bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Zicronapine in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the effect of zicronapine versus risperidone on metabolic parameters comprising
      body weight, body mass index (BMI), waist circumference, levels of fasting blood lipids and
      glucose during 6 months of treatment.
    

Detailed description: 
      Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the
      world's population. Antipsychotic drugs remain the cornerstone in the pharmacotherapy of
      schizophrenia. There are a number of antipsychotic drugs in use but none is ideal, in
      particular because their safety profile is complex and their effectiveness is limited.

      Thus, present treatment options leave room for improvement and call for new, more effective
      pharmacotherapies for the treatment of schizophrenia. In the current study, non-acute
      patients with schizophrenia will be randomised to blinded treatment with either zicronapine
      or a standard antipsychotic treatment for 24 weeks. The safety (with focus on metabolic
      parameters) and efficacy of zicronapine will be evaluated in comparison to risperidone.
    

Intervention name(s): Zicronapine; Risperidone
Intervention type(s): Drug; Drug
Intervention description(s): 7.5 mg/day; orally; 5 mg/day; orally
Other intervention name(s): Past name: Lu 31-130; Risperdal®
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Antipsychotic; Risperidone; Lu 31-130
Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms
Condition: PMS; Menstrual Pain
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      This is an open-label observational single-group clinical trial to study the efficacy of a
      commercially available dietary supplement and its effect on common PMS and menstrual
      symptoms.

      It is hypothesized that the dietary supplement marketed as "Elix Cycle Balance" will improve
      subjective wellbeing in trial participants by alleviating common symptoms of PMS and
      menstrual symptoms, such as cramps, bloating, and mood swings.

      A total of 65 participants will be recruited for the trial following screening, with the
      expectation that at least 50 participants will complete the trial. The trial will be fully
      remote, a technology platform will be utilized to screen, enroll and capture study data of
      the participants. The total intervention study period will be 3 months.
    


Intervention name(s): Elix Cycle Balance
Intervention type(s): Dietary Supplement
Intervention description(s): Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Dose-dependent Effects of Oxytocin on the Amygdala and Reward System
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether effects of intranasal oxytocin on amygdala
      and reward system responses vary as a function of treatment dose in women in comparison to
      men.
    

Detailed description: 
      The objective of the present study is to determine whether intranasal oxytocin (IN-OXT)
      effects on blood oxygenation level-dependent functional magnetic resonance imaging (BOLD
      fMRI) in the amygdala and striatal regions (putamen, nucleus accumbens, caudate, pallidum)
      vary as a function of dose. In particular, the investigators plan to compare effects of three
      different IN-OXT doses (6, 12, and 24 international units, IU) on established neural and
      behavioural correlates of emotion processing in women. Results will be discussed in
      comparison to a previous study of OXT kinetics in men.
    

Intervention name(s): Oxytocin nasal spray; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intranasal administration, 6, 12, or 24 international units (IU) oxytocin.; The placebo nasal sprays contain identical ingredients except for the peptide itself.
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: amygdala; reward; oxytocin; dose; emotion processing; sex differences
A Study to Evaluate the Mass Balance, Pharmacokinetics (PK), Metabolism and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the mass balance, routes of elimination and
      characterize the metabolic profiles of a single intravenous dose of [14C]-TAK-954, identify
      major circulating and excreted metabolites. This study will also determine the single-dose PK
      of total radioactivity, TAK-954 and its metabolites where possible.
    

Detailed description: 
      The drug being tested in this study is called TAK-954. This study will assess the mass
      balance, metabolic profiles and routes of elimination of single intravenous dose of
      [14C]-TAK-954, and will determine the major circulating and excreted metabolites and
      single-dose PK of total radioactivity, TAK-954, THRX513466, and THRX 913682 in healthy male
      participants.

      The study will enroll approximately 6 participants. All participants will receive a single
      dose of [14C]-TAK-954 0.5 mg on Day 1.

      This single-center trial will be conducted in Netherlands. The overall time to participate in
      this study is approximately 6 to 7 weeks. Participants will make a final visit to the clinic
      15 days after last dose of study drug for a follow-up assessment.
    

Intervention name(s): [14C]-TAK-954
Intervention type(s): Drug
Intervention description(s): [14C]-TAK-954 intravenous infusion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug therapy
Serpin C and Soluble Fms-like Tyrosine Kinase-1 Levels in Normotensive Pregnant Women May Predict the Development of Preeclampsia
Condition: Pre-Eclampsia
MeSH terms: Pre-Eclampsia; Eclampsia
Study type: Observational

Summary: 
      Evaluation of the predictability of estimated levels of Serpin C, sFlt-1 and placental growth
      factor (PLGF) in blood samples obtained during the 1st trimester from normotensive pregnant
      women for identification of women liable to develop PE during the course of pregnancy.
    


Intervention name(s): ELISA
Intervention type(s): Diagnostic Test
Intervention description(s): ELISA estimation of PLGF, sFlt-1 and Serpin C
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients were having monthly follow-up of pregnancy and determination of BP measures, and
        estimation of the serum levels of the studied biomarkers.

        Patients who developed GHTN at the 20th GW were grouped as GHTN group and those who were
        normotensive at the 20th GW were considered as control.
Chronic Low Back Pain Rehabilitation in Primary Care: an RCT
Condition: Low Back Pain; Chronic Pain; Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain; Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effectiveness and cost-effectiveness of a new
      primary care intervention "Back on Track" as compared to usual primary care in patients with
      non-specific chronic low back pain in which disability levels are moderate and the role of
      psychosocial factors to this disability is at maximum low (classified as WPN2).
    


Intervention name(s): Back on Track intervention; Primary care as usual
Intervention type(s): Other; Other
Intervention description(s): Biopsychosocial primary care intervention based on multidisciplinary pain rehabiliation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.; Regular physical therapy in primary care. Physical therapists are recommended by their profession (the Royal Dutch Society for Physical Therapy) to work according to a profession-specific guideline for the treatment of patients with low back pain in primary care settings. Maximally 12 individual sessions (30 minutes each) for a maximum of 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive behavioral therapy; Primary health care; Physical Therapy
Assessment of Limb Perfusion During Junctional Tourniquet
Condition: Bleeding
Study type: Interventional

Summary: 
      The goal of this study is to use contrast enhanced ultrasound to determine the degree to
      which flow is reduced during application of a junctional tourniquet (JT). Contrast enhanced
      ultrasound is performed to quantify thigh and calf perfusion at baseline and during
      application of the JT
    


Intervention name(s): Application of a Junctional Tourniquet
Intervention type(s): Device
Intervention description(s): All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tourniquet; Muscle perfusion; Contrast ultrasound
A Study to Evaluate Pharmacokinetic Parameters and Safety of Eliglustat Absorption Through the Mouth
Condition: Gaucher's Disease
MeSH terms: Gaucher Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the absorption of eliglustat through the mouth in healthy subjects and the
      safety of any systemic exposure resulting from oral surface absorption of eliglustat in
      healthy subjects.
    

Detailed description: 
      Duration of the study for each subject, not including screening, will be 3 days including
      follow-up.
    

Intervention name(s): Eliglustat
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:solution -Route of administration: Oral wihtout ingestion
Other intervention name(s): GZ385660; CERDELGA
Intervention MeSH terms: Eliglustat
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Yoga-Based Exercise Program For Temporomandibular Disorders
Condition: Temporomandibular Disorders; Myofascial Pain Dysfunction Syndrome; Temporomandibular Joint Pain; Range of Motion; Yoga; Quality of Life
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Arthralgia; Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Aims:The study was conducted to investigate the effect of Yoga-based exercise program on
      pain, range of motion(ROM), sleep quality, depression and quality of life in female patients
      with myofascial pain dysfunction(MPD) of temporomandibular disorders .

      Methods: MPD will be included in the study. Yoga based exercise program will be performed to
      the first group as 3 times in a week for 6 weeks. The second group will be the control group.
      Outcome measurements; pain ,sleep quality, depression and quality of life will be evaluated.
      Evaluations will be repeated before and 6 weeks after exercise.
    

Detailed description: 
      Total 46 female patients between the ages of 20-50 planned to include in the study. In the
      study, 42 volunteers divided into two groups as yoga group (Group 1) and control group (Group
      2). As a result of randomization, those chose 1 were taken in group 1, 2 were included in
      group 2. Yoga-based exercises performs for 6 weeks and 3 days in a week for the first group.
      The second group will be taken in the waiting list to be included in the program as a control
      group.

      Yoga-based exercises perform by a physiotherapist has Yoga training, by consisting of
      10-person groups, 6 weeks, 3 days in a week for a total of 18 sessions. Yoga-based exercises
      are Hatha yoga-based sessions consisting of breathing exercises, warm-up exercises,
      relaxation, asanas exercises and lasts about one hour.

      Before the treatment, evaluations made immediately after the 6-weeks exercise program ended.
      As the primary outcome measures; jaw pain Visual Analog Scale (VAS), Neck Pain And Disability
      Scale (NPDS), neck and jaw range of motion (ROM) measurements; for secondary outcome
      measurements; the Pittsburg Sleep Quality Index (PUQI), Beck Depression Inventory (BDI) and
      Short Form 36 (SF36) are used. All measurements are repeated at the 6th week after yoga
      application and datas compared with the baseline measurements.
    

Intervention name(s): Yoga Exercises
Intervention type(s): Other
Intervention description(s): Yoga-based exercises are Hatha yoga-based sessions consisting of breathing exercises, warm-up exercises, relaxation, asanas exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Prospective, Randomised, Single-Blinded, Monocentric Clinical Study to Compare Postoperative Analgesia and Outcome After Combined Paravertebral and Intrathecal Versus Thoracic Epidural Analgesia for Thoracotomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare whether epidural analgesia would provide equal
      analgesia than combining intrathecal opioids with thoracic paravertebral local anesthetics.
    

Detailed description: 
      Thoracotomy is an invasive surgical procedure, which is mainly performed in patients with
      pre-existing lung disease such as lung cancer or chronic obstructive pulmonary disease. Pain
      after thoracotomy is considered the most intense acute postoperative pain, adversely
      affecting the ability to cough, deep breathing, and lung function, resulting in respiratory
      complications and delayed recovery. The adverse effects can be further aggravated by
      occurrence of chronic post-thoracotomy pain.

      Thoracic epidural analgesia is often recommended as the gold standard for the relief of acute
      post-thoracotomy pain. Thoracic paravertebral blockade or intrathecal opioid analgesia has
      also been shown to be efficacious for pain relief. Since there is no ideal single regional
      technique for pain relief after thoracotomy an alternative method maybe the combination of
      low-dose intrathecal morphine and sufentanil plus continuous thoracic paravertebral analgesia
      with local anesthetics.

      We therefore hypothesized that combining intrathecal sufentanil and morphine with thoracic
      paravertebral applicated ropivacaine would provide equal analgesia compared to thoracic
      epidural analgesia with ropivacaine and sufentanil. We further speculate that this new
      regimen would have a lower incidence of typical side effects due to TEA, such as block
      failure, hypotension or urinary retention.
    

Intervention name(s): intrathecal opioids and thoracic paravertebral analgesia; thoracic epidural analgesia
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: thoracotomy; pain therapy; thoracic paravertebral blockade; intrathecal opioids; thoracic epidural analgesia; Analgesia after thoracotomy
A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06273340 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate safety, toleration and time course of plasma
      concentration of multiple oral doses of PF-06273340 for 14 days in healthy subjects of two
      age groups, aged 18-55 years (Group 1) and aged 56-75 years (Group 2)
    


Intervention name(s): PF-06273340; Placebo; PF-06273340; Placebo; PF-06273340; Placebo; PF-06273340; Placebo; PF-06273340; Placebo; PF-06273340; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, 100 mg TID, 14 days; Tablets, TID, 14 days; Tablets, to be decided dose, TID or titration, 14 days; Tablets, TID or titration, 14 days; Tablets, to be decided dose, TID or titration, 14 days; Tablets, TID or titration, 14 days; Tablets, to be decided dose, TID or titration, 14 days; Tablets, TID or titration, 14 days; Tablets, to be decided dose, TID or titration, 14 days; Tablets, TID or titration, 14 days; Tablets, to be decided dose, TID or titration, 14 days; Tablets, TID or titration, 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Multiple dose; safety; tolerability; PK
Multiple Dose Ethnobridging PK Study in Healthy Subjects
Condition: Inflammatory Bowel Diseases; IBD
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, double blind, placebo controlled, 4 cohort, multiple dose study in healthy adult
      Japanese and Caucasian subjects.
    


Intervention name(s): TD-1473 - Dose A; TD-1473 - Dose B; TD-1473 - Dose C; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral capsule/tablet, QD; oral capsule/tablet, QD; oral capsule/tablet, QD; oral capsule/tablet, QD
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Japanese Subjects; Healthy Caucasian Subjects; Ethnobridging
Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The objective of this study is to compare asthma-related exacerbations (emergency department
      (ED) or inpatient (IP) visit) and related cost in pediatric patients aged 4-11 years that
      received either fluticasone propionate 44 mcg (FP44) or budesonide (BUD) or montelukast
      (MON). This retrospective observational cohort analysis utilizes a large managed care
      database with linked pharmacy and medical claims. Patients with ≥ 1 pharmacy claim FP44 or
      BUD or MON between January 1, 2000 through June 30, 2008 (4-11 years old at time of index)
      with ≥ 1 diagnosis for asthma (ICD-9 493.xx) in the pre-index period and continuously
      eligible to receive healthcare services for 1-year pre-index and at least 30 days post-index.
      Dose of each inhaled corticosteroid was not known in the database. Follow-up was defined for
      each patient as the period beginning with the index date and ending with the last date of
      continuous claims history, switch to another asthma controller medication, or claim for an
      asthma related event (ED/IP visit or OCS use) post-index, whichever occurred first.
    


Intervention name(s): Fluticasone propionate; Budesonide; Montelukast
Intervention type(s): Drug; Drug; Drug
Intervention description(s): fluticasone propionate 44 mcg; budesonide; montelukast
Other intervention name(s): Flovent® is a registered trademark of GlaxoSmithKline; Singulair®is a registered trademark of Merck and Company; Rhinocort® is a registered trademark of AstraZeneca
Intervention MeSH terms: Fluticasone; Xhance; Budesonide; Montelukast
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Claims related to pediatric patients age 4-12 in the database with one or more outpatient
        pharmacy claims for fluticasone propionate 44 micrograms (FP44) or budesonide (BUD) or
        montelukast (MON) between January 1, 2000 and June 30, 2008.
      
Keywords: pediatric; asthma; outcomes; inhaled cortcosteroids
Efficacy of a Red Yeast Rice Based Nutraceutical Plus Probiotic in Patients With Moderate Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy of a
      red yeast rice based nutraceutical (monacolin K 10 mg/dose) plus probiotic (Bifidobacterium
      longum BB536 ®), versus placebo, in patients with moderate hypercholesterolemia, in terms of
      improvement of the lipid profile and cardiovascular risk.
    


Intervention name(s): Lactoflorene colesterolo; Placebo lactoflorene colesterolo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1.8 g + 1.8 g once a day per os; 1.8 g + 1.8 g once a day per os
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hypercholesterolemia; bifidobacterium longum BB536; red yeast rice; monacolin K; lactoflorene colesterolo
Role of Simvastatin Microsponges in Treatment of Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      the aim of our study is to enhance the dissolution and subsequently the local penetration of
      the drug through the sulcus in addition to controlling the drug release so that, the drug
      could be potentially absorbed.
    

Detailed description: 
      Patients will be divided randomly into three groups: Group (I);will be treated with
      subgingival debridement and subgengival injection of chitosan 2% gel containing a
      microsponges formulated (SV), Group (II); will be treated with subgingival debridement and
      subgingival injection of chitosan 2% gel containing free (SV) and Group (III); will be
      treated by subgingival debridement and placebo gel injected subgingivally. Pocket depth and
      clinical attachment loss bone gain were recorded preoperative and six months postoperative
      for all groups.
    

Intervention name(s): open flap subgingival debridement; Subgingival injection of chitosan 2% gel; Subgingival injection of chitosan 2% gel; Subgingival injection of chitosan 2% gel
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): After the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement.Randomization was then performed and concealment from the assessors.; Group (I); injected subgingivally with chitosan 2% gel containing a microsponges formulated drug weekly; Group (II); injected subgingivally with chitosan 2% gel containing free drug weekly; Group (III); injected subgingivally with placebo chitosan 2% gel weekly
Intervention MeSH terms: Chitosan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment