bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus
Condition: Gestational Diabetes Mellitus in Pregnancy
MeSH terms: Diabetes, Gestational; Pregnancy in Diabetics; Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      Gestational diabetic mellitus (GDM) patients randomised to metformin or insulin group.Aim was
      to achieve blood sugar levels of Blood sugar fasting (BSF) <5.3 mmol/l and 1 hour post
      meal<7.8mmol/l. Both groups were followed till delivery and outcome studied.
    

Detailed description: 
      75 gm Oral Glucose Tolerance Test (OGTT) was done in pregnant patients. Blood sugar
      fasting(BSF) > 5.5 mmol/l & 2 hours postprandial >7.8 mmol/l was labelled as GDM. They were
      randomised to metformin or insulin group. Those assigned to metformin group were started
      metformin 500mg twice daily & increased until 2500mg depending on the blood sugar levels. Aim
      was to achieve blood sugar levels of BSF <5.3 mmol/l and 1 hour post meal<7.8mmol/l. If blood
      sugar levels were not controlled, insulin was added. The insulin group was given 3 injections
      of regular insulin & one intermediate acting insulin injection at night subcutaneously. Both
      groups were followed till delivery and outcome studied
    

Intervention name(s): Metformin; Insulin
Intervention type(s): Drug; Drug
Intervention description(s): metformin 500mg twice daily & increased until 2500mg till normoglycemia was achieved and was continued till delivery; The insulin group was given 3 S/C injections of regular insulin & one intermediate acting injection at night till normoglycemia was achieved and was continued till delivery
Other intervention name(s): Glucophage; Humulin R U 100 and Humulin N
Intervention MeSH terms: Insulin; Metformin; Insulin, Globin Zinc; Isophane Insulin, Human
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gestational Diabetes Mellitus, Metformin, Insulin
Anti-factor Xa Based Venous Thromboembolism Prophylaxis
Condition: Dose Adjustment of Enoxaparin in ICU Patients
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Interventional

Summary: 
      Introduction: Venous thromboembolism (VTE) in the intensive care unit (ICU) is associated
      with significant morbidity and mortality therefore prevention is imperative to reduce its
      burden. VTE prophylaxis in ICU patients is primarily pharmacological using low molecular
      weight heparin. This study aims to determine the proportion of ICU patients receiving VTE
      prophylaxis that achieves appropriate anti-factor Xa activity (aFXa) prophylactic levels and
      to characterize this patient population Methods: Seventy-five patients admitted to the
      General ICU were included. Peak and trough aFXa levels were measured at 4 and 23 hours
      respectively after receiving the second consecutive daily enoxaparin 40 mg sc injection.
      Patients in whom peak aFXa levels were found to be sub-prophylactic, peak and trough levels
      were repeated as above
    


Intervention name(s): Dose adjustment of Enoxaparin in patients with sub-therapuetic (prophylactic) levels of factor 10a
Intervention type(s): Other
Intervention description(s): We screened ICU patients who recieved DVT prophylaxis with fixed dose of Enoxaparin (40 mg SC daily) for peak blood levels of factor 10A. For patients who did not achieve therapuetic 10a levels (0.2-0.4) we increased the Enoxaparin dose to 60 mg SC daily.
Intervention MeSH terms: Enoxaparin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Local Delivery of Aloe Vera Gel as an Adjunct to Non-surgical Treatment in Patients With Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      Aim of the current study was to evaluate the effect of Aloe vera gel as an adjunct to scaling
      and root planing (SRP) in the management of chronic periodontitis.
    

Detailed description: 
      The effect of Aloe vera on treatment of chronic periodontitis will be evaluated in a
      randomized, controlled clinical trial. Thirty patients with mild to moderate chronic
      periodontitis were divided into 2 groups: group 1 (test): will include 15 patients treated
      with SRP followed by application of Aloe vera gel in the periodontal pockets at day 1 and
      after 1 and 2 weeks, and group 2 (control) which includes 15 patients treated with SRP only.
    

Intervention name(s): Aloe vera after SRP; Scaling and root planing (SRP)
Intervention type(s): Other; Procedure
Intervention description(s): Subgingival administration of Aloe vera gel was preceded by flushing the area with saline to wash away any debris. Aloe vera (1cc) gel was applied subgingivally using atraumatic needle. Patients were instructed not to rinse or drink any liquid for at least 30 minutes. The application was performed at baseline and after 1 and 2 weeks.; Removal of supragingival and sub-gingival calculus and debris was performed, followed by smoothing root surfaces and removing cementum or dentine that is impregnated with calculus and toxins.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Once Daily Elvucitabine Versus Lamivudine in Participants With a Documented M184V Mutation
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Human immunodeficiency virus (HIV)-1 infected participants receiving long-term therapy with
      lamivudine or emtricitabine (nucleoside reverse transcriptase inhibitors [NRTIs]) are at risk
      for the development of a mutation at position M184 on the HIV reverse transcriptase gene.
      This mutation confers resistance to both drugs (>100 fold increase in the concentration of
      drug producing 50% inhibition [IC50]).

      In-vitro studies with elvucitabine have shown that HIV-1 isolates with the M184V mutation
      show only a 10-fold increase in IC50 as compared to wild type HIV-1. Alexion Pharmaceuticals
      Inc. intention is to demonstrate that 10 milligrams (mg) of elvucitabine, administered once
      per day for 14 days with continued background anti-HIV-1 medications, will demonstrate a fall
      in HIV-1 ribonucleic acid (RNA) plasma levels, as compared to baseline. The data from this
      study will guide dosing in future long-term studies in HIV-1 infected participants with the
      M184V mutation.
    

Detailed description: 
      This was a Phase 2a, 14-Day randomized, double-blind, comparative viral kinetic study of10 mg
      elvucitabine as compared to lamivudine that was administered once daily (QD) to HIV-1
      infected participants with a documented M184V variant. This study also demonstrated the
      antiviral activity as well as the assessment of safety of the elvucitabine therapy

      Participants must be receiving a stable antiretroviral regimen (defined as no change in
      antiretroviral therapy for at least 4 weeks prior to randomization) that includes lamivudine
      or emtricitabine. At 72 hours prior to randomization, only lamivudine or emtricitabine will
      be stopped for washout; participants will continue to receive the other drugs in their
      prescribed regimen (background antiretroviral therapy) during the 72-hour washout period.
      Participants will then be randomized to receive blinded elvucitabine or lamivudine in a 1:1
      ratio and continue to receive their prescribed background antiretroviral therapy for 14 days
      on an outpatient basis. Participants will be followed for an additional 14 days
      post-treatment for safety unless they enroll in the ACH443-018 extension study where they
      will continue to be treated and followed for safety.
    

Intervention name(s): Elvucitabine; Lamivudine
Intervention type(s): Drug; Drug
Intervention description(s): Elvucitabine 10 mg QD for 14days; Lamivudine 300 mg QD for 14 days
Intervention MeSH terms: Lamivudine; Dexelvucitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV-1; treatment experienced
Influence of Food on the Bioavailability of Two Doses of Telmisartan/HCTZ Fixed-dose Combination in Japanese Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the relative bioavailability and pharmacokinetics of the fixed-dose
      combination tablets (telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg) after
      food intake in comparison with those in the fasting state in healthy Japanese male volunteers
    


Intervention name(s): Telmisartan low; Telmisartan high; Hydrochlorothiazide (HCTZ); Japanese meal
Intervention type(s): Drug; Drug; Drug; Other
Intervention MeSH terms: Hydrochlorothiazide; Telmisartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Effects of Neramexane on the Pharmacokinetics of a Combined Drospirenone/Ethinyl Estradiol Oral Contraceptive in Healthy Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary:

      To assess the effects of repeated dose of Neramexane on the steady-state pharmacokinetics of
      Drospirenone [DRSP] and Ethinyl Estradiol [EE]

      Secondary:

      To assess safety and tolerability of concomitant repeated dose treatments of Neramexane and a
      fixed-combinational DRSP- and EE-containing oral contraceptive [OC] (Yasmin®)
    


Intervention name(s): Neramexane
Intervention type(s): Drug
Intervention description(s): 25 mg q.d., 3 days 2 x 25 mg b.i.d., 11 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: drug-drug interaction study
First Time in Human Study of GSK1223249 in Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The drug being tested in this study is GSK1223249. It is being developed by GlaxoSmithKline
      to treat symptoms in patients with Amyotrophic Lateral Sclerosis (ALS).

      The drug works by inhibiting the protein that prevents nerve growth.

      This will be the first time the drug will be given to man. The trial is expected to involve
      approximately 76 patients. The study objective is to investigate the tolerability, safety and
      the way the body handles GSK1223249 after a range of single doses or repeat dose escalation
      in patients with ALS.
    

Detailed description: 
      This is the first-time-in-human (FTIH) phase I/IIa study of GSK1223249, a humanised
      monoclonal antibody against Nogo-A, a neurite outgrowth inhibitor hypothesised to be involved
      in the pathophysiology of amyotrophic lateral sclerosis (ALS) and some other
      neurodegenerative disorders. This study will be a randomized, placebo-controlled,
      double-blind, sequential dose escalation, 2-part fusion protocol. Approximately 76 patients
      with ALS will be enrolled. In Part 1, single escalating intravenous (i.v.) doses of
      GSK1223249 are planned to be evaluated in 5 sequential patient cohorts (2 placebo and 6
      active in each cohort) to determine single dose safety and pharmacokinetics (PK). Part 2 will
      also be of a sequential dose escalating design, but patients in each of the planned 3 cohorts
      (3 placebo, 9 active in each cohort) will receive 2 repeat i.v. doses approximately 4 weeks
      apart where, safety and PK will also be evaluated. In two cohorts in Part 1 and all cohorts
      in Part 2, blood samples and skeletal muscle biopsies will be taken from patients before and
      at the end of treatment to demonstrate whether or not GSK1223249 binds to its target and
      produces any measurable pharmacodynamic effect. Patients in both parts will receive their
      first dose in a hospital-based unit where they will be monitored for at least 24 hours
      post-dose before being discharged to be followed on an out-patient basis. In each cohort in
      part 1, the first four subjects will be dosed in a staggered manner such that only one will
      receive the dose in any 24 hours. Dosing of the first four subjects in the first cohort of
      part 2 will also be staggered in a similar manner.
    

Intervention name(s): PLACEBO; GSK1223249
Intervention type(s): Drug; Drug
Intervention description(s): Placebo; I.V Infusion
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects
Condition: Chronic Hepatitis c
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects
    

Detailed description: 
      A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple
      Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC74647PA Capsule in
      Healthy Adult Subjects.
    

Intervention name(s): HEC74647PA Capsule; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule administered orally once daily; Matching Placebo Capsule
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The main goal of this present study is evaluate the decreasing of necessity of topic
      corticoids usage to control outbreaks of light to moderate atopic dermatitis by using the
      correct emollients.
    


Intervention name(s): Emollient - Cetaphil Advanced
Intervention type(s): Other
Intervention description(s): Emollient - Cetaphil Advanced - to be applied twice a day for 20 weeks.
Intervention MeSH terms: Emollients
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dermatitis, Atopic; Corticoids, topic; Corticosteroids
The Role of P-glycoprotein in Sitagliptin Clinical Pharmacology
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the pharmacogenetics, pharmacokinetics, and
      drug-drug interactions of sitagliptin therapy.
    


Intervention name(s): Sitagliptin; atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses
Other intervention name(s): Januvia; Lipitor
Intervention MeSH terms: Sitagliptin Phosphate; Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy volunteers
Treatment of Chronic Medium-severe Periodontitis With Mesenchymal Stem Cells Predifferentiated in Osteogenic Direction
Condition: Periodontitis, Chronic
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Treatment of chronic medium-severe periodontitis with mesenchymal stem cells and mesenchymal
      stem cells predifferentiated in osteogenic direction
    

Detailed description: 
      The bone defect will be filled with a porous membrane based on bone collagen measuring 5x5 mm
      or more with mesenchymal stem cells and mesenchymal stem cells predifferentiated in
      osteogenic direction
    

Intervention name(s): mesenchymal stem cells; standard treatment
Intervention type(s): Biological; Other
Intervention description(s): autologous mesenchymal stem cells; standard treatment according to clinical protocols
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Periodontitis; Mesenchymal stem cells
Survey on Menstrual Symptoms, Health Related Quality of Life and Work Productivity in Patients Suffering From Pain During Menstruation (Dysmenorrhea) in Japan
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Observational

Summary: 
      In this study researcher want to gain more information on the treatment effect of Low-dose
      Estrogen Progestin (a hormone treatment) on the health related quality of life and work
      productivity in patients suffering from menstrual pain. The treating doctors will ask the
      study participants to complete questionnaires at start of study, after 2 and 4 months (end of
      study). The questions will be about participant's general and mental health, concentration,
      behavioral and emotional changes, and work productivity and activity level. This study will
      be conducted in Japan and enrols about 380 female participants in the age range of 16 to 39
      years.
    


Intervention name(s): LEP; NSAIDs and/or Chinese medicine (CM)
Intervention type(s): Drug; Drug
Intervention description(s): LEP dosage up to the discretion of the treating gynecologists.; Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Chinese medicine (CM) dosage up to the discretion of the treating gynecologists.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study is a prospective, non-interventional study for patients being treated for primary
        or secondary dysmenorrhea in real-world clinical practice. Patients will be recruited using
        M3 group network. M3 is a company that provides a medical portal site for HCPs, and more
        than 280,000 medical doctors are registered with M3 with 80% coverage in Japan. As many
        patients with dysmenorrhea visit ob/gyn clinics rather than hospitals, patients diagnosed
        as primary or secondary dysmenorrhea will be recruited by gynecologists who work in the
        clinics enrolled in M3. When patients agree to participate in the study, the gynecologists
        provide the QR code or URL to the patients enabling them to access the site from their
        mobile communication equipment such as mobile phones and tablets, and answer the
        questionnaire.
Efficacy and Safety of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH)
Condition: NASH
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the efficacy, safety, tolerability and
      pharmacokinetics of multiple oral administration of MT-3995 in patients with NASH.
    


Intervention name(s): MT-3995; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NASH
Test Albuvirtide in Experienced Patients
Condition: HIV Infections; AIDS
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of albuvirtide combined with
      lopinavir-ritonavir (LPV/r) in HIV-1-infected patients who failed first-line antiretroviral
      therapy (ART).
    

Detailed description: 
      This was a 48-week, multi-center, open-label, randomized and controlled, non-inferiority
      phase 3 clinical trial to evaluate the safety and efficacy of albuvirtide combined with LPV/r
      in HIV-1 infected patients who failed their first-line ART and had HIV-1 RNA levels ≥ 1000
      copies/mL at screening.

      The trial was conducted in 12 sites in China. Subjects meeting inclusion criteria were
      randomized in a 1:1 ratio to ABT group and NRTI group, in which the ABT group received
      albuvirtide and LPV/r combination therapy, and NRTI group received the standard 3-drug
      regimen of LPV/r + Lamivudine (3TC) + Tenofovir (TDF). If TDF was used in the previous
      regimen or genotypic resistance histories showed primary mutation to TDF, zidovudine (AZT) or
      abacavir (ABC) would be used. Albuvirtide was given by weekly intravenous infusion and LPV/r
      was given twice daily orally. A total of 418 subjects were randomized, of whom 401 received
      at least one treatment.
    

Intervention name(s): albuvirtide; lopinavir-ritonavir; tenofovir; lamivudine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): albuvirtide 320mg administered intravenously once a week; lopinavir-ritonavir 400/100mg administered orally twice daily; tenofovir 300mg administered orally once daily; lamivudine 300mg administered orally once daily
Other intervention name(s): ABT; Kaletra; LPV/r; TDF; 3TC
Intervention MeSH terms: Ritonavir; Lopinavir; Tenofovir; Lamivudine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1; AIDS; Albuvirtide; Treatment-experienced; Fusion inhibitor
Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section
Condition: Neonatal Outcome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This prospective double-blind placebo-controlled randomized clinical trial will be conducted
      at Ain-Shams University Maternity Hospital from April 2017 till December 2017. Group 1 women,
      candidates for cesarean section, will receive preoperative rectal 400 microgram of
      misoprostol, and Group 2 women will receive postoperative rectal 400 microgram of
      misoprostol.

      2017. 120 women candidate foe elective cesarean section will receive preoperative sublingual
      400 microgram of misoprostol, and another 120 women will receive postoperative sublingual 400
      microgram of misoprostol.
    


Intervention name(s): Misoprostol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Cytotec; Placebo tablet similar in shape, odour and consistency to misoprostol tablet.
Other intervention name(s): Mesotac
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Clinical Trial Using Topically Applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate the efficacy of various doses of MED2005 versus placebo in male patients with
      clinically diagnosed erectile dysfunction, and to evaluate the long-term efficacy and safety
      (12 months) of MED2005.
    

Detailed description: 
      A phase III, dose-ranging, multi-centre, randomised, double-blind, placebo controlled ,
      home-use, parallel group clinical trial of topically applied glyceryl trinitrate for the
      treatment of erectile dysfunction with an open label extension
    

Intervention name(s): MED2005
Intervention type(s): Drug
Intervention description(s): Topical Product
Other intervention name(s): Glyceryl Trinitrate
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment