bioihbjkbjnl/mcl2 huggingface dataset:
A Study Investigating the Effect of Digesta-Lac in Healthy Adults With Occasional Constipation
Condition: Occasional Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      This investigation will evaluate the effect of Digesta-Lac in adults with occasional
      constipation in a single-center, randomized, double-blind, placebo-controlled, parallel group
      2-arm study for 3 weeks.
    


Intervention name(s): Digesta Lac; Placebo
Intervention type(s): Dietary Supplement; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Probiotic; Digesta-Lac; Occasional Constipation; Constipation
A Dose-Finding Study of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms
Condition: Anxiety Generalized
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, multi-center, randomized, double-blind, parallel-group, dose-finding study
      to assess the effect of 4 doses of MM-120 (25, 50, 100 or 200 μg freebase-equivalent) for the
      treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).
    

Detailed description: 
      The study will enroll approximately 200 male and female subjects 18 years to < 75 years of
      age who meet DSM-5 criteria for GAD and have a minimum HAM-A Total Score of 20. Subjects on
      contraindicated concomitant medications, supplements or other therapeutics at Screening
      (Visit 1) will undergo a medication taper prior to advancing to Baseline (Visit 2).
    

Intervention name(s): MM-120 (LSD D-Tartrate); Placebo
Intervention type(s): Drug; Other
Intervention description(s): A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).; A substance that is designed to have no therapeutic value.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Optimal Training Frequency for Attainment and Maintenance of High-quality CPR on a High-fidelity Manikin
Condition: Simulation Training
Study type: Interventional

Summary: 
      Objectives: The primary objective is to determine the least frequent CPR training interval
      associated with continued performance of guideline-compliant CPR. The secondary objective is
      to determine whether certain physical characteristics, such as age, gender, exercise
      tolerance, height, and weight may be able to identify HCPs at high risk of being unable to
      perform high-quality CPR.

      Design: Randomized trial to compare the effect of different training frequencies on long-term
      CPR performance.

      Participants and setting: Nurses in all adult departments at Health Sciences North. Subjects
      will be randomly assigned to a group that undertakes short CPR assessment and training
      sessions either 1) every month, 2) every 3 months, 3) every 6 months, or 4) every 12 months
      (control group) over the course of a twelve-month period.

      Analysis: The proportion of nurses in each group that is able to perform "excellent CPR" at
      the twelve-month time point will be determined. Excellent CPR is defined as a two-minute CPR
      session where 90% of compressions are performed with correct depth (50-60 mm), 90% with
      correct rate (100-120 /min), and 90% with full chest recoil. A subgroup analysis will also be
      performed where the demographic data of individuals who are unable to perform excellent CPR
      at the twelve-month time point regardless of intervention group are compared against those
      who are successful.

      Conclusion: The results of our study will help determine the longest CPR training interval
      associated with maintenance of high-quality CPR skills to minimize training sessions required
      and decrease associated costs. The results will also generate hypotheses for future study
      about optimizing role assignments and team performance in resuscitation.
    


Intervention name(s): CPR Training
Intervention type(s): Procedure
Intervention description(s): Brief CPR assessment and training done during working hours with real-time performance feedback
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Improvement of Metabolic Health After Thylakoid Supplementation
Condition: Metabolic Syndrome; Obesity
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      Objective:

      The purpose of this study was to investigate the possible effects of green-plant thylakoid
      supplementation to a restricted diet intervention study in overweight to obese men.

      Methods:

      Overweight-obese men (BMI 25 - 35) were treated to a 30 E% restricted diet for one month,
      followed by one month of stabilization. Then they were divided in two treatment arms of one
      month each; one thylakoid-enriched diet (n=10) and one control diet (n=10). Body measurements
      and blood samples were taken throughout the study.
    

Detailed description: 
      Twenty healthy, non-vegetarian, non-smoking Caucasian men were included in the study.
      Inclusion criteria: men aged 40 to 70 years with a BMI of 25 to 35. Exclusion criteria:
      Metabolic disturbances, bariatric surgery, recent diet, food allergies or treatment with
      antibiotics. The study protocol was approved by the Ethical Committee of Lund University,
      Sweden (#2006/361).

      The trial consisted of three periods: 1) diet-restriction period (one month) 2) stabilizing
      period (one month) 3) diet-restriction period with supplementation of thylakoids or placebo
      (one month). The two weight-losing periods included strict diet recommendation with -30
      energy % (E%), and macronutrient composition: 55-65 E% carbohydrates, 10-15 E% protein and
      25-35 E% fat. Sixty minutes of low intensive exercise per day was also required.

      During the stabilizing month participants were instructed to eat a healthy diet to be able to
      keep their achieved weight-loss.

      Day 0, 28, 56 and 84 the participants arrived after 12-hour fasting for blood sampling and
      anthropometric measurements. The blood samples were analyzed for plasma-glucose, insulin,
      HbA1c, inflammation markers, cholecystokinin, ghrelin, total cholesterol, LDL-cholesterol,
      HDL-cholesterol, and triacylglycerol.
    

Intervention name(s): Thylakoids; Control
Intervention type(s): Dietary Supplement; Other
Other intervention name(s): Appethyl; Green-plant membranes; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Quetiapine Augmentation Versus Clomipramine Augmentation of SSRI for Obsessive-compulsive Disorder Patients
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this trial is to compare in an open trial format the efficacy of association
      of clomipramine and quetiapine with SSRI after SSRI treatment failed to produce complete
      remission of obsessive compulsive disorder symptoms.
    

Detailed description: 
      The objective of this trial wis to compare in an randomized open trial format the efficacy of
      association of clomipramine at maximum dosage of 75mg per day and quetiapine at maximum
      dosage of 200mg per day with SSRI after SSRI treatment for 12 weeks failed to produce
      complete remission of OCD symptoms.
    

Intervention name(s): Quetiapine; Clomipramine
Intervention type(s): Drug; Drug
Intervention description(s): Quetiapine once a day at maximum dosage of 200mg per day asociated to a SSRI (maximum dosage of 40mg per day for fluoxetine; 200mg per day for sertraline and 60mg per day for citalopram); Clomipramine once a day at maximum dosage of 75mg per day plus SSRI (maximum dosage of 40mg per day for fluoxetine; 200mg per day for sertraline and 60mg per day for citalopram)
Other intervention name(s): Seroquel; Anafranil
Intervention MeSH terms: Quetiapine Fumarate; Clomipramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obsessive compulsive disorder; pharmacological treatment; quetiapine; clomipramine; SSRI
PlayFit Pilot: Encouraging Social Physical Play in the Community
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The investigator is pilot testing the feasibility and impact of a low-cost intervention that
      uses existing gymnasiums, and therefore has the potential to be replicated across the United
      States. The intervention, PlayFit, is designed for adults aged 21-50. PlayFit has five key
      components, intended to overcome the major barriers to physical activity. First, it will
      assist people in finding others to play with, using the Pick-Up model of designating times to
      play and making those times known in the community. Second, it will overcome a lack of
      confidence in physical activity by including games of lower intensity for relatively unfit
      adults, then building up to moderate and vigorous games. Third, it will require team members
      of varying ages and genders to encourage intergenerational play. Fourth, it will use modified
      equipment (e.g., softer, lighter balls) and smaller game space to require less running, so
      that even relatively unfit people can feel confident participating. Fifth, it will be
      designed to be led by community volunteers, which will increase its disseminability.

      AIM - Understand the optimum design for PlayFit. To meet this aim, the investigators will
      come up with a list of games to play and pilot the games at a gymnasium. The investigators
      will observe the participants playing the games and have them complete a brief survey.
    


Intervention name(s): PlayFit - modified exercise games
Intervention type(s): Behavioral
Intervention description(s): Play modified games with other adults three times a week for 12 weeks. Complete a brief survey on the games played and program satisfaction.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Provocation Study Using Biogenic Amines to Show the Efficacy of Oral Diamine Oxidase Supplementation
Condition: Histamine Intolerance
Study type: Interventional

Summary: 
      This study aims to define a provocation test for histamine intolerance (aka. biogenic amine
      intolerance syndrome) and test the capability of an oral enzyme supplementation to ameliorate
      this condition.
    

Detailed description: 
      The clinical picture of the so-called histamine intolerance has been described by various
      authors since the 1990ies. However, the existence of this multifactorial condition is also
      being contested due to the lack of both a positive definition and unambiguous diagnostics.
      Various provocation studies using pure histamine or histamine-containing foods support the
      existence of the disease pattern, however many questions still remain open.

      A lack of diamine oxidase (DAO) is considered the etiological cause of the condition. DAO is
      an enzyme known to degrade a wide array of biogenic amines. The aim of this study is to
      provoke a response in patients by oral administration of a defined mixture of biogenic
      amines. By administration of DAO before provocation an attenuation of the symptoms is to be
      expected.
    

Intervention name(s): DAOSiN®/ Placebo & ProvokAmin® Ingestion; Drawing blood, measuring BP & pulse
Intervention type(s): Dietary Supplement; Procedure
Intervention description(s): Proband is randomly assigned Daosin® or the Placebo before provocation with ProvokAmin®; Taking of a blood sample and recording of blood pressure & pulse
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: histamine, biogenic amines, diamine oxidase
The Effectiveness of Gain- Versus Loss-framed Health Messages to Improve Oral Health Among Iranian Adolescents
Condition: Health Behavior
Study type: Interventional
Phase: Phase 2

Summary: 
      This study explores the effectiveness of message framing, loss-framed vs. gain-framed
      messages on oral health in Iran.
    

Detailed description: 
      This is a study to explore the impact of two pamphlets with gain-framed and loss-framed
      messages on brushing and flossing attitudes, intentions , behaviors and clinical
      characteristics among a sample of adolescent students.
    

Intervention name(s): Framing (Gain-framed messages); Framing (Loss-framed messages)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The adolescents will randomly assign to three groups: gain-framed message and loss- framed message. Each group of adolescents will read the respective pamphlets with the exception of the control group. The gain-framed pamphlet contains six positive messages with three related full-color images(6.1 X 4.5). The gain-framed pamphlet, entitled The Benefits of good oral hygiene", emphasizes the benefits of brushing, and flossing.; The adolescents will randomly assign to three groups: gain-framed message , loss- framed message and a control group. Each group of adolescents will read the respective pamphlets with the exception of the control group.
The loss-framed pamphlet contains six negative messages with three related full-color images (6.1 X 4.5). The loss-framed pamphlet, entitled The disadvantages of poor oral hygiene, emphasizes the costs of not brushing and flossing.
Other intervention name(s): designing persuasive messages
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: oral health; dental brushing; dental flossing
Changes of GCF Levels of RANKL and Osteoprotegerin in Postmenopausal Osteoporosis
Condition: Chronic Periodontitis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators evaluated the effect of initial periodontal treatment on clinical findings
      and receptor activator of Nuclear Factor-kappa B ligand (RANKL) and osteoprotegerin (OPG) in
      gingival crevicular fluid (GCF) of patients with osteoporosis under bisphosphonate therapy
      within 12 months' follow-up. Clinical recordings and GCF were obtained from postmenopausal
      women; with chronic periodontitis and osteoporosis (Group A, n=13), with chronic
      periodontitis and no osteoporosis (Group B, n=12), without chronic periodontitis and
      osteoporosis (Group C, n=12), systemically and periodontally healthy controls (Group D, n=10)
      at the baseline. Recordings were repeated at the 1st, 6th and 12th months in Group A, B and
      C. RANKL and OPG values were measured by enzyme-linked immunosorbent assays.
    

Detailed description: 
      The study groups were selected from postmenopausal patients those referred to Department of
      Endocrinology, School of Medicine, Ondokuz Mayis University. Bone mineral density (BMD)
      measurements were performed by dual energy-X-ray absorptiometry from L1-L4 site of lumbar
      vertebra and/or femur (g/cm2). Osteoporosis was defined as T scores less than -2.5 at L1-L4,
      femur neck or total femur. Women with T scores less than -2.5 (groups A and C) were started
      on bisphosphonate treatment after their initial periodontal examination.
    

Intervention name(s): periodontal phase 1 therapy; gingival crevicular fluid collection; zoledronic acid
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia and gingival crevicular fluid collection by the same investigator.; gingival crevicular fluid collection by periopapers; 5 mg/year zoledronic acid (i.v.)
Intervention MeSH terms: Zoledronic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Screening
Keywords: Bisphosphonate; osteoporosis; RANKL; OPG; periodontitis
To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.1% and RLD in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.
    

Detailed description: 
      A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing
      TRETINOIN CREAM, 0.1% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.1%
      (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne Vulgaris
    

Intervention name(s): Tretinoin cream 0.1%; RETIN-A® Cream; Vehicle of the test product
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.); RETIN-A® (Tretinoin) Cream (Valeant); Vehicle for Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)
Other intervention name(s): Tretinoin; Tretinoin; Placebo
Intervention MeSH terms: Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to explore the cardiac pharmacodynamics, safety and tolerability
      of MT-1303 in healthy subjects.
    


Intervention name(s): MT-1303-Low; MT-1303-High; Fingolimod; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Fingolimod Hydrochloride
Prednisolone Novel Endpoint Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      Prednisolone will be used as a model medication to identify new clinical outcomes for future
      evaluation of new therapies in short-term studies (up to 4 weeks) in patients with Chronic
      Obstructive Pulmonary Disease (COPD).
    


Intervention name(s): Prednisolone
Intervention type(s): Drug
Intervention MeSH terms: Prednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: CT scan; breathing tests; lung function tests; biomarkers; prednisolone; IOS; COPD; clinical outcomes
Clinical Investigation of Wireless Transmission of Invasive Blood Pressure Signal
Condition: Multiple Trauma; Shock; Atrial Fibrillation; Perioperative/Postoperative Complications
MeSH terms: Atrial Fibrillation; Postoperative Complications; Multiple Trauma
Study type: Observational

Summary: 
      The purpose of this study is to determine whether wireless transmission of invasive arterial
      blood pressure signal (by HMW 10 Wireless System) from patient to patient's bedside monitor
      is feasible, safe and as accurate as conventional cable connection.
    

Detailed description: 
      The technology for invasive arterial blood pressure measurement in emergency room, operating
      theater, recovery room and intensive care unit is well established and uses pressure sensor
      connected via cable to patient's bedside monitor. The wireless sensors result in reduction of
      wires attached to the patient and may enhance nursing, treatment and transportation of
      patients in aforementioned setting.

      The HMW 10 Wireless System was developed and incorporates wireless transmission of patient's
      signal. The purpose of the study was to measure the quality of data transmitted through the
      HMW 10 Wireless System, and to demonstrate that the quality of the data meets the
      requirements of European Directive 93/42/EEC (Medical Device Directive - MDD) and EN/IEC
      60601-1 and EN/IEC 60601-2-34.
    

Intervention name(s): Wireless invasive blood pressure monitoring (Hybymed® Wireless IBPM System)
Intervention type(s): Device
Intervention description(s): The readings of invasive arterial pressure were obtained from 2 identical pressure transducers, connected to a common arterial line via a Y connector. Data was collected from one transducer via a direct cable connection and from the second transducer via wireless transmission of the signal to the patient's bedside monitor using the HMW 10 Wireless System.
A comparison of data received by patient's bedside monitor from the two transducers was done (standard connection vs. wireless connection), as well as a comparison of data collected by the transmitter and data received by the receiver of the HMW 10 Wireless System.
Other intervention name(s): Hybymed® Wireless IBPM System HMW10. Hyb d.o.o., Slovenia
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Critically ill patients
      
Keywords: Invasive blood pressure monitoring; Intensive care unit; Wireless Technology
Acute Effects of a Non Excitatory Cardial Stimulation
Condition: CCM Implantation
Study type: Interventional

Summary: 
      Electric stimulation by cardial contractility modulation (CCM)to improve contractility and
      physical capacity
    


Intervention name(s): Blood sample
Intervention type(s): Other
Intervention description(s): Taking of blood sample
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science