bioihbjkbjnl/mcl2 huggingface dataset:
Attachment and Biobehavioral Catch-up for Depression
Condition: Depressive Symptoms; Anxiety Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      The overarching goal is to pilot the Attachment and Biobehavioral Catch-up (ABC) intervention
      for mothers with heightened depressive symptom and their children with heightened
      internalizing symptoms.
    

Detailed description: 
      Exposure to maternal depressive symptoms increases children's risk for developing anxiety and
      depressive symptoms ("internalizing symptoms"). Maternal depressive symptoms and children's
      internalizing symptoms may be reciprocally related over time. Optimal interventions for
      children's internalizing symptoms may involve treatment components for mothers, children, and
      the maternal-child relationship. The Attachment and Biobehavioral Catch-up (ABC) intervention
      is a empirically-supported, family-based treatment program that has been shown to be
      beneficial for children in varied high-risk family environments, but has yet to be tested
      among mothers and children recruited on the basis of heightened depressive and internalizing
      symptoms, respectively. The overarching goal is to examine the acceptability, feasibility,
      and preliminary effects of the ABC program on a sample of mother-child dyads (n = 20) with
      heightened depressive and internalizing symptoms. Our specific aims are:

        1. To evaluate the feasibility and acceptability of ABC for mothers with depressive
           symptoms and their offspring with internalizing symptoms

        2. To explore whether children who receive ABC show improvement in internalizing symptoms
           from pre- to post-intervention

        3. To explore whether mothers who receive ABC show improvement in depressive symptoms from
           pre- to post-intervention

        4. To explore whether parents and children who receive ABC show more adaptive physiological
           responses to stress from pre- to post-intervention
    

Intervention name(s): Attachment and Biobehavioral Catch-up (ABC) Intervention
Intervention type(s): Behavioral
Intervention description(s): ABC is a 10 session, home-based, dyadic therapy that is delivered by a trained professional. The sessions focus on improving the parent-child relationship and children's biological and behavioral responses to stress.
Other intervention name(s): ABC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Comprehensive Rehabilitation at Beitostølen Healthsports Centre
Condition: Physically Disabled
Study type: Interventional

Summary: 
      The main hypothesis:

      The participants receive treatment at Beitostølen within 8 weeks or within 16 weeks. The
      groups waiting for rehabilitation is compared with the group receiving rehabilitation
    

Detailed description: 
      nn
    

Intervention name(s): Physical activity
Intervention type(s): Behavioral
Intervention description(s): Swimming, physiotherapy, water therapy, alpine skiing, xc-skiing, hippotherapy, climbing, cycling, rowing
Other intervention name(s): Exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: physical disabilities; rehabilitation
A Multiple Dose Study of LY3023703 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study of LY3023703 in healthy participants. The purposes of this study are to look
      at safety, how well the study drug is tolerated, how much of the study drug gets into the
      blood stream and how long it takes the body to remove the study drug. The effects of
      LY3023703 on blood pressure after 28 days of dosing will be studied. Information about any
      side effects that occur will be collected. The study is expected to last 21 weeks.
    


Intervention name(s): Placebo; LY3023703; Celecoxib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing
Condition: Atherosclerosis; Vascular Disease; Cognitive Decline; Hearing Loss; Inflammation; Age-Related Memory Disorder
MeSH terms: Hearing Loss; Memory Disorders; Atherosclerosis; Vascular Diseases; Inflammation; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to determine if folic acid supplementation can slow down
      atherosclerotic progression, age-related cognitive decline and age-related hearing loss.
    

Detailed description: 
      Low levels of B vitamins, in particular folate, and high levels of plasma total homocysteine,
      have been associated with a variety of age-related diseases and disorders, including
      cardiovascular disease, dementia and hearing impairment. Extra folate, for example in the
      form of folic acid, is known to decrease the concentrations of plasma total homocysteine.

      We examined whether 0.8 mg/d folic acid could slow down atherosclerotic progression and the
      above mentioned age-related processes.
    

Intervention name(s): folic acid (0.8 mg)
Intervention type(s): Behavioral
Intervention MeSH terms: Folic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Folic acid; Atherosclerosis; Cognitive function; Hearing; Inflammation; Hemostasis; Arterial stiffness
Effect of Liraglutide on Glucagon Secretion in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to examine the effect of NNC
      90-1170 on the hypoglycaemic counterregulation in subjects with type 2 diabetes.
    


Intervention name(s): liraglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 7.5 mcg/kg, injected subcutaneously followed by a hypoglycaemic clamp by concentration measurement; Single dose injected subcutaneously followed by a hypoglycaemic clamp by concentration measurement
Other intervention name(s): NNC 90-1170
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Ulnar Nerve Entrapment Localization on Ipsilateral Upper Extremity Functions. The Effect of Ulnar Nerve Entrapment Localization on Ipsilateral Upper Extremity Functions. The Effect of Ulnar Nerve Entrapment Localization on Ipsilateral Upper Extremity Functions.
Condition: Ulnar Neuropathies
MeSH terms: Nerve Compression Syndromes; Ulnar Neuropathies; Ulnar Nerve Compression Syndromes
Study type: Interventional

Summary: 
      Regardless of the cause of ulnar nerve entrapment neuropathy, investigators are planning to
      explore the relationship between the ipsilateral upper extremity dysfunction that may develop
      due to ulnar neuropathy and the level of entrapment in electromyelography.
    


Intervention name(s): EMG
Intervention type(s): Diagnostic Test
Intervention description(s): Electromyelography
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
GH and Cardiovascular Risk Factors
Condition: Growth Hormone Deficiency; Cardiovascular Diseases; Metabolic Syndrome; Cognition; Physical Activity
MeSH terms: Dwarfism, Pituitary; Cardiovascular Diseases; Metabolic Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Rationale: Abnormally low and high levels of insulin-like growth factor-I (IGF-I) are both
      associated with increased metabolic risk. Since (U-shaped) associations of IGF-I, within the
      normal range, have also been found with cardiovascular risk factors and disease in the
      general population, it would be interesting to investigate if this association can also be
      found in growth hormone deficient (GHD) adults treated with Growth Hormone (GH). This could
      be of interest for endocrinologists prescribing GH in clinical practice because strict dosing
      may become even more important. Next to that, scientific evidence for clinical practice is
      wanted.

      Objective: Next to cardiovascular risk factors (main objectives: body composition and lipid
      profile; secondary objectives: remainder) we investigate the effect on glucose metabolism,
      physical performance, and neuropsychological functioning of different levels of IGF-I in GH
      treated GHD men and women.

      Study design: Open-label randomized trial.

      Study population: At least 32 subjects, both childhood as adult onset GHD men and women,
      receiving GH treatment for at least one year, with an age between 20 and 65 years.

      Intervention: At entry subjects are already receiving GH treatment according to general
      clinical practice, and are expected to demonstrate an IGF-I concentration of 0 - 1 SD score
      (SDS) (normal dose). The group of men and group of women will be randomized to receive either
      a decrease of their regular dose of GH treatment (IGF-I target level of -2 - -1 SDS) (low
      dose), or an increase of their regular dose, (IGF-I target level of 1 - 2 SDS) (high dose)
      for at least 24 weeks.
    


Intervention name(s): Change in daily dosage of Growth Hormone
Intervention type(s): Drug
Other intervention name(s): Change in daily dosage of Somatropin
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Investigate Multiple Ascending Oral Doses of AZD5213 in Healthy Male and Non Fertile Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      1. The main purpose of this study is to assess the safety and tolerability of AZD5213 after
           multiple oral doses.

        2. Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how
           the study drug enters and leaves your body and how your body acts on the study drug) of
           AZD5213 in your blood and urine.
    


Intervention name(s): AZD5213; Placebo to AZD5213
Intervention type(s): Drug; Drug
Intervention description(s): oral solution, multiple ascending doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: AZD5213 Phase 1; Safety; tolerability
Chinese Medicine WT for Spinocerebellar Ataxia Type 3
Condition: Ataxia, Spinocerebellar; Insulin-Like Growth Factor I; Medicine, Chinese Traditional
MeSH terms: Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations; Machado-Joseph Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Spinocerebellar ataxia type 3 (SCA3) is one of autosomal dominant hereditary ataxias.
      Standing imbalance, unsteady gait, dysmetria, fatigue, and depression would occur gradually.
      There are no effective treatment or palliative methods for patients in the present days.
      However, low-dose growth hormone, or its downstream product, insulin-like growth factor I
      (IGF-1), may deter the progress of SCA3 in transgenic mice. The main bioactive constituent
      among the Chinese medicine WT possesses neuroprotective function against glutamate-induced
      toxicity, which is one major pathology of SCA3. It promotes neurogenesis, and increases the
      protein expression of IGF-1 in ischemic brains of rats. Thus, we designed a randomized,
      double-blind trial for patients with SCA3, if WT is a possible neuroprotective medicine.

      All the subjects will be recruited from Changhua Christian Hospital. Diagnosis is confirmed
      by gene test and magnetic resonance image by a neurologist. They will be assigned in random
      and double blind, prescribed with 3 grams concentrated powder of WT or placebo, twice a day,
      for 12 weeks. After the washout period of 4 weeks, there will be a crossover of placebo or WT
      for another 12 weeks. After that, another 4-week rest will be followed by the end of trial.
      Check items in five check points include: 1. Blood examination (serum IGF-1, Neurofilament
      light chain, mitochondria copy number, 8_OHdG, delta-Ct), 2.Neurological exam (Scale for the
      Assessment and Rating of Ataxia), 3. Questionnaires (Modified Fatigue Impact Scale, Epworth
      Sleepiness Scale), 4. Handgrip strength test (which is correlated to IGF-1 value in elderly),
      and 5. serum metabolites, . All the data will be disclosed after the end of trial. Paired-T
      test or Wilcoxon Ranked Sign Test will be operated in SPSS.
    


Intervention name(s): Chinese medicine WT
Intervention type(s): Drug
Intervention description(s): The Chinese medicine WT is thought to be neurotrophic, and its major constituent may benefit IGF-1 in animal studies, or certain healthy human group. WT is safe in clinical use in Asia.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Assess Safety, Tolerability and Phamacokinetics of KAE609 Administered Intravenously in Healthy Subjects
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a randomized, subject and investigator-blinded, placebo-controlled, single and
      multiple ascending intravenous (iv) dose study in healthy subjects to assess the safety and
      tolerability of KAE609 given in the vein.
    

Detailed description: 
      The study consisted of 2 parts: single-ascending dose (SAD) part and multiple ascending dose
      (MAD) part.

      In Part A (Single-ascending dose (SAD) part), it was planned to recruit 6 active, 2 placebo
      subjects in each cohort:

        -  Cohort A1: 10.5 mg/placebo

        -  Cohort A2: 30 mg/placebo

        -  Cohort A3: 75 mg/placebo

        -  Cohort A4: 120 mg/placebo

        -  Cohort A5: 210 mg/placebo

      In Part B (Multiple-ascending dose (MAD) part), Subjects were assigned to one of the
      following treatment arms in a ratio of 2:1 (6 active, 3 placebo):

        -  Cohort B1: 60 mg/placebo, every 24 hours (q24h) × 5 days

        -  Cohort B2: 120 mg/placebo, every 24 hours (q24h) × 5 days

      Eligible subjects were randomized to receive a single or q24h x 5 doses of either KAE609 or
      placebo. Safety, tolerability and pharmacokinetics were assessed over the period of 8 days
      for single dose and 12 days for multiple dose up to end of study visit for each subject.
    

Intervention name(s): KAE609; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): iv bolus administration over approximately 2 min for doses < 75 mg (Cohorts A1, A2 and B1)
iv infusion over approximately 10 min for doses ≥ 75 mg (Cohorts A3, A4, A5 and B2); matching placeo for iv administration
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: safety; tolerability; pharmacokinetics; healthy volunteers; phase 1; malaria; intravenous; iv; KAE609; Placebo
Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease
Condition: Hypercholesteremia
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to evaluate that 76 weeks of treatment with
      rosuvastatin calcium 2.5-20 mg results in no progression of coronary artery atherosclerotic
      volume as measured by intravascular ultrasonography (IVUS) imaging in hypercholesterolaemic
      subjects with coronary heart disease (CHD).
    


Intervention name(s): Rosuvastatin; HMG CoA inhibitor
Intervention type(s): Drug; Drug
Intervention description(s): 2.5-20 mg; 3-hydroxy-3-methylglutaryl-coenzyme A
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
"Overlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Identification With Antibiotics in Children"
Condition: Primary Sclerosing Cholangitis; Autoimmune Hepatitis; Overlap Syndrome
MeSH terms: Cholangitis; Cholangitis, Sclerosing; Hepatitis, Autoimmune; Undifferentiated Connective Tissue Diseases; Syndrome
Study type: Interventional

Summary: 
      Based upon the possible implication of microbiota and abnormal microbial metabolites such as
      altered bile acids, in the pathogenesis of PSC, emerging data suggests that oral antibiotics,
      such as vancomycin and metronidazole, may have therapeutic effects in this overlap syndrome
      or PSC.

      The goal of our study is to evaluate role of antibiotics and microflora in children with
      AIH/PSC overlap syndrome or with PSC alone. The investigators hope to learn what effects oral
      antibiotics has on the bacteria present in stool, and hope to learn to characterize human
      intestinal microbial communities, in children suffering from overlap syndrome or PSC.

      The hypothesis of the investigators is that overlap syndrome and PSC develop due to altered
      microflora and the resulting abnormal bile acids pool. The outcome of overlap syndrome or PSC
      could be affected by presence or absence of RCUH. Antibiotics to correct the microflora may
      result in disease/cholangiopathy remission.
    

Detailed description: 
      The used antibiotic is Metronidazole (Flagyl), during 14 days, as induction therapy or rescue
      therapy.

      Study participants will provide blood and stool samples in order to evaluate bile acids
      profile and microbiome, before and after the course of metronidazole, and then comparison
      will be made pre- and post-antibiotics.

      The investigators will determine the benefit of oral metronidazole therapy through
      improvement of clinical symptoms and improvement of liver function tests.
    

Intervention name(s): Metronidazole
Intervention type(s): Drug
Intervention description(s): Flagyl x 14 days.
Other intervention name(s): Flagyl
Intervention MeSH terms: Metronidazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Asthmatics who are significantly overweight tend to have more severe symptoms, more flare
      ups, and are more likely to have poorly-controlled asthma when compared to other asthmatics.

      Researchers believe this occurs because excess adipose tissue (fat) in the body can cause
      higher-than-normal levels of leptin and lower-than-normal levels of adiponectin in the blood.

      The researchers of this study are testing a medication called pioglitazone in overweight
      asthmatics because they believe it can help regulate leptin and adiponectin and that this may
      improve symptoms of asthma.
    

Detailed description: 
      Participants in this study will be randomly assigned (like the flip of a coin) to
      pioglitazone or a placebo (an inactive pill). They will be given study medication to take
      everyday for 12 weeks (3 months).

      Participants will complete a number of asthma-related questionnaires and a variety of
      pulmonary function tests. Participants will undergo physical exams, an electrocardiogram, and
      blood sampling to measure leptin, adiponectin, markers of inflammation, blood cell counts,
      glucose levels, BNP hormone levels, and liver function.

      To monitor participants throughout the study, follow-up visits will be done at 2, 6, and 12
      weeks after starting study drug. At these visits many of the pulmonary function tests and
      questionnaires will be repeated.
    

Intervention name(s): pioglitazone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months); matching placebo (inert tablet)
Other intervention name(s): Actos
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; obesity; exacerbation; asthmatics; fat; overweight; adipose tissue; leptin; adiponectin; pioglitazone; Actos; wheezing; Pittsburgh; Pennsylvania; pulmonary; lung
Crutch Use After Arthroscopic Hip Surgery
Condition: Hip Fractures; Hip Injuries
MeSH terms: Hip Fractures; Hip Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether crutch use for 4 weeks following hip
      arthroscopic surgery is superior to crutch use for 2 weeks following hip arthroscopic
      surgery. The primary objective of the study is to compare PRO scores between patients who
      have used crutches for 2 weeks and patients who have used crutches for 4 weeks.
    

Detailed description: 
      This will be a single-center, randomized prospective study. The study will compare
      post-operative patient reported outcome (PRO) scores including the modified Harris hip score
      (mHHS) and the non arthritic hip score (NAHS), both are externally-validated surveys for hip
      function. One cohort will be assigned a rehabilitation regimen that includes 2 weeks of
      partial weight bearing on crutches, and the other will be assigned a regimen of 4 weeks of
      partial weight.
    

Intervention name(s): 2 weeks of partial weight bearing on crutches; 4 weeks of partial weight bearing on crutches
Intervention type(s): Other; Other
Intervention description(s): Following surgery, patients will be instructed by their surgeon to use crutches for 2 weeks, and will follow-up normally, as any patient would. Their crutch use will not impact the quality or style of their postoperative care in any manner. At their 6-week, 6-month, 12-month, and 24 months postoperative visit, the mHHS and NAHS scores will be collected and stored in a secure data system, REDCAPS.; Following surgery, patients will be instructed by their surgeon to use crutches for 4 weeks, and will follow-up normally, as any patient would. Their crutch use will not impact the quality or style of their postoperative care in any manner. At their 6-week, 6-month, 12-month, and 24 months postoperative visit, the mHHS and NAHS scores will be collected and stored in a secure data system, REDCAPS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Arthroscopic hip surgery