bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy
Condition: Diabetic Nephropathy; Type 2 Diabetes
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study investigates the safety, tolerability and efficacy of a single intravenous infusion
      of two doses of mesenchymal precursor cells versus placebo in subjects with diabetic
      nephropathy and type 2 diabetes.
    

Detailed description: 
      This study is taking place in Melbourne, Australia.
    

Intervention name(s): Mesenchymal Precursor Cells (MPCs); Mesenchymal Precursor Cells (MPCs)
Intervention type(s): Biological; Biological
Intervention description(s): Single Intravenous Infusion of MPCs Dose 1 or Placebo; Single Intravenous Infusion of MPCs Dose 2 or Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetic nephropathy; Chronic kidney disease; Metabolic disease; Diabetes mellitus, type 2
The Effect of Dietary Fiber-enriched Cereals on Glycemic Control and Secretion of Gut Hormones
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The aim of this study is to assess whether dietary fiber-enriched cereals effect on
      postprandial glucose levels and plasma glucagon-like peptide 1 (GLP-1) and/or
      glucose-dependent insulinotropic polypeptide (GIP) concentration in patients with type 2
      diabetes mellitus.
    

Detailed description: 
      Fifteen subjects with type 2 diabetes mellitus will be provided with study meals based on
      either dietary fiber-enriched cereals or conventional cereals upon two separate admissions in
      a cross-over fashion. The study meals will be provided at 6 p.m. and 10 p.m. on the day of
      admission, and 8 a.m. on the next day. A hamburger with coke as mixed meal will be given for
      lunch at noon on the second day. Blood sampling will be done every 30 minutes from 8 a.m. to
      4 p.m. on the second day. The plasma levels of glucose, GLP-1, GIP, insulin, glucagon, and
      free fatty acid will be measured.
    

Intervention name(s): dietary fiber-enriched cereal; conventional cereal
Intervention type(s): Dietary Supplement; Other
Intervention description(s): provided with 300 mL (150 mL at 10 p.m.) of milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.)
amount: 79g for dinner and breakfast, 38.5g for night snack (10 p.m.)
one serving of steamed egg is added for dinner and breakfast; provided with 300 mL (150 mL at 10 p.m.) of milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.)
amount: 80 g for dinner and breakfast, 40 g for night snack (10 p.m.)
one serving (40g) of steamed egg is added for dinner and breakfast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: dietary fiber; diabetes mellitus; gut hormone
Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to find the optimal dose of Growth Hormone Replacement in young adult patients
      suffering from childhood onset growth hormone deficiency (GHD).
    

Detailed description: 
      The primary objective of this study is to evaluate the safety, tolerability and
      pharmacodynamic response of three different ARX201 doses (PEG-ahGH) when administered
      repeatedly to young adult patients with childhood onset growth hormone deficiency (GHD).
    

Intervention name(s): ARX201; ARX201; ARX201
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Reconstituted lyophilized drug product at 2.5 mg/wk; 3 periods over six months.; Reconstituted lyophilized drug product at 5.0 mg/wk; 3 periods over six months.; Reconstituted lyophilized drug product at 10.0 mg/wk; 3 periods over six months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: growth hormone; growth hormone deficiency; GHD; PEG; pegylated; IGF-1
Emotion Regulation Group Treatment for Gambling Disorder - a Pilot Trial
Condition: Gambling Disorder
MeSH terms: Gambling
Study type: Interventional

Summary: 
      Group cognitive behavioral therapy for Gambling Disorder (GD) with a focus on emotion
      regulation - A pilot study This pilot study will evaluate the feasibility and possible
      effectiveness of a novel treatment protocol developed within the research group including
      emotion regulation techniques for the treatment of GD.
    

Detailed description: 
      The manual is based on principles from so called third wave cognitive behavioral therapy,
      which differs from current treatment within standard care in that focus is more on emotion
      regulation techniques. The treatment consists of an 8- session program delivered by weekly
      sessions. The study is an open trial in order to evaluate the possible benefit of components
      of emotion regulation in treating gambling disorder (GD). Participants with psychiatric
      comorbidities will be included and symptoms of comorbidities will be measured as secondary
      outcomes.

