bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus
Condition: Obesity and Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo in
      severely obese Type 2 Diabetes Mellitus (T2DM) participants after 12 weeks of treatment on:
      the percentage change in body weight from baseline and safety and tolerability.
    


Intervention name(s): JNJ-64565111 Dose Level 1; JNJ-64565111 Dose Level 2; JNJ-64565111 Dose Level 3; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive JNJ-64565111 Dose Level 1 SC once-weekly until Week 12.; Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 12.; Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 12.; Participants will receive matching placebo to JNJ-64565111 SC once-weekly until Week 12.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Dose-Range Finding Study in Participants With Type 2 Diabetes (MK-3102-006)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the hypothesis that treatment with study medication
      (omarigliptin; MK-3102) provides greater reduction in A1C Hemoglobin (a marker of diabetic
      severity) compared with placebo, after 12 weeks of treatment. The study will evaluate 5
      different doses of omarigliptin to identify which dose is the most effective in the treatment
      of type 2 diabetes.
    

Detailed description: 
      MK-3102-006-Ext 1 added a 66-week extension to the base study (MK-3102 P006) to assess the
      long-term safety and tolerability of omarigliptin. To be eligible for the extension,
      participants must complete the double-blind base study, must have had at least a 75%
      compliance with study drug during the base study and can not meet any of the criteria for
      discontinuation. Participants randomized to placebo in the base study will be switched in a
      blinded manner to pioglitazone 30 mg once daily, in the extension study prior to
      implementation of amendment P006-13. Once amendment P006-13 has been IRB/IEC approved and
      blinded metformin drug supply is available at the site, participants will be switched from
      pioglitazone to metformin, starting at 500 mg once daily and titrated up to 1000 mg twice
      daily. Participants with a contraindication to metformin will be discontinued from the study.
      Participants randomized to 0.25 mg, 1 mg, 3 mg, and 10 mg of omarigliptin in the base study
      will be switched to omarigliptin 25 mg; those randomized to 25 mg of omarigliptin in the base
      study will continue on the same dose in the extension study. After the clinical dose of
      omarigliptin selected for further development has been identified based upon the results of
      the base study, all participants randomized to omarigliptin will be switched to the
      identified clinical dose.
    

Intervention name(s): Omarigliptin; Placebo to omarigliptin; Pioglitazone; Metformin; Placebo to metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Omarigliptin 0.25, 1, 1.5, 10 or 25 mg oral capsule administered once weekly. For omarigliptin 3 mg, participants received two omarigliptin 1.5 mg capsules.; Matching placebo to omarigliptin 0.25, 1, 1.5, 10 or 25 mg oral capsule administered once weekly. For matching placebo to omarigliptin 3 mg, participants received two matching placebo to omarigliptin 1.5 mg capsules.; Pioglitazone 15 mg oral tablet or capsule administered once daily; Metformin 500 mg oral tablet administered once or twice daily; Matching placebo to metformin oral tablet administered once daily
Intervention MeSH terms: Metformin; Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Determine the Bioavailability of Vonoprazan Sprinkle Capsules on Pudding or on Applesauce Relative to a Vonoprazan Tablet in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the bioavailability (BA) of a single oral
      dose of vonoprazan 20 mg sprinkle capsule, either sprinkled on pudding or on applesauce,
      relative to a vonoprazan 20 mg tablet in healthy participants.
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): Vonoprazan; Vonoprazan
Intervention type(s): Drug; Drug
Intervention description(s): Orally via tablet; Orally via sprinkle pellets
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vonoprazan; Gastroesophageal Reflux; Erosive Esophagitis
A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Rituximab (MabThera/Rituxan) in Participants With Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL)
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 3

Summary: 
      This single arm, multicenter study will evaluate the safety, efficacy and pharmacokinetic
      (PK) of subcutaneous (SC) rituximab in previously untreated participants with cluster of
      differentiation 20 positive (CD20+) DLBCL or FL. In addition to standard chemotherapy,
      participants will receive at least 4 doses of rituximab 1400 mg SC once a month during the
      Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during
      the Maintenance period.
    


Intervention name(s): Rituximab; Cyclophosphamide; Vincristine; Doxorubicin; Prednisone; Bendamustine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Rituximab will be administered at a dose of 1400 mg SC once a month for at least 4 doses during the Induction period, and at a dose of 1400 mg SC once every two months for at least 6 doses during the Maintenance period.; Cyclophosphamide will be administered as per standard local practice as a part of standard chemotherapy regimen.; Vincristine will be administered as per standard local practice as a part of standard chemotherapy regimen.; Doxorubicin will be administered as per standard local practice as a part of standard chemotherapy regimen.; Prednisone will be administered as per standard local practice as a part of standard chemotherapy regimen.; Bendamustine will be administered as per standard local practice as a part of standard chemotherapy regimen.
Other intervention name(s): MabThera; Rituxan
Intervention MeSH terms: Prednisone; Cyclophosphamide; Bendamustine Hydrochloride; Rituximab; Doxorubicin; Vincristine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Use of Clear Aligners With Movement Enhancement Techniques
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      The purpose of this study is to use clear aligners to measure tooth movement and length of
      treatment.
    

Detailed description: 
      Orthodontic tooth movement is the result of a force applied to the crown of a tooth and the
      biological remodeling of the gum and bony tissues.
    

Intervention name(s): Movement Enhancement Technique; Clear Aligner
Intervention type(s): Device; Device
Intervention description(s): Conventional Orthodontic treatment; Orthodontic treatment with Clear Aligner
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Terlipressin on Renal Perfusion in Patients With Septic Shock
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Study type: Interventional

Summary: 
      This open-label, randomized controlled trial aimed to investigate the effect of a fixed dose
      of terlipressin added to usual care vs. usual care alone on renal perfusion in patients with
      septic shock.
    

Detailed description: 
      Terlipressin is a synthetic vasopressin analog with great affinity to the V1 receptor
      (vasoconstrictive effect), and could selectively contract efferent arterioles, increase
      glomerular filtration pressure and renal perfusion. The investigators conducted this
      open-label, randomized controlled trial to observe the effects of a fixed dose of
      terlipressin added to usual care vs. usual care alone on renal perfusion in patients with
      septic shock. Renal perfusion was monitored by renal contrast-enhanced ultrasound. The
      primary outcome was peak intensity (renal perfusion parameter) at 24 hours after enrollment.
    

Intervention name(s): Terlipressin treatment; Usual care
Intervention type(s): Drug; Drug
Intervention description(s): Patients in the terlipressin group received a fixed dose of terlipressin added to usual care. Terlipressin was intravenously pumped at a fixed dose of 1.3μg/kg/hour for 24 hours.; Patients in the usual care group were treated with standard care, according to the international guidelines for the management of sepsis and septic shock.
Intervention MeSH terms: Terlipressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: septic shock; terlipressin; renal perfusion; acute kidney injury
Phase2a Primaquine Dose Escalation Study
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low
      single-dose primaquine for gametocidal activity against P.falciparum among adult
      glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.
    


Intervention name(s): dihydroartemisinin-piperaquine; 0.125 mg/kg Primaquine; 0.5 mg/kg Primaquine; 0.25 mg/kg Primaquine; 0.0625 mg/kg Primaquine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Primaquine; Piperaquine; Artenimol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comparison Study of Doxorubicin Versus Epirubicin-induced Cardiotoxicity in Patients With DLBCL
Condition: Lymphoma
MeSH terms: Lymphoma; Cardiotoxicity
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to compare CHOP versus CEOP-induced cardiotoxicity in patients with
      aggressive B-cell lymphoma. The hypothesis is epirubicin is associated with less
      cardiotoxicity without compromising the efficacy.
    

Detailed description: 
      The doxorucin-containing regimen (CHOP) and epirubicin-containing regimen (CEOP) are both
      frequently used in patients with aggress B-cell lymphoma in out institution. According to a
      Cochrane meta-analysis, epirubicin is less cardiotoxic than doxorubicin on a mg per mg basis.
      However, compared with 50mg/m2 of doxorubicin in CHOP, epirubicin was usually used at a
      higher dose (70mg/m2) to treat non-Hodgkin's lymphoma (NHL). Because of the correlation
      between cumulative dose and risk of cardiotoxicity, it is reasonable to speculate that CEOP
      (70mg/m2) has less cardiotoxicity than CHOP (50mg/m2) when both regimens are administered
      with similar cycles.
    

Intervention name(s): CEOP regimen; CHOP regimen
Intervention type(s): Drug; Drug
Intervention description(s): cyclophosphamide 750mg/m2 IV day 1 epirubicin 70mg/m2 IV day 1 vincristine 1.4mg/m2 IV day1 (maximum: 2mg) prednisone 50mg PO days 1~5 twice per day Or combined with rituximab 375mg/m2 IV day 0; cyclophosphamide 750mg/m2 IV day 1 doxorubicin 50mg/m2 IV day 1 vincristine 1.4mg/m2 IV day1 (maximum: 2mg) prednisone 50mg PO days 1~5 twice per day Or combined with rituximab 375mg/m2 IV day 0
Other intervention name(s): CEOP; CHOP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B-cell lymphoma; CHOP; CEOP; Cardiotoxicity
Phase I Study of Ascending Doses of MMV390048 in Healthy Adult Volunteers
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human study of MMV390048. The study will evaluate the safety, tolerability
      and pharmacokinetic properties of escalating single and multiple doses of MMV390048 when
      administered to healthy male volunteers and female volunteers of non-childbearing potential.

      In addition, the effect of food on the pharmacokinetics and tolerability of MMV390048 will be
      investigated.
    

Detailed description: 
      The study is a single centre, double-blind, randomised, placebo-controlled, ascending dose
      study in healthy male and female volunteers (of non-childbearing potential) aged 18 to 55
      years.

      The study will be divided into two parts. The first part will comprise up to seven fasted
      cohorts (8 to 10 volunteers in each) that will receive a single, ascending dose (SAD) of
      MMV390048 to assess its safety, tolerability and pharmacokinetic profile. The starting dose
      administered to the first cohort will be 5 mg. An additional cohort (cohort 8, re-using
      volunteers from one of the previous cohorts) will receive a single dose of MMV390048 in a fed
      state to evaluate the effect of food on the pharmacokinetics and tolerability of the
      compound.

      The data obtained from each cohort during the SAD part of the study will undergo a formal
      review by the Safety Review Team (SRT). Should the safety profile of the compound be deemed
      acceptable, and the pharmacokinetic parameters indicate that acceptable levels of the drug to
      elicit a pharmacodynamic response can be achieved in human plasma, the study will then
      proceed to the second part.

      During the second part of the study volunteers will receive multiple, ascending doses (MAD)
      of MMV390048 to assess the pharmacokinetics, safety and tolerability following multiple oral
      doses. Up to three cohorts of eight volunteers each will be enrolled into this part of the
      study. Each volunteer will receive three consecutive daily doses of MMV390048.
    

Intervention name(s): MMV390048 5mg; MMV390048 20mg; MMV390048 40mg; MMV390048 80mg; MMV390048 120mg; Placebo to match MMV390048
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Supplied as "powder in bottle" formulation for reconstitution pre-dose; Supplied as "powder in bottle" formulation for reconstitution pre-dose.; Supplied as "powder in bottle" formulation for reconstitution pre-dose; Supplied as "powder in bottle" formulation for reconstitution pre-dose; Supplied as "powder in bottle" formulation for reconstitution pre-dose; Supplied as "powder in bottle" formulation for reconstitution pre-dose
Other intervention name(s): MMV390048; MMV390048; MMV390048; MMV390048; MMV390048; Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: safety; tolerability; malaria
Comparison the Effects of 3 Different Intraarticular Ketamine Doses on Postoperative Pain.
Condition: Arthroscopy
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      the aim is to compare the effects of two different doses of intraarticular ketamine on
      postoperative pain scores and analgesic requirements.in knee artroscopy
    

Detailed description: 
      All pateints are going to be operated under general anesthesia. At the end of the study
      patients are going to be randomyl seperated into 3 groups. The surgeon is going the following
      drugs intraarticulary.

      Group KL1: 0.5 mg/kg ketamin in % 0..9 NaCl at a total volume of 20 ml Group KL2: 1 mg/kg
      ketamin in % 0.9 NaCl at a total volume of 20 ml Group SL: 20 ml % 0.9 NaCl ll patients are
      going to receive a periarticula injection of 10 ml 0.5 bupivacaine and patient controlled
      analgesia with morphine.

      VAS scores and total analgesic requirement is going to be evaluated.
    

Intervention name(s): Ketamine 0.5; Ketamine 1; % 0.9 NaCl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): İntrarticular Ketamine 0.5 mg/kg + 0.9 Nacl Total Volume 20 ml; İntrarticular Ketamine 1 mg/kg + 0.9 NaCl Total Volume 20 ml; Intraarticular %0.9 NaCl
Other intervention name(s): Group 1; Group 2; Group 3
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Injection; Intra-Articular; arthroscopy; ketamine
Safety and Immune Response of Different Pediatric Combination Vaccines.
Condition: Diphtheria; Polio; Pertussis
MeSH terms: Whooping Cough; Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      The overall aim of the study is to corroborate that a schedule consisting of 3 doses of
      Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of
      Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3
      doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus
      vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.
    


Intervention name(s): DAPTACEL®. (DTaP), IPOL®., and ActHIB®.; Pentacel®: DTaP-IPV/Hib combined; DTaP-IPV and ActHIB®; Pentacel®: DTaP-IPV/Hib combined
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): DAPTACEL®; IPOL®; ActHIB®; Pentacel®; ActHIB®; Pentacel®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pertussis; Whooping cough; Filamentous Haemagglutinin; Fimbriae Types 2 and 3;; Pertactin; Diphtheria; Tetanus; Poliovirus Types 1, 2, and 3.
The Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this randomized, placebo-controlled (Phase II) study will be to further
      evaluate the effects of oral glutathione on growth in children with CF.
    

Detailed description: 
      a prospective, multi-center, randomized, placebocontrolled, double-blind, Phase II clinical
      trial. Approximately sixty pancreatic insufficient (PI) subjects with CF who are ≥ 2 and < 11
      years of age, will be enrolled to receive either L-Glutathione Reduced (GSH) or placebo given
      orally (tid) for 24 weeks. Each subject will be seen for four study visits: Visit 1
      (Screening), Visit 2 (Baseline/Randomization, Day 0), Visit 3 (Week 12) and Visit 4 (Week
      24). At Visit 2, subjects will be randomized to receive either active treatment or placebo.
      Visit 1 and 2 may be combined if subject meets eligibility requirements and a fecal specimen
      is collected prior to dosing. Safety and clinical outcomes will be assessed throughout the
      study. Assessment of inflammatory and other bio-markers in blood and fecal specimens will be
      performed at Visits 2 and 4
    

Intervention name(s): Oral Glutathione; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Glutathione oral powder; Placebo oral powder
Other intervention name(s): GSH; Inactive powder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Growth Parameters; Cystic Fibrosis
Influence of Probiotics on Atopy With Focus on Respiratory Allergic Diseases- Follow-up to 7 Years
Condition: Asthma; Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Observational

Summary: 
      The investigators had conducted an initial double-blind, placebo-controlled clinical trial
      (NCT00318695) to study the effects of probiotic supplementation from birth to 6 months of age
      in the incidence of atopic diseases at 2 years old. This is then further investigated up to 5
      years of age in a follow-up study NCT00365469 to assess the longer term beneficial effects.

      This current study intends to follow-up for another 2 years until 7 years of age as this is
      critical in the evaluation of respiratory allergies in the form of clinical asthma and
      allergic rhinitis.
    

Detailed description: 
      This study intends to continue the initial double-blind, placebo-controlled randomized
      clinical trial (NCT00318695) which involved 253 subjects with a first degree family history
      of allergic disease. The infants received at least 60ml of commercially available cow's milk
      based infant formula with or without probiotic supplementation (Bifidobacterium longum
      [BL999] 1×10*7 colony-forming unit (cfu)/g and Lactobacillus rhamnosus [LPR]2×10*7 cfu/g)
      daily from the first day of life for the first 6 months. A follow-up study (NCT00365469) up
      to 5 years of age is currently in process.

      This current study plans to continue the follow-up for a further 2 years till the cohort
      reaches 7 years of age. This study will only involve telephone calls which will be conducted
      every 3 months to ascertain for symptoms and incidence of respiratory allergic disease.This
      is critical in the evaluation of asthma and allergic rhinitis which tend to develop later in
      life and this step-wise, temporal development of respiratory allergies has been described as
      "Atopic March".
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subjects who have completed NCT00318695 and NCT00365469 studies will be invited to
        participate in this study.
      
Keywords: Probiotics; Asthma; Allergic Rhinitis