bioihbjkbjnl/mcl2 huggingface dataset:
Cognitive Flexibility Training for Persistent Pain: Neuroimaging Pilot (COFLEX-i)
Condition: Chronic Pain; Knee Pain Chronic; Hip Pain Chronic; Back Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      To determine whether a 5-week computer-based cognitive training intervention results in
      changes in resting-state functional connectivity (rsFC) within the brain networks.
    

Detailed description: 
      This project is a single-center prospective pilot study to assess whether cognitive
      flexibility training through a Lumosity®-based training module over the course a five week
      timeframe in patients with chronic hip, knee, and back pain results in detectable changes in
      resting-state functional connectivity (rsFC). The investigators will explore changes in rsFC
      particularly within the default mode (DMN), frontoparietal (FPN), and cingulo-opercular (CON)
      brain networks.
    

Intervention name(s): Cognitive Training + fMRI
Intervention type(s): Behavioral
Intervention description(s): Consented subjects will be asked to participate in the study for up to five months. Patients will be consented at the Washington University Department of Anesthesiology and will be asked to complete baseline resilience, pain, and anxiety and depression questionnaires, along with cognitive tests by pencil and paper that will be administered by a member of the research team. The participants will also be required to complete a computer-based Trails-making test, Color Match test, and NCPT (Neurocognitive Performance Test) battery at baseline, and undergo a functional magnetic resonance imaging (fMRI) session.
All subjects will be asked to complete the three paper-pencil and computer-based measurements along with repeat pain questionnaire again 1-3 days after completion of training, undergo a second fMRI scan at that time, and complete the questionnaires again 3 months after the completion of training.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effect of Progesterone on Human Endometrium
Condition: Fertility
Study type: Observational

Summary: 
      This study evaluates the relationship between progesterone levels and endometrial gene
      expression
    


Intervention name(s): Microarray
Intervention type(s): Genetic
Intervention description(s): High throughput technique for determining global gene expression of the condition of interest
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Fertile women
      
Biospecimen description: 
      DNA obtained from endometrium
Relative Bioavailability Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate relative bioavailability of crushed tablets suspended in apple sauce or water
    


Intervention name(s): Riociguat(Adempas,BAY63-2521)
Intervention type(s): Drug
Intervention description(s): Single dose of a whole 2.5 mg riociguat tablet
Intervention MeSH terms: Riociguat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Biological Availability
Evaluation of FLEXOFYTOL® Versus PLACEBO
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This study is a prospective, randomized, double-blind, placebo-controlled with 3
      parallel-groups and multicenter trial in patients suffering from knee OA (osteoarthrosis).

      A first exploratory non comparative study (TILFLEXY002, NCT01909037, Henrotin et al., 2014
      BMC Complementary and Alternative Medicine) evaluated the efficacy of FLEXOFYTOL® at the dose
      of 2x3 caps/day, during a 3-month period, in 22 patients suffering from knee OA, on the serum
      levels of cartilage-specific and inflammatory biomarkers, on the evaluation of pain and on
      the global patient assessment of disease activity.

      This study demonstrated a statistically significant decrease of sColl2-1 cartilage specific
      biomarker, an early decrease of the ultrasensitive C-reactive protein (CRP), an improvement
      of the global assessment of the disease by the patient as well as a good tolerance and
      compliance for the treatment. Results of this exploratory study are encouraging and justify
      the setup of a randomized, placebo-controlled double blind and dose-ranging trial.
    

Detailed description: 
      150 patients suffering from symptomatic knee OA will be randomized in 3 parallel groups (50
      patients per group). Each patient will be enrolled in the study for 6 months including 4
      visits: Inclusion visit (T0), follow-up visits after 1 month (T1), 3 months (T3) and 6 months
      (T6).

      A. Primary objective

      - Evaluate the efficacy of two different dosages of FLEXOFYTOL® versus PLACEBO on arthritis
      related biomarker coll2-1 and on patient assessment of disease activity in patients suffering
      from knee OA after a 3 months treatment

      B. Secondary objectives

        -  Evaluate the efficacy of two different dosages of FLEXOFYTOL® versus PLACEBO on
           arthritis-related and inflammatory biomarkers.

        -  Evaluate the efficacy of two different dosages of FL EXOFYTOL® versus PLACEBO on pain
           and function.

        -  Evaluate the tolerance, the compliance and the patients' satisfaction.

        -  Evaluate the use of rescue treatments i.e. Paracetamol and oral non-steroidal
           antiinflammatory drugs (NSAIDs) during the study.
    

Intervention name(s): FLEXOFYTOL®; PLACEBO
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The product FLEXOFYTOL® is bio-optimized curcumin.
Other intervention name(s): curcuma extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: OsteoArthritis; FLEXOFYTOL®; Curcuma; biomarkers
Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2
      diabetes
    


Intervention name(s): Placebo; PF-04937319 - 3mg; PF-04937319 - 20mg; PF-04937319 - 50mg; PF-04937319 - 100mg; Sitagliptin - 100mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): double-dummy placebo tablets administered once-daily for 84-days; PF-04937319 3mg administered as tablets once-daily for 84-days; PF-04937319 20mg administered as tablets once-daily for 84-days; PF-04937319 50mg administered as tablets once-daily for 84-days; PF-04937319 100mg administered as tablets once-daily for 84-days; Sitagliptin 100mg administered as tablets once-daily for 84-days
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Phase 2; type 2 diabetes mellitus; PF-04937319
Preoperative Olaparib Endometrial Carcinoma Study (POLEN)
Condition: Endometrial Carcinoma
MeSH terms: Carcinoma; Endometrial Neoplasms
Study type: Observational

Summary: 
      The primary objective of this study is to identify, in human tumour samples, biomarker
      changes associated to short exposure to AZD2281 as potential predictors of activity in
      Endometrial Carcinoma (EC).

      This is an exploratory study with a biological primary endpoint. Clinical efficacy or safety
      are not a primary objective of the study.
    

Detailed description: 
      The main objective of the present proposal study is to assess the biological consequences of
      PARP inhibition in type I primary EC, in patients who receive therapy with AZD2281 during the
      period of time between diagnosis and surgery.

      This is a phase 0 trial or "Exploratory Investigational New Drug" study, a type of trial that
      involves limited number of patient under drug therapy and has no therapeutic or diagnostic
      intent because the drug exposure has a limited duration and the dosage is lower than 100% of
      the dose required to yield a pharmacologic effect.

      The purpose of the phase 0 studies is to assist in the go versus no-go decision-making
      process of a drug's fate earlier in the development process, using relevant human models
      instead of relying on sometimes inconsistent animal data, thus helping to confirm endpoints
      such as mechanism of action, pharmacology, bioavailability and pharmacodynamics.
    

Intervention name(s): Olaparib
Intervention type(s): Drug
Intervention description(s): Drug exposure has a limited duration 28 (+/- 5) days and at lower dose (600mg/day) than therapeutical accepted (800mg/day).
Other intervention name(s): Lynparza
Intervention MeSH terms: Olaparib
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patinets diagnosed with endometrial carcinoma prior surgery
      
Biospecimen description: 
      Tumor cells Plasma
African American Knowledge Optimized for Mindfully Healthy Adolescents
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of this study was to better understand how African American families identify and
      treat emotional and behavioral concerns associated with depression in their adolescent youth.
      The goals of the study included (a) identifying factors associated with participation in
      psychiatric research and treatment and (b) developing an intervention to increase
      participation in psychiatric research and treatment.
    

Detailed description: 
      The aim of this study was to obtain an in-depth understanding of African Americans'
      perceptions of barriers to adolescent and family engagement in psychiatric treatment and
      research utilizing a mixed methods approach in two Phases. Phase I consisted of data
      collected via surveys, focus groups and individual interviews with African American adults
      and youth. The data generated in Phase I provided a foundation for the domains incorporated
      into manual development and therapist training procedures of the subsequent intervention
      phase of the project (Phase II).

      After the research team developed the depression treatment engagement intervention, the
      intervention was pilot tested in a sample of depressed African American youth and families
      (Phase II)
    

Intervention name(s): Motivational Interviewing Active
Intervention type(s): Behavioral
Intervention description(s): Patients received 2 sessions of an in-person talk based intervention utilizing culturally relevant Motivational Interviewing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Continuous Oral Contraceptives (COCs): Are Bleeding Patterns Dependent on the Hormones Given?
Condition: Breakthrough Bleeding
MeSH terms: Metrorrhagia; Hemorrhage
Study type: Interventional

Summary: 
      While there may be a decrease in the total number of bleeding days women experience with
      continuous-dosed COCs (no menstrual withdrawal week), these regimens frequently result in an
      increased number of "breakthrough" or non-scheduled bleeding days. Breakthrough bleeding is
      among the main reasons cited for discontinuation of combined COCs dosed traditionally (3
      weeks of active pill, 1 week of placebo) or continuously, and may offset the perceived
      benefit of fewer withdrawal bleeding events for many women taking continuous-dosed COCs. The
      exact mechanisms responsible for breakthrough bleeding patterns during hormonal contraception
      are unknown and may be related to the pill formulation. This study is to determine whether
      progestin type or estrogen dose influences bleeding patterns, side effects, or satisfaction
      with combined oral contraceptives (COC) dosed continuously.
    


Intervention name(s): Birth control pills
Intervention type(s): Drug
Intervention MeSH terms: Contraceptives, Oral; Contraceptives, Oral, Combined
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Breakthrough bleeding while taking continuously dosed oral contraceptives
Effects of Marijuana Used on Lung Function in Persons With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Marijuana Abuse
Study type: Observational

Summary: 
      The main hypothesis is that persons that smoke or smoked tobacco and marihuana have worsen
      lung function as compared with persons that only smoke or smoked tobacco.
    

Detailed description: 
      We will follow persons with already diagnosed COPD (chronic bronchitis and/or emphysema).
      Obtain their smoking history: tobacco and marihuana and review their pulmonary function study
      results. Then we are planning to compare both groups.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        COPD patients recruited in pulmonary clinic.
      
Keywords: COPD; pulmonary function; tobacco and marihuana smoking
Effect of Intravenous Metoprolol Combining RIC on Myocardial Protection in STEMI Patients
Condition: Anterior Myocardial Infarction; Heart Failure
MeSH terms: Myocardial Infarction; Anterior Wall Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The main purpose of this study is to compare the myocardial protection effect of intravenous
      metoprolol combined with remote ischemic conditioning (RIC) and single treatment before
      reperfusion in Chinese patients with anterior STEMI. This study sought to find possible
      strategies to further improve myocardial protection in Chinese patients with anterior STEMI.
    

Detailed description: 
      This study is a prospective, multi-center, randomized controlled study. It is planned to
      enroll 1200 patients with anterior STEMI. Immediately after the first medical contact, the
      patients who were determined by the investigator to meet the inclusion/exclusion criteria
      were randomized through the interactive web response system (IWRS) and received different
      pre-reperfusion treatments. The four groups were placebo group, metoprolol group, remote
      ischemic conditioning (RIC) group and metoprolol & RIC group. Subsequently, the investigator
      conduct diagnosis and treatment according to the patient's specific conditions and check the
      serum level of myocardial damage markers (i.e. CK and CK-MB) at the time of admission, 12,
      24, 36, 48, 60 hours, respectively. If the patient undergoes PCI treatment, additional
      detection of myocardial damage markers immediately after PCI is also required. All patients
      were followed for 1 year with an office visit or a telephone call at 1, 3, 6, 9 and 12 months
      to evaluate the health status and adverse clinical events of patients.
    

Intervention name(s): intravenous Placebo; Metoprolol Injectable Product; Romote Ischemic Conditioning (RIC); Metoprolol & RIC
Intervention type(s): Drug; Drug; Device; Combination Product
Intervention description(s): Patients receive intravenous Placebo (saline) injection; Patients receive intravenous Metoprolol injection; Patients receive RIC treatment; Patients receive Metoprolol & RIC treatment
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anterior Myocardial Infarction; Intravenous Metoprolol; RIC; Myocardial Protection
Translational Neuroscience Optimization of GlyT1 Inhibitor
Condition: Cognitive Impairments Associated With Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, randomized, double-blind, placebo-controlled, cross-over POC study of
      stable patients with Schizophrenia or Schizoaffective disorder. The primary objective of this
      study is to test the efficacy of treatment with one of two does of a glycine transporter
      inhibitor (GlyT1I) combined with cognitive remediation to enhavce cognitive function.
      Subjects will be randomized to one of two doses of the glycine transporter inhibitor (GlyT1I)
      and placebo twice daily in addition to their antipsychotic medication for 2 treatment
      periods, each lasting a minimum of 5 weeks. Treatment periods will be separated by a washout
      period lasting approximately 3 weeks.
    


