bioihbjkbjnl/mcl2 huggingface dataset:
Metformin and Sitagliptin in Women With Previous Gestational Diabetes
Condition: Pre-diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Prediabetic State
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the present research is to compare the effects of treatment with metformin and
      sitagliptin, alone or in association, in women with previous gestational diabetes to evaluate
      the impact of the two drugs on beta-cell function. The study results may contribute to give a
      rational approach for future investigations.
    

Detailed description: 
      A randomized, double blinded study, on 45 women with previous gestational diabetes and
      impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) to assess the effects of a
      4-month treatment with metformin and/or a dipeptidyl peptidase-4 inhibitor (sitagliptin) on
      beta-cell function and insulin resistance.

      At baseline, all women will have a standardized medical history, physical, and laboratory
      examination. Plasma glucose, insulin, pro-insulin, C-peptide, glucagon, adipokines,
      pro-inflammatory molecules, and lipid profile will be determined in fasting condition. A 75g
      OGTT will be performed after an overnight fasting and sample will be drawn at 15, 30, 60, 90
      and 120 minutes for plasma glucose, C-peptide, glucagon and GLP-1 determinations. Women with
      IFG or IGT will be recruited and undergo to a hyperglycemic clamp with arginin bolus at the
      end of the test. Then the women will be randomized in 3 treatment groups: metformin (850 mg
      bid), sitagliptin (100 mg qd)or metformin (850 mg bid) + sitagliptin (100 mg qd). After
      4-month treatment, the baseline evaluation will be repeated.
    

Intervention name(s): Metformin; Sitagliptin; Sitagliptin + Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Metformin 850 mg bid; Sitagliptin 100 mg qd; sitagliptin 100mg + metformin 850mg
Other intervention name(s): Glucophage; januvia; janumet
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: beta-cell function; insulin resistance
A Study to Explore the Effect of Food Before a Single Dose of Sitravatinib
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-label, Randomized, Three-period, Crossover Study of the Effect of Food on the
      Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects
    


Intervention name(s): sitravatinib
Intervention type(s): Drug
Intervention description(s): 100 mg sitravatinib on Day 1 of each of 3 periods
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Three Period Crossover
Masking: None (Open Label)
Primary purpose: Treatment
Synaptic Density and Progression of Huntington's Disease.
Condition: Huntington Disease
MeSH terms: Huntington Disease
Study type: Interventional

Summary: 
      AIM: To assess synaptic density and to investigate the potential relationship of regional
      synaptic loss with motor and non-motor symptoms and with disease progression in the human
      brain in vivo in patients with HD.

      DESIGN: The investigators will include 20 HD mutations carriers and 15 healthy controls. All
      subjects will undergo a clinical examination, with comprehensive assessment of motor and
      non-motor symptoms, and imaging evaluation consisting of 11C-UCB-J PET-CT and 18F-FDG PET-MR
      at baseline and after 2 years.
    


Intervention name(s): 11C-UCB-J PET-CT; 18F-FDG PET-MR
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.; Positron Emission Tomography (PET) of glucose metabolism using the radioligand 18F-FDG, and brain MRI performed simultaneously.
Intervention MeSH terms: Fluorodeoxyglucose F18
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Longitudinal study design (2 years follow up) where results of SV2A PET/CT, FDG PET/MR and clinical rating scales are compared between HD patients and healthy controls.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Huntington Disease; PET; 11C-UCB-J; 18F-FDG; SV2A
Efficacy of Intra-articular Neostigmine Versus Ketamine for Postoperative Analgesia in Arthroscopic Knee Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To compare the efficacy of intra-articular administration of neostigmine versus ketamine as
      adjuvant analgesics after knee arthroscopy.
    

Detailed description: 
      Arthroscopic knee surgery is commonly performed as an outpatient procedure and is often
      associated with postoperative pain. Intraarticular (IA) local anesthetics (LA) are often used
      for prevention of pain after arthroscopic knee surgery; however, the degree of postoperative
      pain varies. In an effort to find the ideal regime for sufficient, long-lasting postoperative
      analgesia, many different drugs, including opioids, nonsteroidal anti-inflammatory drugs,
      ketamine, clonidine, and neostigmine, have been added to the IA LAs The investigators
      designed this study to compare the efficacy of intra-articular administration of neostigmine
      versus ketamine as adjuvant analgesics after knee arthroscopy.
    

