bioihbjkbjnl/mcl2 huggingface dataset:
Bhaktapur Maternal and Child Micronutrient Study
Condition: Malnutrition, Infant; Malnutrition; Anemia
MeSH terms: Malnutrition; Infant Nutrition Disorders
Study type: Observational

Summary: 
      Between February 2008 and February 2009, 500 infant-mother pairs in Bhaktapur, Nepal were
      randomly selected in this nutritional survey. The dietary intake, nutritional status of
      several nutrients, growth, and breastfeeding habits were measured in both the women and their
      infants.The objective of this first phase was to estimate the intake and status of several
      nutrients in relation to breastfeeding. These mother-child pairs were revisited around the
      child's fifth birthday when growth, diet, and neurodevelopment was measured. The objective of
      this phase was to create a cohort study where factors in infancy could be related with health
      outcomes and development 5 years later.
    

Detailed description: 
      Over a period of one year, a total of 500 lactating (encompassing both exclusive and partial
      breastfeeding) women were enrolled in the study and completed the first 24-hour dietary
      recall. The women attended a hospital for physical examination, dietary interview, and blood
      sampling. Blood samples were also collected from their infants who also went through a
      detailed clinical examination

      The blood samples from mothers and infant pairs were collected approximately one week apart.
      The blood was spun down, plasma separated and transferred into storage vials immediately.
      Plasma and blood pellets were stored in cryovials at -70 until analysis.

      All women were also requested to provide one breast milk and one urine sample.

      Plasma, blood pellet, urine, and breast milk was stored at -70 degrees celcius until
      analysis.

      Plasma was analyzed for iron, transferrin receptor, ferritin, cobalamin, folate, vitamin A,
      vitamin D, vitamin E, several amino acids and other micronutrient related metabolites.

      The breast milk will be analyzed for iodine, fatty acids, and several B vitamins

      The urine was analyzed for iodine.

      In phase 2, after 5 years we revisited the mother-child pairs and measured growth, diet, food
      security, and neurodevelopment.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A cross-sectional survey was carried out and 500 healthy lactating women (17-44 years old)
        were randomly selected from Bhaktapur municipality, Nepal. Bhaktapur is an urban area
        located 15 km east of the capital Kathmandu and was chosen because of the diversity of this
        population spanning all socio-economic strata, providing a unique opportunity to explore
        dietary variation.
      
Biospecimen description: 
      Breastmilk Plasma Red blood cells Urine
    
Keywords: Nepal; Breastfeeding; Micronutrients; Women; Infants
Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder
Condition: Tourette's Syndrome; Tic Disorders
MeSH terms: Tourette Syndrome; Tic Disorders; Tics
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if Abilify will reduce tics (repetitive,
      uncontrollable movements or vocalizations) in children and adolescents ages 7-18 with
      Tourette's Disorder (TD) or a chronic motor tic disorder (either repetitive, uncontrollable
      movements or vocalizations).
    

Detailed description: 
      The aims of this study are to obtain systematic data regarding dosing and safety of
      aripiprazole (Abilify) in the treatment of youth with Tourette's Disorder (TD). Tourette's
      Disorder is characterized by multiple motor (more than one uncontrollable movement) and vocal
      tics (vocal outbursts) which have been present for more than 1 year, with onset before the
      age of 18. The disorder causes marked distress in social, occupational or other important
      areas of functioning. Abilify has been approved by the United States Food and Drug
      Administration (FDA) to treat adults with schizophrenia but has not been approved to treat
      Tourette's Disorder (TD) so it is considered experimental or investigational in this study.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): Baseline Visit 2: Subjects btw 25-50kg start on 1.25mg/day, btw 50-70kg start on 2.5mg/day, greater than 70kg start on 5mg/day Visit 3: Titrated based on YGTSS & CGI-TS ratings at investigator discretion. Subjects who show evidence of response (reduction in CGI-TS by 1-2 points) may remain on same dose. Subjects who show no response may increase as follows: btw 25-50kg increase to 2.5mg/day, btw 50-70kg increase to 3.75mg/day, greater than 70kg increase to 7.5mg/day Visit 5: Subjects who show no response may increase as follows: btw 25-50kg increase to 3.75mg/day, btw 50-70kg increase to 5mg/day, greater than 70kg increase to 10mg/day Visit 6: Subjects who show no response may be increase as follows: btw 25-50kg increase to 5mg/day, btw 50-70kg increase to 7.5mg/day, greater than 70kg increase to 12.5mg/day Visit 7: Subjects who how no response may be increase as follows: btw 25-50kg increase to 7.5mg/day, btw 50-70kg increase to 10mg/day, greater than 70kg increase to 15mg/day
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychiatric; Clinical Trial; Pediatrics; Tourette's Disorder; Tic Disorder
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Healthy Japanese Volunteers
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 Japan. The aim of this trial is to assess the safety and
      tolerability of NNC 90-1170 (liraglutide) in healthy Japanese male subjects.
    


Intervention name(s): liraglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose administered subcutaneously at four different dose levels: 2.5, 5.0, 10.0 and 15.0 mcg/kg. Following completion of each dose group, an evaluation will be performed to allow progression to the next dose group; Single dose administered subcutaneously at four different dose levels: 2.5, 5.0, 10.0 and 15.0 mcg/kg. Following completion of each dose group, an evaluation will be performed to allow progression to the next dose group
Other intervention name(s): NNC 90-1170
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in Taiwan
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      The study is designed as a prospective, observational study to assess the effect of
      adalimumab on health-related quality of life (QoL) and work productivity in patients with
      rheumatoid arthritis (RA) in Taiwan.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects receiving Adalimumab with Rheumatoid Arthritis (RA) in Taiwan
      
Keywords: Quality of life (QOL); Work productivity; Rheumatoid arthritis (RA)
The Effect of Using Clinical Guidelines on Kangaroo Care on Newborn and Maternal Outcomes
Condition: Premature Infants
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The aim of this study was to determine the effect of the use of clinical guidelines in
      kangaroo care (KB) practice on neonatal and maternal outcomes in premature infants.

      The study was a single-blind, parallel group (experimental-control), randomized controlled
      experimental design with pretest-posttest design.

      It was carried out in the neonatal intensive care unit of Selçuk University Faculty of
      Medicine Hospital in Konya province. Study data were collected from 40 premature newborns
      between September 2022 and November 2022. Premature infants in the intervention (n = 20) and
      control groups (n = 20) were determined by randomization method.
    

Detailed description: 
      Kangaroo care was applied to the intervention group with the Kangaroo Care Guide created by
      reviewing the current literature, and kangaroo care was applied to the control group with the
      standard kangaroo care method of the clinic. Data were collected using the Descriptive
      Information Form, Physiological Parameters Form, Neonatal Comfort Behavior Scale,
      Nurse-Parent Support Scale, Parental Satisfaction Scale and Kangaroo Care Guide/Checklist for
      Infants Without Respiratory Support.

      Premature infants were followed up with skin-to-skin contact with their mothers in kangaroo
      care for 65 minutes. In the study, physiological parameters and Neonatal Comfort Behavior
      Scale scores of premature infants and Nurse-Parent Support Scale and Parental Satisfaction
      Scale scores of mothers were evaluated. Pearson Chi-Square Test, Yates Correction and
      Fisher's Exact Test were used to compare categorical data according to groups. Two
      Independent Sample t Test was used to compare normally distributed variables and Mann Whitney
      U Test was used to compare non-normally distributed variables. Statistical significance level
      was accepted as p˂0.05.
    

Intervention name(s): Kangaroo care based on kangaroo care guide
Intervention type(s): Other
Intervention description(s): Under the supervision of the researcher, a kangaroo care practice was applied to premature babies by their mothers based on the kangaroo care guide. This practice took 65 minutes. In addition, before the application, the kangaroo application information was explained to the mothers through a brochure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel group (experimental-control)
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Kangaroo care; Evidence-based guideline; Prematurity; NICU
Efficacy and Safety of Fexinidazole in Children at Least 6 Years Old and Weighing Over 20 kg With Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open Study, plug-in to the Pivotal Study
Condition: Human African Trypanosomiasis (HAT)
MeSH terms: Trypanosomiasis; Trypanosomiasis, African
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the study is to assess the efficacy and safety of an oral regimen of fexinidazole
      (once daily for 10 days) in the treatment of stage 1 and stage 2 T.b. gambiense sleeping
      sickness in children at least 6 years old and over 20 kg bodyweight.
    


Intervention name(s): fexinidazole
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
Condition: Meningococcal Meningitis; Tetanus; Diphtheria; Pertussis; Poliomyelitis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Meningitis, Meningococcal; Meningitis; Tetany
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of the concomitant
      administration of Menactra® vaccine and DAPTACEL® vaccine.

      The main objectives are:

      Immunogenicity:

      To evaluate the antibody responses to both vaccines when Menactra vaccine is given
      concomitantly with DAPTACEL® compared to when either vaccine is given alone.

      Safety:

      To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are
      administered concomitantly compared to when each vaccine is given alone.
    


Intervention name(s): Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30); 0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30); 0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)
Other intervention name(s): Menactra®; DAPTACEL®; IPOL; Menactra®; DAPTACEL®; IPOL; Menactra®; DAPTACEL®; IPOL
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningococcal meningitis; Tetanus; Diphtheria; Pertussis; Poliomyelitis; Neisseria meningitidis
Physical Activity and Bariatric Surgery
Condition: Bariatric Surgery Candidate
Study type: Interventional

Summary: 
      Bariatric surgery indeed leads to significant weight loss, reduces mortality risk,
      obesity-associated comorbidities (Wolfe et al., 2016) and improves functional physical
      abilities (Herring et al., 2016). Because these benefits are related to decreased energy
      intake, the investigators aim to optimize them by combining them with supervised adapted
      physical activity practice.

      So, the aim of this clinical trial is to measure the effects of a physical training program
      on physical fitness, body composition and quality of life of obese women who have undergone
      bariatric surgery.
    

Detailed description: 
      Upon hospitalization for their bariatric surgery (bypass or sleeve), subjects will sign their
      informed consent and be included in the study. Six weeks' post-surgery, the subjects will be
      randomized in one of the 2 groups (Control group CG or Adapted Physical Activity group APAG).
      Patients in both groups will have 3 postoperative visits one at 6 weeks (V1), one at 18 weeks
      (V2) and one at 30 weeks (V3). During these visits, they will undergo the same assessments
      (body composition, physical condition, quality of life). Patients in the CG will receive
      standard hospital management. Patients in APAG will follow the same management and will also
      follow a 3-month physical activity program 3 times a week between V1 and V2. Then, between V2
      and V3, no APA program will be offered to both groups.

      The subjects will evaluate during each visit V1, V2 and V3:

        -  body composition,

        -  physical condition,

        -  quality of life

        -  daily physical activity
    

Intervention name(s): Physical activity
Intervention type(s): Other
Intervention description(s): Between V1 and V2 (i.e. 12 weeks), the APAG (Adapted Physical Activity Group) will participate at a physical training program, 3 sessions of 1h30 per week consisting of endurance activities (60-75% of VO2 peak) and muscle strengthening while the CG will not perform any controlled physical training program. Then, between V2 and V3, no APA (Adapted Physical Activity) program will be offered to both groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is an open-label, randomized, single-center trial with two groups: an Adapted Physical Activity group and a control group performing no controlled physical activity within each group women undergoing bypass or sleeve surgery
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Physical activity; Bariatric Surgery; Physical Fitness; Quality of life; Body Composition
A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      PH-797804 is a potent ant-inflammatory drug that may reduce the inflammation that is
      associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential
      safety and efficacy profile in COPD.
    


Intervention name(s): PH-797804; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PH-797804 at four dose levels; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics
Condition: Healthy; Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the PK of cenerimod in participants with severe renal impairment as compared
      to healthy control participants.
    


Intervention name(s): Cenerimod
Intervention type(s): Drug
Intervention description(s): A single oral dose of 0.5 mg cenerimod will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions
Other intervention name(s): ACT-334441
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Web-Based CBT Protocol for Treatment of Selective Mutism
Condition: Selective Mutism
MeSH terms: Mutism
Study type: Interventional

Summary: 
      The main aim of this study is to examine the effectiveness of a web-based CBT protocol
      (entitled Meeky Mouse) in the treatment of children with Selective Mutism in Singapore. The
      researchers hypothesized that the Meeky Mouse program would be associated with higher
      frequency of speaking behaviors, lower levels of anxiety, greater improvements in
      clinician-rated severity of mental illness, and higher clinician-rated improvement scores at
      post-treatment.
    


Intervention name(s): Meeky Mouse program; Computer Games
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: anxiety; frequency of speech; selective mutism
Effect of BI 1356 as Single Dose on the QT Interval in Healthy Female and Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Assessment of the effect of BI 1356 or Placebo on prolongation of the QT interval
    


Intervention name(s): BI 1356, low dose; BI 1356, high dose; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Avalox®
Intervention MeSH terms: Linagliptin; Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
BI 836845 in Estrogen Receptor Positive Metastatic Breast Cancer
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase Ib / II study to determine the Maximum Tolerated Dose and Recommended Phase II Dose,
      and to evaluate the safety and antitumour activity, of BI 836845 and everolimus in
      combination with exemestane in women with HR+/HER2- advanced breast cancer
    


Intervention name(s): Everolimus; Everolimus; Everolimus; Exemestane; BI 836845; BI 836845; Exemestane; Exemestane
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 10mg dose; at recommended dose as per Phase I data; Dose escalation (24-48 patients) in Phase I. 3 dose levels depending on the dose cohort explored: 5mg, 7,5mg and 10mg; Fixed dose at 25mg; Human monoclonal antibody at recommended dose as per Phase I data; Human monoclonal antibody. Dose escalation (24-48 patients) in Phase I. 2 dose levels (high or low) depending on the dose cohort explored; Fixed dose at 25mg; Fixed dose at 25mg
Other intervention name(s): xentuzumab; xentuzumab
Intervention MeSH terms: Everolimus; Exemestane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of High-dose Chemotherapy (HDC) Combined With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients
Condition: Breast Neoplasms; Neoplasm Metastasis
MeSH terms: Neoplasms; Neoplasm Metastasis; Triple Negative Breast Neoplasms; Breast Neoplasms
Study type: Observational

Summary: 
      To access the effectiveness of High-dose Cyclophosphamide Combined Chemotherapy combined with
      adoptive cellular therapy with dentritic and cytokine-induced killer cells in triple negative
      metastatic breast cancer patients
    

Detailed description: 
      1. Metastatic breast cancer patients should be definitively diagnosis based on
           histopathology, with ER-negative and PR-negative, FISH testing for her-2-negative

        2. All the patients enrolled will be given standard HDC and cellular therapy.HDC and
           cellular therapy consisting of one cycle of HDC followed by an apheresis and ex vivo
           cultures to generate DC and CIK. DC-CIK infusions were given to each patient, followed
           by two cycles HDC, plus low-dose Oral Cyclophosphamide.

        3. PET-CT scans were done on each patients at baseline and after chemotherapy. The response
           is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.

        4. Estimate time to progression, survival rates and clinical benefit response on patients.

        5. Find biomarkers associated with drug response.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        female patients with metastatic breast cancer
      
Biospecimen description: 
      about 4ml peripheral vein blood，paraffin section on metastatic tissue，
    
Keywords: breast neoplasm; Neoplasm Metastasis; Drug Therapy
Study to Assess Functionality, Reliability, and Performance of a Single-Use Auto-Injector With Benralizumab Administered at Home
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess functionality, performance, and reliability of an
      single-use auto-injector (AI) with benralizumab administered subcutaneously (SC) in an
      at-home setting reported by the patient or caregiver, and to confirm the safety and clinical
      benefit of benralizumab administration in asthma patients with severe asthma
    


Intervention name(s): Benralizumab
Intervention type(s): Biological
Intervention description(s): Benralizumab administered subcutaneously every 4 weeks
Intervention MeSH terms: Benralizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma,; Bronchial Diseases,; Respiratory Tract Diseases,; Lung Diseases,; Obstructive Lung Diseases,; Benralizumab
13-valent Pneumococcal Conjugate Vaccine Study in Adults and Children in India
Condition: Prevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to describe the safety and immunogenicity of 13vPnC in Indian adults 50 to 65
      years of age and in Indian children 6 to 17 years of age.
    


Intervention name(s): 13-valent Pneumococcal conjugate vaccine; Blood sample collection
Intervention type(s): Biological; Procedure
Intervention description(s): 1 dose (0.5 mL/ pre-filed syringe) of 13vPnC administered at visit 1; 10 mL of blood will be collected just before and approximately 1 month after vaccination.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: 13-valent pneunococcal conjugate vaccine; pneumococcal disease prevention; safety and immunogenicity study