bioihbjkbjnl/mcl2 huggingface dataset:
Betaine in Patients With Nonalcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety and efficacy of betaine in patients with NASH on markers of disease
      severity such as liver histology, liver biochemistries, and health related quality of life.
    


Intervention name(s): Cystadane; Identical Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Betaine 20 mg a day or identical placebo for 1 year.; Placebo
Intervention MeSH terms: Betaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Nonalcoholic Steatohepatitis; NASH; Betaine
Basal Insulin And Compensation Glycemic In Diabetic Patients In Basal Bolus Outpatient.
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Multicentric, observational, cross-sectional study in Italy. The aims are to evaluate the
      basal/total ratio of daily insulin dose (b/T) in diabetic outpatients type 1 (T1) and type 2
      (T2) on basal-bolus regimen, by investigating whether there is a relationship with HbA1c and
      episodes of hypoglycemia.
    

Detailed description: 
      The study was commissioned by the Italian Association of Clinical Endocrinologists
      (Associazione Medici Endocrinologi - AME) and approved by the Ethical Committee of Cuneo
      Hospital (BASAL Study- OSS 001/2016 - rif ENDO 30). The research was open to all specialists
      taking care of patients with diabetes in Italy.

      The primary endpoint was glycemic control, evaluated by HbA1c levels, according to b/T.

      Secondary endpoints were occurrence of major hypoglycemic episodes according to b/T;
      differences between patients with T1 and T2.

      An ad hoc form was developed and used to record all medical findings. The form was emailed to
      all participating centers who then emailed or faxed it back to our data manager. Data were
      checked for accuracy.

      The following data were required: age, gender, body weight and height, country of origin,
      type of diabetes and its duration, units of basal and total (basal plus prandial) daily
      insulin, type of basal insulin (Glargine, Detemir or Degludec), use and dosage of metformin,
      and number of major hypoglycemic episodes (<40 mg/dL or requiring caregivers intervention) in
      the last three months. Serum creatinine and HbA1c levels obtained within the previous two
      months were also required.

      Each participating center recruited between 20 and 40 diabetic outpatients. Inclusion
      criteria were as follows: adult outpatients (≥20 and ≤80 years) with T1 or T2 diabetes
      mellitus, on basal-bolus insulin regimen (basal insulin, i.e. Glargine, Detemir or Degludec,
      plus at least two prandial insulin shots) for at least six months, usually assuming three
      daily meals, and capable of informed consent.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All diabetic patients respecting eligibility criteria
A Crossover Study to Evaluate Pegilodecakin (LY3500518) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess how fast pegilodecakin gets into the blood stream and
      how long it takes the body to remove it, when given as a solution formulation via a prefilled
      syringe (PFS) versus from a vial drawn into a conventional syringe. Information about side
      effects will be collected. The study is open to healthy participants. Total participant
      duration in trial is approximately 42 days.
    


Intervention name(s): Pegilodecakin
Intervention type(s): Biological
Intervention description(s): Administered SQ
Other intervention name(s): LY3500518; AM0010
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study To Evaluate The Effect Of Food On The Behavior Of Tofacitinib Modified Release 11 Milligram Tablets In Healthy Western And Japanese Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the drug behavior and safety of a single dose of the 11 milligram
      tofacitinib (CP-690,550) modified-release formulation in 24 healthy volunteers when taken
      after eating a high fat meal (the effect of food). This will be compared to the drug behavior
      and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release
      formulation when taken after a 10 hour fast.
    


Intervention name(s): tofacitinib modified-release (MR) formulation; tofacitinib modified-release (MR) formulation
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of tofacitinib modified release 11 mg tablet after receiving the standard FDA high fat/high calorie meal.; tofacitinib modified release (MR) 11 mg tablet after a 10 hour overnight fast.
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Food effect; pharmacokinetic; healthy volunteer
The Effect of Different Types of Dietary Fiber on Satiation
Condition: Healthy
Study type: Interventional

Summary: 
      It has been suggested that dietary fibers can affect food intake and satiation. Satiation, or
      meal termination, can be induced by sensory properties and energy density of fiber-rich food
      products, but also by the chemical/physical/rheological behavior of the fibers in the stomach
      and/or intestine. It is not clear which properties are the key regulators of satiation by
      fiber sources. There are many types of dietary fiber, which have diverse sensory and chemical
      properties, thus these might have different effects on satiation.
    


Intervention name(s): cellulose, alginate, guar gum
Intervention type(s): Dietary Supplement
Intervention description(s): 6 different food products are developed with different dosages of dietary fiber. Regular flour is replaced by dietary fiber, dosages are described in the 'arms'section.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Dietary fiber; guar gum; alginate; cellulose; food intake; eating behaviour
Treatment of Atrophic Post Acne Scars by Fat Grafting
Condition: Atrophic Acne Scars
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      This single-center, clinical trial consists of a one autologous fat grafting treatment
      followed by1-week , 1month , 3-month and 6-month post-treatment visits in order to assess the
      efficacy and complications of fat grafting when used for facial atrophic acne scars on
      cheeks.
    

Detailed description: 
      This investigation, pilot study will evaluate the safety and efficacy of autologous fat
      grafting for the treatment of atrophic acne scarring on cheeks. Overall assessment of
      clinical outcome and safety will be based clinic visits and evaluation of pre- and post-
      procedural on the Goodman-Barron scale.

      The subject's assessment of satisfaction will be characterized using a non-parametric
      assessment scale at the end of the follow-up period.
    

Intervention name(s): Fat Grafting
Intervention type(s): Procedure
Intervention description(s): This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with atrophic acne scars on the cheeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acne- atrophic scars - autologous fat
Urinary Incontinence and Transtheoretical Model
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the effectiveness of nursing care given online to women
      with urinary incontinence based on the Transtheoretical (Change) Model.
    

Detailed description: 
      The research was planned as a randomized experimental design with pre-test and post-test
      control groups. The research will be conducted in Kutahya, Turkey.

      A total of seven online interviews will be conducted with the women in the experimental
      group, one of which is pre-test, one is the last interview where the post-tests are applied,
      and five of which are motivational. Women in the experimental group were interviewed every 2
      weeks and the women will be followed up by phone/mail every 2 weeks. A total of two online
      interviews will be conducted with women in the control group, one of which is a pre-test
      interview and one is a final interview where post-tests are applied. No application will be
      made to women in the control group. All online calls to be made will be conducted via the
      WhatsApp application.
    

Intervention name(s): Nursing care based on the transtheoretical model
Intervention type(s): Behavioral
Intervention description(s): Nursing care consists of urinary incontinence training, motivational interview and telephone/mail counseling processes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Urinary Incontinence; transtheoretical model; motivational interviewing; nursing care
A Study to Document Long-Term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects With Refractory Solid Tumors (Rollover Study -001, -002)
Condition: Pediatric Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the long term safety of patients with refractory
      solid tumors who have experienced clinical benefit after at least 6 cycles of treatment in
      BMS Protocol CA124-001 or CA124-002.
    


Intervention name(s): Carboplatin; Irinotecan; Irinotecan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV, Infusion, AUC2 mg/ml.min, Once every 21 days, until progression or unacceptable toxicity; IV, Infusion, 12 (9) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity; IV, Infusion, 10 (18) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity
Other intervention name(s): Paraplatin; BMY-26575; Camptosar; Campto; Camptosar; Campto
Intervention MeSH terms: Carboplatin; Irinotecan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study To Examine The Distribution Of PF-05212377 In The Brain Of Healthy Volunteer Subjects Using Positron Emission Tomography And A Radioactive Tracer Following Oral Administration Of One Dose Of PF-05212377
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will see how PF-05212377, an experimental drug to treat symptoms from Alzheimer's
      Disease, distributes in the brain after one dose of PF-05212377 is administered orally to
      healthy volunteer subjects. The study will also evaluate the safety and tolerability of
      PF-05212377 in these subjects and will measure the level of PF-05212377 in the blood.
    


Intervention name(s): PF-05212377; PF-05212377; PF-05212377
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single, oral dose administration of 70 mg PF-0521377 using a capsule formulation.; Single, oral dose administration of 20 mg PF-0521377 using a capsule formulation. This dose is an estimate. The exact dose for Arm 2 will be based on the results from Arm 1.; Single, oral dose administration of 10 mg PF-0521377 using a capsule formulation. This dose is an estimate. The exact dose for Arm 2 will be based on the results from Arms 1 and 2.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PF-05212377; phase 1; open-label; 5-HT2a receptor occupancy; positron emission tomography; healthy subjects; brain; cortex; alzheimers disease
Tolerability and Safety of Subcutaneous Administration of Two Doses of AFFITOPE® PD01A in Early Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I study to assess the tolerability and safety of 4 injections of two
      different doses of AFFITOPE® PD01A formulated with an adjuvant to patients with early
      Parkinson's disease in male and female patients aged 45 to 65 years (or age between 40 and 45
      years if there is no evidence for genetic forms of the disease and the diagnosis of
      idiopathic Parkinson's disease was confirmed, after approval by Sponsor). One study site in
      Vienna (Austria) will be involved. Each patient's participation will last 1 year.

      In addition, up to 8 patients will be offered participation within an untreated control
      group.
    


Intervention name(s): AFFITOPE® PD01A; Control
Intervention type(s): Biological; Other
Intervention description(s): s.c. injection; Untreated control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
New Stage 1 Formula on Gut Comfort and Gut Health
Condition: Health Behavior
Study type: Interventional
Phase: Phase 4

Summary: 
      180 qualified subjects aged from 7 days to 90 days will be enrolled with the 144 completed in
      study (allowing for a 20% drop-out rate). Subjects will be randomly assigned into 3 groups,
      including breast feeding, commercial and new formula group. Study intervention is 12 weeks.
    

Detailed description: 
      Primary objective:

      1. Improvement on gut health and infant comfort

      Secondary objective：

        1. Efficacy on easy digestion;

        2. Changes on SCFA in feces(Baseline and Endpoint)

        3. Improvement on gut microbiome strains(Baseline and Day 21);
           (bifidobacterium/lactobacillus/clostridium perfringens recommended)

        4. Changes on sIgA in feces(Baseline and Endpoint)

        5. Improvement on tolerance(comfort) via infant fussy/bloating/abdominal pain/milk
           regurgitation/sleeping time;

        6. Incidence of eczema and duration;

        7. Infants growth
    

Intervention name(s): Oral intake of Feihe New Formula; Oral intake of Feihe Stage 1 Formula; Breast Feeding
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Oral intake of Feihe New Formula; Oral intake of Feihe Stage 1 Formula; Oral intake of breast milk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Preoperative Chemoradiation With Capecitabine and Cetuximab
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      -  feasibility and tolerance of preoperative therapy with Cetuximab in combination with
           Capecitabine and radiotherapy for patients with locally advanced operable rectal
           carcinoma

        -  collection of response rate (T-downstaging, pathological complete remission),
           correlation of responsiveness with EGFR-status
    


Intervention name(s): Capecitabine; Cetuximab
Intervention type(s): Drug; Drug
Intervention description(s): 825 mg/m2 bid (on each therapy day of first 4 therapy weeks); 400mg/m2 week 1, 250mg/m2 week 2-4
Other intervention name(s): Xeloda; Erbitux
Intervention MeSH terms: Capecitabine; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pilot study; rectal; cancer; phase II; preoperative; chemoradiation; capecitabine; cetuximab; operable; T4; ABCSG; TAKO; R03; 96; 06
PET/MRI in PAH Patients
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Observational [Patient Registry]

Summary: 
      Aim of the study is to compare novel parameters of right ventricle (RV) function from right
      heart catheterization (RHC) and magnetic resonance imaging (MRI) with PET-derived RV FDG
      uptake.
    

Detailed description: 
      Objectives In pilot study investigators aimed to compare novel parameters of right ventricle
      (RV) function from right heart catheterization (RHC) and magnetic resonance imaging (MRI)
      with PET-derived RV FDG uptake.

      Background Right ventricular (RV) function is a major determinant of survival in patients
      with pulmonary arterial hypertension (PAH). Hemodynamic parameters like end-systolic
      elastance (Ees), arterial elastance (Ea), pulmonary arterial compliance (PAC) and Ees/Ea
      ratio have been shown to reflect RV function and prognosis in PAH. Increased RV
      18F-fluoro-2-deoxyglucose (FDG) uptake in positron emission tomography (PET) was recently
      associated with progressive RV dysfunction in these patients.

      Methods Twenty-five stable PAH patients (49.92±15.94 years) and twelve healthy subjects
      (control group, 44.75±13.51 years) had simultaneous PET and MRI scans performed. FDG was used
      as a tracer and its uptake was presented as a standardized uptake value (SUV) for both left
      (LV) and right ventricle.
    

Intervention name(s): PET/MRI
Intervention type(s): Radiation
Intervention description(s): PET/MRI scans
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        We enrolled twenty-five stable adult patients diagnosed with pulmonary arterial
        hypertension. A diagnosis of pre-capillary pulmonary hypertension (PH) was confirmed by
        right heart catheterization [mean pulmonary artery pressure (mPAP) ≥25 mmHg, pulmonary
        artery wedge pressure (PAWP) ≤15 mmHg] and the use of an algorithm that included perfusion
        lung scan, echocardiography, respiratory function tests, and computer tomography to rule
        out secondary PH causes according to European guidelines [16]. The control group consisted
        of twelve healthy controls who were matched based on sex and age. During the baseline
        evaluation, we performed a physical examination, six-minute walk test, laboratory tests
        e.g. serum B-type natriuretic peptide (BNP), morphology and renal function parameters.
A 52 Week Open Label Trial of Memantine for Frontotemporal Lobar Degeneration
Condition: Frontotemporal Lobar Degeneration
MeSH terms: Frontotemporal Lobar Degeneration
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 52-week, multicenter, open label trial of memantine (Namenda) for frontotemporal
      lobar degeneration (FTLD). The goal is to determine the safety and tolerability of this
      FDA-approved medication for Alzheimer's Disease in patients with FTLD. Secondary outcome
      measures include cognitive batteries, rating scales for activities of daily living and
      neuropsychiatric symptoms. All patients receive the FDA-approved dose of this medication for
      Alzheimer's disease.
    


Intervention name(s): Memantine
Intervention type(s): Drug
Intervention MeSH terms: Memantine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I/II Study of KP-100IT in Acute Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is randomized, double-blind, placebo-controlled Phase I/II study designed to
      evaluate safety and efficacy of KP-100IT, code of Hepatocyte Growth Factor (HGF) formulation
      for intrathecal injection, as a treatment for acute spinal cord injury. The study is
      conducted at two clinical sites in Japan.
    


Intervention name(s): KP-100IT; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Hepatocyte Growth Factor; HGF
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatocyte Growth Factor; HGF; KP-100IT; Intrathecal injection
Comparison of Retinal Perfusion Between Diabetic and Non-diabetic Patients With OCT Angiography After Cataract Surgery.
Condition: Diabetes Mellitus Type 2; Age Related Cataracts
MeSH terms: Cataract; Capsule Opacification; Diabetes Mellitus, Type 2
Study type: Observational [Patient Registry]

Summary: 
      This study aims to compare the retinal perfusion between diabetic and non-diabetic patients
      with Optical Coherence Tomography（OCT） Angiography after cataract surgery, to thoroughly
      evaluate the retinal state of diabetics after surgery, and to find out the relationship
      between postoperative complications occurred in retina and diabetes.
    

Detailed description: 
      In this study, we perform a completely comparison of retina state characteristic including
      the foveal avascular zone(FAZ),perifovea vessel density,parafovea vessel density,macular
      thickness,perifovea thickness,parafovea thickness in superficial and deep layers of retina
      with OCT Angiography after cataract surgery,and analysis on the differences of
      EGF,IFN-γ,IL-10,IL-12,IL-1β,IL-6,IL-8,IP-10,MCP-1,VEGF in aqueous humor before surgery
      between diabetic and non-diabetic patients and to explore the potential correlations between
      postoperative complications occurred in retina and diabetes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study Population: Asian
      
Biospecimen description: 
      aqueous humor from the subjects
    
Keywords: diabetes; OCT Angiography; cataract surgery