bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of JNJ-38431055, Sitagliptin, and Co-administration of JNJ-38431055 and Sitagliptin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, pharmacokinetics (explores what the body
      does to the drug), and pharmacodynamics (explores what a drug does to the body) of single
      doses of JNJ-38431055, sitagliptin, and co-administration of JNJ-38431055 and sitagliptin in
      healthy overweight or obese adult male volunteers.
    

Detailed description: 
      This is a double-blind (neither physician or volunteer knows the name of the assigned study
      drug), placebo controlled (substance containing no medication), study in healthy, overweight
      or obese adult male volunteers. For each volunteer, the study consists of a screening phase
      (up to 30 days), a treatment phase during which volunteers will receive 4 study treatments in
      a randomized (study sequence assigned by chance) sequence (28 days), and a follow-up phase
      (10 days). During the treatment phase there will be at least 7 days between each of the 4
      treatments. The four treatments will be JNJ-38431055, sitagliptin, JNJ-38431055 and
      sitagliptin, and placebo. The following safety evaluations will be taken throughout the
      study: Electrocardiogram (an ECG is a painless procedure that gives a picture of the
      electrical activity of the heart), blood pressure, heart rate, and blood samples for
      laboratory tests. The primary outcome will be the effect of JNJ-38431055 and sitagliptin on
      glucagon like peptide-1 (GLP-1) levels. Study drug will be administered as single oral doses
      separated by at least 7 days. The four treatments will be JNJ-38431055, sitagliptin,
      JNJ-38431055 and sitagliptin, and placebo.
    

Intervention name(s): JNJ-38431055; Sitagliptin 100 mg; JNJ-38431055 + Sitagliptin 100 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Liquid suspension of JNJ-38431055 administered as a single dose; Capsule containing 100 mg of sitagliptin administered as a single dose; Liquid suspension of JNJ-38431055 administered as a single dose, and capsule containing 100 mg of sitagliptin administered as a single dose; Placebo suspension and placebo capsule administered as single doses
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus
IMPlementation of gUideLines for the Management of Arterial hypertenSION. The IMPULSION Study
Condition: High Blood Pressure
MeSH terms: Hypertension
Study type: Observational

Summary: 
      The objective of this protocol is to improve awareness, treatment, and control of arterial
      hypertension, within primary prevention of target organ damage, by implementing guidelines,
      after training of the participating physicians.
    

Detailed description: 
      Physicians from 20 hospitals and 40 health centres (primary health care settings) were
      trained to implement guidelines in treating arterial hypertension.

      There will be a baseline recording of patients with arterial hypertension and then physicians
      will have to complete a one page form (by ticking pre-specified boxes) about the baseline
      status of the patients and will have to report the measures they took to improve awareness,
      treatment, and effective control of arterial hypertension. After a six month effort,
      physicians will have to complete the same form at study completion. Previous training of
      physicians and the fact that they will have to report their success in treating hypertension
      will hopefully contribute to an increase in number of hypertensive patients at blood pressure
      target, and will minimise the target organ damage. The estimated reduction in coronary heart
      disease risk will be evaluated by a comparison of this risk (as evaluated by a risk engine,
      i.e. PROCAM) at study completion with that of baseline.
    

Intervention name(s): Implementation of guidelines
Intervention type(s): Behavioral
Observational model: Cohort
Time perspective: Prospective
Keywords: High blood pressure; Awareness; Treatment; Effective Control; Coronary heart disease risk reduction; Hypertension
Clinical Efficacy of a Toothpaste on Hypersensitivity Reduction
Condition: Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      Tooth sensitivity reduction after dentifrices use
    


Intervention name(s): Arginine/Calcium Carbonate; Mint Prophy paste - Fluoride free
Intervention type(s): Device; Device
Intervention description(s): One application; one application
Other intervention name(s): Nupro C Prophylaxis paste - Fluoride free
Intervention MeSH terms: Calcium Carbonate; Calcium; Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Tolerance Study of Recombinant Human Albumin Injection in Healthy Subjects.
Condition: Ascites
MeSH terms: Ascites
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase I, single-center, randomized, double-blind, placebo-controlled single dose escalation
      study, and a positive-controlled multiple dose extension study to evaluate the safety,
      tolerance, pharmacokinetics and immunogenicity of recombinant human albumin injection in
      healthy subjects
    

Detailed description: 
      This study was to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of
      recombinant human albumin injection in healthy volunteers. The safety, tolerance,
      pharmacokinetics and immunogenicity of recombinant human albumin injection were evaluated in
      a single center, randomized, double-blind, placebo-controlled single dose incremental trial
      in healthy volunteers. The study was divided into two stages: the first stage was a single
      dose and dose increasing stage (including 5 dose groups with increasing dose, and each group
      was set with placebo control); the second stage was multiple administration stage (with
      positive control). The safety, tolerance, pharmacokinetics, immunogenicity and other early
      clinical data of recombinant human albumin were collected and analyzed in the two stages. The
      initial dose was 1.25g. The highest dose group was set at 30g. The dose groups of 1.25, 5,
      10, 20 and 30 g / time were preset in the single dose stage (dose increasing stage). The
      dosage was 10 g / Day in multiple administration stage.
    

Intervention name(s): recombinant human albumin injection; Placebo; human albumin injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose or multiple doses of intravenous infusion; Single dose intravenous infusion of 0.9% sodium chloride injection; multiple doses of intravenous infusion
Other intervention name(s): Intravenous infusion of recombinant human albumin injection; Intravenous infusion of 0.9% sodium chloride injection; Intravenous infusion of human albumin injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects (Adults)
Condition: Healthy
Study type: Interventional

Summary: 
      The investigational study product used in this clinical trial is a soft drink containing an
      arabinoxylan-oligosaccharides (AXOS) preparation extracted from wheat bran (hereafter called
      Wheat Bran Extract, WBE).

      The objective of this study is to analyze the effect of the intake of two WBE doses on
      various parameters of gastrointestinal health. Additionally, safety was analyzed using
      treatment emergent Adverse Events (AEs) and clinical blood parameters.
    


Intervention name(s): wheat bran extract; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): soft drink comprising high WBE dose and natural flavor and coloring agent, ingestion after breakfast and after dinner; soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and after dinner
Other intervention name(s): arabinoxylan-oligosaccharides (AXOS)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: gastrointestinal health; healthy subjects
Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current study is to demonstrate bioequivalence of two 2.5 mg
      linagliptin/500 mg metformin fixed dose combination tablets compared to the free combination
      of the linagliptin 5 mg and metformin 1000 mg in healthy male and female volunteers.
    


Intervention name(s): Metformin; Linagliptin; Metformin; Linagliptin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Free combination; Fixed dose combination; Combination; Free combination
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Prospective Open-Label Extension Study of Gaboxadol in Primary Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety and tolerability of gaboxadol in primary insomnia
    

Detailed description: 
      To evaluate long-term safety of gaboxadol in healthy adults.
    

Intervention name(s): Gaboxadol
Intervention type(s): Drug
Intervention MeSH terms: Gaboxadol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary insomnia
Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations
      of candesartan and felodipine in a combination package comparing with the fasting intake of
      commercial formulations of both Atacand ® and Splendil®
    


Intervention name(s): Candesartan (test); Felodipine (test); Candesartan Cilexetil; Felodipine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 16 mg oral tablet, single dose; 5 mg oral extended release tablet, single dose; 16 mg oral tablet, single dose; 5 mg oral extended release tablet, single dose
Other intervention name(s): Atacand®; Splendil®
Intervention MeSH terms: Felodipine; Candesartan; Candesartan cilexetil
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: pharmacokinetics; candesartan; felodipine; test formulations; Atacand®; Splendil®; healthy volunteers; blood samples; after meal intake interaction; Kinetic interaction amongst test formulations of Candesartan and Felodipine and the brands Atacand® and Splendil® in healthy volunteers after a fasting period.
Development of an Arabic Central Auditory Processing Remediation Program for Dyslexic Children With(C)APD
Condition: Central Auditory Processing Disorder; Dyslexia
MeSH terms: Auditory Perceptual Disorders; Dyslexia; Language Development Disorders
Study type: Interventional

Summary: 
      Rehabilitation of dyslexic children with (cental) auditory processing disorder.

      The first group will receive the proposed program the arabic version of differential
      processing training program and the control group will receive the computer based auditory
      traing program (CBAT).
    

Detailed description: 
      Central Auditory Processing Disorder(C)APD is defined as difficulty for children with normal
      hearing to listen selectively in the presence of noise, to combine information from two ears
      properly, to process speech when it is slightly degraded, and to integrate auditory
      information when it is delivered faster than the individual with (C)APD can process.( The
      estimated prevalence of (C)APD in the school-aged population is approximately 2 to 5 %, and
      the estimated prevalence of (C)APD in the older adult population is 76 %. These percentages
      are higher than those affected by hearing loss.

      Dyslexia and (C)APD are common comorbidities and since there is limited research on (C)APD
      within each related academic discipline. Furthermore the language, audiologiological , and
      cognitive nature of the disorder confirmed that a multi-disciplinary effort is needed in
      order to provide clinical decision and effective intervention for the (C)APD population.
      Hence Development of additional intervention tools for use in clinics, schools and home
      settings is warranted .

      The aim of this work is to develop a novel Arabic (C)APD remediation program ,to study the
      outcome of the program and to validate it's effectiveness by comparing it to the Arabic
      computer based auditory training(CBAT) program.
    

Intervention name(s): arabic version of differential processing training program; Arabic computer based auditory traing program(CBAT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): comprehensive training program for central auditory processing disorder contains auditory and linguistic tasks (language organization, phonemic and phonetic awareness, dichotic listening,temporal patterning and auditory discrimination).; comprehensive computer based traing program for central auditory processing disorder contains auditory memory, temporal processing, dichotic listening , selective attention and phonemic awareness games.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Rehabilitation of dyslexic children with (cental) auditory processing disorder.
The first group will receive the proposed program the arabic version of differential processing training program and the control group will receive the computer based auditory traing program (CBAT).
Masking: None (Open Label)
Primary purpose: Treatment
Impact on the Nutritional State and the Quality of Life
Condition: Cancer
Study type: Observational

Summary: 
      The prevalence of malnutrition in cancerous patients varies between 50% and 80%. It is
      variable in function: the location and the extension of the tumor, of the general state , of
      age, of the socio-economic class and the pain. The health consequences of a malnutrition are
      very important: aggravation of the state of health, complications of treatment,
      hospitalization, alteration of the quality of life and decrease the survival, and the
      treatment response.

      Nutrition being very important in patients, there are recommendations for the nutritional
      care of these patients, formulated by the European Society for Clinical Nutrition and
      Metabolism. The investigators do not know to what extent these recommendations are respected
      in practice and their influence on the nutritional status and the quality of life of
      patients.

      The investigators therefore propose to assess the conformity of the nutritional care patients
      in clinical practice in relation to the European recommendations and in a second time to
      assess the influence of this compliance or non-compliance on the nutritional status clinical
      and biological of cancerous patients under chemotherapy, on their quality of life, on their
      response to treatment and on their survival.

      The investigators will try to identify factors that may be linked to the non-compliance such
      as the characteristics of the cancer disease, socio-demographic characteristics of the
      subject and the factors related to the structure in which it is supported.
    


Intervention name(s): answering questionnare in differents time of the treatment
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        cancerous patients benefiting from a treatment by chemotherapy
      
Keywords: chemotherapy
Acoustic Startle Reduction In Cocaine Dependence
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Observational

Summary: 
      Chronic cocaine administration leads to changes in brain function that persist long after the
      acute withdrawal phase. The acoustic startle response (ASR) is a well characterized reflexive
      response to a sudden acoustic stimulus. The ASR is mediated by a simple 3-synapse subcortical
      circuit; it is modulated in part by brain areas and neurotransmitters associated with cocaine
      administration. Our initial study and subsequent replication reveals a profound diminution of
      the ASR in cocaine-dependent subjects after a brief period of abstinence. Our preliminary
      findings indicate that first degree relatives of cocaine-dependent subjects also have reduced
      startle compared to healthy controls. The findings of low ASR in rats and humans during
      cocaine washout and low ASR in family members suggests there may be both a trait and state
      component of the startle reductions we have reported.

      The central objectives of this proposal are to dissect this finding with regard to its
      development and persistence in early and later phases of cocaine abstinence in humans; to
      ascertain whether startle reduction and its potential normalization during later abstinence
      is a predictor of clinical course in human subjects with cocaine dependence; and to examine
      whether startle reduction is, at least in part, a vulnerability trait for the development of
      cocaine dependence. This latter Aim will be carried out in humans by testing siblings of
      cocaine-dependent subjects.

      Cocaine dependence is an enormous public health problem. The significance of this work lies
      in the potential for the ASR reduction to serve as a reliable, easily repeatable biological
      measure of cocaine-induced brain changes that may enhance outcome prediction so that tailored
      treatments may be directed at those patients most vulnerable to relapse, given the
      restriction of resources for available for substance abuse treatment.
    


Intervention name(s): acoustic startle testing
Intervention type(s): Procedure
Intervention description(s): acoustic startle testing: listening to sounds through headphones while the eyeblink component of the acoustic startle reflex is recorded with small surface electrodes
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects with cocaine dependence who are entering substance abuse treatment; siblings of
        these subjects; and healthy controls
      
Biospecimen description: 
      Blood and extracted DNA
Is Protein S100B a Predictor of First-to-chronic Seizure Conversion in Adults?
Condition: Epilepsy; Seizures, Epileptic
MeSH terms: Seizures
Study type: Observational

Summary: 
      Seizures represent an important clinical problem, accounting for at least 40% of adult onset
      epilepsy. Predicting seizure recurrence in subjects experiencing a first seizure is difficult
      due to the lack of prognostic biomarkers. Recent evidence has indicated that blood-brain
      barrier (BBB) dysfunction constitutes an etiological factor to seizures. In particular, it
      has been shown that modification of BBB permeability is associated with seizure activity. In
      addition, it was demonstrated that BBB permeability can be assessed by measuring serum level
      of the protein S100B. Based on these data and considerations the investigators will test
      whether the extent of BBB damage at time of first seizure is predictive for seizure
      recurrence.

      The main objective of this study is to evaluate the association between the absolute (ng/ml)
      serum S100B levels (measured at time of the first seizure) and the experience, or not, of
      seizure recurrence within one year of follow-up.
    

Detailed description: 
      The secondary objectives of this study are to investigate the:

      A) Prognostic capacity of serum S100B levels to predict seizure recurrence. B) Association
      between the variation (%) of serum S100B levels between first seizure episode and scheduled
      follow-up (D14-D28) and seizure recurrence.

      C) Correlation of S100B with IL-1b, IL-6, NSE serum levels at the same time points.

      D) Association of serology data with: a) EEG profile (normal/abnormal); b) recurrence of
      seizures (Y/N).

      E) Comparison of S100B serum levels in lesional vs non-lesional patients. F) Establishment of
      a bio-bank (serum and cells).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population is composed of patients between 18 and 60 years of age, of both sexes,
        recruited during consultations for a first epileptic seizure at the emergency department of
        Nîmes and Marseille Hospitals (CHRU).
      
Biospecimen description: 
      Processing of blood samples: 4-5ml of the blood sample will be centrifuged to isolate serum;
      S100B, IL-1b, IL-6, NSE levels will be investigated at D0 (T0+6h, T0+12h where T0 is seizure
      time) D14-D28. The remaining blood and cells will be stored at -80°C for future analyses.
Clinical Trial to Investigate the Pharmacokinetics Drug Interaction Between Metformin and Rosuvastatin
Condition: Hyperlipidemia; Diabetes
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetic drug interaction between
      Metformin and Rosuvastatin in healthy male volunteers.
    

Detailed description: 
      Drug-drug Interaction Following Co-administration of Metformin and Rosuvastatin in Healthy
      Male Volunteers
    

Intervention name(s): Metformin; Rosuvastatin; Metformin and Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Metformin,1000mg, once daily; Rosuvastatin, 20 mg, once daily; Metformin, 1000mg, once daily Rosuvastatin, 20mg, once daily
Other intervention name(s): Glucodown OR SR tablet; Crestor tablet; Glucodown OR SR tablet and Crestor tablet
Intervention MeSH terms: Metformin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Stress Heart Imaging in Patients With Diabetes at Risk for Coronary Disease.
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is designed to see if stress heart imaging can be used as a screening exam in
      patients with diabetes and risk factors of developing of coronary artery disease and
      experiencing future cardiac events.
    


Intervention name(s): Technetium Tc99m Sestamibi
Intervention type(s): Drug
Intervention MeSH terms: Technetium Tc 99m Sestamibi
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic