bioihbjkbjnl/mcl2 huggingface dataset:
Trial of AD036 in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double blind, placebo-controlled, repeat-dose, parallel arm, outpatient
      and inpatient phase 2 clinical study to examine the efficacy and safety of three dose levels
      of AD036 versus placebo in patients with obstructive sleep apnea.
    

Detailed description: 
      This was a randomized, double-blind, placebo-controlled, repeat-dose, parallel arm,
      outpatient and inpatient, multicenter, dose-finding study of the combination of atomoxetine
      and oxybutynin in adults with OSA documented by polysomnography (PSG).

      Approximately 140 subjects were to be randomized 1:1:1:1 to receive 1 of 3 different
      fixed-dose combinations of oxybutynin and atomoxetine or matching placebo.

      For all subjects, the study consisted of:

        -  A screening and baseline period in which subjects' eligibility was determined

        -  An initial 2-night, at-home blinded baseline period in which all subjects received
           placebo

        -  A 3-night, run-in period in which subjects received:

             -  Low-dose combination for subjects randomized to one of the 3 study treatment arms

             -  Placebo for subjects randomized to the placebo treatment arm

        -  A 7-night treatment period in which subjects received the treatment to which they were
           randomized, i.e., 1 of the 3 different fixed-dose combinations of drugs, or placebo

        -  An end of study visit
    

Intervention name(s): AD036 Dose 1; AD036 Dose 2; AD036 Dose 3; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): AD036 Dose 1 oral capsule administered before sleep; AD036 Dose 2 oral capsule administered before sleep; AD036 Dose 3 oral capsule administered before sleep; Placebo oral capsule administered before sleep
Other intervention name(s): 25/5; 75/1.5; 75/5
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate Safety and Efficacy of Infliximab in Chinese Participants With Moderate to Severe Plaque-type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the superiority and efficacy of infliximab
      induction therapy in chinese participants with moderate to severe plaque-type psoriasis
      (scaly skin rash) compared with placebo (an inactive substance that is compared with a drug
      to test whether the drug has a real effect in a clinical trial).
    

Detailed description: 
      This is a double-blind (neither physician nor participant knows the treatment that the
      participant receives), multicenter (when more than one hospital or medical school team work
      on a medical research study) and placebo-controlled study of infliximab in participants with
      moderate to severe plaque-type psoriasis. All the eligible participants will be randomly
      assigned to infliximab and placebo groups. The infliximab group will receive 5 milligram per
      kilogram (mg/kg) infliximab infusions (a fluid or a medicine delivered into a vein by way of
      a needle) intravenously (into a vein) at Week 0, 2 and 6 in the induction treatment phase
      followed by maintenance regimen of the intervention every 8 weeks up to 26 weeks. Placebo
      infusions will also be given at Week 10, 12 and 16. The placebo group will receive placebo
      infusion at Week 0, 2, 6, 14 and 22. At Week 10, participants in placebo group will then
      receive infliximab induction therapy. Efficacy of the participants will primarily be
      evaluated by percentage of participants who achieve a Psoriasis Area and Severity Index 75
      (PASI) response at Week 10. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Placebo; Infliximab
Intervention type(s): Drug; Drug
Intervention description(s): Placebo matched to infliximab given at Weeks 10, 12 and 16 in Infliximab arm and at Weeks 0, 2 and 6 in Placebo arm; 5 mg/kg infusion given intravenously at Week 0,2,6 (induction treatment phase) and at Week 14 and 22 in maintenance phase in infliximab arm and at Week 12 and 16 in Placebo arm.
Other intervention name(s): Remicade
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Psoriasis; Infliximab; Remicade
Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder
Condition: Bipolar Disorder; Bipolar I Disorder; Bipolar II Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study evaluates the effects of anFDA-approved medication NAC in individuals
      with Bipolar Disorder. Participants in the study will will be assigned to two medication
      conditions and will take both NAC and a matched placebo. The order in which they take each
      medication will be random. Study medication will be taken for 14 days. There will be 5 study
      visits, with 2 MRI brain imaging scans completed. Questionnaires and clinical interview
      measures will be completed at study visits along with consistent assessment of potential side
      effects from study medication.
    


Intervention name(s): N-Acetyl cysteine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Group A and Group B will receive N-Acetylcysteine (NAC). Group A will receive NAC as their first 14 day condition and Group B will receive NAC as their second 14 day condition. Participants will take NAC for 14 days and then have a MRI exam after completing various assessments (clinical interview, questionnaires, etc).; Group A and Group B will receive Placebo. Group A will receive Placebo as their first 14 day condition and Group B will receive Placebo as their second 14 day condition. Participants will take Placebo Oral Capsule for 14 days and then have a MRI exam after completing various assessments (clinical interview, questionnaires, etc).
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety/Efficacy Study of Retigabine vs. Placebo in Post-Herpetic Neuralgia (PHN)
Condition: Postherpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy of retigabine vs. placebo in reducing
      pain associated with post-herpetic neuralgia.
    

Detailed description: 
      This is a Phase 2a proof of concept study evaluating the safety/efficacy of retigabine vs.
      placebo in patients with post-herpetic neuralgia. After screening, patients will enter a
      maximum 6 week titration period followed by a 4 week maintenance period and a 3 week taper
      phase.
    

Intervention name(s): Retigabine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 150mg/day up to 900mg/day; daily
Intervention MeSH terms: Ezogabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postherpetic Neuralgia, PHN, Shingles,
Efficacy and Safety of Sibutramin-containing Drugs in Patient With Alimentary Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      This is Open multicenter randomized Phase IV study to evaluate the efficacy and safety of the
      drug Reduxin® Forte, film-coated tablets, in comparison with the drug Reduxin®, capsules, in
      patients with alimentary obesity was conducted in 5 cities of the Russian Federation (St.
      Petersburg, Ivanovo, Kirov, Samara, Rostov-on-Don) on the basis of 8 research centers.
    

Detailed description: 
      Male and female patients (240 people) inclusive with alimentary obesity, meeting the
      inclusion criteria and not meeting the non-inclusion criteria, were randomized into 2 groups
      in a 1:1 ratio. One group (n=120) received sibutramine+ metformin p. o., 1 tablet (850 mg +
      10 mg) once per day, the second group (n=120) received sibutramine+ microcrystalline
      cellulose (MCC) p. o., 1 capsule (10 mg + 158.5 mg) once per day in the morning. On day 30 ±
      1, in the absence of a 2 kg weight loss compared to the first visit, the dose was increased
      in accordance with the medical instruction. The therapy period was 180 days.
    

Intervention name(s): metformin+sibutramine; sibutramine+ microcrystalline cellulose
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet (850 mg + 10 mg) once per day in the morning, without chewing and followed with a glass of water, during meals, for 180 days. At Visit 3 (Day 30 ± 1), in the absence of a 2 kg weight loss compared to Visit1 (Day 1), the zero dose was increased to 1 tablet (850 mg + 15 mg); 1 capsule (10 mg + 158.5 mg) once per day in the morning, without chewing and followed with a glass of water, during meals for, 180 days.At Visit 3 (Day 30 ± 1), in the absence of a 2 kg weight loss compared to Visit 1 (Day 1), the zero dose was increased to 1 capsule (15 mg + 153,5 mg)
Other intervention name(s): Reduxin® Forte; Reduxin®
Intervention MeSH terms: Metformin; Sibutramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; sibutramine; metformin; Reduxin; Reduxin Forte; pharmacotherapy
Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to assess the safety and tolerability of E5555 in
      subjects with coronary artery disease.
    

Detailed description: 
      This was a multicenter, randomized, double-blind, placebo-controlled trial of E5555, a PAR-1
      inhibitor. The total duration of individual study participation was 28 weeks (196 days). This
      included a treatment period of 24 weeks (168 days) and a follow-up period of 4 weeks (28
      days).
    

Intervention name(s): E5555; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg or 100 mg E5555 tablets; 50 mg and/or 100 mg placebo tablets
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Coronary Artery Disease
Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections
Condition: Complicated Intra-abdominal Infection
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to
      assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared
      with ertapenem in the treatment of adult community-acquired complicated intra-abdominal
      infections (cIAIs).
    


Intervention name(s): TP-434; Ertapenem; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered IV to maintain the blind.
Other intervention name(s): Eravacycline; Invanz
Intervention MeSH terms: Ertapenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
SUPREME-DM (Diabetes Mellitis) Treatment Study
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This multisite pragmatic clinical trial was designed to assess the effectiveness of a single
      scripted telephone call to diabetes patients who (a) were currently above recommended
      clinical goals for glucose, blood pressure, or lipids, and (b) had recently been prescribed a
      new medication for that specific clinical domain. The goals of the intervention were to
      improve primary adherence and persistence to the newly prescribed medication and to improve
      control of glucose, blood pressure, and lipids.
    

Detailed description: 
      This randomized trial tested the hypothesis that a telephone contact with a patient recently
      prescribed a new medication for uncontrolled glycated hemoglobin (A1c), blood pressure, or
      low-density lipoprotein cholesterol would improve (a) primary medication adherence, (b)
      medication persistence, (c) medication possession ratio, and (d) A1c, blood pressure or
      low-density lipoprotein cholesterol control. This study was part of the larger Agency for
      Healthcare Research and Quality funded SUPREME-DM study. The clinical trial reported here was
      coordinated and led by HealthPartners Institute for Education and Research, while data
      collection was coordinated through Kaiser Permanente Northwest and analysis was conducted at
      Kaiser Permanente Colorado. The clinical intervention sites for this study included Kaiser
      Permanente Northern California, Group Health Cooperative, Marshfield Clinic, and Geisinger
      Clinic.
    

Intervention name(s): Intervention Phone Call
Intervention type(s): Behavioral
Intervention description(s): The intervention arm consisted of one protocol-structured telephone call from an interventionist who was a nurse health manager (1 site), diabetes educator or diabetes educator trainee (1 site), or pharmacist (2 sites). Interventionists followed the same structured telephone interview protocol to ascertain whether the subject had started taking the new prescription. Those taking the new medication as prescribed received positive reinforcement. Those who either had not filled the prescription or were not taking the medication as directed, were asked about reasons for nonadherence and assisted in identifying and resolving barriers. The median call lasted < than 5 minutes, and up to 3 call attempts were made. Most intervention calls occurred within 2 to 6 weeks after the prescription date.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: diabetes type 2; primary care; chronic disease care improvement; adherence, randomized trial; BP control; lipid control; glucose control; natural language processing.
Metformin and Omega-3 Fatty Acids in Woman With a History of Early Stage Breast Cancer
Condition: Stage 0 Breast Carcinoma; Breast Neoplasms; Stage I Breast Carcinoma; Stage II Breast Carcinoma; Stage III Breast Carcinoma
MeSH terms: Carcinoma; Breast Neoplasms; Breast Carcinoma In Situ
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether it is feasible to give a combination of
      Metformin and omega-3 fatty acids for one year to women with a history of early stage breast
      cancer. We will also evaluate whether the metformin and omega-3 fatty acids combination
      causes changes in breast tissue, blood, and mammograms.
    

Detailed description: 
      Metformin is a medication used to treat and prevent diabetes and omega-3 fatty acids has been
      shown to lower cholesterol and improve cardiovascular health. Research has shown that
      Metformin and omega-3 fatty acids may also be effective in preventing cancer. In this study,
      we want to find out what effects, good and/or bad, the Metformin and omega-3 fatty acids
      combination has on you and your risk of developing a new breast cancer.
    

Intervention name(s): Metformin; Omega-3 fatty acids
Intervention type(s): Drug; Drug
Intervention description(s): Metformin 850mg, oral, twice a day for 12 months; Omega-3 fatty acids 2 capsules (560 mg each) oral, twice a day for 12 months
Other intervention name(s): N,N-dimethyl biguanide hydrochloride; Docosahexaenoic acid (DHA)/eicosapentaenoic acid (EPA)
Intervention MeSH terms: Metformin; Biguanides
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; Early Stage
The Safety and Pharmacokinetics of Intraperitoneal Administration in Patients Undergoing Appendectomy for Uncomplicated Appendicitis
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this trial is to evaluate the safety of the intraperitoneal administration
      of the combination of fosfomycin, metronidazole, and granulocyte-macrophage
      colony-stimulating factor (GM-CSF) in patients undergoing surgery for uncomplicated
      appendicitis. Further, in a sub-trial the aim is to investigate the plasma concentrations of
      fosfomycin and metronidazole after intraperitoneal administration.
    


Intervention name(s): A combination of fosfomycin, metronidazole and GM-CSF i.p.
Intervention type(s): Drug
Intervention description(s): All drugs will be administered together intraperitoneally at the end of the surgery after the appendix has been removed.
Intervention MeSH terms: Metronidazole; Fosfomycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Knowledge, Beliefs and Attitudes of Greek Physiotherapists About Communication With Chronic Musculoskeletal Patients
Condition: Musculoskeletal Pain; Chronic Pain
MeSH terms: Musculoskeletal Pain; Chronic Pain
Study type: Observational

Summary: 
      The purpose of current research study is to assess physiotherapists's knowledge, beliefs and
      attitudes about empathy, motivational interviewing and shared decision making in chronic
      musculoskeletal patients. An e-survey study will be conducted based on Checklist for
      Reporting Results of 52 Internet E-Surveys (CHERRIES)
    

Detailed description: 
      The main questions it aims to answer are:

      What physiotherapists know about the use of empathy, motivational interviewing and shared
      decision making? What beliefs do physiotherapists have about the appropriate use of
      communication skills? Whether and how much they use empathy, motivational interview, shared
      decision-making in clinical practice? What are the main barriers of using communication
      skills (empathy, motivational interview, joint decision-making) in clinical practice?
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Physiotherapists with chronic musculoskeletal experience and clinical practice in Greece
      
Keywords: empathy; shared decision making; motivational interviewing; physiotherapy; chronic musculoskeletal patients
Outcome of Patients With Thoraco-abdominal Injury and Stress-induced Hyperglycemia or Diabetic Hyperglycemia
Condition: Abdominal Injury; Thoracic Injury; Hyperglycemia; Hyperglycemia Stress
MeSH terms: Hyperglycemia; Wounds and Injuries; Abdominal Injuries; Thoracic Injuries
Study type: Observational

Summary: 
      This study aimed to measure the effects of SIH and DH on the mortality outcomes of the adult
      patients with moderate to severe thoracoabdominal injury
    

Detailed description: 
      Because the pathophysiologic response of the patients with a thoracoabdominal injury is
      different from those who had a traumatic brain injury, this study aimed to measure the
      effects of hyperglycemia induced by stress or by diabetes on the outcomes of patients with
      thoracoabdominal injuries in comparison with those who had non-diabetic normoglycemia (NDN).
      The primary study hypothesis stated that, following thoracoabdominal injuries, the patients
      with SIH had a worse outcome than patients with DH. The primary outcome was mortality rate of
      these patients.
    

Intervention name(s): Stress-induced hyperglycemia; Diabetic hyperglycemia; Diabetic normoglycemia; Non-diabetic normoglycemia
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Stress-induced hyperglycemia (SIH)was defined as a serum glucose ≥ 200 mg/dL in the patients without Diabetes mellitus.; Diabetic hyperglycemia (DH) which indicated a serum glucose ≥ 200 mg/dL in patients with Diabetes mellitus.; Diabetic normoglycemia (DN), which was defined when there was a serum glucose < 200 mg/dL in the patients with Diabetes mellitus.; Non-diabetic normoglycemia (NDN) indicating a serum glucose < 200 mg/dL in patients who were absent of Diabetes mellitus.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This retrospective study reviewed data from trauma patients registered between January 1,
        2009 and December 31, 2018. The inclusion criteria were age ≥20 years Adult patients with
        moderate to severe thoracoabdominal injuries (n = 802) were grouped into four exclusive
        subgroups: (1) SIH, which was defined as a serum glucose ≥ 200 mg/dL in the patients
        without DM (n = 52); (2) DH, which indicated a serum glucose ≥ 200 mg/dL in patients with
        DM (n = 79); (3), DN, which was defined when there was a serum glucose < 200 mg/dL in the
        patients with DM (n = 50); and (4) NDN, indicating a serum glucose < 200 mg/dL in patients
        who were absent of DM (n = 621)
      
Keywords: admission hyperglycemia; stress-induced hyperglycemia; diabetic hyperglycemia; diabetes mellitus; thoracoabdominal trauma; mortality