bioihbjkbjnl/mcl2 huggingface dataset:
Phenotyping of High Dose Rifampicin
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Higher doses of rifampicin as a means of more efficient use of this pivotal TB drug has shown
      promising results and might become standard in future. This means that higher doses of
      rifampicin will be co-administered with many other drugs taken by TB patients, including
      anti-retroviral, anti-diabetic, cardiovascular and other drugs. Therefore, in this study the
      aim is to quantitatively assess the drug interaction potential of high dose rifampicin (~40
      mg/kg daily dose, the currently available maximum tolerated dose) with respect to five major
      human drug-metabolizing CYP enzymes and P-gp in comparison to the conventional dose of 10
      mg/kg daily in pulmonary TB patients. A phenotyping approach with single administration of
      several selective substrates for multiple enzymes will be used, in order to prevent multiple
      drug-drug interaction studies.
    


Intervention name(s): phenotyping cocktail; rifampicin
Intervention type(s): Combination Product; Drug
Intervention description(s): A single dose of a cocktail of phenotyping probe drugs (caffeine, tolbutamide, omeprazole, dextromethorphan, midazolam and digoxin) will be administered together with standard dose rifampicin and 40 mg/kg rifampicin, respectively. Blood samples will be taken to assess phenotyping metrics of the cocktail agents and rifampicin pharmacokinetic parameters. The effect of high and standard dose rifampicin on the phenotyping metrics of the cocktail agents will be compared by using the bioequivalence approach; A single dose of a cocktail of phenotyping probe drugs (caffeine, tolbutamide, omeprazole, dextromethorphan, midazolam and digoxin) will be administered together with standard dose rifampicin and 40 mg/kg rifampicin, respectively. Blood samples will be taken to assess phenotyping metrics of the cocktail agents and rifampicin pharmacokinetic parameters. The effect of high and standard dose rifampicin on the phenotyping metrics of the cocktail agents will be compared by using the bioequivalence approach
Other intervention name(s): digoxin; caffeine; tolbutamide; midazolam; dextromethorphan; omeprazole
Intervention MeSH terms: Tolbutamide; Rifampin; Digoxin; Midazolam; Dextromethorphan; Caffeine; Omeprazole
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: each participants will receive phenotyping probe drugs with the standard dose of rifampicin and with a high dose rifampicin in a fixed oreder
Masking: None (Open Label)
Primary purpose: Other
Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Condition: Postoperative Nausea; Postoperative Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      In the present study, midazolam and palonosetron in combination were more effective than
      palonosetron alone in lowering the incidence and severity of postoperative nausea and
      vomiting in the initial 2 h after laparoscopic cholecystectomy. Postoperative clinical
      complications were not different in both groups.
    


Intervention name(s): midazolam and palonosetron group; palonosetron group
Intervention type(s): Drug; Drug
Intervention description(s): intravenous midazolam and palonosetron administraion as prevention of postoperative nausea and vomiting; intravenous palonosetron administraion as prevention of postoperative nausea and vomiting
Intervention MeSH terms: Midazolam; Palonosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: postoperative nausea and vomiting; midazolam; palonosetron
Influence of CYP2C19 Genetic Variants on Clopidogrel in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To test pharmacodynamic response to clopidogrel 150mg once daily during 7 days in healthy
      subjects carriers of a mutated allele (*2) associated with CYP2C19 deficiency and non
      responders to the usual regimen of 75 mg once daily
    

Detailed description: 
      Thirty individuals genotyped for specific variants of 2C19 cytochrome and P2Y12 platelet ADP
      receptor will receive during one week a daily dose of 75 mg of clopidogrel. Depending on
      their pharmacodynamic response to this dose of clopidogrel, subjects will be affiliated to
      two groups, "good responders" and "bad responders". After a wash-out period, "bad responders"
      will receive a double dose of clopidogrel, while the "good responders" will receive 75 mg of
      clopidogrel, associated with a CYP2C19 inhibitor. Such study will allow to evaluate both the
      impact of raising daily dose of clopidogrel in patients with defected variants of 2C19 and
      potential interactions of clopidogrel with other drugs.
    

Intervention name(s): Clopidogrel
Intervention type(s): Drug
Intervention description(s): Clopidogrel
Intervention MeSH terms: Clopidogrel
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human; Adults; Male; Alleles; Genotype; Platelet Aggregation/drug effects; Platelet Aggregation Inhibitors/*pharmacology; Platelet Function Tests; Pharmacogenetics; *Polymorphism, Genetic; Ticlopidine/*analogs & derivatives/pharmacology; Healthy subjects
Randomized Trial of G-CSF Alone Versus Intermediate-dose Ara-C Plus G-CSF Mobilization in Multiple Myeloma Patients.
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to compare safety and efficacy of stem cell mobilization using
      G-CSF (filgrastim) alone vs. intermediate-dose cytosine arabinoside plus G-CSF in multiple
      myeloma patients.
    

