bioihbjkbjnl/mcl2 huggingface dataset:
A Study of HNC664 in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this First-in-Human study is to evaluate the safety , tolerability，PK and PD
      after single ascending of HNC664 given to healthy subjects, compared to placebo. Also, food
      effect will be evaluated.
    


Intervention name(s): HNC664 capsules Single dose; HNC664 placebos Single dose; HNC664 capsules FED
Intervention type(s): Drug; Drug; Drug
Intervention description(s): HNC664 capsules,single ascending doses Single dose, PO,starting dose of 40mg escalating up to 500mg; HNC664 placebos single ascending doses,PO,Single dose, matching placebo; HNC664 capsules,single doses Single dose, PO,food effect（dosage will be based on data from SAD cohorts and decided by the IDRC）
Other intervention name(s): HNC664 capsules; HNC664 placebos; HNC664 capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Noninvasive Peripheral Nerve Stimulation for Medication-Naive and Medication-Refractory RLS
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional

Summary: 
      Prospective multi-site randomized sham-controlled study evaluating tolerability and efficacy
      of noninvasive peripheral nerve stimulation (NPNS) for patients with moderate-severe primary
      Restless Legs Syndrome (RLS) who are either medication-naive or medication-refractory.
    

Detailed description: 
      The study consists of a series of two 2-week phases:

      Phase 1: Baseline evaluation of RLS and sleep Phase 2: Prospective, single-blinded, 1:1
      randomized evaluation of response to NPNS treatment (Active treatment: Sham control)

      Additionally, subjects will have the option to consent to a third phase, which includes
      overnight polysomnography (PSG) evaluation of sleep with Active treatment and with no
      treatment (baseline), in randomized order.
    

Intervention name(s): NTX100 Neuromodulation System - Active; NTX100 Neuromodulation System - Sham
Intervention type(s): Device; Device
Intervention description(s): Noninvasive peripheral nerve stimulation device programmed to active mode; Noninvasive peripheral nerve stimulation device programmed to sham mode
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized 1:1 between Active treatment and Sham control
Masking: Single (Participant)
Primary purpose: Treatment
Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability
    


Intervention name(s): Zoledronic acid
Intervention type(s): Drug
Intervention MeSH terms: Zoledronic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate Cancer; Bone Metastases; Zoledronic acid
Inspiratory Muscle Training in Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Respiratory Aspiration; Hypertension
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effective of inspiratory muscle training on
      respiratory function, exercise capacity, physical activity and quality of life.
    

Detailed description: 
      Pulmonary hypertension (PH) is a condition which is seen with hemodynamic differences,
      pulmonary vascular resistance and right heart failure. Patients with pulmonary hypertension
      have, dyspnea, physical inactivity, reduced condition and respiratory muscle dysfunction.
      Aerobic exercise programs in patients with pulmonary hypertension are reported to result in
      improved exercise capacity and endurance of the patients, improvement in WHO functional class
      and quality of life, increased peak workload and increased peripheral muscle function. In
      recent years, few studies have investigated the efficacy of inspiratory muscle training in
      patients with PH.The aim of this study is to investigate the effective of inspiratory muscle
      training on respiratory function, exercise capacity, physical activity and quality of life.
    

Intervention name(s): inspiratory muscle training
Intervention type(s): Other
Intervention description(s): The treatment group received IMT. Patients were trained using an inspiratory threshold-loading device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will randomize into two groups as Group A: inspiratory muscle training, and Group B (control group)
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pulmonary hypertension; inspiratory muscle training; functional capacity; physical activity
Parent Partnership Project
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      To evaluate the acceptability and feasibility of peers as interventionists in delivering
      family-based behavioral pediatric weight control intervention.
    

Detailed description: 
      A new model of delivering family-based pediatric overweight treatment that decreases costs
      but sustains short- and long-term efficacy is needed. One possible opportunity for this is a
      peer intervention model in which families receiving professionally-led intervention then
      subsequently providing intervention to other families. In addition, peer interventionists'
      continued engagement in the behavior change process through providing intervention to others
      could improve their own long-term efficacy. The project begins with the standard approach of
      having professional interventionists provide family-based behavioral pediatric overweight
      treatment to overweight children and their parent (1st generation families; n=30).
      Subsequently, half of 1st generation families will be randomly assigned to serve as peer
      interventionists to other overweight parents and children (2nd generation families; n=30).
      The remaining 1st generation families will neither receive nor provide any additional
      treatment. This project aims to develop the peer intervention training and delivery and then
      to examine the feasibility and acceptability of the peer intervention. This project also aims
      to derive an estimate of the efficacy of peer intervention (receiving and providing) both at
      the end of receiving treatment and 6 months later, as well as the impact of providing
      intervention on peer interventionists' weight outcomes.
    

Intervention name(s): Behavioral: Family-based behavioral intervention
Intervention type(s): Behavioral
Intervention description(s): This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Childhood Obesity
Brain Machine Interface Control of an Robotic Exoskeleton in Training Upper Extremity Functions in Stroke
Condition: Stroke; Hemiparesis
MeSH terms: Stroke; Paresis
Study type: Interventional

Summary: 
      The purpose of this study is:

        1. To augment the MAHI Exo-II, a physical human exoskeleton, with a non-invasive brain
           machine interface (BMI) to actively include patient in the control loop and thereby
           making the therapy 'active'.

        2. To determine appropriate robotic (kinematic data acquired through sensors on robotic
           device ) and electrophysiological ( electroencephalography- EEG based) measures of arm
           motor impairment and recovery after stroke.

        3. To demonstrate that the BMI controlled MAHI Exo-II robotic arm training is feasible and
           effective in improving arm motor functions in sub-acute and chronic stroke population.
    

Detailed description: 
      This study aims to provide an adjunct to accelerate neurorehabilitation for stroke patients.
      The MAHI EXO-II, a physical human-robot interface, will be combined with a non-invasive
      brain-machine interface (BMI) to actively include the patient in the training of upper
      extremity motor functions.
    

Intervention name(s): MAHI EXO-II exoskeleton augmented with BMI system
Intervention type(s): Device
Intervention description(s): In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period.
Other intervention name(s): Brain Machine Interface System; Rehabilitation robotics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brain machine interface; Rehabilitation robotics; Stroke; Hemiparesis
Effects of Non-calorie Sweeteners, Mono- and Disaccharides on Intestinal Barrier Function
Condition: Dietary Habits; Endotoxemia
MeSH terms: Endotoxemia
Study type: Interventional

Summary: 
      The aim of the present study is to determine the effect of non-nutritive sweeteners on
      intestinal barrier function and inflammatory markers in healthy subjects in comparison to
      mono- and disaccharides.
    

Detailed description: 
      In the intervention study normal weight participants will receive beverages sweetened with
      non-nutritive sweeteners, mono- and disaccharides for a defined number of days. Before and
      after intervention parameters of intestinal barrier function will be assessed.
    

Intervention name(s): Dietary intervention 1; Dietary Intervention 2; Dietary Intervention 3; Dietary Intervention 4
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Participants receive a beverage with a defined amount of non-nutritive sweetener.; Participants receive a beverage with a defined amount of non-nutritive sweetener and maltodextrin.; Participants receive a beverage with a defined amount of monosaccharide.; Participants receive a beverage with a defined amount of disaccharide.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants receive all interventional diets
Masking: Single (Participant)
Primary purpose: Basic Science
Endometrioma Related Reduced Ovarian Reserve
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      Prior studies have shown surgical excision of endometriomas are associated with a decline in
      ovarian reserve as assessed by serum anti-Mullerian Hormone (AMH) levels. However, the
      natural history of serum AMH levels in the presence of untreated endometriomas are unknown.
      Purpose of this study is to determine whether the presence of endometriomas cause a faster
      decline in serum AMH levels than in healthy women over a six months period.
    

Detailed description: 
      The study is a prospective cohort study. Women diagnosed with endometriomas by transvaginal
      or transabdominal ultrasound or MRI will be recruited from a tertiary care endometriosis
      clinic. Age matched healthy controls will be recruited from the staff of the same hospital. A
      priorly published historical group of women who underwent endometrioma excision will be a
      second comparator.
    

Intervention name(s): laparoscopic endometrioma excision; Conservative follow up
Intervention type(s): Procedure; Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The decision to include a healthy control group was taken five months after starting
        recruitment of women with endometrioma. Only 12 women with endometriomas had been recruited
        until then and none of them had six month serum AMH level measured.

        Since healthy controls were reluctant to undergo transvaginal ultrasound examination,
        antral follicle counts were not measured as another marker of ovarian reserve for healthy
        controls and some women in the endometrioma group.
      
Biospecimen description: 
      Serum Anti-mullerian hormone (AMH)
    
Keywords: ovarian endometriomas; AMH; ovarian reserve
Dose/Response of Exercise on Long Term Weight Loss
Condition: Cardiovascular Diseases; Heart Diseases; Obesity
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To examine the dose-response of exercise on long-term weight loss in overweight adult women.
    

Detailed description: 
      BACKGROUND:

      Exercise is a key component of behavioral weight loss programs because of its effect on
      weight loss, body composition, cardiovascular disease risk factors, and other obesity related
      diseases such as type 2 diabetes mellitus. Despite these benefits, it is unclear whether
      there is an optimal exercise duration and/or intensity that will enhance long-term weight
      loss. The current public health recommendation for physical activity is for individuals to
      participate in at least 30 minutes of moderate intensity physical activity on most days of
      the week (approximately 150 minutes per week total). However, it is unclear whether this
      amount of exercise is adequate for long-term weight loss. Moreover, cross-sectional studies
      have shown that individuals that have been successful at long-term weight loss participate in
      levels of physical activity that are greater than the current public health recommendations.

      DESIGN NARRATIVE:

      The researchers hypothesized that adopting higher levels of exercise duration and/or
      intensity, coupled with a strong behavioral intervention would enhance long-term weight loss.
      To test this hypothesis, they recruited 200 overweight women and randomly assigned them to
      one of four treatment groups: (1) moderate intensity, moderate 1000cal/wk duration exercise,
      (2) vigorous intensity moderate duration exercise, (3) moderate 2000cal/wk intensity, high
      duration exercise, and (4) vigorous intensity, high duration exercise. All subjects
      participated in a 24-month behavioral weight loss program, with subjects attending group
      meetings and receiving periodic telephone contacts from the weight loss program, with
      subjects attending group meetings and receiving periodic telephone contacts from the
      interventionists. In addition, to facilitate the adoption of the exercise protocols, all
      subjects were provided with a home treadmill. Assessment of body weight occured at 0, 6, 12,
      and 24 months and exercise participation was measured throughout the program. In addition,
      body composition, cardiorespiratory fitness, cardiovascular disease risk factors, and
      mediators of behavior change were measured at 0, 6, 12, and 24 months.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
To Evaluate the Efficacy of DDB/Garlic Oil in Patients With Elevated Transaminase Chronic Liver Disease
Condition: Chronic Liver Disease
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose

      - To evaluate the efficacy of Biphenyl dimethyl dicarboxylate(DDB)/Garlic Oil in patients
      with elevated transaminase chronic liver disease.
    

Detailed description: 
      Biphenyl dimethyl dicarboxylate (DDB) combined with garlic oil (pennel) has been used to
      treat chronic liver disease. A randomized, double-blind, active- and placebo-controlled
      clinical trial was conducted to investigate the efficacy, safety and quality of life in
      chronic liver disease patients.
    

Intervention name(s): Pennel; Legalon; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pennel 2 Tablet, Legalon Placebo 1 tablet, Tid; Pennel Placebo 2 Tablet, Legalon 1 tablet, Tid; Pennel Placebo 2 Tablet, Legalon Placebo 1 tablet, Tid
Other intervention name(s): DDB/Garlic oil; Silymarin; Lactose
Intervention MeSH terms: Silymarin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluate Analgesic Efficacy of Fast Release Aspirin
Condition: Drugs, Investigational
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study is to evaluate the analgesic efficacy of a single, oral dose of
      fast release aspirin tablets, 650 mg (2 x 325 mg) compared to regular aspirin tablets, 650 mg
      (2 x 325 mg) and placebo in subjects with postsurgical dental pain.
    


Intervention name(s): Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036); Acetylsalicyclic acid (Aspirin, BAYE4465); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of fast acting aspirin 2 x 325 mg = 650 mg total; Single dose of regular aspirin 2 x 325 mg = 650 mg total; Two placebo tablets
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Aspirin
Fed-Fast Crossover Study to Assess the Effect of Food With CTx-1301 in Healthy Subjects
Condition: Healthy Volunteers in Fed and Fasted State
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the effect of food on the rate and extent of
      absorption and the overall bioavailability of a single dose of CTx-1301 25 mg trimodal
      tablets in healthy adult volunteers.
    

