bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Immunogenicity of a Novel Glucagon Formulation
Condition: Drug-specific Antibodies; Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      This study provides information on immunogenicity of Nasal Glucagon (AMG504-1) with regards
      to the potential development of treatment-emergent anti-glucagon antibodies.
    

Detailed description: 
      This study is a single center, randomized, laboratory-blinded, three periods, parallel design
      study.

      The main objective of this study is to evaluate the immunogenicity of repeated single doses
      of glucagon following nasal and intramuscular (IM) administration in adults with Type 1 or
      Type 2 diabetes (T1D or T2D). The secondary objective is to evaluate the safety and
      tolerability of glucagon following NG and IM administration in adults with T1D or T2D.

      A single dose of glucagon was administered in the morning after a 10-hour overnight fast,
      either by intranasal or intramuscular route, on 3 occasions. Each drug administration was
      separated by at least seven calendar days. Patients were randomized in a 2:1 ratio (NG:IMG)
      to receive NG or IMG at each of the 3 periods.

      Blood samples were collected for measurement of anti-glucagon antibodies at screening visit,
      prior to dosing at Period 3, and at the post-study visit (approximately 4 weeks after the
      last glucagon administration).
    

Intervention name(s): Nasal Glucagon (NG); Glucagon IM
Intervention type(s): Drug; Drug
Other intervention name(s): Nasal Glucagon; AMG504-1 Dry-Mist Intranasal Glucagon; LY900018; GlucaGen® HypoKit
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diabetes Mellitus; Hypoglycemia; Glucagon; Anti-glucagon Antibody; Immunogenicity
Effect of Prebiotic or Synbiotic on Inflammatory Response and Indicators of Nutritional Status in Obesity
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of prebiotic or synbiotic supplementation
      on inflammatory response and indicators of nutritional status in patients with morbid
      obesity. Study hypothesis: Supplementation of 12 g/day of fructooligosaccharides (prebiotic)
      or 12 g/day of fructooligosaccharides + strains of lactobacilli and bifidobacteria
      (synbiotic) during 30 days promotes reduction of plasma/serum levels of acute phase proteins,
      cytokines, metabolic and anthropometric parameters in individuals with BMI ≥ 40kg/m².
    

Detailed description: 
      The purpose of this study is to evaluate the effect of prebiotic or synbiotic supplementation
      on inflammatory response and indicators of nutritional status in patients with morbid
      obesity. Adult individuals of both sexes with morbid obesity (body mass index ≥ 40 kg/m²)
      will be invited to participate in this randomized, placebo-controlled, triple-blind study.
      The participants will be divided into three groups: G1 - control group (placebo), G2 -
      prebiotic group and G3 - synbiotic group. The study will consist of four experimental time
      points: M0 - baseline and start of supplementation; M1 - after fifteen days of the first
      outpatient visit and fifteen days after the start of supplementation with prebiotic,
      synbiotic or placebo; M2 - after thirty days from the first outpatient visit and end of
      supplementation with prebiotic, synbiotic and placebo; and M3 - time after sixty days from
      the first outpatient visit. At all time points the inflammatory response will be assessed by
      determination of plasma cytokines (IL-1, IL-6, IL-10, TNF) and acute phase proteins
      (c-reactive protein and albumin), besides the evaluation of laboratory and anthropometric
      indicators of nutritional status. The primary endpoint will be the reduction in
      concentrations of inflammatory markers (cytokines and acute phase proteins).

      Investigators expect to contribute with new information in this field of knowledge, which may
      facilitate the clinical application of these results.
    

Intervention name(s): Placebo; Prebiotic; Synbiotic
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Maltodextrin - 11g/day; Fructooligosaccharide - 11g/day; Fructooligosaccharide + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019 - 11g/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Inflammation; Nutritional status; Prebiotic; Synbiotic
Study to Investigate the Effects of Food on the Pharmacokinetics/Pharmacodynamics of CKD-519
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effects of food on the
      pharmacokinetics/pharmacodynamics of CKD-519.
    

Detailed description: 
      A randomized, open-label, single dose, 1-sequence, 3-treatment, 3-period crossover study to
      investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519 in
      healthy male subjects.
    

Intervention name(s): CKD-519 100mg; CKD-519 200mg; CKD-519 100mg; CKD-519 200mg
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): CKD-519 tablet(formulation Ⅱ) 100mg(100mg X 1Tab); CKD-519 tablet(formulation Ⅱ) 200mg(100mg X 2Tabs); CKD-519 soft capsule(formulation Ⅲ) 100mg(100mg X 1Cap); CKD-519 soft capsule(formulation Ⅲ) 200mg(100mg X 2Caps)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dyslipidemia; CKD-519; CETP inhibitor; Food Drug Interaction
A Study of LY3522348 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study in healthy participants is to learn more about the safety of
      LY3522348 and any side effects that might be associated with it. Blood tests will be
      performed to check how much LY3522348 gets into the bloodstream and how long it takes the
      body to eliminate it. This study has two parts: Part A will last up to about six weeks and
      Part B will last up to about eight weeks for each participant.
    


Intervention name(s): LY3522348; Placebo; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered orally to some participants.
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study was to evaluate the effect of 12 months of treatment with
      romosozumab compared with teriparatide on total hip bone mineral density (BMD) in
      postmenopausal women with osteoporosis who were previously treated with bisphosphonate
      therapy.
    


Intervention name(s): Romozosumab; Teriparatide
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection once a month.; Administered by subcutaneous injection once a day.
Other intervention name(s): AMG 785; Forteo; Forsteo
Intervention MeSH terms: Teriparatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postmenopausal Osteoporosis
Reducing Energy Density by Different Methods to Decrease Energy Intake
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this research is to investigate how using different methods to reduce the
      energy density of entrees affects daily energy intake in adults. It is hypothesized that
      reducing the energy density of entrees will decrease energy intake. It is also hypothesized
      that reducing the energy density by incorporating fruit and vegetables will decrease energy
      intake more than reducing the energy density by decreasing fat content or adding plain water.
    


Intervention name(s): Energy density feeding study
Intervention type(s): Other
Intervention description(s): In a crossover design, adults are served breakfast, lunch, and dinner, 1 day a week for 4 weeks. Meal entrees will vary in energy density (100% and 80%) and the method used to reduce the energy density (added fruit & vegetables, decreased fat, added plain water).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Gametocytocidal and Transmission-blocking Efficacy of PQ in Combination With AL and TQ in Combination With SPAQ in Mali
Condition: Malaria,Falciparum
MeSH terms: Malaria, Falciparum
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the gametocytocidal and transmission reducing
      activity of artemether-lumefantrine (AL) with and without a single dose of 0.25mg/kg
      primaquine (PQ) and sulfadoxine-pyrimethamine with amodiaquine (SPAQ) with and without single
      dose of 1.66mg/kg tafenoquine (TQ). Outcome measures will include infectivity to mosquitoes
      at 2, 5 and 7 days after treatment, gametocyte density throughout follow-up, and safety
      measures including haemoglobin density and the frequency of adverse events.
    

Detailed description: 
      Full protocol available on request.
    

Intervention name(s): Artemether-lumefantrine; Primaquine Phosphate; Sulphadoxine-pyrimethamine with amodiaquine; Tafenoquine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets containing 20/80 mg artemether and 120/480 mg lumefantrine will be administered according to weight as per manufacturer guidelines.; The single dose of 0.25mg/kg PQ will be administered in an aqueous solution, according to a standard operating procedure (SOP) provided by the manufacturer.; Sulfadoxine/pyrimethamine tablets contain 500mg sulfadoxine and 25mg pyrimethamine. Amodiaquine tablets contain 150mg amodiaquine (as hydrochloride). Tablets will be administered according to weight as per manufacturer guidelines.; 100mg tafenoquine tablets are prepared into a 1mg/mL solution in water. Solution will be given according to weight as indicated per treatment arm in 5kg bands.
Other intervention name(s): Riamet; Primaquine; Supyra; Arakoda
Intervention MeSH terms: Lumefantrine; Pyrimethamine; Artemether; Primaquine; Sulfadoxine; Artemether, Lumefantrine Drug Combination; Fanasil, pyrimethamine drug combination; Amodiaquine; Tafenoquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Bipolar Depression
Condition: Mood Disorder; Bipolar Disorder; Major Depression; Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder; Mood Disorders
Study type: Interventional

Summary: 
      This is a pilot project to study if repetitive Transcranial Magnetic Stimulation (rTMS) will
      benefit patients with bipolar depression safely. Based on published studies, this study
      hypothesizes that rTMS on the left dorsal prefrontal lobe will improve symptoms in some
      patients who have failed at least two medications.
    

Detailed description: 
      Candidate with bipolar depression will be screened after signing informed consent. Those who
      meet the selection criteria will be treated with daily rTMS for 3 weeks and be followed-up at
      2 weeks. Participants will keep their ongoing medication unless a medication significantly
      increases the possibility of seizure. They must be on the same dose of antidepressant
      medication for least 4 weeks without improvement of symptoms before being recruited into the
      study. Mood and other observed mental status will be measured by standard psychological
      scales.
    

Intervention name(s): Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.
Intervention type(s): Device
Intervention description(s): High frequency repetitive TMS given daily on weekdays for 3 weeks
Other intervention name(s): Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Bipolar; Depression; TMS; repetitive Transcranial Magnetic Stimulation; treatment; Efficacy; Safety
Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects
Condition: Ventricular Septal Defects
MeSH terms: Heart Septal Defects; Heart Septal Defects, Ventricular
Study type: Interventional

Summary: 
      The purpose of this study is to investigate effectiveness and safety of transcatheter closure
      of perimembranous ventricular septal defects.
    

Detailed description: 
      Perimembranous Ventricular septal defect (VSD) is the most common congenital cardiac
      malformation and constitutes over 20% of all congenital cardiac disease. Though conventional
      surgery for VSD is a widely accepted procedure with minimal operative mortality, it carries a
      small but definite risk of morbidity and mortality associated with cardiopulmonary bypass and
      surgical closure. The newly appeared transcatheter device closure technique provides an
      alternative to surgical closure. However, the mid-to-long term effects of this technique
      using occluders is not clear. The aim of this study was to evaluate the safety and
      effectiveness of transcatheter closure of perimembranous ventricular septal defects using
      septal occluders.
    

Intervention name(s): Shanghai pmVSD occluder; surgery
Intervention type(s): Device; Procedure
Intervention description(s): Ventricular Septal Defects Occluders with sizes from 4mm to 20mm.; Patient in this group received open surgical repair of pmVSD.
Other intervention name(s): Shanghai pmVSD-O; open surgery
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: transcatheter closure; ventricular septal defects
Effects of TPV/r on the Pharmacokinetics of Carbamazepine in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the steady-state pharmacokinetics of carbamazepine (CBZ) at 200 mg or 100 mg
      twice daily, depending on tolerability, and administered alone and in combination with
      tipranavir/ritonavir (TPV/r) after a single dose (500/200 mg) and at steady-state (500/200 mg
      twice-daily)
    


Intervention name(s): Carbamazepine; Tipranavir; Ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ritonavir; Tipranavir; Carbamazepine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Comparing Amounts of Tafamidis (PF-06291826) in the Blood Without Food in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      3 different formulations and doses of tafamidis will be compared. Subjects will be fasted for
      each test and every subject will test all 3 different formulations. After swallowing
      tafamidis, tafamidis blood concentrations will be measured periodically for 8 days. After 14
      days, subjects will take a different formulation of tafamidis and tafamidis blood
      concentrations will be measured periodically for 8 days. After another 14 days, the last
      formulation will be tested in the same way.
    


Intervention name(s): tafamidis
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients
Condition: Graft Rejection; Kidney Failure; Kidney Transplantation
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12
      months after transplantation in patients receiving either a regimen of sirolimus plus
      mycophenolate mofetil following an antibody induction (RATG) or a standard regimen combining
      tacrolimus plus mycophenolate mofetil, both regimens including corticosteroids in patients
      undergoing renal allograft transplantation. In addition, the two treatment groups will be
      compared with respect to the incidence of acute rejection at 3, 6 and 12 months following
      transplantation, and the patient and graft survival at 6 and 12 months after transplantation.
      The safety of sirolimus plus mycophenolate mofetil following an antibody induction (ATG) will
      be evaluated beginning in the immediate post-operative period.
    


Intervention name(s): tacrolimus; mycophenolate mofetil; methylprednisolone; prednisolone; sirolimus
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Mycophenolic Acid; Sirolimus; Methylprednisolone; Prednisolone; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney Transplant
Electrogram and Hemodynamic Characteristics of Adaptive LBBAP in Patients With Heart Failure or Bradycardia
Condition: Cardiac Pacing; Pacing Therapy
MeSH terms: Heart Failure; Bradycardia
Study type: Observational

Summary: 
      This is a multi-site, non-randomized, data collection study. The purpose of this study is to
      investigate the cardiac electrical and mechanical function during LBBAP with different AV
      intervals.
    

Detailed description: 
      Left bundle branch pacing (LBBP), achieved via trans-septal approach with the pacing tip at
      the left side of the ventricular septum, has recently initiated and been well practiced in
      China. LBBP is characterized with relatively ease of implantation (usually <5 minutes
      fluoroscopic use time), narrow paced QRS duration (similar to physiological pacing), low and
      stable pacing threshold (usually around 0.5V @0.5ms, good for device longevity and long-term
      stability without need of back-up pacing lead), high R wave amplitude for pacing management,
      and LBBB (left bundle branch block) correction by a low pacing output.

      LBBAP (left bundle branch area pacing) can generate a relatively narrow QRSd and fast left
      ventricular activation. As AV interval is an important pacing parameter relevant to cardiac
      function. This study is to investigate the cardiac electrical and mechanical function during
      LBBAP with different AV intervals.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who received LBBAP for at least 3 months and come back to hospital for regular
        follow-up will be considered to be recruited voluntarily.
Investigation Drug-drug Interaction Between Dabigatran and Clarithromycin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Dabigatran (Pradaxa ®) is a new oral anticoagulant. It is used to prevent venous
      thromboembolism in orthopedic surgery and has recently demonstrated efficacy and safety at
      least as good as anticoagulants in the prevention of thromboembolism in atrial fibrillation
      and the treatment of venous thromboembolism. It is administered with fixed dose and does not
      require laboratory monitoring because of the low inter and intra individual pharmacokinetic
      (PK) and pharmacodynamics (PD) of dabigatran. However, the bioavailability of dabigatran is
      very low (6.5%) and is controlled by an efflux protein, P-GP. This molecule has a genetic
      polymorphism. The inhibition of this protein can cause a significant increase in intestinal
      absorption of dabigatran and expose patients to a risk of bleeding by overdose. Two major
      drug interactions have been identified : quinidine (cons-indication) and amiodarone
      (precautions). It is likely that other interactions exist and can be clinically significant
      in patients not selected such as testing. The development of tools to study the influence of
      P-GP on the PK and PD of dabigatran is therefore interesting. As the P-GP has a genetic
      polymorphism, the study of the latter is an important element in the detection of drug
      interactions. In this sense, clarithromycin, a potent inhibitor of P-GP is a good model to
      evaluate the primary mechanism of drug interaction of dabigatran and optimize the
      experimental design of studies to be conducted.
    


Intervention name(s): Dabigatran then dabigatran and clarithromycin; Clarithromycin and dabigatran then dabigatran
Intervention type(s): Drug; Drug
Intervention description(s): D4 : dabigatran 300 mg (4 tablets) one time. D8 to D10 : Clarithromycin 500mg (1 tablet) twice daily. D11 : Clarithromycin 500mg (1 tablet) + 300mg dabigatran (4 tablets); D1 to D3 : Clarithromycin 500mg (1 tablet) twice daily. D4 : Clarithromycin 500mg (1 tablet) + 300mg dabigatran (4 tablets). D11 : dabigatran 300 mg (4 tablets) one time.
Other intervention name(s): Dabigatran (Pradaxa)75 mg; Clarithromycin (Zeclar) 500 mg; Dabigatran (Pradaxa) 75 mg; Clarithromycin (Zeclar) 500 mg
Intervention MeSH terms: Clarithromycin; Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Keywords: Healthy volunteer; Pharmacokinetic; pharmacodynamic; Polymorphism, Genetic
The Temporo-spatial Dynamics of Genital Tract Microbiota
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      The investigators aim to examine the endometrium with state of the art sequencing techniques
      to investigate the endometrial microbiota. The endometrial microbiota has been perceived to
      be sterile, however, this seems incorrect from recent studies. Thus, the primary outcome is
      to compare the rate of ascending infection from the semen to the vagina to the endometrium
      and to investigate which bacteria are capable of inhabiting these environments. Furthermore,
      cervical mucus will be obtained in order to test for immunological, microbiological and
      mechanical properties that may be involved in ascending infection. Finally, the study aim to
      characterize the temporal changes in the vaginal microbiota during estrogenic treatment with
      Estrofem® or Vivelle Dot (R) for preparation of the endometrium prior to embryo transfer.
    


Intervention name(s): Estrofem
Intervention type(s): Drug
Intervention description(s): Patients will be asked to obtain self-collected vaginal swabs from the mid-vagina from the beginning of their Estrofem® treatment
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infertile couples attending IVF treatment and referred to a segmentation protocol.
      
Biospecimen description: 
      Vaginal, cervical and endometrial. Also semen of patients with male partner.