bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Antenatal Exercises in Primagravida
Condition: Pregnancy Related
Study type: Interventional

Summary: 
      The goal of this Randomized control trial is to determine the effects of antenatal exercises
      on low back pain in Primagravida. The main questions it aims to answer are whether supervised
      antenatal exercises have an effect on low back pain and depression in primagravida.
    

Detailed description: 
      Females usually tend to avoid physical activity during pregnancy. Concept of antenatal
      exercises and its effects on low back pain or antenatal depression is yet not common amongst
      pregnant females in Pakistan. Low back pain and antenatal depression are common in pregnancy.
      These can have an impact on both their own health and the health of their unborn child.
      Understanding the benefits of antenatal exercises will encourage pregnant females to engage
      in regular physical activity. The results of this study will help physical therapists to
      implement effective exercise interventions for this population.
    

Intervention name(s): Supervised antenatal exercises; Antenatal Education
Intervention type(s): Other; Other
Intervention description(s): Supervised antenatal exercises along with education twice a week. Protocol consists of warm up (10 min), Aerobic training (20 mins, 60-75% of max. HR), Strength training (25 minutes), followed by a cool down of 15 minutes.
The Interventions to be provided for a period of 12 weeks.; Antenatal education at 12th week of pregnancy. Which consists of education on Posture in pregnancy, Role of pelvic floor muscles, Labor and breathing and relaxation techniques.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pregnancy Related; antenatal depression; low back pain
Influence of the Vitreomacular Interface on the Progression of the Diabetic Macular Edema After Anti-VEGF Injection
Condition: Diabetic Macular Edema; Vitreomacular Interface; Anti-VEGF Treatment
MeSH terms: Macular Edema; Edema
Study type: Observational

Summary: 
      Influence of the vitreomacular interface on the progression of diabetic macular edema after
      treatment with intravitreal injection of vascular endothelial growth factor inhibitors
    


Intervention name(s): Intravitreal Ranibizumab injection
Intervention type(s): Drug
Intervention MeSH terms: Ranibizumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with diabetic macular edema
FOB in HSCT and Leukemia Patients With Acute Respiratory Symptoms and Pulmonary Infiltrates
Condition: Pulmonary Infiltrate New
MeSH terms: Leukemia; Signs and Symptoms, Respiratory
Study type: Interventional

Summary: 
      Pulmonary infiltrates frequently complicate the care of hematopoietic stem cell transplant
      (HSCT) and leukemia patients. Bronchoalveolar lavage (BAL) is frequently used to evaluate new
      pulmonary infiltrates in this population, however utility is limited by a historically low
      diagnostic yield for infection.

      In an effort to improve diagnostic yields, this study will complete a Fiberoptic Bronchoscopy
      (FOB) within 8 hours of radiographic documentation of pulmonary infiltrates, prior to
      initiating new antibiotic therapy. To further improve detection of microbiological pathogens,
      the study will utilize PCR testing with rapid turnaround time to detect atypical pneumonia (M
      pneumoniae, C. Pneumonia, Legionella species, and respiratory viruses) and aspergillosis.
    

Detailed description: 
      Proper diagnosis and prompt treatment favorably impacts survival in the post transplant
      setting, but is often difficult and frequently results in inappropriate or late therapy. Low
      yields may be linked with empiric antibody therapy begun prior to the procedure, delayed time
      to procedure, procedure technique, the presence of graft versus host disease (GVHD),
      neutropenia, and diffuse infiltrates (as opposed to localized infiltrates or focal masses and
      nodules). One recent study found that early FOBs (less than or equal to 4 days between
      detection of pulmonary infiltrates and FOB) were 2.5 times more likely to establish a
      diagnosis of pneumonia compared to late examinations. Delaying this procedure(greater than 5
      days between detection of pulmonary infiltrates and FOB) was associated with drug resistant
      organisms, polymicrobial infections, and worsened patient prognosis.
    

Intervention name(s): Microbiological analysis
Intervention type(s): Other
Intervention description(s): Bronchoalveolar lavage (BAL) with subsequent testing for pathogens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary infiltrates; stem cell transplant; leukemia
Effect of Nutrition Ingredients on Microbiota Modulation
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The objective of this study is to evaluate in healthy volunteers the time-dependent effect of
      daily consumption for four weeks of six different nutrition ingredients on relative abundance
      of microbial taxa in fecal samples. Second, the study looks at the time-dependent effect of
      six different nutrition ingredients on alpha and beta diversity of microbiota in fecal
      samples. Moreover, the time-dependent effect of six different nutrition ingredients on
      gastrointestinal symptoms and quality of life will be measured.
    


Intervention name(s): Vitamin B2; Vitamin C; Vitamin B2 + C; Vitamin A; Vitamin D3; Vitamin E; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): One capsule of 75 mg Vitamin B2 once a day for 4 weeks; One capsule of 500 mg Vitamin C once a day for 4 weeks; One capsule of of 75 mg Vitamin B2 plus 500 mg Vitamin C once a day for 4 weeks; One capsule of 250 µg Vitamin A once a day for 4 weeks; One capsule of 60 µg Vitamin D3 once a day for 4 weeks; One capsule of 100 mg Vitamin E once a day for 4 weeks; One capsule of 575 mg microcrystalline cellulose once a day for 4 weeks
Other intervention name(s): Riboflavin; Cholecalciferol; alpha-tocopherol
Intervention MeSH terms: Vitamin D; Cholecalciferol; Vitamins; Vitamin E; Tocopherols; alpha-Tocopherol; Vitamin A; Riboflavin; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, parallel trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Intestinal microbiota
Contraceptive Effectiveness and Safety of the SILCS Diaphragm
Condition: Contraception
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This multi-center contraceptive effectiveness and safety study of the SILCS diaphragm will
      enroll approximately 450 couples at risk for pregnancy at six study sites in the U.S. The
      study will randomly assign approximately 300 couples to use the SILCS diaphragm with
      BufferGel and approximately 150 couples to use the SILCS diaphragm with Gynol II (2% N-9
      gel). At two sites, a substudy involving colposcopy and microflora will be conducted in about
      80 women (40 at each site). The primary objective of this study is to estimate the cumulative
      6-month typical-use pregnancy probability for women using the SILCS diaphragm with a
      contraceptive gel.
    

Detailed description: 
      This multi-center contraceptive effectiveness and safety study of the SILCS diaphragm will
      enroll approximately 450 couples at risk for pregnancy w at six study sites in the U.S. The
      study will randomly assign approximately 300 couples to use the SILCS diaphragm with
      BufferGel (BG) and approximately 150 couples to use the SILCS diaphragm with Gynol II (2% N-9
      gel). At two sites, a substudy involving colposcopy and microflora will be conducted in about
      80 women (40 at each site). For certain evaluations, the data from a contraceptive study
      conducted by NICHD of the Ortho All-Flex diaphragm used with either BG or N-9 will be used as
      historical controls.

      In the current study, each participant will agree to use the SILCS diaphragm with her
      assigned contraceptive gel as her only method of contraception for approximately 7 months (at
      least 190 days) and at least 6 menstrual cycles. Emergency contraception will be offered if
      unprotected intercourse occurs, according to local prescribing practices.

      Each female participant will undergo four scheduled visits: Enrollment, After Cycle 1, After
      Cycle 3, and Final visits. Two weeks after enrollment, each participant will be called to
      determine if she has had any problems with the method and to assess compliance.

      Recruitment for this study is expected to take about 12 months. Each subject's participation
      will last about 6-7 months. Site closeout is expected to take three months. The clinical
      portion of the study should last about 21 months. Data closure and analysis are expected to
      take three months and the Final Report two additional months.
    

Intervention name(s): SILCS Diaphragm; Nonoxynol-9 Gel; Buffer Gel
Intervention type(s): Device; Combination Product; Combination Product
Intervention description(s): SILCS Diaphragm used with 5 ml gel; Gynol II (2% N-9 gel); Buffer Gel
Intervention MeSH terms: Nonoxynol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Contraception; SILCS Diaphragm; Contraceptive Gel
Method for Improved Intraoperative Blood Loss Estimates
Condition: Improved Intraoperative Blood Loss Estimates
MeSH terms: Hemorrhage
Study type: Observational

Summary: 
      The purpose of this study is to develop a mathematical algorithm which the investigators plan
      to use to more accurately estimate intraoperative blood loss.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Elective surgical patients
Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products
Condition: Aged Skin
Study type: Interventional

Summary: 
      The aim of the study was to assess the long-term efficacy and barrier protection properties
      of two cosmetic products on the volar forearms of 20 elderly subjects after four weeks of
      treatment compared to two untreated test areas.
    


Intervention name(s): C - pH 4 Cosmetic Product WO 3741; D - pH 5.8 Cosmetic Product WO 4081-1
Intervention type(s): Other; Other
Intervention description(s): Application of the product on the pre-defined skin area on the forearms twice daily for four weeks; Application of the product on the pre-defined skin area on the forearms twice daily for four weeks
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: pH of the skin; SDS; Lipbarvis; TEWL; Skin hydration
Supplemental Oxygen in Pulmonary Fibrosis
Condition: Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      To enhance understanding of supplemental oxygen-its utility in and adoption by patients with
      pulmonary fibrosis-by examining how patients perceive it and by determining how perceptions
      and patient-centered outcome measures change from before to after supplemental oxygen is
      prescribed.
    

Detailed description: 
      The investigators aim to recruit patients with PF to participate in interviews and/or a
      one-year study of supplemental oxygen (O2). In the one-year study, the investigators will
      collect data before and for one year after PF patients are prescribed daily-use supplemental
      oxygen and compare outcomes, including shortness of breath, quality of life, fatigue, cough,
      and day-to-day functioning before and after O2.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with pulmonary fibrosis of any cause (idiopathic, related to connective tissue
        disease [e.g., rheumatoid arthritis, systemic sclerosis/scleroderma, dermato-/polymyositis,
        sjogren's syndrome], familial or genetic) or the primary supporter/caregiver of a patient
        with pulmonary fibrosis
      
Keywords: Pulmonary fibrosis; Interstitial lung disease; Connective tissue disease; Chronic hypersensitivity pneumonitis; Idiopathic pulmonary fibrosis; Pulmonary fibrosis of any cause; Primary supporters/caregivers
Effects of Dietary Polyphenols and ω-3 Fatty Acids on Cardiovascular Risk Factors in High Risk Subjects
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to explore if a 8-weeks dietary intervention with polyphenols and
      omega 3 fatty acids (alone or combined) may be effective on postprandial lipids metabolism
      and other cardiovascular risk factors in people at high cardiovascular risk.
    

Detailed description: 
      Fish consumption is associated with a lower cardiovascular risk and dietary supplementation
      with ω-3 fatty acids reduces plasma triglyceride levels. The mechanisms of action of ω-3
      fatty acids are currently not completely understood. It has been hypothesized that
      polyunsaturated ω-3 fatty acids beneficial effects may be mediated through their ability to
      facilitate plasmalogen replenishment.

      Polyphenols are associated with beneficial effects on some cardiovascular risk factors, in
      particular with a reduced lipid oxidation. Less data are available on their effects on lipid
      metabolism. Recent data suggest that these effects could be mediated by changes in
      plasmalogen levels.

      The effects on lipid metabolism of combining the two dietary approaches (ω-3 fatty acids and
      polyphenols) are not known.

      While developed populations live for the most part in the postprandial state, much of the
      information on lipid metabolism refers to fasting condition.

      Dietary Intervention Study Design

      Eighty people at high cardiovascular risk randomly assigned to one of the four different
      nutritional 8-week interventions:

      (A) Control diet poor in omega-3 fatty acids and polyphenols (B) Diet rich in omega-3 fatty
      acids (C) Diet rich in polyphenols (D) Diet rich in omega-3 fatty acids and polyphenols
    

Intervention name(s): Diet rich in omega-3 fatty acids; Diet rich in polyphenols; Control diet; diet rich in omega-3 and polyphenols
Intervention type(s): Other; Other; Other; Other
Intervention description(s): fish at least 3 times per week, large leaf vegetables; extra virgin olive oil, green tea, berries,fruits rich in polyphenols, dark chocolate, decaffenated coffee; low content of omega-3 fatty acids and polyphenols (low intake of fish, nuts and legumes,oil rich in monounsaturated fatty acids, vegetables and fruits poor in polyphenols); Fish at least 3 times x week,large leaf vegetables + extra virgin olive oil, green tea, berries,fruits rich in polyphenols, dark chocolate, decaffenated coffee
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: polyphenols omega-3 postprandial lipemia adipose tissue
MSB11022 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, randomized, double-blind, parallel-group trial to compare Investigation
      Medicinal Product (IMP) MSB11022, US- Reference Product (RP), and EU- Reference Medicinal
      Product (RMP) (Humira®) in healthy subjects.
    


Intervention name(s): MSB11022; US-licensed Humira; EU-approved Humira
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive single dose of 40 milligram (mg) MSB11022 as a subcutaneous injection in the lower abdomen on Day 1.; Subject will receive single dose of 40 mg US-licensed Humira as a subcutaneous injection in the lower abdomen on Day 1.; Subject will receive single dose of 40 mg EU-approved Humira as a subcutaneous injection in the lower abdomen on Day 1.
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: MSB11022; Humira®
Plus Epicatechin Duchenne Muscular Dystrophy in Non-ambulatory Adolescents
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This single center open-label pilot study will enroll 15 non-ambulatory children with
      Duchenne muscular dystrophy at least 8 years of age and who demonstrate pre-clinical
      cardiomyopathy (defined as a cardiac ejection fraction >55% with abnormal LV strain by
      cardiac MRI). They will receive (+)-epicatechin at one of three doses during an 8-week
      dose-ranging study with assessments at baseline, 2 Weeks, 4weeks, and 8 weeks. The study will
      determine optimal dosing for future cardiac efficacy studies based on serum / plasma
      biomarker response using follistatin: myostatin ratio, nitrite/nitrate ratio, cardiac
      troponins and cardiac BNP. Secondary endpoints will include additional biomarker assessments
      by SOMAscanTM, cardiac functional evaluations by cardiac MRI (LV strain), and echocardiogram
      (LV strain by speckle tracking) and measures of strength, range of motion and mobility, and
      clinical safety assessments. Results of secondary endpoint analysis will be used to refine
      design of subsequent clinical trials powered to detect changes in clinical outcomes.
    


Intervention name(s): (+)- Epicatechin
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric; muscle disease; Duchenne muscular dystrophy; cardiomyopathy
BAY38-9456 - Supportive Trial for Spinal Injury
Condition: Erectile Dysfunction; Sexual Dysfunction; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Erectile Dysfunction; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      BAY 38-9456 10 mg and 20 mg can be given as safe and efficacious medications to patients with
      spinal cord injury suffering from erectile dysfunction, and that erectile dysfunction can be
      improved by uptitration to BAY 38-9456 20 mg when the treatment with 10 mg is not
      sufficiently effective
    


Intervention name(s): Levitra (Vardenafil, BAY38-9456)
Intervention type(s): Drug
Intervention description(s): Patients received BAY 38-9456 10 mg for the first 4 weeks of the treatment period, and then went on to receive 10 mg or 20 mg for the following 8 weeks.
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vardenafil; PDE5 inhibitor; Erectile dysfunction; Spinal cord injury
Comparison of Bottle and Cup Feeding on Transition to Full Breastfeeding and Discharge Time
Condition: Preterm; Feeding, Bottle; Feeding Behavior; Feeding, Breast
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Breastfeeding is the ideal feeding method and that in the absence of breastfeeding the bottle
      and cup feeding are common alternatives. There is a lack of evidence regarding superiority of
      either of these methods. This study aimed to evaluate bottle feeding and cup feeding in
      preterm infants on the outcomes of full breastfeeding and discharge time.
    

Detailed description: 
      An estimated 20 million infants are born preterm each year (>37 weeks) and this number is
      increasing. The preterm newborn population is potentially unable to be fed orally for a long
      time in the postnatal period.However, it is not a disease that preterm infants cannot be fed
      orally as soon as they are born. Since the physiological functions are not yet fully mature,
      their adaptation to the external uterine environment is more complicated.This situation also
      means a long hospital stay. Therefore, the American Academy of Pediatrics (AAP) has
      determined oral feeding of the preterm baby as the main criterion for discharge.

      In preterm infants, sucking and swallowing coordination occurs in the 32 to 34 gestation
      weeks.Oral feeding skills are developed by applying various sensorimotor interventions and
      cue-based feeding protocols to increase oral feeding performance.Tube feeding (orogastric and
      nasogastric) is widely preferred as their oral-motor skills are still immature.As postnatal
      age increases, alternative oral feeding methods are often used along with tube feeding.Bottle
      feeding, cup feeding spoon feeding and syringe feeding are the most popular methods in
      clinical practice. While determining the most available method of oral feeding in preterm
      infants, the selection criteria include their capacity to facilitate the transition to full
      breastfeeding to help sustain breastfeeding to shorten the duration of hospitalization and to
      ensure sufficient nutrition.

      Direct full breastfeeding is the important and most recommended feeding method in new-borns.
      However, since full breastfeeding is not immediately possible in preterm infants, they
      definitely need an alternative feeding method.
    

Intervention name(s): Bottle feeding; Cup feeding
Intervention type(s): Device; Device
Intervention description(s): Bottle was used as an alternative oral feeding method for preterm infants.; Cup was used as an alternative oral feeding method for preterm infants.
Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm infants between 30-34 weeks and healthy
      
Keywords: Preterm infants; Bottle feeding; Cup feeding; Feeding methods; Breastfeeding