bioihbjkbjnl/mcl2 huggingface dataset:
The Most Effective Intervention for Reducing Posterior Shoulder Tightness Acutely in the Post-operative Population
Condition: Postoperative Posterior Shoulder Tightness
Study type: Interventional

Summary: 
      This study will look at which, if any, active stretching procedure is most effective at
      correcting posterior shoulder tightness (PST) in the post-operative population. Posterior
      shoulder tightness can influence shoulder mobility and function within both a symptomatic and
      an asymptomatic population. There are previous studies that have examined the effectiveness
      of different active stretching procedures and their ability to correct PST but only in the
      asymptomatic population. As clinicians it will be helpful to investigate their effect within
      a symptomatic population in order to prescribe appropriate and effective stretches within an
      individual's home exercise program. The study design is a double blinded randomized control
      trial. During evaluation a passive measurement of PST and internal rotation will be
      performed. Another therapist, blinded to the measurements, will randomly select which
      subgroup the individual will be placed in for the first three individuals and this sequence
      will be followed for the remainder of the participants. At this time the therapist will
      instruct the individual on the corresponding exercise which they will perform in front of
      that therapist. The individual will perform this exercise one more time that day and twice
      the following day and once again upon follow up prior to having internal rotation and PST
      measured once again. At this point this will be the conclusion of that individuals
      involvement in the study.

      Null Hypothesis1: Stretches are no more effective than no treatment for reducing PST acutely
      in the post-operative shoulder population.

      Hypothesis1: Stretches are more effective than no treatment for reducing PST acutely in the
      post-operative population.

      Null Hypothesis2: There is no significant difference in the reduction of PST between the
      horizontal adduction stretch and the modified sleeper stretch acutely in the post-operative
      shoulder population.

      Hypothesis2: There is a significant difference in the reduction of PST between the horizontal
      adduction stretch and the modified sleeper stretch acutely in the post-operative shoulder
      population.
    


Intervention name(s): Horizontal Adduction Stretch and Pendulums; Modified Sleeper Stretch and Pendulum
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Shoulder; Surgery; Posterior Shoulder Tightness; Flexibility; Range of Motion
Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of BILR 355 BS Plus Low Dose Ritonavir in HIV-uninfected Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the safety, tolerability and pharmacokinetics of BILR 355 BS plus low dose
      ritonavir in healthy male volunteers.
    


Intervention name(s): BILR 355 BS, solution; BILR 355 BS, tablet; Ritonavir; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Migraine is a neurological disease characterized by moderate or severe headache, associated
      with nausea, vomiting, and/or sensitivity to light and sound. This study will assess the
      safety and efficacy of the combination use of ubrogepant for the acute treatment of migraine
      headache in participants taking atogepant once daily for preventive treatment of migraine.

      Ubrogepant is an approved drug for the acute treatment of migraine. Atogepant is an approved
      drug for the preventive treatment of EM. Approximately 235 adult participants with EM will be
      enrolled in approximately 45 sites in the United States.

      Participants will receive oral atogepant tablets once daily (QD) for 12 weeks followed by
      continued atogepant treatment with ubrogepant tablets taken as needed for the next 12 weeks.

      There may be higher treatment burden for participants in this trial compared to their
      standard of care. Participants will attend regular visits during the study at a hospital or
      clinic. The effect of the treatment will be checked by medical assessments, blood tests,
      checking for side effects and completing questionnaires.
    


Intervention name(s): Atogepant; Ubrogepant
Intervention type(s): Drug; Drug
Intervention description(s): Oral Tablet; Oral Tablet
Other intervention name(s): QULIPTA; UBRELVY
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Episodic Migraine; Ubrogepant; Atogepant; QULIPTA; UBRELVY
Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain
Condition: Low Back Pain; Workplace
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The Purpose of this trial is to investigate the efficacy and safety of
      Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work Related Chronic Low Back Pain
    

Detailed description: 
      Investigating the efficacy and safety of Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With
      Work-related Chronic Low Back Pain
    

Intervention name(s): Sogyeonghwalhyeol-tang; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): herbal extract; extract powder with same appearance, odor and color as SGHH
Other intervention name(s): SGHH
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Work Related Chronic Low Back Pain; Korean Medicine; Sogyeonghwalhyeol-tang
Computerized Intervention for Loneliness
Condition: Loneliness
Study type: Interventional

Summary: 
      This study assesses whether a month long computerized interpretation bias modification
      intervention will reduce levels of loneliness compared to a control treatment.
    

Detailed description: 
      This study hopes to assess whether a month long interpretation bias modification intervention
      will reduce levels of loneliness compared to a control treatment. Participants will be
      randomized into an active treatment condition or a control treatment that involves a healthy
      living and relaxation protocol. The investigators hypothesize that participants in the IBM
      condition will have lower levels of negative interpretation bias and loneliness than those in
      the healthy habits condition at post treatment and follow up. The investigators further
      hypothesize that the effects of IBM on loneliness will be accounted for by changes in
      interpretation bias.
    

Intervention name(s): Interpretation Bias Modification for Loneliness; Healthy Habits Psychoeducation and Relaxation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive eight treatment sessions. They will be presented with ambiguous training scenarios on a computer screen. Scenarios will be presented in two discrete formats: a word-sentence relatedness task (adapted from Beard & Amir, 2008 and Beard, Weisberg, & Amir, 2011), and a sentence completion and comprehension task (adapted from paradigms used by Mathews and Mackintosh (2000), Steinman and Teachman (2010), and Beard and Amir (2008)). Both of these formats have been used to reduce maladaptive threat interpretations and increase benign interpretations.; Participants will receive eight computerized sessions consisting of psychoeducation on healthy behaviors as well as relaxing video clips with pleasant music (e.g., videos of rainforests, wildlife, and space). These sessions will be matched for time with the active condition, lasting approximately 25-30 minutes each. Psychoeducation will cover the topics of exercise, diet, hygiene, social support, healthy activities, and sleep. The relaxing videos will be presented after the psycho-education in each session. At the conclusion of the study, participants will be provided with the active IBM treatment free of charge if they wish to receive it.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to receive one of two treatments
Masking: Single (Participant)
Primary purpose: Treatment
"Improved Mother Infant Feeding Interaction (MI-FI) at 12 Months With Very Early Parent Training"
Condition: Picky Eaters, Feeding Interaction, Good Enough Parenting, Family Meals, Emotional Eating Prevention
Study type: Interventional

Summary: 
      Rise in childhood obesity and poor eating habits and eating problems is apparent over the
      last decades. Parents are at lose what the correct way to tackle these problems may be. This
      study examined whether professional behavioral and nutritional training of first time mothers
      improves feeding relationship and infants eating habits at 12 months.
    

Detailed description: 
      From 166 first time mother-infant recruited, 128 completed the trail. Intervention group,
      mother-infant dyads got a month long weekly based training in small workshop groups about
      nutrition, feeding and parenting when infants were 4-6 months old. training was given by a
      highly experience pediatric dietitian and social worker. Thereafter, internet-based support
      continued until infants reached 12 months. The control group received customary support via
      municipal mother-child health clinics. Mealtime interactions were videotaped at home setting
      at 12 months and were evaluated using the Chatoor feeding scale by blinded (to group)
      viewers.
    

Intervention name(s): Mother Infant Feeding Interaction very early training
Intervention type(s): Behavioral
Intervention description(s): weekly training meetings on 4 topics:
What - proper nutrition and supplements for solid feeding phase (dietitian); What - the meaning of feeding to mother and infant (social worker).
Who - feeding skills - knowledge and actual practices
From anxiety to serenity - knowledge concerning growth patterns and common physical and emotional issues troubling parents of infants 4-12 months old.
Prevention of obesity and emotional eating - practical advise and tips.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention group got 4 sequential weekly training meetings, in small workshop groups setting, by a highly experience pediatric dietitian and social worker. The program covered nutritional aspects, as well as feeding and parenting topics. Training took place when infants were 4-6 months old. Thereafter, internet-based support continued until infants reached 12 months. The control group received customary support via municipal mother-child health clinics. Mealtime interactions by videotaped home setting feeding were documented at 12-13 months.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: feeding interaction, infant eating habits, hunger satiety cues, childhood obesity
A Bio-equivalence Study of Sofosbuvir From Magicbuvir 400 mg Film Coated Tablets ( Magic Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, three way three sequence two treatment partial replicate
      crossover open-label study to determine the bioequivalence of Sofosbuvir from Magicbuvir 400
      mg Film Coated Tablets ( Magic Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences,
      Canada)
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, Area under cover (AUC0→t and AUC0→∞ ) Secondary
      Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for
      transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and
      AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of
      logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within
      80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Magicbuvir; Sovaldi (fist dose); Sovaldi (second dose)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet contains 400 mg sofosbuvir; 1 tablet contains 400 mg sofosbuvir; 1 tablet contains 400 mg sofosbuvir
Other intervention name(s): Sovaldi; Sovaldi; Sovaldi
Intervention MeSH terms: Sofosbuvir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Study of Baricitinib and Omeprazole in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to find out how the body will react to a study drug called
      baricitinib when taken with another drug called omeprazole.

      For each participant, this study will include 2 periods in fixed order. The study will last
      approximately 25 days, not including screening.
    


Intervention name(s): Baricitinib; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY3009104
Intervention MeSH terms: Omeprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Single and Multiple Dose Study in Japanese
Condition: Gout
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will explore the safety, tolerability, and serum uric acid lowering effect of
      lesinurad in healthy Japanese males to allow comparison with the Western population.
    

Detailed description: 
      While there is extensive clinical experience with lesinurad in the Western population, it is
      recognized that both intrinsic and extrinsic factors may impact the PK, PD, safety, and dose
      response in different ethnic populations. The purpose of this study is to explore the safety,
      tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of single and multiple doses of
      lesinurad in healthy Japanese males, and to allow comparison of these parameters with the
      Western population.
    

