bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of GRT9906 Tablets Compared to Placebo in Patients With Fibromyalgia
Condition: Primary Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The study was performed in participants suffering from fibromyalgia and investigated efficacy
      after treatment with several doses of GRT9906 versus placebo. Furthermore, it was to be found
      out if treatment with GRT9906 was safe and well-tolerated.
    

Detailed description: 
      This Phase 2 study had a randomized, multi-center, double-blind, placebo-controlled,
      crossover, multiple-administration design.

      The objectives of the study were the following:

        -  To assess the multiple-dose analgesic efficacy and safety of an oral prolonged-release
           (PR) tablet formulation of GRT9906 at daily doses between 80 and 240 milligrams (mg) in
           comparison to placebo in participants with moderate to severe pain due to primary
           fibromyalgia syndrome (FMS).

        -  To compare the tolerability of multiple-dose GRT9906 PR to placebo in participants with
           primary FMS.

        -  To generate data that could be used, in combination with data from other studies, to
           explore the population pharmacokinetic analysis and pharmacokinetic/pharmacodynamic
           (PK/PD) properties of GRT9906 PR.

      The study consisted of 5 phases:

        1. Enrollment including tapering, if necessary, and washout (at least 1 week) of previous
           medication.

        2. First treatment period with 1-week titration and 5-weeks dosing on participant's last
           well-tolerated titration dosage.

        3. Interim washout period of at least 1 week.

        4. Second treatment period with 1-week titration and 5-weeks dosing on participant's last
           well-tolerated titration dosage.

        5. Final washout period of at least 1 week, terminated by a Follow-up Visit.
    

Intervention name(s): GRT9906; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One prolonged-release tablet containing 40 mg of GRT9906; Placebo matching GRT9906 tablets
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This dose-titration study was conducted with randomized, multi-center, double-blind, placebo-controlled, crossover design and multiple administrations in 2 treatment sequences in treatment periods 1 and 2: Sequence GRT9906-Placebo and sequence Placebo-GRT9906.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic pain
Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis
Condition: NASH - Nonalcoholic Steatohepatitis; Diabetes Mellitus, Type 2; Hyperlipidemias
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2; Hyperlipidemias
Study type: Interventional

Summary: 
      Effects of Wheat-based diet vs. ATI-free diet on NASH
    

Detailed description: 
      40 patients with the diagnosis of a non-alcoholic- steatohepatitis (NASH) will be recruited
      at the University Hospitals of Mainz and Frankfurt. Patients are assessed with regards to
      their diet using standardized questionnaire and nutritionists.

      Patients will be randomized into two parallel groups. The first group will continue a
      wheat-based Nutrition, while the second Group will receive dietary counselling to achieve an
      ATI-free nutrition, trying to reduce the daily ATI consumption.

      The clinical trial will run over 16 weeks including 4 visits at the study center. Study
      visits include physical examinations, blood-based parameters, cytokines and urine samples, as
      well for the analysis of the intestinal microbiome by using stool samples. In addition the
      patients have to complete dietary and health-related quality of life (HRQL) questionnaires.
      Visits are planned at baseline, W4, W8 and W16.
    

Intervention name(s): Nutritional Intervention
Intervention type(s): Other
Intervention description(s): Dietary Counselling
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective, randomized, controlled, bicentric pilot study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hepatic inflammation
The Effects of Unilateral Balance Training Among Athletes With Chronic Ankle Instability
Condition: Ankle Injuries; Ankle Sprains
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      The aim of the study is to investigate the effects of a 4-week, unilateral balance exercise
      training program on bilateral balance and explosive power in athletes with chronic ankle
      instability. The participants were randomly divided into Stable Ankle Training Group (SG)
      (n=9), Unstable Ankle Training Group (UG) (n=9) and control group (CG) (n=10). The balance
      exercise training program was administered for only the stable ankle of athletes in SG and
      only the unstable ankle of athletes in UG, twice a week and for a 4-week duration.
    

Detailed description: 
      The aim of the study is to investigate the effects of a 4-week, unilateral balance exercise
      training program on bilateral balance and explosive power in athletes with chronic ankle
      instability (CAI). The study included 28 volunteer athletes with a history of CAI who
      registered as a team player at Yeditepe University Culture and Sports Directorate February
      2019 - June 2019. The severity of functional ankle instability of all the athletes was
      assessed by the Cumberland Ankle Instability Tool (CAIT). Functional limitations of the
      athletes with CAI were evaluated by Foot and Ankle Ability Measure Activity of Daily Living
      Subscale (FAAM-ADL) and Sports Subscale (FAAM-S). Balance Error Scoring System (BESS) was
      used to determine the static balance performance of athletes. Dynamic balance was evaluated
      by the Y Balance Test (YBT). Sport performance including vertical jumping and hopping was
      assessed with Single-Legged Countermovement Jump (CMJ) Test, Figure-of-Eight Hop Test, and
      Side Hop Test. The athletes were randomly divided into Rehabilitation for the Stable Ankle
      Group (SG) (n=9), Rehabilitation for the Unstable Ankle Group (UG) (n=9) and Control Group
      (CG) (n=10). Athletes in SG and UG were included balance exercise training program. The
      balance exercise training program was administered for only the stable ankle of athletes in
      SG and only the unstable ankle of athletes in UG, twice a week and for a 4-week duration.
    

Intervention name(s): Balance Exercise Training for Stable Ankle; Balance Exercise Training for Unstable Ankle
Intervention type(s): Procedure; Procedure
Intervention description(s): Balance and hop stabilization exercises were administered for 30 minutes of each exercise session.; Balance and hop stabilization exercises were administered for 30 minutes of each exercise session.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The sample of the study consists of athletes with a history of CAI who registered as a team player at Yeditepe University Culture and Sports Directorate between February 2019 and June 2019.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ankle, joint instability, cross-education, rehabilitation
Motivational Enhancement to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse - 1
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the therapeutic usefulness of incorporating
      Motivational Enhancement Treatment into the standard drug abuse treatment entry process of
      Community Treatment Programs on improving treatment engagement, retention, and outcome.
    

Detailed description: 
      Participants seeking treatment at the participating CTPs will be randomly assigned to either
      "standard" or "MET/MI" treatment, with a 1- and 3-month follow-up. Primary outcome measures
      will include (1) treatment retention (e.g., number of sessions/weeks completed, the rate of
      patients completing 3 or more subsequent sessions, and (2) substance use (e.g., urinalyses,
      days of opioid, cocaine, marijuana, alcohol use, rates of abstinence). Secondary outcomes
      will include motivation, psychosocial functioning, HIV risk behaviors, treatment utilization,
      and patient satisfaction. Process assessments will include measures of the working alliance
      as well as therapist adherence/competence ratings which will evaluate how effectively MET/MI
      was implemented. Participating CTPs will implement one of two independent protocols,
      depending on which is the best suited or feasible for the intake procedures at their clinic.
      Thus, following an invitation to participate, explanation of the study, and provision of
      informed consent, patients would complete a brief assessment battery followed by either: 1)
      Random assignment to 3 individual sessions of standard treatment (treatment as usual) at the
      program versus 3 individual sessions of MET. or 2) Random assignment to 1 individual standard
      assessment/evaluation session.
    

Intervention name(s): Behavior Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Treatment
Keywords: substance use disorder
Lidocaine Spray vs Coughing for Pain Relief During Colposcopy
Condition: Colposcopy
MeSH terms: Cough
Study type: Interventional

Summary: 
      Cervical cancer is the third most common genital cancer worldwide. The diagnosis of cervical
      cancer is performed with the cervical biopsy which is guided by the colposcopy. The
      colposcopy guided cervical biopsy creates pain and several methods have been reported to
      overcome the pain related with this procedure. Local anesthetic agent injection into the
      cervix has been studied and found to be effective and also, forced coughing was compared with
      local anesthetic injection and it is found to be more effective. In fact local injections can
      create the pain by itself.However no study compared the effect of forced coughing to local
      anesthetic spray. The study aims to evaluate the comparison of forced coughing with local
      anesthetic spray with respect to perceived pain during colposcopy guided biopsy.
    


Intervention name(s): local lidocaine spray; forced coughing
Intervention type(s): Drug; Other
Intervention description(s): The lidocaine spray will be introduced to the cervix just before the biopsy procedure; The patients will be asked to forced coughing during the biopsy procedure
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: colposcopy; pain; coughing; anesthetic spray
A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to evaluate the safety and tolerability of single
      ascending doses of UCB7853 in healthy male study participants and to evaluate the safety and
      tolerability of multiple ascending doses of UCB7853 administered in study participants with
      Parkinson's Disease (PD)
    


Intervention name(s): UCB7853; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Subjects will receive UCB7853 at pre-specified time-points.; Subjects will receive Placebo at pre-specified time-points.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Parkinson's Disease; Phase 1; Healthy Volunteers; Patients
Ambu Aura-i and Air-Q Intubating Laryngeal Airways as a Conduit for Tracheal Intubation in Children
Condition: Tracheal Intubation in Children
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether there is a clinically relevant difference
      in time to tracheal intubation when using fiberoptic bronchoscope as a guide to intubate
      through the Ambu Aura-i or air-Q ILA.
    

Detailed description: 
      The goal of this prospective randomized study is to compare the Ambu Aura-i and air-Q ILA in
      children with normal airway anatomy, in order to evaluate the effectiveness of fiberoptic
      tracheal intubation through these two devices. The ease of placement, fiberoptic grade of
      laryngeal view, time to tracheal intubation, time for device removal after intubation, and
      peri-operative complications will also be assessed.
    

Intervention name(s): Ambu Aura-i size 1.5; air-Q ILA size 1.5; Ambu Aura-i size 2; air-Q ILA size 2
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed; Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed; Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed; Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Keywords: laryngeal mask airway; children; tracheal intubation; fiberoptic bronchoscopy
A Controlled Study of Olanzapine in Children With Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 12-week study which investigates the use of olanzapine to decrease disruptive
      behaviors sometimes associated with Autism in children, aged 3 to 12 years old. The first six
      weeks of the study are double-blind and placebo controlled, meaning that patients receive
      either placebo or olanzapine, and that neither the researchers nor the patients know whether
      or not they are receiving placebo or olanzapine. In the second six weeks all of the patients
      receive olanzapine. The purpose in using placebo is that it is otherwise impossible to know
      how effective the drug is or whether or not the drug causes side effects. Patients treated
      with placebo can have improvement and can have side effects. In the study patients receive a
      psychiatric evaluation, physical examination, laboratory tests, and study medication
      (olanzapine or placebo), free of charge.
    


Intervention name(s): olanzapine (Zyprexa); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Olanzapine tablets given po at a dosage of 2.5 - 20 mg per day for up to 12 weeks.; Matching Placebo
Other intervention name(s): Antipsychotic Drug; Placebo controlled
Intervention MeSH terms: Olanzapine; Antipsychotic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Pervasive Developmental Disorder; Treatment; Olanzapine; Antipsychotic
Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection
Condition: Postoperative Analgesia; Pain, Postoperative; Opioid Consumption
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Breast cancer is the most common type of cancer in women. Mastectomy and axillary lymph node
      disection are commonly performed as part of the cancer management. This surgery can cause
      significant postoperative pain. The serratus plane block (SPB) has been described for
      analgesia of the hemithorax and reported for many cases such as thoracoscopy, shoulder
      arthroscopy, breast surgery and axillary lymph node dissections. Serratus plane block may be
      a viable alternative to current regional anaesthetic techniques such as thoracic
      paravertebral and central neuraxial blockade.

      The aim of this study is to determine effectiveness of ultrasound guided superficial serratus
      plane block in patients undergoing modified radical mastectomy and axillary lymph node
      dissection surgery.
    


Intervention name(s): Bupivacaine; Saline; Ultrasound
Intervention type(s): Drug; Drug; Device
Intervention description(s): 30 ml %0,25 bupivacaine; 2 ml saline subcutaneously; Ultrasound guided block
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Superficial Serratus Plane Block; Modified Radical Mastectomy; Axillary Lymph Node Disection; bupivacaine
Arabic Gum-Absorption Study
Condition: Bioavailability
Study type: Interventional

Summary: 
      Previous studies have indicated that menaquinone-7 (MK-7) is the most effective form of
      vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7, but
      its taste is not appreciated by the Western society. For this reason, the active biological
      compound has been manufactured as enriched oil or casein (≈80% of proteins in cow's
      milk)-enriched powder. However, cow's milk allergy is the most common cause of food allergy
      affecting a minimum of 2-3% of infants. The investigators will therefore compare this
      protein-delivery system to an alternative delivery system (Arabic gum; 98% polysaccharides).
      To compare the difference between powder and oil as MK-7 delivery vehicle, the investigators
      will also test the efficacy of enriched linseed oil.
    


Intervention name(s): menaquinone-7 from casein capsules; menaquinone-7 from arabic gum capsules; menaquinone-7 from linseed oil capsules
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 90 µg menaquinone-7 daily during 8 weeks; 90 µg menaquinone-7 daily during 8 weeks; 90 µg menaquinone-7 daily during 8 weeks
Intervention MeSH terms: Vitamin K 2; Vitamin K; Menaquinone 7; Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: vitamin K2; absorption; efficacy
REducing Blood Pressure Variability in Essential Hypertension With RAmipril vErsus Nifedipine GITS Trial
Condition: Hypertension; High Blood Pressure Variability
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is

        1. to compare the effects of nifedipine GITS and ramipril on blood pressure variability in
           subjects with elevated blood pressure variability.

        2. to assess whether the degree of treatment-induced changes in blood pressure variability,
           is related to the degree of regression (or progression) of organ damage in heart,
           kidneys and carotid arteries.
    

Detailed description: 
      Elevated blood pressure variability (BPV) is associated with adverse cardiovascular outcomes
      and organ damage in hypertensive subjects. An antihypertensive treatment able to reduce BPV
      independently of BP lowering effect might thus provide additional protection in terms of
      cardiovascular risk in subjects with elevated BPV, independently on its effect of BP itself.
      However, data on the effects of different classes of antihypertensive drugs on BPV are
      limited and inconsistent. Some studies have suggested a possible usefulness of calcium
      antagonists in this setting. Based on the above considerations the investigators hypothesize
      that a calcium channel blocker nifedipine GITS, will provide a greater BPV lowering effect,
      when compared with ramipril, independently from the reduction in mean BP level. Based on the
      above considerations, the primary objective of this study is to compare the effects of
      nifedipine GITS and ramipril on different estimates of BPV (24 h BPV, home BPV, and
      visit-to-visit BPV) in subjects with elevated BPV. The secondary objective is to assess
      whether the degree of treatment-induced changes in BPV, is related to the degree of
      regression (or progression) of organ damage, after accounting for mean BP reduction by
      treatment.
    

Intervention name(s): Nifedipine GITS; Ramipril
Intervention type(s): Drug; Drug
Intervention description(s): Commercially available drug formulations are used. Study medication will be assumed in a single morning (7-10 a.m.) administration per os.; Commercially available drug formulations are used. Study medication will be assumed in a single morning (7-10 a.m.) administration per os.
Intervention MeSH terms: Ramipril; Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension; Blood pressure variability; Home systolic blood pressure; Organ damage; Nifedipine GITS; Ramipril
Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice
Condition: Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      In situ study to compare treatment effect on enamel remineralization potential, measured by
      surface microhardness recovery (SMHR) and Enamel Fluoride Uptake (EFU). The study will
      explore the efficacy of an experimental sodium monofluorophosphate (SMFP) dentifrice
      containing calcium sodium phosphosilicate (CSP) in comparison to an experimental SMFP only
      dentifrice.
    


Intervention name(s): Calcium sodium phosphosilicate; Sodium monoflurophosphate; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CSP high percentage weight by weight; 500 to 1500 parts per million (ppm) of fluoride; No CSP and no fluoride
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment