bioihbjkbjnl/mcl2 huggingface dataset:
Comparing Enoxaparin to Fondaparinux to Prevent Venous Thromboembolism (VTE) in Bariatric Surgical Patients
Condition: Deep Venous Thrombosis; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Venous Thrombosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This pilot study is designed to determine the feasibility of conducting a randomized clinical
      trial comparing fondaparinux sodium (Arixtra) once daily with enoxaparin (Lovenox®) twice
      daily with respect to preventing deep vein thrombosis (DVT) and pulmonary embolism (PE) after
      bariatric surgery in obese patients.
    

Detailed description: 
      In order to determine the feasibility of such a trial we need to determine the necessary
      sample size. In order to determine the necessary sample size, we need to obtain estimates of
      the incidence of DVT and the prevalence of PE using MRV in each treatment group. Descriptive
      statistics and 95% confidence intervals will be calculated to determine the incidence of DVT
      and the prevalence of PE using MRV in obese patients who have received treatment to prevent
      DVT and PE associated with bariatric surgery.

      Anti-factor Xa levels will be used to help determine if treatments are reaching appropriate
      levels.
    

Intervention name(s): Enoxaparin; Fondaparinux
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive enoxaparin 40mg subcutaneously twice daily during perioperative period of bariatric surgery. Patients will be encouraged to ambulate and compression stockings while in bed.; Fondaparinux 5mg subcutaneously 6 hours following surgery, fondaparinux 5mg subcutaneously once daily during hospitalization. Patients will be encouraged to ambulate and compression stockings while in bed.
Intervention MeSH terms: Enoxaparin; PENTA; Fondaparinux
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: DVT; PE; MRV; bariatric surgery
Ascending Dose Study of the Safety and Tolerability of REGN727(SAR236553) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the safety and tolerability (how the body reacts to the drug) of REGN727
      compared with placebo (an inactive substance that contains no medicine) in healthy subjects.
      The study drug and placebo will be administered by intravenous (I.V) infusion at one clinic
      visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be
      monitored by the study staff for side effects and the body's response to the study drug.
      Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood
      and urine samples will be collected at some or all visits.
    


Intervention name(s): REGN727; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 IV cohorts (dose 1, 2, 3, 4, and 5); 5 IV cohorts (dose 1, 2, 3, 4, and 5)
Intervention MeSH terms: Alirocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome
Condition: Infertility
MeSH terms: Infertility; Ovarian Hyperstimulation Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to compare the effect of oral Diosmin to oral Cabergoline in the
      prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent
      intracytoplasmic sperm injection (ICSI).
    

Detailed description: 
      Two hundred women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be
      randomly scheduled into two equal groups. In group A, (Diosmin group), 2 tab / 8 hs Diosmin (
      500mg) will be given at day of HCG injection and for 2 weeks ; while in group B (Cabergoline
      group), 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for eight
      days.
    

Intervention name(s): Diosmin; Cabergoline
Intervention type(s): Drug; Drug
Intervention description(s): 2 tab / 8 hs Diosmin ( 500mg) will be given at day of HCG injection and for14 days; 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days
Other intervention name(s): Daflon; Dostinex
Intervention MeSH terms: Cabergoline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: infertility; ICSI; OHSS; Diosmin; Cabergoline
Vitamin D Supplementation in Psychiatric Illnesses
Condition: Obesity; Vitamin D Deficiency; Psychosis; Schizophrenia; Schizoaffective Disorder
MeSH terms: Vitamin D Deficiency; Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      Children and adolescents with psychiatric illnesses who are treated with medications called
      second generation antipsychotic agents (SGA) often gain excessive weight during their
      treatment with these medications. This weight gain may result in the development of features
      of the metabolic syndrome or frank diabetes mellitus. There is no consensus on the best way
      to prevent these complications. The investigators' hypothesis is that daily vitamin D
      supplementation in these patients will result in decreased levels of the markers of metabolic
      syndrome with associated reduction in waist circumference.
    

Detailed description: 
      In this 8-week open label trial, we will enroll 10 subjects who fulfill the Inclusion
      Criteria.
    

Intervention name(s): Ergocalciferols
Intervention type(s): Drug
Intervention description(s): 2000 international units by mouth daily for 8 weeks.
Other intervention name(s): Drisdol
Intervention MeSH terms: Ergocalciferols; Vitamin D
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychiatric illnesses; Vitamin D deficiency; Obesity
Randomised Study Comparing the Effects of Inhaled Fluticasone Furoate (FF)/Vilanterol (VI; GW642444M) Combination and FF on an Allergen Induced Asthmatic Response
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      We propose to use an inhaled allergen challenge model to explore the individual contributions
      of the components of a novel long-acting beta agonist (LABA)/ inhaled corticosteroid (ICS)
      combination product on protection from allergic triggers in asthma.
    


Intervention name(s): Fluticasone Furoate; FF/Vilanterol (VI; GW642444M); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): FF; FF/VI; Placebo Inhaler
Other intervention name(s): FF; FF/VI
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: mild asthma; allergen challenge; early asthmatic response
A Study to Evaluate Persistence of Immune Responses After Post-exposure Prophylaxis of Rabipur® (Purified Chicken-embryo Cell Rabies Vaccine) in Chinese Children
Condition: Virus Diseases
MeSH terms: Virus Diseases; Rabies
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the long-term persistence of immune responses
      approximately 5 years or more after simulated rabies post-exposure prophylaxis provided in
      2012 according to Essen (1-1-1-1-1) or Zagreb (2-1-1) intramuscular (IM) regimens in the
      subset of subjects who participated in the parent study (V49_24 [NCT01680016]) who were aged
      ≥6 and ≤17 years at the time of enrollment.

      This study is aimed to respond to a post-marketing commitment by the China Food and Drug
      Administration (CFDA) requested at the time of the renewal of the purified chicken-embryo
      cell rabies vaccine license in China, granted in August 2015.
    


Intervention name(s): Blood draw
Intervention type(s): Procedure
Intervention description(s): Subjects aged from ≥6 to ≤17 years at the time of enrolment in the parent clinical trial (following the CFDA post-marketing commitment requirement) and who received the full PEP rabies regimen as an intramuscular injection according to the vaccine group to which they were assigned in the V49_24 (NCT01680016) study will be invited to take part in this study. Single blood draw from subjects at Day-1/Visit-1. Subjects will be observed for 15 minutes after the blood draw.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Persistence; Purified chicken-embryo cell rabies vaccine; Rabies Virus Neutralizing Antibody (RVNA); Immunogenicity; Post-Exposure Prophylaxis (PEP); Rabipur
Broncho-Vaxom (OM 85 BV) in Children Suffering From Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this pilot double-blind study was to evaluate the efficacy and the safety of
      Broncho-Vaxom 1 capsule (3.5 mg) per day for 9 months compared to placebo on the evolution of
      the disease in children suffering from Atopic Dermatitis (AD).
    

Detailed description: 
      Children outpatients of both sexes, aged 6 months to 7 years, with AD confirmed by
      Haniffin-Rajka or Williams et al, and an AD score (SCORAD) between 25 and 70 were included
      and followed for 9 months. Patients were randomized to receive either Broncho-Vaxom 1 capsule
      (3.5 mg) per day or the corresponding placebo over 9 months.

      Children under general corticotherapy within one month of study start, patients with
      immunodeficiency, patient's affected body surface area less than 15% or greater than 70% or
      with known allergy to desonide were excluded.

      Outcome measures were a comparisons between the two groups in the number of AD flares during
      the study after the first month of treatment. Secondary outcome measures were comparisons
      between the two groups based on SCORAD evolution, area of eczema, amount of corticoids used
      and parents/investigator assessments.
    

Intervention name(s): Broncho-Vaxom; Placebo - Cap
Intervention type(s): Drug; Drug
Intervention description(s): BV is an orally administered immunostimulating preparation, which consists of a lyophilised bacterial extract prepared from 8 bacterial species (Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis); Matching Placebo capsule administered
Other intervention name(s): Imocur; Broncho-Munal; Ommunal; Paxoral; Vaxoral
Intervention MeSH terms: Broncho-Vaxom
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Nutrient Nutritional Advise for Low Back Pain Patients Seeking Chiropractic Care
Condition: Low Back Pain; Nutrition Poor
MeSH terms: Malnutrition; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The nutritional intervention will reduce LBP and cause 10% weight loss.
    

Detailed description: 
      This feasibility study will assess a two-armed low-back pain (LBP) randomized, prospective
      clinical trial with nutritional offerings provided for one-arm.
    

Intervention name(s): Combination: Nutrition AND Chiropractic Adjustment; Chiropractic Adjustment: Spinal Manipulation Therapy
Intervention type(s): Dietary Supplement; Other
Intervention description(s): LBP chiropractic adjustment per protocol, nutrition counseling/ 4 Nutrient offerings (Vitamin Booster, Shake + 2 other offerings); LBP chiropractic adjustment per protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized into one of two arms: 1) nutrition+chiropractic or 2) chiropractic only
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chiropractic manipulation; spinal manipulation therapy; osteopathic manipulation
Linagliptin Response to OGTT in Prediabetes and Type 2 Diabetes Mellitus
Condition: PreDiabetes; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
Study type: Interventional
Phase: Phase 3

Summary: 
      There are studies that suggest glycemic response to incretin-based therapies differs between
      Asians and Caucasians, whereby Asians have better response compared to Caucasians. Hence, the
      therapeutic response could also be augmented by difference in incretin system among various
      ethnicities. This study is carried out to study the effect of dipeptidyl-peptidase IV (DPPIV)
      inhibitors in prediabetes and T2DM patients who have different levels of GLP-1 and to
      determine the effect on glycemic profiles, insulin resistance/sensitivity, beta-cell functon.
    

Detailed description: 
      A 12-week, open-label, single treatment study using linagliptin is conducted in 28
      prediabetes and 22 T2DM subjects who are divided into low and high fasting GLP-1 groups.
      Prediabetes are recruited from OGTT screening. Type 2 diabetes patients are recruited from
      specialised diabetes clinic and routine follow-up. A 75-g oral glucose tolerance test (OGTT)
      is performed at week 0 and 12. Venous blood samples were drawn at times 0 (before initiation
      of OGTT), 30, 60, 90, 120 min from the indwelling catheter for measurement of glucose and
      insulin.All prediabetes and T2DM subjects receive Linagliptin 5mg once daily for a duration
      of 12 weeks.
    

Intervention name(s): Dipeptidyl-Peptidase IV Inhibitors
Intervention type(s): Drug
Intervention description(s): All subjects were given linagliptin 5mg once daily for 12 weeks. Comparison of their OGTT response at week 0 and week 12
Other intervention name(s): linagliptin
Intervention MeSH terms: Linagliptin; Dipeptidyl-Peptidase IV Inhibitors
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: open-labelled, single treatment study between Low GLP-1 group and High GLP-1 group of prediabetes/type 2 diabetes
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glucagon-like peptide 1; Dipeptidyl peptidase inhibitor; oral glucose tolerance test; prediabetes; type 2 diabetes
Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to compare the safety and effectiveness (how well the
      medicine works) of esomeprazole (study drug) to placebo (a capsule that does not contain any
      medication) taken daily in relieving nighttime heartburn and problems sleeping in patients
      with gastroesophageal reflux disease (GERD).
    


Intervention name(s): Esomeprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate; once daily
Other intervention name(s): Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: GERD; Esophageal Reflux; Gastro-Esophageal Reflux; Regurgitation; Gastric
Chest Dysphoria in Transmasculine Spectrum Adolescents
Condition: Gender Dysphoria
MeSH terms: Depressive Disorder, Major; Gender Dysphoria
Study type: Observational

Summary: 
      The investigators hypothesize that masculinizing top surgery (e.g., mastectomy and chest
      masculinization) leads to an improvement in self-report chest dysphoria, gender dysphoria,
      and gender congruence in assigned-female-at-birth, transgender and non-binary youth and young
      adults. This is a prospective, observational study that will enroll assigned-female-at-birth,
      transmasculine spectrum individuals age 13 to 25 years old who are or are not undergoing top
      surgery. Participants will complete a set of standard of care questionnaires regarding their
      chest dysphoria (e.g., distress about the chest), gender dysphoria (e.g., distress about a
      gender identity that does not match assigned sex), and gender congruence (e.g., degree to
      which an individual feels they are living in their authentic appearance and gender identity).
      They will complete this same set of questionnaires either three months after their top
      surgery or three months after the initial set of surveys.
    


Intervention name(s): Mastectomy and chest masculinization
Intervention type(s): Procedure
Intervention description(s): A surgical procedure in which the breasts are removed and the chest is given a masculine contour.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Top surgery participants will be recruited from plastic surgery practices at Northwestern
        University, the Ann and Robert H Lurie Children's Hospital of Chicago, and the University
        of Illinois Chicago. Matched controls will be recruited from the Lurie Children's Hospital
        Gender and Sex Development Program.
Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      In this study the investigators hypothesize that the presence of a Mayo Clinic certified
      therapy dog will provide additional benefits above typical therapy for patients suffering
      from fibromyalgia currently enrolled in the Mayo Clinic Fibromyalgia Program.
    

Detailed description: 
      The human animal bond refers an emotional relationship between animals and people. The
      purpose of this study is to evaluate whether the presence of a dog provide additional
      benefits above typical therapy for patients suffering from fibromyalgia and also to assess
      the emotional wellbeing state of the therapy dog.
    

Intervention name(s): Dog Interaction; Human Interaction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A therapy dog will visit the patients.; A human will visit the patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Correlation Study of Corneal Nerve Changes and Dry Eye in Contact Lens Wearers
Condition: Contact Lens Complication; Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Observational

Summary: 
      This study aims to analyze the changes of corneal nerve morphology and function in contact
      lens-related dry eye(CLADE) patients and further discuss the role of corneal nerve in the
      genesis and development of CLADE.
    

Detailed description: 
      33 daily disposable soft contact lens wearers with dry eye disease(DED), 33 DED without
      contact lens wear and 33 normal control subjects will be involved in study. One experienced
      ophthalmologist will evaluate the DED symptoms and signs, which include ocular surface
      disease index(OSDI), tear film breakup time(TBUT), Schirmer Ⅰ test, corneal fluorescein
      staining, lissamine green staining and meibomian gland dropout rate. After evaluating,
      corneal sensitivity are measured using a Cochet-Bonnet aesthesiometer. Corneal nerve
      morphology will be assessed in the right eye using in vivo confocal microscopy(IVCM). Fifteen
      to twenty minutes after IVCM, 20μL of basal tears will be collected from the inferior
      meniscus of each participant to test tear neuropeptides. Then investigators analyse the
      correlation of corneal nerve changes and DED symptoms and signs.
    

Intervention name(s): contact lens
Intervention type(s): Other
Intervention description(s): daily disposable soft contact lens
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        DED patients from Peking University Third Hospital
      
Biospecimen description: 
      tear
    
Keywords: contact lens; tear film; dry eye; corneal sub-basal nerve
An Improved Method for the Measurement of Oxygen and Anaesthetic Agent Uptake in Patients Using the Foldes-Biro Equation
Condition: E03.155.197; E03.155.253
Study type: Observational

Summary: 
      The primary aim is to confirm the efficacy of a new non-invasive method for measuring the
      oxygen uptake during general anesthesia of patients undergoing surgery under cardiopulmonary
      bypass. The method has already been successfully tested in the laboratory under controlled
      conditions. In the patient group chosen, oxygen uptake is simultaneously calculated, for
      comparison purposes, from monitoring measurements made routinely as part of normal patient
      care in these cases, using a pulmonary artery catheter - an invasive technique from which
      severe complications occasionally arise, including death.

      A secondary aim is to elucidate the time course of uptake of the anaesthetic vapor,
      isoflurane, during this kind of surgery.
    

Detailed description: 
      In a series of 30 patients undergoing cardiopulmonary bypass, the change in nitrogen
      concentration between fresh gas entering the anesthetic breathing system and the exhaust gas
      leaving it in an otherwise closed system is used to determine total gas uptake by the
      principle of insoluble gas dilution. Oxygen and anaesthetic agent uptakes are then
      automatically determined by a computer directly linked to a rapid gas analyzer, every 15
      seconds.

      As a control, oxygen is calculated using the reverse Fick method. Measured arterial and mixed
      venous oxygen saturations were used to do this, and the cardiac output which was determined
      by thermodilution.
    

Time perspective: Prospective
Keywords: Oxygen uptake; Anesthetic gas uptake