bioihbjkbjnl/mcl2 huggingface dataset:
Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate the safety and tolerability of multiple doses of AAB-003
      (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients who complete
      study B2601001 may participate in this trial and receive AAB-003 (PF-05236812). Each
      patient's participation will last approximately 52 weeks.
    


Intervention name(s): AAB-003 (PF-05236812); AAB-003 (PF-05236812); AAB-003 (PF-05236812); AAB-003 (PF-05236812); AAB-003 (PF-05236812)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.5 mg/kg AAB-003, IV; 1 mg/kg AAB-003, IV; 2 mg/kg AAB-003, IV; 4 mg/kg AAB-003, IV; 8 mg/kg AAB-003, IV
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Randomized; Safety Study; Open Label
Phase 2 Efficacy Study of Primaquine and Methylene Blue
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the most efficacious transmission blocking drug
      regimen for seasonal malaria chemoprophylaxis in Mali. The primary outcome measure will be
      the proportion of mosquitoes infected pre and post-treatment, assessed through membrane
      feeding and measured by oocyst prevalence in mosquitoes dissected on day 7 post feed. Primary
      endpoint will be a within group comparison between the mean of the pretreatment infectivity
      (Day 0) and infectivity at 7 days post first dose.
    

Detailed description: 
      Protocol will be shared on request.
    

Intervention name(s): Sulphadoxine-pyrimethamine; 0.25 mg/kg primaquine; Dihydroartemisinin-piperaquine; Methylene blue; Amodiaquine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Each Fansidar tablet is scored containing 500mg sulphadoxine and 25 mg pyrimethamine. Doses will be administered by weight.; Primaquine will be administered in an aqueous solution according to weight-based dosing.; 160mg/20mg or 320mg/40mg of dihydroartemisinin/piperaquine tablets will be used to administer weight-based doses.; Methylene blue will be given as minitablets in prepackaged sachets according to weight groups.; Amodiaquine will be administered once daily for 3 days, following weight-based dosing of 150 mg tablets.
Other intervention name(s): Fansidar; Eurartesim
Intervention MeSH terms: Pyrimethamine; Primaquine; Piperaquine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Amodiaquine; Artenimol; Methylene Blue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of an Optimal Heart Team Protocol on Decision-making Stability
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      This study is aimed to evaluate the effect of the optimal heart team implementation protocol
      on the stability of decision-making for patients with complex coronary artery disease.
    

Detailed description: 
      Current guidelines recommend a heart team in the decision making for patients with complex
      coronary artery disease (CAD). Previous study reported that the agreement between heart teams
      for revascularization decision-making in complex CAD patients was moderate. Potential factors
      associated with decision discrepancies were summarized in several aspects and a detailed
      heart team implementation protocol was generated and further validation is needed. This study
      is designed to evaluate the effect of the optimal heart team implementation protocol on the
      stability of decision-making for patients with complex coronary artery disease.
    

Intervention name(s): optimal heart team protocol
Intervention type(s): Behavioral
Intervention description(s): Heart teams in the experimental group will be established and trained based on the optimal heart team implementation protocol. The protocol included instructions on specialist selection, specialist training, team composition, team training and formal implementation precess.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart Team protocol; Coronary Artery Disease; decision-making agreement
The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-387 Under Fed Condition
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to evaluate the pharmacokinetics and
      safety/tolerability after oral administration of CKD-387 and D484 under fed condition in
      healthy adults.
    


Intervention name(s): CKD-387; D484
Intervention type(s): Drug; Drug
Intervention description(s): Test drug; reference drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy Study of Zinc Supplementation on Anemia, Oxidative Stress and Inflammation in Hemodialysis Patients
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the effect of Zinc supplementation on health status
      of hemodialysis patients through measurement of the following before and after Zinc
      administration: Inflammatory markers, Oxidative stress markers and Anemia markers. Also,
      Evaluation of quality of life of hemodialysis patients before and after Zinc administration
      using Fatigue severity scale questionnaire.
    


Intervention name(s): Zinc Sulphate; Corn Starch filled Hard Gel Capsules; Epoetin alfa 2000-4000 IU solution for injection; Iron Hydroxide Saccharate Complex Solution for injection
Intervention type(s): Dietary Supplement; Other; Drug; Drug
Intervention description(s): Zinc Sulphate Hard Gel capsules 110mg; Corn Starch filled Hard Gel Capsules; Epoetin alfa 2000-4000 IU solution for injection; Iron Hydroxide Saccharate Complex Solution for injection
Intervention MeSH terms: Zinc Sulfate; Epoetin Alfa; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hemodialysis patients; Zinc; Anemia; Oxidative stress
A Randomised, Double-Blind, Placebo-Controlled Study Assessing the Effect of Fenofibrate, Coenzyme Q10 and Their co-Administration on Ventricular Diastolic Function in Patients With Type 2 Diabetes
Condition: Patients With Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to study the effect of different combinations of fenofibrate
      and coenzyme Q10 on ventricular diastolic function in patients with Type II diabetes
    


Intervention name(s): Fenofibrate/CoQ10; Fenofibrate/CoQ10; Fenofibrate/CoQ10; Fenofibrate/CoQ10; Fenofibrate/CoQ10; Fenofibrate/CoQ10; Fenofibrate/CoQ10
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Fenofibrate pbo/CoQ10 placebo; Fenofibrate pbo/CoQ10 200 mg; Fenofibrate 160mg/CoQ10 placebo; Fenofibrate 80/CoQ10 100 mg; Fenofibrate 160mg/CoQ10 100 mg; Fenofibrate 80 /CoQ10 200 mg; Fenofibrate 160mg/CoQ10 200 mg
Intervention MeSH terms: Coenzyme Q10; Ubiquinone; Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ventricular diastolic Function; Diabetes
Effect of Tenofovir on Genital Herpes Simplex Virus (HSV) Shedding
Condition: Herpes Simplex Type II
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators propose a randomized, double blind, placebo-controlled, cross-over trial to
      evaluate the effect of oral and topical (vaginal gel) tenofovir on genital herpes simplex
      virus (HSV) shedding among herpes simplex virus type-2 (HSV-2) seropositive, human
      immunodeficiency virus (HIV) seronegative women. The investigators hypothesize that tenofovir
      will reduce genital HSV shedding compared to placebo.
    

Detailed description: 
      The investigators propose a randomized, double-blind, placebo-controlled, cross-over study of
      55 adult, healthy women who are HSV-2 seropositive and HIV-1 seronegative. Women will first
      participate in a run-in phase with twice daily swabbing. Following 4 weeks of swabbing,
      participants will be randomized 2:2:1 to one of three groups: 1) oral tenofovir and placebo
      gel, 2) oral placebo and tenofovir gel, or 3) oral placebo and placebo gel. Participants will
      begin treatment and swab the genital region twice daily for 5 more weeks. Study drug will be
      administered daily.
    

Intervention name(s): TDF; Placebo Vaginal Gel; Vaginal TFV Gel; Placebo Tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral tenofovir will be administered as tablets. TDF (Viread®) tablets contain 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.; Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.
The placebo gel (known as the 'universal' placebo gel) is formulated to minimize any possible effects - negative or positive - on study endpoints.; Tenofovir 1% gel (w/w) is a gel formulation of tenofovir. Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.; TDF placebo tablets are film-coated and contain denatonium benzoate, a bittering agent, in addition to other inactive ingredients. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.
Other intervention name(s): Tenofovir disoproxil fumarate (TDF) oral tablets; Placebo gel; Tenofovir 1% Vaginal Gel; Oral placebo
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Bronchoprovocation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CSJ117 in Adult Subjects With Mild Atopic Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a non-confirmatory, randomized, subject and investigator blinded, placebo-controlled,
      parallel-design, multi-center bronchoprovocation study. Approximately 55 subjects with mild
      stable atopic asthma who exhibit an EAR and LAR to a common inhaled allergen will receive
      multiple once daily doses of inhaled CSJ117 or placebo over 12 weeks. Two sequential dose
      cohorts are planned for this study, Cohort 1 and Cohort 2. Cohort 2 will be split into two
      parts, Cohort 2a and 2b
    


Intervention name(s): CSJ117; Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): inhaled once daily dose; inhaled once daily dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthma; allergen bronchoprovocation; pharmacodynamics; pharmacokinetics; safety; tolerability
Highly Cross-linked Polyethylene in Total Knee Arthroplasty
Condition: Knee Arthroplasty, Total
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to determine clinical and radiographic results after posterior
      cruciate-substituting total knee arthroplasties with highly cross-linked polyethylene in one
      knee and compression mold conventional polyethylene in the contralateral knee in the same
      patients.
    


Intervention name(s): Total knee arthroplasty with HXLPE liner; Total knee arthroplasty with conventional polyethylene liner
Intervention type(s): Procedure; Procedure
Intervention description(s): Replacing arthritic knee with a metal device, and using a highly cross-linked polyethylene(HXLPE) liner in between metallic surfaces.; Replacing arthritic knee with a metal device, and using a conventional polyethylene liner in between metallic surfaces.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Total knee arthroplasty is performed on patients with knee osteoarthritis. One group will receive a highly cross-linked polyethylene liner and one group will receive a conventional polyethylene liner. Other parts of procedures will be the same.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: total knee arthroplasty; highly cross-linked polyethylene
A Study of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia
Condition: X-linked Hypophosphatemic Rickets/Osteomalacia
MeSH terms: Rickets; Osteomalacia; Rickets, Hypophosphatemic; Familial Hypophosphatemic Rickets
Study type: Interventional
Phase: Phase 3

Summary: 
      Before switching to the post-marketing study:

      To evaluate the efficacy and safety of KRN23 administered subcutaneously once every 2 weeks
      in children with X-linked hypophosphatemic rickets/osteomalacia(XLH).

      After switching to the post-marketing study:

      To evaluate the safety and efficacy of KRN23, which is switched from the investigational
      product to the post-marketing study drug, at the approved dose and dosing regimen in subjects
      who continue treatment
    


Intervention name(s): KRN23
Intervention type(s): Drug
Intervention description(s): Subjects will receive subcutaneous injections of KRN23 every 2 weeks from Week 0 through Week 86
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JT-001, JT-002 and JLP-2008
Condition: Healthy Adult
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and pharmacokinetic characteristics after the administration of
      JT-001, JT-002 and JLP-2008
    

Detailed description: 
      A randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to
      evaluate the pharmacokinetics and safety between the administration of JLP-2008 and the
      co-administration of JT-001, and JT-002 for healthy subjects in fasted state
    

Intervention name(s): SGLT2 inhibitor
Intervention type(s): Drug
Intervention description(s): SGLT2 dual inhibitor
Intervention MeSH terms: Sodium-Glucose Transporter 2 Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics After High Single Ascending Oral Doses of AZD1656 in T2DM Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate safety and tolerability after high Single
      Ascending Oral Doses of AZD1656.
    


Intervention name(s): AZD1656; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 escalating dose levels are planned. Administration of the escalating doses of AZD1656 will be based on review of available safety from the previous dose.; Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Diabetes Mellitus
Effect of Lactobacillus Reuteri in Cystic Fibrosis
Condition: CYSTIC FIBROSIS
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate in patients with cystic fibrosis the effect of
      Lactobacillus Reuteri (LR) on the rate of respiratory exacerbations and of the infections of
      both upper respiratory and gastrointestinal tracts.
    

Detailed description: 
      The hallmarks of cystic fibrosis (CF) are recurrent severe and destructive pulmonary
      inflammation and infection, beginning in early childhood and leading to morbidity and
      mortality due to respiratory failure. During the disease, most children become colonized with
      Pseudomonas aeruginosa (PA) and undergo progressive impairment of respiratory function.
      Therefore, patients colonized with Pseudomonas are at increased risk for pulmonary infections
      and persistent inflammation and have a decrease in survival rate. In an attempt to reduce the
      rate and severity of pulmonary exacerbations, children with CF are put on heavy load of
      antibiotics.

      Intestinal inflammation is another typical finding in CF patients and gut bacterial
      overgrowth may be present.

      Probiotics are live bacteria administered orally, successfully used in children with acute
      gastroenteritis, as well as in preventing and treating atopic diseases in children. In
      addition, probiotics have been used as adjuvant therapy in patients with pouchitis and
      inflammatory bowel diseases. Interestingly, probiotic supplementation is able to reduce the
      incidence of fever, child care absences, antibiotic prescription and to prevent nosocomial
      gastrointestinal and respiratory infections. The effect of probiotics may be through
      improvement of intestinal barrier function and modulation of immune response. The latter
      mechanism could well explain the clinical effects of probiotics observed in extraintestinal
      diseases.
    

Intervention name(s): Lactobacillus reuteri; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lactobacillus reuteri was administered in 5 drops per day (10^10 colony-forming units) for 6 months.; The placebo was packed in identical bottles, had the same color, weight, smell, and taste of the probiotic formulation, was administered in 5 drops per day
Other intervention name(s): (LR) ATCC55730
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: cystic fibrosis; probiotics; Lactobacillus reuteri
Hypofractionated Radiation Therapy in Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators at PGIMER have been practicing hypofractionation radiotherapy with a dose
      of 35Gy/15#/3wks to the chest wall in post mastectomy and 40Gy/16#/3wks in breast
      conservation in breast cancer patients for the last 4 decades. It is also a routine practice
      in UK and few centers in Canada. Hypofractionation reduces treatment time to half while
      maintaining cosmesis and gives control rates equal to conventional fractionation. As breast
      cancer is a leading cancer in females and radiation therapy is an important part of its local
      management, hypofractionation help the radiation centers worldwide to meet the growing need
      for radiation in breast cancer, particularly in developing countries where resources are
      limited. It also reduces the financial burden on the patient and family. In this study the
      investigators want to reduce the treatment duration from 3 weeks to 2 weeks. The study will
      include 1000 patients, 500 in each arm, with breast cancer post mastectomy or after breast
      conservative surgery to be treated with a radiotherapy dose of 34Gy in 10 fractions over 2
      weeks in the study arm and 35Gy in 15 fractions over 3 weeks in the control arm. The primary
      endpoint of the study will be ipsilateral local tumour control. Secondary endpoints will be
      early and late adverse effects in normal tissues, quality of life, contralateral primary
      tumours, regional and distant metastases and survival.
    

Detailed description: 
      Patients to be included in this study will be pre-operatively staged according to American
      Joint Committee on Cancer (AJCC) 7th edition, International Union against cancer ( which uses
      TNM staging ) as stage I-III of breast carcinoma. Total 500 patients of histologically proven
      post lumpectomy/mastectomy cases of carcinoma breast suitable for radiotherapy will be
      enrolled in this study. Patients would be evaluated at the Department of Radiotherapy PGIMER,
      Chandigarh by doing a thorough clinical examination followed by routine investigations which
      will include hemogram, liver function tests, kidney function tests, chest X-ray. Patients
      will be treated by standard rectangular tangential fields.
    

Intervention name(s): Hypofractionated Radiation therapy
Intervention type(s): Radiation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; hypofractionated radiotherapy; Hypofractionated radiation