bioihbjkbjnl/mcl2 huggingface dataset:
Urdu Translation and Cross Cultural Validation of PedsQL Inventory Infant Scale Parent Report 1 to 12 Months
Condition: Infant Development
Study type: Observational

Summary: 
      The current study aimed to translate and validate Urdu version of that module from PedsQL, to
      measure the "quality of life" outcomes for Pakistan and Urdu speaking people.
    

Detailed description: 
      Data will be collected by PedQL Infants Scale Parent report A mix method approach will be
      applied Forward translation Backward translation Review of forward and backward translation
      The process of translation will be followed the guidelines in the translation manual.
      Translators will translate the PedsQL Inventory Infants Scale Parent Report independently
      from each other in Urdu language following the proper forward and backward translation
      procedure.

      Data Analysis Quality of life pediatric population will assess through Urdu translated
      version of PedsQL Inventory Infants Scale Parent report. Data will be analyzed through SPSS.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The sample size was 43. Sample size was calculated by raosoft online software. Margin of
        error 5% Confidence level 95% Population size 20000 Response distribution 50% Sample
        Selection Criteria
      
Keywords: Health related quality of life of Infants
Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and tolerability of PF-04236921 administered monthly as
      three intravenous infusions. Each group of patients will be assigned to a dose level; Safety
      and tolerability of a low dose level will be required before proceeding to successively
      higher dose levels. Blood tests will be performed to measure the amount of drug and changes
      in measures of inflammation.
    

Detailed description: 
      Safety and Tolerability and Pharmacokinetic/Pharmacodynamic assessment of
      inflammation-related biomarkers.
    

Intervention name(s): Placebo; dose level 1; dose level 2; dose level 3; dose level 4
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): intravenous infusion on three consecutive months; intravenous infusion on three consecutive months; intravenous infusion on three consecutive months; intravenous infusion on three consecutive months; intravenous infusion on 3 consecutive months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Safety and tolerability Pharmacokinetics Pharmacodynamics PF-04236921
HES Patch Versus Blood Patch
Condition: Intracranial Hypotension
MeSH terms: Intracranial Hypotension; Hypotension
Study type: Interventional

Summary: 
      The injection of autologous blood Blood Patch (BP) into the epidural space is the standard
      treatment for headache associated with intracranial hypotension. It provokes cerebral
      vasoconstriction. It is cons-indicated in a number of situations (HIV positive, fever,
      sepsis, leukemia). The purpose of this study is to evaluate another technique using a patch
      made by injecting an epidural hydroxyethylstarch solution (HES 130, 0.4, 6%) instead of blood
      patch. This alternative technique is simple to implement and does not have some of the
      specific blood pressure contra-indications. The study aims at comparing the "Blood Patch"
      group versus the "HES Patch" in terms of clinical efficacy , tolerance, satisfaction of the
      anesthetist, ease of implementation and effect of the injection of epidural anesthesia on
      cerebral blood flow within 24 hours.
    


Intervention name(s): injection of HES " Voluven® "; blood patch
Intervention type(s): Drug; Biological
Intervention description(s): Injection into the epidural space of 15 to 30 ml Voluven ® at a rate of 1 ml / about 5 seconds.
Other intervention name(s): HYDROXYETHYL STARCH; injection of autologous blood
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Partial Breast Irradiation With Multi-Catheter Brachytherapy for pT1-2pN0 Breast Cancer After Breast Conserving Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether accelerated partial breast irradiation
      (APBI) with multi-catheter brachytherapy is safe and effective.
    


Intervention name(s): Accelerated partial breast irradiation
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: accelerated partial breast irradiation; multicatheter brachytherapy; high dose rate brachytherapy; pulsed dose rate brachytherapy
Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children
Condition: Sinusitis
MeSH terms: Sinusitis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate efficacy of azithromycin prophylaxis in preventing
      recurrent acute sinusitis in children.
    

Detailed description: 
      A Prospective, Randomized, Double-blind, Placebo Controlled Trial of azithromycin in
      preventing recurrent acute sinusitis in children
    

Intervention name(s): placebo; azithromycin
Intervention type(s): Drug; Drug
Intervention description(s): placebo tablet or syrup 3 days/week; azithromycin 3 days/week
Other intervention name(s): treatment
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: sinusitis; azithromycin
Anesthesia Type on Percutaneous Nephrolithotomy in Aging Male
Condition: Kidney Stone; Anesthesia
MeSH terms: Kidney Calculi
Study type: Observational

Summary: 
      The aim of this study is to compare the anesthesia methods in percutaneous nephrolithotomy in
      terms of safety and effectiveness in elderly men.
    

Detailed description: 
      Data recorded since 2003 will be analyzed retrospectively. Elderly men with PNL will be
      divided into two groups according to the type of anesthesia. The results determined in both
      arms will be compared with appropriate statistical methods.
    

Intervention name(s): Percutaneous nephrolithotomy surgery (PNL)
Intervention type(s): Procedure
Intervention description(s): Percutaneous nephrolithotomy (PNL) surgery was performed in all arms of the study to remove the renal stones. This surgery was performed with 2 anesthesia methods, CSEA and GA. These formed the groups of the study.
Other intervention name(s): spino-epidural anesthesia (CSEA); general anesthesia (GA)
Intervention MeSH terms: Anesthetics
Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Above 65 years of age, male sex and having kidney stone
Early Childhood Caries in Jordanian Children
Condition: Early Childhood Caries
Study type: Interventional

Summary: 
      In this cross sectional epidemiological study, we aimed to report the prevalence of early
      childhood caries (ECC) in children attending kindergartens in Jordan, and its associated risk
      factors. We also, aimed to determine the effectiveness of silver diamine fluoride as a caries
      control material and its acceptance among parents of children with ECC. Children (n=887) with
      mean age 4.64 ± 1.56 were examined. Among this sample there was a number of children (n=159)
      who were enrolled in a randomized controlled trial to study silver diamine fluoride efficacy
      in caries control. The sample consisted of two groups; the study group (children who received
      single spot application of 38% SDF) and control group (children who were examined only).
    

Detailed description: 
      Background: Early childhood caries is a well-known international public health challenge
      amongst young children.

      Aims: To report the prevalence of early childhood caries in children attending kindergartens
      in Jordan, and its associated risk factors. To determine the effectiveness of silver diamine
      fluoride as a caries control material and its acceptance among parents of children with ECC.

      Methods: This is a cross sectional epidemiological study comprised of children (n=887) with
      mean age 4.64 ± 1.56 who attended kindergartens of different cities in Jordan, this sample
      received questionnaires to fill data related to their demographic, socioeconomic, oral
      hygiene, oral health, nursing and nutritional habits. These children were also examined to
      determine early childhood caries prevalence in Jordan. Among this sample there was a number
      of children (n=159) with the mean age 4.8 ± 0.85 who were planned to be involved in a sample
      of a randomized controlled trial to study silver diamine fluoride efficacy in caries control.
      The sample consisted of two groups; the study group (children who received single spot
      application of 38% SDF) and control group (children who were examined only). Application of
      SDF started after distribution and receiving back approval letters from children's parents
      accompanied with questionnaires for data related to the approval/disapproval of the
      application. The sample were followed up for 1 year.
    

Intervention name(s): Silver Diamine Fluoride
Intervention type(s): Drug
Intervention description(s): A colourless solution known with its alkaline nature; it simply consists of a union of silver, fluoride and ammonia. It can be applied on caries cavities using a micro-brush.
Other intervention name(s): SDF
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients
Condition: Headache; Migraine; Aura
MeSH terms: Migraine Disorders; Migraine with Aura; Headache
Study type: Interventional

Summary: 
      To investigate the role of KATP channels in migraine with aura patients.
    


Intervention name(s): Levcromakalim; Saline
Intervention type(s): Drug; Drug
Intervention description(s): To investigate the role of levcromakalim compared with placebo in migraine with aura patients; To investigate the role of levcromakalim compared with placebo in migraine with aura patients
Intervention MeSH terms: Cromakalim
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Levcromakalim
Dry Needling & Trigger Point Compression Release in Neck Pain
Condition: Neck Pain; Trigger Point Pain, Myofascial; Neck Muscle Issue; Muscle Tightness; Neckache
MeSH terms: Myofascial Pain Syndromes; Neck Pain
Study type: Interventional

Summary: 
      This randomized control trial was conducted to investigate the efficacy of trigger point dry
      needling which is a modern treatment intervention compared with ischemic compression release
      in the patients having neck pain due to myofascial trigger points.
    

Detailed description: 
      Many treatment protocols have been used in the clinical arena for the improvement of neck
      pain but un-availability of follow-up studies and lack of evidence of modern treatment
      interventions are few shortcomings a researcher faces. Thus, a need stands up to address
      these perspectives for newer treatment strategies. This randomized control trial is conducted
      to investigate the efficacy of trigger point dry needling which is a modern treatment
      intervention compared with ischemic compression release in the patients having neck pain due
      to myofascial trigger points. Findings of this research will assist in creating awareness
      about better treatment intervention for trigger point release among medical community.
    

Intervention name(s): Dry Needling
Intervention type(s): Other
Intervention description(s): Dry Needling includes the insertion of a fine, strong filiform needle without presentation of any pain relieving medicine.
Ischemic pressure is usually applied to trigger point, in what is known as trigger point therapy, where enough continuous pressure is applied to a trigger point within a tolerable measure of pain, and as discomfort is decreased, extra pressure is gradually applied
Other intervention name(s): Ischemic Compression
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dry Needling; Ischemic Compression; Neck Pain
Lifestyle Intervention in Primary Health Care - the Björknäs Study
Condition: Hypertension; Type 2 Diabetes; Obesity; Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether a short group intervention programe aiming
      at lifestyle changes at a local health centre can improve risk factors for cardiovascular
      disease
    

Detailed description: 
      Successfully transferring the findings of expensive and tightly controlled lifestyle
      intervention programmes to the primary care setting is necessary if such knowledge is to be
      used for disease prevention at the population level. Therefore, our objective was to evaluate
      the efficacy of a lifestyle intervention programe in the primary health care setting,
      targeted at patients with moderate- to high-risk of cardiovascular disease according to
      cardiovascular risk factor levels, physical activity and quality of life ratings.

      Randomised controlled trial with follow-up at 3, 12, 24 and 36 months, carried out in a
      primary health care centre in Northern Sweden. A total of 151 middle-aged men and women, with
      hypertension, dyslipidemia, type 2 diabetes or obesity were enrolled. The subjects were
      randomised to an intervention (n = 75) or control group (n = 76). 120 subjects completed the
      three-year follow-up. The intervention was based on the protocols used in the Finnish
      Diabetes Prevention study (DPS) and the U.S Diabetes Prevention Program
    

Intervention name(s): Exercise and diet - based on DPS and DPP
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Primary Prevention; Health Promotion; Diet; Exercise; Risk Factors; Randomized Controlled Trial
Sleep Quality and Cognition in Young Adults
Condition: Healthy Adults
Study type: Observational

Summary: 
      Sleep quality is impaired in young adults due to current conditions. Recent studies emphasize
      that this situation may also affect the cognitive status of individuals. The aim of this
      study was to investigate the relationship between sleep quality and cognitive status in young
      adults. A total of 122 young adults (61 female, 61 male) aged between 18 to 25 and studied at
      Istanbul Medipol University, Faculty of Health Sciences, were included in the study.
      Individuals were evaluated with "Pittsburgh Sleep Quality Index (PSQI)" for sleep quality;
      with "Montreal Cognitive Status Scale (MoCA)" for cognitive status, with "STROOP Test" for
      selective attention; with "Verbal Fluency Test" for sustained attention; with "WMS-R digit
      Span Test" for auditory attention
    


Intervention name(s): Cognitive Assessment (not diagnostic)
Intervention type(s): Other
Intervention description(s): Sleep quality and cognition will be assessed in young adults
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults aged between 18 to 25
      
Keywords: Sleep Quality; Cognitive Status; healthy adult
Cardiac Safety of Indacaterol
Condition: Healthy Volunteers; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral
      moxifloxacin.
    


Intervention name(s): Indacaterol 150 µg; Indacaterol 300 µg; Indacaterol 600 µg; Placebo; Placebo/moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Once daily (QD) via single-dose dry powder inhaler (SDDPI); QD via SDDPI; QD via SDDPI; QD via SDDPI; Placebo QD via SDDPI for 14 days, followed by a single dose of moxifloxacin 400 mg
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Indacaterol; Moxifloxacin
HEALTHY (Health Education Adolescent Leadership Training to Help Youth) Leaders
Condition: Stress
Study type: Interventional

Summary: 
      This project will measure baseline stress among a group of youth in foster and kinship care.
      The investigators will implement a pilot program to target stress reduction by using an
      evidence-based group therapy technique teaching mindfulness skills. The investigators
      hypothesize that the mindfulness skills will help youth to reduce stress, which will be
      measured using psychological and physiological techniques.
    


Intervention name(s): Mindfulness based stress reduction; only pre and post evaluation measures
Intervention type(s): Behavioral; Behavioral
Intervention description(s): an 8 week group intervention to teach mindfulness skills
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: youth; Stress; mindfulness; foster care; stress reduction; high risk teens
CARBETOCIN VERSUS RECTAL MISOPROSTOL FOR MANAGEMENT OF THIRD STAGE OF LABOR IN WOMEN AT LOW RISK OF POSTPARTUM HEMORRHAGE
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      150 pregnant women admitted for spontaneous, induced or augmented vaginal delivery and
      categorized as low risk for postpartum hemorrhage (PPH) were divided randomly into two
      groups. Carbetocin group (C) received 1 ampoule of Carbetocin (100 μg/ml) (Pabal®,
      Draxis/Multipharma, Egypt, under license from DRAXIS PHARMA-Canada) added to 10 cc saline and
      given IV after the delivery of the baby. Misoprostol group (M) received 2 rectal misoprostol
      tablets (800 μg) (Misotac; SIGMA Pharm, Cairo, Egypt) after the delivery of the baby. Blood
      samples were tested to measure hemoglobin levels upon admission to the labor room and 12
      hours after delivery
    

Detailed description: 
      150 pregnant women admitted for spontaneous, induced or augmented vaginal delivery and
      categorized as low risk for postpartum hemorrhage (PPH) were divided randomly into two
      groups. Carbetocin group (C) received 1 ampoule of Carbetocin (100 μg/ml) (Pabal®,
      Draxis/Multipharma, Egypt, under license from DRAXIS PHARMA-Canada) added to 10 cc saline and
      given IV after the delivery of the baby. Misoprostol group (M) received 2 rectal misoprostol
      tablets (800 μg) (Misotac; SIGMA Pharm, Cairo, Egypt) after the delivery of the baby. Blood
      samples were tested to measure hemoglobin levels upon admission to the labor room and 12
      hours after delivery
    

Intervention name(s): Carbetocin; Misoprostol
Intervention type(s): Drug; Drug
Intervention description(s): 1 ampoule of Carbetocin (100 μg/ml) added to 10 cc saline and given IV after the delivery of the baby; 2 rectal misoprostol tablets (800 μg) after the delivery of the baby.
Intervention MeSH terms: Misoprostol; Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Bioequivalence Study of Torrent's Olmesartan Medoxomil, Amlodipine and Hydrochloride Tablets Under Fasting Conditions.
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects to compare the single dose bioavailability of Torrent's Olmesartan medoxomil,
      Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg and Tribenzor® 40+10+25 mg Tablets of
      Daichi Sankyo Inc, USA. Dosing periods of studies were separated by a washout period of 22
      days.
    

Detailed description: 
      An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose
      Bioequivalence Study of FDC of Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide
      Tablets 40+10+25 mg containing Olmesartan medoxomil 40 mg, Amlodipine 10 mg and
      Hydrochlorothiazide 25 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus
      Tribenzor® 40+10+25 mg Tablets containing Olmesartan medoxomil 40 mg, Amlodipine 10 mg and
      Hydrochlorothiazide 25 mg (Reference , Daichi Sankyo Inc, USA.) in Healthy Human Volunteers
      Under Fasting Condition.
    

Intervention name(s): Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets; Tribenzor Tablets of Daichi Sankyo Inc, USA
Intervention type(s): Drug; Drug
Intervention description(s): Oral, crossover; Oral, crossover
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Dose and Multiple Dose Safety, Tolerability, PK，and Food Effect Study，and Interaction With Oseltamivir Study of HEC116094 in Healthy Adult Subjects
Condition: Influenza
Study type: Interventional
Phase: Phase 1

Summary: 
      The Safety, Tolerability, Pharmacokinetic, Food Effect Study and the interaction with
      Oseltamivir Phosphate Capsules of HEC116094 in Healthy Subjects
    


Intervention name(s): HEC116094
Intervention type(s): Drug
Intervention description(s): Part B：Mulltiple doses up to 5 days； Part C：Each cycle was administered for 5 days
Other intervention name(s): Oseltamivir
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment