PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT02850276: Autonomic Neuropathy, GI Motility, and Inflammation in HIV
Official title: Autonomic Neuropathy, Gastrointestinal Motility, and Inflammation in HIV
Conditions: HIV Disease
Summary: The purpose of this study is to explore a possible link between the autonomic nervous system and immune function in patients with HIV. Sometimes HIV can cause these nerves to function abnormally, this is called HIV-associated autonomic neuropathy (HIV-AN). HIV-AN is a condition that is different from person to person. In some people it causes no symptoms and is not harmful, in others it may cause symptoms such as dizziness or lightheadedness, nausea, vomiting, diarrhea, constipation, or problems urinating. Most people with HIV-AN don't know that they have it. One of the important nerves in the autonomic nervous system is the vagus nerve. Abnormal function of the vagus nerve may cause stomach and intestinal slowing, which could lead to an overgrowth of bacteria. The body senses these bacteria and tries to fight them, leading to inflammation.
In this study the researchers will test whether abnormal function of the vagus nerve in HIV is associated with stomach slowing and overgrowth of bacteria, and if a drug called pyridostigmine can help.
Interventions:
name: Pyridostigmine
other_name: Gravitor
Mestinon
Pyridostigmine Bromide
Regonol
type: Drug
Study arms:
design_group_description: 30mg PO three times a day
design_group_title: Pyridostigmine
design_group_type: Experimental
Sponsor: Icahn School of Medicine at Mount Sinai
Collaborators: National Institute of Diabetes & Digestive & Kidney Diseases
National Institutes of Health
Drug name mappings:
name: 溴吡斯的明
lang: CN
name: Pyridostigmine Bromide
lang: EN
name: ピリドスチグミン臭化物
lang: JP
Clinical trial NCT00424242: Pemetrexed Disodium in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases
Official title: A Pharmacokinetic Study of Pemetrexed in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases
Conditions: Brain and Central Nervous System Tumors
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Lymphoproliferative Disorder
Metastatic Cancer
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Precancerous Condition
Secondary Myelofibrosis
Unspecified Adult Solid Tumor, Protocol Specific
Summary: RATIONALE: Pemetrexed disodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Studying samples of cerebrospinal fluid and blood from patients with cancer in the laboratory may help doctors learn how pemetrexed disodium works in the body and identify biomarkers related to cancer.
PURPOSE: This clinical trial is studying the side effects and how well pemetrexed disodium works in treating patients with leptomeningeal metastases.
Interventions:
description: Orally beginning at 500 mg/m2 every 3 weeks until disease progression
name: Pemetrexed
other_name: Alimta
LY231514
type: Drug
Study arms:
design_group_description: Escalating doses of Pemetrexed beginning at 500 mg/m2
design_group_title: Escalating doses of Pemetrexed
design_group_type: Experimental
Sponsor: Northwestern University
Collaborators: National Cancer Institute
Drug name mappings:
name: 培美曲塞二钾
lang: CN
name: Pemetrexed Dipotassium
lang: EN
Clinical trial NCT03098836: Apalutamide and Abiraterone Acetate in African American and Caucasian Men With Metastatic Castrate Resistant Prostate Cancer
Official title: Prospective Study of Apalutamide and Abiraterone Acetate iN ChemoTHerapy-Naïve mEn With mCRPC Stratified by Race
Conditions: Prostate Cancer
Summary: The primary goal is to prospectively estimate the median PFS of African American and Caucasian men with mCRPC taking apalutamide, abiraterone acetate, and prednisone. Secondary objectives include: PSA kinetics: to determine the duration of PSA response, time to nadir, and percent of men who achieve a PSA < 0.1; Radiographic assessments: to estimate the rate of objective response and incidence of bone flares; Safety (NCI CTC v4.0) and tolerability, particularly incidence and grade of hypertension in the two populations.
This is a non-comparative pilot open-label, parallel arm, multicenter study of apalutamide and abiraterone acetate in African American and Caucasian men with mCRPC. It is anticipated that 3 additional sites will be needed to accrue 100 subjects (50 African American and 50 Caucasian) over a 24 month accrual period. The study agents will be administerd at the following doses: apalutamide 240mg orally once daily, abiraterone acetate 1000mg orally once daily, and prednisone 5 mg BID in 4-week cycles throughout the treatment period.
Fifty (50) patients will be enrolled in each group (AA and Caucasians). The proportion of patients who experience PSA decline of 30%, 50% and 90% will be estimated with exact 95% confidence intervals based on the binomial distribution will be computed. In addition, post therapy changes in PSA will be explored as a continuous outcome. The Kaplan-Meier product limit method will be used to estimate the rPFS, biochemical PFS and overall survival distributions.
Interventions:
description: 240 mg orally daily
name: ARN-509
other_name: apalutamide
type: Drug
description: 1000 mg orally daily
name: Abiraterone Acetate
other_name: Zytiga
type: Drug
description: 5 mg orally twice daily (for total daily dose 10 mg)
name: Prednisone
type: Drug
Study arms:
design_group_title: Caucasian
design_group_type: Experimental
design_group_title: African American
design_group_type: Experimental
Sponsor: Duke University
Collaborators: Janssen Scientific Affairs LLC
Drug name mappings:
name: 阿帕他胺
lang: CN
name: Apalutamide
lang: EN
name: アパルタミド
lang: JP
name: 泼尼松
lang: CN
name: Prednisone
lang: EN
name: 醋酸阿比特龙
lang: CN
name: Abiraterone acetate
lang: EN
name: アビラテロン酢酸エステル
lang: JP
Clinical trial NCT00003960: Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Official title: Matched Unrelated and Haploidentical Bone Marrow Transplantation for Hematologic Malignancies
Conditions: Leukemia
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus donor bone marrow transplantation in treating patients who have hematologic cancer.
Interventions:
name: busulfan
type: Drug
name: cyclophosphamide
type: Drug
name: methylprednisolone
type: Drug
name: allogeneic bone marrow transplantation
type: Procedure
name: in vitro-treated bone marrow transplantation
type: Procedure
Study arms:
Sponsor: The Sidney Kimmel Comprehensive Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 甲泼尼龙
lang: CN
name: Methylprednisolone
lang: EN
name: メチルプレドニゾロン
lang: JP
name: 白消安
lang: CN
name: Busulfan
lang: EN
name: ブスルファン
lang: JP
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
Clinical trial NCT04597801: Comparison of Fluorescein-INtra-VItal Microscopy Versus Conventional Frozen Section Diagnosis for intraOperative Histopathological Evaluation
Official title: Comparison of Fluorescein-INtra-VItal Microscopy Versus Conventional Frozen Section Diagnosis for intraOperative Histopathological Evaluation (INVIVO)
Conditions: Intracranial Tumor
Summary: With the appliance of the in-vivo microscopy after Fluorescein staining, the investigators hypothesize that the preliminary in-vivo histopathological diagnostic accuracy is not inferior to conventional frozen section analysis accuracy when using the final histopathological result as gold standard.
Interventions:
description: Fluorescein sodium is administered intravenously with a bolus injection of 5 mg per kg of bodyweight 20-40 minutes prior to the planned tumor resection.
name: Alcon
other_name: Fluorescein sodium
type: Drug
Study arms:
design_group_description: A single dose of fluorescein sodium is applied before brain tumor resection. 20-40 minutes prior to the planned tumor resection, a bolus of 5 mg per kg body weight is administered intravenously, staining tumor tissue with fluorescent dye to visualize tumor cells.
design_group_title: Fluorescein sodium
design_group_type: Experimental
Sponsor: Technische Universität München
Collaborators: Carl Zeiss Meditec AG
Drug name mappings:
name: 荧光素钠
lang: CN
name: Fluorescein Sodium
lang: EN
name: フルオレセインナトリウム
lang: JP
Clinical trial NCT06907485: A Multicenter Study to Assess the Feasibility of 5-Aminolevulinic Acid (5-ALA) in Pediatric Brain Tumor Patients
Official title: A Multicenter Study to Assess the Feasibility of Gleolan (ALA / Aminolevulinic Acid HCl) in Pediatric Brain Tumor Patients After Delayed Administration
Conditions: Pediatric Brain Tumor
Summary: This clinical trial focuses on pediatric patients aged 2 up to 18 years of age with a new or recurrent pediatric brain tumor, suspected to be either a high-grade or low-grade glioma, and scheduled for surgical removal. 5-aminolevulinic acid (5-ALA) is FDA-approved for improving brain tumor visualization in adults during surgery through fluorescence, enabling more complete removal of the tumor. This study aims to evaluate the feasibility of administering 5-ALA to pediatric brain tumor patients and to assess the quality of tumor fluorescence during surgery in this patient population.
