bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Study to Compare the Bioavailability of HR17031 in Healthy Subjects at Different Sites
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioavailability and safety of HR17031 injection
      in healthy subjects at different sites.
    


Intervention name(s): HR17031; HR17031; HR17031
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Receive a single dose of HR17031 at every period (First period：abdomen. Second period. upper arm. Third period: thigh).; Receive a single dose of HR17031 at every period (First period：upper arm. Second period: thigh. Third period: abdomen).; Receive a single dose of HR17031 at every period (First period：thigh. Second period: abdomen. Third period: upper arm).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is a single-center, randomized, open-label, three-period, and three-sequence crossover design trial, consisting of three sequences (sequence 1, sequence 2 and sequence 3) and three periods (first period, second period and third period). Each sequence receives a same dose of HR17031 at every period.
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 2 Study of ABT-199 in Subjects With Acute Myelogenous Leukemia (AML)
Condition: Acute Myelogenous Leukemia; AML; Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a Phase 2, open-label, multicenter study evaluating the preliminary efficacy and
      safety of venetoclax (ABT-199) administered orally in participants with acute myelogenous
      leukemia (AML).
    

Detailed description: 
      The primary objective was to evaluate the preliminary efficacy of venetoclax administered
      orally in participants with relapsed and/or refractory (R/R) acute myelogenous leukemia (AML)
      or frontline therapy in patients with AML who were unfit for intensive therapy. The secondary
      objective was to evaluate the preliminary safety of venetoclax administered orally in
      patients with AML. The first portion of the study was to consist of 19 participants with the
      objective of evaluating anti-tumor effects and confirming the safety of the regimen. The
      second portion (expansion) was to consist of 35 additional subjects to evaluate anti-tumor
      effects and safety and was to commence if an adequate efficacy signal (i.e., ≥ 5/19 achieved
      complete remission [CR], CR with incomplete bone marrow recovery [CRi] or partial remission
      [PR]) had been observed in the first portion of the study. The criterion for success would
      have been met if ≥ 16 of 54 participants achieved remission. The efficacy signal from first
      portion of the study was deemed insufficient for enrollment into the second portion of the
      study, as 4 of the 19 subjects achieved CR/CRi. During the trial, a number of participants
      were in screening at the point of the interim analysis. Given the early signs of clinical
      activity of venetoclax, disease severity, and prognosis of these participants without
      available options for therapy, they were allowed to initiate treatment ahead of completion of
      the interim analysis. Therefore, 32 participants were enrolled. No additional participants
      were screened or treated after the interim analysis was completed.
    

Intervention name(s): ABT-199
Intervention type(s): Drug
Intervention description(s): Tablet
Other intervention name(s): ABT-199 also known as venetoclax
Intervention MeSH terms: Venetoclax
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GDC-0199; Acute Myelogenous Leukemia; AML; ABT-199; Acute Myeloid Leukemia; Myeloid Leukemia
Assessing the Effects of Three Oral Care Regimens
Condition: Dental Plaque; Gingivitis
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional

Summary: 
      Assessing the effects of three oral care regimen on plaque, gingivitis, and tooth whitening:
      A randomized, person-centric, comparative effectiveness clinical research study by the
      Practitioners Engaged in Applied Research and Learning (PEARL) Network.
    

Detailed description: 
      Six month, five visit study of plaque, gingivitis, and tooth whitening with three randomized
      intervention groups using FDA marketed and approved products and devices. One hundred fifty
      (150) subjects from the patient base of 10 PEARL Network associated dental offices on the
      East Coast of the United States will be entered into the clinical research study. This is a
      post-marketing comparative effectiveness research study. Having a total of 5 visits over a
      six month period. Adverse events and side effects for the products used are being assessed.
    

Intervention name(s): Toothbrushing; Fluoridated Dentifrice (.15% sodium monofluorophosphate); Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide); Whitening (4.5% hydrogen peroxide); Other Fluoridated Dentifrice (.454% stannous fluoride)
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Mechanical plaque removal; Fluoridated dentifrice application; Application of Tooth Whitening Agent in Dentifrice; Application of Whitening Agent; Fluoridated dentifrice application
Other intervention name(s): Toothbrush; Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide) and toothbrushing; Fluoridated dentifrice (.454% stannous fluoride)
Intervention MeSH terms: Hydrogen Peroxide; Fluorides; Tin Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tooth Whitening
Nutramax Joint Health Formulation Biochemical Response Study
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The Nutramax test article is a nutritional supplement that contains several ingredients shown
      to potentially provide benefit to patients suffering from a painful and sometimes
      debilitating condition of the knee called "osteoarthritis."

