bioihbjkbjnl/mcl2 huggingface dataset:
A Single Escalating Dose and Multiple Dose Study of BAY 1093884 in Subjects With Severe Hemophilia Types A or B, With or Without Inhibitors
Condition: Hemophilia A; Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigate the safety, tolerability and pharmacokinetics of BAY1093884 after Intravenous
      (IV) and subcutaneous (SC) administration of increasing single doses and SC administration of
      multiple doses.
    


Intervention name(s): BAY1093884; BAY1093884
Intervention type(s): Drug; Drug
Intervention description(s): Single escalating dose with a starting dose of 0.3 mg/kg for the first cohort. Drug will be administered via IV infusion over 1 hour and SC injection. Based on safety, PK and PD results the doses for the other cohorts will be determined.; Multiple dose cohort with a single 150-mg SC injection once a week for 6 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Destiffening and Hypotensive Effects of Whole Milk and Full-fat Dairy Products
Condition: Hypertension; Prehypertension
MeSH terms: Prehypertension
Study type: Interventional

Summary: 
      The specific aim of the proposed study is to address the efficacy of conventional full-fat
      dairy products as part of the normal routine diet for improving vascular function and
      reducing blood pressure in middle-aged and older adults with elevated blood pressure. The
      investigators hypothesize that dietary intervention including whole milk and full-fat milk
      products will induce significant decreases in systolic blood pressure and arterial stiffness.
      The investigators also test the hypothesis that the reductions in blood pressure will be
      associated with the corresponding decreases in arterial stiffness and/or increases in
      endothelial vasodilatory function as well as improvements in arterial baroreflex sensitivity.
      If our hypotheses are supported by the results, the information could be used as a basis for
      recommendations for the use of whole milk and full-fat milk products in the secondary
      prevention of elevated blood pressure and vascular dysfunction.
    


Intervention name(s): High fat dairy; Plant-based
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Add 4 daily servings per day of high fat dairy (yogurt, milk, cheese) for a period of 4 weeks; Add 4 daily servings of fruit (fruit cup, apple sauce) and/or plant-based milk, remove all dairy for a period for 4 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Dose-response Study With Subcutaneous Immunotherapy of an Standardized Dermatophagoides Pteronyssinus (DPT) Extract
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      As part of the registration plan of our products and after performing a Phase I study the
      present trial has been designed to compare the efficacy of 5 different doses of subcutaneous
      immunotherapy in depot presentation.
    


Intervention name(s): Allergovac depot; Allergovac depot; Allergovac depot; Allergovac depot; Allergovac depot; Allergovac depot
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Depot sterile suspension fpor subcutaneous injection
Increasing concentrations to reach the following maintenance doses:
Group 1: 0.25 SPT; Depot sterile suspension for subcutaneous injection.
Increasing concentrations to reach the following maintenance doses:
Group 2: 0.5 SPT; Depot sterile suspension for subcutaneous injection.
Increasing concentrations to reach the following maintenance doses:
Group 3: 1 SPT; depot sterile suspension for subcutaneous injection
Increasing concentrations to reach the following maintenance doses:
Group 4: 2 SPT; Depot sterile suspension for subcutaneous injection.
Increasing concentrations to reach the following maintenance doses:
Group 5: 4 SPT; Sterile suspension for subcutaneous injection.
Same number of administration as the active groups
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergy; Allergic rhinoconjunctivitis; Immunotherapy; D. pteronyssinus; house dust allergy
Metformin Extended Release Versus Metformin Immediate Release in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4, prospective, open label, randomized, parallel controlled multicenter trial
      in which metformin extended release (XR) will be compared with metformin immediate release
      (IR) for the gastrointestinal tolerability and efficacy in the newly diagnosed subjects with
      Type 2 diabetes who have glycosylated hemoglobin (HbA1c) value between 7.0 to 10.0 percent
      (%).
    


Intervention name(s): Metformin IR; Metformin XR
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive Metformin Immediate Release (IR) tablets, orally once daily at a dose of 500 milligram (mg) for 1 week, and then dose will increase with increments of 500 mg every week in first 2 weeks to 1500 mg. After that dose will increase up to maximum dose of 2000 mg for the next 2 weeks and will be maintained at 2000 mg until Week 16.; Subjects will receive Metformin Extended Release (XR) tablets, orally once daily at a dose of 500 mg for 1 week, and then dose will increase with increments of 500 mg every week in first 2 weeks to 1500 mg. After that dose will increase up to maximum dose of 2000 mg for the next 2 weeks and will be maintained at 2000 mg until Week 16.
Other intervention name(s): Glucophage IR; Glucophage XR
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Metformin XR; Metformin IR
Revision Total Hip Replacement Arthroplasty and Hematologic Variables
Condition: Avascular Necrosis of Hip; Degenerative Hip Joint Disease
MeSH terms: Joint Diseases; Osteoarthritis, Hip; Necrosis
Study type: Observational

Summary: 
      Revision total hip replacement arthroplasty is a surgery having intra- and postoperative
      substantial blood loss. The investigators will investigate the relationship between the
      various hematologic variables and postoperative bleeding volume.
    


Intervention name(s): RTHRA group
Intervention type(s): Other
Intervention description(s): hematologic variables measurement in patients undergoing revision total hip replacement
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing revision total hip replacement
Removal of Massive Subretinal Organized Blood Clot With Fragmatome
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Thrombosis
Study type: Observational

Summary: 
      By using the ultrasound power delivered by fragmatome, the hard, organized blood clot could
      be removed easily.
    


Intervention name(s): fragmatome
Intervention type(s): Procedure
Intervention description(s): Patients with massive subretinal hemorrhage from age related macular degeneration and organized subretinal blood clot were managed by inferior retinectomy. The subretinal organized blood clot was dragged to the preretinal space and removed by fragmatome. The retinal was reattached with perfluorocarbon liquid and laser was applied at the margin of retinectomy. Silicon oil was infused at the end of surgery.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with massive subretinal hemorrhage from age related macular degeneration and
        organized subretinal blood clot were managed by inferior retinectomy
      
Keywords: organized blood clot; fragmatome; exudative age related macular denegeration
First-in-Human Study With Single and Multiple Doses of TS-161 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, first-in-human study involving single and multiple oral doses of TS-161 in
      healthy male and female participants. The safety, tolerability, pharmacokinetics and
      pharmacodynamics of TS-161 will be evaluated.

      The study includes 3 parts; Part A (single ascending dose: Cohorts 1 to 5) , Part B (single
      dose, cerebrospinal fluid [CSF] collection: Cohort 6), and Part C (multiple ascending dose:
      Cohorts 7 to 9). Participants will be assigned to one of the 9 Cohorts.
    


Intervention name(s): TS-161; TS-161 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TS-161 capsules; TS-161 matching placebo capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: TS-161; CSF; first-in-human
Efficacy and Safety of the Device Siesta-SystemTM for Inducing Objective Sleep and re Rest
Condition: Sleep
Study type: Interventional

Summary: 
      NTRODUCTION: The investigators have developed a new device to help passengers of vehicles to
      rest, sleep, and to avoid cervical injuries due to sleepiness postures while travelling. The
      device is attached to the headrest and is based in a new concept called "dynamic vertical
      holding of the head and neck". It could also provide some help in avoiding accidents by
      allowing a sleeping time for a secondary driver while the main one is driving. Several
      studies have shown that up to 30% of car crashes are related to sleepiness.

      AIM: To estimate the efficacy and safety of a new device in "patent pending" phase to
      facilitate the sleep and rest in the passenger.

      METODOLOGY: DESIGN: Prospective, cross-over and open clinical assay, comparing the results of
      40 different passengers during a journey after using both systems, that is the new device and
      the standard headrest.

      MEASUREMENTS: A) Standard polysomnography for 3 and a half hours during the night; B)
      Anthropometric and clinical variables; C) Sleepiness scale and Epworth sleepiness; D)
      Questionnaires of sleep, health and quality of life. E) Evaluation of the neck posture in
      recorded images.

      ANALYSIS: To compare the results of questionnaires of sleep quality, comfort and safety as
      well as the images recorded and polysomnographic variables of objective sleep variables
      obtained by the device Siesta-SystemTM and the conventional headrest.
    


Intervention name(s): Siesta-System; Standard headrest
Intervention type(s): Device; Device
Intervention model: Crossover Assignment
Primary purpose: Supportive Care
Keywords: passenger,; sleep,; rest,
Phenotyping the Alignment of the Lower Limb
Condition: Lower Limb Deformity
MeSH terms: Congenital Abnormalities
Study type: Observational

Summary: 
      In the international literature there are only few publication about the normal biomechanical
      parameters of the lower limb examined prospectively in healthy population. The goal of our
      study to determine 15 anatomical and biomechanical parameters of the lower limb using 3D
      reconstruction based on upright, stereo radiographs in young, healthy volunteers.
    


Intervention name(s): EOS
Intervention type(s): Diagnostic Test
Intervention description(s): EOS Micro Dose imaging will be done. SterEOS 3D recontruction of the lower limb and pelvis will be performed.
Other intervention name(s): EOS 2D/3D scanning and SterEOS 3D reconstruction
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young, healthy volunteers
      
Keywords: EOS 2D/3D; Lower limb alignment; Lower limb rotation; Osteoarthritis of the Knee; Osteoarthritis of the Hip
NMES and Pelvic Fracture Rehabilitation
Condition: Trauma; Rehabilitation
MeSH terms: Hip Fractures
Study type: Interventional

Summary: 
      Objectives: The acute care of pelvic fractures has improved recently however there are no
      formal guidelines for rehabilitation of these types of fractures. Patients have long periods
      of non-weight bearing causing muscle wastage. Neuromuscular electrical stimulation (NMES) has
      proven to minimise muscle loss. However, this has not previously been investigated within
      this patient population.

      Design: Double blind, randomised, feasibility study.

      Setting: NHS trust hospital setting.

      Participants: Nine patients with surgically fixed pelvic fractures were randomly allocated at
      six weeks post fracture.

      Interventions: The intervention group completed six weeks of NMES. The placebo group used
      transcutaneous electrical nerve stimulation (TENS).

      Main outcome measures: Peak torque (Nm) was calculated in the operated limb at 12 weeks using
      the non-operated limb as a baseline. Compliance and intensity levels were recorded.
      Feasibility of NMES was evaluated using a feasibility questionnaire. Pain was measured at six
      and 12 weeks using a visual analogue scale (VAS).
    


Intervention name(s): Neuromuscular muscle stimulation machine- Strength Setting; Neuromuscular muscle stimulation machine - TENS Setting
Intervention type(s): Device; Device
Intervention description(s): Muscle stimulation to strength skeletal muscle; Muscle stimulation to mimic the intervention but without the strength gains.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Treatment and intervention group
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effect of Aureobasidium Pullulans Produced β-glucan on Musculoskeletal Biomarkers in Adults With Relative Sarcopenia
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      The investigators conduct a randomized, double-blind, placebo-controlled study to investigate
      the effects of Aureobasidium pullulans produced β-glucan on muscle strength, muscle mass, and
      muscle function in adults with relative sarcopenia for 12 weeks.
    

Detailed description: 
      A previous study has indicated that Aureobasidium pullulans produced β-glucan may increase
      muscle mass and strength. Therefore, the investigators conduct a randomized, double-blind,
      placebo-controlled study to investigate the effects of Aureobasidium pullulans produced
      β-glucan on muscle strength, muscle mass, and muscle function in adults with relative
      sarcopenia; the safety of the compound are also evaluated. The Investigators examine the peak
      torque/body weight at 60°/s knee extension, handgrip strength, skeletal muscle mass, physical
      performance, and metabolic parameters at baseline, as well as after 6 and 12 weeks of
      intervention. Eighty adults were administered either 1,000 mg of Aureobasidium pullulans
      produced β-glucan or a placebo each day for 12 weeks.
    

Intervention name(s): Aureobasidium pullulans produced β-glucan group; placebo group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Aureobasidium pullulans produced β-glucan 1,000 mg/day for 12 weeks; Placebo 300 mg/day for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Prospective Study of Medical Therapy Against Cryoballoon Ablation in Symptomatic Recent Onset Persistent AF
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      Prospective trial comparing the efficacy and safety of CryoBalloonAblation (CBA) to
      standardized medication for treatment of early onset persistent atrial fibrillation (AF)
      without structural heart disease. The value of CBA in these patients has never been studied;
      the endpoints for persistent patients are much easier than for paroxysmal patients. Reduction
      in left atrial (LA) size will be compared versus patients on drug therapy and versus failing
      patients.
    

Detailed description: 
      The total AF history should be shorter than 24 months. Symptomatic patients can be included
      if they have had within the last year at least 2 episodes of documented AF, lasting minimal
      30 sec. One episode in the entire history should have lasted more than 48 h, requiring
      electrical or pharmacological cardioversion or stopped spontaneously after more than 7 days.

      All patients eligible for the study will sign informed consent, have an echocardiogram prior
      to inclusion to exclude severe left ventricular dysfunction, to rule out significant valve
      abnormalities, left ventricular hypertrophy and to assess the LA volume and diameter.

      Prior to randomization, and after inclusion it is suggested to the local investigators to
      perform an MRI-scan or CT scan of the LA and pulmonary veins (in both branches of the study )
      in eligible patients to assess the anatomy and the left atrial volume. The results should not
      influence the strategy of treatment.
    

Intervention name(s): single ablation (CryoBalloonAblation (CBA); sequential drug adjustment (propafenone, sotalol or flecainide)
Intervention type(s): Device; Drug
Intervention description(s): Cryoablation at entry, after randomization to this group; Correct drug dosage at entry, sequential adjustment / titration, in stage 2 amiodarone
Intervention MeSH terms: Flecainide; Sotalol; Propafenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atrial fibrillation; cryoablation; catheter ablation
Heredity of Retinal Vessel Tortuosity
Condition: Retinopathy of Prematurity
MeSH terms: Retinopathy of Prematurity
Study type: Observational

Summary: 
      The purpose of this study is to asses the relative influence of genetic and environmental
      influence on the tortuosity of retinal arterioles in eyes of 218 healthy Danish twins aged
      20-46 years. We expect to find a high heredity for the variation in tortuosity. This
      knowledge can contribute to the elucidation of the pathology in retinal diseases.
    

Detailed description: 
      All persons underwent an ophthalmic examination including refraction, slit lamp biomicroscopy
      and digital fundus photography. Two independent graders (both with an MD degree) made a
      visual grading of the severity of tortuosity of the retinal arterioles in the fundus images.
    

Observational model: Defined Population
Time perspective: Other
Keywords: retinal vessels; tortuosity
Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease; Hiatal Hernia
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Hernia, Hiatal
Study type: Interventional

Summary: 
      The study objective is to evaluate the relative merits, safety and effectiveness of transoral
      incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients
      compared with sham procedure.
    

Detailed description: 
      Primary Effectiveness Endpoint: The proportion of patients in clinical remission after 6
      months (without being classified as treatment failure).

      Secondary Effectiveness: PPI consumption, esophageal acid exposure, reduction in QOLRAD and
      GSRS scores and healing of reflux esophagitis.
    

Intervention name(s): Transoral Incisionless Fundoplication (TIF)
Intervention type(s): Procedure
Intervention description(s): The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degress around the esophagus.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: GERD; Esophagitis; Fundoplication; Anti-reflux surgery; PPI dependent
Acupuncture in Menopause
Condition: Vasomotor Symptoms
Study type: Interventional

Summary: 
      The primary purpose of this study is to determine the effectiveness of acupuncture for
      treating vasomotor and other symptoms associated with menopause as acupuncture is generally
      practiced in the "real world" setting and to obtain a comprehensive assessment of use
      patterns and symptom relief over time. This study will allow us to determine treatment
      patterns recommended by practicing acupuncturists, adherence to these treatments, and the
      effectiveness of different treatment patterns for reducing hot flashes. Results of this study
      will provide meaningful information to women in terms of number and frequency of acupuncture
      treatments likely to be needed to reduce hot flashes.
    


Intervention name(s): Acupuncture
Intervention type(s): Procedure
Intervention description(s): For the Acupuncture group: Women will be eligible to receive from 1 to 20 treatments over a six month period. These women will receive an initial evaluation by a acupuncturist and will be given a Traditional Chinese Medicine (TCM) diagnosis as well as a recommended treatment schedule which they can then negotiate.
Women in the waitlist group will not receive any acupuncture for 6 months. At the end of the 6 month period the participants will be allowed to begin the acupuncture treatments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acupuncture; Hot Flashes; Menopause; Vasomotor Symptoms
Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      To screen women who are high risk for breast cancer with breast MRI, mammogram and random
      periareolar fine needle aspiration.
    

Detailed description: 
      General Purpose: The purpose of our protocol is develop a comprehensive screening protocol
      for women at high risk for developing breast cancer in the hopes of detecting breast cancer
      or it's precursor lesions at the earliest possible stage and reducing breast cancer
      mortality.

      The following are our specific goals in this endeavor;

        1. To assess the sensitivity and specificity of MRI in breast cancer detection in women at
           high risk compared to mammography

        2. To assess the ability of random periareolar fine needle aspiration to detect abnormal
           ductal cells and to correlate these results with MRI and mammogram findings

        3. To assess appropriate screening intervals for BRCA1/2 mutation carriers and women with a
           >10% risk of developing breast cancer in ten years The following aims will be outlined
           in detail under methodology.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with high risk of breast cancer