For the clinical trial, the patient will orally ingest 5-ALA 6 to 12 hours before brain surgery. All study participants will be provided standard medical care for removal of the brain tumor. All children enrolled in the study will be closely monitored prior to, during, and after surgery to ensure there are no reactions to the study drug. 5-ALA can make the patient more sensitive to sunlight and direct indoor lighting, referred to as photosensitivity, and can cause a sunburn-type reaction. It is for this reason that patients will be kept in subdued light conditions for 48 hours following surgery. Study participation starts once the patient is enrolled in the study until 6-month post-surgery.
Interventions:
description: Pediatric patients diagnosed with a new or recurrent brain tumor, suspected to be either a high-grade or low-grade glioma, and scheduled for surgical removal will receive aminolevulinic acid hydrochloride prior to surgery for resection of the brain tumor.
name: Aminolevulinic acid hydrochloride
other_name: 5-ALA
ALA HCl
Aminolevulinic acid
Aminolevulinic acid HCl
Gleolan®
type: Drug
Study arms:
design_group_description: Single arm study administering a single oral solution of aminolevulinic acid hydrochloride at a dose of 20 mg/kg body weight, 6-12 hours prior to brain surgery for resection of the tumor.
design_group_title: Aminolevulinic acid hydrochloride
design_group_type: Experimental
Sponsor: University of Pittsburgh
Collaborators: NX Development Corp.
University of Pittsburgh Medical Center
Brain Research Foundation
Advocate Health Care Network
Drug name mappings:
name: 盐酸氨酮戊酸
lang: CN
name: Aminolevulinic Acid Hydrochloride
lang: EN
name: アミノレブリン酸塩酸塩
lang: JP
Clinical trial NCT01817582: Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)
Official title: A Randomized, Multi-Center, Parallel-Group, Safety and Efficacy Study of Lotemax® Gel 0.5% and Restasis 0.05% for 12 Weeks in Subjects With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease; DED)
Conditions: Keratoconjunctivitis Sicca
Summary: This study is being conducted to investigate the safety, comfort, and tolerability of 3 treatments: loteprednol etabonate ophthalmic (Lotemax®) gel 0.5 percent (%) administered twice daily (BID) with or without cyclosporine ophthalmic emulsion (Restasis) 0.05% administered BID, and Restasis 0.05% treatment alone for 12 weeks and at a follow-up safety visit 1 week post-treatment. This study will also investigate the relative efficacy of Lotemax gel 0.5% administered BID with or without Restasis 0.05% treatment administered BID and of Restasis 0.05% treatment alone for the reduction of clinical signs or symptoms of keratoconjunctivitis sicca (DED) over the first 4 weeks of a 12-week treatment period and at the end of a 12-week treatment period.
Interventions:
description: Lotemax gel will be administered as per the dose and schedule specified in the arms.
name: Lotemax
other_name: loteprednol etabonate ophthalmic gel 0.5%
type: Drug
description: Restasis emulsion will be administered as per the dose and schedule specified in the arms.
name: Restasis
other_name: cyclosporine ophthalmic emulsion 0.05%
type: Drug
name: Soothe® Lubricant Eye Drops
other_name: Soothe lubricant eye drops will be administered as needed.
type: Drug
Study arms:
design_group_description: Participants will administer lotemax gel 0.5 % BID in both eyes (OU) for 2 weeks, then administer both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administer restasis emulsion 0.05% BID OU for 8 weeks. Participants will also receive preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
design_group_title: Lotemax Gel 0.5% and Restasis 0.05%
design_group_type: Experimental
design_group_description: Participants will administer lotemax gel 0.5% BID OU for 12 weeks. Participants will also receive preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
design_group_title: Lotemax Gel 0.5%
design_group_type: Experimental
design_group_description: Participants will administer restasis emulsion 0.05% BID OU for 12 weeks. Participants will also receive preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
design_group_title: Restasis 0.05%
design_group_type: Active Comparator
Sponsor: Bausch & Lomb, Inc.
Collaborators: Synteract, Inc.
Drug name mappings:
name: 环孢素
lang: CN
name: Cyclosporine
lang: EN
name: シクロスポリン
lang: JP
name: 氯替泼诺
lang: CN
name: Loteprednol Etabonate
lang: EN
Clinical trial NCT06933706: Losartan to Improve Outcomes After Multi-ligament Knee Injury
Official title: Losartan to Improve Outcomes After Multi-ligament Knee Injury
Conditions: Multi-ligament Knee Injury
Summary: Multi-ligament knee injuries (MLKIs) can occur during military training, sports injuries, or traumatic events such as motor vehicle accidents and can be devastating events. These complex injuries involving disruption of 2 or more ligaments often coincide with injuries to arteries, nerves, tendons, menisci, and/or fractures and can be devastating events. MLKIs often require complex treatments nearly 2 in 5 patients suffer complications after surgery. Loss of knee range of motion is the most common complication and is associated with military separation. There are also long-term effects of motion loss, as the need for motion-restoring surgery after MLKI is associated with an increased risk of osteoarthritis within 5 years of surgery. A person's ability to perform both activities of daily living and higher demand physical activities is often impaired both in the short and long term. In fact, only 1 in 3 people return to high-level sport after MLKI. The purpose of this translational randomized clinical trial is to determine if a 30-day course of oral Losartan improves a person's ability to return to work or sport, range of motion and strength, and reduce knee inflammation in the first year after surgical treatment of an MLKI.
Interventions:
description: Losartan is an angiotensin-II inhibitor that modulates the renin-angiotensin system by blocking the activation of angiotensin type 1 receptors, thus preventing binding with angiotensin-II and decreasing blood pressure. Losartan has a broader therapeutic potential for muscle healing and treatment for diseases ranging from rheumatoid arthritis, osteoarthritis, chronic kidney disease, Marfan syndrome, and fatty liver. TGF-β plays an active role in fibrosis leading to the formation of adhesions and scar tissue. By limiting the formation of adhesions and scar tissue, losartan may reduce pain, myofibroblast activity, synovitis, fibrosis, and cartilage degeneration.
name: losartan 25 mg
type: Drug
description: The placebo capsule will look identical to the active study drug, but will not have any active ingredient and will be filled with corn starch
name: Placebo capsule
type: Other
Study arms:
design_group_description: Participants randomized to the Losartan arm will be asked to take 25 mg of losartan per day for 30 days.
design_group_title: Losartan
design_group_type: Experimental
design_group_description: Participants randomized to the Placebo arm will be asked to take one placebo capsule per day for 30 days.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: The Brigham & Women's Hospital, Inc.
Collaborators: University of Kentucky
Walter Reed National Military Medical Center
Drug name mappings:
name: 氯沙坦钾
lang: CN
name: Losartan Potassium
lang: EN
name: ロサルタンカリウム
lang: JP
Clinical trial NCT07216690: Pregnenolone as a Treatment for Cannabis Intoxication
Official title: Pregnenolone as a Treatment for Cannabis Intoxication
Conditions: Cannabis Intoxication
Summary: The present study will characterize the ability of pregnenolone to reverse the acute intoxication and associated symptoms of cannabis. Healthy adults with a history of cannabis use will be recruited to participate in a placebo-controlled, within-subject crossover study at Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). By clarifying the ability of pregnenolone to reverse cannabis intoxication symptoms, this study will pave the way for larger clinical studies that provide a foundation for the development of future CB1-receptor NAM medications that could be applied in emergency situations and potentially validate pregnenolone as a treatment for cannabis intoxication.
Interventions:
description: Cannabis brownie, 25mg THC
name: Cannabis
other_name: THC
delta-9-THC
delta-9-tetrahydrocannabinol
type: Drug
description: Pregnenolone, low dose, one 250mg pregnenolone capsule and one 0 mg pregnenolone capsule
name: Pregnenolone 250 mg
other_name: Pregnenolone
type: Drug
description: Pregnenolone, high dose, two 250 mg pregnenolone capsules
name: Pregnenolone 500 mg
other_name: Pregnenolone
type: Drug
description: Placebo capsule, 0mg
name: Placebo
type: Drug
description: Placebo brownie, 0mg THC
name: Placebo brownie
type: Drug
Study arms:
design_group_description: Placebo brownie, 0mg THC; two 0 mg pregnenolone capsules
design_group_title: Placebo Brownie and Capsules
design_group_type: Placebo Comparator
design_group_description: 25mg Cannabis/THC Brownie; two 0 mg pregnenolone capsules
design_group_title: Cannabis/THC brownie and Placebo Capsules
design_group_type: Placebo Comparator
design_group_description: 25mg Cannabis/THC Brownie; one 250 mg pregnenolone capsule and one 0 mg pregnenolone capsule
design_group_title: Cannabis/THC Brownie and Pregnenolone, low dose
design_group_type: Experimental
design_group_description: 25mg Cannabis/THC Brownie and two 250 mg pregnenolone capsules
design_group_title: Cannabis/THC Brownie and Pregnenolone, high dose
design_group_type: Experimental
Sponsor: The Johns Hopkins University
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 屈大麻酚
lang: CN
name: Dronabinol
lang: EN
name: 孕烯醇酮
lang: CN
name: Pregnenolone
lang: EN
Clinical trial NCT02314156: Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy
Official title: Intra-mammary Distribution of Transdermal Telapristone Versus Oral Telapristone: A Randomized Window Trial in Women Undergoing Mastectomy
Conditions: BRCA1 Mutation Carrier
BRCA2 Mutation Carrier
Ductal Breast Carcinoma In Situ
Lobular Breast Carcinoma In Situ
Stage 0 Breast Cancer
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Summary: This randomized trial studies transdermal or oral telapristone acetate in treating patients undergoing surgery to remove the breast (mastectomy). Telapristone acetate may help prevent breast cancer from forming in premenopausal women. Giving telapristone acetate transdermally may be safer and have fewer side effects than oral administration.
Interventions:
description: Given transdermally
name: Telapristone Acetate
other_name: CDB-4124
Proellex
Progenta
type: Drug
description: Given PO
name: Placebo
other_name: PLCB
type: Other
description: Given PO
name: Telapristone Acetate
other_name: CDB-4124
Proellex
Progenta
type: Drug
description: Given transdermally
name: Placebo
other_name: PLCB
type: Other
description: Correlative studies
name: Laboratory Biomarker Analysis
type: Other
description: Ancillary studies
name: Questionnaire Administration
type: Other
Study arms:
design_group_description: Patients receive telapristone acetate transdermally and placebo PO QD for 4 weeks.
design_group_title: Arm I (transdermal telapristone acetate)
design_group_type: Experimental
design_group_description: Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.
design_group_title: Arm II (oral telapristone acetate)
design_group_type: Active Comparator
Sponsor: Northwestern University
Collaborators: National Cancer Institute
Drug name mappings:
name: 醋酸特拉司酮
lang: CN
name: Telapristone Acetate
lang: EN
Clinical trial NCT01382706: Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder
Official title: Single Arm Phase II Study of Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder as Second Line Treatment
Conditions: Recurrent Bladder Cancer
Stage III Bladder Cancer
Stage IV Bladder Cancer
Transitional Cell Carcinoma of the Bladder
Summary: This phase II trial studies how well giving docetaxel and lapatinib ditosylate together as second-line therapy works in treating patients with stage IV bladder cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel and lapatinib ditosylate together may kill more tumor cells.
Interventions:
description: Given IV
name: docetaxel
other_name: RP 56976
TXT
Taxotere
type: Drug
description: Given PO
name: lapatinib ditosylate
other_name: GSK572016
GW-572016
GW2016
Lapatinib
Tykerb
type: Drug
description: Correlative studies
name: immunohistochemistry staining method
other_name: immunohistochemistry
type: Other
description: Correlative studies
name: fluorescence in situ hybridization
other_name: fluorescence in situ hybridization (FISH)
type: Genetic
description: Correlative studies
name: laboratory biomarker analysis
type: Other
Study arms:
design_group_description: Patients receive docetaxel IV over 1 hour on day 1 and lapatinib ditosylate PO QD on days 1-21. Courses repeat every 21 days until disease progression or unacceptable toxicity.
design_group_title: Treatment
design_group_type: Experimental
Sponsor: University of Southern California
Collaborators: National Cancer Institute
GSK Plc
Drug name mappings:
name: 二甲苯磺酸拉帕替尼
lang: CN
name: Lapatinib Ditosylate Hydrate
lang: EN
name: 多西他赛
lang: CN
name: Docetaxel
lang: EN
name: ドセタキセル
lang: JP