bioihbjkbjnl/mcl2 huggingface dataset:
Treatment for Depressed Preadolescent Girls
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the effectiveness of three therapies for the treatment of depression
      in preadolescent girls.
    

Detailed description: 
      Depressive disorders during childhood are virulent, long-lasting disorders that are a risk
      factor for the development of future depressive episodes and other psychiatric difficulties.
      A dysfunctional family environment is a possible pathway to the development of depression in
      adolescents. The family environment is an especially salient context for the development of
      depression in preadolescent girls.

      Depression is expressed differently between male and female adolescents; girls may not
      benefit as much as boys from treatments such as cognitive behavioral therapy (CBT) because
      the treatments may not target disturbances and skills that are specific to preadolescent
      girls. This study will identify effective treatments for depression in preadolescent girls.

      Depressed participants are randomly assigned to receive CBT, CBT plus parent training (PT),
      or a minimal contact control (MCC). The CBT group receives treatment twice a week for 10
      weeks. Participants in the CBT plus PT group receive therapy sessions and group treatment for
      10 weeks. Participants in the MCC group meet with a research associate once a week for 10
      weeks. During the control visits, the child's depressive symptoms are assessed, but no advice
      or treatment is given. Participants are assessed at baseline, post-treatment, and at yearly
      follow-up visits for up to 4 years. School performance, home environment, and the impact of
      the interventions on parent adjustment are evaluated.
    

Intervention name(s): Cognitive Behavior Therapy Child Only; CBT plus Parent Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief.; Participants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief. Parents learned skills that helped their child to apply the strategies they learned. Parents learned how to better communicate positive information that helped their child build a positive core belief. Parents learned how to use reinforcement to support healthy behavior.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Soy on HDL-C Function, Central Blood Pressure, and Arterial Stiffness
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of the proposed pilot study is to evaluate the effects of a soy protein isolate
      with naturally occurring isoflavones on the properties of HDL-C (total HDL-C, HDL particle
      size and HDL function), central blood pressure, and indices of arterial stiffness.
    

Detailed description: 
      The investigators propose to conduct a randomized three-period, crossover study to evaluate
      the effect of soy protein supplementation on HDL function. To ensure that there are no
      effects of treatment order on outcome measures, subjects will be randomized to a treatment
      sequence. Healthy males and females (n = 20; 35 to 60 years of age) with systolic blood
      pressure greater than 120 mm Hg and/or diastolic blood pressure greater than 80 mm Hg will be
      recruited for this study. Subjects will undergo 3 treatment periods in random order. These
      treatment periods will include: A) 25 g/d soy protein powder; B) 50 g/d soy protein powder;
      C) 0 g/d protein powder (control). Each treatment will be provided for 6 weeks separated by a
      2-week break between treatment periods. All subjects will be encouraged to maintain body
      weight and physical activity levels during the study.
    

Intervention name(s): Soy Protein Powder (25g/d); Placebo; Soy Protein Powder (50g/d)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will consume 25g soy protein powder daily for a 6 week treatment period.; Participants will consume a placebo control powder containing 0g soy protein powder daily for a 6 week treatment period.; Participants will consume 50g soy protein powder daily for a 6 week treatment period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: soy; hypertension; HDL-C; cholesterol efflux; cardiovascular disease
Naltrexone and Memantine Effects on Alcohol Drinking Behaviors
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking; Drinking Behavior
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the combined effects of the study medications
      naltrexone and memantine on alcohol drinking behaviors.
    

Detailed description: 
      Participants will be randomized to receive a combination of naltrexone/memantine over a one
      week period and then participate in a laboratory session. During this session, participants
      are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks
      over a three-hour period. These medications are hypothesized to reduce craving and number of
      drinks consumed prior to and after exposure to the initial drink of alcohol and during the
      three hour drinking period.
    

Intervention name(s): Naltrexone and memantine first; Naltrexone and Placebo first
Intervention type(s): Drug; Drug
Intervention description(s): Naltrexone 50mg memantine 20mg; Naltrexone 50 mg Placebo
Other intervention name(s): memantine's brand name is Namenda; naltrexone's brand name is Revia; naltrexone's brand name is Revia
Intervention MeSH terms: Naltrexone; Memantine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Alcohol; Drinking; Drinkers; Alcohol Drinking; Memantine; Naltrexone; Alcohol Dependence; Alcohol Abuse; Alcohol-Related Disorders; Ethanol; Alcoholism
Functional Connectivity Parkinson Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      In this study the investigators are looking at two subtypes of Parkinson Disease (PD);
      "tremor-dominant" (TD) and postural imbalance and gait disorder (PIGD). This study will use
      magnet resonance imaging (MRI) to see how the brain reacts while resting and doing a
      finger-tapping task while on and off PD medication. This study will look at the differences
      between the two sub-types of PD and healthy volunteers.

      The investigators will test the hypothesis that connectivity at rest within the motor cortex
      and between the motor cortex and motor-associated regions such as the supplementary motor
      area and the pre motor cortex will not be as strong in PIGD compared to TD (increased
      activity and functional connectivity in TD group)
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with PD according to UK Brain Bank Criteria will be recruited from the UCD
        Neurology clinic. Controls will be recruited from spouses and from the community
      
Keywords: Parkinson; Parkinson Disease
Evaluation of the Effect of Corticotomy and Low Level Laser Therapy on Orthodontic Tooth Movement
Condition: Dental Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      The aim of the present study was to compare, a standard efficient technique in accelerating
      OTM as surgical corticotomy as a gold standard versus surgical corticotomy combined with LLLT
      in an attempt for further acceleration of OTM.
    

Detailed description: 
      The study design was a randomized split mouth design to compare, clinically and
      radiographically, between the two interventions (Corticotomy and Laser versus Corticotomy
      only) by assessing the rate of maxillary canine retraction achieved in 4 months. Secondary
      outcomes were to evaluate 1st maxillary molar anchorage loss, changes in tipping, torque and
      rotations values of maxillary canine and 1st molar. In addition, the impact of both
      interventions on root resorption was assessed. The present study was carried on 16 female
      patients. All patients required maxillary 1st premolar extraction and subsequent maxillary
      canine retraction.
    

Intervention name(s): Corticotomy and low laser therapy; Corticotomy facilitated Orthodontics
Intervention type(s): Procedure; Procedure
Intervention description(s): Corticotomy is carried out under local anesthesia followed by low-intensity laser therapy that is started on the selected experimental side on the same day as placement of the coil spring; Corticotomy is carried out under local anesthesia in right side.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics of Oral Mirabegron With Different Release Rates Versus Intravenous (IV) Mirabegron
Condition: Healthy; Pharmacokinetics of Mirabegron
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics of three doses of oral mirabegron
      formulations with three different release rates versus three doses of mirabegron administered
      intravenously; to study safety and side effects of the oral and IV doses of mirabegron.
    

Detailed description: 
      Subjects will be randomly assigned to one of three oral mirabegron doses and then randomly
      assigned to one of three oral mirabegron doses and then randomly assigned to one of six
      treatment sequences.

      For all subjects the first treatment will be a reference IV dose. Treatments 2, 3, and 4 will
      be a random order of slow, fast and target release oral doses of mirabegron. Treatment 5 will
      be a target release dose of mirabegron from a different batch.

      There will be at least 10 day washout between dose administrations.
    

Intervention name(s): mirabegron; mirabegron
Intervention type(s): Drug; Drug
Intervention description(s): oral tablet; IV solution
Other intervention name(s): YM178; YM178
Intervention MeSH terms: Mirabegron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: oral administration; YM178; IV infusion; pharmacokinetics; mirabegron; Healthy volunteer subjects
Effect of BIBT 986 Followed by BIBT 986 Given as IV Infusion on Tissue Factor Triggered Coagulation in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare with placebo the anticoagulant activity of three dosages of BIBT 986 on parameters
      of coagulation, platelet activation and inflammation in a model of tissue factor triggered
      activation of the coagulation system; to examine the safety of BIBT 986 in this setting
    


Intervention name(s): Low dose of BIBT 986 CL, per i.v. infusion; Medium dose of BIBT 986 CL, per i.v. infusion; High dose of BIBT 986 CL, per i.v. infusion; Placebo; Lipopolysaccharide (LPS), single i.v. bolus
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Endotoxin derived from E. coli bacteria, used for activation of coagulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America (USA). The aim of this trial is to
      evaluate the clinical performance of two formulations of insulin aspart (NovoLog®) in
      subjects with type 1 diabetes.
    


Intervention name(s): insulin aspart; insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): An initial priming dose of insulin aspart is administered, then a continuous subcutaneous insulin aspart infusion followed by a bolus of insulin aspart on top of the continuous insulin aspart infusion; An initial priming dose of insulin aspart is administered, then a continuous subcutaneous insulin aspart infusion followed by a bolus of insulin aspart on top of the continuous insulin aspart infusion
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Multicenter Study to Evaluate the Efficacy of a 91-Day Extended Cycle Oral Contraceptive for Menstrually-Related Migraine Headaches
Condition: Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to evaluate the efficacy of a 91-day extended cycle oral
      contraceptive compared to placebo for decreasing the frequency and severity of
      menstrually-related migraine headaches.
    


Intervention name(s): 91-day Levonorgestrel Oral Contraceptive; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.; 1 tablet daily to match experimental arm
Other intervention name(s): Seasonique; DR-105
Intervention MeSH terms: Contraceptive Agents; Levonorgestrel; Contraceptives, Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Migraine headache; menstrual; oral contraceptive; Menstrually-Related Migraine Headache
Magnesium vs Placebo for Tonsillectomy
Condition: Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is a double-blind randomized controlled trial using intravenous magnesium versus
      placebo to determine if systemic magnesium can decrease postoperative pain in pediatric
      patients undergoing tonsillectomy.

      Participants will be in one of two arms. Those in Arm 1 will receive magnesium (30 mg/kg
      bolus followed by a 10mg/kg/hr infusion) while those in Arm 2 will receive an equal volume of
      normal saline bolus followed by infusion (placebo).

      The primary objective is to determine if systemic magnesium will decrease postoperative pain
      in patients undergoing tonsillectomy. The secondary objectives will determine if systemic
      magnesium administration is associated with a decrease in opioid-related side effects,
      decrease the incidence of emergence delirium, and improve postoperative functional recovery.

      The study hypothesis is that the use of intravenous magnesium will decrease postoperative
      pain, decrease opioid-related side effects, decrease the incidence of emergence delirium, and
      improve functional recovery in patients undergoing tonsillectomy.
    


Intervention name(s): Magnesium; Normal saline
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial
Condition: Growth Failure; Growth Hormone Deficiency
MeSH terms: Failure to Thrive
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the trial was to assess the bioequivalence for two concentrations
      (5.83 mg/mL and 8 mg/mL) of the new r-hGH liquid multidose formulation using the r hGH
      freeze-dried multidose formulation (Saizen® 8 mg, 8.8 mg/1.51 mL) as reference.

      Each volunteer received three r hGH treatments, with each treatment being administered as a
      single subcutaneous dose of 4 mg r-hGH in a randomized sequence with at least one week of
      wash-out period between successive treatments.
    


Intervention name(s): r-hGH liquid (Saizen); r-hGH liquid (Saizen); r-hGH freeze-dried
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Treatment Arm A: r-hGH liquid multidose formulation 5.83 mg/mL, needle injection (0.686 mL); Treatment Arm B: r-hGH liquid multidose formulation 8.0 mg/mL, needle injection (0.5 mL); Treatment Arm C: r-hGH 8 mg (8.8 mg/1.51 ml) freeze-dried formulation ( reconstituted in metacresol 0.3% w/v) needle injection (0.686 mL)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Saizen®; bioequivalence; recombinant human; Growth Hormone; treatment of growth failure in children; growth hormone deficiency in adults
Comparison of Cryotherapy and Peeling Agent in the Treatment of Common Warts
Condition: Warts
MeSH terms: Warts
Study type: Interventional

Summary: 
      Objective: To compare the efficacy of cryotherapy using liquid nitrogen (cryoget method)
      versus trichloroacetic acid 90% (applicator method) in treatment of common warts.

      Study Design: Randomized Control Trial. Place And Duration of Study: Department of
      Dermatology, CMH Abbottabad from Jun 2022 to Nov, 2022.
    

Detailed description: 
      A total of 60 patients were enrolled in this investigation by non-probability consecutive
      sampling technique. Sample size was calculated using WHO sample size calculator and patients
      were randomized into two equal groups, A and B, each comprising of 30 patients through
      lottery method. Patients with common warts such as hard lesions, raised lumps with rough
      surfaces at the back of their fingers, around nails and palm of their hands between the ages
      of 18 and 60 were included, whereas those with genital warts, cardiac, hepatic, renal, or
      hypercholesterolemia were excluded.
    

Intervention name(s): CRYOTHERAPY; Tricholoracetic acid
Intervention type(s): Drug; Drug
Intervention description(s): Group A had their warts treated once every two weeks for a total of twelve weeks, with liquid nitrogen using cryoget method for 10 to 15 seconds on each lesion (depending on size, until a narrow white rim of around 1 mm developed around it).; Group B were treated with liquid TCA 90% by an applicator every two weeks for a total of twelve weeks. After 20 minutes, patients were instructed to remove the solution by washing their warts with water or regular saline.
Other intervention name(s): Liquid nitrogen; Peeling agent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Utility of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Cardiology Practice Pattern
Condition: Angina Pectoris; Coronary Artery Disease; Chest Pain; Cardiovascular Diseases; Coronary Heart Disease; CAD; CVD; CHD
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Angina Pectoris; Chest Pain
Study type: Observational

Summary: 
      To investigate whether the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood
      assay changes the diagnostic testing pattern in patients referred to a cardiologist for the
      evaluation of chest pain or anginal equivalent symptoms.
    

Detailed description: 
      A prospective cohort of 88 subjects receiving the Corus CAD (Age/Sex/Gene Expression score -
      ASGES) assay were compared to a retrospective cohort of 83 subjects that did not receive the
      assay.
    

Intervention name(s): Corus CAD (ASGES)
Intervention type(s): Diagnostic Test
Intervention description(s): Age/Sex/Gene Expression Score - ASGES
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study will enroll a patient population that present with chest pain or anginal
        equivalent symptoms who are referred to a cardiologist for evaluation.
      
Biospecimen description: 
      PaxGene tube for RNA collected
    
Keywords: Corus CAD; Age/Sex/Gene Expression Score; Molecular Genetics; Atherosclerosis; ASGES; Gene Expression; GES; CAD; CVD; CHD; Clinical Utility; Precision Medicine; Coronary Artery Disease; Angina Pectoris; Chest Pain; Cardiovascular Disease; Coronary Heart Disease; IMPACT; IMPACT-CARD
The Recovering Strategy on Forward Head Posture in Chinese Adolescents: Tai Chi and Manual Therapy
Condition: Forward Head Posture
Study type: Interventional

Summary: 
      Forward head posture (FHP) is a prevalent deformity that can cause various health issues in
      adolescents. The programs combining manual therapy (MT) and stability exercises (SE) have
      shown better effectiveness than stability exercises and home exercises in recovering FHP.
      However, the effectiveness of the therapy program consisting of Tai Chi and MT for recovering
      FHP remains unclear. Therefore, this study aimed to investigate the effects of Tai Chi with
      MT on FHP recovery. Meanwhile, with a particular focus on personalized medicine, we utilized
      explainable artificial intelligence (XAI) to predict if individuals would reverse to healthy
      posture based on different interventions.
    


Intervention name(s): Manual therapy; Tai Chi; Tai Chi and Manual therapy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The therapist checks the range of motion of the cervical joints and gives manual treatment to the restricted joints. Throughout the examination, the subject lied in a supine position on a professional rehabilitation bed with the seventh cervical vertebra (C7) on the edge of the bed and the other the body above the C7 were placed off the bed. The therapist held the subject's occipital bone with one hand and the radial aspect of the second metacarpophalangeal joint of the other hand to grip the spinous process of the sixth cervical vertebra and slowly pushed the occiput downward to check the joint mobility of the fifth cervical vertebra and the sixth cervical vertebra. After the examination, the restricted joint was accurately located and treated with targeted manual therapy. For example, stretching was performed with the right side of C4-C5 flexed, closing only the right side of the subject's C4-C5 as much as possible to increase joint mobility on the right side of C4-C5.; Based on the characteristics of young people and the need to correct their FHP, the classic Yang's 24 Forms of Tai Chi has been improved. The movements are mostly upper limb movements and the lower limb movements have been simplified to make the movements easy to learn. The modified Tai Chi exercise retains the traditional Tai Chi movements but is simple and easy to learn; at the same time, it increases the movement of the shoulder and neck joints. The subjects performed each exercise session in a group setting at the school gymnasium, with a professional Tai Chi instructor guiding them through a warm-up session, followed by a Tai Chi exercise session.; Intervention content of MSG included 15-min Tai Chi exercise and 15-min manual therapy, with the order of intervention being Tai Chi exercise first and then manual therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: forward head posture