bioihbjkbjnl/mcl2 huggingface dataset:
Study of Efficacy and Long-Term Safety of Mometasone Furoate in Combination With Formoterol Fumarate Versus Mometasone Furoate in Children (5 to 11 Years of Age) With Persistent Asthma (MK-0887A-087)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study compares the 12-week efficacy and 24-week safety of mometasone furoate/formoterol
      fumarate (MF/F) 100/10 mcg and mometasone furate (MF) 100 mcg, both administered twice daily
      (BID) via metered-dose inhaler (MDI) in children aged 5 to 11 years with persistent asthma.
    


Intervention name(s): MF MDI 100 mcg BID (Open Label); MF/F MDI 100/10 mcg BID; MF MDI 100 mcg BID; Albuterol/Salbutamol PRN; Prednisone/Prednisolone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Eligible participants will receive open-label MF MDI 100 mcg BID during a 2-week run-in period.; After a 2 week run-in on open-label MF MDI 100 mcg BID, eligible participants will receive double-blinded treatment with MF/F MDI 100/10 mcg BID.; After a 2 week run-in on open-label MF MDI 100 mcg BID, eligible participants will receive double-blinded treatment with MF MDI 100 mcg BID.; Participants may use study-provided short-acting beta agonist (SABA), albuterol/salbutamol, as needed (PRN) for the relief of asthma symptoms.; Participants may use a systemic corticosteroid (prednisone/prednisolone) for acute asthma worsening per investigator discretion.
Other intervention name(s): ASMANEX HFA®; SCH 032088 (MK-0887); DULERA®/ZENHALE®; SCH 418131 (MK-0887A); ASMANEX HFA®; SCH 032088 (MK-0887)
Intervention MeSH terms: Mometasone Furoate; Prednisone; Prednisolone; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
At Work and Coping - Effect Study of Workcoping for Patients With Anxiety and Depression
Condition: Anxiety; Depression
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      Mental disorders, mainly various anxiety and depressive disorders, are an increasing reason
      for sick leave and disability pension. Cognitive behaviour therapy (CBT) has been shown to
      have an effect on anxiety and depression, but the investigators know little about this in
      relation to employment. Close follow-up in ordinary employment increase employment
      participation for serious mental illness, but this is not yet investigated to the same degree
      for lighter mental disorders.

      Center for Work-Coping (No: "Senter for Jobbmestring" - SJM) combines Cognitive behaviour
      therapy (CBT) and individual placement and support (IPS) and facilitation of work for people
      with anxiety and depression who are in danger of falling out of work.

      The purpose of this project is to evaluate the effectiveness of the model in SJM. The effect
      will be evaluated through a randomized controlled trial (RCT) in which participants will be
      randomized to SJM or regular follow-up by The Norwegian Labour and Welfare Administration
      (NAV) or by their regular general practitioners (GP) and self-help resources. The main
      outcome measures are work participation with changes in mental health as a secondary outcome.
    


Intervention name(s): Workcoping and IPS; Ordinary care by GP or NAV
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Maximum 15 sessions of CBT-based counseling with workcoping as primary focus in addition to work support according to the IPS-model (individual placement and support); Ordinary care by the participants physician or the local Labour and Welfare Administration
Other intervention name(s): Cognitive behavior therapy; Cognitive Counseling; Treatment as usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anxiety; Depression; Vocational Rehabilitation; Common Mental Disorders; Mental Health Problems; Work Related Therapy
An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and
      tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by
      patients, parents and physicians, and its impact on quality of sleep in children (aged 6
      through 11 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in
      Germany. An 8-week treatment phase is followed by a 16-week extension period.
    


Intervention name(s): Atomoxetine
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
DAYLIGHT: Vitamin D Therapy in Individuals at High Risk of Hypertension
Condition: Hypertension; Vitamin D Deficiency; Pre-Hypertension
MeSH terms: Hypertension; Prehypertension; Vitamin D Deficiency
Study type: Interventional

Summary: 
      This is a randomized, double-blind, multicenter, 6-month follow-up trial of low (400 IU/day)
      versus high (4000 IU/day) dose vitamin D supplementation in individuals with pre- and early
      stage 1 hypertension and vitamin D deficiency. A total of 530 participants (265 participants
      per treatment arm) will be randomized between 3 sites. Approximately 2,250 participants will
      be screened between the 3 sites. Vital signs, 24-hour ambulatory blood pressure monitoring,
      clinical laboratory safety tests and adverse event assessments will be performed to evaluate
      the effectiveness of the two doses of vitamin D on blood pressure. Blood samples will be
      stored for future biomarker assessments. The total duration of the study is anticipated to be
      18 months, assuming a 12 month enrollment period.
    


Intervention name(s): Cholecalciferol
Intervention type(s): Drug
Intervention description(s): Vitamin D3 (cholecalciferol) 200 IU and 2000 IU drops will be supplied by D Drops. It is supplied as a liquid containing 400 drops/bottle with a potency of 200 IU/drop or 2000 IU/drop. The contents of the label will be in accordance with all applicable regulatory requirements. The droppers are gravity-metered to deliver a consistent drop size (dosage). Two drops (either 200 IU or 2000 IU) of Vitamin D (cholecalciferol) is to be taken orally once-daily.
Other intervention name(s): Vitamin D3
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Effect of Progressive Relaxation Exercises on Premenstrual Syndrome Symptoms
Condition: Premenstrual Syndrome
MeSH terms: Syndrome; Premenstrual Syndrome
Study type: Interventional

Summary: 
      The aim of this study; to determine the effect of progressive relaxation exercises on
      premenstrual syndrome symptoms. The study is a randomized controlled trial, and women between
      the ages of 18-35 who meet the inclusion criteria will be included. Participant information
      form and premenstrual syndrome scale will be used in the research. There are two groups in
      the study as experimental (n=40) and control (n=40).
    

Detailed description: 
      Institutional permission and ethics committee approval were obtained for the research. The
      population of the study consisted of 218 women. The sample of the study consisted of 80
      women, 40 of which were experimental and 40 control. Participants were evaluated according to
      the www.randomizer.org program and randomization was achieved among the women participating
      in the study.

      The research process and the participants in the experimental and control groups will be
      explained again and the necessary equipment will be provided by the researchers. The
      "Progressive Relaxation Exercises Guide" prepared by the researcher in accordance with the
      literature will be given to the women in the experimental group (40), taking the opinions and
      suggestions of eight experts. At the same time, the comprehensibility and applicability of
      the guide were evaluated by making a pilot application to 10 women before the research.
      Afterwards, all the information in the guide will be explained to the women in the
      experimental group and training will be given until adequate feedback is received. At the
      same time, progressive relaxation exercises belonging to the Turkish Psychological
      Association were given to the women in CD form, and listening to the audio recordings
      together with the relaxation exercises to be performed in accordance with the guide will be
      indicated. These exercises will be performed by the women in the experimental group for 25-30
      minutes a day, every day for 8 weeks. At the end of 8 weeks, women will be reassessed with
      PMSS. The women in the control group (40) will be told to continue their routine habits
      regarding PMS in parallel with the study group, without any application. At the end of 8
      weeks, women in the control group will be re-evaluated with PMSS.
    

Intervention name(s): Progressive Relaxation Exercises
Intervention type(s): Behavioral
Intervention description(s): Progressive muscle relaxation (PMR) is a relaxation technique that tenses and relaxes muscles in an unprompted, regular, and consecutive manner until the whole body is relaxed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled study
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Premenstrual Syndrome, Exercises, Women Health
Safety and Efficacy Study of ADL5859 in Participants With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Condition: Peripheral Neuropathy; Neuropathic Pain
MeSH terms: Peripheral Nervous System Diseases; Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness of ADL5859 in relieving the pain
      associated with diabetic peripheral neuropathy (DPN) compared with placebo and duloxetine (a
      marketed drug approved for the treatment of painful DPN). The pain symptoms of DPN are
      thought to be due to damage to nerves caused by the diabetes.
    

Detailed description: 
      Participants were permitted to take acetaminophen 650 to 975 mg every 4 to 6 hours (up to a
      total of 4 grams in 24 hours) as needed for pain relief.
    

Intervention name(s): ADL5859; Duloxetine; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetic Peripheral Neuropathy; Neuropathic Pain
Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this study is to evaluate the effectiveness and safety of field-initiated
      magnesium sulfate in improving the long-term functional outcome of patients with acute
      stroke.
    

Detailed description: 
      Stroke is the third leading cause of death and the leading cause of adult disability in the
      United States. Each year, more than 750,000 Americans suffer a symptomatic stroke.

      Currently, tissue plasminogen activator (rt-PA) is the only approved treatment for acute
      ischemic stroke; however, its usefulness is limited because most patients cannot reach
      medical attention within the necessary 3-hour time window. In addition, rt-PA cannot be given
      in the field because it is contraindicated for treatment of patients with brain hemorrhage.

      The purpose of this multi-center, randomized, double-blind trial is to demonstrate that
      paramedic initiation of the neuroprotective agent magnesium sulfate in the field is an
      effective and safe treatment for acute stroke. This study will analyze magnesium sulfate, an
      experimental therapy for stroke, versus placebo among ambulance-transported patients with
      acute stroke. This trial will also demonstrate that paramedics can safely, effectively, and
      rapidly start neuroprotective therapies for stroke.
    

Intervention name(s): Magnesium Sulfate; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.; Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
Other intervention name(s): MA 135 magnesium sulfate heptahydrate; SO155 sodium chloride
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; brain attack; magnesium sulfate; neuroprotection; prehospital care; emergency medical services
A Study of MK-0893 on Glucagon-Induced Glycemic Excursion in Healthy Male Participants Following Intravenous Administration of Glucagon, Sandostatine® and Insulin (MK-0893-002)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to assess the pharmacokinetics, safety, and tolerability of sequential single
      oral doses of MK-8093 10 mg, 40 mg, 200 mg, or placebo to MK-8093 (Part 1) depending on
      treatment assignment in young healthy male participants. In Part 2 of this study, sequential
      single oral doses of MK-8093 200 mg, 1000 mg or placebo to MK-8093 depending on treatment
      assignment will be evaluated. The primary hypothesis of the study is that at least one dose
      of MK-0893 will produce greater reduction of glucagon-induced glycemia as compared to placebo
      following the infusion of glucagon, Sandostatine®, and basal insulin.
    


Intervention name(s): MK-0893 10 mg; MK-0893 40 mg; MK-0893 200 mg; MK-0893 1000 mg; Placebo; Sandostatine®; Insulin; Glucagon
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Biological; Biological; Biological
Intervention description(s): MK-0893 10 mg administered orally in 240 mL of water; MK-0893 40 mg administered orally in 240 mL of water; MK-0893 200 mg administered orally in 240 mL of water; MK-0893 1000 mg administered orally in 240 mL of water; Placebo administered orally in 240 mL of water; Sandostatine® is a somatostatin analogue. At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period. These compounds are IV compatible and will be combined in one syringe. Intravenous Sandostatine® will be administered at 30 ng/kg/min.; At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period. These compounds are IV compatible and will be combined in one syringe. Intravenous insulin will be administered at 0.10 milli-international unit (mIU)/kg/min.; At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period. These compounds are IV compatible and will be combined in one syringe. Intravenous glucagon will be administered at 3 ng/kg/min.
Other intervention name(s): Octreotide acetate; Humuline Regular, Insulin for human injection; Glucagen
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Octreotide; Glucagon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Therapeutic Uses; Pharmacologic Actions; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs
Effect of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Zinc carnosine is a food supplement which is available in the health food shops. The
      investigators wish to see if it can reduce intestinal swelling in people who take
      non-steroidal anti-inflammatory (anti-swelling) drugs (NSAIDs: non-steroidal antiinflammatory
      drug.).
    

Detailed description: 
      The study was about exploring the influence of zinc carnosine (ZnC) on changes in small bowel
      permeability caused by indomethacin.

      Healthy volunteers (n = 10) participated in this double-blind randomised controlled crossover
      protocol. Each arm comprised two baseline urine collections, followed by a third at the end
      of that study period. In each arm, volunteers took ZnC (37.5 mg twice daily, orally) or
      placebo for 7 days, with indomethacin for the final 5 days.

      Results were expressed as lactulose:rhamnose (L:R) ratios and mean values for each stage were
      therefore estimated: when taking placebo, volunteers had a threefold increase in L:R ratios
      in response to indomethacin administration (p,0.01), whereas no increase was seen if ZnC was
      also being taken.

      All 10 participants completed the study without protocol violations. Two of ten participants
      developed mild nondescript upper abdominal discomfort while taking the indomethacin (control)
      arm, but completed the course. None reported symptoms during the ZnC (plus indomethacin) arm,
      and no side effects due to ingestion of ZnC were reported.
    

Intervention name(s): Zinc Carnosine coadministered with Indomethacin; Placebo coadministered with Indomethacin
Intervention type(s): Other; Other
Intervention MeSH terms: Indomethacin; Polaprezinc
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Zinc carnosine or placebo for 7 days with 5 days of indomethacin from days 2-7. It was a cross over protocol with 2 week washout inbetween.
Masking: Double
Primary purpose: Prevention
Keywords: Reduction in NSAID related gut damage
The Party Balloon Assisted Valsalva in Diagnosis of Superficial Venous Valvular Reflux of Lower Limb
Condition: Varicose Veins; Venous Insufficiency
MeSH terms: Venous Insufficiency; Varicose Veins
Study type: Interventional

Summary: 
      This study was designed to compare the party balloon assisted Valsalva with the conventional
      Valsava for exhibiting the reverse venous flow in superficial venous valvular incompetence
      duplex examination.
    

Detailed description: 
      In this study, we compared the Party Balloon assisted Valsalva with Conventional Valsalva
      maneuver in diagnosis of superficial venous valvular reflux of lower limb by crossover study.
    

Intervention name(s): Valsava
Intervention type(s): Procedure
Intervention description(s): The patients were randomized to 2 groups. The first group performed conventional Valsava 3 times before balloon assisted Valsava 3 times. The second group performed balloon assisted Valsava 3 times before conventional Valsava 3 times for venous reflux examination by duplex scan.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Varicose Veins; Venous Insufficiency; Doppler; Duplex; Valsava
Recombinant Factor VII for Intractable Postpartum Haemorrhage
Condition: Post Partum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Observational

Summary: 
      Postpartum haemorrhage remains at the top of the causes of maternal deaths in both developed
      and developing countries .
    

Detailed description: 
      Major postpartum haemorrhage is a dangerous complication that accounts for the highest
      maternal morbidity rate
    

Intervention name(s): recombinant factor VIIa
Intervention type(s): Drug
Intervention description(s): using recombinant factor VIIa
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        women who has resistant postpartum hemorage
Antibiotic Regimens Tailored by Clinical Pharmacist Suppored by Intensivist Enhanced Rational Use of Antibiotics
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      adding pharmaceutical services to patient care and changing the professional activity of
      pharmacists from drug-focused to patient-oriented care,in the current study, clinical
      pharmacists will be assigned to monitor pharmacotherapy regimens, participate in patient
      care, and cooperate in educating the staff and evaluating care.
    

Detailed description: 
      During the intervention period, the pharmacist attended daily unit rounds with ICU
      intensivist with a focus on optimization of antibiotic regimens. Pharmacist consultative
      services were also available by phone calls 24 hours x 7 days if needed. For every patient
      surgical prophylactic antibiotic initiated immediately before surgery and continued for 48
      hours following surgery. Antibiotic therapy had given as either directed or empiric. Directed
      therapy was defined as treatment of a documented infection based on culture and sensitivity.
      Empiric therapy was defined as any antibiotic therapy administered when no documented
      infection was present, and the patient had clinically suspected infection following surgery.
      Empiric antibiotic administration was required in majority of our SICU patients. Antibiotics
      had given after exclusion of allergy by history and intradermal sensitivity test.
    

Intervention name(s): Clinical pharmacy sharing in the patient care regimen
Intervention type(s): Other
Intervention description(s): antibiotic regimens will be directed by a trained clinical pharmacist recommendation and supported by intensivist.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All the information including the age, gender, comorbidity (presented as Charlson
        comorbidity index score ), surgical procedure done, patients' temperature, white blood
        cells count, type of infection (e.g., pneumonia, wound infection, Urinary tract
        infection,…..), prescribed antibiotics regimen either they will use empirical or based on
        cultures, results of culture sensitivity tests, length of stay, and mortality of patients