bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will assess and compare the immune response to full-dose inactivated polio vaccines
      (IPV) via intramuscular (IM) administration and of the fractional dose of inactivated
      poliovirus vaccine (f-IPV) via intradermal (ID) administration, in different schedule
      combinations in the Expanded Program on Immunization (EPI) primary series.
    

Detailed description: 
      This study prioritizes comparisons involving two-dose regimens recently recommended by the
      World Health Organization (WHO) Strategic Advisory Group of Experts on immunization (SAGE)
      and Pan American Health Organization (PAHO) in response to global IPV supply shortages 21.
      Furthermore, the study will provide data on the comparative humoral immunogenicity of various
      schedules to inform polio immunization policy for the post-eradication era.

      The study population will include infants in Dominican Republic and Panama. Absence of wild
      and circulating vaccine derived polioviruses along with the lack of regular Supplementary
      Immunization Activities (SIAs) in the Latin America region provide an ideal epidemiologic
      setting to study polio vaccine immunogenicity.

      Infants will receive two or three doses of full-dose IPV IM or f-IPV ID, in two schedules
      (10, 14 and 36 weeks and 14 and 36 weeks). Immunological and safety assessments will be made
      after one dose, two doses and three doses.

      A total of 773 infants will be enrolled and distributed into 4 groups, according to a
      randomization scheme. During the study period, infants will be administered other concomitant
      vaccines according to the national schedules of the participating countries, but the effect,
      if any, of the concomitant administration on IPV immunogenicity will not be assessed.

      Optimum immunogenicity expected from the dose(s) of IPV in the post-eradication era will have
      to be balanced with the cost and supply constraints of IPV. This study will be critical to
      determine how many doses of IPV and which schedule are optimal for the post-eradication era
      after the global cessation of Oral Polio Vaccine (OPV) use.
    

Intervention name(s): IPV; f-IPV
Intervention type(s): Biological; Biological
Intervention description(s): Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID); Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study of ACT-541468 in Healthy Japanese and Caucasian Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      So far, ACT-541468 has been studied mainly in Caucasian subjects. The present study will
      bridge results obtained in Caucasian subjects to those in Japanese subjects.
    


Intervention name(s): ACT-541468; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule; Matching placebo capsule
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: safety; Japanese; pharmacokinetics
Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects
Condition: Hepatitis B
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 1

Summary: 
      Non-randomized, 3-part, open-label, drug-drug interaction (DDI) study to evaluate the effect
      of itraconazole, carbamazepine, or quinidine on the PK and safety of EDP-514 in healthy adult
      subjects.
    


Intervention name(s): EDP-514; EDP-514; EDP-514; Itraconazole; Carbamazepin; Quinidine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive EDP-514 on Days 1 and 14; Subjects will receive EDP-514 on Days 1 and 23; Subjects will receive EDP-514 on Days 1 and 8; Subjects will receive itraconazole QD for 14 days; Subjects will receive carbamazepine BID for 23 days; Subjects will receive quinidine BID for 8 days
Intervention MeSH terms: Itraconazole; Quinidine; Carbamazepine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: drug-drug interaction
Effect of Different Intensities of Exercise on Daily Energy Expenditure With Physical Activity in Overweight Boys
Condition: Obesity
Study type: Interventional

Summary: 
      The main purpose of this study is evaluate the effect of different intensities of exercise
      (moderate vs. intense) on the daily energy expenditure in overweight adolescents.
    

Detailed description: 
      The specific objectives are:

        1. Assess and quantify the existence of compensatory effect of exercise on subsequent
           physical activity.

        2. Compare the amount of daily physical activity in adolescents subjected to different
           protocols of training intensity.
    

Intervention name(s): physical activity-moderate; Intense physical activity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): cross -over of moderate and intense physical activity; cross -over of moderate and intense physical activity
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: physical activity; energy expenditure; compensatory mechanisms; adolescent
Regulatory Post Marketing Surveillance Study on YAZ
Condition: Contraception; Premenstrual Syndrome; Acne
MeSH terms: Premenstrual Syndrome
Study type: Observational

Summary: 
      The objective of this Post Marketing Surveillance (PMS) is to gain information about safety
      and efficacy in real practice.
    


Intervention name(s): EE20/DRSP (YAZ, BAY86-5300)
Intervention type(s): Drug
Intervention description(s): Patients under daily life treatment with YAZ according to local drug information.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Korean female who need only contraception or contraception and management of PMDD or
        contraception and treatment of acne.
      
Keywords: Contraception; Premenstrual Dysphoric Disorder; PMDD; Acne
Vibration Training in Chronic Obstructive Pulmonary Disease (COPD)-Patients During a Three-week Rehabilitation
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The aim of this study is to investigate the change of physical activity in COPD-patients
      performing a whole body vibration training additional to a standard three-week rehabilitation
      program in comparison to patients performing merely a standard rehabilitation program.
    


Intervention name(s): whole body vibration training
Intervention type(s): Procedure
Intervention description(s): pulmonary rehabilitation with strength and endurance training and additionally vibration training
Other intervention name(s): whole body vibration; Galileo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD III/IV; Activity Monitoring; SenseWear; Vibration training; Galileo; Pulmonary rehabilitation
Neurodevelopmental Assessment of Infants With Cystic Fibrosis
Condition: Neurodevelopmental Disorders; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis; Neurodevelopmental Disorders
Study type: Observational

Summary: 
      Infants included in the study will be divided into two groups as healthy infants and cystic
      fibrosis infants . Demographic, natal and postnatal information of the infants will be
      available from patient files. 12 months infants with cystic fibrosis and healthy infants will
      be assessed by the Bayley-III Baby and Child Development Assessment Scale (Bayley III) and
      the Gross Motor Function Measure. The assessment outcomes of healthy and cystic fibrosis
      infants will be compared.
    


Intervention name(s): Neurodevelopmental assessments
Intervention type(s): Other
Intervention description(s): Infants' neurodevelopmental assessments will be done by the Bayley-III Baby and Child Development Assessment Scale (Bayley III) and the Gross Motor Function Measure. Bayley-III assess the development of five distinct scales to be consistent with areas of appropriate developmental assessment for children from birth to age 3. The Bayley-III revision includes Cognitive, Language, Motor, Social-Emotional, and Adaptive Behavior scales.The Gross Motor Function Measure (GMFM) has 5 dimensions: A-lying and roll- ing; B-sitting; C- kneeling and crawl- ing; D-standing; and E-walking, run- ning, and jumping. The items are scored from 0 to 3. All items are summarized and expressed as a value of total points for each dimension of the GMFM.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infants with cystic fibrosis will be provided from the Hacettepe University Faculty of
        Medicine, Pediatric Chest Diseases Clinic and healthy infants will be provided from the
        Hacettepe University Department of Physiotherapy and Rehabilitation Developmental and Early
        Physiotherapy Unit.
      
Keywords: cystic fibrosis; neurodevelopment; early rehabilitation
Study of VX-770 on Desipramine
Condition: In Development for Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the effects of VX-770 on Desipramine
    


Intervention name(s): VX-770; VX-770
Intervention type(s): Drug; Drug
Intervention description(s): In period 1, subjects will receive a single oral dose of desipramine on Day 1.; In period 2, subjects will receive 150 mg VX-770 q12h orally from the morning of Day 1 through the evening of Day 9. Subjects will receive 50 mg Desipramine as a single dose on Day 5 of period 2.
Intervention MeSH terms: Ivacaftor
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dietary Effects on Weight Loss and Lipid Profile in Sedentary Men
Condition: Men; Life Style; Lipid Metabolism Disorders; Obesity; Overweight
MeSH terms: Overweight; Metabolic Diseases; Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Negative-calorie diet is among the popular dieting guides for weight loss; however, there is
      still little knowledge about this method. The present study aimed to determine the effects of
      negative-calorie diet on weight loss and lipid profile, and to compare its efficiency with
      low-calorie diet in men.
    


Intervention name(s): NCD; LCD
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Negative Calorie Diet; Low Calorie Diet
Other intervention name(s): group I; group II
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Dietary Formulations; Lifestyle; Obesity; Overweight; weight loss
Efficacy and Safety of 3% Hypertonic Saline Inhalation (24h vs 72h) to Treat Acute Bronchiolitis in Hospitalized Infants
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Efficacy/Safety of 3% hypertonic saline inhalation (24H vs 72H) to treat acute bronchiolitis
      in infants.
    

Detailed description: 
      In acute bronchiolitis in infants, 3% hypertonic saline nebulizations proved to be efficient,
      reducing the hospitalization length and clinical severity scores. Among the questions
      remaining, treatment length is still being discussed in the literature. The trial hypothesis
      is that the efficiency of a 24 hours treatment by 3% hypertonic saline is not inferior to a
      72 hours treatment, in acute bronchiolitis in infants. The primary objective of the study is
      to compare the efficiency of a 24 hours treatment by 3 % hypertonic saline, versus a 72 hours
      treatment maximum, on clinical remission, judged by the Wang score measured 72 hours after
      starting treatment, in children younger than 12 month hospitalized for acute bronchiolitis.
    

Intervention name(s): 3 % hypertonic saline up to 72H; 3 % hypertonic saline up to 24H
Intervention type(s): Drug; Drug
Intervention description(s): Treatment by inhalation of 3 % hypertonic saline, up to 72H. Test group.; Treatment by inhalation of 3 % hypertonic saline, up to 24H.
followed by 48h of placebo : isotonic saline inhalation. Placebo control group.
Other intervention name(s): 3 % hypertonic saline; palcebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Saline Solution, Hypertonic (3 %); Infant
Escitalopram (Lexapro) for the Treatment of Postpartum Depression
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether women with postpartum major depressive
      disorder (MDD) will experience a significant decrease in depressive symptoms from baseline
      over an eight-week treatment intervention with escitalopram (Lexapro). Also, to determine
      whether women with postpartum MDD will experience a significant decrease in anxiety symptoms.
    


Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): Once daily by mouth
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: women; postpartum depression; anxiety
A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fed Conditions
Condition: Clinical Pharmacology
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the relative bioavailability of naproxen sodium/diphenhydramine hydrochloride
      (DHP HCL) 220/25 mg soft capsules (Test) versus naproxen sodium/DPH HCl 220/25 mg tablets
      (Reference) after a single oral administration (2 x naproxen sodium 220 mg and DPH HCl 25 mg
      combination product) under fed conditions in healthy adult subjects.

      To assess the safety and tolerability of the investigational products in terms of adverse
      events (AEs) and clinical parameters (systolic/diastolic blood pressure, pulse rate, physical
      examination, clinical and laboratory testing).
    


Intervention name(s): Naproxen sodium and diphenhydramine hydrochloride soft capsules; Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve PM, BAY98-7111)
Intervention type(s): Drug; Drug
Intervention description(s): Single oral administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 capsules); Single administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 tablets)
Intervention MeSH terms: Diphenhydramine; Promethazine; Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adrenal Artery Ablation Treats Primary Aldosteronism
Condition: Primary Aldosteronism; Hypertension
MeSH terms: Hypertension; Hyperaldosteronism
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary aldosteronism (PA) is one of the most common cause of endocrine and resistant
      hypertension. Current studies have shown that the activation of the
      renin-angiotensin-aldosterone system (RAAS) and the increased sympathetic nerve activity in
      the central or local tissue are the key mechanisms of high blood pressure and its organ
      damages.

      The classical method for diagnosis of primary aldosteronism depends on the detection of
      peripheral venous blood aldosterone level, which is incapable of accurate positioning
      diagnosis. On the other hand, the current guidelines recommend that surgery and aldosterone
      receptor inhibitors were the only treatment for primary aldosteronism. However, only about
      35% of aldosterone tumors and a small part of unilateral adrenal hyperplasia can be treated
      by surgery. More than 60% of idiopathic aldosteronism and bilateral adrenal hyperplasia need
      long-term drug therapy. However, long-term aldosterone inhibitor treatment may also cause
      hyperkalemia, male breast hyperplasia, female hirsutism and other adverse reactions.

      Therefore, the investigators proposed that endovascular chemical partial ablation of the
      adrenal gland can lower the aldosterone level, reduce the blood pressure and recover the
      potassium metabolism balance. In order to confirm the above effects, the investigators
      conduct an open, prospective, positive controlled study in patients with primary
      aldosteronism patients (including aldosterone, idiopathic aldosteronism and adrenal
      hyperplasia). The effects on blood pressure, blood electrolytes, adrenal hormones, metabolic
      indexes, target organ damages were observed to explore the efficacy and safety of the
      endovascular ablation of the adrenal gland in the treatment of primary aldosteronism.
    


Intervention name(s): Endovascular chemical Ablation of Adrenal Gland
Intervention type(s): Procedure
Intervention description(s): Patients in this group will be treated with partial ablation of adrenal gland by endovascular injection of dehydrated alcohol.
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients in the Intervention group will be treated with endovascular chemical ablation of adrenal gland by endovascular injection of dehydrated alcohol. Patients in the Control group will be treated with conventional anti-hypertensive drugs
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary Aldosteronism; Hypertension; Ablation; Adrenal Gland
Effectiveness of Buddhist Intergrated Group Intervention on Minefulness in Adolescents
Condition: Other Conditions That May Be A Focus of Clinical Attention
Study type: Interventional

Summary: 
      The pupose of the study is to determine the effectiveness of the Buddhist integrated group
      intervention improve the mindfulness in adolescents by a randomized controlled trial.The
      study divede the adolescents in two groups group A recieved the 8 time Buddhist group
      interventions.Group recieved nothing.The measurement were done pre and post intervention at
      week1 and week8.The mindfulness score ,the EQ,the MASS score were compared between both
      groups.
    

Detailed description: 
      Adolescence behavioural problems are increasing including learning disabilities,game
      addiction,intolerance etc.The improvement of mindfulness ,the emotional quotient(EQ) proved
      to be effective to reduce the problems.The original teaching methods in school or in the
      temple are inadequate from increasing number of adolescent problems. The new technique
      integrated between Buddhism and group intervention is proposed to improve the mindfulness and
      EQ in adolescence.
    

Intervention name(s): buddhist mind fullness
Intervention type(s): Behavioral
Intervention description(s): there are two group one group recieve Buddhist mindfulness group intervention 8 times second group recieve nothing
Other intervention name(s): no other name
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mindfulness EQ adolescents
The Effect of Low Dose Aspirin in Increasing the Chance of Pregnancy
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      It has been reported that low-dose aspirin and Heparin would lead to an increased Pregnancy
      rate in patients undergoing IVF-ET. Low-dose aspirin may improve uterine and ovarian
      perfusion and that aspirin might enhance endometrial receptivity and ovarian responsiveness
      as well, which could result in better implantation and pregnancy rates after IVF or ICSI
      treatment. This study assesses potential effects of low-dose aspirin (100 mg daily) on
      pregnancy rate following frozen embryo transfer.
    

Detailed description: 
      In the present randomized double-blind prospective study, the patients will be randomly
      assigned to the study and control groups. With the onset of endometrial preparation and
      estrogen treatment, the study group will receive 100 mg of oral aspirin and the control group
      will be given placebo. When endometrial thickness will be found between 8-14 mm, therapy with
      progesterone (100 mg IM daily) will be started and embryo transfer will be performed 48 to 72
      hours later. Doppler ultrasonography also is done to calculate Resistive Index (RI) and
      Pulsatility Index (PI), the day after progesterone administration.

      βHCG will be assessed 14 days after ET. If a pregnancy will be achieved, the patients in
      study and control groups will be instructed to continue the aspirin or placebo through 5
      weeks and if the pregnancy test result will be negative, the treatment with aspirin or
      placebo will be stopped. The patients will be followed until 20 weeks of gestation and the
      results of treatment cycle will be compared in two groups.
    

Intervention name(s): Asprin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg; 100mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low dose aspirin endometrial thickness pregnancy rate ICSI IVF embryo transfer