bioihbjkbjnl/mcl2 huggingface dataset:
Reliability and Validity of Urdu Translation of Western Ontario Shoulder Instability Index
Condition: Instability, Joint
MeSH terms: Joint Instability
Study type: Observational

Summary: 
      The goal of this study is to translate Western Ontario Shoulder Instability Index into Urdu
      and test its authenticity and coherence among the Pakistani community with Shoulder
      instability.

      Also check its correlation with Disability of Arm, Shoulder, and Hand Questionnaire, Rowe
      score , Walch-Duplay score and Visual Analogue Scale.
    

Detailed description: 
      The original English version of the Western Ontario Shoulder Instability Index will be
      translated and culturally adapted .Among Shoulder Instability population, Western Ontario
      Shoulder Instability Index will provided to 90 participants which will be choose through
      convenience sampling technique . This sampling method based on pre-defined inclusion and
      exclusion criteria .To check intra-observer reliability of the final Urdu Translation of
      Western Ontario Shoulder Instability Index, Disability of Arm, Shoulder, and Hand
      Questionnaire, Walch-Duplay score, Rowe score and Visual Analogue Scale questionnaires will
      be filled at the same day by two observers for test inter-observers assessment second
      application will be applied after 35 minutes of first application. Third assessment will be
      performed after seven days by first observer. Data will be entered and analyzed by using
      Statistical Package of Social Sciences Version 24 . Internal consistency will be analyzed
      with Cronbach's alpha value . Intra-class correlation coefficient will be used to check
      retest reliability. Urdu Translation of Western Ontario Shoulder Instability Index will be
      evaluated for content validity ,construct validity ,criterion validity and responsiveness.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The population of Pakistanis with shoulder instability will be included in the study.
      
Keywords: Western Ontario Shoulder Instability Index; Urdu Version; Reliability; Validity; Shoulder Instability; Walch-Duplay Score
Induction Chemotherapy With Nimotuzumab in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to evaluate the role of nimotuzumab in the neo-adjuvant setting in
      patients with locally advanced HNSCC. The hypothesis is that the response would be increased
      with the combination of nimotuzumab and cisplatin and fluorouracil (PF) regimen.
    

Detailed description: 
      Induction chemotherapy followed by radiotherapy is the standard treatment for patients with
      unresectable HNSCC. However, the role of induction chemotherapy remains uncertain for
      resectable disease. Therefore, we plan to perform a phase II study to evaluate it, focusing
      on radiographic and pathologic response after induction chemotherapy. Moreover, a new EGFR
      monoclonal antibody (nimotuzumab) is incorporated with PF regimen. The hypothesis is the
      addition of nimotuzumab would improve the response without remarkably increase the toxicity.
    

Intervention name(s): nimotuzumab; PF regimen (cisplatin and 5-FU)
Intervention type(s): Drug; Drug
Intervention description(s): nimotuzumab 400 mg d1; cisplatin 75 mg/m2 d1 and 5-FU 750 mg/m2/d CIV d1-5
Other intervention name(s): h-R3; PF
Intervention MeSH terms: Nimotuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HNSCC; induction chemotherapy; nimotuzumab
Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula
Condition: Cow's Milk Allergy
MeSH terms: Milk Hypersensitivity
Study type: Interventional

Summary: 
      Infants/children with cow's milk allergy will take part in 2 double-blinded
      placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random
      order. If both food challenges are passed, subjects will be asked to consume the Test formula
      in an at-home open challenge for 7 days.
    


Intervention name(s): Test extensively hydrolyzed formula; Control extensively hydrolyzed formula
Intervention type(s): Other; Other
Intervention description(s): extensively hydrolyzed formula made with a new enzyme; commercially available extensively hydrolyzed formula
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates
Condition: Safety Issues
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and
      neonates.
    

Detailed description: 
      To describe the safety of this vaccine after each immunization. To assess preliminary
      information of immunogenicity following Rotavirus (Bio Farma) vaccine immunization.
    

Intervention name(s): Rotavirus (Bio Farma) Vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Rotavirus (Bio Farma) Vaccine; Placebo contains 30% sucrose in DMEM
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Adults and Children Group: Experimental, open labeled, prospective intervention study
Neonates Group: Experimental, randomized, double blind, prospective intervention study
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Use of a Tummy Time Intervention and Parent Education in Infants Born Preterm
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The purpose of this research study is to see if tummy time and parent education helps motor
      development among infants born preterm. Participants will be recruited from Ann and Robert H.
      Lurie Children's Hospital of Chicago neonatal intensive care unit.
    

Detailed description: 
      The purpose of this randomized control trial will be to investigate the effects of a tummy
      time intervention, as compared to standard care, on motor outcomes among premature infants
      over a four-week period. Additionally, the study will measure tummy time adherence rates
      between groups post intervention for an additional four weeks.

      To meet this purpose, the following objectives will be addressed:

        1. To determine if there will be a difference in motor outcome scores on the Test of Infant
           Motor Performance (TIMP) among infants born preterm and utilizing a tummy time
           intervention and parent education compared to those in the standard care group receiving
           parent education only.

        2. To determine if there will be a difference in adherence rates (average minutes/day)
           between groups among infants born preterm utilizing a tummy time intervention and parent
           education compared to those in the standard care group receiving parent education only.
    

Intervention name(s): Tummy time and parent education; Parent education only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive tummy time positioning while awake for 10 minutes two times a day. Physiological monitoring will be maintained throughout the entire intervention and the intervention will be adjusted if needed to maintain stability. Participants will also receive parent education on tummy time prior to the tummy time intervention. The primary investigator will perform the tummy time intervention. Participants will be encouraged to continue performing tummy time on their own and record their adherence via the PT Pal application.; Participants will receive the same tummy time education as those in the intervention group and will be asked to continue the intervention on their own and record their adherence via the PT Pal application.
Steps of the intervention for group 2 (standard care).
Complete educational session with primary investigator.
Adherence during the four-week intervention period will be measured remotely through the PT Pal® application.
Other intervention name(s): Group 1; Group 2
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a randomized controlled trial using a pretest /posttest control group design to allow for comparison between an intervention group that receives tummy time and parent education and a standard of care group that receives parent education only
Masking: Single (Investigator)
Primary purpose: Treatment
Study Evaluating the Timing of Intrauterine Insemination in Relation to Positive Home Ovulation Prediction Kit
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The aim of this study is to assess the impact of the timing of intrauterine insemination
      (IUI) in relation to the natural surge of luteinizing hormone (LH), as detected by home
      ovulation predictor kits, on pregnancy rates per treatment cycle. The study will take place
      at the offices of Midwest Fertility Specialists and include patients who have been
      independently recommended by their primary physician to undergo ovulation induction with
      clomiphene citrate (CC) or letrozole and IUI as therapy for infertility.
    

Detailed description: 
      Intrauterine insemination is a procedure that is performed in the physician's office. During
      the procedure the sperm from the male partner are placed directly into the female partner's
      uterus around the time of ovulation (release of oocyte or egg). Ovulation predictor kits,
      available over the counter at pharmacies, test for the presence of luteinizing hormone in the
      urine. When the test result is a positive, it means the hormone is present in the urine. This
      is a sign of ovulation. Physicians typically choose to perform intrauterine insemination
      either the day of a positive ovulation test or the day after a positive ovulation test. The
      purpose of this study is to determine if the day when intrauterine insemination is performed
      influences the chance of becoming pregnant.
    