Intervention name(s): Neostigmine; ketamine
Intervention type(s): Drug; Drug
Intervention description(s): patient receive 0.5mg/dose neostigmine +18ml 0.25%bupivacaine in a total volume of 20 ml.; patient receive 0.5 mg/kg ketamine+18ml 0.25%bupivacaine in a total volume of 20 ml.
Other intervention name(s): epistigmine; Ketalar
Intervention MeSH terms: Ketamine; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin
Condition: Fungal Infection
MeSH terms: Mycoses; Agranulocytosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is evaluating the efficacy and safety of generics caspofungin in
      the treatment of the patients with neutropenic and fever.Another purpose of this study is
      comparing the pharmacokinetic characteristics of generics caspofungin and original
      medicine(Cancidas®) for providing a basis for clinical rational administration.
    

Detailed description: 
      Caspofungin, a member of the new echinocandin class of compounds，had been proved as effective
      as and generally better tolerated than liposomal amphotericin B when given as empirical
      antifungal therapy in patients with persistent fever and neutropenia，and It was approved by
      FDA in 2001.The generics caspofungin of Chia Tai TianQing Pharmaceutical Group Co. , Ltd.
      (CTTQ) will be approved by CFDA.The purpose of this study is evaluating the efficacy and
      safety of this generics caspofungin in the empirical antifungal therapy in patients with
      persistent fever and neutropenia.

      This is a prospective,multicenter,randomized,controlled,open label study,the designed cases
      are 60 subjects.This study is divided into two stages,one is pharmacokinetics study stage
      ,the purpose of this stage is comparing the blood concentration of generics caspofungin and
      original medicine(Cancidas®) ,24 of 60 subjects will participate in this stage,the
      randomization in a 1:1 ratio will be performed at each group.The other 36 subjects will
      participate in another stage that is a single study,all subjects will use generics
      caspofungin.
    

Intervention name(s): Caspofungin
Intervention type(s): Drug
Intervention description(s): Considering the possibility of fungal infection, we take empiric therapy for the patients with persistent fever and agranulocytosis using caspofungin for injection.
Other intervention name(s): original caspofungin
Intervention MeSH terms: Caspofungin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex
Condition: HSV Infection
MeSH terms: Infections; Herpes Simplex
Study type: Interventional
Phase: Phase 2

Summary: 
      Study aimed to evaluate the efficacy and tolerance of Lazolex®, an emollient gel, to treat
      mucocutaneous lesions caused by herpes simplex virus.
    

Detailed description: 
      A single-center, single-arm, open-label, phase II clinical trial was conducted with 30
      patients divided into two groups: 15 patients with herpes simplex virus type 1 (HSV-1)
      infections and 15 with herpes simplex virus type 2 (HSV-2) infections. All received topical
      treatment with Lazolex® Gel four times daily for 10 days. The efficacy and tolerance of the
      treatment were evaluated on day 10 and day 20 after the study started. In addition,
      recurrence rates were evaluated before treatment with Lazolex® and after a 4-year follow-up
      period after treatment.
    

Intervention name(s): walnut extract
Intervention type(s): Drug
Intervention description(s): Four times a day over a 10-day period
Other intervention name(s): Lazolex gel
Intervention model: Single Group Assignment
Intervention model description: Lazolex gel
Masking: None (Open Label)
Primary purpose: Treatment
An Open, Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Intravenous Followed by Oral Azithromycin Versus Cefuroxime Alone or With Oral Erythromycin for the Treatment of Chinese Patients Who Were Hospitalized for Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 3

Summary: 
      To validate the efficacy and safety of azithromycin for the treatment of Chinese patients
      hospitalized with community-acquired pneumonia (CAP), compared with cefuroxime or the
      combination of cefuroxime plus oral erythromycin.
    


Intervention name(s): cefuroxime plus erythromycin; azithromycin (Zithromax); cefuroxime
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intravenous cefuroxime 1.5 g twice daily for 4 +/-1 days, followed by oral cefuroxime 0.5 g twice daily for a total duration of 9 +/-1 days plus erythromycin ethylsuccinate 0.5 g twice daily, which was given for a total duration of 14 days for subjects with suspected pneumonia due to atypical pathogens; intravenous azithromycin 500 mg once daily for 4 +/-1 days, followed by oral azithromycin 500 mg once daily for a total duration of 9 +/-1 days; intravenous cefuroxime 1.5 g twice daily for 4 +/-1 days, followed by oral cefuroxime 0.5 g twice daily for a total duration of 9 +/-1 days
Intervention MeSH terms: Azithromycin; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Cefuroxime; Cefuroxime axetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to establish if the same amount of drug is absorbed
      into the blood after ingesting a combination dapagliflozin/metformin tablet vs. the
      individual dapagliflozin tablet and individual metformin tablet.
    


Intervention name(s): Dapagliflozin/Metformin; Dapagliflozin; Metformin; Dapagliflozin/Metformin; Dapagliflozin; Metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Fixed dose combination dapagliflozin/metformin IR tablet 2.5 mg/850 mg Oral Single dose; dapagliflozin tablet 2.5 mg Oral Single dose; metformin IR tablet 850 mg Oral Single dose; Fixed dose combination dapagliflozin/metformin IR tablet 5 mg/1000 mg Oral Single dose; dapagliflozin tablet 5 mg Oral Single dose; metformin IR tablet 1000 mg Oral Single dose
Other intervention name(s): Glucophage; Glucophage
Intervention MeSH terms: Metformin; Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy volunteers; bioequivalence; dapagliflozin; metformin
Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Non-operable) Chronic Thromboembolic Pulmonary Hypertension (CTREPH)
Condition: Non-operable Chronic Thromboembolic Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to determine the effect on six-minute walking test
      (6MWT) distance after 24 weeks treatment with subcutaneous (SC) Treprostinil Sodium in
      patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension.
    

Detailed description: 
      Chronic thromboembolic pulmonary hypertension (CTEPH) is characterized by non-resolving
      organized thromboembolic obstructing the pulmonary vascular bed. These thrombi are resistant
      to thrombolytic therapy and chronic plasmatic anticoagulation. An increase in pulmonary
      vascular resistance (PVR), right ventricular overload, and eventually right ventricular
      failure ensue.

      The treatment of choice for CTEPH is pulmonary endarterectomy (PEA), providing a potential
      cure for the disease. However, about 50 % of patients are not candidates for surgery, mainly
      because of distal location of thromboemboli. Despite recent advances in the treatment of
      pulmonary arterial hypertension (PAH), medical treatments have not been recommended for
      inoperable CTEPH, because of the concept that a predominantly major vessel obstructive
      arteriopathy would not be suitable for vasodilators. Furthermore, a major drawback of i.v.
      prostacyclin therapy is the need for a permanent central venous access that increases the
      risk of infection (0.22-0.68 per patient per year), thrombosis and new major vessel
      thromboembolism.
    

Intervention name(s): Treprostinil sodium
Intervention type(s): Drug
Intervention MeSH terms: Treprostinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial of Sarilumab in Adults With COVID-19
Condition: SARS-CoV 2; SARS
Study type: Interventional
Phase: Phase 2

Summary: 
      Early administration of sarilumab in hospitalized patients infected with COVID-19 who have
      pulmonary infiltrates and are at high risk of unfavorable evolution could decrease/prevent
      progression to acute respiratory distress syndrome (ARDS) requiring high flow nasal
      oxygenation (HFNO) or either invasive or non-invasive mechanical ventilation.
    


Intervention name(s): Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]; Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA]; Best available treatment
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Best available treatment up to 14 days plus Sarilumab 200 mg; Best available treatment up to 14 days plus Sarilumab 400 mg; Best available treatment up to 14 days
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions
Condition: Post COVID-19 Condition; Long COVID
MeSH terms: Post-Acute COVID-19 Syndrome; Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of Ampligen® administered
      twice weekly by intravenous (IV) infusions in subjects experiencing the Post-COVID Condition
      of fatigue.
    

Detailed description: 
      This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to
      evaluate the efficacy and safety of Ampligen® in patients experiencing the Post-COVID
      Condition of fatigue. Patients will be randomized 1:1 to receive twice weekly IV infusions of
      Ampligen® or placebo.
    

Intervention name(s): Rintatolimod; Placebo / Normal Saline
Intervention type(s): Drug; Other
Intervention description(s): 100 to 400 mg twice weekly; 40 to 160 mL twice weekly
Other intervention name(s): Ampligen; poly I : poly C12U; Rintatolimod (poly I : poly C12U)
Intervention MeSH terms: poly(I).poly(c12,U); Poly I-C
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Coronary Microcirculatory and Bioresorbable Vascular Scaffolds
Condition: CHD - Coronary Heart Disease; Angina, Stable; Myocardial Ischemia
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Angina, Stable; Ischemia
Study type: Interventional

Summary: 
      Angina and heart attacks are caused by narrowings in the coronary arteries (blood vessels)
      supplying the heart. These narrowings can be opened using a balloon and stent (angioplasty).
      Traditionally, stents are constructed from metal and are permanent. However, newer stents are
      being constructed from carbohydrate polymers (scaffolds), which allow them to reabsorb over
      time leaving no permanent implant. New data has suggested that these scaffolds appear to
      reduce recurrent angina and may alter the blood flow down the artery. However, it is not
      known whether this is due to the scaffolds themselves or the way the scaffolds are inserted.
      In this study we hope to measure the blood flow to the heart and assess changes in that flow
      during stent and scaffold insertion. It is also important to know whether these effects are
      durable and thus, a cohort of patients will return at 3-months to be restudied. These data
      are important to help us understand why blood flow is affected by stent/scaffold selection or
      device implantation technique and whether this results in better long-term outcomes.
    


Intervention name(s): Bioresorbable Vascular Scaffolds (BVS); Drug-Eluting Stent (DES) - slow; Drug-Eluting Stent (DES) - standard(std)
Intervention type(s): Device; Device; Device
Intervention description(s): Bioresorbable Vascular Scaffold. Introduced after the interim analysis (phase 2) for comparison with DES-slow.; Slow device inflation (mandated in the BVS IFU). To be compared with the DES-std group at interim analysis at the end of phase 1 stage.
After the interim analysis DES-slow to be compared with BVS.; Metallic DES implanted in standard fashion. To be compared with the DES-slow group at interim analysis at the end of phase 1 stage.
Other intervention name(s): ABSORB; Xience; Xience
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary Stent; PCI; BVS; Index of microcirculatory resistance
Examining Cognitive Mechanisms of Clinical Improvement Following Mindfulness Based Therapy for Depressed Individuals
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      Depression one of the leading causes of disability worldwide. Individuals suffering from
      depression typically exhibit impairments in various mental abilities, such as the ability to
      effectively direct and control attention and the ability to switch between thinking about
      different things and concepts (commonly referred to as "cognitive flexibility").

      Mindfulness meditation training is a technique which involves focusing one's awareness on the
      present moment, while calmly acknowledging and accepting one's feelings, thoughts, and bodily
      sensations. It has been well documented to improve depressive symptoms and prevent recurrence
      of depressive episodes, yet little is known about how mindfulness does so and what are the
      underlying mental mechanisms involved. Here the investigators propose to examine the efficacy
      of an 8-week mindfulness training program in improving the ability to direct and control
      attention, as well as in cognitive flexibility.

      Individuals diagnosed with recurrent depression will undergo an 8-week mindfulness training
      program. Participants' depressive symptoms as well as their performance on measures of
      attention and cognitive flexibility will be examined. Participants will be assigned to
      mindfulness training or a wait-list control group. Half of the participants will be examined
      before and after the mindfulness training program and the other half will be tested 8-weeks
      apart and then begin their training.
    


Intervention name(s): Mindfulness Based Cognitive Therapy
Intervention type(s): Behavioral
Intervention description(s): 8 weekly meetings in which basic mindfulness and meditation skills are taught, such as breathing meditation, body scan meditation, open awareness meditation, movement meditation, and targeting depression related cognitions and emotions in a mindful manner, as well as awareness exercises, group discussions, and daily home meditation practice routines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial
Condition: Sensorineural Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      The purpose of this study is to see if noise reduction programs in digital hearing aids help
      patients hear better than hearing aids without these programs. We also want to know if we can
      predict how successful patients will be with hearing aids.
    

Detailed description: 
      The first goal of this project is to examine the efficacy of digital hearing aids
      incorporating three noise reduction strategies (i.e., directional microphones alone vs.
      directional microphones with DSP noise reduction algorithm 1 vs. directional microphones with
      DSP noise reduction algorithm 2) in terms of both speech understanding outcomes and
      functional outcomes. The second goal is to identify individual characteristics that are
      predictive of successful functional outcomes with hearing aids.

      This study employs a multi-site, randomized, blinded, 2x2 factorial parallel group design.
      Three hundred subjects will be studied at three VA Medical Centers (Mountain Home, TN; Bay
      Pines, FL; and Los Angeles, CA) over a period of three years.

      Objective (word recognition ability and performance with degraded speech stimuli) subjective
      (self-assessment questionnaires, personality and depression assessments) and
      cost-effectiveness assessments will be measured for 4 randomized treatment groups receiving
      different digital hearing aid technology. Subjects will be randomly assigned to wear hearing
      aids with directional microphones alone or directional microphones with noise reduction
      algorithm 1 or directional microphones with noise reduction algorithm 2 for a period of 8
      weeks. Subjects will complete post-testing after 8 weeks of hearing aid use.
    

Intervention name(s): Digital noise reduction
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aging; hearing aids; hearing loss, sensorineural; speech recognition