bioihbjkbjnl/mcl2 huggingface dataset:
A Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study evaluating a 28-day course followed by a 56-day course of itacitinib in
      patients with active rheumatoid arthritis (RA). The study will evaluate safety and efficacy
      parameters of itacitinib.
    


Intervention name(s): Itacitinib; Itacitinib Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): INCB039110
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; RA; Active
Development of Clinical Method to Triclosan Retention in Plaque Following Brushing
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective is to develop a method to determine active ingredient uptake in oral care
      products.
    


Intervention name(s): Fluoride; Fluoride and triclosan
Intervention type(s): Drug; Drug
Intervention description(s): Brush half mouth once with assigned study treatment; Brush half mouth once with assigned study treatment
Other intervention name(s): Colgate Total toothpaste
Intervention MeSH terms: Triclosan; Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Affecting the Epidemiology of HIV in Uganda
Condition: Sexual Abstinence; HIV; Contraceptive Usage
Study type: Interventional

Summary: 
      The investigators propose to develop a comprehensive, text messaging-based HIV prevention
      program for Ugandan adolescents 18-22 years of age.
    

Detailed description: 
      The investigators propose to develop a comprehensive, text messaging-based HIV prevention
      program for Ugandan adolescents 18-22 years of age. The guiding theoretical model is the
      Information-Motivation-Behavioral Skills (IMB) Model of HIV Preventive Behavior.

      Intervention development will be iterative: In Phase 1, the investigators will identify an
      intervention content "map." Then, online focus groups (FG) will be conduct online with
      Ugandan young adults (n = 40-80) to confirm program components (e.g., social support via Text
      Buddy, optimal time of delivery of daily text messages) and saliency of intended program
      topics.

      In Phase 2, the investigation team will "translate" content into a bank of text messages that
      will be reviewed for comprehensiveness and inclusion of the most pertinent topics. The final
      pool of messages among Ugandan young adults will be tested in the Content Advisory Council
      (CAC; n = 30) to assess their reactions to the content, scope, style, and tone of the
      messages.

      In Phase 3, the investigators will merge the content with the software program developed to
      deliver the intervention and then internally conduct a functionality test of the programmed
      messages. Following, the protocol and program will be tested in a beta test of 20 Ugandan
      adults.

      In Phase 4, the investigators will test the intervention in a randomized controlled trial of
      200 Ugandan young adults randomly assigned to either the intervention (n = 100) or control (n
      = 100) arms. The main outcome measures will focus on feasibility (e.g., recruitment and
      retention rates) and acceptability (e.g., Text Buddy). The primary efficacy outcome measures,
      measured at 3-months post-intervention, will be: (a) frequency of unprotected sex acts; (b)
      sustained sexual abstinence, and (c) increased HIV testing rates.

      Specific Aims are as follows:

      Specific Aim 1: Design a 6-week text messaging-based HIV prevention and healthy sexuality
      program for adolescents 18-22 years old.

      Specific Aim 2: Pilot test the intervention for feasibility and acceptability among 18- to
      22-year-old Ugandans.

      Specific Aim 3: Obtain preliminary data needed for a larger-scale controlled trial services
      study to examine program efficacy.
    

Intervention name(s): ITG (In This Together)
Intervention type(s): Behavioral
Intervention description(s): Comprehensive, mHealth-based HIV prevention program for Ugandan adolescents 18-22 years of age.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: technology; adolescent; developing country; hiv prevention; mHealth
Cognitive-Behavioral Therapy for Pediatric Body Dysmorphic Disorder
Condition: Body Dysmorphic Disorder
MeSH terms: Body Dysmorphic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to develop and test the effectiveness of Cognitive-Behavioral
      Therapy (CBT) for children and adolescents suffering from Body Dysmorphic Disorder.
    

Detailed description: 
      The main purpose of this trial is to develop and investigate the effects of a CBT protocol
      for children and adolescents with BDD. It is important to investigate CBT in this population
      given the disorder's early onset and poor trajectory if left untreated.

      In the first phase of this trial, we will develop the treatment manual, adapting the adult
      manual for use in a pediatric population. In the second phase of this trial we will test the
      effectiveness of the CBT treatment in 12 pediatric BDD patients. We intend to treat 12
      children and adolescents with BDD. All patients will receive CBT. We will also examine
      treatment feasibility and acceptability (e.g., retention and reasons for treatment refusal
      and dropout, expectancy, and motivation), and we will explore predictors of outcome.
      Therapeutic progress will be broadly assessed with measures of beliefs, behaviors, mood,
      functioning, and quality of life before, during, and after treatment.
    

Intervention name(s): Cognitive-Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): 20 sessions of Cognitive-Behavioral Therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric; Body Dysmorphic Disorder; BDD; CBT; Cognitive-Behavioral Therapy
BAX 855 Dose-Escalation Safety Study
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to assess the tolerability and safety after single dose
      treatments of BAX 855 in previously treated patients (PTPs) with severe hemophilia A, to
      determine the pharmacokinetic (PK) parameters of BAX 855 compared in crossover with ADVATE,
      and to evaluate the impact of anti-polyethylene glycol (PEG) antibodies on PK parameters.
    


Intervention name(s): Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method; PEGylated Recombinant Factor VIII
Intervention type(s): Biological; Biological
Intervention description(s): 1 PK infusion of ADVATE (low dose in Cohort 1, high dose in Cohort 2); 1 PK infusion of BAX 855 (low dose in Cohort 1, high dose in Cohort 2)
Other intervention name(s): ADVATE; BAX 855
Intervention MeSH terms: Factor VIII; BAX 855
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Qualitative Evaluation of Tear Fluid and Blood for Auto Antibodies Produced in Response to COVID-19
Condition: SARS-CoV 2 Infection; Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      This study objective is to collect tear and blood samples from individuals with positive
      SARS-COV2 diagnosis and test those samples for the presence of various SARS-COV2 viral
      antigens and autoantibodies.
    


Intervention name(s): SARS-CoV2 Autoantibody detection
Intervention type(s): Diagnostic Test
Intervention description(s): Through the data collected from this study we hope to support the development of an ELISA assay for the detection of IgM and IgG autoantibodies produced in response to the presence of SARS-CoV2
Intervention MeSH terms: Autoantibodies
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Study participants will be recruited from hospital and health care settings testing and/or
        treating individuals for the presence of the SARS-CoV2 virus and resulting COVID-19
        disease.
      
Biospecimen description: 
      Tears and Blood
The Effect of the Kinesio Tape on the Muscle Power Performance of Elite Weightlifters
Condition: Muscle Power Performance
Study type: Interventional

Summary: 
      This study is aimed to investigate the effect of the Kinesio Tape facilitation technique on
      the muscle power performance of elite weightlifters.
    

Detailed description: 
      Most sportsmen require the power of muscles for their performance. Weightlifting exercises
      such as the snatch or clean and jerk and their variations are frequently included in the
      power training programs of athletes who contest or participate in sports that need muscle
      power. The weightlifting exercises require athletes to accelerate the weight throughout the
      whole second pull phase, causing the barbell to be raised overhead and the athlete's body
      into the air, a movement in which the feet leave the platform. Furthermore, the movement
      patterns of the weightlifting exercises are mostly considered to be similar to athletic
      movements in different sports such as jumping and sprinting in soccer and basketball.
      Empirically, the kinetic qualities of the second pull phase are similar in both weightlifting
      and jumping movements. The role of the sport physical therapist is not restricted only to
      rehabilitation and injuries prevention, but they can also contribute to the performance of
      the athletes in a different aspect. Therefore, finding tools which may improve the muscle
      power of the weightlifters could increase the success in performing the sport-specific
      movements with higher loads. This could make the difference between winning or losing a
      competition. Thus, if it could be proven that the Kinesio Tape has the capability to improve
      muscle power, it could be used as a tool by the physiotherapist, either for enhancing the
      athlete's performance or for accelerating the last stage of the rehabilitation and,
      therefore, decreasing the number of absent days of athletes from training or matches due to
      injury.
    

Intervention name(s): Kinesio Tape original brand (Kinesio® Tex GoldTM finger print, black, Georgia, Albuquerque).
Intervention type(s): Other
Intervention description(s): Kinesio Tape: An elastic therapeutic tape, which mimics the skin's thickness. It is a cotton, porous fabric and acrylic adhesive, which is non-medicated and free of latex. The Kinesio Tape is applied in a specific manner to enhance muscle function, increase circulation, decrease pain and improve proprioception.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Olympic Weightlifting; Taping; Muscles Facilitation; Jumps
Correlation Between Change of HbA1c, Urinary Glucose Excretion and Other Factors in Patients Treated With Ipragliflozin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the correlation between change of HbA1c, urinary
      glucose excretion and other factors when ipragliflozin is added to preexisting therapy in
      subjects with type 2 diabetes.
    


Intervention name(s): Oral administration of Ipragliflozin
Intervention type(s): Drug
Intervention MeSH terms: Ipragliflozin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Non-invasive Assessment of Pulmonary Vascular Resistance in Elderly Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension; Cor Pulmonale
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Pulmonary Heart Disease
Study type: Observational

Summary: 
      Many studies have evaluated the viability of measuring the pulmonary vascular resistance
      (PVR) by non-invasive methods in patients with pulmonary hypertension, pulmonary
      thromboembolism, ischemic cardiopathy and valvular disease. The investigators have not found
      other studies which evaluate the PVR in elderly patients with COPD. The hypothesis is that in
      patients with COPD, the severity of obstruction, expressed by GOLD class, is associated with
      an increase of PVR.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Consecutive series of patients with a diagnosis of COPD who were treated in the consulting
        rooms of the department of respiratory physiopathology.
      
Keywords: COPD; PVR
Relationships Between OLST, GMFM and Pedobarographic Values in CP
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The primary aim of this study was to investigate the relationship between the One
      Leg-Standing Test (OLST) and the Gross Motor Function Measurement (GMFM) and stance phase
      stability during gait in Unilateral Cerebral Palsy (UCP). The secondary aim was to explore a
      new well-defined pedobarographic parameter as a functional factor in the stability of stance
      in gait.

      The investigator's hypotheses are (1) OLST has relationship between T2-T1 in children with
      UCP; (2) OLST has relationship between GMFM D and E.

      Eighteen children with UCP and ten typically developing children (TDC) participated in the
      study. All participants and their legal guardians signed an informed consent form before
      participating. Firstly, to asses the stability in stance all participants were analyzed by
      using pedobarographic analysis and the OLST. After analysis, only the UCP group was evaluated
      with the GMFM. The TDC group was used for comparison of pedobarographic stance phase
      stability (T2-T1) and OLST values.
    


Intervention name(s): one leg standing test, gross motor function measurement, pedobarographic measurement
Intervention type(s): Diagnostic Test
Intervention description(s): OLST:During the OLST,the participants were asked to shoes off,place both hands on their hips and look at a point on the wall at eye level.A recording stopwatch was used to assess their standing duration on one leg while keeping the other leg in 90 degrees of knee flexion.The test was stopped when the contralateral foot touched the ground or when the participant broke 90 degrees of knee flexion.The OLST was repeated three times for each leg.GMFM:To assess standing and walking,running and jumping functions of the UCP group,the D and E dimensions of GMFM were utilized by a certificated physiotherapist.Each item was tested by three trials and the best trial was used.Pedobarography:The participants' plantar pressure was analyzed using pedobarography.For each participant, the pedobarography was calibrated before the assessment.During the pedobarographic analysis, the participants walked barefoot in 90 BPM cadence. Three steps were analyzed for each side.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: cerebral palsy,; gait,; Gross Motor Function Measurement,; stability,; foot pressure
Clinical Performance of One-shade Universal Dental Resin Composite as Posterior Restoration
Condition: Carious Teeth
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study is aimed to evaluate the clinical performance of new One-shade universal composite
      resin as posterior restoration using US Public Health Service "USPSH" criteria for color
      match, marginal adaptation, surface texture, retention, recurrent caries and others after 1,
      3, 6 and 9 months.
    

Detailed description: 
      One operator will place all restorations under rubber-dam isolation. The patients will
      receive restorations with both materials, randomly after shade selection (The shade of single
      shade universal resin composite "Omnichroma" will be taken before and after placement into
      the cavity). During the referred period, only the two composites in study will be placed in
      posterior teeth in the dental office. The various materials' application procedure will be
      applied according to manufacturer's instructions.
    

Intervention name(s): US Public Health Service "USPSH" criteria for assessment of success of resin composite restorations
Intervention type(s): Other
Intervention description(s): US Public Health Service "USPSH" criteria for color match, marginal adaptation, surface texture, retention, recurrent caries and others after 1, 3, 6 and 9 months.
Other intervention name(s): assessment of Universal single shade resin composite and Nano-hybrid multi-shade resin composite restorative material using the US Public Health Service "USPSH" criteria
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Multi-joint Coordination Underlies Upright Balance Control in Elderly With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      Osteoporosis is a prevalent health concern among older adults and is associated with an
      increased risk of falls that can cause fracture, injury and even mortality. Identifying the
      factors related to falls occur within this population is essential for the development of
      effective regimes for fall prevention. The long-term objectives of this work are to ascertain
      the mechanisms for effectively controlling balance in seniors with osteoporosis and to
      provide a basis for developing fall prevention programs. The entire body's center of mass
      (CoM) is a critical indicator for balance control and the coordination among joints and
      muscles to control the CoM is still unclear. The aim1 of this study is to develop
      biomechanical models that control the entire body's center of mass (CoM) during upright quiet
      stance in seniors with osteoporosis. The aim2 of this study is to identify the mechanism to
      control the entire body's CoM after receiving a balance perturbation in seniors with
      osteoporosis. The findings of this research can provide needed information regarding the
      processes of balance control in this vulnerable osteoporosis population, and has the
      potential to be applied to individuals with other neuromuscular and orthopedic deficits.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        community sample
      
Keywords: To ascertain the mechanisms for effectively controlling balance in seniors with osteoporosis and to provide a basis for developing fall prevention programs.; To develop biomechanical models that control the entire body's center of mass (CoM) during upright quiet stance in seniors with osteoporosis.; To identify the mechanism to control the entire body's CoM after receiving a balance perturbation in seniors with osteoporosis.
Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Condition: Cigarette Smoking; Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this proposed pilot study is to examine the use of varenicline in people with
      schizophrenia to specifically assess tolerability and efficacy for smoking cessation.
      Specifically, The primary objective of this pilot study is to determine if taking of
      varenicline along with an individual smoking cessation supportive program is a safe and
      effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the
      varenicline treated patients will achieve higher rates of smoking cessation than those who
      receive placebo and individual support.
    

Detailed description: 
      The primary objective of the data analysis will be to measure the rate of smoking cessation
      in the two treatment groups. Smoking cessation will be measured weekly through a composite
      measure of self-reported abstinence, end expired carbon monoxide (CO) of less than C10 ppm
      and urine cotinine dipstick measure of < 30 ng/ml. The primary endpoint will be point
      prevalence at 12 weeks. The four week continuous abstinence rate for the last four weeks of
      the treatment phase will also be evaluated. The point prevalence abstinence rates will also
      be obtained. The secondary objective is to determine whether smoking cessation is associated
      with a worsening of cognition and psychiatric symptomology. We hypothesize that subjects who
      achieve abstinence in the varenicline group will not show worsening on neurocognitive and
      symptom measures compared to abstinence subjects in the placebo group. Lastly, we will
      attempt to identify any clinical or topographic markers which predict cessation.
    

Intervention name(s): varenicline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.; At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
Other intervention name(s): chantix, study drug; sugar pill
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Treatment of Prisoners With Attention Deficit Hyperactive Disorder in Trondheim Prison
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The treatment of ADHD in jail will help the prisoners in their rehabilitation process
    

Detailed description: 
      Prisoners with ADHD will be offered treatment with Stratera, and we wanted to study their use
      of the prisons rehabilitation offers as school, programs and work training before and after
      treatment with Stratera.
    

Intervention name(s): Strattera
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder, treatment,; Strattera,; rehabilitation