Intervention name(s): Intrauterine Insemination; Clomiphene; Letrozole
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.; Patient is to take clomiphene citrate during cycle days 3-7.; Patient is to take letrozole during cycle days 3-7.
Other intervention name(s): clomid
Intervention MeSH terms: Letrozole; Clomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Infertility; Intrauterine insemination; Luteinizing hormone surge
Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
Condition: Cutaneous Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

        -  Assess the efficacy of SAR443122 in cutaneous lupus erythematosus (CLE)

      Secondary Objectives:

        -  Assess the effect of SAR443122 on the physician's global assessment of disease activity
           (PhysGA - disease activity)

        -  Assess the effect of SAR443122 on CLE induced itch and overall pain

        -  Assess the effect of SAR443122 on the proportion of disease activity responders compared
           to placebo

        -  Assess the effect of SAR443122 on the CLASI components score

        -  Assess the effect of SAR443122 on the Investigator's global assessment for CLE (IGA-CLE)

        -  Assess oral cavities for patients with oral lesions

        -  Assess the disease specific quality of life (QoL)

        -  Assess the safety and tolerability of SAR443122 in patients with CLE

        -  Assess the pharmacokinetics (PK) exposure of SAR443122 in patients with CLE
    

Detailed description: 
      Total study duration per participant will be up 20 weeks including:

        -  A screening period of up to 4 weeks

        -  A treatment period of 12 weeks

        -  A post treatment follow-up period of 4 weeks
    

Intervention name(s): SAR443122; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: Capsule Route of administration: Oral; Pharmaceutical form: Capsule Route of administration: Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Investigation of the Acute Effect of Novel Olive Oil on Postprandial Oxidative Stress Biomarkers (BioliveCT)
Condition: Cardiometabolic Risk
Study type: Interventional

Summary: 
      The purpose of this study was the investigation of the hypothesis that the enhancement of a
      refined olive oil with orange peel extract, may improve the postprandial lipidemic, glycemic
      profile and blood oxidative status, of volunteers with high cardiometabolic risk, due to
      increased content of bioactive compounds (polyphenols, carotenoids etc.).
    

Detailed description: 
      In a randomized, acute, single-blinded and cross-over study, participated 21 volunteers with
      high cardiometabolic risk, aged 30-65, were randomized and divided into two groups. The first
      group consumed a meal of mashed potatoes with added refined olive oil, rich in fat and
      carbohydrates (300g, control meal), while the second group consumed mashed potatoes with
      added olive oil, enhanced with 10% w/w orange peel extract (functional meal). After a
      one-week washout period, the volunteers were crossed over and consumed the meals in reverse.
      Blood samples were withdrawn in a fasting state, 30, 90 and 180 min after meal consumption.
      Plasma Total Antioxidant Capacity (FRAP), serum lipid levels [Total, High-Density Lipoprotein
      (HDL-) and Low-Density Lipoprotein (LDL-) cholesterol and triglycerides], glucose and uric
      acid were determined at each time point using a biochemical analyzer (Roche Cobas c111).
    

Intervention name(s): Functional olive oil, enhanced with orange peel extract; Control
Intervention type(s): Other; Other
Intervention description(s): The functional olive oil was enriched with 10% w/w orange peel extract; Refined olive oil
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants were randomly divided into control and interventional group. In the first study period, the control group consumed the meal with the refined olive oil and the interventional group received the meal with the novel, functional olive oil, enhanced with 10% w/w orange peel extract. After a washout week participants were crossed over and consumed the meals in reverse.
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Novel olive oil; Orange peel extract; Postprandial bioactivity; Cardiometabolic risk
Effect of Nicotinic Acid on Adipose Tissue Inflammation in Obese Subjects
Condition: Obesity
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      Our working hypothesis postulates that lipolysis is a determinant of inflammation in adipose
      tissue (AT). Inhibition of lipolysis, e.g. using the oldest normolipidemic drug, nicotinic
      acid, has proved valuable to combat the metabolic syndrome. Our proposal will determine
      whether part of the beneficial effects of this antilipolytic compound is due to a diminution
      of AT inflammation.

      To this aim, the effect of nicotinic acid or placebo will be studied in male obese subjects
      with or without a training program which goal is to enhance lipolysis.
    

Detailed description: 
      24 male obese insulin resistant subjects will receive nicotinic acid or placebo for 16 weeks.
      The last 8 weeks, the subjects will follow a training program calculated to optimize use of
      lipid. Insulin sensitivity and glucose tolerance will be assessed using, respectively,
      fasting-based estimates of insulin sensitivity (plasma and muscle) and oral glucose tolerance
      test. Plasma parameters of adipokines and, inflammatory and metabolic parameters will be
      determined. As an index of AT inflammation, the percentage and the phenotype of macrophages
      will be determined using flow cytometry of cells of the stromavascular fraction of
      subcutaneous AT. Macrophage infiltration will be investigated by light microscopy. The
      characterization of the inflammatory profile of AT will be completed by measurements of the
      expression of genes that are either specific markers of human AT macrophages or inflammatory
      and anti-inflammatory adipokines. This combination of approaches has never been carried out
      during a pharmacological intervention in humans. The following points will be addressed:

        -  determine the influence of lipolysis on AT inflammation, specifically on macrophage
           activation and adipokine production.

        -  examine the causal relationship between adipocyte FA metabolism, AT inflammation and
           insulin sensitivity.

        -  establish whether the beneficial effect of antilipolytic drugs may be attributable at
           least in part to a decrease in AT inflammation.
    

Intervention name(s): training; nicotinic acid; Placebo
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): the last 8 weeks, the subjects will follow a training program calculated to optimize use of lipid; Obese subjects will receive nicotinic acid or placebo for 16 weeks; Obese subjects will receive nicotinic acid or placebo for 16 weeks
Intervention MeSH terms: Nicotinic Acids; Niacin; Niacinamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: nicotinic acid; lipolysis; training program; adipose tissue inflammation; obese
Effects of Physical Training and Nutrition Education on Adipocytokines in Severely Obese Teenagers
Condition: Healthy; Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Obesity is now becoming significantly prevalent of an environment characterized by easily
      available calorics foods combined with sedentary lifestyles. Moreover, it has been
      demonstrated that obesity is associated with metabolic complications such as disturbed
      adipocytokines, hormones secreted by adipose tissue. Given these observations, the purpose of
      this study is to assess the effects of a lifestyle intervention focused on various physical
      activities and nutrition education on adipocytokines hormones, in severely obese teenagers.
    


Intervention name(s): obesity lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): physical activity 5 times per week + nutrition education
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        obese teenagers
      
Keywords: childhood obesity; adipocytokines; physical exercise; nutrition education
A Study of the Safety, Tolerability and Pharmacokinetics of ALN-TTR02 in Japanese Healthy Volunteers
Condition: Transthyretin (TTR)-Mediated Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)
      of patisiran (ALN-TTR02) in Japanese subjects
    


Intervention name(s): patisiran (ALN-TTR02); Sterile Normal Saline (0.9% NaCl)
Intervention type(s): Drug; Drug
Intervention description(s): Ascending doses administered by intravenous (IV) infusion; Calculated volume to match active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: RNAi therapeutic
Comparison of Techniques in Determining Femoral Veins Location
Condition: Vascular Access Complication
Study type: Interventional

Summary: 
      This study aimed to determine the accuracy of the V technique in predicting the location of
      the femoral vein compared to the technique of palpating the femoral artery with the use of
      USGss as a standard in determining the exact location of the femoral vein.
    

Detailed description: 
      One hundred and fifteen subjects were allocated into two large groups, V tecnique group and
      palpation tecnique group. Researchers will perform the V technique on the patient's inguinal
      area. This technique was performed using the researcher's contralateral hand. After the V
      technique is performed, the next researcher will perform the technique of palpating the
      femoral artery pulse at the exact location as the V technique. This technique is done by
      palpating the femoral artery pulsation using the examiner's index and middle fingers along
      the inguinal ligament; the location of the femoral vein is at 1 cm. medial to the femoral
      artery 2 cm inferior to the inguinal ligament. This location is marked "y" with a UV marker.
      researchers will compare the accuracy of both techniques in determining the exact location of
      femoral veins.
    

Intervention name(s): femoral vein identification; femoral vein identification
Intervention type(s): Procedure; Procedure
Intervention description(s): Femoral vein identification using V technique; Femoral vein identification using palpation technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: arterial palpation technique; femoral access; femoral vein; V tecnique; vascular access