Intervention name(s): Lesinurad; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lesinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Mentor-Based Approach to Long-Term Weight Loss
Condition: Weight Loss; Obesity
MeSH terms: Body Weight; Weight Loss
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study to examine the effect of having a weight loss mentor on long-term
      weight loss in overweight adults.
    


Intervention name(s): behavioral weight loss program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Efficacy of Graminex® Flower Pollen Extracts in Healthy Women With Urinary Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to investigate the effect of Graminex® Flower Pollen
      Extracts in healthy women with urinary incontinence. The change in severity of urinary
      incontinence between baseline and 24 weeks will be assessed by an International Consultation
      on Incontinence Questionnaire-Short Form (ICIQ-SF), and compared between the investigational
      product and placebo groups. Additionally, the safety and tolerability of Graminex® Flower
      Pollen Extracts, as compared to placebo, will be measured by the occurrence of and/or changes
      in treatment-emergent adverse events (AEs).
    


Intervention name(s): Placebo; Water soluble pollen extract fraction; Lipid soluble pollen extract fraction + water soluble pollen extract fraction; Lipid soluble pollen extract fraction; Water soluble pollen extract fraction + cranberry powder
Intervention type(s): Other; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): One capsule of placebo will be taken twice daily for 24 weeks.; Each capsule contains 180 mg of water soluble pollen extract fraction. One capsule will be taken twice daily (360 mg/day) for 24 weeks.; Each capsule contains a combination of 9 mg of lipid soluble pollen extract fraction and 180 mg of water soluble pollen extract fraction. One capsule will be taken twice daily (18 mg/day and 360 mg/day, respectively) for 24 weeks.; Each capsule contains 9 mg of lipid soluble pollen extract fraction. One capsule of will be taken twice daily (18 mg/day) for 24 weeks.; Each capsule contains a combination of 42 mg of water soluble pollen extract and 125 mg of cranberry powder. One capsule will be taken twice daily (84 mg/day and 250 mg/day, respectively) for 24 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Safety and efficacy; Urinary incontinence; Urinary leakage
Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function
Condition: Renal Impairment; Healthy
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of mild, moderate, or severe renal
      impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and
      tolerability of 1 or 2 single doses of sotagliflozin compared with healthy,
      demographically-matched subjects with normal renal function.
    


Intervention name(s): Sotagliflozin; Sotagliflozin
Intervention type(s): Drug; Drug
Intervention description(s): Single dose; 2 single doses
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of Intravenously Administered BMS-986168 in Healthy Subjects
Condition: Tauopathies
MeSH terms: Tauopathies
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo controlled, single ascending dose escalation,
      safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an
      intravenous infusion in healthy subjects.
    

Detailed description: 
      This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a
      licensing agreement.
    

Intervention name(s): BMS-986168; BMS-986168 Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Other Names: BIIB092
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED)
Condition: Pneumococcal Infections
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study of V114 in children infected with HIV. Participants will be randomly assigned
      in a 1:1 ratio to receive either V114 or Prevnar 13™ followed 8 weeks later by a single dose
      of PNEUMOVAX™23. The primary objectives of this study are to evaluate the safety and
      tolerability of V114 in children 6 to 17 years of age inclusive infected with HIV and to
      evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG)
      Geometric Mean Concentrations (GMCs) at 30 days following vaccination with V114 or Prevnar
      13™ by each vaccination group. There are no formal hypotheses.
    


Intervention name(s): V114; Prevnar 13™; PNEUMOVAX™23
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL dose.; 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each 0.5 mL dose.; 23-valent pneumococcal polysaccharide vaccine containing 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F) in each 0.5 mL dose
Other intervention name(s): VAXNEUVANCE™; Pneumococcal 15-Valent Conjugate Vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pneumococcal conjugate vaccine (PCV), 15-valent, 22F, 33F
Study of Milnacipran for the Treatment of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a
      dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with
      fibromyalgia.
    


Intervention name(s): Placebo; Milnacipran 100mg
Intervention type(s): Drug; Drug
Intervention description(s): Placebo, oral administration, twice daily for 12 weeks; Milnacipran 100mg per day (50mg BID [twice a day])
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fibromyalgia
Pathophysiology Analysis of "Costello Syndrome" on Cellular Models
Condition: Costello Syndrome
MeSH terms: Costello Syndrome; Syndrome
Study type: Interventional

Summary: 
      The objective is to collect skin biopsies rom patients with Costello syndrome to analyze the
      molecular mechanisms responsible for this syndrome caused by a mutation in the HRAS gene and
      the effects of this mutation on energy metabolism and mitochondrial physiology.
    


Intervention name(s): Biopsy
Intervention type(s): Procedure
Intervention description(s): Skin biopsy is performed at the arm with a punch of 3 mm in diameter or a scalpel under local anesthesia, and then preserved in low glucose DMEM at room temperature.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science