bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of CKD-333 in Healthy Volunteers
Condition: Hypertension; Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, open-label, fasted, single dose, crossover study to investigate
      the pharmacokinetic profiles and safety of CKD-333 in healthy volunteers.
    

Detailed description: 
      To healthy subjects of twenty-four (24), following treatments are administered dosing in each
      period and wash-out period is a minimum of 14 days.

      Reference drug: 1) CKD-330 16/10mg Tab. 2) D086 Tab. Test drug: 1) CKD-333 16/10/40mg
      formulation 1 Tab. 2) CKD-333 16/10/40mg formulation 2 Tab.

      Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics
      and safety are assessed.
    

Intervention name(s): CKD-330 16/10mg Tab. 1T and D086 Tab. 1T; CKD-333 16/10/40mg formulation 1 Tab. 1T; CKD-333 16/10/40mg formulation 2 Tab. 1T
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single oral administration under fasting condition; single oral administration under fasting condition; single oral administration under fasting condition
Other intervention name(s): Treatment A; Treatment B; Treatment C
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cost- Effectiveness Study of Brief Interventions for Mood and Anxiety Disorders
Condition: Depressive Disorder; Anxiety Disorder
MeSH terms: Anxiety Disorders; Depressive Disorder
Study type: Interventional

Summary: 
      This study compares both clinical effectiveness and cost-effectiveness of a brief,
      intensified therapy and diagnostic method for patients with mood and/or anxiety disorders
      with Treatment As Usual (TAU) at five outpatient Mental Healthcare Centers in the
      Netherlands.
    


Intervention name(s): Cognitive behavioral treatment/farmacotherapy intervention; Treatment As Usual
Intervention type(s): Other; Other
Intervention description(s): Brief cognitive behavioral intervention/farmacotherapy; intake, treatment and ROM; Other: Treatment As Usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Comparison of Perennial and Preseasonal Subcutaneous Immunotherapy
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 4

Summary: 
      Specific immunotherapy, which involves the administration of allergic extracts to patients
      with symptoms of allergic disorder, is the leading therapeutical tool of modern allergology.
      According to the latest studies immunotherapy not only reduces symptoms' severity but also
      may modify the course of allergic disease by reducing the risk of new sensitisations and
      development of more advanced stages of the disease.It has been hypothesized basing on
      clinical observation that perennial immunotherapy is more effective and safer in comparison
      to preseasonal immunotherapy. The aim of the study was to compare the effect of perennial and
      preseasonal immunotherapy on rhinoconjunctivitis symptoms and safety of both treatments.
    


Intervention name(s): grass (80%) and rye (20%) pollens allergoids
Intervention type(s): Drug
Intervention description(s): comparison of two schemes of immunotherapy - preseasonal and perennial immunotherapy.
Other intervention name(s): Allergovit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: allergic rhinitis; perennial immunotherapy; preseasonal immunotherapy
Linguistic Characteristics of Suicidal Patients in the Emergency Department
Condition: Suicide
MeSH terms: Emergencies; Suicide
Study type: Observational

Summary: 
      The purpose of this study is to determine whether patients who have a high risk for serious
      suicide behavior will demonstrate a speech pattern that has a relationship to language
      patterns found in suicide notes.
    

Detailed description: 
      In an average week the CCHMC Emergency Department (ED) evaluates 40 patients with suicidal
      behavior. Currently, there is no systematic method for assessment of suicide risk in these
      patients and often, emergency department staff are required to make judgments about the
      disposition of these patients without a full understanding of the patient's risk for another
      serious suicide attempt. This pilot project involves experts in child psychiatry, biomedical
      informatics, and emergency medicine to collect pilot data for developing a method to estimate
      the risk of serious suicidal behavior based on computational linguistics.
    

Intervention name(s): Standardized questionnaires and a ubiquitous questionnaire
Intervention type(s): Other
Intervention description(s): Columbia Suicide Severity Rating Scale, Suicidal Ideation Questionnaire,Peabody Caregiver Background Form,CCHMC Suicide History Form,and ubiquitous questionnaire(UQ ver.2011)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        CCHMC suicidal and non-suicidal adolescents
The Effects of Lasmiditan on Simulated Driving Performance - Healthy Participants
Condition: Migraine
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, single dose, double-blind, placebo-controlled, Latin-square design
      with 5-period (full) crossover study with participants randomized to treatment sequences.
      Participants will complete all 5 Periods.

      During each Period, participants will come to the clinical research unit (CRU) and remain
      overnight before being dosed with a single dose of either lasmiditan, alprazolam, or placebo
      in the morning. Cognitive testing and driving simulation will be conducted post dosing.
      Participants will have a washout of at least 5 days between each Period.

      This study is designed to test non-inferiority of lasmiditan doses relative to placebo, with
      an alprazolam test versus placebo to confirm the sensitivity of the simulator to detect
      treatment effects.
    


Intervention name(s): Lasmiditan; Alprazolam; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Dose is based on treatment sequence in 5-way crossover; Active comparator based on treatment sequence in 5-way crossover; Placebo comparator based on treatment sequence in 5-way crossover
Other intervention name(s): LY573144
Intervention MeSH terms: Alprazolam; Lasmiditan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
The Effect of Intraoperative Magnesium Sulfate Infusion on the Occurrence of Emergence Agitation
Condition: Agitation,Psychomotor
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      This study designed to evaluate the correlation between the effect of intraoperative
      magnesium sulfate infusion and the incidence of emergence agitation after pediatric
      ophthalmic surgery
    

Detailed description: 
      Emergence agitation (EA) is a frequent postoperative complication in pediatric patients after
      general anesthesia. There are several suggested causes of EA and pain has been considered one
      of them. Magnesium is an N-methyl-D-aspartate (NMDA) receptor antagonist and increasingly
      used as an analgesic-adjuvant. We evaluate the Pediatric Anesthesia Emergence Delirium (PAED)
      Scale to investigate whether the intraoperative infusion of magnesium sulfate reduces the
      incidence of EA in pediatric patients who undergo ophthalmic outpatient surgery.
    

Intervention name(s): Magnesium Sulfate; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Comparing the effect of continuous infusion magnesium sulfate and normal saline in the occurrence of emergence agitation; Comparing the effect of continuous infusion magnesium sulfate and normal saline in the occurrence of emergence agitation
Other intervention name(s): 10% magnesium sulfate; 0.9% isotonic normal saline
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Effect of Transcutaneous Electrical Nerve Stimulation on Posterior Neck Pain After Thyroidectomy
Condition: Thyroid Cancer; Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The purpose of tihs study is to determine whether transcutaneous electric nerve stimulation
      (TENS) during thyroidectomy is effective in the reduction of posterior neck pain after
      thyroidectomy.
    

Detailed description: 
      Thyroidectomy is performed in supine position with the neck fully extended. After
      thyroidectomy, 80 percent of patients experience posterior neck pain as well as the incision
      site pain. The posterior neck pain is thought to be due to hyperextension is continued during
      an average of 90 minutes of surgery. Non-steroidal anti-inflammatory agents or opioids are
      administrated to reduce the pain, but the pain still remained.

      TENS is simple, non-invasive analgesic technique that is used extensively to reduce acute and
      chronic pain. TENS has beneficial effect for the reduction of postoperative pain. The
      conventional way of administering TENS is to use electric characteristics that selectively
      activate large diameter Aβ fiber mediating touch perception without activating smaller
      diameter Aδ and C fiber.

      In this study, TENS during thyroidectomy in posterior neck pain will be evaluated.
    

Intervention name(s): TENS
Intervention type(s): Device
Intervention description(s): transcutaneous electric nerve stimulation frequency of 100 Hz pulse duration of 200 µs wih stimulation intensity of feeling strong but non-painful paresthesia in the upper trapezius
Other intervention name(s): LT1061 (Shenzhen Dongdixin Technology, Shenzhen, China)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: transcutaneous electric nerve stimulation; thyroidectomy; neck pain; pain management
Alterations of GCF Levels of Sclerostin and DKK-1 in Postmenopausal Osteoporosis
Condition: Osteoporosis, Postmenopausal; Periodontitis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Symptoms of periodontal disease are tissue destruction and destruction of the alveolar bone
      which supports the tooth. Wnt way (wingless-type MMTV integration site family) plays a role
      in the regulation of bone homeostasis in periodontal disease-induced bone resorption. The Wnt
      / β-catenin signal is controlled by physiological antagonists, including dickkopf released
      from osteocytes-associated protein 1 (DKK-1) and sclerostin (SOST). Thus, Wnt inhibitors SOST
      and DKK-1 affect bone mass changes. Bisphosphonates used in osteoporous treatment are
      selective inhibitors of bone resorption. In the serum of postmenopausal osteoporotic women
      treated with bisphosphonate, short-term and decreased DKK-1 level during the treatment, and
      increased SOST in the late period were reported. Increased bone formation after
      bisphosphonate treatment in postmenopausal osteoporotic patients has been associated with
      increased serum SOST level. The aim of our study is to investigate the effect of
      bisphosphonate in patients with post-menopausal osteoporosis on the bone demolition
      metabolism in periodontally healthy and periodontally diseased tooth regions and gingival
      health with the clinical data by investigating the SOST and DDK-1 molecules that play role in
      bone destruction mechanism.
    

Detailed description: 
      This study aims to reveal the effect of initial periodontal treatment together with
      bisphosphonate on sclerostin (SOST) and dickkopf-related protein-1 (DKK-1) in gingival
      crevicular fluid (GCF) of patients with osteoporosis.

      Clinical recordings and GCF were obtained from postmenopausal women; with chronic
      periodontitis and those using bisphosphonate (Group A, n=12), with chronic periodontitis and
      otherwise healthy (Group B, n=10), without chronic periodontitis and those using
      bisphosphonate (Group C, n=11), systemically and periodontally healthy controls (Group D,
      n=10) at the baseline.

      GCF sampling were recorded and repeated at the 6th and 12th months in Group A, B and C. SOST
      and DKK-1 values were measured by ELISA.
    

Intervention name(s): Phase 1 periodontal therapy; Bisphosphonate therapy
Intervention type(s): Procedure; Drug
Intervention description(s): Scaling and root planning with ultrasonic and hand instruments under local anesthesia.; Using aclasta: intravenous infusion of 5 mg of zoledronic acid once a year
Other intervention name(s): Periodontal treatment; Osteoporosis treatment
Intervention MeSH terms: Diphosphonates
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: sclerostin; dickkopf-related protein-1
First in Man Clinical Trial of Emodepside (BAY 44-4400)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the safety, tolerability, and pharmacokinetics of single
      ascending doses of emodepside (BAY 44-4400) in healthy male volunteers. This study will also
      conduct an exploratory investigation of the relative bioavailability of emodepside
      administered as tablets and determine the effect of food on the pharmacokinetics.
    


Intervention name(s): emodepside (BAY 44-4400); placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Emodepside
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Parasitic Diseases; Helminthiasis; Nematode Infections; Secernentea Infections; Spirurida Infections; Filariasis; Skin Diseases, Parasitic; Skin and Connective Tissue Diseases; Skin Diseases; Skin Diseases, Infectious; Depsipeptides; Emodepside; Neglected disease; Africa; New drug; Oral drug; Parasite; Anthelmintic drug; Cyclooctadepsipeptide; Single ascending dose; Volunteers; Phase 1; Safety; Tolerability; Pharmacokinetics; Relative bioavailability; Onchocerciasis
Determining the Effects of Risperdal Consta in Patients With Psychotic Disorders and Incomplete Adherence
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      As many as 75 percent of patients with schizophrenia have difficulty taking their oral
      medication on a regular basis. This may lead to worsening of symptoms. Clinicians commonly
      respond to these problems by adding adjunctive medications, despite the absence of systematic
      studies that support such practices. It is possible, however, that in many of these cases,
      the unstable course and/or unsatisfactory treatment response reflects incomplete adherence
      with the originally prescribed oral antipsychotic, rather than a need for adjunctive
      medications. This study will examine whether switching patients who demonstrate an unstable
      course and/or an unsatisfactory clinical response to a long-acting injectable preparation as
      the primary antipsychotic may enhance medication adherence and improve outcomes.
    


Intervention name(s): Depot Risperidone Microsphere (Consta)
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome
Condition: Restless Legs Syndrome (RLS); Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the
      treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period
      limb movements during sleep.
    


Intervention name(s): ropinirole CR-RLS
Intervention type(s): Drug
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Restless Legs Syndrome; ropinirole; polysomnography; RLS; PSG
Health Effects of Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy
Condition: Prostatic Neoplasms; Exercise; Soccer Training; Androgen Deprivation Therapy
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Androgen Deprivation Therapy (ADT) is standard treatment for locally advanced or advanced
      Prostate Cancer (PC).

      The musculoskeletal toxicity associated with ADT is well established, leading to a decrease
      in muscle mass, increased fat percentage, weight gain, sexual dysfunction and increased risk
      of depression, fatigue, diabetes, cardiovascular disease and reduced quality of life.

      Numerous studies have shown an association between physical activity, physical capacity and
      quality of life in cancer patients and recent epidemiological research suggest that regular,
      moderate-intensity physical activity may have a positive effect on survival in men with
      prostate cancer.

      Within exercise physiology there is new evidence pointing to recreational soccer as a unique
      form of intermittent exercise that effectively stimulates aerobic and anaerobic energy
      delivery systems, leading to beneficial musculoskeletal, metabolic and cardiovascular
      adaptations of importance for health.

      It is our overall hypothesis that 12 weeks of recreational soccer training 2-3 times per week
      will improve the health profile of PC patients receiving ADT treatment.
    


Intervention name(s): Soccer training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Prostatic Neoplasms; Prostate Cancer; Exercise; Soccer; Androgen Deprivation Therapy; Body Composition; Cardiovascular fitness; Bone Health; Health Related Quality of Life
Cryoballoon Ablation for Early Persistent Atrial Fibrillation (Cryo4 Persistent AF)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The purpose of this clinical study is to assess the single procedure outcomes of using
      cryoballoon ablation without additional empirical lesions and/or complex fractionated
      electrogram (CFE) ablations for patients with early persistent atrial fibrillation (<1 year
      from first diagnosis of persistent AF).
    


Intervention name(s): Holter monitoring
Intervention type(s): Other
Intervention description(s): Subjects will wear holter monitors at baseline, 6 months and 12 months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial Fibrillation; Persistent Atrial Fibrillation; Cryoablation; Cryoballoon; Pulmonary Vein Isolation
Varenicline and Nicotine Interactions in Humans (VA)
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      To examine the effects of varenicline on the subjective, physiological and cognitive
      responses to intravenous nicotine. Varenicline is a partial nicotine agonist and it is
      approved as a treatment for smoking cessation. We predict that varenicline treatment will
      modify subjective, physiological and cognitive responses to IV nicotine.
    

Detailed description: 
      This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female
      smokers will have two 4-day treatment periods, in which they will be randomized to
      varenicline (1 mg/day) or placebo. During the first 3 days of each treatment period, smokers
      will have daily clinic visits and receive their study medication. On Day 4, subjects will
      come to the laboratory, where they will receive ascending doses of intravenous (IV) nicotine
      (0.1, 0.4, and 0.7 mg per 70kg). This procedure will allow accurate assessment of varenicline
      effects on the subjective, physiological and cognitive responses to nicotine. Following a
      washout period, subjects will be crossed over to the alternative treatment.
    

Intervention name(s): Varenicline; Placebo; IV Nic
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Varenicline (1 mg per day) given for 4 days prior to laboratory session; Sugar Pill; IV Nicotine given during the laboratory session following 4 days of exposure to the study medication (varenicline or placebo). This nicotine was given during each laboratory session which followed the 4 days of exposure to either placebo then varenicline or varenicline then placebo.
Other intervention name(s): Chantix; Sugar Pill; IV Nicotine
Intervention MeSH terms: Nicotine; Varenicline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: therapeutic effects
PATET Ratio to Rule Out Transient Tachypnea of the Newborn
Condition: Transient Tachypnea of the Newborn
MeSH terms: Tachypnea; Transient Tachypnea of the Newborn
Study type: Observational

Summary: 
      This study aims to find out whether diagnosis of Transient Tachypnea of the Newborn(TTN) can
      be predicted via evaluating pulmonary artery Doppler indices.
    

Detailed description: 
      Transient Tachypnea of the Newborn(TTN) is the most common diagnosed disease in state of
      neonatal respiratory distress. However there is not an adequate method to diagnose or rule
      out TTN.

      In several studies pulmonary artery Doppler indices are investigated as the possible
      indicators of pulmonary function. As a result of these studies, physiological processes in
      fetal lung maturation were established; pulmonary tissue impedance or resistance decreases
      with increasing gestational age, leading to increased pulmonary blood flow. In a normal lung
      maturation process the peak sistolic velocity is reached in midsystole, but in case of any
      reason disturbing the nornal development process,the peak occurs earlier.

      We suggested that TTN, which is a factor increasing pulmonary tissue impedance like
      respiratory distress syndrome(RDS) and pulmonary hypoplasia, would change pulmonary
      artery(PA) Doppler indices, thus by the way of evaluating pulmonary artery Doplerr indices,
      we could predict possible diagnosis of TTN
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Singleton pregnancies beyond 34 weeks gestational age, with no congenital fetal
        abnormalities and without any chronicle maternal disease or pregnancy complication like
        gestational diabetes, preeclampsia, etc. were included in the study.