Intervention name(s): PF-03463275; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of the Effects of Different Exercise Types
Condition: Healthy
Study type: Interventional

Summary: 
      This study perform to investigate the comparison of the effects of different exercise types
      on lower extremity muscle thickness, tendon thickness, muscle strength, proprioception and
      balance.
    

Detailed description: 
      The choice of exercise type is affected by many different factors. The purpose of exercise
      and the physical fitness parameter they want to develop gain importance in this choice.

      Resistance exercises (RE) specifically designed to increase muscle strength and hypertrophy;
      Plyometric exercises (PE) based on energy storage of the muscle during the deceleration phase
      and release of this energy during the acceleration period and high-intensity interval
      training (HIIT), which is an advanced form of interval training that includes shorter and
      lighter recovery periods following short to heavy anaerobic exercise are some of the many
      types of exercises in the literature and practice.

      The purpose of the study is investigate the comparison of the effects of different exercise
      types on lower extremity muscle thickness, tendon thickness, muscle strength, proprioception
      and balance.
    

Intervention name(s): 3 different type of exercise
Intervention type(s): Other
Intervention description(s): Group 1: Resistance Exercise Group 2: Plyometric Exercise Group 3: Hight Intensity Interval Training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized 3 exercise group (RE, PE and HIIT)
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: muscle structure; muscle thickness; joint position sense; postural stability
A Novel Protocol for Labour Induction
Condition: Failed Induction of Labor
Study type: Interventional
Phase: Phase 3

Summary: 
      The use of foley catheter was tested many times and proved to be effective for induction of
      labour.
    

Detailed description: 
      The investigators compare between vaginal misoprostol versus foley catheter plus vaginal
      isosorbide mononitrate (IMN) for induction of labour
    

Intervention name(s): foley catheter; Misoprostol; Vaginal IMN
Intervention type(s): Device; Drug; Drug
Intervention description(s): foley 14 catheter intracervical plus vaginal IMN 40 mg evry 6 hours; misoprostol 50 Ug , vaginally every 4-6 hours; IMN vaginal 40 mg every 4-6 hours
Other intervention name(s): misoprostol vaginally
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: labour induction; Foley catheter; misoprostol; isosorbide mononitrate
Phase III Trial of Dantonic® (T89) Capsule to Prevent and Treat Stable Angina
Condition: Angina Pectoris
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase III study is designed as a double blind, randomized, multi-nation, multi-center,
      placebo controlled clinical research, which aims to evaluate the safety and efficacy of
      Dantonic® (T89) in patients with chronic stable angina pectoris.
    

Detailed description: 
      Dantonic® (T89) is a botanical drug consists of extracts of Danshen (Radix Salviae
      Miltiorrhizae) and Sanqi (Radix Notoginseng) with borneol in a capsule form. The drug is
      currently approved in 26 countries outside the USA for the treatment and prevention of
      chronic stable angina pectoris and other cardiovascular disease related conditions. This
      pivotal confirmative Phase III clinical trial is to confirm the efficacy and safety of the
      drug at 150mg and 225mg doses in the prevention and treatment of angina pectoris in patients
      with Chronic Stable Angina. The contribution of the main herb Danshen to, and the difference
      of various production batches in, the overall efficacy and safety profiles will also be
      explored. Patients will take a morning and an evening dose orally (every 12 hours) for 6
      weeks while stop taking any long-acting nitroglycerin, ranolazine, and/or multiple
      beta-blockers or beta blocker(s) with calcium channel blocker during the trial. Single
      beta-blocker and/or on-demand short acting nitroglycerin to relief angina pectoris is allowed
      during the trial. After physical exams and if eligible to participation, patients will stop
      taking other drugs, and undergo two baseline screen Exercise Treadmill Tests (ETT) on
      Standard Bruce Protocol in the clinic one week before and right before starting the drug
      treatment. Patients will perform three more ETTs before the morning dose at the end of week
      2, 4 and 6 after receiving the drug treatment. The primary efficiency endpoint is the change
      of symptom-limited Total Exercise Duration of the ETT at the end of the 4th week of treatment
      from the average of the two screening baselines compared with that of placebo treatment.
    

Intervention name(s): T89 high dose; T89 Low dose; Sanqi+Bingpian; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 225mg bid; 150mg bid; 225 mg bid; 225mg bid
Other intervention name(s): Dantonic®; Compound Danshen Dripping Pills; Salvtonic®; Dantonic®; Salvtonic®; Compound Danshen Dripping Pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Angina Pectoris Treatment Prevention