bioihbjkbjnl/mcl2 huggingface dataset:
Autologous Transplantation of Mesenchymal Stem Cells (MSCs) and Scaffold in Full-thickness Articular Cartilage
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the efficacy and safety of autologous
      transplantation of Bone Marrow Mesenchymal stem cells (MSCs) mixed with collagen I scaffold
      in patient with Knee cartilage defects and osteoarthritis
    

Detailed description: 
      Articular cartilage defects have a weak potential for self-repair because of the reduced
      mitotic capacity of chondrocytes in vivo. Because some patients with articular cartilage
      defects may progress to osteoarthritis, such defects need to be repaired even though their
      exact natural course remains obscure. Traditional methods for repair, such as micro fracture,
      perforations, abrasion arthroplasty, have not produced consistent satisfactory long term
      clinical results. Transplantation of autologous bone marrow MSCs expanded in culture would be
      a promising approach in the repair of articular cartilage defects in human osteoarthritic
      knees. This method is clinically straightforward to perform because autologous cells can be
      readily harvested and expanded in culture without losing their capacity to differentiate into
      chondrocytes. The purpose of this study was to evaluate the clinical results obtained with
      autologous MSCs expanded in culture for the treatment of full-thickness chondral defects in
      human knee.
    

Intervention name(s): Bone marrow derived mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): Bone Marrow Aspiration A total volume of 300 ml bone marrow will be aspirated from the iliac crest and are cultured for mesenchymal stem cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Knee cartilage diseases
A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be the first-in-human study designed to evaluate the safety, pharmacokinetics (PK),
      and pharmacodynamics (PD) of single ascending doses of DS-7011a in healthy participants.
    

Detailed description: 
      This study will assess the safety, PK, and PD properties of single ascending intravenous (IV)
      and subcutaneous (SC) doses of DS-7011a in healthy participants.

      This study will be conducted in 3 stages:

        -  Stage 1 - single ascending IV dose cohorts of DS-7011a (ie, up to 6 dose levels will be
           assessed starting at 0.1 mg/kg);

        -  Stage 2 - single ascending SC cohorts of DS-7011a (ie, up to 3 dose levels centered
           around the estimated therapeutic dose confirmed in Stage 1 will be assessed); and

        -  Stage 3 - a single IV cohort of DS-7011a in healthy participants of Japanese ethnicity
           (ie, 1 dose level at the estimated therapeutic dose as confirmed in Stage 1 will be
           assessed).
    

Intervention name(s): DS-7011a; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous or subcutaneous administration, single dose; Intravenous or subcutaneous administration, single dose
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Systemic Lupus Erythematosus; DS-7011a
USI and/or DO in Women With Cystocele Before and After Cystocele Repair
Condition: Urodynamic Stress Incontinence; Detrusor Overactivity
MeSH terms: Urinary Incontinence, Stress; Urinary Bladder, Overactive; Cystocele
Study type: Observational

Summary: 
      The changes of lower urinary tract function after cystocele repair are important for
      perioperative consultation and management. Thus, the aim of this retrospective study was to
      evaluate the prevalence of urodynamic stress incontinence and/or detrusor overactivity in
      women with ≥ stage II cystocele and the changes of incontinence function after cystocele
      repair.
    

Detailed description: 
      Between November 2010 and October 2020, all women with ≥ stage II cystocele who visited the
      urogynecological department of a medical center for cystocele repair were reviewed. Those
      women who had complete data of preoperative and postoperative 3-month follow-up urodynamic
      data were excluded from this study. Urodynamic stress incontinence was diagnosed by the
      finding of involuntary leakage during filling cystometry or stress urethral pressure profile,
      associated with increased intra-abdominal pressure, in the absence of a detrusor contraction.
      Detrusor overactivity was defined as the occurrence of involuntary detrusor contractions
      during filling cytometry.

      STATA software was used for statistical analysis. Chi2 test, univariate and multivariable
      logistic regression tests were used for statistical analysis as appropriate. A p < 0.05 was
      considered as statistically significant.
    

Intervention name(s): Cystocele repair
Intervention type(s): Procedure
Intervention description(s): Fascial repair for endopelvic fascia and anterior colporrhaphy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        women with ≥ stage II cystocele who visited the urogynecological department of a medical
        center for cystocele repair
      
Keywords: Urodynamic stress incontinence; Detrusor Overactivity; Cystocele
The Effects of Oxytocin on Affective Touch
Condition: Healthy
Study type: Interventional

Summary: 
      The main aim of the study is to investigate whether intranasal oxytocin (24IU) increases the
      affective processing of touch in general or whether it's effect vary according to the
      affective valence of the touch (positive, neutral, negative). Moreover, associations with
      trait autism will be explored.
    

Detailed description: 
      A double-blind, within-subject, placebo controlled design will be employed in this study. In
      a randomized-order a total of 40 healthy male subjects will receive oxytocin- and
      placebo-nasalspray (interval between the administration > 2 weeks). 45 minutes after
      treatment subjects will be administered the touch-stimulation to the dorsal forearm by a
      trained experimenter (lengths: 8cm, rate 8cm/s). After each block of stimulation, the
      subjects will be asked to rate their subjective experience of the touch.The neural basis of
      touch processing will be measured via simultaneously acquired fMRI.

      Levels of trait autism will be assessed using the Autism Spectrum Quotient (ASQ) and related
      scales such as the Empathy Quotient (EQ), Liebowitz Social Anxiety Scale (LSAS), or the
      Sensory over Responsivity Scale (SOR) and Under Responsively Scale (URS).
    

Intervention name(s): intranasal oxytocin; intranasal placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each subject will be assigned to intranasal administration of oxytocin (24 IU).; An identical amount of intranasal administration of placebo will be assigned to each subject.
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized placebo-controlled double-blind within-subject design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Oxytocin; affective touch; trait autism
Safety and Tolerability of LEO 138559 in Healthy Subjects and Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the safety and tolerability of LEO
      138559 in healthy subjects and subjects with moderate to severe atopic dermatitis.

      The secondary objective of this trial is to study the pharmacokinetics and pharmacodynamics
      following administration of LEO 138559 to healthy subjects and subjects with moderate to
      severe atopic dermatitis.

      Healthy subjects will be exposed to 7 different dose regimens of LEO 138559 (one dose regimen
      per subject).

      Subjects with moderate to severe atopic dermatitis will be exposed to 2 different dose
      regimens of LEO 138559 (one dose regimen per subject).
    


Intervention name(s): LEO 138559; LEO 138559 placebo
Intervention type(s): Drug; Drug
Intervention description(s): LEO 138559 is a compound in development at LEO Pharma A/S; LEO 138559 placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Iron Fish in Dominican Republic (DR) Children
Condition: Iron Deficiency Anemia; Anemia; Iron-deficiency
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      The objective of the study is to assess the acceptability, feasibility, and barriers to Lucky
      Iron Fish™ (LIF) utilization among families with young children in a Latin American community
      with a high prevalence of iron deficiency and iron-deficiency anemia.

      .
    

Detailed description: 
      The primary objective is to assess the acceptability of cooking with an iron ingot (Lucky
      Iron Fish™) compared to traditional oral iron supplementation methods among preschool aged
      children in a Dominican community with a high prevalence of anemia (> 50%). Data will be
      collected to characterize the natural history of iron deficiency and anemia in pre-school
      aged children in a Dominican community. The study will involve a randomized control trial to
      assess the primary objective: children > 1 year and < 5 years of age will be randomized into
      two study arms: LIF plus citrus (LIF arm) versus standard iron-supplementation (enhanced
      standard of care). Participants enrolled in the both study arms will have study labs drawn
      every 3, 6, and 12-months (hemoglobin, serum ferritin, c-reactive protein) to assess the
      natural history of iron deficiency in these children. Concomitant to study labs,
      parents/guardians will be surveyed on acceptability, compliance, and barriers to use of their
      assigned iron supplementation method.

      Primary study outcomes are the change in hemoglobin within the LIF group and then difference
      in change in hemoglobin between study arms over a 12-month study period. Secondary outcomes
      include changes in serum ferritin within and between study arms and exploring the
      relationship between changes in hemoglobin, serum ferritin, and C-reactive protein
    

Intervention name(s): Lucky Iron Fish; enhanced standard of care
Intervention type(s): Device; Other
Intervention description(s): 200g iron ingot that is placed in boiling water for 10+ minutes, and then removed. The water is then used to eating and drinking.; parents of subjects are provided oral iron supplementation per usual clinical care at clinic and followed for their anemia in addition to study visits
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: iron intake; iron bioavailability
A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      Osteoarthritis is a common, chronic, progressive, skeletal, degenerative disorder that
      frequently affects several joints such as knee, hip, spine and hands.This placebo-controlled
      clinical trial assessed the effects of naproxen sodium, acetaminophen and celecoxib on
      stiffness in subjects with osteoarthritis.
    

Detailed description: 
      The primary objective of the study was to assess the responsiveness of the Brief Arthritis
      Stiffness Scale (BASS) for detecting treatment effects of common over-the-counter (OTC)
      analgesics and a common prescription analgesic in subjects with knee osteoarthritis.
    

Intervention name(s): Naproxen Sodium (Aleve, BAY117031); Acetaminophen ER; Celecoxib; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 660 mg daily for 3 days, 440 mg on the fourth day, over-encapsulated tablet, oral (Treatment A); 3900 mg daily for 3 days, 1300 mg on the fourth day, over-encapsulated extended release (ER) tablet, oral (Treatment B); 200 mg daily for 3 days, 100 mg on the fourth day, over-encapsulated capsule, oral (Treatment C); Over-encapsulation capsule, 4 days, oral (Treatment D)
Intervention MeSH terms: Acetaminophen; Celecoxib; Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Laxative Effectiveness of a Phytotherapeutic Tea
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the efficacy and safety of a phytotherapeutic laxative
      tea, composed by Pimpinella anisum, Foeniculum vulgare, Sambucus nigra and Cassia
      angustifolia, in a randomized crossover placebo-controlled clinical trial in patients with
      chronic constipation.
    

Detailed description: 
      The Klein Laxative Tea is a pharmaceutical phytotherapeutic product that's been used for
      several years in Brazil for the treatment of constipation. This product contains fruit of
      Pimpinella anisum (green anises), fruit of Foeniculum vulgare (fennel), flowers of Sambucus
      nigra (elder tree) and flowers of Cassia angustifolia (senna). In spite of the beneficial
      effects of its components, separately demonstrated in vitro, it never had its effectiveness
      appraised in a randomized clinical trial.The purpose of this study was to evaluate the
      efficacy and safety of this product in a randomized crossover placebo-controlled clinical
      trial. Twenty patients presenting with the criteria of the American Association of
      Gastroenterology for chronic constipation were included, and concluded a two-phase crossover
      study. The primary endpoint was the evaluation of the intestinal transit time measured
      through radiological technique. The secondary endpoints were the number of evacuations,
      subjective impression of the quality in the intestinal habit, quality of life appraised
      through WHOQOL-brief and adverse effects.
    

Intervention name(s): Placebo; Klein Laxative Tea
Intervention type(s): Other; Other
Intervention description(s): In order to produce similar taste and color, 7 drops of caramel color and 10 drops of orange essence were mixed into 1.6 liters of boiling water. The patients received 150 ml of placebo 3 times a day for 5 days.; The laxative tea was prepared using 1 gram of grinded plant into 150 ml of water, left under infusion by 5 minutes. Patients received 150 ml of tea 3 times a day for 5 days.
Other intervention name(s): Phytotherapeutic tea; laxative tea
Intervention MeSH terms: Laxatives; Cathartics
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: constipation; RCT; phytotherapy
Adipose Tissue Function After Pancreas Transplantation
Condition: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Clinical measures of adipose tissue mass (BMI, waist circumference, waist-to-hip ratio) do
      not adequately explain the inter-individual and ethnic heterogeneity in diabetes. . There is
      a need to identify novel/universal markers of risk for diabetes (DM) and cardiovascular
      disease (CVD). These biomarkers also can become additional outcome measures for an
      intervention such as pancreatic/kidney transplant. If biological markers show an improvement
      with an intervention before anthropometric changes occur, intermediate outcomes can be an
      encouraging finding for practitioners. This study will focus on the central question of
      "adipose tissue dysfunction" as mediator of metabolic complications of positive energy
      balance, independent of body fat content and distribution. This study will address the
      question of effect of hyperglycemia on adipose tissue function independent of body fat mass.
      This project will take advantage of unique expertise of our investigators to perform detailed
      metabolic studies in patients with diabetes who undergo pancreatic/kidney transplant. The
      results of the proposed study will provide support to the novel approach of identifying
      adipose tissue dysfunction, rather than obesity and fat distribution, as predictor of
      diabetes and CVD across all ethnic groups, age and gender. We will obtain necessary
      preliminary data for future grant submissions to support our central hypothesis and develop
      stronger interactions within and outside The University of Texas Medical Branch (UTMB) with
      clinical investigators in the area of DM and its complications.
    

Detailed description: 
      detailed description is his protocol
    

Intervention name(s): Adipose tissue biopsy
Intervention type(s): Procedure
Intervention description(s): Adipose tissue biopsy is done at time of transplant surgery. There is a second needle biopsy done between 3-12 months post transplant surgery.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients that have Diabetes mellitis and End Stage Renal Disease who will be receiving
        pancreas/kidney or only kidney transplantation.

        Patients that have End Stage Renal Disease and who will be receiving an isolated kidney
        transplant. This control group will account for effects of immuno-suppression and for
        potential metabolic changes induced by the kidney transplant on adipose tissue function.
      
Biospecimen description: 
      adipose tissue blood samples
A Study to Characterize the Effect on the Pharmacokinetics of ASP1941 and Sitagliptin When Given Together to Healthy Subjects
Condition: Healthy; Pharmacokinetics of ASP1941
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate pharmacokinetics, pharmacodynamics and safety
      following the administration of ASP1941 and sitagliptin in single and multiple doses.
    

Detailed description: 
      All subjects will be enrolled at one center and confined to the unit for up to 17 days.
      Subjects will be dosed in the fasting state in one of the four groups.
    

Intervention name(s): ASP1941; sitagliptin
Intervention type(s): Drug; Drug
Intervention description(s): oral tablet; oral tablet
Other intervention name(s): Januvia
Intervention MeSH terms: Sitagliptin Phosphate; Ipragliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: ASP1941; Januvia; sitagliptin
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Carotid Intima-media Thickness (CIMT)
Condition: ST-segment Elevation Myocardial Infarction; Subclinical Carotid Atherosclerosis
MeSH terms: Carotid Artery Diseases; Myocardial Infarction; Atherosclerosis; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to measure the effect of moderate and intensive lipid-lowering
      treatment with rosuvastatin on the carotid intima-media thickness (CIMT) as a surrogate
      marker of cardiovascular risk.
    

Detailed description: 
      The aim of this study was to measure the effect of moderate (5mg) and intensive (40mg)
      lipid-lowering treatment with rosuvastatin on the carotid intima-media thickness as a
      surrogate marker of cardiovascular risk and to obtain whether CIMT correlated with the plaque
      components in coronary arteries evaluated with Intravascular Ultrasound Virtual Histology
      (IVUS-VH).
    

Intervention name(s): Rosuvastatin; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Rosuvastatin 5mg/day for one year; Rosuvastatin 40mg/day for one year
Other intervention name(s): Crestor; Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: CIMT; IVUS-VH; Coronary artery disease
Detection of COPD in Primary Care
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Chronic obstructive pulmonary disease (COPD) is a common chronic disease with a significant
      medical and economic impact. Its prevalence is increasing and is estimated at 7.5% of people
      over 40 in France. COPD is responsible for a significant impairment of quality of life and
      was the 3rd leading cause of death in the world in 2010 when it was 4th place 20 years ago.

      However, about 75% of patients with COPD are not diagnosed. Spirometry is the only
      examination for the diagnosis of COPD. Patients identified at risk for COPD are
      insufficiently using spirometry and general practitioners (GPs) underestimate the severity of
      COPD when they do not practice spirometry in their patients. COPD is often diagnosed too
      late, the disease being discovered at the stage of complications requiring hospitalization.
      The underdiagnosis is mainly due to poor knowledge of patients, their difficulty in accessing
      a specialist performing spirometry, their reluctance to perform spirometry, and the
      insufficient involvement of general practitioners.

      Currently in France, targeted screening for COPD and diagnosis in primary care is a major
      challenge. The international (GOLD 2014) and French (HAS 2014) recommendations do not
      indicate a systematic screening in the general population for COPD but advocate targeted
      screening of patients by five questions to identify risk factors and symptoms of COPD. The
      presence of at least one of these factors in an adult over the age of 40 requires spirometry.

      Recent studies suggest the relevance of finding primary care variables for smoking and
      respiratory symptoms in order to identify new cases of COPD.

      However, the impact of the use of these questionnaires on the prevalence of diagnoses of COPD
      in general practice has not been demonstrated. Moreover, the heterogeneity of the provision
      of care according to the territories limits a fast or easy access (distance) to the
      spirometry.

      It is therefore necessary to evaluate in primary care the interest of a targeted screening of
      COPD and the interest of a coordination of care for the realization of a spirometry, in order
      to improve the rate of diagnosis of the disease.
    


Intervention name(s): Questionnaire; Coordination
Intervention type(s): Other; Other
Intervention description(s): Targeted screening of COPD by GPs via the GOLD / HAS questionnaire. The questionnaire includes 4 questions for patients over 40. At least one positive response is an indication to perform a spirometry.; Information of the GPs of the existence of a coordination of the care of proximity to facilitate the access to the spirometry (identification of a referent specialist, making appointments).
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Screening