bioihbjkbjnl/mcl2 huggingface dataset:
D-Cycloserine Facilitation of Cocaine - Cue Extinction
Condition: Cocaine Use Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore the use of d-cycloserine (DCS) to facilitate
      extinction of response to cocaine cues in cocaine-dependent individuals, in hopes that it may
      lead to the development of new treatment options for cocaine dependence.
    

Detailed description: 
      Cocaine dependence remains a serious problem in the United States today and in spite of two
      decades of intense research, efficacious pharmacotherapeutic treatments have not been
      identified. Cocaine-associated environmental cues can elicit drug craving and exposure to
      cocaine-related cues is likely to be involved in relapse. Emerging data supports the role of
      glutamate in extinction learning. D-cycloserine (DCS), a partial glutamate agonist,
      facilitates extinction of associative learning in animal models of fear-conditioning and
      clinical studies of exposure treatment for anxiety disorders. A recent study demonstrated DCS
      acceleration of extinction of cocaine-induced conditioned place preference in rats (Botreau
      et al., 2006). Exploration of DCS in facilitating extinction of response to drug-related cues
      in humans is needed. The proposed study will extend these innovative and promising findings
      from the basic science arena and anxiety disorders field in a proof of concept investigation
      of DCS facilitation of extinction of response to cocaine-related cues in a human laboratory
      paradigm. In addition, to examine the neural substrates of extinction learning, a sub-set of
      individuals that are willing and eligible will undergo fMRI scanning procedures before and
      after the extinction protocol.
    

Intervention name(s): D-Cycloserine (DCS); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg d-cycloserine or placebo taken orally
Other intervention name(s): seromycin
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: substance-related disorders
An Efficacy Trial of Iron, Zinc and Vitamin A Fortified Rice in Children in Satun, Thailand
Condition: Vitamin A Deficiency; Iron Deficiency; Zinc Deficiency
MeSH terms: Night Blindness; Iron Deficiencies; Vitamin A Deficiency
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Iron, zinc and vitamin A deficiencies are particularly common among children and young women
      in the developing countries of South and Southeast Asia resulting in important adverse health
      effects. Simultaneous fortification of rice with iron, zinc and vitamin A could be a novel
      and sustainable approach to control these deficiencies.

      Recently conducted extrusion trials have demonstrated that extruded rice grains containing
      iron, zinc and vitamin A show acceptable stability during production and storage and good
      sensory properties. The grains were produced using a twin-screw extruder equipped with a
      special cutter and a rice shaping die. The Fe, Zn and vitamin A content of the extruded
      product is 10 mg, 9 mg and 1050 μg per g of rice, respectively.

      In this study the investigators plan to test the efficacy of the extruded triple fortified
      rice in Satun, Thailand, an area where rice is the staple food. Preliminary data from this
      area show that zinc and vitamin A intakes are low. Biochemical indicators have confirmed zinc
      deficiency and suboptimal vitamin A status in 1/3 of school aged children. The efficacy of
      the fortified rice will be evaluated in a 9 months, controlled, double-blind intervention
      trial in 7-12 y-old children. Children will be selected from primary schools in Satun
      Province based on low serum zinc values as the primary goal is to investigate Zn efficacy. As
      secondary outcome the effect on iron and vitamin A status will be investigated. The children
      will be randomized into two groups: a control group will receive a daily non-fortified rice
      lunch meal at school, while the second group will receive a daily rice meal containing the
      triple fortified rice. The rice meals will be given 5 days a week. At baseline, weight and
      height will be measured and determination of hemoglobin, serum ferritin, zinc protoporphyrin,
      serum zinc, serum retinol and C-reactive protein will be done. At mid-point and at 9 months,
      the baseline measurements will be repeated to judge the efficacy of the triple fortified
      rice.
    


Intervention name(s): fortified extruded rice
Intervention type(s): Dietary Supplement
Intervention description(s): fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fe deficiency, Zn deficiency, vitamin A deficiency
Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis
Condition: Acute Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 3

Summary: 
      Oral rehydration therapy is the only treatment recommended by the World Health Organization
      in acute diarrhea in children. The aim of this study was to compare the efficacy and safety
      of a therapy with gelatin tannate plus oral rehydration versus oral rehydration alone in
      children with acute gastroenteritis.

      This is a single-blind, prospective, randomized and parallel study performed in two Pediatric
      Services of tertiary referral hospitals. Patients, ages 3 to 36 months with acute
      gastroenteritis randomized to receive an oral rehydration solution (OR), or an oral
      rehydration solution plus gelatin tannate (OR+G). The primary outcomes evaluated were: the
      number of bowel movements after 48 and 72 hours after initiating treatments. Secondary
      outcomes were: duration of diarrhea (days), stool characteristics and adverse events. Other
      clinical variables, as weight, fever, vomiting, appetite and the acceptability of the two
      treatments were also recorded.
    


Intervention name(s): Gelatin tannate
Intervention type(s): Device
Other intervention name(s): Gelenterum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Dose Finding Study of CHF 4226 for Treating Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to identify the optimal once-daily dose of CHF 4226 to be
      further developed for the treatment of patients with COPD.
    


Intervention name(s): carmoterol (CHF 4226); carmoterol (CHF 4226); carmoterol (CHF 4226); salmeterol; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): carmoterol pMDI 2.0 μg once a day, in the morning
(1 puff of carmoterol 1.0 mcg + 1 puff of carmoterol 1.0 mcg); carmoterol pMDI 1.0 μg once a day, in the morning
(1 puff of carmoterol 1.0 mcg + 1 puff of placebo pMDI)); carmoterol pMDI 4.0 μg once a day, in the morning
(1 puff of carmoterol 2.0 mcg + 1 puff of carmoterol 2.0 mcg); Salmeterol 50 μg DPI, in the morning and in the evening (1 blister BID); Placebo pMDI once a day, in the morning (1 puff of placebo pMDI + 1 puff of placebo pMDI)
Other intervention name(s): CHF 4226; CHF 4226; CHF 4226; Serevent® Diskus®/Accuhaler®
Intervention MeSH terms: Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Role of Salbutamol and Furosemide in TTN
Condition: Transient Tachypnea of the Newborn
MeSH terms: Tachypnea; Transient Tachypnea of the Newborn
Study type: Interventional
Phase: Phase 3

Summary: 
      to see the effects of slabutamol and IV furosemide in the treatment of transient tachypnea of
      newborn
    


Intervention name(s): Furosemide Injection
Intervention type(s): Drug
Intervention description(s): efficacy of salbutamol and furosemide in TTN
Other intervention name(s): salbutamol inhalation
Intervention MeSH terms: Furosemide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain in Potentiel Organ Donors.
Condition: Alternative Method of Apnea Test
MeSH terms: Apnea
Study type: Observational [Patient Registry]

Summary: 
      Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem
      reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous
      breathing is established the apnea test (according to the American Academy of Neurology's
      Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and
      cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some
      data suggest modifying the apnea test : replace the ventilator switching off with continuous
      positive airway pressure (CPAP) use. These studies showed that this alternative method (CPAP)
      increased the level of lung harvest but they were not sufficient because these studies were
      monocentric with little patients,. That why the aim of the present study is to compare the
      standard strategy and CPAP strategy with a prospective, multicenter,cluster trial; each
      center will use the method of apnea test which it uses usually.
    


Intervention name(s): Apnea test - Standard; Apnea test - CPAP
Intervention type(s): Procedure; Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Potentiel organs donors in brain death.
The Effects of a Zeaxanthin Intervention on Visuomotor Function
Condition: Behavior and Behavior Mechanisms
Study type: Interventional

Summary: 
      This study was designed to test whether two zeaxanthin formulations (supplements containing
      different nutritional compounds with zeaxanthin and omega fatty acids being the primary
      ingredients of interest) influenced visual motor function. Visual motor function refers to
      the processing speed of the visual system and how individuals respond behavioral to visual
      stimuli (e.g., reaction time).
    

Detailed description: 
      This study was designed to test whether two zeaxanthin formulations (supplements containing
      different nutritional compounds with zeaxanthin and omega fatty acids being the primary
      ingredients of interest) influenced visual motor function. Visual motor function refers to
      the processing speed of the visual system and how individuals respond behavioral to visual
      stimuli (e.g., reaction time).
    

Intervention name(s): zeaxanthin; combinatory supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): softgel; softgel
Other intervention name(s): zeaxanthin + lutein + DHA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: zeaxanthin; visual function; reaction time; processing speed
Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients
Condition: Cardiotoxicity; Chemotherapeutic Toxicity
MeSH terms: Cardiotoxicity
Study type: Interventional
Phase: Phase 4

Summary: 
      In cancer patients, the increase of troponin I soon after chemotherapy is a strong predictor
      of left ventricular dysfunction and poor cardiologic outcome. This information provides a
      rationale for the development of prophylactic strategies directed against
      chemotherapy-induced cardiotoxicity (CTIC). Activation of the renin-angiotensin system has
      been proved to be involved in the development and progression of cardiac dysfunction in
      several clinical settings, and has been suggested to have a role in the occurrence of CTIC.
      We investigated the role of treatment with ACE-inhibitors in the prevention of CTIC in
      high-risk cancer patients.
    


Intervention name(s): Enalapril
Intervention type(s): Drug
Intervention description(s): enalapril orally administered
Intervention MeSH terms: Enalapril
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Chemotherapy induced cardiotoxicity; Troponin; Heart failure
Permanent Occlusion of Uteine Arteies in Management of Abnormal Uterine Bleeding
Condition: Other Abnormal Uterine and Vaginal Bleeding
MeSH terms: Uterine Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Prospective observational interventional study , The study done in two phases:

        1. Phase one from October 2011to May 2012 pilot study including twenty nine (29)
           premenopausal patients followed up for six months

        2. Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal
           patients all of them needing to preserve their uteri.
    

Detailed description: 
      Abstract Objectives: To assess the effectiveness of permanent bilateral occlusion of uterine
      arteries in treatment of abnormal uterine bleeding.

      Design: prospective observational study Setting: Done in Mansoura university hospital,
      department of Obstetrics and gynecology.

      Patients and Methods: The study done in two phases:

        1. Phase one from October 2011to May 2012 pilot study including twenty nine (29)
           premenopausal patients followed up for six months

        2. Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal
           patients all of them needing to preserve their uteri.

      Results: Results are hopeful and courageous in phase one as regards patients satisfaction,
      Quality of life and improvements of bleeding. Results of phase two will be implemented,
      analyzed and presented in tables. All data will be statistically analyzed and the results
      will be presented after completion of eighteen (18) months follow up to rule out any bias
      and/ or errors in the results.

      Conclusion: permanent bilateral uterine arteries occlusion may be a good alternative to
      radical surgery in abnormal uterine bleeding.
    

Intervention name(s): bilateral permanent occlusion of uterine arteries
Intervention type(s): Procedure
Intervention description(s): bilateral permanent Occlusion of uterine arteries through abdominal route
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: permenant occlusion; uterine bleeding; uterine arteries
Menopause Sample Collection
Condition: Menopause
Study type: Observational

Summary: 
      This study will provide daily urine samples from women during early and late stage
      peri-menopause as well as post-menopause over the course of three calendar months in order to
      maintain the SPD sample bank.

      Urine samples will be received in the clinical laboratory and aliquoted into 2.25ml amounts
      and stored at -80˚C until required.

      Symptom information will also be recorded to determine whether there are any noticeable
      physiological changes that can be related to stage of the menopause.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy female volunteers
      
Biospecimen description: 
      Urine Samples
Effects of Medium-Chain Triglycerides on Chylomicron Secretion and Expression of Genes That Regulate Intestinal Lipid Metabolism in Men With Dyslipidemia Associated With the Metabolic Syndrome
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Dyslipidemias; Syndrome
Study type: Interventional

Summary: 
      Several lines of evidence indicate that a significant proportion of cardiovascular disease
      (CVD) events are attributable to the presence of a cluster of metabolic abnormalities and
      perturbations, defined as the metabolic syndrome. It has been estimated that approximately
      25% of the North American adult population is living with the metabolic syndrome. Recent
      studies from the investigators group show that overaccumulation of atherogenic
      triglyceride-rich lipoproteins (TRL) seen in insulin-resistant patients is partly due to
      increased production rate of intestinally derived apolipoprotein (apo) B-48-containing
      lipoproteins. This is of interest because substantial evidence exists indicating that
      elevated levels of intestinal lipoproteins are associated with increased CVD risk. In this
      regard, there is some evidence that medium-chain triglycerides (MCTs) may beneficially modify
      lipoprotein metabolism in hypertriglyceridemic patients. However, as emphasized in the body
      of this grant proposal, the specific impact of MCTs on the intestinal lipoprotein secretion
      and on expression of genes that regulate intestinal lipid absorption and chylomicron
      synthesis has not yet been investigated in humans.

      The general objective of the proposed research is to investigate the mechanisms by which MCTs
      beneficially modify intestinal lipoprotein metabolism in patients with the metabolic
      syndrome. The primary hypothesis is that MCT supplementation will decrease plasma levels of
      intestinal lipoproteins by reducing secretion of these particles.
    


Intervention name(s): Medium-chain triglycerides; Corn oil
Intervention type(s): Other; Other
Intervention description(s): During Medium-Chain Triglycerides (MCT period), participant will asked to consume two pastries per day that will provide a total of 20 g of MCT/day for 4 weeks.; During Corn oil period (Control period), participant will asked to consume two pastries per day that will provide a total of 20 g of corn oil/day for 4 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to investigate whether
      differences exist between three different concentrations of the drug, NN9535, administered in
      healthy male subjects in equal doses.
    


Intervention name(s): semaglutide; semaglutide; semaglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Comparison of different formulations of the drug, semaglutide: Formulation 1 administered in equimolar doses; Comparison of different formulations of the drug, semaglutide: Formulation 2 administered in equimolar doses; Comparison of different formulations of the drug, semaglutide: Formulation 3 administered in equimolar doses
Other intervention name(s): NN9535
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/Hib
Condition: Hepatitis B; Whole Cell Pertussis; Tetanus; Haemophilus Influenzae Type b; Diphtheria
MeSH terms: Hepatitis B; Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      This booster study will assess the immunogenicity, reactogenicity and safety of a booster
      dose of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine versus DTPw-HBV/Hib vaccine, in healthy
      children, 18 to 24 months of age, who received the same vaccine for primary vaccination.
      Prior to the booster dose, this study will also assess the persistence of antibodies to the
      vaccine antigen components administered in the primary vaccination course. The Protocol
      Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    


Intervention name(s): DTPw-HBV/Hib Kft vaccine GSK323527A; Tritanrix™-HepB/Hiberix™
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 1 dose; Intramuscular injection, 1 dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to evaluate the safety, tolerability and immune response when 13-valent
      pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are
      given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal
      polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also
      evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of
      13vPnC given 5 years after the first dose.
    


Intervention name(s): 13 valent pneumococcal conjugate vaccine; 13 valent pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5; TIV + placebo at dose 1 13vPnC at dose 2, one month after dose 1 and 13vPnC at year 5
Other intervention name(s): 0.5 mL dose of TIV and 13vPnC at dose 1, 0.5 mL dose of of placebo at dose 2, and 0.5ml dose of 13vPnC at year 5 will be administered into left deltoid muscle; 0.5 mL dose of TIV and of placebo at dose 1 and 0.5 mL dose of 13vPnC at dose 2 and year 5 will be administered into left deltoid muscle
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pneumococcal Conjugate Vaccine
Supplementation of Infant Formula With Synbiotics
Condition: Infant Formula
Study type: Interventional

Summary: 
      The primary hypothesis is that Lactobacillus paracasei ssp. paracasei strain F19 in an infant
      formula containing FOS/GOS is safe and tolerable for use in infants from 0 to 6 months.
    


Intervention name(s): Lactobacillus paracasei paracasei strain F19
Intervention type(s): Other
Intervention description(s): Provided in an infant formula, 10^8 CFU per day from 28 days to 6 months of infant age
Other intervention name(s): F19
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: F19; Lactobacillus paracasei paracasei