bioihbjkbjnl/mcl2 huggingface dataset:
Metabolic Health Benefits of Dairy Protein
Condition: Hyperlipidemia; Obesity
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of regular low fat diary consumption on
      markers of cardiovascular (CV) and metabolic (cardiometabolic) health including body
      composition (% body fat, body weight), blood lipids, blood glucose, arterial compliance,
      blood pressure, insulin sensitivity and resting metabolic rate.
    

Detailed description: 
      This is a multi-centre, randomized, dietary intervention study of 12 months. A total of 100
      overweight/obese individuals will be recruited, half recruited in Adelaide, South Australia
      and the other half from Manitoba, Canada. At baseline, subjects assigned to HD will be given
      standard serves of low fat dairy products (eg. 250mL milk, 200g yoghurt) on a regular basis
      for 6 months and asked to incorporate 4 serves/day into their diet. Volunteers randomized to
      the LD will be asked to continue with their habitual diet and consume less than 2 serves of
      dairy on a regular basis for 6 months. All participants will be asked to complete a food
      frequency questionnaire, physical activity diary, 3-day food record, and keep a record of
      dairy serves (food log) consumed each day. In total, participants will be asked to come to
      the centre 5 times throughout the study. However, the HD group will be asked to return to the
      centre every two weeks to receive diary product and return dairy record (food log). At
      baseline subjects will be asked to attend the Richardson Centre for Functional Foods and
      Nutraceuticals (RCFFN) fasted for various measurements including: body weight, blood
      pressure, arterial compliance, dual energy x-ray absorptiometry (DEXA) scan for measurement
      of body fat, abdominal fat and bone mineral density, waist and hip circumferences and provide
      a blood sample for the measurement of blood lipids, insulin and glucose.
    

Intervention name(s): High Dairy
Intervention type(s): Other
Intervention description(s): Consuming 4 or more servings of dairy products per day for a period of 6 months
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: body weight; lipids; glucose; insulin
A Relative Bioavailability Study of Quinine Sulfate Capsules 324mg
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate and compare the relative bioavailability of Quinine
      Sulfate capsules following a single, oral dose in healthy volunteers under fasting and fed
      conditions.
    

Detailed description: 
      The purpose of this study is to evaluate and compare the relative bioavailability of Quinine
      Sulfate capsules following a single, oral dose in healthy volunteers under fasting and fed
      conditions.

      Twenty-two healthy, non-smoking, non-obese, male and female volunteers between the ages of 18
      and 45 years of age will be randomly assigned in a crossover fashion to receive each of two
      Quinine Sulfate dosing regimens in sequence with a 7 day washout period between dosing
      periods. On the morning of Day 1, subjects will receive either a single oral dose of Quinine
      Sulfate (2 x 324 mg capsules) following an overnight fast of at least 10 hours, or a single
      oral dose of Quinine Sulfate (2 x 324 mg capsules) 30 minutes after a standardized, high-fat
      breakfast. After a 7 day washout period, on the morning of Day 8, subjects will receive the
      alternate regimen. Blood samples will be drawn from all participants before dosing and for 48
      hours post-dose to adequately define the pharmacokinetics of Quinine Sulfate. A further goal
      of this study is to evaluate the safety and tolerability of this regimen in healthy
      volunteers. Subjects will be monitored throughout the confinement portion of the study for
      adverse reactions to the study drug and/or procedures. Blood pressure and heart rate will be
      measured prior to dosing and at 1, 2, 4 and 12 hours after each dose and at study exit. A 12
      lead electrocardiogram (EKG) will be recorded at study check-in and at 2, 4, 6, 12 and 24
      hours after dose administration. All adverse events whether elicited by query, spontaneously
      reported, or observed by clinic staff will be evaluated by the Investigator and reported in
      the subject's case report form.
    

Intervention name(s): Quinine Sulfate 2 x 324 mg Capsules; Quinine Sulfate 2 x 324 mg Capsules
Intervention type(s): Drug; Drug
Intervention description(s): Quinine Sulfate (2 x 324 mg capsules) administered after an overnight fast of at least 10 hours.; Quinine Sulfate (2 x 324 mg capsules) administered 30 minutes after a standardized, high fat breakfast.
Intervention MeSH terms: Quinine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioavailability
Impact of Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy
Condition: Anesthesia; Analgesia; Hysterotomy
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 4

Summary: 
      The analgesic effect of perioperative use of aripiprazole has not been fully investigated.

      So, this study aims to test the effects of aripiprazole versus placebo in reducing
      postoperative pain following laparoscopic hysterectomy and to explore the potential side
      effects.
    


Intervention name(s): ARIPiprazole 30 MG; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive Aripiprazole 30 mg tablet orally 3 h before surgery; Patients will receive placebo tablet which is identical in appearance, size, shape, and color to aripiprazole 3 h before surgery
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics of NPC-01 After Single Oral Administration in Healthy Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the pharmacokinetic profiles of norethisterone and
      ethinyl estradiol after single oral administration of NPC-01 in healthy female volunteers.

      Pharmacokinetics of norethisterone and ethinyl estradiol will be evaluated on the basis of
      AUC, Cmax, tmax, t1/2, MRT, kel and AUC∞.
    


Intervention name(s): NPC-01
Intervention type(s): Drug
Intervention description(s): NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
Other intervention name(s): Norethisterone and Ethinyl Estradiol
Intervention MeSH terms: Ethinyl Estradiol; Norethindrone; Norinyl; Estradiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NPC-01; Pharmacokinetics; Healthy female volunteer; Norethisterone; Ethinyl Estradiol
Safety of ALK Ragweed Tablet
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is performed to assess whether ALK Ragweed Tablet is safe to use in adults
    


Intervention name(s): ALK Ragweed Tablet
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Does Routine Screening for Intimate Partner Violence Against Women in Health Care Settings do More Good Than Harm?
Condition: Intimate Partner Violence Against Women
Study type: Interventional

Summary: 
      The purpose of the research is to evaluate whether routine screening for woman abuse in
      health care settings, as compared to no screening, does more good than harm. Recent reviews
      have identified the need for high quality research to understand 1) the actual impact on all
      women of instituting mass screening procedures to identify woman abuse and 2) the extent to
      which early identification through screening is effective in preventing or ameliorating
      important outcomes. The main outcomes for the study are reduction in violence, improvement in
      life quality, and potential harms of screening. A number of secondary outcomes to help
      understand the process by which screening and usual care might lead to changes in the primary
      outcomes will also be assessed.
    


Intervention name(s): Screening for intimate partner violence
Intervention type(s): Other
Intervention description(s): Women are screened for intimate partner violence prior to seeing a health care provider.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: Domestic violence; Spouse Abuse
Study to Evaluate Improvements of the Quality of Sleep With NOVANUIT® Triple Action in Healthy Volunteers With Sleep Disorders
Condition: Sleep Disorder (Healthy Volunteers)
MeSH terms: Sleep Wake Disorders; Parasomnias
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To estimate the range of improvement of NOVANUIT® triple action on sleep quality global
      score.

      Secondary Objectives:

        -  To estimate the range of improvement of NOVANUIT® triple action on following parameters:
           time for getting asleep, sleep time, number of nocturnal awakening, number of
           nightmares, sleep quality (score from 0 to 10), and mean tiredness during the day (score
           from 0 to 10).

        -  To estimate persistency of NOVANUIT® triple action effects after end of study product
           consumption.

        -  To assess dependency to NOVANUIT® triple action after study product cessation.

        -  To assess tolerance of NOVANUIT® triple action during the study.
    

Detailed description: 
      Study participation duration for each participant will be 4 weeks including a 2-week
      treatment period.
    

Intervention name(s): MELATONIN (MELATL07959)
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:Capsule Route of administration: Oral
Intervention MeSH terms: Melatonin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy
Condition: Relapsed/Refractory Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a Phase 3, multicenter, randomized, double blind, placebo-controlled study
      evaluating the efficacy and safety of venetoclax plus bortezomib and dexamethasone in
      participants with relapsed or refractory multiple myeloma who are considered sensitive or
      naïve to proteasome inhibitors and received 1 to 3 prior lines of therapy for multiple
      myeloma.
    


Intervention name(s): Venetoclax; Bortezomib; Dexamethasone; Placebo for venetoclax
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants self-administered venetoclax tablets by mouth QD in combination with bortezomib. Venetoclax was to be given before other agents administered on the same day, if applicable. Each venetoclax dose was to be taken all at one time with approximately 240 mL of water within 30 minutes after completion of breakfast or the subject's first meal of the day. Tablets were to be swallowed whole and must not have been broken, chewed, or crushed. On days that pre-dose PK sampling was required, dosing occurred at the clinic to facilitate PK sampling.; Bortezomib (subcutaneous injection [preferred] or IV) was given following administration of venetoclax or placebo in Cycles 1 -8 on Days 1, 4, 8 and 11, and for Cycles 9 and beyond, on Days 1, 8, 15 and 22 and was to be administered per the prescribing information. The route of administration was to stay the same during the study.; Dexamethasone was to be given orally, administered per the prescribing information, the day of bortezomib dosing and the following day, given the protocol-defined dosing window (bortezomib dosing window is ± 1 day) is maintained. If bortezomib was interrupted or a dose is skipped, dexamethasone was to be administered as scheduled per protocol (unless dexamethasone was interrupted due to toxicity).; Participants self-administered placebo tablets by mouth QD in combination with bortezomib. Placebo was to be given before other agents administered on the same day, if applicable. Each placebo dose was to be taken all at one time with approximately 240 mL of water within 30 minutes after completion of breakfast or the subject's first meal of the day. Tablets were to be swallowed whole and must not have been broken, chewed, or crushed. On days that pre-dose PK sampling was required, dosing occurred at the clinic to facilitate PK sampling.
Other intervention name(s): VENCLEXTA; VENCLYXTO; Velcade
Intervention MeSH terms: Dexamethasone; Bortezomib; Venetoclax
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Relapsed/refractory multiple myeloma; Relapsed multiple myeloma; Refractory multiple myeloma; Multiple myeloma
Coronary Flow Rate Measurement in T-Grafts
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      Is the surgical treatment of patients with coronary heart disease using the T-graft technique
      an adequate solution that provides a sufficient myocardial flow reserve? A magnetic resonance
      examination (MRI) is required.
    


Intervention name(s): T-Graft
Intervention type(s): Procedure
Intervention description(s): T-Graft
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: patients scheduled for bypass grafting
Oral Contraceptive and Cardiovascular Risk in PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Oral contraceptive therapy is routinely used for the treatment of menstrual disturbances of
      patients with polycystic ovary syndrome (PCOS).

      To date, the cardiovascular risk (CVR) of the oral contraceptives (OC) are known but no data
      are available on the CVR in PCOS patients treated with OC or physical exercise.

      The purpose of this study is to compare the effects of OC to physical exercise on the CVR of
      PCOS women and show the hormonal and metabolic effects of these two different treatment.

      We hypothesize that physical exercise has the same beneficial effects of OC therapy on
      hormonal and metabolic features of PCOS women with less cardiovascular consequences.
    

Detailed description: 
      One hundred and fifty PCOS women will be enrolled. The diagnosis of PCOS was made based
      according to the Rotterdam criteria (1). Specifically, patients with anovulation and clinical
      and/or biochemical hyperandrogenism were enrolled.

      Patients will be randomly allocated in three groups (OC, physical exercise and placebo group)
      using a computer-software. Fifty PCOS patients will be treated with OC (Drospirenone 3 mg,
      Ethynylestradiol 30 microgram = Yasmin, Schering, Milan,Italy) other fifty PCOS will be
      undergone physical exercise, whereas other fifty will be treated with placebo tablets (one
      tablet once daily; placebo group). The duration of the treatment will be 6 months.

      Patients treated with OC will be instructed to follow their usual diet and physical activity,
      whereas patients undergone to physical exercise will be instructed to follow a detailed
      regular physical training program and for the diet they will be advised for the quality of
      food to eat. All subjects will be nonsmokers and none will drink alcoholic beverages.

      Each subject will undergo follow-up visits under (at three and 6 months from treatment
      starting) and after treatment (at three and 6 months from treatment withdrawal). At each
      follow-up visit, in all subjects the same operator will perform clinical, hormonal, metabolic
      and cardiovascular assessments by carotid and brachial artery US
    

Intervention name(s): Physical exercise; OC - Drospirenone plus Ethynylestradiol; Vitamin, polyvitamins tablets
Intervention type(s): Behavioral; Drug; Dietary Supplement
Intervention description(s): 45 minutes each day for three times/week for 6 months; 1 cp for 21 days each month for 6 months of OC (Drospirenone 3 mg plus Ethynylestradiol 30 microgram = Yasmin, Schering, Milan, Italy); Tablet of vitamin 1cp for 21 days each month for 6 months
Intervention MeSH terms: Drospirenone; Ethinyl Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PCOS; oral contraceptives; physical exercise; CVR
Effects of Breathing Retraining in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      Conventional pulmonary rehabilitation programs improve exercise tolerance, peripheral muscle
      strength, and health related quality of live but not pulmonary function in patients with
      chronic obstructive pulmonary disease (COPD). The role of breathing retraining techniques in
      the rehabilitation of patients with COPD remains unclear. The hypothesis to be tested in this
      study is that pulmonary function, cardio-pulmonary exercise capacity, health related quality
      of life and cardiac autonomic modulation of patients with COPD who undergo pulmonary
      rehabilitation plus breathing retraining will be better than that of patients undergoing a
      conventional pulmonary rehabilitation.
    

Detailed description: 
      To address this uncertainty, we performed a randomized controlled trial to assess the effects
      of a 4-week rehabilitation program including breathing retraining on pulmonary function
      (PFT), cardio-pulmonary exercise capacity (CPET), health related quality of life (HRQL) and
      cardiac autonomic modulation (CAM).

      A randomized controlled trial comparing the effects of a conventional 4-week pulmonary
      rehabilitation program with those of a 4-week pulmonary rehabilitation program plus breathing
      retraining on pulmonary function (FEV1), cardiopulmonary exercise capacity (6-minute walking
      distance, 6MWD), health related quality of life (chronic respiratory questionnaire, CRQ) and
      cardiac autonomic function (rMSSD) was performed.
    

Intervention name(s): respiratory biofeedback
Intervention type(s): Other
Intervention description(s): In order to train effortless diaphragmatic breathing techniques the biofeedback loop starts at the sensor that measures the patient's breathing rhythm at both umbilical and abdominal level. The sensor is connected to an amplifier that converts the electrical impulses into acoustical and visual outputs. Patients were encouraged to regulate their breathing patterns at a 10-20% slower respiration rate resulting in increased tidal volumes. Furthermore, the patients were encouraged to reduce dynamic hyperinflation by completing the expiration prior to the initiation of the next breath while using pursed-lips breathing. Patients were trained to breath as comfortable as possible with predominant abdominal expansion during the inhalation and smooth abdominal contraction during exhalation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: clinically stable; COPD (GOLD-classification I-IV); COPD; breathing retraining; pulmonary rehabilitation; cardiac autonomic function; quality of life; exercise capacity; pulmonary function
Modified Story Memory Technique (mSMT) in Persons With TBI
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      The current RCT is designed to:

        1. test the efficacy of the group based mSMT in persons with TBI on NPE, the current
           gold-standard for measuring memory functioning

        2. assess the effectiveness of the group mSMT on more global measures of everyday life,
           including an objective measure shown through our previous work to be sensitive to memory
           changes following the mSMT, as well as additional questionnaires to be completed by both
           the participant and a significant other

        3. evaluate the changes in brain functioning following treatment with the mSMT via fMRI and

        4. evaluate the long-term effects of the treatment protocol.

      To accomplish these goals investigators will conduct a double-blind, placebo-controlled, RCT,
      applying the group mSMT to a sample of 60 participants with moderate to severe TBI (30
      treatment; 30 control).
    

Detailed description: 
      Outcome measures will assess objective memory abilities, everyday memory abilities and
      patterns of cerebral activation during learning. A long-term follow-up assessment will be
      conducted, designed to measure the impact of the mSMT 3 months following treatment
      completion. Alternate forms will be utilized wherever available.
    

Intervention name(s): Group Memory retraining exercises; Placebo controlled group memory exercise training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.; Placebo group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: memory; learning; cognition; traumatic brain injury; treatment and therapy
Safety Study of Airway Clearance Techniques in Infants.
Condition: Gastro-esophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether three airway clearance techniques (
      Bouncing, Assisted Autogenic Drainage ( AAD) and bouncing and AAD) provoke or aggravate
      gastro-esophageal reflux in infants under the age of 1 year.
    


Intervention name(s): Assisted Autogenic Drainage (AAD); bouncing and AAD; bouncing
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastro-esophageal reflux; GOR; GER; airway clearance techniques