bioihbjkbjnl/mcl2 huggingface dataset:
Study In Patients With Depression Not Responding to Selective Serotonin Re-uptake Inhibitors
Condition: Depressive Disorder
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the efficacy and safety in depressive patients who did not
      respond sufficiently to selective serotonin re-uptake inhibitors (SSRI).
    


Intervention name(s): 323U66 (Bupropion Hydrochloride Sustained Release); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg.; Subjects with Major Depressive Disorder who were randomised to placebo to match Bupropion SR during the treatment period.
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; double-blind; placebo-controlled; bupropion hydrochloride; SSRI; comparative study; non-responder
Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke
Condition: Infarction, Middle Cerebral Artery
MeSH terms: Ischemic Stroke; Infarction, Middle Cerebral Artery; Infarction
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a open label study to assess the safety of autologous bone marrow transplantation in
      patients with a ischemic stroke in the middle cerebral artery territory within 90 days from
      symptoms onset.
    

Detailed description: 
      Objective: The purpose of this study is to evaluate the safety and feasibility of
      intra-arterial and intravenous injection of autologous bone marrow mononuclear cells in
      patients in the acute and sub-acute phase (> 3 and < 90 days after symptoms onset) of
      ischemic cerebral infarct in the middle cerebral artery territory.

      Methods: 15 patients with cerebral infarct within the middle cerebral artery territory will
      be enrolled in this prospective, nonrandomized, open-labeled study. Up to 10 patients will
      receive up to 500x 10 6 autologous bone marrow cells injected intra-arterially into the
      middle cerebral artery through percutaneous approach. The procedure is monitored by
      Transcranial Doppler (TCD) and electroencephalogram (EEG). Other 5 patients will receive up
      to 500x 10 6 autologous bone marrow cells injected intravenously. Changes in neurological
      deficits and improvements in functions will be evaluated at baseline and at regular intervals
      during follow-up ( 4 months). EEG and neuroimaging exams will be performed at baseline and at
      regular intervals during the follow-up period.
    

Intervention name(s): Autologous cell transplantation
Intervention type(s): Other
Intervention description(s): Intra-arterial or intravenous delivery of autologous bone marrow cells
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute stroke; middle cerebral artery; autologous transplantation; bone marrow cells; stem cells; cell therapy
Randomized Prospective Study Comparing the Effectiveness of Massed and Spaced Learning in Microsurgical Procedures
Condition: Mass Learning, Spaced Learning, Microsurgery
Study type: Interventional

Summary: 
      Title: Randomized prospective study comparing the effectiveness of spaced learning to mass
      learning in microsurgical procedures.

      Background:

      Spacing phenomenon occurs when learning outcomes are greater with the teaching process spread
      out over time (spaced learning), as opposed to having the same total duration of teaching
      carried out over a single session (mass learning). Spaced learning has been shown to improve
      explicit memory tasks including free recall, recognition, cued -recall and frequency
      estimation. It has been used in various medical specialties with promising results and has
      been shown to be at least as good as mass training in learning clinical skills such as
      cardio-pulmonary resuscitation and laparoscopy skills.

      We aim to test the concept of spaced learning in learning delicate and complex skilled
      procedures like microsurgery. Our hypothesis is that spaced learning is better than mass
      learning in acquiring microsurgical suturing skills.

      Methodology:

      Medical students with no prior exposure to microsurgical training were randomized into
      control (mass-learning) and treatment (spaced learning) groups. The students were all taught
      to handle microsurgical instruments and to suture a prefabricated 4mm wide elastic strip
      under the microscope using Digital Surgicals MicroTrainer. The control group was taught
      continuously over 8hrs while the treatment group was taught in 2-hour sessions held each week
      over a span of 4 weeks. The learning outcomes that were measured included duration taken as
      well as the placement of the sutures in relation to each other, with the latter being
      objectively assessed with the use of a computer program from Digital Surgicals. In addition
      to being assessed at the beginning of the sessions, all participants completed another test 1
      month after the completion of the sessions.
    


Intervention name(s): Spaced learning
Intervention type(s): Other
Intervention description(s): Instead of learning over a single session, teaching is carried out over a few weekly sessions but maintaining the overall total number of hours spent on teaching
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Pancreatic Stent for Distal Pancreatectomy
Condition: Distal Pancreatectomy
Study type: Interventional

Summary: 
      The purpose of this study is to compare outcomes of patients undergoing distal pancreatectomy
      with or without pancreatic stent
    


Intervention name(s): Pancreatic stent: PSOF COOK®
Intervention type(s): Device
Intervention description(s): After removing the distal pancreas, PSOF COOK will be place in the main pancreatic duct
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Distal Pancreatectomy; Pancreatic stent; Post-operative pancreatic fistula
Study to Determine the Digestive and Physiological Effects of an Extract From Bran in Healthy Men and Women
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this trial is to determine whether two doses of an extract from bran
      demonstrate a prebiotic effect on colonic bacteria (by modulating selected fecal microbial
      populations, particularly bifidobacteria). The secondary objective is to measure the
      potential beneficial effects of consuming an extract from bran on the following physiological
      parameters: laxation, fecal pH, fecal moisture and stool consistency, blood glucose and
      insulin concentrations, plasma lipid profiles and serum free fatty acids, colonic bacterial
      short chain fatty acid production, ammonia metabolism and protein degradation, and biomarkers
      of oxidative stress and inflammation.
    


Intervention name(s): wheat bran extract; control wheat bran extract
Intervention type(s): Other; Other
Intervention description(s): Comparison of control cereal (containing no added wheat bran extract)to two test cereals containing different amounts of added wheat bran extract; Comparison of control cereal (containing no added wheat bran extract) to two test cereals containing different amounts of added wheat bran extract
Other intervention name(s): wheat bran oligosccharides; prebiotic oligosccharides; wheat bran oligosccharides; prebiotic oligosccharides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: prebiotic study; modulating colonic bacteria
Harnessing the Power of Technology: MOMBA for Postpartum Smoking
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      Through a smartphone platform, financial incentives for smoking abstinence in postpartum
      women can be delivered remotely, thus minimizing the need for participants to come to the
      office to receive traditional contingency management.
    

Detailed description: 
      The specific aims of the proposal are:

        1. To develop through a 15-month pilot study, a novel smartphone-based system, Momba
           Smoking, that can be used in further relapse prevention trials for postpartum smokers.

        2. To determine, through a pilot randomized controlled trial, the potential feasibility,
           acceptability, and methodological parameters that are necessary to design a subsequent,
           appropriately powered, randomized controlled trial of the Momba Smoking smartphone-based
           system.

        3. To advance discovery and understanding on the use of technology to translate smoking
           cessation interventions from clinical to community settings through the training of the
           next generation of scientists.
    

Intervention name(s): MoMba Live Long app & Sensordrone™ carbon-monoxide sensor; Office contingency management; Sensordrone™ carbon-monoxide sensor; MoMba Live Long Smartphone application
Intervention type(s): Behavioral; Behavioral; Device; Device
Intervention description(s): MoMba Live Long application & Sensordrone™ carbon-monoxide sensor to deliver contingency management remotely; A control group which will receive financial incentives at an in-person office/clinic visit based on expired CO levels obtained through the piCO sensor.; A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.; The MoMba Live Long app provides an interface for the Sensordrone which allows participants to complete a breath test and see results of smoking status. The app verifies the user is correctly taking the tests by recording pictures using the front facing camera as well as recording audio to verify that the participants where exhaling while taking the test. The app also provided a platform for social interaction based on a previous system where app users can interact with each other and provide support during the quitting process.
Intervention MeSH terms: Carbon Monoxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tobacco cessation
A Study of the Effect of Vemurafenib on the Pharmacokinetics of Phenprocoumon in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy
Condition: Malignant Melanoma, Neoplasms
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, multicenter, parallel study will evaluate the effect of multiple doses of
      vemurafenib on the pharmacokinetics of a single dose of phenprocoumon in patients with
      BRAFV600 mutation-positive metastatic malignancies. Patients will be randomized to receive
      either treatment A: a single oral dose of phenprocoumon 6 mg on Day 1 (Eligible patients will
      have the option to continue treatment with vemurafenib as part of an extension study
      (NCT01739764).), or treatment B: vemurafenib 960 mg orally twice daily on Days 1-29 plus a
      single oral dose of phenprocoumon 6 mg on Day 22 (with the option to receive vemurafenib in
      the extension study after completion of pharmacokinetic assessments).
    


Intervention name(s): phenprocoumon; vemurafenib
Intervention type(s): Drug; Drug
Intervention description(s): 6 mg oral single dose; 960 mg bid orally
Intervention MeSH terms: Vemurafenib; Phenprocoumon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Efficacy and Safety Study of Fluticasone/Salmeterol Administered With Elpenhaler
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The aim of this study is to establish the therapeutic equivalence between the test
      (Fluticasone/Salmeterol administered with Elpenhaler®db, Rolenium®) and the reference
      formulation (Seretide®, administered with Diskus®), both containing 250/50μg of the
      Fluticasone/Salmeterol combination.

      In case of inhaled products, it is not possible to follow the classic scheme, based on
      similarity of plasma concentration-time behavior of parent drug in assessing bioequivalence.
    

Detailed description: 
      A pharmacodynamic study was designed in order to assess the therapeutic equivalence of the
      new formulation of Fluticasone/Salmeterol with the innovative one. The test and reference
      Fluticasone/Salmeterol formulations will be compared in terms of their bronchodilator effects
      in lung function. Forced Expiratory Volume in 1 second (FEV1) will be the primary efficacy
      measure and will be measured in such a way that a similar time-dependent increase in
      pulmonary function can be demonstrated for both Fluticasone/Salmeterol formulations in
      patients with asthma. In terms of safety comparison, repeated measurements of adverse events,
      vital signs, heart rate, blood hematology and biochemistry as well as ECG changes will enable
      the establishment of the similar safety profile of the test and reference
      Fluticasone/Salmeterol combinations.

      The study will be conducted in a randomized, double-blind, double-dummy, placebo-controlled,
      3x3 crossover fashion.
    

Intervention name(s): RP - TA
Intervention type(s): Device
Intervention description(s): randomized, double-blind, double-dummy, placebo-controlled, 3-way crossover, single dose study, comparing the efficacy and safety of the Fluticasone/Salmeterol combination administered with Elpenhaler®db (Rolenium®) versus the innovative one (Seretide Diskus®)
Other intervention name(s): Rolenium; Seretide
Intervention MeSH terms: Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: respiratory; combination treatment; Elpenhaler; Diskus
Effects of Yoga Training on Cardiovascular Reactivity to Psychological Stress in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Stress, Psychological
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of 12-week yoga training on blood
      pressure, heart rate, heart rate variability, arterial stiffness, and total peripheral
      resistance during rest and psychological stress in patients with hypertension. All eligible
      participants will be randomly assigned to either yoga (n=40) or usual care control (n=40)
      group. During the 1st lab visit, the experimenter will explain the purpose and procedures of
      the study. If the participants understand and agree to participate in this study, they will
      be asked to sign the informed consent. Next, participants will fill out questionnaires,
      including demographic information, Physical Activity Readiness Questionnaire, perceived
      stress scale, anxiety inventory, exercise behavior questionnaire, and quality of life scale.
      Participant's resting blood pressure will be measured. Participants will then be instructed
      to relax in a supine position for 15 minutes while ECG is recording. Next, participants will
      perform 5 minutes of stroop task and 5 minutes of mental arithmetic task (mental stressors).
      ECG and cardiac output will be monitored throughout the whole session. After the stress
      period, participants will be asked to relax until heart rate becomes stable and return to
      baseline. The participants will perform the sit-and-reach test. After completing all the
      baseline testing, the yoga group will begin the training program which is 60 minutes per
      session, 2 times per week for 12 weeks. The control group will be asked not to participate in
      any exercise program during the course of the study. Participants will be filling out the
      same questionnaires and receive measures of blood pressure, ECG, and cardiac output at week 6
      and week 12. Additionally, participants will perform the stress tasks and the sit-and-reach
      test again at week 12.
    


Intervention name(s): Yoga training program
Intervention type(s): Behavioral
Intervention description(s): The hatha yoga program will be led by an experienced yoga instructor. Each 60 minutes session will consist of 10 minutes of breathing exercises (pranayama), 40 minutes of yoga pose practice (asana), and 10 minutes of supine meditation/relaxation (savasana). Yoga props, such as blocks and belts, will be used in accordance to each participant's particular body type and needs to help he/she achieve precise yoga postures safely and comfortably. The yoga poses are chosen for providing a restorative session and based on their purported relationship to restorative effects. Participants will be instructed to maintain their concentration and breath control at all times during the yoga session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Role Of Phospholipid Transfer Proteins (Pltp) On Endotoxemia Caused By Buccal Inflammation
Condition: Patients With Periodontal Disease
MeSH terms: Endotoxemia; Periodontal Diseases; Inflammation
Study type: Interventional

Summary: 
      This is a transversal double-centre study. Patients will be recruited from outpatient
      consultations. They will have buccal inflammation caused by periodontal disease (frequent
      oral infections, mostly with GRAM (-) bacteria). Three groups of 80 patients, corresponding
      to slight, moderate and severe periodontal disease, will be formed according to the results
      of radiological and clinical examinations.
    


Intervention name(s): Sampling of blood
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)
Condition: Parkinson Disease; Cognitive Dysfunction
MeSH terms: Parkinson Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this two-part study was to evaluate the safety and tolerability of
      SAGE-718 and its effects on cognitive, neuropsychiatric, and motor symptoms in participants
      with Parkinson's disease mild cognitive impairment (PD-MCI).
    


Intervention name(s): SAGE-718
Intervention type(s): Drug
Intervention description(s): Oral tablets.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The study had two parts: Part A and Part B with unique participants for each study part. Part B was started after Part A was completed.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Cognitive Dysfunction; SAGE-718
Randomized Controlled Trial Evaluating an Incentive-based Community Eye-care Programme
Condition: Visual Impairment
MeSH terms: Vision Disorders; Vision, Low
Study type: Interventional

Summary: 
      Elderly with visual impairment (VI) who undergo community eye screening often do not attend
      tertiary follow-up even if significant eye diseases are detected. Investigators evaluate an
      incentive-care scheme (ICS) to improve the attendance rates of tertiary eye-care visits of
      participants following community eye screening.
    

Detailed description: 
      A randomized controlled study individuals with VI with baseline visual acuity (VA) and
      vision-related quality of life (VRQoL) assessed in the community. Participants were
      randomised to either receiving ICS or usual care (UC). ICS is a novel intervention that
      incorporates patient education, social support, and financial assistance to assist
      individuals. Participants in UC received a standard GP referral letter advising them to seek
      further care. Our main outcome measure was compliance to tertiary eye-care referral. Our
      secondary outcome measure was VA and VRQoL assessed at 3 months.
    

Intervention name(s): Incentive Care
Intervention type(s): Other
Intervention description(s): ICS is a novel intervention that incorporates patient education, social support, and financial assistance to assist individuals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the long-term safety and tolerability of
      ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS). The secondary
      objective of this study is to evaluate treatment effect over time in adult participants with
      RRMS treated with ALKS 8700.
    


Intervention name(s): ALKS 8700
Intervention type(s): Drug
Intervention description(s): Administered as specified in the treatment arm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MS; Relapsing Remitting Multiple Sclerosis; RRMS; dimethyl fumarate; DMF