bioihbjkbjnl/mcl2 huggingface dataset:
Suspension of Falciform Ligament During Mini Gastric Bypass
Condition: Upper GIT Surgery
Study type: Interventional

Summary: 
      The falciform ligament is hanging down in the upper abdomen and usually impede the work
      during laparoscopic upper GIT surgery, especially in obese patient, so the aim of this study
      is to evaluate the impact of routine suspension of falciform ligament during mini gastric
      bypass, which is advanced laparoscopic procedure, by comparing the outcomes in 2 groups of
      patient in the fist group the investigators will routinely suspend the falciform ligament and
      the other group the investigators will working without suspension
    

Detailed description: 
      The falciform ligament is hanging down in the upper abdomen and usually impede the work
      during laparoscopic upper GIT surgery, especially in obese patient, so the aim of this study
      is to evaluate the impact of routine suspension of falciform ligament during mini gastric
      bypass, which is advanced laparoscopic procedure, by comparing the outcomes in 2 groups of
      patient in the fist group the investigators will routinely suspend the falciform ligament and
      the other group the investigators will working without suspension
    

Intervention name(s): Falciform ligament suspension; no suspension
Intervention type(s): Procedure; Procedure
Intervention description(s): routine of falciform ligament suspension during Mini gastric bypass; working without of falciform ligament suspension during Mini gastric bypass
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety of MMFS in Early AD
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the safety and efficacy of MMFS for improving cognition
      and global function in patients with probable Early Alzheimer's disease.
    

Detailed description: 
      This is a phase 2 study in patients with probable Early Alzheimer's disease (AD). Early AD
      includes Stage 3 AD patients (MCI due to AD) and Stage 4 AD patients (mild AD). The study is
      a randomized, double-blind, placebo controlled, parallel group design, in which participants
      (up to 6 per arm; 12 total) will receive oral placebo or MMFS twice daily for 24 weeks.
      Randomized patients and their informants (required) will complete 3 assessments total: at
      baseline (prior to taking any study tablets), week 12, and week 24 visits. At each of the
      three visits, participants will complete cognitive and behavioral measures and clinical
      interviews, a blood sample will be collected for safety and biomarkers related to Alzheimer's
      disease, and the informant will complete an interview concerning the patient's cognition,
      mood, and function. A range of safety and tolerability assessments will also be performed
      (including vital signs, laboratory tests, and ECGs). Participants will be contacted by phone
      between clinical assessments for monitoring.
    

Intervention name(s): MMFS-205-SR; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Twice daily, oral, 500 mg tablets; Twice daily, oral
Other intervention name(s): L-threonic acid magnesium salt, L-TAMS; Inactive sugar pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Study of Expectorant Activity of Oral N-acetylcystein (NAC) in Patients With Stable Chronic Bronchitis
Condition: Chronic Bronchitis
MeSH terms: Bronchitis; Bronchitis, Chronic; Acute Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randonmized, masked, placebo-controlled parallel group, clinical trial to evaluate
      the effects of three different doses of N-acetyl L-cysteine (NAC) and placebo on patient
      safety and on physical and transport properties of expectorated sputum. Patient sumptoms,
      quality of life and exacerbation will also be followed as well as pulmonary function testing
      and functional exercise capacity. We hypothesized that a prolongeed course of oral NAC
      favorably affects the morbidity of chronic bronchitis, particularly the incidence of acute
      exacerbations.
    


Intervention name(s): Oral N-acetycystein (NAC)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Chronic Bronchitis; N-acetylcysteine (NAC); Quality of Life; Mucus
Comparison of the Vocal Cord Imaging Techniques After Thyroidectomy
Condition: Thyroid Nodule
MeSH terms: Thyroid Nodule
Study type: Interventional

Summary: 
      Recurrent nerve palsy is a complication of thyroidectomy. Most surgeons want to visualize the
      vocal cords after tyroidectomy. The aim is to compare the direct laringoscopy,
      videolaringoscopy, fiberoptic laringoscopy and ultrasonography methods in terms of efficacy,
      duration and hemodynamic responses during the procedure.
    

Detailed description: 
      The vocal cord will be visualised after the extubation with one of the following methods:

      direct laringoscopy videolaringoscopy fiberoptic laringoscopy ultrasonography The of efficacy
      of the method (0= not able to visualize the vocal cords, 1= the vocal cords were visualized)
      duration of the procedure and hemodynamic responses (heart rate, mean arterial pressure)
      during the procedure will be compared between the groups.
    

Intervention name(s): direct laringoscopy; fiberoptic nasal laringoscopy; ultrasonograph
Intervention type(s): Device; Device; Device
Intervention description(s): the vocal cords will be visualized after extubation with direct laringoscopy; the vocal cords will be visualized after extubation with fiberoptic nasal laringoscopy; the vocal cords will be visualized after extubation with fiberoptic ultrasonography
Other intervention name(s): direct laryngoscopy; fiberoptic laryngoscopy; ultrsonography
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Spiration Valve System for the Treatment of Severe Emphysema
Condition: Empyhsema; Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Chronic Disease; Emphysema
Study type: Interventional

Summary: 
      This is a multicenter, prospective, randomized, controlled study being conducted in China to
      evaluate improvement of lung function after treatment with the Spiration Valve System as
      compared to medical management in the control group. The control group will be evaluated in
      the same manner as the treatment group.

      The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the
      airways of one lung. It is used to redirect air from the less healthy to the more healthy
      parts of the lung. This helps to reduce over-inflation and may improve overall lung function
      and quality of life for people living with emphysema.
    


Intervention name(s): Spiration Valve System; Medical Management
Intervention type(s): Device; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endobronchial Valves; Intrabronchial Valves; Bronchial Valve; Chronic Obstructive Pulmonary Disease; COPD; Pulmonary Disease, Chronic Obstructive; Bronchoscopic Lung Volume Reduction; BLVR; TLVR; Emphysema; Pulmonary Emphysema; Pathologic Process; Lung Diseases; Respiratory Tract Disease; China; Spiration Valve System (SVS)
Collection of Blood and Bone Marrow From Healthy Volunteers and Patients for Research Purposes
Condition: Bone Marrow Diseases; Healthy Volunteers
MeSH terms: Bone Marrow Diseases
Study type: Observational

Summary: 
      This study is designed to provide bone marrow and/or blood cells for other research studies.
      Patients participating in this study will be asked to provide small amounts of medical
      information and undergo a limited physical examination designed to detect the presence of any
      obvious blood disease. A blood and bone marrow sample will be obtained to verify that the
      patient has normal blood cell production.

      Researchers plan to obtain bone marrow samples to be used in laboratory studies directed
      toward understanding the formation of blood cells. Bone marrow samples will be taken from the
      hip bone of patients and healthy volunteers.

      These samples are valuable to many research studies within the Hematology Branch of the
      National Heart, Lung, and Blood Institute, including studies of normal and abnormal
      production of blood cells, the viral causes of blood diseases, and the role of the immune
      system in bone marrow failure and related conditions....
    

Detailed description: 
      This protocol defines in general terms the purposes for which blood and bone marrow specimens
      will be collected by members of the Hematology Branch and the conditions under which the
      sampling will be performed. Samples of blood and bone marrow from healthy volunteers and from
      patients are indispensable for many research projects, including studies of normal and
      abnormal hematopoiesis, the viral etiology of blood diseases, and the role of the immune
      system in marrow failure and related conditions.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Normal Volunteers and patients
      
Keywords: Bone Marrow; Hematopoiesis; DNA; RNA; Viruses
Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women
Condition: HIV Infections
MeSH terms: Infections; HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a double-blind, randomised, placebo-controlled study to assess the safety and
      efficacy of a silicone elastomer vaginal matrix ring.
    

Detailed description: 
      A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness
      Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in
      Women." MTN-020 will enroll approximately 3676 sexually active HIVnegative women aged 18-45
      years randomized in a 1:1 ratio to receive either a vaginal ring containing 25 mg of
      dapivirine or a placebo vaginal ring. Rings will be inserted once every 28 days for 12
      consecutive months. MTN expects to initiate this study in August 2012.
    

Intervention name(s): Dapivirine Vaginal Ring; Placebo Ring
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months; Vaginal ring containing no drug substance
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV Infections; Anti-HIV agents; HIV-1
A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this trial is to investigate the safety, tolerability and efficacy
      of BI 655130 in patients with Atopic Dermatitis (AD) following repeated intravenous
      administrations compared to placebo.
    


Intervention name(s): BI 655130; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for infusion; Solution for infusion
Other intervention name(s): Spesolimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Tolerability of Riluzole in Treatment Resistant Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to examine the antidepressant efficacy of riluzole, employing a randomized,
      double-blind, placebo-controlled, adjunctive trial in treatment-resistant major depressive
      disorder (TRD).
    

Detailed description: 
      This study aims to examine the antidepressant efficacy of riluzole, employing a randomized,
      double-blind, placebo-controlled, 8 week trial of adjunctive trial in treatment-resistant
      major depressive disorder (TRD). Preclinical studies have shown riluzole to modulate Glu
      release and clearance, and to have potent neuroprotective properties, promoting
      neuro-resiliency. Other preclinical data now also show the drug to have antidepressant-like
      effects in rodent models used to screen for antidepressant activity. In addition, several
      small open-label clinical studies further suggest riluzole has antidepressant and anxiolytic
      properties, even in patients who do not respond to standard monoaminergic antidepressant and
      anxiolytic medications.
    

Intervention name(s): Riluzole; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Riluzole 100mg PO; placebo
Other intervention name(s): Rilutek
Intervention MeSH terms: Riluzole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MDD; Depression; Treatment refractory; Glutamate; Riluzole; Major depressive disorder; psychopharmacology; rilutek
A Clinical Analysis of Bella Blankets® Protective Coverlets
Condition: Screening Mammogram
Study type: Interventional

Summary: 
      This study will collect and compare clinical image quality measurements of randomly
      scheduled, asymptomatic, screening mammography patients, right breast mammogram performed
      with and without the use of Bella Blankets protective coverlets on the receptor plate.

      The measurements will determine if the use of Bella Blankets protective coverlets increases
      the mammogram's clinical image quality and if Bella Blankets protective coverlets can be used
      as an aid for EQUIP compliance.

      In addition, a patient satisfaction survey will be conducted with participants to determine
      if the use of Bella Blankets protective coverlets improves patient satisfaction.
    


Intervention name(s): Bella Blankets protective coverlets
Intervention type(s): Device
Intervention description(s): Bella Blankets protective coverlets is a Class II 510(k) Cleared (2008) single-use, adhering, non-woven fabric sheet applied to the mammography equipment receptor plate to provide a more comfortable mammogram.
Intervention model: Single Group Assignment
Intervention model description: Participants will be female, asymptomatic patients randomly scheduled for a screening mammogram.
Masking: None (Open Label)
Primary purpose: Supportive Care
A Sub-study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
Condition: Non-Alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this sub-study of MB130-045 is to determine the pharmacokinetic effects,
      pharmacodynamic effects, efficacy and safety of BMS-986036 20 mg QD in subjects with
      Non-alcoholic Steatohepatitis (NASH)
    


Intervention name(s): BMS-986036; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BMS-986036 20 mg QD; Placebo QD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: First Line Therapy; NASH
Exploring the Effects of Aquatic Exercise on Cardiovascular Function in Older Adults
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      Cardiovascular ageing is implicated in the development of cardiovascular disease (CVD).
      Aquatic exercise is being considered as a co-adjuvant form of rehabilitation, but there is
      limited evidence for its cardiovascular risk-reduction properties for older people. Our study
      aims to address this by exploring the cardiovascular effects of long-term aquatic exercise in
      older adults in comparison to those who are either inactive or engaged in land-based/mixed
      training by measurement of micro- and macro-circulation.
    


Intervention name(s): Aquatic exercise
Intervention type(s): Procedure
Intervention description(s): Participants belonging to Group D (sedentary group) will be randomised 1-to-1 between remaining sedentary (n=20) and following a self-managed, 8-week, aquatic-based exercise programme (n=20). The latter group will be offered an 8-week access to pool facilities. For Group D participants, all baseline assessments will be repeated at 8 weeks.
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Group A (n=20) consists of participants engaging in swimming or other aquatic, primarily
        aerobic-based, training regimes for more than 2 times a week, for more than 6 months, at
        the time of the assessments. Similarly, Group B (n=20) consists of participants engaging in
        land-based, primarily aerobic training regimes (e.g. aerobic exercise) for more than 2
        times a week, for a period longer than 6 months, at the time of the assessments. Group C
        (n=20) consists of participants who were cengaging in both land-based and aquatic,
        primarily aerobic, exercise regimes on an equal basis, for more than 6 months, while Group
        D (n=40) consists of people who were sedentary (e.g., defined as undertaking less than 60
        min of structured/planned physical activity per week), for a period longer than 6 months.
Activity Wristband-based Intermittent Teaching Unit and Students Physical Activity and Its Psychological Mediators
Condition: School
Study type: Interventional

Summary: 
      Objective: The main objective of the present study was to examine the effects of an
      intermittent teaching unit based on the use of activity wristbands and behavior modification
      strategies on high school students perceptions of autonomy support, satisfaction of basic
      psychological needs, motivation toward Physical Education and physical activity, intention to
      be physically active, and habitual physical activity levels.

      Materials and methods: An initial sample of 353 high school students (final sample = 175;
      45.7% females; mean age = 13.3 ± 1.2 years) from two public high schools were
      cluster-randomly assigned into the intermittent (n = 100) and control (n = 75) groups. The
      intermittent group performed an intermittent teaching unit twice a week for eight weeks.
      Specifically, the last 15 minutes of each lesson were used. As the main strategy to promote
      the practice of regular physical activity, students wore an activity wristband the whole day
      during the intervention period. Additionally, other behavior modification strategies were
      also applied (e.g., educational counseling, physical activity goals or reminders). The
      control group also performed two Physical Education sessions a week during the intervention
      period, but without using wristbands or other behavior modification strategies. Before and
      after the intervention, as well as at the end of the follow-up period (six weeks), students'
      physical activity practice mediators and physical activity levels were measured by validated
      questionnaires.
    


Intervention name(s): Intermittent teaching unit; No intervention group
Intervention type(s): Other; Other
Intervention description(s): The intermittent group students performed an intermittent teaching unit twice a week for eight weeks aimed at promoting healthy physical activity habits. Specifically, the last 15 minutes of each lesson were used. The rest of lessons' time other contents were worked on with no relation to any health physical activity habit (i.e., acrosport, badminton, basketball, volleyball, soccer and athletics).; The control group students also carried out two Physical Education lessons a week during the intervention period. During these lessons, contents of handball, basketball, alternative sports and traditional games were developed. However, this group did not wear physical activity activity wristbands or receive any behavior modification specific strategy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Evaluate the Clinical Efficacy of Whole Body Cryotherapy in the Cryosense Cabin for the Treatment of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effectiveness of an intervention with sessions of 3
      minutes of whole body cryotherapy (WBC) in the Cryosense cabin. Measurement period time: 8
      weeks.
    

Detailed description: 
      The aim of this study is to evaluate the effectiveness of an intervention with sessions of 3
      minutes of whole body cryotherapy (WBC) in the Cryosense cabin, on the main clinical
      manifestations of patients with Fibromyalgia (FM).

      A randomized, open and crossed 8-week clinical trial comparing a WBC intervention with the
      waiting list control group. Patients diagnosed with FM according to ACR 2010 criteria, in
      treatment and regular follow-up recruited consecutively. Two groups were made, one of
      intervention and one of waiting list which served as control during the first phase. At the
      end of the first phase, and after a week of washout, the groups crossed and went on to carry
      out the second phase following the opposite intervention. The pharmacological treatment was
      not modified during the entire study.

      Trial endpoints were changed in pain after 2 and 4 weeks, measured by a visual analogue scale
      (VAS) and burden of disease, evaluated by the Fibromyalgia Impact Questionnaire(FIQ).
    

Intervention name(s): Whole body cryotherapy sessions
Intervention type(s): Device
Intervention description(s): Whole body cryotherapy (WBC) 10 sessions of 3 minutes at a temperature of -196ºC (point of evaporation of liquid nitrogen), on the basis of three sessions a week.Fills in questionnaires.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants received WBC sessions and after that become controls
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fibromyalgia, Whole body cryotherapy