bioihbjkbjnl/mcl2 huggingface dataset:
Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the present study is to establish the safety and efficacy of Prochymal®
      following first acute myocardial infarction.
    

Detailed description: 
      The standard of care treatment for acute myocardial infarction (AMI) usually includes
      immediate perfusion, optimal pain relief, oxygen, aspirin or other anti-coagulants,
      Beta-Blockers, nitrates and Ace-inhibitors. However, because salvaging the viable myocardium
      is dependent on early reperfusion, only a minority of participants will reach the hospital
      within the time-window for myocardial rescue. Thus, even if the participant manages their
      tobacco use, hypertension, lipid levels, diabetes, weight and exercise, many participants
      will go on to develop Congestive Heart Failure (CHF). Though the medical management for CHF
      may improve symptoms and slow disease progression, such treatment cannot restore a
      functioning myocardium. A therapy that could improve the myocardial remodeling process and
      reduce the incidence or severity of CHF following acute MI would provide a significant
      benefit. The characteristics and biologic activity of Prochymal®, along with a good safety
      profile in human trials to date, suggest that Prochymal® may be a good candidate for
      addressing this unmet medical need.
    

Intervention name(s): Prochymal®; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells; Intravenous infusion of excipients of Prochymal®
Other intervention name(s): Remestemcel-L
Intervention MeSH terms: Remestemcel-l
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute myocardial infarction; AMI; Myocardial infarction; Heart attack; Mesenchymal stem cells; MSC; Adult human stem cells; Osiris
Evalutation of Insulin Sensitivity Through Hyperinsulinemic Clamp in Children With GH Deficiency
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Insulin Resistance
Study type: Interventional

Summary: 
      Data about the impact of growth hormone treatment on insulin sensitivity in children are
      quite controversial, due to the different surrogate indexes that have been used, like
      Homa-IR, QUICKI, ISI-Matsuda or adipokine levels.

      The investigators aimed to evaluate insulin sensitivity through the euglycemic
      hyperinsulinemic clamp, considered the gold standard technique, in children affected by
      growth hormone deficiency and to compare the M-value with the most commonly used surrogate
      indexes of insulin sensitivity.
    

Detailed description: 
      The investigators aimed of this study was to use the hyperinsulinemic clamp to evaluate the
      impact of GH treatment on insulin-stimulated glucose utilization (M-value) in a group of
      children affected by GH deficiency and to compare the clamp-derived index with the most
      commonly used surrogate indexes of insulin sensitivity.

      In all patients the auxological and metabolic evaluation was performed at baseline and after
      12 months of GH treatment, while in controls these evaluations were only performed at
      baseline. In all children the investigators measured body height, body mass index (BMI) and
      waist circumference (WC). A blood sample was drawn after an overnight fast for the
      measurement of glucose, insulin, Hemoglobin A1c (HbA1c) and IGF-I. This sample served as the
      baseline for the oral glucose tolerance test (OGTT). Blood samples were collected every 30
      min for 120 min for glucose and insulin measurements. As surrogate estimates of insulin
      sensitivity the investigators used the insulin sensitivity index, a composite index derived
      from the OGTT and validated by Matsuda and DeFronzo (ISI-Matsuda). On a different day, as a
      gold standard measurement of insulin sensitivity the investigators performed the euglycemic
      hyperinsulinemic clamp. As other insulin sensitivity markers, the serum levels of adiponectin
      and resistin after an overnight fast were also measured.
    

Intervention name(s): euglycemic hyperinsulinemic clamp
Intervention type(s): Diagnostic Test
Intervention description(s): In addition to auxological and baseline biochemical parameters, we performed the clamp to evaluate insulin sensitivity (M-value) at baseline (GHD group and controls) and after 12 months of GH treatment (GHD group).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: We prospectively studied 23 prepubertal children with GH deficiency treated with GH for at least 12 months and 12 healthy subjects with short stature, matched for age and pubertal status
Masking: None (Open Label)
Primary purpose: Diagnostic
Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)
Condition: In Vitro Fertilization
Study type: Observational

Summary: 
      To collect the outcome of frozen-thawed embryo transfer cycles after the embryos are
      cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), in order to estimate the
      cumulative pregnancy rate for each treatment group.
    

Detailed description: 
      This is a follow-up protocol to collect the outcome of frozen-thawed embryo transfer cycles,
      performed after the embryos are cryopreserved up to at least 1 year in Trial P05787
      (NCT00696800), to enable estimation of the cumulative pregnancy rate for each treatment
      group.
    

Intervention name(s): 150 µg Corifollitropin Alfa; 200 IU RecFSH/Follitropin beta (Days 1 to 7); Placebo for Corifollitropin Alfa; Placebo for RecFSH/Follitropin beta; 200 IU RecFSH/Follitropin beta (Days 8 to hCG); Ganirelix; hCG; Progesterone
Intervention type(s): Drug; Biological; Drug; Drug; Biological; Drug; Biological; Biological
Intervention description(s): On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.; Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.; Pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.; Identical ready-for-use solution, but without the active ingredient, supplied in cartridges for SC injection with the Follistim Pen. Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.; From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.; On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG; When 3 follicles >= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP; On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.
Intervention MeSH terms: Progesterone; Follicle Stimulating Hormone; Ganirelix
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women from whom embryos have been cryopreserved in Base Trial P05787 (NCT00696800).
      
Keywords: In-vitro fertilization; Controlled Ovarian Stimulation; Cumulative pregnancy data; Follow-up
Upper Limb Evaluation in Non Ambulatory Patients With Neuromuscular Disorder
Condition: Neuromuscular Disorders
MeSH terms: Neuromuscular Diseases
Study type: Interventional

Summary: 
      The aim of this study is to evaluate different devices to quantify upper limb function
      (Motriplate) and strength (Myogrip, Myopinch) in non-ambulatory patients with neuromuscular
      disorder. Motriplate measures the ability of the patient to reproduce a repetitive movement
      of the wrist to push two 5cm*5cm targets during 30 seconds. One hundred patients aged 8-30
      years and 60 controls will be evaluated during twelve months (M0, M6 and M12) with theses new
      tools, and results will be compared to other testing, such as wrist, grip and pinch strength,
      taping, MFM measurement, and self evaluation of hand ability.
    


Intervention name(s): Motriplate; Motriplate
Intervention type(s): Device; Device
Intervention description(s): Number of contact couples; Number of contact couples
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Neuromuscular disorders; Evaluation; Strength; Upper limb
Prediction of Fetal Lung Maturity
Condition: Fetal Distress
MeSH terms: Fetal Distress
Study type: Interventional

Summary: 
      Diabetes is the most common medical complication of pregnancy in the united states four to
      five percent of pregnancies are complicated by diabetes.

      Pregestational diabetes (diabetes diagnosed before pregnancy, type 1 or type 2 diabetes
      mellitus) comprises approximately 13 percent of all diabetes in pregnancy, while gestational
      diabetes ( diabetes with onset or first recognition in pregnancy) comprises the remaining 87
      percent . The prevalence of pregestational diabetes has been increasing due to the increasing
      prevalence of type 2 diabetes in women of reproductive age . The mainstay of the medical
      management of pregestational diabetes involves frequent monitoring of blood glucose levels
      with adjustment of diet and insulin therapy to achieve normoglycemia. Normoglycemia is
      important because maintenance of maternal blood glucose concentration at or near
      normoglycemic levels decreases the likelihood of adverse pregnancy outcomes, such as
      miscarriage , congenital anomalies , macrosomia and fetal death.
    


Intervention name(s): fetal lung volume; pulmonary artery resistance index; Fetal adrenal gland volume:
Intervention type(s): Radiation; Radiation; Radiation
Intervention description(s): the best method for measurement of fetal lung volume is by the rotational technique in which each lung is obtained by serial contouring of the pulmonary area after rotating the volumetric image.this is more recent method seems to have advantages allowing finer contouring of the lung and subsequent modification of the contour as well as being better able to estimate the volumes of irregular and small lung as in congenital diaphragmatic hernia; Women placed in semirecumbent position and an axial plane through the fetal thorax to achieve 4 chamber view of the heart. The main pulmonary artery was followed to the point where it divides into right and left branches by rotating the transducer from the 4 chamber view to the short axis view of the heart. Pulsed and colour Doppler was used. The fetal pulmonary artery flow waveform measurements was taken within the proximal portion of the main pulmonary artery; the adrenal gland has a characteristic sonographic appearance; each limb is seen as a long anechoic structure with a thin, echogenic line within its center . Both limbs can sometimes be seen in the coronal plane, and if so there is a strong echogenic line between limbs (probably fat). On the basis of pathologic and histologic studies , we believe the anechoic bulk of the gland represents the fetal zone of the cortex, while the central echogenic core is the medulla.
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study to Assess the Pharmacokinetics (PK) and Safety of Staccato Alprazolam in Adolescent Study Participants With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the pharmacokinetics (PK), tolerability, and safety of
      Staccato alprazolam in adolescent study participants with epilepsy following single-dose
      administration.
    


Intervention name(s): Alprazolam
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: Inhalation powder.
Study participants will receive Staccato alprazolam at prespecified time-points.
Other intervention name(s): UCB7538
Intervention MeSH terms: Alprazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Epilepsy; Staccato alprazolam; Phase 1; Adolescents; STAP-001; Alprazolam
A Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of DBPR108 Tablets in Type 2 Diabetes Mellitus Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I study to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of single-dose and multiple-dose of DBPR108 tablets in Type 2 Diabetes
      Mellitus Patients.
    

Detailed description: 
      This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics
      characteristics, single-dose and multiple-dose of DBPR108 tablets in Chinese Type 2 Diabetes
      Mellitus Patients. The 30 eligible patients will be randomized to receive 50 mg, 100 mg, or
      200 mg DBPR108 tablets.
    

Intervention name(s): DBPR108 tablets
Intervention type(s): Drug
Intervention description(s): DBPR108 tablets, oral, once daily on Day 1 and Day 3-9 for a total of 8 doses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sub-study for the Validation and Calibration of Data Regarding Physical Activity, Anthropometry and Diet
Condition: Chronic Disease
MeSH terms: Chronic Disease
Study type: Observational

Summary: 
      This study was an update and amplification of exposure measurements of the EPIC-Potsdam
      Study, which started in 1994-1998.
    

Detailed description: 
      The sub-study was conducted in the German Institute of Human Nutrition according to an
      approved study protocol.

      The study program included comprehensive surveys on diet and lifestyle (smoking, physical
      activity, and anthropometry). The aim was to achieve repeated measurements in a sub-cohort of
      about 600 people to validate (measurement error correction) and calibrate (adjustment of
      insufficient data collected to the actual data location) existing baseline data in the entire
      cohort (EPIC-Potsdam cohort).

      To this end, within age groups and by gender, active EPIC participants were then randomly
      selected in the years 2009 to 2012 from the cohort, contacted and invited to re-visit the
      respective study center. 816 subjects were acquired for re-examination, participation rate
      was 56.4%.

      Each participant gave informed consent. The study protocol has been approved by the Ethics
      Committee of the Medical Association of the State of Brandenburg, Cottbus, on 18/12/2009.

      The information in this section are study hypothesis and contains no results or conclusions.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Participants of the EPIC-Potsdam cohort study were 35-64 years old at recruitment
        (1994-1998). For this study (re-examination 2010-2012), participants were 47-81 years old
        (mean age 65.5, were largely sedentary and with a mean BMI of 27.5 kg/m2). Participants
        were living in the state of Brandenburg or in Berlin, Germany.

        The information in this section are study hypothesis and contains no results or
        conclusions.
Program for Alleviating and Resolving Trauma and Stress 1
Condition: Post-traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This single-arm pilot study (Phase 1) will test the preliminary efficacy of a virtually
      delivered, live-online 16-week group model of Internal Family Systems (IFS) for individuals
      with PTSD, called the PARTS program, on PTSD symptoms measured by Clinician-Administered PTSD
      Scale (CAPS-5). In addition, feasibility, acceptability, and effects on self-report PTSD and
      disturbances of self-organization (DSO) will be secondary outcomes.
    

Detailed description: 
      The investigators will conduct a single-arm pilot study to test the preliminary efficacy of a
      virtually delivered, live-online 16-week group model of Internal Family Systems (IFS) for
      individuals with PTSD, called the PARTS program, on PTSD symptoms measured by
      Clinician-Administered PTSD Scale (CAPS-5).

      Secondary outcomes include feasibility and acceptability of the PARTS program measured by a
      Credibility/Expectancy Questionnaire (CEQ) and Treatment Satisfaction Questionnaire.
      Secondary clinical outcomes include the effects of the PARTS program on self-report PTSD and
      disturbances of self-organization (DSO). Exploratory aims of the study are to investigate the
      effects on emotion regulation (DERS), self-trauma fusion (iPRISM-trauma), disassociation
      (MDI), depression (CAT-DI), self-compassion (SCS-SF), perceived stress (PSS), mindfulness
      (TMS), and interception (MAIA-2). Additional exploratory outcomes include changes in outcome
      variables among PTSD subjects with baseline DSO and those without DSO as defined by the
      International Trauma Questionnaire (ITQ).
    

Intervention name(s): PARTS Program
Intervention type(s): Behavioral
Intervention description(s): The PARTS Program is a 16-week group intervention model, with 8 individual clinical sessions on a biweekly basis, developed to resolve and alleviate trauma and stress for individuals diagnosed with PTSD.
Intervention model: Single Group Assignment
Intervention model description: PARTS is a live-online group program intended to alleviate and resolve symptoms of stress and PTSD for patients in a community health care system.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PTSD; stress
Kefir and Metabolic Syndrome
Condition: Metabolic Syndrome; Obesity; Hypertension; Hyperlipidemias; Insulin Resistance
MeSH terms: Metabolic Syndrome; Insulin Resistance; Hyperlipidemias; Syndrome
Study type: Interventional

Summary: 
      Metabolic syndrome is a cluster of metabolic disorders which increases the risk for diabetes
      and cardiovascular disease. In recent years, research has shown that probiotics may have
      positive effects on metabolic syndrome components. Although several health-promoting effects
      of kefir, have been suggested, there is limited evidence for its potential effect on
      metabolic syndrome. Therefore, it is necessary to clarify the effects of kefir on metabolic
      disorders including obesity, dyslipidemia, diabetes, and hypertension. To address the
      research gap, this study aimed to investigate the effects of daily kefir consumption on
      metabolic syndrome components, inflammatory response and gut microbiota composition in adults
      with MetS. The study was planned as a randomized, controlled, parallel design and completed
      with a total of 62 individuals who were diagnosed with metabolic syndrome according to the
      International Diabetes Federation (IDF) criteria. Participants were randomized into two
      groups and received daily 180 ml of kefir (n=31) or milk (as control) (n=31) for 12 weeks.
      Participants were assessed at baseline, week 4, week 8, and week 12 and at all controls
      dietary records, anthropometric measurements, and blood samples were collected. At baseline
      and 12th-week fecal samples were also collected in order to analyze gut microbiota
      composition.
    


Intervention name(s): Kefir; Milk
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There were two experimental groups. The kefir group, that received orally kefir, and the control group received milk
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: probiotics; dairy products; kefir; gut microbiota
Effects of Plyometrics Versus Conventional Exercises on Speed, Strength, and Injury Prevention in Bowlers.
Condition: Sports Injury; Sports Physical Therapy
MeSH terms: Wounds and Injuries; Athletic Injuries
Study type: Interventional

Summary: 
      To compare the effects of upper body plyometric versus conventional exercises on speed,
      strength, and injury prevention in bowlers
    

Detailed description: 
      Bowling action is a highly skilled activity acquired over the year. A bowler needs speed and
      strength to challenge the batsman but the conventional protocols they follow for the speed
      and strength are not specific to their bowling actions. Bowling can result in different types
      of upper extremity injuries, such as rotator cuff sprains, impingement and stress fractures.
      There are many injury prevention programs such as electrostimulation training, resistance
      training, and plyometric training that can be used to treat upper limb injuries and improve
      maximal strength.

      Plyometric training can be done by overhead athletes to improve the effectiveness of throwing
      activity and to strengthen the rotator cuff muscles to prevent shoulder injury from overhead
      throwing activity.

      This study aims to evaluate the effectiveness of upper limb plyometric exercises on speed,
      strength and injury prevention in comparison with conventional exercises.
    

Intervention name(s): PLYOMETRIC EXERCISE PROGRAM; CONVENTIONAL EXERCISE PROGRAM
Intervention type(s): Other; Other
Intervention description(s): This group will perform following exercises in first four weeks. Reverse overhead throw Rotational wall throws Overhead medicine ball Chest passes Resistance tubing 90-90 external rotation
Frequency
Rest between Exercises-: 60-120 Seconds
Rest between Set of Exercise-: 45-60 Seconds after four weeks rest between exercise and rest between set of exercise will be reduced:
Rest between Exercises-: 45-60 Seconds
Rest between Set of Exercise-: 20-30 Seconds
Tools used:
Medicine Ball, Resistance band; This group will perform following exercise through out the session with different frequencies after 4 weeks Bench presses Triceps kickbacks bicep curls Overhead presses Push-ups
Frequency:
Rest between Exercises-: 60-120 Seconds Rest between Set of Exercise-: 45-60 Seconds
After 4 weeks the frequency will be:
Rest between Exercises-: 45-60 Seconds Rest between Set of Exercise-: 20-30 Seconds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention