bioihbjkbjnl/mcl2 huggingface dataset:
PNU-100480 In Newly Diagnosed, Drug Sensitive Patients With Pulmonary TB; Early Bactericidal Activity; Whole Blood Assay
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      PNU-100480 is being developed for the treatment of both drug resistant and sensitive
      tuberculosis. This is an efficacy and safety study to characterize the effect of PNU-100480
      when given for 14 days to treatment-naive patients with drug-sensitive pulmonary
      tuberculosis.
    


Intervention name(s): PNU-100480; PNU-100480; RHZE
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 600 mg twice daily (BID) for 14 days; 1200 mg once daily (QD) for 14 days; Combination tablet (RHZE) dosed by weight. Dosage strength per tablet is 150 mg Rifampicin (R)/75 mg Isoniazid (H)/400 mg Pyrazinamide (Z)/275 mg Ethambutol (E)
Other intervention name(s): Rifafour, Rimstar
Intervention MeSH terms: Oxazolidinones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tuberculosis; EBA; WBA
Nutritional and Metabolic Disorders in HIV Infected Children and Adolescent
Condition: HIV-1
MeSH terms: Metabolic Diseases
Study type: Observational [Patient Registry]

Summary: 
      The advent of highly active antiretroviral treatment has resulted in the survival into
      adolescence of an increasing proportion of infants and children with perinatal HIV infection
      in Senegal. However, the transformation of HIV into a chronic disease needing lifelong
      antiretroviral treatment (ART) raises new challenges, among others related to a disturbance
      of glucose metabolism, lipid abnormalities, in addition to the potential effects on
      children's growth and puberty. Little is known on nutritional and metabolic changes in
      HIV-infected children on ART in Africa, while implementation of the latest WHO
      recommendations should eventually lead to an increase in the number of children on ART in
      this region. Moreover, bio-clinical evolution of untreated children is poorly documented in
      the African context. It therefore urgently needed to institute a cohort study to evaluate, in
      the long term, the impact of HIV infection and/or ART on nutritional and metabolic disorders
      and to characterize the risk factors of their occurrence in children and adolescents infected
      as they move through adolescent into adulthood.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-1 infected individuals age between 2 ans 16 years
      
Biospecimen description: 
      Plasma, blood cells and urine samples to be retained
    
Keywords: HIV-1; Child; Adolescent; Growth; Lipodystrophy; ARV treatment; Senegal
Efficacy of Buffered Lidocaine in Patients With Facial Swelling
Condition: Orofacial Swelling
Study type: Interventional

Summary: 
      The purpose of this study is to determine the clinical efficacy of a buffered 4% lidocaine
      solution for incision and drainage. Ninety patients will be examined clinically to determine
      a diagnosis of cellulitis or fluctuance. The diagnosis will be confirmed by incision and
      drainage. Patients will receive either 3.6 ml 4% lidocaine with 1:100,000 epinephrine or 3.6
      ml 4% lidocaine with 1:100,000 epinephrine buffered with 8.4% sodium bicarbonate. Patients
      will rate pain prior to and throughout the procedure.
    

Detailed description: 
      Incision and drainage of swellings is painful and anesthetic failure is common. One reason
      may be related to the lowered pH of inflamed tissue reducing the amount of the base form of
      anesthetic. A buffered anesthetic solution may result in more effective anesthesia than a
      non-buffered solution.
    

Intervention name(s): 4% lidocaine with 1:100,000 epinephrine; 4% buffered lidocaine with 1:100,000 epinephrine
Intervention type(s): Drug; Drug
Intervention description(s): see arm/group description; see arm/group description
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Individualized Diet Improvement Program for Weight Loss and Maintenance, Cohort 1
Condition: Obesity; Overweight; Weight Loss; Diet Habit
MeSH terms: Overweight; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      This research is to develop a weight loss and weight maintenance program through dietary
      modifications for adults with obesity. Although scientific studies have shown the feasibility
      of rapid and safe dietary weight loss and subsequent weight maintenance, no efficacious
      dietary weight management program is widely available, and thus bariatric surgery remains the
      most reliable approach for weight loss/management. Safe and effective dietary weight loss and
      subsequent weight maintenance require flexible, individualized advice by an experienced
      dietitian/nutritionist.
    


Intervention name(s): Weight Management Intervention
Intervention type(s): Behavioral
Intervention description(s): Participants attend group and individual dietary education sessions. Participants create a diet plan that satisfies their needs. Participants aim to lose 1 pound weekly until a BMI of 25 is reached. Participants are evaluated through daily self-weighing, dietary records, and food frequency questionnaires.
Intervention model: Single Group Assignment
Intervention model description: Before and after study design
Masking: None (Open Label)
Primary purpose: Treatment
V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)
Condition: Cytomegalovirus (CMV) Infections
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluated the safety, tolerability, and efficacy of the cytomegalovirus (CMV)
      vaccine (V160) administered in a 2-dose or 3-dose regimen to healthy seronegative women 16 to
      35 years of age. Participants received blinded V160 on Day 1, Month 2, and Month 6 (3-dose
      regimen), V160 on Day 1 and Month 6 and placebo at Month 2 (2-dose regimen), or placebo on
      Day 1, Month 2, and Month 6, and were followed to approximately Month 24. The primary
      hypothesis of the study was that administration of a 3-dose regimen of V160 will reduce the
      incidence of primary CMV infection compared to placebo.
    


Intervention name(s): V160; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): V160 was administered as a 0.5 mL (100 Units/0.5 mL dose with Merck aluminum phosphate adjuvant [MAPA], 4°C stable formulation) IM injection.; Saline solution administered as a 0.5 mL IM injection
Other intervention name(s): Human cytomegalovirus vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Prevention of cytomegalovirus infection (CMVi)
Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of
      single doses of BMS-686117
    


Intervention name(s): BMS-686117; Byetta; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.; Injection solution, Subcutaneous, 5 mcg, Once daily, Single dose.; Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Preoperative Twice Daily Chemoradiation in Addition to Chemotherapy Prior to Surgery in Stage III Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients are randomized to (arm A) 3 cycles of cisplatin/etoposide, followed by
      hyperfractionated radiotherapy (hfRT)with concurrent carboplatin and vindesine then surgery
      and, if no or R1/2-resection, additional hfRT versus (arm B) 3 cycles of cisplatin/etoposide,
      followed by surgery and then RT.

      The primary endpoint was progression free survival (PFS). With 500 patients evaluable an
      improvement of median PFS from 10 to 14 months could be detected.
    

Detailed description: 
      Patients are randomized to (arm A) 3 cycles of cisplatin 55 mg/m2 (d 1 + 4)/etoposide 100
      mg/m2 (d 1-4), followed by hyperfractionated radiotherapy (hfRT; 45 Gy, 2x1.5 Gy/d) with
      concurrent carboplatin (100 mg/m2) and vindesine (3 mg) (d 1, 8, 15), then surgery and, if no
      or R1/2-resection, additional hfRT (24 Gy; 2x1.5 Gy/d) versus (arm B) 3 cycles of cisplatin
      55 mg/m2 (d 1 + 4)/etoposide 100 mg/m2 (d 1-4),followed by surgery and then RT (1.8 Gy/d)
      with 54 Gy or, if no or R1/2-resection, 68.4 Gy.

      The primary endpoint was progression free survival (PFS). With 500 patients evaluable an
      improvement of median PFS from 10 to 14 months could be detected.

      (University of Münster was the lead sponsor; as the trial was implemented in
      clinicaltrials.gov by the principal investigator after he had moved to University of
      Heidelberg this account is announced above)
    

Intervention name(s): preoperative radiochemotherapy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multimodality treatment
A Single Ascending Dose Study of BMS-650032 in HCV Infected Subjects
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary purpose of this study is to evaluate the safety profile and tolerability of
      single oral doses of BMS-650032 in subjects with chronic hepatitis C infection
    


Intervention name(s): BMS-650032 or Placebo
Intervention type(s): Drug
Intervention description(s): Oral, Once daily, Single Dose
Intervention MeSH terms: Asunaprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Food Effects of Single Oral Dose of 600mg TR-701
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an evaluation of the safety, tolerance, and pharmacokinetics of single oral doses of
      TR-701 given to normal, healthy, adult volunteers in the fed and fasted state.
    

Detailed description: 
      Subjects will receive the following treatments in a crossover design:

      Treatment A: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL
      room temperature tap water after at least a 10-hour fast.

      Treatment B: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL
      room temperature tap water following a high-fat meal preceded by at least a 10-hour fast.

      Descriptive statistics will be calculated for PK parameters where available, including Cmax,
      Tmax, AUC0-t, and AUC0-inf. Minimum, maximum, mean, and median values will be determined and
      standard deviations will be calculated. Where data are available, food effect will be
      examined between test (fed state) and reference (fasted state) groups.
    

Intervention name(s): TR-701 600mg
Intervention type(s): Drug
Intervention description(s): TR-701 600mg
Intervention MeSH terms: Tedizolid phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Food effects
Contrast Sensitivity Assessment in Pediatric Cataract Surgery With IOL Implantation
Condition: Contrast Sensitivity
MeSH terms: Cataract; Hypersensitivity
Study type: Interventional

Summary: 
      The study evaluates contrast sensitivity in older children following surgery for lamellar and
      posterior subcapsular cataracts. Often, pediatric surgeons tend to delay surgery in these
      children who present beyond the amblyogenic age group. These cataracts are often compatible
      with reasonable visual acuity and therefore some surgeons prefer to wait for surgery, whereas
      others tend to operate.

      The study evaluates improvement in contrast sensitivity at different spatial frequencies
      following cataract surgery for lamellar and posterior subcapsular cataracts in older
      children.
    

Detailed description: 
      All patients undergoes temporal clear corneal incision, manual anterior continuous
      curvilinear capsulorhexis, bimanual irrigation/aspiration for lens removal and residual
      cortex, posterior capsule management based on the age of the patient either manual posterior
      capsulorhexis (PCCC) upto 6 years or leaving intact posterior capsule and implantation of
      single-piece AcrySof SN60WF (Alcon Laboratories, Forth Worth, Texas) hydrophobic acrylic IOL
      in-the-bag. Postoperatively, all the patients are examined first for high contrast
      sensitivity and then for low contrast at 1 week, 1 and 3 months respectively.

      The results are analyzed for corrected distance visual acuity (CDVA) which is recorded in
      LogMAR units at preoperative and 1 and 3 months postoperatively. Monocular high-contrast
      Snellen visual assessment for distance is done with the Early Treatment Diabetic Retinopathy
      Study chart (Vector Vision acuity chart at 100% contrast) with Corrected distance visual
      acuity CDVA at 4 m under photopic condition.

      Similarly at preoperative and 1 and 3 months postoperatively contrast sensitivity testing is
      also performed using the CSV 1000E sine wave grating test face (Vector Vision, USA) with the
      patient seated at a distance of 2.5 m from the chart. The test is performed after the patient
      is adapted to the room luminance for 5 minutes. The non viewing eye was occluded for each
      measurement, and the best spectacle refractive correction is placed in front of the viewing
      eye. Testing is being tested under two lighting conditions: photopic (85cd/m2) and mesopic
      (2.7cd/m2). The contrast sensitivity values are documented in log units. Sensitivity levels
      at each frequency range from 0.7 to 2.08 (3 cpd), 0.91 to 2.29 (6 cpd), 0.61 to 1.99 (12
      cpd), and 0.17 to 1.55 (18 cpd) log units. This testing is performed with the patient wearing
      their refractive correction in form of spectacles.
    

Intervention name(s): Cataract Surgery
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Contrast Sensitivity , Pediatric Cataract Surgery,
Pringle Time Exceeding 120 Min in Liver Resection
Condition: Tolerance of the Liver
Study type: Observational

Summary: 
      Intermittent Pringle's maneuver is widely used to limit blood loss during hepatectomy,
      without an established time-limit. However, many authors claims its danger for patients'
      outcome. The investigators check the short term outcome of a consecutive cohort of patients
      who underwent hepatectomy with intermittent clamping exceeding 120 minutes.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Among 426 consecutive patients who underwent hepatectomy, we retrospectively selected 189
        patients with clamping time exceeded 60 minutes: 117 having intermittent Pringle maneuver
        less 120 minutes and 72 having clamping time exceeding 120 minutes were analysed.
      
Keywords: Liver ischemia; Pringle time
Safety Study of a Sutureless Amniotic Membran Transplantation to Treat Ocular Surface Disorders (Expanded Access)
Condition: Corneal Ulcers; Corneal Melting
MeSH terms: Corneal Ulcer
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The investigators aimed at developing a technique to apply amniotic membrane to a diseased
      ocular surface without surgical intervention (sutureless amniotic membrane transplantation).
      This system needs to be concordant with laws and guidelines for the use of medical and
      pharmaceutical products.
    

Detailed description: 
      A ring system (AmnioClip) was developed for mounting an amniotic membrane (AM) that can be
      applied like a large contact lens. AM is mounted between the two rings with a special
      designed, accessory mounting device. The safety of the ring system AmnioClip was tested in an
      interventional including 7 patients with ocular surface disorders and need for AM
      transplantation (1, 2, 3). About similar systems was reported (3, 4).
    

Intervention name(s): Amniotic membrane ring
Intervention type(s): Device
Intervention description(s): The amniotic membrane ring system (AmnioClip) is device for sutureless application of amniotic membrane to oculare surfaces. Amniotic membrane is mounted between the two rings with a specially designed, accessory mounting device.
Other intervention name(s): Amniotic membrane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: amniotic membrane holder, aminiotic membrane transplantation
Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma
Condition: Asthma; GERD
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether treatment with esomeprazole for 6 months
      will improve asthma in adult patients with moderate to severe asthma and symptoms of
      gastroesophageal reflux disease.
    


Intervention name(s): Esomeprazole; Esomeprazole; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Esomeprazole 40 mg twice daily; Esomeprazole 40 mg once daily; Placebo twice daily
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Moderate to severe Asthma; Gastroesophageal Reflux Disease; esomeprazole; GERD
A Study of Combination Treatment With an HCV Polymerase Inhibitor (RO5024048) and an HCV Protease Inhibitor (RO5190591/Danoprevir) in Genotype 1 Chronic Hepatitis C Patients
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This 7 cohort study will evaluate the efficacy and safety of combination treatment with an
      HCV nucleoside polymerase inhibitor(RO5024048)and an HCV protease
      inhibitor(RO5190591/ITMN-191/danoprevir) in patients with chronic hepatitis C, genotype
      1.Cohorts A,B,C,D and G will be treatment-naive patients, cohort E will be
      treatment-experienced excluding null responders, and cohort F will be null responders.
      Cohorts A and B will evaluate doses of 500mg po bid RO5024048 and 100mg po q8h RO5190591,
      alone or in combination, for up to 7 or 14 days. Cohort C will evaluate combination treatment
      with either 1000mg po bid RO5024048 and 100mg q8h RO5190591 or 500mg po bid RO5024048 and
      200mg q8h RO5190591 for 14 days. Cohort D will evaluate 1000mg po bid RO5024048 and 200mg q8h
      RO5190591 for 14 days.Cohort E will evaluate 1000mg RO5024048/600mg RO5190591 po twice daily
      for 14 days, and Cohorts F and G will evaluate 1000mg RO5024048/900mg RO5190591 po twice
      daily for 14 days. Cohorts will be tested sequentially or in parallel, if supported by
      appropriate safety and pharmacokinetic data.Following the last dose of study medication
      patients have the option of continuing treatment with Standard of care therapies. The
      anticipated time on study treatment is <3 months, and the target sample size is <100
      individuals.
    


Intervention name(s): RO5024048; danoprevir; danoprevir; danoprevir; danoprevir; danoprevir
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 500mg po bid/100mg po q8h for 7 days; 500mg po bid/100mg po q8h for 14 days; 1000mg po bid/100mg po q8h for 14 days\n500mg po bid/200mg po q8h for 14 days; 1000mg po bid/200mg po q8h for 14 days; 1000mg/600mg po twice daily for 14 days; 1000mg/900mg po twice daily for 14 days
Intervention MeSH terms: Lactams
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study Evalutating the Pharmacokinetics (PK) and Safety of a Single Dose of Desvenlafaxine Sustained Release (DVS SR)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the initial pharmacokinetic profile of single doses of 25mg and 50 mg of DVS SR to
      healthy subjects.
    


Intervention name(s): Desvenlafaxine Sustained Release (DVS SR)
Intervention type(s): Drug
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; MDD
Clinical Trial on Pharmacokinetics and Tolerability of AP707
Condition: Pharmacokinetics; Tolerability; Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      Brief Summary:This study aims to investigate the uptake of AP707, a preparation from cannabis
      flowers, into the bloodstream after in single administration in healthy volunteers.
    

Detailed description: 
      Pharmacokinetic parameters and tolerability of AP707 is studied over 24 hours after single
      dose administration in healthy volunteers in a prospective and open-label manner at a single
      study center.
    

Intervention name(s): AP707
Intervention type(s): Drug
Intervention description(s): Preparation of Cannabis flowers (Cannabis flos)
Other intervention name(s): THC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cannabis; Cannabis based medicine; THC; Tetrahydrocannabinol