      This is a pilot study that is intended to determine whether results from a proprietary
      testing panel conducted on blood and urine samples will correlate with data from physical
      examination and validated surveys that measure participants' quality of life and physical
      capabilities.
    

Detailed description: 
      Osteoarthritis (OA) of the knee is a significant source of morbidity, especially in patients
      over the age of 40 and is associated with more than $90 billion in US health care costs
      annually. While a myriad of clinical interventions are available, the mainstays of OA therapy
      are the NSAIDs, a class of compounds with well documented side effects including death; the
      risks of which increase with patient age and chronic use. Assessing the effectiveness of OA
      treatment modalities is often complicated by a high placebo effect, making purely clinical
      assessment of outcomes difficult. It is therefore desirable to develop an objective
      assessment tool for both the diagnosis/staging of knee OA and patient response to
      interventional therapies.

      Participants in this study will receive a formulation of the nutraceutical (test article).
      They will be asked to take 3 pills at once per day for 40-44 days. There will be either 4 or
      5 study visits. If participants have been using certain medications or dietary supplements,
      they will be asked to return one week from the initial screening, making a total of 5 visits
      in the study. If they have not been using key medications or dietary supplements, then study
      activities will begin on the day of the initial screening and they will only have 4 study
      visits.

      Participants will be asked to complete a series of questionnaires about their health, and
      have their blood drawn (15 mls or about 3 teaspoons), and provide a urine sample at 4 visits.
      In addition, at the first visit, we will collect information from participants' medical
      record and they will have a physical exam.
    

Intervention name(s): Nutraceutical joint health formulation
Intervention type(s): Dietary Supplement
Intervention description(s): A Proprietary Blend
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: knee; pain; osteoarthritis; nutraceutical; nutrition; supplement; non-surgical; biomarker; joint health
A Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Dental Strip Application
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      Single-blind study to evaluate whether C16G2 Strip administered in multiple doses can
      effectively kill the bacteria in the oral cavity that cause dental caries..
    

Detailed description: 
      A single-blind, randomized, placebo-controlled, phase 2 study to evaluate oral microbiology
      and safety of multiple C16G2 Strip applications in male and female dental subjects 12-75
      years of age.

      The study will compare multiple study drug administrations of 9.2 mg, 18.4 mg, and 36.8 mg
      C16G2 Strip or Placebo in Study Arms 1 through 3, respectively. Enrollment of subjects in
      Study Arms 1 through 3 will occur sequentially in an ascending dose-escalation manner. Before
      dosing of study drug, eligible subjects will receive professional dental prophylaxis between
      Days -7 and -2. Subjects will receive 11 doses administered over approximately two weeks.
      Each subject will receive a single dose on Day 0, followed by 5 days of AM and PM dosing
      starting on Day 7. To evaluate the durability of S. mutans suppression, study subjects will
      be followed for microbiology for up to 1 month after the last study drug administration.

      Clinic visits include Visit 1 (Screening/Days -30 to -1), Visit 2 (Prophylaxis/Day -7 to -2),
      Eligibility Confirmation & Baseline Visit 3, Follow-up Visits 4-7 (Safety and Microbiology),
      Visits 8-17 (Study Drug Administration), Follow-up Visits 18-20 (Safety and Microbiology) and
      Follow-up Visits 21-22 (Microbiology only).
    

Intervention name(s): C16G2 Strip; Placebo Strip
Intervention type(s): Drug; Other
Intervention description(s): Antimicrobial Peptide; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Three dose groups will be enrolled in an ascending dose escalation manner
Masking: Single (Participant)
Primary purpose: Treatment
Intranasal Diagnostics in Food Allergy: a Feasibility Study
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional

Summary: 
      The investigators will conduct low-dose intranasal allergen challenges on
      children/adolescents with a diagnosis of food allergy to egg/cow's milk/soya/wheat/peanut.
      The data will be used to determine the safety and potential utility of intranasal food
      challenges in the diagnosis of food allergy.
    


Intervention name(s): Intranasal challenge with active substance (food protein); Intranasal challenge with placebo
Intervention type(s): Other; Other
Other intervention name(s): placebo = 0.9% NaCl saline solution
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Food allergy; Diagnosis
Effectiveness of GSK598809, a Selective D3 Antagonist, Added to CBT and NRT for Smoking Cessation and Relapse Prevention
Condition: Nicotine Dependence
MeSH terms: Recurrence; Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to find out if an investigational drug, GSK598809 can
      help people who have very recently quit smoking; the investigators want to find out if
      continuing to take GSK598809 over six weeks can help prevent smokers from relapsing. To
      relapse means you "fall back" into smoking again after quitting. The investigators also want
      to find out if GSK598809 is safe to take without causing too many side effects.
    

Detailed description: 
      We propose to conduct a first test of the effect of the dopamine D3 receptor antagonist,
      GSK598809, on smoking behavior when treatment is started immediately following the quit date.
      To do this, we propose to conduct a 10-week, double-blind, placebo-controlled, proof of
      mechanism study in 90 adult smokers. Participants will complete baseline evaluations. They
      will receive manualized cognitive behavioral therapy, beginning prior to the quit date, and
      will set a quit date for the day before their week 2 study visit. They will be given short
      acting NRT (gum or lozenge) to use on their quit date. They will be asked to arrive for the
      week 2 visit with 18-24 hours abstinence and an expired air CO ≤ 10ppm. Those who do so will
      be randomly assigned to receive double blind GSK598809 or identical placebo for six weeks.
      Participants will begin double blind GSK598809 or placebo, both in conjunction with prn NRT
      up to 8 mg per day for two weeks. Participants will then continue double blind GSK598809 or
      placebo in the absence of NRT for 4 more weeks. At the end of this period (week 8 of the
      study), participants will then be followed 2 weeks after discontinuation of double blind
      treatment to complete the 10 weeks of the study.
    

Intervention name(s): GSK598809; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral dose of 60 mg/day for a treatment period six weeks; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Drugs, Investigational; Nicotine Dependence; Therapies for Relapse to Nicotine; Relapse Prevention; Smoking Cessation; Nicotine Cessation Therapies
Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans
Condition: Aging; Obesity; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether DHEA replacement therapy decreases
      abdominal fat and improves insulin sensitivity.
    

Detailed description: 
      Studies on rats and mice have shown that the adrenal hormone dehydroepiandrosterone (DHEA)
      reduces abdominal visceral fat and protects against insulin resistance. This study was done
      to learn if DHEA replacement therapy decreases abdominal obesity and improves insulin action
      in humans.

      Participants were randomly assigned to receive 50 mg per day of DHEA or a placebo at bedtime
      for 6 months. Participants underwent magnetic resonance imaging (MRI) and oral glucose
      tolerance tests at the beginning and conclusion of the study. Other tests included
      measurements of hormones and lipids.
    

Intervention name(s): DHEA
Intervention type(s): Drug
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Keywords: abdominal fat; dehydroepiandrosterone; Insulin sensitivity
The Effects of Video Based Cervical and Thoracal Posture Exercises on Office Workers
Condition: Physical Inactivity; Quality of Life
Study type: Interventional

Summary: 
      Aim of this study was investigate the effects of video-based cervical and thoracic postural
      exercises on muscle strength and endurance, hand grip strength, head-neck posture, quality of
      life and patient satisfaction in office workers.
    

Detailed description: 
      60 office workers between the ages of 25-65 were included in the study. Participants were
      randomly divided into Exercise group (EG, n=30) and Control group (KG, n=30). The video-based
      postural exercises were uploaded to the computers of the EG participants. They were asked to
      perform the exercises simultaneously with the video, 3 days a week for a total of 6 weeks.
      The control group was given one session of training on postural exercises. Cervical and
      scapular muscle strength and endurance, grip strength, craniovertebral angle, muscle
      endurance and strength, grip strength and head-neck posture measurements were made before the
      study and at the end of the 6th week. In addition, quality of life and satisfaction were
      evaluated with questionnaires.
    

Intervention name(s): Posture Exercises
Intervention type(s): Other
Intervention description(s): A 10-minute video consisted of 14 cervical and thoracal postural exercises was uploaded to the computers of the participants. Participants were asked to do these exercises simultaneously with the video, 3 days in a week for 6 weeks. During theese weeks, the participants were checked by sms and they were asked to keep an exercise diary. For progression, the number of repetitions was increased in the 3rd week and the number of sets in the 5th week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Exercise; Posture; Workers
Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
Condition: Hepatitis C; Chronic Pain
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Chronic Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with
      either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard
      of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and
      3. In addition, triple therapy with DEB025 plus standard of care will be applied to
      participants not achieving rapid viral response (RVR) in the different arms.
    


Intervention name(s): Alisporivir; Peginterferon alfa-2a; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ALV 200 mg soft gel capsules administered orally; PEG 180 μg administered via subcutaneous (s.c.) injection once weekly; RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
Other intervention name(s): DEB025; ALV; Pegasys®; PEG; Copegus®; RBV
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis C genotype 2; Chronic hepatitis C genotype 3; Cyclophilin inhibitor
Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Breeze
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the safety of the gynecological formulation in
      normal and usual usage condition of Dermacyd Breeze.
    


Intervention name(s): Lactic acid (Dermacid)
Intervention type(s): Drug
Intervention description(s): Liquid soup to be applied in the external genital area, in small quantity, with abundantly rinse after use, during 21 days
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Comparison of Hemoccult, Magstream and OC-Sensor Faecal Occult Blood Tests in Colorectal Cancer Screening
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Colorectal cancer screening by faecal occult blood test (FOBT) is a high public health
      priority. The interest of guaiac tests (G-FOBT) is limited by their poor sensitivity, while
      the superiority of I-FOBT in comparison with G-FOBT is now established. Nevertheless
      automated quantitative I-FOBTs have not been compared, and the optimal number of samples and
      threshold is not yet fixed. The aim of this study is to compare the performances of the 2
      more well-known I-FOBTs with automated analyzers (magstream by Fujirebio, and OC Sensor by
      Eiken) for different positivity thresholds and numbers of samples in general average risk
      population. Patients will performed a two samples Magstream, a two samples OC Sensor and
      Hemoccult II. In case of a positive test, a colonoscopy will be performed. Sensitivity and
      specificity for detection of cancer and advanced neoplasias will be compared between tests
      using ratio of sensitivities (RSN) and ratio of false positives (RFP) according to number of
      samples and positivity threshold.
    


Intervention name(s): Colonoscopy
Intervention type(s): Other
Intervention description(s): Colonoscopy if at least one of the faecal occult blood tests is positive (blinded to each test result)
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Screening
Keywords: Colorectal cancer; Screening; Average-risk population; faecal occult blood tests
The Effect Of Medical Nutritional Therapy On Patients With Sarcopenic Obesity Receiving Peritoneal Dialysis Treatment
Condition: Peritoneal Dialysis Complication; Sarcopenic Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      In this study, it was aimed to evaluate the effectiveness of medical nutrition therapy to be
      applied to patients with sarcopenic obesity receiving peritoneal dialysis treatment by
      measuring anthropometric measurements and blood parameters.
    

Detailed description: 
      Efficacy of medical nutrition therapy in patients with saecopenic obesity receiving
      peritoneal dialysis treatment, general information form after patients filled in the
      voluntary consent form, SARC-F questionnaire as sarcopenia screening test, International
      Physical Activity Questionnaire (IPAQ), muscle mass, muscle strength, physical performance,
      BIA measurement, anthropometric measurements, laboratory findings and three-day food
      consumption records will be evaluated.
    

Intervention name(s): medical nutrition therapy in kidney diseases
Intervention type(s): Other
Intervention description(s): Planning and implementation of diets containing high protein, low potassium, low phosphorus, personalized adjusted carbohydrates
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pharmacokinetic Study of Lanifibranor in Healthy Adult Chinese Subjects
Condition: Pharmacokinetic
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, open-label parallel design and single centre study conducted at
      the 1st hospital affiliated to Jilin University. Approximately 24 healthy Chinese volunteers,
      male and female will be recruited and divided into two equal groups (12 subjects per dose).
      The primary objective of this study is to evaluate the pharmacokinetic profile of
      lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese
      subjects. The secondary objective is to evaluate the safety of lanifibranor after single dose
      and multiple doses 800 and 1200 mg in healthy adult Chinese subjects.
    


Intervention name(s): Lanifibranor
Intervention type(s): Drug
Intervention description(s): Lanifibranor is a pan-peroxisome proliferator-activated receptor (PPAR) agonist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment