use setting in adults with distal subungual onychomycosis of the toenails.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female of any race and between the ages of 18 and 70 inclusive
2. Clinically diagnosed onychomycosis of the target nail
3. Presence of moderate to severe distal subungual onychomycosis
4. A positive potassium hydroxide(KOH) microscopy test result
5. A positive fungal culture for a dermatophyte
6. Females of childbearing potential must be using a highly effective method of birth control and be willing to remain on the same method of birth control throughout the study
7. Good general health as determined by the Investigator based on the subject's medical history and physical examination

Exclusion Criteria:

1. Clinical significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize subject's safety
2. Subjects with a history of diabetes mellitus
3. Unwilling to refrain from the use of nail cosmetics such as clear and/or colored nail solutions
4. Females who are nursing, pregnant, or planning a pregnancy during the study
5. Failure to complete the specified washout period(s) for the following topical medications: Antifungals drugs within 4 weeks; Anti-inflammatory drugs, corticosteroids, immunomodulators within 2 weeks
6. Failure to complete the specified washout period(s) for the following systemic medications: Corticosteroids within 2 weeks; Antifungals for treatment of onychomycosis or any antifungal with known activity against dermatophyte within the previous 24 weeks or 5 half-lives of the drug, whichever is longer; Immunomodulators within 4 weeks
7. History of cardiac disease and cardiac arrhythmic activity, or prolonged QT interval
8. Received treatment for any type of cancer within the last 6 months
9. History of any significant disease or disorder that might put subjects at risk by participating in study or influence results of study
10. Nail or anatomic abnormalities of the toe
11. Positive test for HIV, Hepatitis B or Hepatitis C
12. History of street drug or alcohol abuse
13. Donated or lost blood or participated in a clinical study which involved the withdrawal of a large volume of blood (500 mL or more), within the last 6-week
14. Participated in any other trial of an investigational drug or device within 30 days or 5 half-lives of the investigational drug or participation in a research study concurrent with this study
15. Unable to communicate or cooperate with the Investigator due to comprehension, mental development, or impaired cerebral function
16. Presence of any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subjects safety while participating on the study
Depression and Interleukin-6 Production in Patients With Ovarian Epithelial Cancer

RATIONALE: Measuring levels of interleukin-6 and depression may help doctors understand the relationship between interleukin-6 and depression. It may also help the study of cancer in the future.

PURPOSE: This clinical trial is studying depression and interleukin-6 production in patients with ovarian epithelial cancer.

OBJECTIVES:

* Correlate tumor production of interleukin (IL)-6, serum levels of IL-6, and IL-6 coding or promoter single nucleotide polymorphisms with IL-6 protein production in patients with ovarian epithelial cancer.
* Correlate tumor culture supernatant, ascitic fluid, and/or serum IL-6 level with levels of depression and/or anxiety in these patients to determine whether catecholamines or cortisol may alter production of IL-6 by cultured ovarian cancer cells.
* Determine the effects of neuroendocrine activity on modulation of IL-6 production in these patients.
* Compare immune response to autologous tumor tissue in "MLR-like" reactions between tumor and peripheral blood mononuclear cells in vitro.
* Correlate the levels of immunologic response with relapse and/or survival times, clinical response to CA 125 antibody treatment (e.g., in a pre- vs post-therapy sampling framework), and IL-6 parameters in these patients.
* Determine the use of epitope prediction bioinformatic tools in consultation with Coulter to set up a major histocompatibility complex (MHC) tetramer assay for assessing cytotoxic T lymphocyte levels in peripheral blood from these patients.
* Determine the incidence of herpes virus infections in these patients.

OUTLINE: This is a pilot study.

Before and after cytoreduction surgery, patients complete multiple questionnaires, including Beck Depression Inventory, Positive \& Negative Mood State, Fatigue Symptom Inventory, Revised NEO Personality Inventory, COPE, SF-36, Pittsburgh Sleep Quality Inventory, and Mental Adjustment to Cancer, to assess depression and coping mechanisms.

Blood samples are collected at baseline and on postoperative days 1-4 and analyzed for interleukin (IL)-6, c-reactive protein, herpes simplex virus-8 (HSV8), epinephrine, adrenocorticotropic hormones, and cortisol. Ovarian carcinoma tissue samples and peritoneal fluid are also collected and evaluated for production and utilization of IL-6, HSV8, and autonomic nervous system and hypothalamic-pituitary-adrenal activity.

PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of ovarian epithelial cancer
* Scheduled to undergo cytoreduction of ovarian tumor

PATIENT CHARACTERISTICS:

* Able to communicate with the investigator

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B

Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on either days 1-3 or days 1-3 and 8-10. Follow-up visits are also required periodically through day 43, and potential viral load follow-up visits at weeks 3 and 6 months post last dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic, and safety assessments


Eligibility Criteria:
Inclusion Criteria:

* Chronic HBV infection ≥ 6 months
* HBsAg ≥ 250 IU/mL
* HBV treatment naïve
* Absence of extensive bridging fibrosis (Metavir 3 or greater) or cirrhosis
* Creatinine clearance ≥ 70 mL/min

Exclusion Criteria:

* Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV
* History of Gilberts disease
* Laboratory parameters not within defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid-stimulating hormone (TSH), or other evidence of hepatic decompensation
* Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease(COPD), malignancy, hemoglobinopathy, retinal disease, or patients who are immunosuppressed
* Evidence of hepatocellular carcinoma
Community Based Trial for AMEVIVE®

To evaluate the safety of treating subjects with up to 12 additional doses of alefacept.

