bioihbjkbjnl/mcl2 huggingface dataset:
Whole Body Vibration on Running Biomechanics
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Whole body vibration (WBV) acutely improves quadriceps strength, and may improve long-term
      outcomes in individuals with anterior cruciate ligament reconstruction (ACLR). However, it is
      unclear if WBV influences athletic tasks such as running. The purpose of this study is to
      evaluate the influence of WBV on running biomechanics in individuals with ACLR.
    

Detailed description: 
      Individuals with anterior cruciate ligament reconstruction (ACLR) have deficits in quadriceps
      muscles function that influences walking and running biomechanics. In the long term,
      alterations in walking and running contribute to physical disability and the development of
      knee osteoarthritis. Unfortunately, rehabilitation for the quadriceps muscles is often
      ineffective, and novel strategies to improve rehabilitation efforts are needed. Whole body
      vibration (WBV) acutely improves quadriceps strength, and may improve long-term outcomes in
      individuals with ACLR. However, it is unclear if WBV influences athletic tasks such as
      running.

      Specific Aim 1: The purpose of this study is to determine the effect of WBV on running
      biomechanics in individuals with ACLR. The investigators hypothesize that WBV will improve
      running characteristics associated with knee osteoarthritis development.
    

Intervention name(s): Whole Body Vibration
Intervention type(s): Other
Intervention description(s): Participants will stand in a squatted position on a platform that provides a brief vibratory stimuli.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC
      HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in
      participants with relapsing remitting multiple sclerosis.

      The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in
      slowing functional decline and disability progression and maintaining quality of life in this
      participant population.
    


Intervention name(s): BIIB019 (Daclizumab High Yield Process); Interferon beta-1a Placebo; Interferon beta-1a; Daclizumab High Yield Process Placebo
Intervention type(s): Biological; Drug; Biological; Drug
Intervention description(s): Daclizumab High Yield Process for subcutaneous injection; Placebo to interferon beta-1a intramuscular injection; Interferon beta-1a for intramuscular injection; Placebo to Daclizumab High Yield Process subcutaneous injection
Other intervention name(s): DAC HYP; Avonex; IFN β-1a
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Daclizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Specific Diet and Physical Activity on Weight and/or Fat Loss
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The main purpose of this study is to assess metabolic effects (decreased amount of body fat
      content, insulin sensitivity and lipid profile improvement) of weight loss intervention based
      on specific life style counseling (low calorie "metabolic stairs" diet and circuit-based
      exercise in a comparison to conventional diet and exercise. The main hypothesis is that more
      significant beneficial metabolic effects will have specific life style counseling effect than
      conventional diet and exercise. The main purpose of this study is to assess above mentioned
      metabolic changes before and after 6-8 weeks of weight loss intervention.

      The investigators will also study the following:

        1. The impact of life style counseling induced weight and/or fat loss on physical fitness

        2. The impact of life style counseling induced weight and/or fat loss on metabolic
           parameters (e.g. insulin sensitivity, lipid profile, ect.)
    

Detailed description: 
      I
    

Intervention name(s): Lifestyle Counseling
Intervention type(s): Behavioral
Intervention description(s): In both arms life style counseling: Low calorie diet- 30% reduction of weight maintenance calories (TDEE); and recommended moderate exercise 3 times per week 45 minutes.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: overweight and obesity; adipose tissue; weight loss program; low-calorie diet; circuit-based exercise; metabolic cardiovascular syndrome
Efficacy Evaluation of Wasabi Leaf Extract on Skin
Condition: Skin Condition
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      To assess the efficacy of Wasabi Leaf Extract on skin
    


Intervention name(s): Placebo drink; Wasabi Leaf Extract Drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): consume 1 bottle per day; consume 1 bottle per day
Other intervention name(s): Wasabi (Wasabia japonica) leaf extract drink
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism and Effect of Testosteron Treatment
Condition: Hypogonadism
MeSH terms: Obesity; Hypogonadism
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is designed to answer the following questions:

        1. What is the levels of visceral adiposity index and Triglycerides/HDL cholesterol ratio
           in hypogonadism?

        2. What is the effect of testosterone replacement on the visceral adiposity index and
           Triglycerides/HDL cholesterol ratio?
    

Detailed description: 
      This is a retrospective design, which is performed by investigating the registrations of
      patients with hypogonadotrophic hypogonadism between the years 2007-2010.
    

Intervention name(s): Testosterone
Intervention type(s): Drug
Intervention description(s): Testosterone 250 mg injection per 3-4 weeks for 6 months
Other intervention name(s): sustanon 250 mg
Intervention MeSH terms: Testosterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: visceral adiposity index; triglycerides / hdl cholesterol ratio; testosterone
HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) Vaccine Study
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluated the safety, immunogenicity, and preliminary assessment of efficacy of a
      novel vaccine encoding conserved elements (CE) of the HIV-1 Gag core protein, p24Gag, as a
      therapeutic vaccine in HIV-1 infected persons who were on antiretroviral therapy (ART). The
      study aimed to induce potent virus-specific cytotoxic T lymphocytes (CTL) responses.
    

Detailed description: 
      This study evaluated the safety, immunogenicity, and preliminary assessment of efficacy of a
      novel vaccine encoding conserved elements (CE) of the HIV-1 Gag core protein, p24Gag, as a
      therapeutic vaccine in HIV-1 infected persons who were on antiretroviral therapy (ART).

      The study randomly assigned participants to one of three groups. Participants in Arm 1
      received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with
      full-length p55^gag pDNA vaccine at Weeks 12 and 24. Participants in Arm 2 received
      full-length p55^gag pDNA vaccine at Weeks 0, 4, 12, and 24. Participants in Arm 3 received
      placebo at Weeks 0, 4, 12, and 24.

      Study visits occurred at Weeks 0, 4, 6, 12, 24, 26, and 48 and included physical examinations
      and blood and urine collection. Some participants underwent leukapheresis and stool sample
      collection.
    

Intervention name(s): p24CE1/2 pDNA vaccine; p24CE1/2 pDNA vaccine admixed with full-length p55^gag pDNA vaccine; Full-length p55^gag pDNA vaccine; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 4 mg administered by one injection/electroporation; 2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55^gag pDNA administered by one injection/electroporation; 4 mg full-length p55^gag pDNA vaccine administered by one injection/electroporation; 1 mL placebo administered by one injection/electroporation
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Therapeutic Vaccination
The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control
      and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic
      control.
    


Intervention name(s): Placebo (linagliptin); Placebo (linagliptin); Sitagliptin; Placebo (sitagliptin); Placebo (sitagliptin); Linagliptin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): once daily for 28 days; once daily for 28 days; 100 mg once daily for 28 days; once daily for 28 days; once daily for 28 days; 5mg once daily for 28 days
Intervention MeSH terms: Sitagliptin Phosphate; Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Identification of Nutrient Receptors Gastrointestinal Tract
Condition: Distribution of Nutrient Receptors Studied in Intestinal Tissue Obtained Via Endoscopy
Study type: Interventional

Summary: 
      Investigating which receptors are involved in nutient sensing of enteroendocrine cells and on
      nerve endings, gives further knowledge on the kind of nutrients responsible for the secretion
      of gut hormones involved in satiety signalling. So far only little is know about the
      distribution of potential nutient sensing receptors along the gastrointestinal tract. The
      investigators are interested in the intestinal parts which highly secrete CCK and GLP-1. By
      comparing these tissues, it is expected to further elucidate which receptors are important
      for satiety signalling in the intestine.

      Having this information gives rise to further reseach on how these receptors stimulate the
      secretion of gut hormones. Moreover, knowing which receptors are involved in satiety
      signalling, gives oppertunity for targeting these receptors to increase satiety and
      influencing food intake.

      The investigators aim to investigate the distribution of the above mentioned receptors, in
      the following referred to as 'nutrient sensing receptors', which have been suggested to be
      involved in satiety signalling, throughout the intestinal tract. For these receptors the gene
      expression, localisation and protein expression will be determined at different locations.
      This will be measured in intestinal mucosal biopsies of two locations in the duodenum, in the
      terminal ileum, the ascending colon, the transverse colon and the descending colon.
    


Intervention name(s): Taking intestinal biopsies
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Effects of Hippotherapy on Physical Fitness and Attention in Cerebral Palsy
Condition: Cerebral Palsy; Physical Activity; Attention Disorder
MeSH terms: Paralysis; Cerebral Palsy; Cognition Disorders
Study type: Interventional

Summary: 
      This research analyzes whether hippotherapy improves the physical activity, cardiopulmonary
      fitness, and attention in children with cerebral palsy and whether this enhances their
      general health and quality of life.
    

Detailed description: 
      This research aims to promote hippotherapy by scientifically proving its therapeutic effects
      and mechanism to contribute to improving the health and quality of life of the patients as
      well as reducing their global burden of disease by shifting the current passive
      "therapy-oriented" paradigm to a more proactive "participation-oriented" paradigm.

      Ever since physical activity and physical fitness have been reported to have an inverse
      relationship with the mortality rate, especially deaths due to cardiovascular disease,
      various efforts have been made to optimize physical activity and physical fitness among
      children with cerebral palsy. ADHD is one of the most common coexisting conditions of
      cerebral palsy. More participation in engaging sports activities like therapeutic riding is
      anticipated to improve patient health and their quality of life.

      Hippotherapy is expected to improve clinical symptom of ADHD in children with cerebral palsy
      while preventing possible ensuing psychiatric disorders, thereby bringing significant
      improvement in their health and quality of life.
    

Intervention name(s): hippotherapy
Intervention type(s): Behavioral
Intervention description(s): 16weeks hippotherapy program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: cerebral palsy; hippotherapy; cardiopulmonary fitness; physical activity; attention
ARTIST: ARThrose Intervention STandardisée
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      International recommendations (ACR,EULAR) emphasize physical exercise and weight loss for
      patients suffering from knee osteoarthritis. Nevertheless, number of patients receiving
      advices for these 2 points still low. This study evaluates the impact of a standardized
      medical intervention (patient education, weight reduction and physical exercise) in knee
      osteoarthritis patients.
    


Intervention name(s): Education, weight reduction and physical exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Educational/Counseling/Training
The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia
Condition: Depression; Anxiety; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The study examined the effects of adding the sleep aid eszopiclone to Lexapro on mood and
      levels of the neurotransmitters glutamate, glutamine, and GABA in women with depression,
      anxiety, and insomnia. Specifically, the objective was to determine the role of glutamate,
      glutamine, and GABA in mediating the response the to the combined treatment. The hypothesis
      was that levels of glutamine and glutamate will be increased in women receiving eszopiclone
      compared to those receiving placebo. The antidepressant effect of the medication combination
      and its effect on sleep status was also assessed.
    


Intervention name(s): Eszopiclone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects receive 10 mg escitalopram daily for four weeks and 10 or 20 mg for an additional six weeks. Subjects also receive 3 mg eszopiclone.; Subjects receive 10 mg of escitalopram daily for four weeks followed by 10 or 20 mg for an additional six weeks. Subjects also receive placebo for eszopiclone.
Other intervention name(s): Lunesta
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Magnetic Resonance Spectroscopy; Glutamate; Glutamine; GABA; Lexapro; Lunesta; Escitalopram; Eszopiclone
Healing With Venlafaxine After Injury (HELP)
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Purpose: The purpose of this study is to demonstrate the potential efficacy of venlafaxine
      administration in reducing acute and chronic musculoskeletal pain in individuals presenting
      to the ED for evaluation after motor vehicle collision.

      Participants: Participants will consist of 60 patients between the ages of 18-50 who present
      to the ED within 12 hours post-motor vehicle collision. Patients who report a neck pain score
      > 6 will be screened for further eligibility.

      Procedures (methods): Using a placebo-controlled, randomized, double-blind trial design, 60
      high risk patients will be randomized to venlafaxine vs. placebo in the ED. The ability of
      venlafaxine to decrease acute and persistent musculoskeletal neck pain will be assessed
      during serial short-term telephone follow-ups as well as more in-depth follow-ups at 6 weeks,
      4 months, and 6 months post-MVC.
    

Detailed description: 
      Results from both animal and human studies suggest that treatment with the
      serotonin-norepinephrine reuptake inhibitor (SNRIs) venlafaxine may reduce post-MVC pain. In
      addition, venlafaxine has been shown to be beneficial in reducing posttraumatic stress
      disorder (PTSD) symptoms, and in some patients PTSD symptoms may contribute to reinforcing
      pain persistence after trauma.

      This phase IIB pilot trial will screen patients presenting to the ED after MVC for the
      presence of severe axial pain (>4 on a 0-10 numeric rating scale). Sixty of these "high risk"
      patients will be randomized to venlafaxine vs. placebo, and the ability of venlafaxine to
      decrease acute and persistent musculoskeletal axial pain will be assessed.

      Results will be used to design a large-scale RCT assessing the efficacy of venlafaxine
      intervention in decreasing acute and persistent musculoskeletal pain in high-risk patients
      presenting to the ED after minor MVC.
    

Intervention name(s): Venlafaxine
Intervention type(s): Drug
Intervention description(s): Sixty patients who present following a minor motor vehicle collision will be randomized to venlafaxine vs. placebo, and the ability of venlafaxine to decrease acute and persistent musculoskeletal neck pain will be assessed.
Other intervention name(s): Effexor
Intervention MeSH terms: Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Neck Pain; Musculoskeletal pain; Venlafaxine
Promoting Early Adolescent Non-smoking With a Game Intervention Supporting Self-efficacy
Condition: Self Efficacy; Smoking
Study type: Interventional

Summary: 
      This intervention study evaluates the effectiveness of a digital game intervention supporting
      smoking refusal self-efficacy among early adolescents (10-13 y). The participants are
      randomly allocated to two groups: the experimental group that receives the digital game
      intervention, and the control group that receives no intervention.
    


Intervention name(s): Game intervention
Intervention type(s): Behavioral
Intervention description(s): Game intervention consists of 15-30 minutes digital health game playing at school and 2 weeks free usage of the digital health game during free time. In addition, after the 2 weeks period of game playing, 30-minute debriefing sessions with a research are held.
The digital health game includes visualized elements with sound effects that aim at increasing understanding about the consequences of tobacco product use and supporting refusal skills. The health game includes different mini-games and also textual information.
The debriefing sessions with a researcher include small group and group discussions about the themes presented in the game. A researcher leads and teachers facilitate the discussions. The debriefing sessions aim to connect the game experience with daily life situations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
E4/DRSP Ovarian Function Inhibition Study
Condition: Prevention of Pregnancy
Study type: Interventional
Phase: Phase 2

Summary: 
      A combined oral contraceptive (COC) containing 15 mg E4 and 3 mg DRSP administered for 24
      days followed by 4 placebo tablets, is being evaluated for further development. This study
      will investigate the effect of this COC on ovarian function inhibition, levels of serum
      luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol (E2) and progesterone
      during 3 treatment cycles in comparison with the reference COC 20 mcg EE/3 mg DRSP.
    


Intervention name(s): 15 mg E4/3 mg DRSP; 20 mcg EE/3 mg DRSP
Intervention type(s): Drug; Drug
Intervention description(s): 15 mg E4/3 mg DRSP combined tablets will be administered orally once daily in a 24/4 day regimen for three consecutive cycles; 20 mcg EE/3 mg DRSP combined tablets will be administered orally once daily in a 24/4 day regimen for three consecutive cycles
Other intervention name(s): 15 mg estetrol combined with 3 mg drospirenone; 20 mcg ethinylestradiol combined with 3 mg drospirenone (Yaz)
Intervention MeSH terms: Drospirenone; Ethinyl Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin
Condition: Prurigo Nodularis; Pruritus; Chronic Pruritus; Chronic Prurigo; Skin Diseases
MeSH terms: Pruritus; Skin Diseases; Prurigo; Neurodermatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to assess the efficacy, safety, and tolerability of Abrocitinib for
      the treatment of Prurigo Nodularis (PN) or Chronic Pruritus of Unknown Origin (CPUO) in
      patients experiencing moderate to severe pruritus.
    

Detailed description: 
      This is a trial to assess the efficacy of Abrocitinib as a therapeutic for Prurigo Nodularis
      (PN) and Chronic Pruritus of Unknown Origin (CPUO). The study will consist of a 4-week
      Screening period, a 12-week treatment period and then a 4-week follow up period. The arms
      will run in parallel and patients will take 200 mg oral Abrocitinib daily for the duration of
      the 12-week treatment period.
    

Intervention name(s): Abrocitinib
Intervention type(s): Drug
Intervention description(s): During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Intervention MeSH terms: Abrocitinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a non-randomized study with two arms conducted in parallel: an arm of 10 Prurigo Nodularis (PN) patients, and an arm of 10 Chronic pruritus of unknown origin (CPUO) patients.
Masking: None (Open Label)
Primary purpose: Treatment