      Once included in the study the participant will be measured weekly on symptoms of gambling
      disorder.

      By increasing competencies in emotion regulation (such as active problem solving, acceptance
      and reappraisal of events in order to change their emotional impact) the hypothesis is that
      the participants will improve on measures of symptoms of GD as well as gambling expenditure
      in terms of time and money.
    

Intervention name(s): CBT for problem gambling with emotion regulation
Intervention type(s): Behavioral
Intervention description(s): CBT group treatment for problem gambling with emotion regulation focus, with 8 sessions.
Intervention model: Single Group Assignment
Intervention model description: Open label pilot study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gambling disorder; psychiatric comorbidities; emotion regulation
High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone
Condition: HDL Cholesterol
Study type: Interventional
Phase: Phase 4

Summary: 
      Tibolone (Livial) has been shown in previous studies to lower HDL cholesterol by up to 40%.

      This study aims to study the effects of fenofibrate on HDL and subfractions in women taking
      tibolone.
    

Detailed description: 
      Tibolone decreases plasma concentrations of HDL cholesterol and HDL-apoA1 and pre-beta HDL,
      consistent with a pro-atherogenic effect. The mechanism of tibolone on HDL cholesterol has
      been suggested to result from an acceleration of the catabolism of HDL by stimulation of
      hepatic lipase with no effect on cellular cholesterol efflux.

      PPAR-a agonists, in particular fenofibrate, improve HDL metabolism by increasing the
      expression and hepatic secretion of HDL apoAI and apoAII.

      We hypothesise that fenofibrate will rectify the perturbations on HDL metabolism wrought by
      tibolone.
    

Intervention name(s): fenofibrate and tibolone; tibolone
Intervention type(s): Drug; Drug
Intervention description(s): fenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks; tibolone 2.5 mg daily 23 weeks
Other intervention name(s): Lipidil; Livial; Livial
Intervention MeSH terms: Tibolone; Fenofibrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Menopause; menopausal symptoms; tibolone; HDL-C; fenofibrate
Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ
Condition: Contraception; Ovulation Inhibition; Contraceptives, Oral
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the study drug is safe and effective.
    

Detailed description: 
      The primary efficacy parameter is the number of observed unintended pregnancy during 1 year
      of treatment. Secondary efficacy parameter include bleeding parameters and menstrual related
      symptoms Safety parameters included assessment of adverse events, laboratory evaluations.
    

Intervention name(s): EE20/DRSP (BAY86-5300); EE20/DRSP (BAY86-5300); EE20/DRSP (YAZ, BAY86-5300)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone; Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone; Fixed package per cycle containing combination tablets containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone (24 per cycle) + tablets without active substance (4 per cycle)
Other intervention name(s): SH T00186D; SH T00186D; SH T00186D
Intervention MeSH terms: Drospirenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Oral Contraception; Birth Control pill; Healthy women requesting oral contraception; Contraceptive efficacy
MEDAM (Menopur Retrospective Data prograM)
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      French, non-interventional, retrospective, multicentric analysis of patients who have
      undergone a controlled ovarian stimulation (COS) for in-vitro fertilization (IVF)/
      intracytoplasmic sperm injection (ICSI). The main objective is to determine the cumulative
      live birth rate with highly purified menotropin (HP-hMG) which is defined as the occurrence
      of live birth per started COS, further to transfer of fresh and frozen embryos generated from
      the same COS.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): All directions for medication usage were solely at the discretion of the investigator in accordance with their usual routine clinical practice and are assumed to be consistent with the national prescribing information of the medicinal product in the country in which the study will take place.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult women, fitting the inclusion/exclusion criteria, who were prescribed Menotropin
        during 2009 to 2016 for COS in a treatment of infertility will be included in this study.
      
Keywords: Menotropin; HP-hMG
Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to test the effectiveness of two different weight loss diets on
      obstructive sleep apnea (OSA) severity.
    

Detailed description: 
      Sleep apnea is a sleep disorder in which breathing repeatedly stops and starts during sleep.
      The most common type is obstructive sleep apnea (OSA), which occurs when the muscles in your
      throat relax and block your airway during sleep. The most noticeable sign of OSA is snoring.
      OSA is a risk factor for other chronic conditions like type 2 diabetes, cardiovascular
      disease, and high blood pressure.

      Although anyone can develop OSA, it commonly affects people who are obese. The more someone
      weighs, the more likely the OSA is to be severe. Weight loss is typically recommended for
      overweight individuals to help improve OSA. However, not enough research has been done for
      doctors to be able make specific recommendations to their patients.
    

Intervention name(s): Low Calorie Diet; Very Low Calorie Diet; Standard Care
Intervention type(s): Other; Other; Other
Intervention description(s): Weight management program designed around a low calorie diet.; Weight management program designed around a very low calorie diet.; Care provided that would normally be given to people meeting eligibility criteria for this study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the amount of tirzepatide that gets into the blood
      stream and how long it takes the body to get rid of it, when given as a solution formulation
      via an autoinjector versus a conventional prefilled syringe. The tolerability of tirzepatide
      will also be evaluated and information about any adverse effects experienced will be
      collected.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the total duration of the clinical trial will be about 14 weeks, including screening.
    


Intervention name(s): Tirzepatide; Prefilled syringe (PFS); Auto-injector (AI)
Intervention type(s): Drug; Device; Device
Intervention description(s): Administered SC; PFS used to administer tirzepatide; AI used to administer tirzepatide
Other intervention name(s): LY3298176
Intervention MeSH terms: Tirzepatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effectiveness of Dance Therapy in Fibromyalgia.
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to analyze the effects of an intervention with dance on
      balance,movility, pain and sleep in patients with Fibromyalgia in comparison to a control
      group that will have an educational intervention.
    

Detailed description: 
      Fibromyalgia is a chronic disease consisting of widespread pain, fatigue, sleep disturbances,
      and cognitive impairments, among other symptoms, which affect daily physical activity.

      The regular physical exercise improves the functional, physiological, and behavioral
      components of physical fitness. Dance therapy seems to increase motivation and adherence to
      therapy, and can provide a real alternative to conventional exercise

      The experimental group will receive a dance program treatment .

      The control group will receive an educational intervention.
    

Intervention name(s): Dance therapy; Educational group
Intervention type(s): Other; Other
Intervention description(s): The experimental group will receive a dance treatment.This protocol will be administered at weekly sessions of 60 minutes with a period of 2 times / week with a total of 16 sessions, distributed over a 8-week period. They will be evaluated at baseline, after the end of the last treatment session.; The control group will receive an educational intervention. They will be evaluated at baseline, after the end of the last treatment session.
Other intervention name(s): Exercise treatment; Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Balance; Pain; TUG; Dance
Investigation the Effects of Stabilization Exercises on Pain, Disability and Activity of Pelvic Floor Muscles in Patients With Postpartum Lumbopelvic Pain
Condition: Postpartum Lumbopelvic Pain
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the effects of stabilization exercises on pain,
      disability and pelvic floor muscles function in patients with lumbopelvic pain.
    

Detailed description: 
      Pregnancy is a specific experience that leads to several physical changes in women's body and
      influence most aspects of their lives. Pregnancy and delivery can cause serious complications
      such as urinary incontinence, pelvic organ prolapse, fecal incontinence, and low back pain
      (LBP) that have negative effects on women's sexual, physical, social and psychological
      health.

      Based on Wu et al. systematic review, prevalence of pregnancy related low back pain (PLBP)
      during pregnancy and postpartum is 45% and 25% respectively.

      LBP is one of the most current causes of disability and sick leave after delivery.Abnormal
      load transfer in the lumbopelvic region has been considered as one possible explanation to
      lumbopelvic pain.The local stabilizing muscles, i.e. the transversely oriented abdominal,
      diaphragm, the lumbar MF and the PFM Play an important role in load transfer in the
      lumbopelvic region.so, we considered that an exercise program that addresses muscular
      dysfunction, such as lumbar stabilization exercise can improve motor pattern of local
      stabilizing muscles and can use in management of postpartum lumbopelvic pain.
    

Intervention name(s): Stabilization exercise; Control group
Intervention type(s): Other; Other
Intervention description(s): 18 sessions during 6 consecutive weeks, three times per week, 30 or 40 minutes per session including: Twenty minutes for receiving hot pack and TENS and 10 or 20 minutes for training the exercises in 7 level : 1.Train the specific contraction of the deep abdominal muscles, multifidus and pelvic floor muscles(PFM). 2.Train the specific contraction of deep abdominal muscles with coactivation of multifidus and PFM in supine, prone, sitting, standing and quadruped position. 3. Segmental control exercises in close kinematic chain. 4. Segmental control exercises in open kinematic chain with limb loading, emphasis on abdominal muscles. 5. Segmental control exercises in open kinematic chain with limb loading, emphasis on back extensor muscles. 6. Progress exercises to functional task. 7. Coactivation of abdominal and multifidus muscles with limb loading in aerobic tasks.; 8 sessions during 6 consecutive weeks, three times per week, per session including: Twenty minutes for receiving hot pack and TENS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pregnancy; pelvic floor muscles; Lumbo-pelvic pain; Stabilization exercises; abdominal muscles thickness; Multifidus muscles thickness; Multifidus muscles cross section area
Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to investigate the effects of taking repeated doses of AZD6280 on
      the blood levels of midazolam and caffeine in healthy volunteers
    


Intervention name(s): AZD6280; Midazolam; Caffeine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral; oral; oral
Intervention MeSH terms: Midazolam; Caffeine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Phase I
Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery
Condition: Irritant Contact Dermatitis
MeSH terms: Dermatitis; Dermatitis, Contact; Dermatitis, Irritant
Study type: Interventional

Summary: 
      Irritant contact dermatitis induced by sodium lauryl sulphate (SLS) is often used as a model
      for testing efficacy of various topical preparations. Aforementioned model is standardized
      and described in guidelines, but it is not explicitly stated where the irritation should be
      induced. Published clinical trials usually irritate volar aspect of forearms or upper back.
      Also, lower back and dorsal aspect of forearm are sometimes used.

      Skin parameters vary depending on anatomic location of measured skin. There is a difference
      in stratum corneum thickness, hydration and transepidermal water loss across different
      locations, including between volar forearm and upper back.

      Furthermore, regional difference in skin response to irritation by tape stripping and
      benzalkonium chloride were observed. Such differences are also possible in SLS irritation
      model. One study has shown higher, but not statistically significant, response of back in
      comparison to forearms, but it had a very small sample size (n=9).

      Moreover, there are regional variations of topical preparations absorption. Hydrocortisone
      had 1,7 times higher absorption when applied to upper back in comparison to forearms. Those
      variations could be explained by different corneocyte size and number of their layers between
      back and hands.

      Skin baseline properties and response to irritation seem to be dependent on anatomic
      position. Those differences could mean different response to treatment. Since published
      trials only tested efficacy of various preparations on one anatomic location, it is possible
      their results would be different if tested on other body parts. It could limit validity and
      usefulness of conducted trials. The aim of this study is to determine if there are regional
      differences of skin response to irritation and emollient cream treatment in irritant contact
      dermatitis model.
    


Intervention name(s): Sodium lauryl sulphate induced irritation; Emollient, moisturizing cream
Intervention type(s): Procedure; Other
Intervention description(s): Sodium lauryl sulphate will be applied to specified skin sites according to randomization protocol to induce irritation. 60 uL of 2% w/v SLS will be applied to skin under occlusion by large Finn chamber for 24 hours as described in the guidelines by Standardization group of European Society of Contact Dermatitis.; Commercially available topical emollient cream will be applied by each participant to treatment sites according to randomization protocol.
Intervention MeSH terms: Emollients
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: irritant contact dermatitis; sodium lauryl sulphate; emollients; transepidermal water loss