Male and female subjects at least 18 years of age with moderate to severe plaque psoriasis treated with 12 weeks of alefacept 15 mg IM and who have not achieved the desired response.

Dosing Groups: Subjects will receive either 4, 8, or 12 doses of alefacept 15 mg IM weekly immediately (within 14 days) following a standard 12-dose course of AMEVIVE® 15 mg IM. Determination of number of doses will be based on physician qualitative assessment at weeks 4 and 8.

Eligibility Criteria:
Inclusion Criteria:

1. Must give written informed consent.
2. Must have had moderate, moderately severe or severe chronic plaque psoriasis as determined by the investigator prior to initial treatment (baseline) with AMEVIVE.
3. Must be 18 years of age or older.
4. Must have completed a standard 12-week course of AMEVIVE and have received at least 10 doses.
5. Response to current AMEVIVE therapy must be less than a desired response as determined by the physician, and subject and some residual psoriasis must be present.

Exclusion Criteria:

1. Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or not willing to practice effective contraception during the study.
2. Nursing mothers, pregnant women, and women planning to become pregnant
3. Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy.
4. Treatment with another investigational drug, or approved therapy for investigational use, within 3 months of investigational drug administration.
5. Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab, adalimumab or mycophenolate mofetil or other systemic immunosuppressant agents within 4 weeks of investigational drug administration.
6. Treatment with Ultraviolet B (UVB) phototherapy or Psoralen + Ultraviolet A (PUVA), within 4 weeks of investigational drug administration.
7. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
8. History of \>3 cutaneous squamous cell carcinomas or any systemic malignancy.
9. Skin lesions suspicious for malignancy.
10. Known HIV, viral hepatitis, or tuberculosis infection.
11. History of severe allergic or anaphylactic reactions.
12. ALT or AST greater than three times the upper limit of normal.
13. Significantly abnormal hematology (hemoglobin, hematocrit, platelets, white blood cells), as determined by the investigator.
14. CD4+ T lymphocyte count at screening visit less than 250 cells/mm3.
15. Known hypersensitivity to AMEVIVE or any of its components.
16. Subject's inability to comply with study requirements.
Airway Responses Following Chlorine Gas Exposure

To determine lung airway responses following chlorine gas exposure.

DESIGN NARRATIVE:

The specific aims of the study are to determine: (1) the effects of asthma with pre-existing airway hyper reactivity on the pulmonary function and airway reactivity and inflammation responses to chlorine; (2) the effects of chlorine concentration on the pulmonary function and airway reactivity and inflammation responses to chlorine; and (3) to assess the time dynamics of the pulmonary function and airway reactivity and inflammation responses to chlorine. It is hypothesized that both airway hyperactivity and higher chlorine concentration will result in larger changes in pulmonary function and airway reactivity and inflammation responses, and that these changes will have differential time courses following chlorine exposure. This study uses two controlled human exposure experiments, utilizing a single-blind, repeated-measures, and counter- balanced design. The two subject groups for both experiments will consist of 21 individuals with no airway hyperactivity, and 21 individuals with both asthma and airway hyperactivity. In Experiment One, subjects are exposed for 15 minutes separately to each of: (1) chlorine at 0.4 ppm; (2) chlorine at 1.0 ppm; and (3) filtered air (Control). Pulmonary function and airway reactivity are measured immediately pre-exposure and 1 and 20 hours post-exposure. Airway inflammation, as determined by cellular and biochemical components from sputum-induction, is measured 65 hours pre-exposure and 20 hours post-exposure. In Experiments Two, subjects are exposed for 15 minutes separately to each of: (1) chlorine (concentration determined from Experiment One); (2) filtered air (Control). Pulmonary function and airway reactivity are measured immediately pre-exposure and at 3 and 72 hours post-exposure. Sputum-induction is performed 65 hours pre-exposure and at 3 and 72 hours post-exposure. The results of this study will provide information on a major irritant chemical relevant to occupational environments. Specially, the susceptibility of a large sub-population at increased risk, the dose-response effects, and the post-exposure time dynamics of the effects of chlorine gas will be determined.

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
Expanded Access Using Allogeneic Bone-marrow Derived Human Mesenchymal Stem Cells (Allo-hMSC) for a Individual Parkinson's Disease Subject

This is a expanded access use of allogeneic bone marrow-derived mesenchymal stem cells for a single subject with moderate Parkinson's disease that has progressed.


Eligibility Criteria:
Examination of Biomechanical Characteristics of Linea Alba in Diastasis Recti Patients

Diastasis recti is an increased distance between the rectus abdominis muscles at the midline caused by weakness in the anterior abdominal wall.

Most healthcare providers agree that in diastasis rectus abdominis there is a weakness, thinning, and widening of the linea alba and weakness of the associated abdominal musculature.

Ultrasonography is regarded as the most accurate method for measuring the IRD and its results are consistent with the data derived from palpation, calipers, and intraoperative measurements.

The MyotonPRO Device is used for the non-invasive measurement of Device is for the non-invasive measurement of biomechanical and viscoelastic properties of superficial soft biological tissues. Skeletal muscles or tendons can be measured at different regions, at full rest or in contraction.

This study aims to assess the biomechanical and viscoelastic properties of the Linea Alba in patients who are diagnosed with diastasis rectus abdominis by ultrasonography.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum Mothers who delivered by a cesarean section.
* Postpartum Mothers with a BMI below 30 or a Waist-hip ratio below 1.
* Postpartum Mothers above 18 years old and those below 35 years old.

Exclusion Criteria:

* Postpartum Mothers who delivered by a vaginal delivery.
* Postpartum Mothers who had hernias in the abdominal region or laparotomy.
* Postpartum Mothers with a BMI over 30 or a Waist-hip ratio over 1.
* Postpartum Mothers below 18 years old and those above 35 years old.
Use of RM Technology in Pediatric BAI Recipients

The purpose of this research study is to learn about the hearing outcomes of children with conductive hearing loss who are treated with bone conductive devices and their outcomes with remote microphone technology.

The purpose of this research study is to learn about the hearing outcomes of children with unilateral conductive hearing loss who are treated with bone conductive devices and their outcomes with remote microphone technology. It has been shown that the use of intervention (hearing aids, cochlear implants, bone conduction devices) alone does not alleviate the difficulties children with hearing loss encounter in noisy environments such as a classroom or restaurant. One of the most common methods to help children hear better in these types of environments is the use of a personal remote microphone (RM) system. This study will evaluate how much benefit children are getting from their bone conduction device alone compared to the bone conduction device with a personal RM system.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* unilateral conductive hearing loss with a minimum of a 30 dB air-bone gap and their parent/guardian

Exclusion Criteria:

* Do not meet inclusion criteria
Effect of Transcutaneous Electrical Nerve Stimulation in Diabetic Neuropathy

Double-blind, randomized, placebo-controlled, clinical trial. Patients with diabetic neuropathy will be randomly assigned to treatment with either TENS or TENS sham three times a week during 90 days. Clinical determinations are: pain, levesls of TNF-alpha, IL-6 and RPC-us


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic of type 2 diabetes \> 10 years
* Diagnostic of peripheral diabetic neuropathy less than 5 years
* HbA1C \> 6.5 and \< 9%
* Plasmatic glucose \>140 mg/dL and lees than 350 mg/dL
* Informed consent signed

Exclusion Criteria:

* Use of implanted pacemaker or heart defibrillator
* Implanted brain stimulator
* History of alcohol abuse
* Use of NSAID, stereoids
* Subjects with wounds, ulcers in legs
* Subjects with hepatic, renal o neurologic diseases
Comparison of Saphenous Vein Graft Harvested From Upper Versus Lower Leg in Coronary Artery Bypass Grafting

In coronary artery bypass grafting, saphenous veins are widely used as a composite grafts that are Y-anastomosed to in-situ left internal thoracic artery. Based on our observation that remodeling of saphenous vein graft differs between those harvested from upper leg vein and lower leg, this study aims to compare histologic and immunohistochemical findings between saphenous vein grafts harvested from upper leg and lower leg.

Inclusion criteria:

* Patients aged from 40 to 75 years with triple vessel disease
* Patients who are eligible for the use of left internal thoracic artery as an in situ primary conduit
* Operation plan: saphenous vein graft will be Y-anastomosed to left internal thoracic artery.
* Patients whose saphenous vein grafts can be harvested from both upper legs and lower legs
* Patients who are eligible for off-pump coronary artery bypass grafting
* Patients who agreed with the participation in the research based on thorough explanation.

Patients will be randomly assigned to upper leg vein (ULV) group and lower leg vein (LLV) group immediately after anesthetic induction.

Pieces of residual saphenous vein graft will be sent for histologic and immunohistochemical examination for the evaluation of endothelial cell preservation and the expression of matrix proteins.

Eligibility Criteria:
Inclusion Criteria:

* Patients with multivessel disease who were planned to undergo off-pump coronary artery bypass grafting
* Patients whose left internal thoracic arteries can be used, and whose saphenous vein grafts will be Y-anastomosed to left internal thoracic arteries.
* Patients whose saphenous vein grafts can be harvested from both upper and lower legs.

Exclusion Criteria:

* Patients with overt heart failure symptoms
* Patients with intractable ventricular arrhythmia
* Patients with history of cancer or malignancy
* Patients with coagulation or other hematologic disorder
* Patients who needs concomitant cardiac procedures