bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin D Supplementation in Physical Performance
Condition: Healthy; Athletes
Study type: Interventional

Summary: 
      This study was performed to evaluate the efficacy of weekly vitamin D supplementation on
      athletic performance in Iranian athletes
    

Detailed description: 
      Seventy subjects were enrolled in the study. The athletes were randomly divided into two
      groups: vitamin D supplement (D; received 50,000 IU of vitamin D supplement weekly) and
      control (P, received a placebo weekly). Duration of the study was eight weeks.
      Anthropometric, dietary, athletic performance and biochemical evaluations were performed for
      all subjects in the beginning and in the end of the intervention period.
    

Intervention name(s): vitamin D supplement; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): D; received 50,000 IU of vitamin D supplement weekly; placebo
Other intervention name(s): D; P
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vitamin D; atletes; physical performance
Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one chemotherapy drug may kill more tumor
      cells.

      PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and ifosfamide in
      treating patients who have metastatic kidney cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the efficacy in terms of objective response after treatment with
      ifosfamide and doxorubicin in patients with metastatic sarcomatoid renal cell cancer. II.
      Determine the toxicity of this regimen in these patients. III. Determine the effect of this
      regimen on the survival of these patients.

      OUTLINE: This is a multicenter study. Patients receive doxorubicin IV on day 1 and ifosfamide
      IV over 2 hours on days 1 and 2. Treatment is repeated every 3 weeks for up to 8 courses in
      the absence of disease progression or unacceptable toxicity.

      PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 3 years.
    

Intervention name(s): doxorubicin hydrochloride; ifosfamide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Ifosfamide
Primary purpose: Treatment
Keywords: stage IV renal cell cancer
Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm
Condition: Back Muscle Spasm; Back Pain; Back Strain; Back Spasm Upper; Muscle Spasm; Acute Pain
MeSH terms: Muscle Cramp; Spasm; Hyperkinesis; Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a double-blind, randomized, placebo-controlled, multicenter study of the efficacy and
      safety of tolperisone (a non-opioid) or placebo administered in subjects with pain due to
      acute back muscle spasm.
    


Intervention name(s): Tolperisone Hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TID; TID
Other intervention name(s): Tolperisone
Intervention MeSH terms: Tolperisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)
Condition: Intragastric Acidity
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, crossover study is to evaluate the early effectiveness, defined as effect on
      intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter
      (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional
      purposes are to:

        1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the
           1st, 4th, and 11th days of dosing with each of the indicated treatments;

        2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for
           controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing.

        3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4
           hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid
           inhibition at steady-state when administered on the 11th day of dosing.
    

Detailed description: 
      Participants were randomized in a 3-way crossover design and received, in random order,
      Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate), Prilosec OTC Tablets
      (20 mg-equivalent omeprazole), and Placebo Capsules. Participants received each treatment for
      11 days. There was a minimum of a 2-week washout period between treatment arms.
    

Intervention name(s): Zegerid; Prilosec OTC™ Tablets; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Zegerid taken once daily for 11 days.; Prilosec OTC™ Tablets taken once daily for 11 days.; Placebo taken once daily for 11 days.
Intervention MeSH terms: Omeprazole; Omeprazole, sodium bicarbonate drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Gastric Acid; Human Experimentation
Effects of Exercise on sRAGE Levels and Cardiometabolic Risk Factors
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of exercise on diverse cardiometabolic
      risk factors and indicators of atherosclerosis in patients with type 2 diabetes mellitus
      (T2DM).
    


Intervention name(s): Aerobic Exercise Group; Control Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 weeks Aerobic exercise; maintaining usual activities
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects
Condition: Severe Sepsis
MeSH terms: Sepsis
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to measure the amount of study drug (BMS-986189) in the
      blood and urine and to see if BMS-986189 is safe and well-tolerated in healthy people after a
      single dose.
    


Intervention name(s): BMS-986189; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Safety and Efficacy of EPI-743 in Patients With Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the effects of EPI-743 on visual function and
      neurologic function in patients with Friedreich's ataxia.
    


Intervention name(s): Placebo; EPI-743 400 mg; EPI-743 200 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo capsules
Intervention MeSH terms: Ubiquinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Friedreich's; Ataxia; FRDA; FA; EPI-743; Edison
Interest of Catalepsy in the Hypnotic Trance
Condition: Hypnosis
MeSH terms: Catalepsy
Study type: Interventional

Summary: 
      Catalepsy seems to facilitate hypnotic induction and deepen hypnotic trance, although no work
      confirms the usefulness of this technique which is in common use in hypnosis. Furthermore, it
      has been shown that the hypnotic trance state is accompanied by an increase in
      parasympathetic tone, the non-invasive measurement of which is easy by the ANI monitor
      (Analgesia Nociception Index).

      The research hypothesis is that, by adding a body dissociation, catalepsy could facilitate
      and intensify the hypnotic trance, the intensity of which can be monitored and is
      proportional to the parasympathetic tone.
    

Detailed description: 
      After randomization, subjects will either benefit from the normal hypnotic trance, or from
      the hypnotic trance associated with catalepsy of the hand.

      T0 = installation in a sitting position and collection of an accompanying theme T1 =
      induction of the hypnotic trance (closing eyes) with restitution of the theme to the patient
      and suggestion of comfort over a period of 5 to 10 min T2 = validation of comfort by a
      pre-established signal T3 = return to consciousness (opening eyes) T4 = end of questionnaire
      about absorption, dissociation and time perception
    

Intervention name(s): Hypnosis session; Catalepsy
Intervention type(s): Procedure; Other
Intervention description(s): Comfort hypnosis: accompaniment of a pleasant memory.; Catalepsy of the hand.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hypnosis; Catalepsy; Parasympathetic tone; Absorption; Dissociation; Perception of time
Relationship of Endoplasmic Reticulum Stress and Adenoid Diseases
Condition: Adenoiditis Acute Infective
Study type: Observational

Summary: 
      Adenoid tissue is a significant organ for the performing of immune systems in children. The
      Endoplasmic Reticulum (ER), is an organelle needed for the care of a stable function of
      cells. The purpose of the study was to explore the correlation among ER stress and adenoid
      tissue disorders and to explain the structure of diseases related to the immune system.
    


Intervention name(s): Adenoidectomy surgery
Intervention type(s): Procedure
Intervention description(s): All patients underwent adenoidectomy under general anesthesia by routine curettage method and adenoid tissues were put in formaldehyde and sent to the genetics department for the exploration of ER stress and apoptosis markers.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study was performed on 54 patients (28 male, 26 female) between the ages of 3 and 9
        (mean 5) with the clinical diagnosis of chronic adenoiditis and adenoid hypertrophy and who
        underwent adenoidectomy due to either chronic adenoiditis or adenoid hypertrophy.
      
Biospecimen description: 
      Adenoid tissues were gathered in groups in accordance with their size and analyzed in regards
      to ER stress and apoptosis markers by Real-Time PCR and Western Blotting method.
    
Keywords: Adenoidectomy; ; Endoplasmic Reticulum
ACTH for Fatigue in Multiple Sclerosis Patients
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Fatigue
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study of Acthar gel (ACTH) in patients with relapsing multiple sclerosis who are
      experiencing chronic fatigue.
    

Detailed description: 
      This is a multi-center, randomized, double-blind, placebo-controlled study to demonstrate the
      safety, tolerability, and effect of ACTH on fatigue in patients with relapsing multiple
      sclerosis (RMS). The primary objective of this study is to assess the efficacy of ACTH versus
      placebo in reducing fatigability in patients with RMS. Secondary objectives include
      assessment of the tolerability and safety of twice-weekly ACTH treatment vs. placebo and
      evaluation of ACTH on depression, sleepiness, and quality of life measures and correlations
      between these measures.
    

Intervention name(s): ACTH; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ACTH injections twice weekly for 28 weeks.; Placebo injections twice weekly for 28 weeks.
Other intervention name(s): Acthar Gel; Repository Corticotropin Injection; Control
Intervention MeSH terms: Adrenocorticotropic Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Acthar Gel; ACTH; Fatigue
Comparison Between Laryngoscope McCoy With Macintosh
Condition: Surgery
Study type: Interventional

Summary: 
      This study aimed to compare cardiovascular response and ease of intubation using laryngoscope
      McCoy with Macintosh
    

Detailed description: 
      Eighty-two subjects were given informed consent before enrolling the study and randomized
      into two groups: McCoy and Macintosh. Non-invasive blood pressure
    

Intervention name(s): Laryngoscope McCoy; Laryngoscope Macintosh
Intervention type(s): Device; Device
Intervention description(s): Subjects who fulfill inclusion criteria will be intubated using laryngoscope McCoy; Subjects who fulfill inclusion criteria will be intubated using laryngoscope Macintosh
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Intubation; Cardiovascular response; Laryngoscope
Evaluating Celecoxib Activity in Mycobacterium Tuberculosis: A Whole Blood Bactericidal Activity Study in Healthy Volunteers
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bactericidal activity against Mycobacterium
      tuberculosis of celecoxib in combination with established drugs used to treat tuberculosis
      (TB). Pharmacokinetics (PK) and whole blood bactericidal activity (WBA) will be measured in
      healthy volunteers following administration of the study drugs alone and in combination.
    

Detailed description: 
      The whole blood bactericidal activity (WBA) assay is an ex vivo model for measuring the
      combined effects of administered drugs, host factors and strain factors on mycobacterial
      sterilisation. If performed in parallel with PK measurements, the method can be used to
      evaluate the effect of drugs throughout the dosing cycle. Celecoxib is a COX-2 inhibitor with
      immuno-modulatory properties important in the host defence against tuberculosis (TB). The aim
      of this trial is to investigate the effect on WBA of manipulation of the host response to TB
      using celecoxib, in combination with established TB drugs.
    

Intervention name(s): Celecoxib; Rifampicin; Pyrazinamide
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Celebrex; Rifampin
Intervention MeSH terms: Rifampin; Pyrazinamide; Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Active Induction of Labor in Pregnancies Complicated With Oligohydramnios at Term
Condition: Oligohydramnios
MeSH terms: Oligohydramnios
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the risk of cesarean delivery in pregnancies
      complicated with isolated oligohydramnios managed by induction of labor. This prospective
      case-control study was conducted in Hamıdıye Sisli Etfal Teaching and Research Hospital
      between January 2013 and June 2014. 159 women with isolated oligohydramnios and 165 women
      with postdate pregnancies who met the inclusion criteria underwent induction of labor with
      dinoprostone or oxytocin. The rate and the indications of C/S deliveries were compared
      between two groups.
    

Detailed description: 
      The study was designed as a prospective study. The rates of cesarean section and
      maternal/fetal outcomes had been compared between pregnancies complicated with isolated
      oligohydramnios at term and postdate pregnancies. All patients with isolated oligohydramnios
      were term (37-40 weeks' gestation according to accurate last menstrual period and first
      trimester sonographic examination). Oligohydramnios was defined as an amniotic fluid index <
      5 cm. The control group consisted of prolonged pregnancies in the absence of spontaneous
      labor and oligohydramnios. Prolonged pregnancy is diagnosed if 41 gestational weeks are
      completed according to accurate date of last menstrual period and first trimester ultrasound.
      All patients who accepted to join the study gave informed consent. All patients had a
      complete physical and obstetrical examination. Vital signs were recorded at regular
      intervals. The primary outcome measure was defined as cesarean section rates in pregnancies
      complicated with isolated oligohydramnios managed by induction of labor.
    

Intervention name(s): normal delivery tracking
Intervention type(s): Other
Intervention description(s): normal delivery tracking
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients with isolated oligohydramnios were term (37-40 weeks' gestation according to
        accurate last menstrual period and first trimester sonographic examination).
        Oligohydramnios was defined as an amniotic fluid index < 5 cm. The control group consisted
        of prolonged pregnancies in the absence of spontaneous labor and oligohydramnios. Prolonged
        pregnancy is diagnosed if 41 gestational weeks are completed according to accurate date of
        last menstrual period and first trimester ultrasound.
      
Keywords: induction; cesarean delivery
Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome
Condition: Dry Eye Due to Sjögren's Syndrome
MeSH terms: Sjogren's Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Dry eye complaints occur in 5.5 to 33.7% of the population, and are ranked as the most
      frequent symptoms of patients visiting ophthalmologists. Dry eye syndrome is caused by the
      reduced production and/or improper quality of the tear film. One of the causes of reduced
      tear production is Sjögren's syndrome. Sjögren's is estimated to affect up to 4 million
      patients in the US alone. It affects mostly middle aged women (40-50 years of age) with a
      female to male prevalence ratio of 9:1.

      The current study seeks to evaluate the safety and efficacy of LO2A ophthalmic solution in
      the symptomatic treatment of dry eye in patients with Sjögren's syndrome. This study will be
      conducted in compliance with the protocol, GCP,and applicable regulatory requirements.
    

Detailed description: 
      This is a randomized, double-masked, comparative study versus Systane ultra UD, to evaluate
      the efficacy and safety of LO2A eye drops for symptomatic improvement of dry eye in Patients
      with Sjögren's syndrome. Eligible patients will be randomly assigned in a 1:1 ratio to one of
      two treatment groups, LO2A or Systane ultra UD, respectively.

      The study will consist of a screening period of up to two weeks and a 3-month double blind
      treatment period (topical application of eye drops four times daily)

      Up to 60 subjects are planned to be recruited to this study, randomized to one of two
      treatment arms using a 1:1 active (LO2A) to Systane ultra UD ratio.
    

Intervention name(s): LO2A eye drops; Systane Ultra UD
Intervention type(s): Drug; Drug
Intervention description(s): Sodium hyaluronate; Active Ingredients; Polyethylene Glycol Propylene Glycol
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, double-Masked, comparative study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Thoracic Spine Manipulation on Pressure Pain Sensitivity of Active Myofascial Trigger Points in Rhomboid Muscle
Condition: Trigger Points
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      This study intends to determine the effects of thoracic manipulation on pressure pain
      sensitivity in patients with rhomboid active trigger points.
    

Detailed description: 
      This is a single blinded controlled trial and will be conducted at physiotherapy clinic of
      women institute of rehabilitation sciences Abbottabad. The "screw" manipulation is a fairly
      aggressive manipulative technique in which the transverse processes are forced into a
      posterior to anterior direction Individual will be screened out according to inclusion
      criteria. Individuals will be allocated randomly into two groups, 30 in thoracic manipulation
      group and 30 in conventional physiotherapy protocol group by sealed envelope method. Both
      groups will receive conventional physiotherapy protocol (manual pressure release technique
      and muscle imbalances exercises) for rhomboid trigger points in common and the experimental
      group will receive thoracic manipulation in addition to conventional protocol.

      Assessment will be done on baseline and after 3 weeks. Data will be analyzed on SPSS version
      21.
    

Intervention name(s): Thoracic manipulation; conventional pt protocol
Intervention type(s): Other; Other
Intervention description(s): Session will be performed twice a week for a three week period if a pop sound occurred then the therapist moved on next procedure ,if not subject will be repositioned and technique will performed again. This procedure will be performed for maximum of two attempts. Approximately 3 minutes of time is required to complete thrust manipulation subjects assigned to thrust manipulation also received general exercise program and manual pressure release technique as the control group. General exercise group involve Stretching exercises for the pectoral muscles and resisted strengthening exercises for the scapular retractors and elevators and the glenohumeral abductors and external rotators were performed three times per week for 3 weeks.; This group will receive manual pressure release technique along with general exercises program. General exercise group involve Stretching exercises for the pectoral muscles and resisted strengthening exercises for the scapular retractors and elevators and the glenohumeral abductors and external rotators were performed three times per week for 3 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Both experimental and control groups will be treated simultaneously with one treatment option common to both groups
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Trigger Area