bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin
Condition: Chemotherapy-Induced Nausea and Vomiting; Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Nausea; Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      The current recommended guideline for patients receiving moderately emetogenic chemotherapy
      (MEC) is the combination of a 5-HT3 receptor antagonist and corticosteroid. Incidence of
      chemotherapy induced nausea and vomiting (CINV) is approximately 50% in patients receiving
      MEC. An incidence rate of 25-38% for delayed emesis and 55-60% for delayed nausea has been
      observed. Hence, there is clearly a need for more effective prevention of CINV in patients
      receiving MEC, especially in women with ovarian carcinoma who are particularly susceptible to
      these symptoms. Therefore the investigators designed a study with the objective to evaluate
      if new combination (Aprepitant/Ramosetron/Dexamethasone) may improve actual CINV control in
      ovarian carcinoma patients treated with taxane/carboplatin.
    


Intervention name(s): Aprepitant/Ramosetron/Dexamethasone
Intervention type(s): Drug
Intervention description(s): Aprepitant: The first day, one 125 mg capsule will be administered per oral, 1 hour before chemotherapy. Thereafter one 80 mg capsule will be repeated daily between 8 to 10 a.m. during days 2 to 3.
Ramosetron: 0.3 mg i.v. a single dose on day 1, administered over 30 seconds, 30 minutes prior to chemotherapy.
Dexamethasone: 20mg diluted in 50ml of 0.9% saline i.v. a single dose on day 1, administered over 30minutes prior to chemotherapy (taxane). Because all patients are premedicated with dexamethasone 20 mg before taxane administration, the dose of dexamethasone can not be reduced to 12 mg.
Intervention MeSH terms: Dexamethasone; Aprepitant; Ramosetron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: efficacy and safety of Aprepitant/Ramosetron/Dexamethasone in ovary cancer patients with taxol and carboplatin
Pregnancy Intervention Revolving Around Goal-focused Education (GIRAFE)
Condition: Pregnancy
MeSH terms: Gestational Weight Gain
Study type: Interventional

Summary: 
      The purpose of study is to learn if consuming ≥30 grams or more of fiber per day can help
      pregnant women gain an appropriate amount of weight during their pregnancy.
    


Intervention name(s): Dietary Fiber Intervention
Intervention type(s): Behavioral
Intervention description(s): Intervention included weekly group-based phone counseling with a Registered Dietitian (RD) to encourage consumption of a high fiber diet (≥30 g/day). All women reported their body weight weekly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dietary Fiber; Gestational weight gain
Intermittent Preventive Treatment for Malaria in Infants in Navrongo Ghana
Condition: Anaemia; Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      Evaluation of the safety and effectiveness of malaria intermittent chemotherapy and iron
      supplementation delivered through Expanded Programme on Immunisation vaccination clinics.
    

Detailed description: 
      Anaemia is one of the main disease burdens of children in developing countries. Severe
      anaemia is often fatal, while moderate anaemia leads to growth and cognitive disorders. The
      incidence of anaemia in children is extremely high in malaria endemic areas since episodes of
      clinical malaria and asymptomatic parasitaemia result in red cell destruction. It has been
      shown in Tanzania that the incidence of severe anaemia in infants can be reduced by 30% by
      regular administration of iron supplements, and by 60% if regular malaria chemoprophylaxis is
      given in addition. One way to operationalise this research finding, with minimal additional
      cost to governments and communities, is to link the distribution of iron and antimalarial
      drugs to the EPI programme. We propose a community-randomised trial to study the
      effectiveness of intermittent iron supplements and malaria chemotherapy in reducing the
      incidence of anaemia and clinical malaria, and to investigate any possible interactions of
      iron and antimalarial drugs with EPI vaccines. The study will have two arms: children in both
      arms will receive monthly supplies of twice weekly iron supplements when they attend EPI and
      growth monitoring clinics. In addition, children in arm 1 will receive a placebo when they
      receive Polio/DPT 2, Polio/DPT 3 and measles vaccines, while those in arm 2 will receive
      sulfadoxine-pyrimethamine (SP). The baseline incidence of anaemia and malaria, and immune
      response to EPI vaccines, will be estimated in a sample of children from a non-intervention
      area adjacent to the study area. The immune response to EPI vaccines, drug side-effects, and
      the incidence of anaemia and malaria will be compared between the two arms of the study and
      with the non-intervention area. Any possible 'rebound' in malaria incidence due to impairment
      of immunity will be monitored and treated during the six months after stopping the
      chemotherapy and supplementation.
    

Intervention name(s): Sulfadoxine-pyrimethamine; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: incidence of anaemia
Exploration of the Mechanism of Movement Improvement During RBD in Parkinson's Disease Using NIRS
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this study is to confirm the improvement of movement during RBD in Parkinson's
      disease and to explore the neuronal network involved in this improvement using NIRS.
    

Detailed description: 
      The aim of this study is to compare the quality of movement during REM sleep during RBD
      episodes and movement awake without and with dopaminergic treatment while measuring cortical
      activity using NIRS.
    

Intervention name(s): Near Infrared Spectroscopy
Intervention type(s): Other
Intervention description(s): Use of the near-infrared-spectroscopy (NIRS) to explore the cortical mechanism by which this sleep disorder would allow a disappearance of parkinsonian signs at night
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Parkinson Disease; Near infrared Spectroscopy; REM sleep behaviour disorder; Supplementary motor area
BEhavioral EConomics for Oral Health iNnovation Pilot Trial
Condition: Toothbrushing; Dental Plaque; Parent-Child Relations; Oral Hygiene; Dental Caries
MeSH terms: Dental Caries; Dental Plaque
Study type: Interventional

Summary: 
      This Phase I randomized pilot trial will assess the efficacy of a fixed incentive payment
      program and drawing incentive payment program versus a control program to promote early
      childhood caries (ECC) preventive health behaviors (i.e., toothbrushing performance and
      dental visit attendance) for young children of predominantly Latino parents/caregivers
      enrolled in/waitlisted for Early Head Start (EHS) home visit programs.
    

Detailed description: 
      If both groups are acceptable and feasible, the reward group with toothbrushing outcomes at
      least 20% better than the other one (and the control) will be chosen for a future Phase
      II/III trial; if they are similar, the fixed monetary reward will be used because it is
      simpler to explain, monitor, and implement.
    

Intervention name(s): Fixed Incentive; Drawing Incentive
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Fixed Incentive intervention is a fixed reward, in which participants are eligible for fixed weekly payments based on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app.; The Drawing Incentive intervention is a drawing reward, in which participants are eligible for weekly payments based on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible consenting parent-child participant dyads, within strata and permuted blocks, will be randomized in equal allocation to one of three arms. Strata will be based on smartphone operating system (iOS or Android).
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Preventive Dentistry; Health Disparities; Health Behavior; Behavioral Economics; Monetary Incentives
An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      A 3-way cross-over trial of two weeks of treatment with three drug conditions. AZD3480 will
      be given in doses of (A) 5mg/day, (B) 50 mg/day and (C) placebo to 24 non-smoking adults with
      DSM-IV confirmed ADHD. Three week washout between each treatment period. CYP2D6 genotyping
      will be completed at screening and slow metabolisers will be excluded from participation in
      this study. Cognitive, ADHD symptom, safety and pharmacokinetic (PK) assessments will be made
      during each treatment period. Safety and tolerability assessments will be a major component
      of the trial and all serious adverse events (SAE) will be immediately (within 24 hours)
      reported to both Targacept and to AstraZenca.
    


Intervention name(s): Placebo; AZD3480; AZD3480
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsules 5 mg/day (once a day) for 2 weeks; Capsules 50 mg/day (once a day) for 2 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Placebo-Controlled Study of Collagen Hydrolysate in Subjects With Knee Osteoarthritis (OA)
Condition: Knee Osteoarthritis (OA)
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is designed to evaluate, by MRI, knee cartilage and structure in all subjects.
      Half the subjects in this study will take collagen hydrolysate each day for 48 weeks and the
      other half of the subjects will take a placebo dose, that looks like and tastes like the
      collagen hydrolysate, each day for 48 weeks. MRIs will be taken at Study Weeks -1, 24, and
      48.
    

Detailed description: 
      This is a single-site, double-blind, pilot study to evaluate the sensitivity of MRI to detect
      cartilage structure and composition in subjects taking daily oral collagen hydrolysate (a
      nutritional supplement) or placebo for 48 weeks. 30 subjects will be randomized to collagen
      hydrolysate or placebo (1:1 ratio). The goal is to evaluate, by MRI, knee cartilage and
      structure in all subjects. The primary functional outcome measure will be the WOMAC
      questionnaire and the primary pathological outcome measure will be knee cartilage structure
      and composition as measurements done by MRI imaging. Subjects will have contrast dGEMRIC MRIs
      done at Study Weeks -1, 24 and 48.
    

Intervention name(s): Collagen Hydrolysate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Collagen Hydrolysate solution 10 grams per day by mouth for 48 weeks; Matching placebo solution per day by mouth for 48 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: OA; Knee arthritis; Osteoarthritis; Nutritional supplement; CAM; MRI
A Study of Amolimogene (ZYC101a) in Patients With High Grade Cervical Intraepithelial Lesions of the Uterine Cervix
Condition: Uterine Cervical Dysplasia
MeSH terms: Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of amolimogene, in the
      treatment of patients with high-grade cervical intraepithelial lesions of the uterine cervix.
    

Detailed description: 
      This is a double-blind study, so neither the patient not the doctor will know which treatment
      has been assigned.
    

Intervention name(s): Amolimogene; Amolimogene; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 1-dose amolimogene Group: Two intramuscular (IM) injections (100 micrograms ZYC101a per injection), one in each quadriceps, at Treatment Initiation. Single IM placebo injections (approximately 1 mL 0.9% sterile saline) at Weeks 3 and 6 in alternating quadriceps.; 3-dose amolimogene Group: Two IM injections (100 micrograms ZYC101a per injection), one in each quadriceps, at Treatment Initiation. Single IM injections of 100 micrograms ZYC101a at Weeks 3 and 6 in alternating quadriceps.; Placebo Group: Two IM placebo injections at Treatment Initiation (1 injection in each quadriceps). Single placebo injections at Weeks 3 and 6 in alternating quadriceps. Each placebo injection consists of approximately 1 mL 0.9% sterile saline.
Other intervention name(s): ZYC101a; ZYC101a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cervical lesions; cervical dysplasia; Human papilloma virus; abnormal Pap; High-grade cervical intraepithelial lesions (CIN 2/3)
Daily Dystonia Practice - A Trial to Investigate NT 201, the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to confirm efficacy and safety of NT 201 (Xeomin®, also known as
      IncobotulinumtoxinA) after one injection session and to determine the efficacy and safety
      profile and the duration of treatment effect of NT 201 in long-term treatment with repeated
      injection sessions.
    


Intervention name(s): NT 201
Intervention type(s): Drug
Intervention description(s): Subjects to receive up to 5 injection sessions, with a total dose of up to 300 Units each. No more than 50 units should have be given at any one injection site during one session.
Intervention MeSH terms: incobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Topiramate for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)
Condition: Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome
MeSH terms: Peripheral Nervous System Diseases; Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The TopCSPN trial is a double blinded randomized placebo controlled study of oral topiramate
      as a potential disease modifying therapy for cryptogenic sensory peripheral neuropathy
      (CSPN). Patients with CSPN who also have metabolic syndrome (defined by the ATPIII criteria)
      who do not have an alternative cause for neuropathy will be potentially eligible. The co
      primary outcome measures are change in the Norfolk Quality of Life - Diabetic Neuropathy
      (NQOL-DN) Scale and intraepidermal nerve fiber density (IEFND) at the distal thigh. The
      treatment phase will last 24 months.
    


Intervention name(s): topiramate; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral topiramate at a target dose of 50mg twice daily.; overencapsulated placebo of identical color, shape and packaging to topiramate
Other intervention name(s): Topamax
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
FGF-23 Suppressibility by Calcitonin
Condition: Hypophosphatemia
MeSH terms: Hypophosphatemia
Study type: Interventional

Summary: 
      Introduction:

      Based on our experience with calcitonin as an FGF-23 suppressive agent in a patient with an
      FGF-23 producing tumor we hypothesize that calcitonin may be a physiologically important
      regulator of FGF-23 production and secretion in healthy humans.

      Aim:

      In this study we wish to examine the FGF-23 suppressive effects of calcitonin in healthy men.

      Study Design:

      placebo-controlled, cross-over study

      Method:

        -  All twelve subjects are examined on two occasions, once after exposure to placebo 1 ml
           NaCl 0.9% subcutaneously, and once following calcitonin 200 IU/ml subcutaneously

        -  On both occasions frequent bloodsampling will take place, out an indwelling catheter in
           de forearm vein.

        -  Sampling times: -15, 0, 60, 120, 240, 360, and 480 minutes

        -  Mealtimes: Calcium and Phosphate intake standardized on both occasions

        -  All samples are analyzed for FGF-23, using a C-terminal FGF-23 ELISA kit (Immunotopics,
           San Clemente, USA) that measures intact and C-terminal fragments of FGF-23, and one that
           measures only intact FGF-23

        -  Samples obtained at T-15, T0, T240 and T480 are stored for later analysis of Ca,
           albumin, PO4, PTH, 25-OHD and 1,25-OHD

      Endpoint:

      A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of
      calcitonin 200 IU.
    


Intervention name(s): Calcitonin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Calcitonin 200 IU/ml, single subcutaneous injection, experimental group; NaCl 0,9 % 1ml, single subcutaneous injection, placebo group
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Fibroblast growth factor - 23; Calcitonin
Effects of N-acetylcysteine on Cardiorespiratory Control in COPD Patients With Mild-to-moderate Airflow Obstruction
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to determine whether pharmacological treatment with
      N-acetylcysteine improves central and peripheral cardiorespiratory control and physical
      capacity in COPD patients with mild-to-moderate airflow obstruction.
    

Detailed description: 
      Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality
      worldwide. Cardiovascular complications constitute the main causes of poor physical capacity
      and healthcare resources utilization in COPD. There is emerging evidence that these
      impairments have a major impact on the health of patients with mild-to-moderate disease, the
      largest sub-population of COPD. This important problem, however, is currently neglected as no
      specific pharmacological treatment is offered to these patients. Recent studies indicate that
      vascular abnormalities are mediated, at least in part, by circulating inflammatory substances
      and direct damage of the arteries by oxygen radicals (oxidative stress). The current
      investigation will test the hypothesis that N-acetylcysteine (NAC), via its anti-inflammatory
      and antioxidant properties, improves systemic vascular function and physical capacity in COPD
      patients with mild-to-moderate airflow obstruction.
    

Intervention name(s): N-acetylcysteine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmacological treatment with N-acetylcysteine (NAC): 3 pills of 600 mg of NAC/day orally for 4 days prior to experimental procedures and 1 pill of 600 mg of NAC orally on the day of the experiment.; Placebo: 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.
Other intervention name(s): NAC pills; Placebo pills
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Simultaneous FMRI and NIRS to Estimate Brain Cerebral Metabolism
Condition: Healthy
Study type: Observational

Summary: 
      The principal advantages of functional magnetic resonance imaging (fMRI) with
      blood-oxygenation- level-dependent (BOLD) contrast for studying brain function are:
      non-invasiveness, ubiquitous availability, relatively high spatiotemporal resolution, and the
      ability to map function over the entire brain. Thus, BOLD fMRI is the most widely applied
      technology to study healthy brain function and pathophysiology associated with disease. In
      studies of drug abuse and psychiatric illness though, normal assumptions mapping BOLD signals
      to neurometabolism may be violated. Generally, these effects are ignored, resulting in large
      study-to-study variability.

      Quantitative fMRI (qfMRI) measures metabolism directly and is more suitable for studies of
      drug abuse and psychiatric illness. However, qfMRI is too complex for routine use. Cerebral
      metabolism during brain activation during visual stimulation measured with a new fMRI
      approach that is simple enough for clinical applications will be compared to CMRO2 activation
      measured using standard qfMRI.
    

Detailed description: 
      Healthy subjects will undergo a single imaging session. During the imaging session, fMRI and
      simultaneous near-infrared spectroscopy measurements will be made during visual stimulation
      (e.g., viewing a flashing checkerboard). This is a methods development study focused on
      comparing a new method for estimating CMRO2 associated with brain activation with the
      standard fMRI approach for estimating CMRO2.
    

Observational model: Case-Only
Sampling method: Non-Probability Sample
Study population: 
        1 healthy subject will be recruited for the study from the general population to undergo 12
        separate study visits.
      
Keywords: cerebral metabolism; functional magnetic resonance imaging; near infrared spectroscopy