bioihbjkbjnl/mcl2 huggingface dataset:
Immediate Effect of Energy Alignment and Mantra on Stress Related Pain in Adolescents
Condition: Stress Related Disorder; Musculoskeletal Pain; Headache
MeSH terms: Musculoskeletal Pain; Headache
Study type: Interventional

Summary: 
      Psychiatrists have expressed concern at the emergence of education as a serious source of
      stress for school-going children - causing high incidence of deaths by suicide. Many
      adolescents in India are referred to hospital psychiatric units for school-related distress -
      exhibiting symptoms of depression, high anxiety, frequent school refusal, phobia, physical
      complaints, irritability, weeping spells, and decreased interest in school work. Previous
      studies have found significant anxiety, distress, depression, worn outs and severe impact of
      psychological factors on the performances of dental, engineering and medical student. But
      students preparing for competitive exams have not been studied yet.

      Current study reports the scientific evidence of immediate effect of yoga based techniques
      combined with music and Vedic chants on adolescents preparing for competitive exams.
    


Intervention name(s): Yoga based Energy Alignment and Mantra
Intervention type(s): Behavioral
Intervention description(s): Yoga intervention was based on the concept that there is not just a physical body, but a "subtle energy" body can be bound with residue of stress, unprocessed emotions, and excess mental energy. Using Yoga based practices combined with Mantra chants, Music and energy alignments poses, stress induced pain can be alleviated.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
REmodeling the Left Ventricle With Atrial Modulated Pacing
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      New therapy tested in heart failure with preserved ejection fraction (HFpEF) patients with
      approved indications for pacing to determine if elevated pacing therapy is tolerated and
      whether there is a signal for efficacy.
    


Intervention name(s): Elevated night pacing on; Elevated night pacing off
Intervention type(s): Device; Device
Intervention description(s): Device will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times; Device will be programmed to normal lower rates
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Investigation of the Effect of Vitamin K3-lotion for the Treatment of Cetuximab Induced Folliculitis
Condition: Folliculitis
MeSH terms: Folliculitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study aims to explore the benefit of topical vitamin K3 lotion for the
      reactivation/rephosphorylation of EGF-receptor in the skin and the possible reduction in
      cutaneous side effects of EGFr-inhibition.

      Primary aim: The possible reduction of cutaneous side effects: folliculitis, dryness and
      redness of the skin.

      Secondary aim: To explore any possible side effects of topical vitamin K3 lotion.

      Methods: 36 patients with metastatic colorectal cancer or metastatic head and neck cancer
      allocated to treatment with chemotherapy and biweekly cetuximab. Two equally sized areas of
      at least 10x10 cm on the back or chest of the patient is marked. Patients receive in a double
      blinded procedure placebo lotion on one side and vitamin K3 lotion on the other side. The
      treatment may last for a maximum of two months and the patients are followed biweekly with
      photos, VAS-scores, questionnaires and CTCAE estimations. The patient will be able to take
      weekly photos at home during the weeks they are not seen at the outpatient clinic. During the
      treatment all other skin products or antibiotics is allowed and will be carefully registered
      by the health care professionals in the outpatient clinic.

      The patient may enter the trial in two different ways: 18 patients start treatment with study
      lotions at the time they start treatment with cetuximab. The other 18 patients start
      treatment with study lotions when folliculitis appears.

      Patients are asked for 1.5 mm skin biopsies of both study areas of the skin before start of
      treatment and after 4 weeks of treatment with placebo lotion and vitamin K3 lotion. These
      biopsies will be investigated for EGFr, phosphorylated EGFr and other central downstream
      mechanisms. The biopsy part of the study is optional for the patient.
    


Intervention name(s): Vitamin K3
Intervention type(s): Other
Intervention description(s): Lotion containing 1.5 mM Vitamin K3
Intervention MeSH terms: Vitamin K; Vitamin K 3
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Vitamin K3 lotion; Cetuximab induced folliculitis
Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
Condition: Fetal Alcohol Spectrum Disorders; Fetal Alcohol Syndrome; Partial Fetal Alcohol Syndrome; Alcohol Related Neurodevelopmental Disorder; Prenatal Alcohol Exposure
MeSH terms: Fetal Alcohol Spectrum Disorders; Syndrome; Neurodevelopmental Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if choline bitartrate can be administered daily to
      children with prenatal alcohol exposure, ages 2.5 to 5, as a potential treatment for brain
      development and cognitive functioning.
    


Intervention name(s): Choline bitartrate; Placebo for choline bitartrate
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.; Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.
Intervention MeSH terms: Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: FASD; FAS; Alcohol; Prenatal Alcohol
Hand Grip Strength in Athletic and Non-Athletic Girls at Different Phases of Menstrual Cycle
Condition: Grip; Athlete; Non-athlete; Menstrual Cycle
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      The study was designed as an observational study
    

Detailed description: 
      The study was designed as an observational case-control study
    

Intervention name(s): Hydraulic hand dynamometer (Jamar, Product model J00105, U.S.A)
Intervention type(s): Device
Intervention description(s): The hydraulic hand dynamometer is a reliable and valid an evaluation tool that's used to measure isometric grip force (hand grip strength) .
The hydraulic pinch gauge is a reliable and valid an evaluation tool that's used to measure isometric pinch force.
Other intervention name(s): Hydraulic pinch gauge(Jamar, Model 65861, U.S.A)
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Forty healthy post-pubertal virginal females participated in this study. They were divided
        into two groups' athletic group of twenty basketball and tennis players and non-athletic
        group of twenty students. The non-athletic girls were recruited from undergraduate students
        of Faculty of Physical Therapy, Misr University for science and technology, while the
        athletic girls were recruited from basketball and tennis teams from Mena Garden City Club,
        6 October Club and Shooting Club October.
      
Keywords: Menstrual cycle; Female sex hormones; Athletic female; Power
Gastro-intestinal and Hormonal Responses to Systemic Inflammatory Disease
Condition: Motility Disorder; Catabolic State; Endotoxemia
MeSH terms: Endotoxemia
Study type: Interventional

Summary: 
      The aim of this study is to describe hormonal responses and changes of the gastrointestinal
      (GI) tract during healthy and catabolic inflammatory conditions.

      Participants will receive isocaloric, isonitrogenous beverages of either whey or 3-OHB+whey
      in a randomized crossover design during either healthy (overnight fast) or catabolic
      conditions (inflammation/endotoxemia + 36 h fast and bed rest).
    

Detailed description: 
      Background: Endotoxemia (LPS) is known to cause fever, inflammation and nausea, but the
      underlying mechanisms are unknown. In a human disease model comprising LPS-induced
      inflammation, 36 hour fast and bed rest the investigators want to investigate mechanisms
      accounting for the nausea and decreased food intake often observed in hospitalized patients.

      Aim: This study aims to investigate total transit time and motility of the GI-tract together
      with the regulation of gut- and appetite hormones following catabolic conditions compared
      with healthy controlled conditions

      Hypothesis:

      Catabolic stress (endotoxemia/inflammation + 36 h fast and bed rest) induces GI-tract and
      hormonal changes compared with healthy conditions (overnight fast)

      Interventions:

      In a randomized crossover design, eight healthy, lean, young men will undergo either:

      i) Healthy conditions (overnight fast) + whey protein

      ii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest*) + whey protein

      iii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest*) + 3-ketone/whey
      protein

      Beverages will be isonitrogenous with 45 g whey protein + 20 g maltodextrin +/- 50 g of
      3-OHB. Bolus/sip administration will be applied (1/3 bolus, 2/3 sip).Beverages will be
      isocaloric (fat will be added to interventions without 3-OHB)

      *LPS will be administered (1 ng/kg) the day prior to the study together with fast and bed
      rest. On the study day LPS (0.5 ng/kg) will be injected.
    

Intervention name(s): Whey; 3-OHB/whey
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 45 g whey protein + 20 g maltodextrin; 50 g 3-OHB + 45 g whey protein + 20 g maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In a randomized crossover design, eight healthy lean young men will undergo either:
i) Healthy conditions (overnight fast) + whey protein ii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest) + whey protein iii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest) + 3-OHB/whey protein
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: gastric emptying; gastro-intestinal motility; endotoxemia; catabolism; GLP-1; GIP
Bioequivalence Study Between VHX-896 Tablets and Iloperidone Tablets in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, two-period, randomized study to evaluate the Bioequivalence of
      VHX-896 Tablets Relative to Iloperidone Tablets in Healthy Volunteers
    


Intervention name(s): VHX-896 and iloperidone; Iloperidone and VHX-896
Intervention type(s): Drug; Drug
Intervention description(s): oral tablet; oral tablet
Intervention MeSH terms: Iloperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Iloperidone; VHX-896; Bioequivalence
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of MYK-461 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish safety, tolerability, pharmacokinetics and
      pharmacodynamics of multiple doses of MYK-461 in human subjects. This is a randomized,
      double-blind, placebo-controlled, sequential group, multiple ascending (oral tablet) dose
      study in healthy volunteers aged 18-55 years.
    


Intervention name(s): MYK-461; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Bone Age of Chinese Child (BACC)
Condition: Bone Development
Study type: Observational

Summary: 
      The bone age of the hand and wrist will be assessed with X-rays in more than 20,000 healthy
      children age 3-18 years old recruited in 28 sites from 14 province.The bone mineral density
      (BMD) will be measured as well.
    

Detailed description: 
      As part of the "National Nutrition and Health Systematic Survey for 0-18 years old Children
      and Utilization of Survey Findings "(ChiCTR1900022825), more than 20,000 children age 3-18
      years old was recruited from 28 sites of 14 provinces within the framework of the
      ChiCTR190002282 study protocol. The population of this study was proportional to the
      ChiCTR190002282 study. The X-ray of no-dominant hand and wrist was taken with a mobile X-ray
      unit with shielding. A step wedge was imaged along the side of the hand at the same time for
      bone mineral density measurement. The bone age of the hand and wrist was assessed by trained
      MSK radiologists according to Chinese standard. The bone mineral density of the wrist was
      measured with radioabsorptiometry (RA). The demographic parameters were collected by the
      study of ChiCTR190002282 protocol.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        As part of the "National Nutrition and Health Systematic Survey for 0-18 years old Children
        and Utilization of Survey Findings" (ChiCTR1900022825). This population is the subset of
        the ChiCTR1900022825 study, age 3-18 years old, sample proportion to the general study
        population. General healthy children age over 3 years old up to 18 years old from the
        kindergarden, primary school, middle school and high school.
      
Keywords: bone age; bone mineral density; X-ray; Chinese child
Effectiveness of Pharmacopuncture for Chronic Neck Pain
Condition: Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      In this study, the investigators will evaluate the efficacy and safety of pharmacopuncture
      therapy for chronic neck pain compared to physical therapy.
    

Detailed description: 
      This study is prgmatic RCT of pharmacopuncture therapy for chronic neck pain compared to
      physical therapy.
    

Intervention name(s): pharmacopuncture therapy; Physical therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): The participants in the treatment group will be receive one or more pharmacopuncture therapy according to the physician's decision.; The participants in the control group will be receive one or more physical therapy according to the physician's decision.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Deep Dry Needling for the Management of Post-stroke Spasticity
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Stroke is the leading cause of physical disability, particularly due to the presence of
      spasticity. Different needling techniques, including the use of Botulinum Toxin A are
      proposed for the management of spasticity. The presence of spasticity in the lower extremity
      implies several impairments for standing and walking inducing high disability. No study has
      investigated the effects of deep dry needling inserted into the targeted spastic musculature
      in patients with stroke. The investigators will conduct a randomized controlled trial
      investigating the effects of a single session of deep dry needling over the musculature of
      the leg on spasticity, widespread pressure pain sensitivity and plantar pressures
      (baropodometry) in individuals with chronic stroke. The investigators hypothesize that
      patients receiving a single session of dry needling would exhibit a greater reduction in
      spasticity and pressure sensitivity than those who will not receive the intervention.
    


Intervention name(s): Dry needling
Intervention type(s): Other
Intervention description(s): Once the most painful spot is located within a palpable spastic taut band, the overlying skin is cleaned with alcohol. The needle will be inserted, penetrating the skin about 15-20mm, until the first local twitch response is obtained. Once the first local twitch response is obtained, the needle will be moved up and down (4 to 5 mm. vertical motions with no rotation) in the muscle at approximately 1Hz for 25-30 seconds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Tele-Yoga Therapy on Patients With Chronic Musculoskeletal Pain During Covid-19 Lockdown
Condition: Chronic Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain
Study type: Interventional

Summary: 
      Covid-19 outbreak and lockdown measures raised significant concerns over clinical management
      of chronic pain patients around the world. Patients with chronic musculoskeletal pain (CMSP)
      are at high risk of physical disability, psychological distress, and poor quality of life.
      Analgesic medications were main management during lockdown, but opioid-related concerns have
      prompted to find immediate alternatives.

      Present study was undertaken to determine whether patients randomized to tele-yoga therapy
      would experience less pain, disability and improved global health, adherence and
      satisfaction, compared with patients assigned to usual care.
    


Intervention name(s): Tele-yoga therapy; Primary care
Intervention type(s): Other; Other
Intervention description(s): Each session included combinations of different yoga exercises, postures, yoga breathing, yoga relaxation techniques, yoga counselling and meditative practices based on individualisation.; Patients will follow standard care provided by primary care physicians including analgesics and self care management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Tele-Yoga Therapy; Chronic musculoskeletal pain; Randomized controlled trial
Evogliptin in Type 2 Diabetes Mellitus (EVOLUTION: EVOgLiptina no Diabetes Mellitus TIpO 2)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II, multicenter, randomized, double-blind, double-dummy study with four parallel
      treatment groups, with active control, will be performed only in brazilian sites under the
      sponsorship of Eurofarma Laboratórios S.A.. The enrollment for participants in the study will
      start after the relevant ethical and regulatory approvals and will have an estimated duration
      of 18 months.

      One hundred and forty-four participants with T2DM according to the criteria of ADA who
      consent to participation in the study by signing the Informed Consent Form (ICF) will be
      enrolled in the study. In order to be enrolled, the patients must meet all the inclusion
      criteria and none of the exclusion criteria. The eligible participants will be randomized
      1:1:1:1 to receive evogliptin (EVO) at the doses of 2.5 mg/day (N = 36), 5.0 mg/day (N = 36)
      or 10 mg/day (N = 36) or sitagliptin (SITA) at the dose of 100 mg/day (N = 36), as a single
      daily dose, for 12 weeks.
    


Intervention name(s): Evogliptin; Sitagliptin; Placebo Evogliptin; Placebo Sitagliptin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 tablet per day; 1 tablet per day; 1 tablet per day; 1 tablet per day
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus Type 2
Effect of American Ginseng on Exercise-induced Muscle Soreness
Condition: Muscle Damage
MeSH terms: Myalgia
Study type: Interventional
Phase: Phase 1

Summary: 
      Healthy participants will ingest American ginseng daily or a placebo for four weeks prior to
      engaging in a unaccustomed exercise bout designed to induce mild-moderate muscle soreness.
      Muscle soreness will be assessed via decrements in muscle strength and with a self-rating of
      perceived soreness before and several times after the exercise.
    

Detailed description: 
      Healthy men and women will consume either 2000 mg of American ginseng daily (four 500 mg
      pills will be taken at four different times during the day always with food/meals) or a
      placebo (4 cellulose) for four weeks prior to engaging in a 40 minute downhill treadmill jog
      (12% decline) at a speed of 7 miles per hour. Participants will consume one pill with
      breakfast, one pill with lunch, one pill with dinner and another pill with a snack either
      between meals or prior to bedtime. The exercise will be consist of five, eight minute bouts
      of jogging with two minutes of rest/recovery in between. The degree of muscle soreness will
      be assessed using a Biodex strength testing machine (isometric and concentric isokinetic
      torque), and a self-rating of perceived soreness on a scale from zero to ten. All of the
      above measures will be taken before and several times after the downhill jogging protocol.
    

Intervention name(s): Ginseng
Intervention type(s): Dietary Supplement
Intervention description(s): Effect of four weeks of daily Ginseng intake (2gm/day) on muscle soreness following downhill running exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Muscle; Soreness; Muscle function; Damage; Ginseng
Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of a New Ultra Low Molecular Weight Heparin (RO-14) Administered Subcutaneously Increasing Single-doses to Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Clinical trial to evaluate the tolerability and pharmacokinetics of a new ultra low molecular
      weight heparin (RO-14) administered subcutaneously increasing single-doses to healthy male
      volunteers
    


Intervention name(s): RO-14
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics; ultra low molecular weight heparin