bioihbjkbjnl/mcl2 huggingface dataset:
Response of VEGF and AT-II to HCG in PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This research is to investigate the response of vascular active factors, vascular endothelial
      growth factor (VEGF) and angiotensin-Ⅱ (AT-Ⅱ) to ovary stimulation during 24h in patients
      with polycystic ovary syndrome (PCOS).Controled prospective clinical study involved 60 women
      undergoing in vitro fertilization. Fifty-two patients with PCOS and 8 control cases were
      stimulated with human chorionic gonadotropin (HCG) during the early follicular phase of the
      menstrual cycle (4st to 7th days of the cycle).The blood was sampled before the injection (0
      hour) and at the 3, 6, 12, 18 and 24 hours points after the stimulation. VEGF, AT-Ⅱ were
      measured by radioimmunoassay.
    

Detailed description: 
      After ovary stimulation, the level of VEGF in typical PCOS patients is obviously increased at
      the 3hs time point (p<0.05), while there is no difference with VEGF at all other time point
      among the four groups. As for AT-Ⅱ, before and after the ovary stimulation, at all time
      points, the AT-Ⅱ levels in serum of patients with different phenotypes of PCOS by Rotterdam
      criteria are all higher than the controls without PCOS. After the ovary stimulation, AT-Ⅱ in
      typical PCOS patients is obviously increased at 3hs time point, p<0.05. The response of VEGF
      and AT-Ⅱ to HCG in women with typical PCOS is higher in 24 hours after the stimulation during
      the early follicular phase. The response to the stimulation is different in patients with
      different phenotypes of PCOS by Rotterdam criteria. Serum VEGF and AT-Ⅱ levels as a possible
      contributor to a great risk of developing OHSS in patients with typical PCOS during the early
      follicular phase in 24 hours after the ovary stimulation.
    

Intervention name(s): HCG
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Polycystic ovary syndrome; Vascular endothelial growth factor; Angiotensin-Ⅱ; Ovarian hyperstimulation syndrome
Vitamin D Levels in Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Polycystic ovary syndrome is the commonest endocrinopathy among women of reproductive age.
      Its worldwide prevalence has been estimated between5-10%.

      Vitamin D, a fat-soluble vitamin, can be produced in two ways: by intestinal absorption and
      endogenous synthesis from a precursor of 17-hydroxyl cholesterol on the skin with sufficient
      exposure to ultraviolet sunlight.
    

Detailed description: 
      The aim of this work is assessment of the level of vitamin D in female have polycystic ovary
      syndrome & healthy female.and also make diagnostic criteria for patient who is in need for
      supplementations with vitamin D.
    

Intervention name(s): Vitamin D Levels measurement using chemiluminescent assay; Vitamin D level assessment
Intervention type(s): Drug; Device
Intervention description(s): Measurement of serum vitamin D levels; Using lIAISON DEVICE
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel study
Masking: None (Open Label)
Primary purpose: Diagnostic
The Risk of Falling in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease; Fall; Balance; Distorted; Activity, Motor
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      This cross-sectional study aims to investigate what daily activities increase the risk of
      falling in Chronic Obstructive Pulmonary Disease patients (COPD).
    

Detailed description: 
      To investigate the what daily activities increase the risk of falling in patients with COPD,
      twenty-eight voluntary patients with COPD, aged between 35-80 years will be divided into two
      groups: Group-1 have at least one fall (fallers) and Group-2 have no history of falls
      (non-fallers). Fall frequency will be investigated by asking patients to report any fall
      event in the last one month and the last 12-months. Assessments will be performed at
      baseline. Fear of falling will be assessed with Activities-Specific Balance Confidence (ABC)
      scale. Balance will be evaluated by Berg Balance Scale (BBS). The level of dyspnea during
      daily activities will be assessed with London Chest Activity of Daily Living (LCADL) scale.
      The global impacts of COPD symptoms on overall health status will be evaluated by The COPD
      Assessment Test (CAT). The Modified Medical Research Council Dyspnea (MMRC) scale and
      Six-Minute Walking Test (6MWT) will be used for evaluating the how dyspnea limits the
      patients' daily activities and functional capacity, respectively. Isometric muscle strength
      will be measured with a handheld dynamometer of quadriceps femoris. Pulmonary function data
      will be retrieved from the last 1-month clinical records of the COPD patients. Statistical
      analysis will be performed using the Statistical Package for Social Sciences (SPSS) version
      21.0. Among the groups, demographic and clinical variables will be compared with independent
      sample t-test for continuous variables and a chi-square test for categorical variables. The
      significance level will be set as p<0.05.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): There is no intervention.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All participants will be patients with COPD diagnosed according to the Global Initiative
        for Chronic Obstructive Lung Disease (GOLD) guidelines were recruited from Istanbul
        University, Department of Chest Diseases.
Mitigating Cephalad Fluid Shifts: A NSBRI Study
Condition: Intracranial Pressure
Study type: Interventional

Summary: 
      This is a feasibility study to determine optimal thigh cuff design using a cephalad fluid
      shift protocol in patients who have an intraventricular catheter (such as Ommaya reservoir)
      placed for the delivery of central nervous system chemotherapy or for diagnosing potential
      elevation of ICP and monitoring its progression as part of standard medical care.
    


Intervention name(s): Custom Thigh Cuff
Intervention type(s): Device
Intervention description(s): The aim is to achieve positive and near normal forward arterial vascular blood flow to the lower extremities. Milder cuff pressures up to 65 mmHg will be used to limit venous return to the upper body.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: NSBRI
Estimated Echocardiographic Pulmonary Capillary Wedge Pressure in Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study was to verify the effects of moderate versus low sodium intake on
      pulmonary capillary wedge pressure (PCWP), determined by Doppler echocardiography and tissue
      Doppler imaging in patients suffering from compensated heart failure.
    

Detailed description: 
      the study outcome is hospital readmission and mortality after 12 months of two different
      sodium diet.
    

Intervention name(s): normal sodium diet
Intervention type(s): Dietary Supplement
Intervention description(s): normal sodium diet (120 mmol/daily) for 1 year
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sodium ,diuretics, PCWP
Evaluation of Artesunate-mefloquine as a Novel Alternative Treatment for Schistosomiasis in African Children
Condition: Schistosoma Haematobium; Schistosoma Mansoni
MeSH terms: Schistosomiasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The SchistoSAM study is an open label, two-arm, individually-randomized controlled trial with
      a non-inferiority design, conducted in northern Senegal.

      The study aims at determining if the efficacy of one and of repeated courses of
      artesunate-mefloquine (AM) is respectively similar to or higher than that of a standard
      praziquantel (PZQ) treatment. Secondly, the study will assess if novel DNA- and antigen-based
      diagnostics are more accurate than microscopy in assessing antischistosomal treatment
      response.
    

Detailed description: 
      The SchistoSAM study is an open label, two-arm, individually-randomized controlled trial with
      a non-inferiority design, conducted in northern Senegal.

      The study aims at determining if the efficacy of one and of repeated courses of
      artesunate-mefloquine (AM) is respectively similar to or higher than that of a standard
      praziquantel (PZQ) treatment. Secondly, the study will assess if novel DNA- and antigen-based
      diagnostics are more accurate than microscopy in assessing antischistosomal treatment
      response.

      For this purpose, 726 school children, aged 6-14 years old and infected with Schistosoma (as
      demonstrated by presence of eggs in stool and/or urine) will be randomized in one of the
      following arms:

        1. AM, available in fixed dose tablets of 25/50 mg and 100/200 mg will be administered once
           daily for three days in a dose closest to 4 mg/kg artesunate and 8 mg/kg mefloquine.
           This treatment course will be repeated 2 times at 6-week intervals.

        2. PZQ, available in tablets of 600 mg, will be administered as a single dose of 40 mg/kg.

      Trial participants will be regularly followed-up:

        1. At each dose administration

        2. At day 7 after each dose for follow-up of safety

        3. At week 4, 10 and 16 for parasitological assessment and follow-up of safety

        4. At week 6 and 12 for clinical assessment before the second and third drug administration
           (only in the AM arm)

        5. At week 24 and 48 for assessment of Schistosoma spp. and malaria infection and
           associated morbidity (compared to baseline)
    

Intervention name(s): Praziquantel; Artesunate + Mefloquine
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg/kg at baseline; 4mg/kg artesunate and 8 mg/kg mefloquine at baseline (3 consecutive days) and repeated at Week 6 and Week 12
Intervention MeSH terms: Artesunate; Mefloquine; Praziquantel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schistosoma; Schistosomiasis; Senegal; Praziquantel; Artesunate; Mefloquine
This is a Study to Get More Information About Non Ambulatory Boys & Men With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Observational

Summary: 
      Many therapeutic trials in DMD exclude non-ambulatory boys and men. Rate of progression in
      these non-ambulatory patients has been studied but consensus has not been reached for what
      measures are most reliable and reproducible. Furthermore, any treatment trial would be
      expected to demonstrate improved function and improvement in quality of life. Therefore,
      function, strength, and quality of life must be understood and standardized. While the goal
      of this proposal is to standardize clinical outcomes for therapeutic trials, careful
      understanding of the progression of DMD in non ambulatory boys may also lead to better
      medical treatment.
    

Detailed description: 
      For Non-ambulatory study, boys must be unable to walk without assistive devices for greater
      than or equal to one year.

      Age at onset of study for non-ambulatory boys and men: greater than or equal to 7 years
      through age 22 years.

      Genetic or biopsy confirmation of dystrophinopathy or clinical diagnosis of DMD with
      biopsy/genetic confirmation in a primary relative.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Non ambulatory boys and men with Duchenne muscular dystrophy
      
Keywords: DMD; non ambulatory
Assessment of an School-based Intervention in Eating Habits and Physical Activity in Schoolchildren: the AVall Study
Condition: Obesity; Food Habits; Physical Activity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the efficacy of an intervention on food habits and
      physical activity in school-age children.
    

Detailed description: 
      A two-year cluster-randomised prospective study with two parallel arms was used to evaluate
      an intervention programme in children in their first year of primary schooling (5-6 years of
      age) in schools in the city of Granollers. The intervention consisted of the promotion of
      healthy eating habits and physical activity by means of the educational methodology
      Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of the study
      (2006 and 2008) the weight and height of each child was measured in situ, while the families
      were given a self-report physical activity questionnaire and the Krece Plus quick test.
    

Intervention name(s): Educational program
Intervention type(s): Other
Intervention description(s): The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of 1st phase of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Children; School-based program; Obesity
Improving Care for Patients With Diabetes and Poor Numeracy Skills
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The aim of this research will be to perform a randomized controlled trial (RCT) of a new
      diabetes educational intervention that teaches self-management skills that compensate for
      poor numeracy skills among a sample of patients with diabetes and low numeracy.
    

Detailed description: 
      Results of the National Adult Literacy Survey (NALS) suggest that over 90 million adult
      Americans have poor quantitative skills. Numeracy, the ability to understand and use numbers
      and math skills in daily life, may be particularly important to patients with diabetes
      because caring for diabetes often requires self-management skills that rely on the daily
      application of math skills, such as counting carbohydrates, interpreting blood glucose
      monitoring, applying sliding scale insulin regimens, and calculating insulin to carbohydrate
      ratios. Presumably diabetes patients with poor numeracy have more difficulty with
      self-management and are at risk for poorer clinical outcomes, but to date, there are no
      published studies that rigorously examine the role of numeracy in diabetes. We have recently
      completed the initial development of a new scale to measure numeracy in patients with
      diabetes: the Diabetes Numeracy Test (DNT).

      The aim of this research will be to perform a randomized controlled trial (RCT) of a new
      diabetes educational intervention that teaches self-management skills that compensate for
      poor numeracy skills among a sample of patients with diabetes and low numeracy. We
      hypothesize that a group of patients with poor numeracy who are taught self-management skills
      that accommodate their poor numeracy will have: (1) improved treatment satisfaction and
      perceived self-efficacy, (2) improved performance in self-management tasks, and (3) improved
      glycemic control compared to a control group that receives usual education.
    

Intervention name(s): Literacy/Numeracy oriented educational intervention; Control Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Comprehensive educational Intervention; Receives comprehensive education that is not literacy/numeracy sensitive
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Diabetes; Education; Health Literacy
Safety and Maximum Tolerated Dose (MTD) Study of INNO-206 in Subjects With Advanced Solid Tumors
Condition: Malignant Solid Tumour
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1b open-label study evaluating the preliminary safety and maximum tolerated
      dose of a new formulation of INNO-206 administered at doses of 230 mg/m2, 350 mg/m2 and 450
      mg/m2 (165, 260, 325 mg/m2 doxorubicin equivalents, respectively) through intravenous
      infusion on Day 1 every 21 days for up to 6 cycles.
    


Intervention name(s): INNO-206
Intervention type(s): Drug
Intervention description(s): INNO-206 at dosages of 230, 350, and 450 mg/m2 (doxorubicin equivalents of 165, 260, and 325 mg/m2) will be administered as a 30 minute IVI on Day 1 of each cycle.
Other intervention name(s): DOXO-EMCH
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: INNO-206; Phase 1; DOXO-EMCH; Advanced solid tumors
A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma
Condition: Sarcoma, Kaposi; HIV Infections
MeSH terms: Sarcoma, Kaposi; Sarcoma; Necrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate tolerance, toxicity, and preliminary evidence of antitumor efficacy of
      intralesionally administered tumor necrosis factor (TNF) and to define a maximum tolerated
      dose (MTD) for single intralesional injections. In addition, to assess the effects of TNF
      injections on Kaposi's sarcoma (KS) lesions as measured by P-32 magnetic resonance
      spectroscopy.
    


Intervention name(s): Tumor Necrosis Factor
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: Skin Neoplasms; Tumor Necrosis Factor; Acquired Immunodeficiency Syndrome
A Pilot Study to Evaluate the Effect of a Probiotic Mixture in Acne
Condition: Acne; Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      A 12-week randomized, double-blind, placebo-controlled pilot study to evaluate the effect of
      a probiotic blend in the treatment and clinical and subjective evolution of acne vulgaris in
      adolescent and adult patients between 12 and 30 years.
    


Intervention name(s): Probiotic Bths-003; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Probiotic with maltodextrin as a carrier.; Placebo with maltodextrin base.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Probiotic
Use of Prophylactic Steroids in the Prevention of Post-thyroidectomy Hypocalcaemia and Voice Dysfunction
Condition: Thyroid Diseases; Hypocalcemia; Vocal Cord Dysfunction
MeSH terms: Vocal Cord Dysfunction; Hypocalcemia; Thyroid Diseases
Study type: Interventional

Summary: 
      Total thyroidectomy for benign surgical pathologies is associated with risks related to
      temporary hypocalcaemia and vocal quality dysfunction. Dexamethasone, as an anti-inflammatory
      steroid, has been proposed to have a physiological effect on hypocalcaemia and voice quality.
      Investigators conducted a double-blinded controlled trial to assess the effect of
      preoperative dexamethasone on the vocal dysfunction and hypocalcaemia following thyroidectomy
    


Intervention name(s): Dexamethasone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 8 mg/2 ml dexamethasone IV, 60 minutes before the induction of anaesthesia; 2 ml normal saline (0.9%) IV, 60 minutes before the induction of anaesthesia
Other intervention name(s): normal saline (0.9%)
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Thyroidectomy; Postoperative Hypocalcaemia; Postoperative Vocal cord dysfunction; Dexamethasone
Evaluation of Two Regimens, With Healthy Male and Female Babies, Ages 3-6 Months Old, Using Various Assessments.
Condition: Microbiome
Study type: Interventional

Summary: 
      This study is to assess the impact of two skincare regimens on the cutaneous microbiome and
      skin physiology of healthy male and female infants, ages 3-6 months using clinical,
      instrumental, D-Squame tape, microbiome and parental assessments over a five-week period.
    

Detailed description: 
      Skin cleansing has been demonstrated as a simple strategy to help keep skin healthy. There
      are many types of cleansing and moisturizing routines that have been shown to have different
      effects on the skin barrier such as reducing sebum and exogenous contaminants, controlling
      odors, and affecting the skin microbiome.1 A previous study in an adult population showed
      that use of a mild surfactant cleanser had less of an impact on the skin barrier than a
      liquid castile soap (data on file ).2 Because infant skin differs from an adult's in
      structure, function, and composition3, cleanser and/or lotion regimens may impact the skin
      barrier of infants differently.

      There is very little information in the literature on how the use of product regimens impacts
      the cutaneous microbiome and skin physiology of adults1 and even less about how it impacts
      the skin of children.

      This study will explore the impact that the use of two regimens - one cleansing and the other
      cleansing and moisturizing - has on the holistic skin barrier of infants ages 3-6 months.

      The IPs are a baby wash and a baby lotion, which are both cosmetic body products. The
      auxiliary product is a commercially available, cosmetic baby body wash.
    

Intervention name(s): Cleanser; Cleanser and Lotion
Intervention type(s): Other; Other
Intervention description(s): Cosmetic Baby Cleanser/Shampoo; Cosmetic Baby Cleanser/Shampoo and Baby Lotion
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The duration of this trial will be approximately 5 weeks and will consist of a screening visit followed by an approximately 1-week (7-day) washout period; a 4-week (28 day) treatment period with visits conducted at baseline (Day 0, ± 2 days), week 2 (Day 14, ± 2 days), and week 4 (Day 28, ± 2 days); and a regression period with a visit 3-5 days after the week 4 visit.
During the one week washout period, subjects will use a commercial available Baby Wash at least 3x per week.
For the next 4 weeks, subjects will be randomly assigned to use one of two IP regiments. Subjects in Group 1 will use the Baby Wash & Shampoo at least 3x per week, but no more than once daily. Subjects in Group 2 will use the Baby Wash & Shampoo at least 3x per week, but no more than once daily, plus the Baby Lotion at least once daily. The lotion should be applied after bathing (as applicable).
At Visit 4, subjects will begin a 3-5 day regression period.
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Microbiome; Microbiota