cyrilzakka/clinical-trials huggingface dataset:
A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease

PRIMARY: To determine the pharmacokinetics, MTD, and long-term safety and tolerance of oral ganciclovir in HIV-infected infants, children, and adolescents.

SECONDARY: To evaluate the effect of oral ganciclovir on the virologic parameters of CMV.

Maintenance treatment with intravenous (IV) ganciclovir for cytomegalovirus retinitis in AIDS patients is now standard therapy, but daily IV therapy can be complicated by catheter infections and thrombosis. An oral regimen of ganciclovir has been administered safely in adult AIDS patients and may be of significant benefit to children and infants as well.

Maintenance treatment with intravenous (IV) ganciclovir for cytomegalovirus retinitis in AIDS patients is now standard therapy, but daily IV therapy can be complicated by catheter infections and thrombosis. An oral regimen of ganciclovir has been administered safely in adult AIDS patients and may be of significant benefit to children and infants as well.

Patients are assigned to 1 of 5 (PER AMENDMENT 10/24/95, was 4) oral (syrup or capsules) dose levels following a single intravenous dose of ganciclovir. Treatment continues for 72 (PER AMENDMENT 10/24/95, was 24 weeks) weeks after the last patient has been enrolled.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

PER AMENDMENT 10/24/95: Allowed:

* All antiretroviral agents and other medications except those listed under Exclusion - Concurrent Medications.
* Didanosine. However, patients receiving both drugs (didanosine and ganciclovir) should be monitored for toxicity.
* Amphotericin B is allowed but requires additional monitoring.

Patients must have:

* HIV infection.
* CMV infection.
* CD4 count \< 150 cells/mm3 or \< 15 percent AND/OR quiescent CMV disease.
* NO loss of sight from CMV retinitis.
* NO acute opportunistic infection.
* Life expectancy at least to study completion.
* Consent of parent or guardian.

NOTE:

* Infants \< 6 months of age at enrollment must have been \>= 36 weeks gestational age at birth.

NOTE:

* Patients may co-enroll in other ACTG protocols that do not involve the administration of disallowed medications.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Loss of sight in one eye for any reason, with evidence of CMV retinitis in the other eye.
* Acute or chronic diarrhea that would affect absorption.
* Clinical or laboratory toxicities of grade 3 or worse.

Concurrent Medication:

Excluded:

* Foscarnet.
* Acyclovir.
* Interferon.
* Myelotoxic agents for malignancy or other condition.
* Other agents with anti-CMV activity. (NOTE:

Enrollment of patients on IVIG must be discussed with protocol chair.)

* Imipenem/cilastatin sodium.

Prior Medication:

Excluded within 30 days prior to study entry:

* G-CSF or GM-CSF.
Effects of CBT-Based Intervention Among Patients With Liver Cancer

This study investigates the effects of a CBT- based intervention on depression, anxiety, immune function, quality of life, and overall survival. It also explores if the effects of the intervention on immune function and quality of life are mediated through the improvements in depression and anxiety among patients with liver cancer.

In the present research project, the investigators have developed a Cognitive Behavioral Therapy (CBT)-based intervention protocol to investigate the impact of this intervention on depression, anxiety, quality of life, immune function, and overall survival in patients diagnosed with liver cancer. Additionally, this research protocol aims to examine the hypothesized mechanisms underlying the effects of the CBT-based intervention on quality of life and immune function. Specifically, we will investigate: 1) whether the effect of the CBT-based intervention on quality of life is mediated by improvements in anxiety and depression, and 2) whether the effect of the CBT-based intervention on immune function is mediated by improvements in anxiety and depression among patients with liver cancer.

A total of 160 participants will be recruited and randomly assigned to either the CBT-based intervention group or an educational group receiving non-psychological interventions. Assessments will be conducted at baseline (pre-treatment) and at 3, 6, and 12 months after the intervention period. Survival data will be collected throughout the follow-up period until the patients' end-of-life.

By examining the effects of the CBT-based intervention on multiple outcomes and exploring the potential mediating mechanisms, this research project aims to contribute to a comprehensive understanding of the intervention's effectiveness and its impact on the well-being of liver cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (aged ≥18);
2. Diagnosed with liver cancer based on pathological findings or imaging findings in the medical record;
3. The severity level of depression and anxiety: Depression \> 7 using HAD-D, or Anxiety \> 7 using HAD-A (Hospital Anxiety and Depression Scale, HADS; HAD-D, Hospital Depression Scale; HAD-A, Hospital Anxiety Scale).

Exclusion Criteria:

1. Patients who are taking part in another psychological intervention clinical trial or consented to receive another psychotherapy, suffered from aphasia and other communication difficulties will be excluded from the study
2. Patients with active immunological diseases, such as autoimmune diseases, and inflammatory diseases.
3. Patients accepting hormone therapy or taking long-term antibiotic drugs.
4. Patients who lack the basic ability of understanding and expression and are incompetent in giving consent.
Metabolic Abnormalities in Children With Epilepsy

This study is designed to use positron emission tomography to measure brain energy use. Positron Emission Tomography (PET) is a technique used to investigate the functional activity of the brain. The PET technique allows doctors to study the normal processes of the brain (central nervous system) of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain.

When a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases blood flow to and from the area of activity increases also.

Researchers can label a sugar with a small radioactive molecule called FDG (fluorodeoxyglucose). As areas of the brain use more sugar the PET scan will detect the FDG and show the areas of the brain that are active. By using this technique researchers hope to answer the following questions;

4. Are changes in brain energy use (metabolism) present early in the course of epilepsy

5. Do changes in brain metabolism match the severity of patient's seizures

6. Do changes in metabolism occur over time or in response to drug therapy

We propose to study children with recent onset partial epilepsy, cryptogenic infantile spasms, and idiopathic Lennox-Gastaut Syndrome with serial FDG-PET to elucidate the natural history and evolution of metabolic abnormalities associated with such epilepsies. The severity of the seizure disorder, and cognitive impairment, when present, will be correlated with the presence and extent of focal and global cerebral metabolic abnormalities.

Eligibility Criteria:
INCLUSION CRITERIA:

Patients with partial seizures, infantile spasms and Lennox-Gastaut syndrome will be selected.

EXCLUSION CRITERIA:

Evidence of a structural lesion as cause for epilepsy.

Degenerative or metabolic disease.

Inability to comply with the protocol.
Kidney Graft Tolerance KTOL

Prospective experimental study using PBMC from a limited number of adult patients (15) treated at Nantes University Hospital for a kidney transplant from a related living donor.

The study will be carried out on PBMC from both donors and recipients, collected during visits scheduled as part of the clinical management of the donor/recipient pair.

The study will test the hypothesis that DP8α Tregs expressing CD73, whose frequency in blood increases stably after non-rejected kidney transplants, but not when patients have undergone or will subsequently undergo rejection, are enriched in donor-specific cells, which would be a strong argument in favor of a direct role for these Tregs in preventing transplant rejection, through their ability to inhibit immune responses directed against donor alloantigens.


Eligibility Criteria:
Inclusion Criteria:

* Adult donor-recipient pair.
* First or second kidney transplant from a related ABO-compatible living donor.
* BMI \< 35 for recipients.
* Adult patients.
* Patients weighing over 50 kgs.

Exclusion Criteria:

* Donor/recipient ABO incompatibility
* BMI \> 35 for recipients
Manual Acupuncture (MA) for Asymptomatic Hyperuricemia (HUA)

Assess the effectiveness of manual acupuncture in modulating serum uric acid levels among patients diagnosed with asymptomatic hyperuricemia.

This is a multicenter randomized, single-blind, sham-controlled trial. A total of 260 eligible patients with asymptomatic hyperuricemia will be randomly assigned in a 1:1 ratio to manual acupuncture group or sham acupuncture group.

Eligibility Criteria:
Inclusion Criteria:

* With serum uric acid (SUA) level \>7 mg/dL after 1 month of a low-purine diet.
* No history of gouty arthritis.
* Has not received uric acid-lowering drug treatment or stopped uric acid- lowering drug treatment ≥ 12 weeks.
* 18.5kg/m2 ≤ body mass index (BMI) ≤ 30.0 kg/m2.
* Can write informed consent.

Exclusion Criteria:

* Patients with poorly controlled hypertension: systolic blood pressure (SBP) ≥ 160mmHg, diastolic blood pressure (DBP) ≥ 100 mmHg.
* Patients with poorly controlled diabetes (hemoglobin A1c ≥ 8.4%).
* Patients with severe liver and kidney damage: chronic kidney disease (CKD) ≥ stage 2 or a serum creatinine, urea, alanine, or aspartate aminotransferase level more than twice of the upper limit.
* Patients with blood system diseases, such as acute and chronic leukemia, polycythemia, multiple myeloma, hemolytic anemia, lymphoma, or undergoing chemotherapy for multiple solid tumors.
* Patients with stroke, coronary heart disease, or severe neuropsychological diseases.
* Patients who are pregnant.
* Illiterate or unwilling to accept acupuncture treatment.
Safety and Effectiveness of an Experimental Drug, IM862, in Treating Kaposi's Sarcoma in AIDS Patients

The purpose of this study is to see if it is safe and effective to use IM862 to treat Kaposi's sarcoma (KS) in AIDS patients.

Patients are stratified by CD4 count, viral load, and prior systemic chemotherapy. Patients are randomized equally to receive either IM862 or placebo given intranasally every other day. Patients are seen every 4 weeks for 6 months or until disease progression to evaluate toxicity and efficacy. Quality of life is assessed before treatment, then every month for 6 months. At the end of the 6-month study evaluation period, patients with PR/CR (responders) remain on study and continue blinded treatment for an additional 6 months. For patients with stable disease (non-responders), the treatment assignment is unblinded and off-study IM862 compassionate use is offered for 6 months, regardless of treatment group. For patients with documented progressive disease (treatment failure), the treatment assignment is unblinded and off-study IM862 is offered for 6 months to any patient in the placebo group. For treatment failures in the IM862 group, IM862 is stopped and the patient is allowed other therapy options.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have AIDS-related Kaposi's sarcoma.
* Have at least 5 skin or mouth sores that do not require chemotherapy.
* Have been taking anti-HIV drugs for at least 8 weeks before study entry with no changes in the regimen.
* Are at least 18 years old.
* Agree to practice effective methods of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have an AIDS-related opportunistic infection (except for genital herpes) within 2 weeks of study entry.
* Have had another type of cancer within the past 2 years (except for certain types of skin cancer, cervical cancer, or anal cancer).
* Have a severe chest cold.
* Have certain other serious medical conditions.
* Have received certain medications, including chemotherapy, within the past 4 weeks.
* Abuse alcohol or drugs.
* Are pregnant or breast-feeding.
Implementation of Directly Observed Hand Hygiene in Residential Care Home for the Elderly: a Cluster Randomized Trial

To screen the prevalence of multidrug resistant organisms among the resident in the residential care home for the elderly, and assess the practicability of directly observed hand hygiene in this setting.


Eligibility Criteria:
Inclusion Criteria:

* Residents living the residential care home for the elderly and able to give consent

Exclusion Criteria:

* Those who cannot give consent
A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy

This is a randomized, controlled, parallel group, assessor-blinded study to compare two colon cleansing preparations for colonoscopy. Subjects meeting all inclusion and exclusion criteria will be randomized and assigned to one of two study groups: Group I (PicoPrep) or Group II (Mannitol). In Group I, subjects will take one sachet of PicoPrep on the day before colonoscopy, and another sachet on the day of colonoscopy. In Group II, subjects will take Bisacodyl on the day before colonoscopy, and Mannitol on the day of colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 to 60 years
* Subjects scheduled for an elective colonoscopy
* Women of child-bearing potential using at least one highly effective contraceptive method
* Subjects able to understand all instructions
* Informed consent signed

Exclusion Criteria:

* Hypersensitivity to active ingredients
* Female participants pregnant or with a positive blood pregnancy test
* Acute surgical abdomen
* Previous colorectal surgery
* Gastrointestinal (GI) surgery
* GI diseases, active inflammatory bowel disease, colon disease
* Ascites/hepatic cirrhosis, cardiac disease, advanced pulmonary or renal disease
* Use of laxatives or antidiarrheal agents 72 hours prior to screening
* Significant alterations in laboratory values or other diseases that could interfere with the results
Early Response to Interferon Combined Short-Term Nucleoside Analogue Therapy in HBeAg(+) Chronic Hepatitis B

For HBeAg(+) patients, interferon is used for 12 weeks. On 12th week of treatment, If HBV DNA is undetectable (\<1000 copies/ml), interferon is continued alone for one year. If HBV DNA is still positive, nucleoside analogue is added for 3 months. After nucleoside analogue is added for 3 months, HBV DNA is tested again. If negative, stop nucleoside analogue and use interferon alone for another 6 months or longer. If HBV DNA is still positive, change to another nucleoside analogue or add another nucleoside analogue.


Eligibility Criteria:
Inclusion Criteria:

* HBsAg posive for 6 months
* HBeAg positive, and HBeAb negative
* HBV DNA\>1.0×E5 copies/ml
* ALT\>80 u/L within 3 months

Exclusion Criteria:

* pregnant women
* conbination infection of HCV, HAV, or HEV
* conbination infection of HIV
* any contraindication of interferon α
Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.


Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed diagnosis of urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra, that is transitional cell, or mixed transitional/non-transitional (predominantly transitional) cell type.
* Progression or recurrence of urothelial carcinoma following one prior platinum containing chemotherapy regimen for metastatic or unresectable locally advanced disease. A participant who receives a neoadjuvant or adjuvant platinum-containing regimen following cystectomy for localized muscle-invasive urothelial carcinoma is acceptable (without further systemic treatment), if recurrence/progression occurs ≤ 12 months following completion of therapy.
* Measurable disease based on RECIST v1.1.
* Have provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for PD-L1 analysis.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function per protocol-defined criteria.

Exclusion Criteria:

* Urothelial carcinoma that is suitable for local therapy with curative intent.
* History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging.
* Active autoimmune disease that has required systemic treatment in past 2 years.
* Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
* Known history of or is positive for active hepatitis B (HBsAg reactive) or has active hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
* Use of protocol-defined prior/concomitant therapy.
Randomized Comparative Efficacy and Safety Study of Intermittent Simvastatin and Fenofibrate in Hemodialysis

Sixty chronic hemodialysis patients were randomly assigned to receive fenofibrate 100 mg (group 1, n = 30) or simvastatin 20 mg (group 2, n = 30) three times/week after their dialysis session. The safety and efficacy of drugs on lipid profile, oxidized low density lipoproteins (ox-LDL), glutathione peroxidase (GSH-Px) and C-reactive protein (CRP) were compared before and after 16-week treatment.

This is a prospective randomized open label parallel study.

The selected patients will be randomly allocated to one of two groups

* Group I (30 patients): Patients receiving fenofibrate (100 mg) taken on dialysis days after the dialysis session (three times per week).
* Group II (30 patients): Patients receiving simvastatin (20 mg) taken on dialysis days after the dialysis session (3 times per week).

A careful history of all patients including demographic characteristics, physical examination, chief complaint, past medical history, drug history, familial history, social history, disease(s).

Monitoring Parameters:

For efficacy, the following parameters are measured:

1. Lipid profile (total cholesterol, HDL, TG and LDL from Friedwald formula \[10\] {LDL-C= TC-\[HDL + TG\\5\]). (measured at baseline and every month for 4 months)
2. C-reactive protein (CRP). (measured at baseline and after 4 months)
3. Oxidative stress markers: oxidized LDL and human glutathione peroxidase (measured at baseline and after 4 months).

For safety: (measured at baseline and every month for 4 months)

1. Observe for signs \& symptoms of muscle toxicity and measure phosphocreatine kinase (CPK).
2. Liver function tests: ALT, AST, ALP \& albumin.
3. Urea \& serum creatinine. (to monitor renal function)
4. Hemoglobin
5. Other measurements: Body mass index (BMI), Blood Pressure, electrolytes (Sodium,potassium, calcium, phosphorous) and assess patient compliance by tablet counting.

Statistical analysis will be used to compare the effects of simvastatin and fenofibrate on lipid profile, inflammatory marker (CRP) and oxidative stress markers (oxidized LDL and glutathione peroxidase). In addition, comparing their safety on renal and hepatic functions, phosphocreatine kinase, blood pressure and blood glucose level.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Chronic hemodialysis patients with 3 dialysis sessions per week.
3. Lipid profile:

   1. Total Cholesterol ≥ 200 mg/dl or LDL ≥ 130 mg/dl.
   2. Triglycerides ≥ 150 mg/dl.

Exclusion Criteria:

1. Previous intolerance to fibrates or statins.
2. Use of any fibrates or statins within 6 months prior to study.
3. Hypothyroidism.
4. Active liver disease \[unexplained persistent increase in liver enzymes (ALT \& AST \> 2x ULN)\].
5. Uncontrolled hypertension.
6. History of MI or coronary bypass surgery in last 3 months.
7. Muscle toxicity (Phosphocreatine kinase (CPK) \> 2x ULN).
8. Gall bladder disease.
9. Use of any immunosuppressant or steroid.
Countering Stimulus-Induced Alpha-Desynchronization to Treat Tinnitus

The purpose of the study is to examine the effect of alpha-neurofeedback while subjects listen to a noise on tinnitus.


Eligibility Criteria:
Inclusion Criteria:

* Duration of Tinnitus \>= 6 months and \<= 20 years
* Subjective Tinnitus

Exclusion Criteria:

* History of neurological or more than mild psychiatric diseases
LY293111 in Treating Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of LY293111 in treating patients who have advanced solid tumors.

OBJECTIVES: I. Determine the maximum tolerated dose of LY293111 in patients with advanced solid tumors. II. Determine the safety profile and pharmacokinetics of this regimen in these patients. III. Determine the antitumor activity of this regimen in these patients.

OUTLINE: This is a dose escalation study. Patients receive oral LY293111 twice daily. Treatment continues for a maximum of 6 months in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of LY293111 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicity. Additional patients are treated at the MTD. Patients are followed at 30 days.

PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced and/or metastatic solid tumor for which no curative therapy exists No hematologic malignancies Measurable or evaluable disease No known CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT and AST no greater than 2.0 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No concurrent systemic disorder that would preclude study No active infection

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No concurrent immunotherapy Chemotherapy: No more than 3 prior chemotherapy regimens for metastatic disease At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered No other concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior anticancer hormonal therapy and recovered No concurrent anticancer hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified Other: At least 4 weeks since prior investigational therapy No other concurrent experimental medications