Detailed description: 
      An open-label, randomized, single-dose, two-sequence, two-period, in-clinic crossover study
      with two treatments (fed vs fasted) in approximately 26 healthy adult subjects aged 18 to 50
      years.

      Fed arm: Following an overnight fast of 10.5 hours, subjects should begin and finish
      consuming the test meal within 30 minutes, prior to administration of CTx-1301 (25 mg).
      CTx-1301 (25 mg) should be administered with approximately 240 mL (8 fluid ounces) of water.
      No food should be allowed for at least 4 hours post-dose. Water can be allowed as desired
      except for at least one hour before and at least one hour after drug administration. Subjects
      should receive standardized meals as defined in the study schedule for the fed treatment arm.

      Fasted arm: Following an overnight fast of 10.5 hours, subjects should be administered
      CTx-1301 (25 mg) with approximately 240 mL (8 fluid ounces) of water. No food should be
      allowed for at least 4 hours post-dose. Water can be allowed as desired except for at least
      one hour before and at least one hour after drug administration. Subjects should receive
      standardized meals as defined in the study schedule for the fasted treatment arm.

      A high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie
      (approximately 800 to 1000 calories) meal is used as the test meal for food-effect
      bioanalytical (BA) and fed bioequivalency (BE) studies. This test meal allows approximately
      150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively. The test
      meal, eaten within 30 minutes prior to administration of CTx-1301, is two eggs fried in
      butter, two strips of bacon, two slices of toast with butter, four ounces of hash brown
      potatoes and eight ounces of whole milk.
    

Intervention name(s): Dexmethylphenidate
Intervention type(s): Drug
Intervention description(s): Subjects will be randomized to one of two sequences. Subjects will be dosed with 25 mg dose of CTx-1301 during each sequence. Subjects will serve as their own control.
Intervention MeSH terms: Dexmethylphenidate Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will be randomized to one of two sequences: Sequence 1) Fasted: Fed or Sequence 2) Fed: Fasted
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy Normal Volunteers; Fed Study; Pharmacokinetics; Dexmethylphenidate; Bioavailability; d-MPH; dMPH
A Phase III Study of FE 999913 in Japanese Female Patients Undergoing Fertility Treatment
Condition: Luteal Hormone Supplementation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purposes of the study are to verify sufficient supplementation of luteal hormone after
      administrating FE999913 Vaginal Tablet twice a day (BID) or three times a day (TID) and to
      determine the efficacy and safety of FE999913 Vaginal Tablet in Japanese women undergoing
      fertility treatment with IVF-ET (a fresh embryo transfer).
    


Intervention name(s): FE 999913 vaginal tablet
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparing the Location of the Motor Cortex in Children Using Two Methods
Condition: Congenital Hemiparesis
MeSH terms: Paresis
Study type: Observational

Summary: 
      Hypothesis: In typically developing children (TDC), use of conventional EEG landmarks to
      determine the brain area that controls hand function will not differ from TMS-guided
      determination of individual motor hotspots. In children with hemiparesis, however, those two
      locations will diverge. The prediction is that TMS will best guide Transcranial Direct
      Current Stimulation (tDCS) interventions
    

Detailed description: 
      Congenital hemiparesis, mainly due to stroke, affects approximately 25% of children with
      cerebral palsy. Noninvasive brain stimulation has emerged to influence improvements in hand
      function specifically in children with congenital hemiparesis due to stroke.

      The use of one type of noninvasive brain stimulation, Transcranial Direct Current Stimulation
      (tDCS), in conjunction with rehabilitation training intervention for a child with hemiparesis
      proposes a synergistic approach to improving hand function. Application of electrodes over
      certain targeted areas are placed with the intent to stimulate and influence neuronal
      activity.

      Our preliminary evidence suggests that in children with hemiparesis due to stroke, the area
      for placement is variable as noted by electroencephalogram (EEG) and Transcranial Magnetic
      Stimulation (TMS) measurement methods, influencing the site location of optimal stimulation
      for tDCS.

      Due to this variation, the optimal site of stimulation warrants investigation for the optimal
      placement of tDCS.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children with congenital hemiparesis and typically developing children
      
Keywords: Hemiparesis; Cerebral Palsy; Congenital Stroke; Congenital Infarct