Detailed description: 
      Autologous hematopoietic stem cell transplantation (autoHSCT) is a standard treatment of
      eligible patients suffering from multiple myeloma (MM). Tandem autoHSCT allows to further
      improve results of the therapy. Nowadays, 99% of the procedures are performed using
      peripheral blood as a source of stem cells. Hence, the crucial point is to harvest adequate
      number of stem cells allowing hematopoietic recovery. The number of 5 × 10^6 CD34+ cells/kg
      is considered the optimal level, as far as double autoHSCT is concerned. There are two main
      mobilization strategies being used: based on G-CSF alone or in combination with chemotherapy
      (cyclophosphamide (CY) at dose range 1.5-7 g/m2 is mainly used in MM setting). However, a
      proportion of patients (5-40%) fail to collect the minimum number of cells required. Novel
      agents, like plerixafor, CXCR4 inhibitor, may enable effective CD34+ cell harvest in "poor
      mobilizers". Nevertheless, the optimal first-line and cost-effective protocol for
      mobilization of hematopoietic stem cells has not been determined so far.

      Randomized trials comparing chemomobilization with use of CY + G-CSF to G-CSF alone, which
      had been conducted so far, did not demonstrate clear advantage of addition of CY to growth
      factor. Intermediate-dose cytosine arabinoside (AraC), 1.6 g/m2 plus filgrastim, has been
      shown to produce very high efficacy as a first or second-line mobilization regimen in
      patients with lymphoid malignancies, including MM. In a retrospective comparison, this
      strategy was significantly more effective than CY + filgrastim. This suggest that the type of
      chemotherapy agent added to G-CSF may play role in mobilization efficacy and that the
      combination of AraC and G-CSF may be more effective than G-CSF used alone. The goal of
      current study is to verify this hypothesis in randomized controlled trial.
    

Intervention name(s): G-CSF (filgrastim); Cytosine arabinoside + G-CSF (filgrastim)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cytarabine; Lenograstim
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple myeloma; mobilization; G-CSF; filgrastim; cytosine arabinoside; autologous stem cell transplantation
Use of Mobile Technology to Promote Sustained Lifestyle Changes to Prevent Type 2 Diabetes in India and the UK
Condition: Prediabetic State
MeSH terms: Diabetes Mellitus, Type 2; Prediabetic State
Study type: Interventional

Summary: 
      Primary prevention of diabetes is of paramount importance in both developed and in developing
      countries. Several studies including the Indian Diabetes Prevention Programmes have shown
      that Lifestyle modification in people with prediabetes can reduce the progression to diabetes
      by 58%. However, there are two main problems in applying diabetes prevention strategies to
      the population as a whole. (1) Trial based interventions are unrealistic on a population
      level in any country. (2) The oral glucose tolerance test applied so far to identify those at
      high risk is a poorly reproducible and time consuming test both for the participant and for
      health care workers. Hence more practical means of defining individuals who would benefit
      from lifestyle intervention are required.

      The current study proposes a prevention strategy that will employ a lifestyle modification
      programme delivered by text messaging in both India and the UK.Subjects will be identified
      based on the HbA1c measurement instead of the oral glucose tolerance test. The study will
      also assess the efficacy, acceptability and cost effectiveness of mobile phone based
      intervention both in India and the UK.

      Messages will be based to deliver education, treatment targets, advice, support and
      motivation. Subjects will be invited to participate and, once recruited, will be randomised
      to usual care or the SMS intervention group.

      Usual care will consist of a one-to-one 30 minute interview, conducted by the research team,
      delivering personalised diet and exercise advice.

      The intervention group will undergo the same initial interview and, in addition, will receive
      3 times weekly text messaging with education, advice, support and motivation. These messages
      will be personalised to individual targets set at the initial interview.

      Primary Outcome:Progression to Diabetes Secondary Outcomes will be based on Physical activity
      / Cardiovascular risk factors/and quality of life.

      The study programme is compatible with major initiatives in both the UK and India for the
      prevention of diabetes and cardiovascular disease (CVD).
    


Intervention name(s): Lifestyle Modification
Intervention type(s): Behavioral
Intervention description(s): The mobile phone based intervention will use short messaging service (SMS or text messaging) to deliver education, treatment targets, advice, support and motivation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Lifestyle changes to prevent type 2 diabetes
Mild Preeclampsia Near Term: Deliver or Deliberate?
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Interventional

Summary: 
      Preeclampsia with new-onset hypertension and proteinuria is a pregnancy-specific disease that
      affects 5-7% of gestations usually after the 20th week. Most cases are mild, but severe cases
      exhibit multiple abnormalities in blood and maternal organ systems. Severe forms of
      preeclampsia/eclampsia are a major contributor to maternal death in the world. Delivery stops
      disease progression and recovery can begin. Patients with mild preeclampsia between 34-38
      weeks' gestation usually are hospitalized for evaluation and close monitoring of signs,
      symptoms, and certain laboratory studies as reflectors of disease status. As inpatients
      mothers are monitored frequently for evidence of maternal or fetal compromise until 38 weeks
      gestation when delivery is accomplished. If a patient with mild preeclampsia labors after 34
      weeks, no attempt is made to stop labor and delivery is undertaken. It remains unclear when
      during the third trimester that delivery should be accomplished for maximal maternal safety
      and minimal fetal risk. In this research project, we will identify patients who are at least
      34 weeks pregnant with mild preeclampsia. After informed consent to participate in the trial,
      we will randomize participants to either be delivered immediately or treated with observation
      and maternal-fetal surveillance in hospital as described previously with delivery at 38
      weeks. There will be 110 participants enrolled in each arm of the study for a total of 220
      patients who will be managed in the Wiser Hospital. We intend to analyze a number of maternal
      and fetal outcomes including cost comparisons for the care of both mother and fetus in the
      two groups of randomized patients. The findings should impact care of the pregnant patient
      with mild preeclampsia in the third trimester with regard to how early and how late in
      gestation that delivery should be accomplished for optimal maternal and perinatal benefit.
    


Intervention name(s): Delivery of infant
Intervention type(s): Procedure
Intervention description(s): Vaginal delivery or cesarean section, whichever is indicated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mild Preeclampsia
To Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of Samatasvir (IDX719) in Healthy Participants (MK-1894-006)
Condition: Chronic Hepatitis C Infection
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the potential for an effect of Ritonavir (Norvir®) or
      omeprazole (Prilosec®) on the pharmacokinetics of samatasvir and to assess the safety and
      tolerability of the study drugs when administered alone and in combination in healthy
      participants.
    


Intervention name(s): Samatasvir; Omeprazole; Ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Samatasvir 150 mg oral tablets (50mg x 3), single dose; 40 mg delayed-release oral capsules, once daily; 100 mg oral tablets, once daily
Intervention MeSH terms: Ritonavir; Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCV; Hepatitis C; antiviral drugs; liver
Study of AERAS 422 in Healthy Adults
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of AERAS-422 in
      healthy, BCG-naïve adults.
    

Detailed description: 
      This is a Phase I, randomized, controlled, double-blind, dose-escalation study of AERAS-422.
      This study will be conducted in 24 HIV-negative, healthy adults who are BCG-naïve and
      negative for prior exposure to Mtb at enrollment. The study will be conducted at one or more
      clinical research sites in the United States.

      AERAS-422 will be administered on Study Day 0 as a single 0.1 mL intradermal (ID) injection
      containing either >= 10^5 to <10^6 CFU (low-dose) or >=10^6 CFU (high-dose). BCG Tice® will
      be used as an active control for AERAS-422 and will be administered as a single 0.1 mL ID
      injection containing 1-8 x 10^5 CFU on Study Day 0.
    

Intervention name(s): AERAS-422; BCG Tice
Intervention type(s): Drug; Drug
Intervention description(s): rBCG; 1-8 x 10^5 CFU
Other intervention name(s): BCG Tice
Intervention MeSH terms: BCG Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Is the Nerve Growth Factor (NGF) a Useful Biomarker in Neurogenic Bladder Dysfunction After Spinal Cord Injury?
Condition: Spinal Cord Injury; Neurogenic Detrusor Overactivity; Neurogenic Lower Urinary Tract Dysfunction
MeSH terms: Spinal Cord Injuries; Urinary Bladder, Overactive
Study type: Observational

Summary: 
      Spinal cord injury (SCI) almost always affects bladder function as well. As a result of this
      bladder dysfunction, individuals with SCI have to undergo regular invasive examination of
      their bladder function (urodynamic examination).

      The nerve growth factor (NGF) is released from smooth muscle cells of the bladder, and there
      are reports, that the concentration of NGF is elevated in the urine of patients with bladder
      dysfunction. The NGF concentration can also be measured in the blood. The concentration of
      NGF in the blood and urine of SCI individuals has not yet been investigated. These
      concentrations may correlate with the severity of bladder dysfunction, and may thus be used
      to replace or at least reduce the number of the more invasive urodynamic examinations.

      The hypothesis that urine and blood NGF concentrations in individuals with SCI are higher
      compared to individuals with healthy bladder function will be tested.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        individuals suffering from neurogenic lower urinary tract dysfunction, namely neurogenic
        detrusor overactivity
      
Keywords: spinal cord injury; neurogenic lower urinary tract dysfunction; nerve growth factor; neurogenic detrusor overactivity; urodynamics
A Phase III Study of Human Papillomavirus (HPV)-16/18 Vaccine.
Condition: Human Papilloma Virus Infection Type 16; Human Papilloma Virus Infection Type 18; Cervical Intraepithelial Neoplasia
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Papillomavirus Infections; Papilloma; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection
      Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of Recombinant Human
      Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Healthy
      Females Aged 18-30 Years.
    

Detailed description: 
      This is a multi-centre, randomized, double blinded, placebo controlled study. The study
      vaccine is recombinant human papillomavirus bivalent (types 16 and 18) vaccine (Yeast), the
      placebo is aluminium phosphate diluent.

      This study planned to enrol 12000 healthy female aged 18-30 in 10 study sites. Each
      participants will received a three-dose schedule of vaccine or placebo randomly but with the
      proportion controlled as 1:1 for vaccine group and placebo group. After each inoculation, the
      immediate reaction will be observed for 30 minutes, and the local and systemic reaction will
      be systematically observed for 7 days. After the first inoculation, adverse event will be
      collected until one month after the final inoculation, while serious adverse event will be
      collected until 6 months after the final inoculation. Blood samples will be collected before
      the first inoculation, and one month after the final injection, blood samples will also be
      collected in a group of participants containing 800 people to detect antibody titer.

      Follow-up visit will be conducted 14 times: month 0, month 0 + 8 days, month 2, month 2 + 8
      days, month 6, month 6 + 8 days, month 7, month 12, month 18, month 24, month 30, month 36,
      month 48, month 60. When cervical intraepithelial neoplasia grade 2+ (CIN2+) is indicated,
      the participant will receive standard treatment and drop out from the study.
    

Intervention name(s): HPV-16/18 vaccine; HPV-16/18 placebo
Intervention type(s): Biological; Biological
Intervention description(s): 0.5ml of recombinant human papillomavirus virus-like particle vaccine (Type 16 and 18 L1 Proteins, Yeast) on upper arm deltoid muscle with a three-dose-schedule (0, 2, 6 months).; 0.5ml of placebo on upper arm deltoid muscle with a three-dose-schedule (0, 2, 6 months).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Comparison of Comprehensive Multi-disciplinary Program and Conventional Care Program on Fragility Fracture Elderly
Condition: Hip Fracture
MeSH terms: Fractures, Bone; Hip Fractures
Study type: Interventional
Phase: Phase 3

Summary: 
      Fragility fractures are one of the commonest injuries among elderly people in Hong Kong and
      account for 12% of the disease burden in elderly aged 65 or above.

      A good management healthcare program and training helps elderly to restore full functional
      level and prevent re-fracture in the following 2 years after primary fracture, but Hong Kong
      lacks of such program. Some reports from other countries pointed out a well-organized
      multi-disciplinary management programs are cost-effective to identify and treat osteoporosis,
      reduce the fracture rate, improve quality of life and raise awareness of fragility fracture.

      This study aims to compare the cost-effectiveness of multi-disciplinary management program
      with conventional care controls. The clinical effectiveness outcomes (re-fracture rate, fall
      rate, mortality, mobility, quality of life and specialist follow-up time) of the fragility
      hip fracture patients in New Territories East receiving the proposed management program will
      be compared with those from Kowloon Central with usual care as controls. The findings will
      provide useful data for the policy maker to evaluate the current clinical service for
      fragility fracture patients and consider the implementation of new multi-disciplinary
      management program into our healthcare system.
    


Intervention name(s): Multi-disciplinary management program
Intervention type(s): Other
Intervention description(s): conventional healthcare program for fragility fracture patients plus vibration treatment, exercise class and educational talk
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Multi-disciplinary management program; Conventional care program; Balance Ability; Quality of Life