bioihbjkbjnl/mcl2 huggingface dataset:
Role of Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section
Condition: Cesarean Section
Study type: Interventional

Summary: 
      Our aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine
      0.25% alone in transversus abdominis plane (TAP) block for postoperative analgesia in
      patients undergoing an elective Caesarean section.

        -  Group 1: bupivacaine 0.25% + dexamethasone 8 mg

        -  Group 2: bupivacaine 0.25% A prospective Randomized Interventional double-blind study.
    

Detailed description: 
      The pain and discomfort following cesarean delivery are mostly due to the abdominal wall
      incision and dissection of muscles; it delays early ambulation and breastfeeding. This can
      lead to postoperative complications such as thromboembolic disorders. So, providing an
      effective and safe postoperative analgesic method seems to be mandatory. Opioid analgesia
      remains the most effective means of relieving pain in a wide variety of conditions; however,
      it may cause adverse effects such as nausea, vomiting, pruritus, urinary retention, and
      respiratory depression. As the analgesia and the side effects of opioids are dose-dependent,
      a multimodal approach may enhance analgesia, which in turn would decrease the side effects .

      Mc Donnell and colleagues have reported that a transversus abdominis plane (TAP) block can
      decrease the postoperative pain following abdominal surgery. The landmarks of this block were
      first described in 2001 by Rafi. The TAP block has been performed for postoperative analgesic
      control in patients undergoing radical prostatectomy, hysterectomy, cesarean delivery under
      spinal anesthesia, and laparoscopic surgery.
    

Intervention name(s): bupivacaine; dexamethasone; placebo to dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TAP block with 20 ml of 0.25% bupivacaine bilaterally; TAP block with 4 mg dexamethasone bilaterally; TAP block with 4 mg placebo to dexamethasone bilaterally
Other intervention name(s): Active Comparator; active comparator; Placebo
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Bupivacaine; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective Randomized Interventional double-blind study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dexamethasone; transversus abdominis plane block; cesarean section
Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily
      (QD), in adults with generalized anxiety disorder.
    

Detailed description: 
      Participants in this study will be randomly assigned to receive either 2.5 mg, 5 mg or 10 mg
      of vortioxetine, once daily, 60 mg of duloxetine once daily, or a placebo once daily for
      eight weeks.

      Participants will be seen weekly during the first 2 weeks of treatment, and then every 2
      weeks up to the end of the 8-week treatment period. Participants who complete the 8-week
      treatment period will enter a 2-week discontinuation period in order to assess potential
      discontinuation symptoms. Total commitment time is up to 12 weeks.
    

Intervention name(s): Placebo; Vortioxetine; Duloxetine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo-matching capsules; Encapsulated vortioxetine immediate release tablets; Overencapsulated duloxetine capsules
Other intervention name(s): Lu AA21004; Brintellix®; Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride; Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Generalized Anxiety Disorder; Mood Disorder; Affective Disorder; Anxiety Disorder; Drug Therapy
Safety and Efficacy of Sofwave Treatment to Lift Lax Skin
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional
Phase: Phase 3

Summary: 
      Open-label, non-randomized 2 arms prospective, multi-center, self-controlled clinical study
      with masked evaluation.
    

Detailed description: 
      This study is a two-arm study. Eligible patients will receive 2-4 face and/or neck and/or
      submental or "off the face" (abdomen, or arms, or thighs, or Décolleté) treatments (per PI
      discretion, 2-12 weeks apart) using the Sofwave System. In arm 1, each investigational site
      would treat the full face and/or neck and/or submental zones including 1. -The forehead and
      temples (left and right including the peri orbital zone) to lift the eyebrows 2. The cheeks
      (left and right including perioral zone and nasolabial folds) 3. Submental and sides of the
      neck (left and right) to lift lax skin. In arm 2, each site would treat "off the face" areas:
      abdomen, or arms or thighs or Décolleté. Each patient could be assigned to both arms.
      Treatment may be administered after the enrollment and screening at the first visit or it may
      occur at a later date following the enrollment and screening activities based on site
      scheduling availabilities. All patients will return to the clinic for one follow up visitat3
      months ± 2 weeks post last treatment (FU1) and a second optional visit at 2. 6 months ± 2
      weeks post last treatment (FU2; optional). Each treatment visit will also serve as a follow
      up.
    

Intervention name(s): Sofwave
Intervention type(s): Device
Intervention description(s): The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laxity Brow Lifting Skin Saggy
Investigating the Pharmacokinetic Drug Interactions Between HGP1201 and HGP0904
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetic drug interactions between
      HGP1201 and HGP0904
    

Detailed description: 
      Randomized, open-label, multiple dose , 3-treatment, 6-sequence, 3-period, crossover study,
      The purpose of this study is to investigate the pharmacokinetic drug interactions between
      HGP1201 and HGP0904
    

Intervention name(s): HGP1201; HGP0904; HGP0904 and HGP1201 co-administraion
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can
      help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well
      controlled on diet and exercise alone. The safety of this treatment will also be studied
    


Intervention name(s): Dapagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, Once Daily, Up to 24 weeks; Tablets, Oral, Once Daily, Up to 24 weeks
Other intervention name(s): BMS-512148; Farxiga™
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases
A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double blind, active and placebo controlled, 4 way crossover study in
      patients with seasonal allergic rhinitis. Patients will receive a single dose of bilastine 20
      mg, Cetirizine 10 mg, Fexofenadine 120 mg, and placebo in the Vienna Challenge Chamber.
    

Detailed description: 
      The objective of the study is to determine the effect of a single dose of bilastine 20 mg on
      nasal symptoms of allergic rhinitis provoked by spending 4 hours in the Vienna Challenge
      Chamber . This effect will be compared to that action of Cetirizine 10 mg, Fexofenadine 120
      mg, and placebo. To explore the onset of action, patients will receive study drug two hours
      after the start of the provocation on Day 1.Patients will remain in theVCC for an additional
      four hours. On Day 2, patients will return to the VCC post-dose hours 22-26.
    

Intervention name(s): Bilastine; Fexofenadine; Cetirizine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Encapsulated Bilastine 20 mg tablets Q.D.; Encapsulated Fexofenadine 120 mg tablets Q.D.; Encapsulated Cetirizine 10 mg tablets Q.D.; Encapsulated Placebo tablets Q.D.
Other intervention name(s): Allegra; Zyrtec
Intervention MeSH terms: Cetirizine; Fexofenadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rhinitis; Seasonal; Allergic; Pollen allergy; Environmental Exposure Chamber; Challenge Chamber
Girls First - India (2013-2015)
Condition: Emotional Wellbeing; Social Wellbeing; Physical Wellbeing
Study type: Interventional

Summary: 
      The purpose of this study is to determine the social, emotional, physical, and educational
      effects of Girls First, a combined resilience and adolescent health program, vs. its
      components and a control group, among adolescents in India.
    


Intervention name(s): Peer support groups
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
PETACC-8 miR-31-3p and miR-31-5p Ancillary Study
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective-retrospective study to determine if the expression of the miRNA's
      miR-31-3p and miR-31-5p are prognostic of patient outcomes or predictive of the benefit from
      anti-EGFR therapy in stage III Colon Cancer. The present study will utilize FFPE tumor
      samples collected from patients enrolled in the PETACC-8 study conducted by the Fédération
      Francophone de Cancérologie Digestive (FFCD). This phase 3 clinical trial prospectively
      randomized fully resected stage III colon cancer patients to receive adjuvant treatment with
      either FOLFOX-4 plus cetuximab or FLOFOX-4 alone.
    


Intervention name(s): Cetuximab; FOLFOX
Intervention type(s): Drug; Drug
Intervention description(s): Cetuximab every 2 weeks; FOLFOX-4 every 2 weeks
Intervention MeSH terms: Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Physical Activity and Its Correlation to Maximal Oxygen Uptake in an Elderly Population
Condition: Aging
Study type: Observational

Summary: 
      This is a substudy of the Generation-100 study (NCT01666340). Self reported physical activity
      versus objectively measured physical activity and its correlation to maximal oxygen uptake in
      an elderly Norwegian population (observational study).
    

Detailed description: 
      Data is collected using activity monitors. This data then compared to self reported physical
      activity obtained through questionnaires. Questionnaires are based on recall. Overall
      physical activity will then be correlated to maximal oxygen uptake to see whether people with
      high activity also have high maximal oxygen uptake.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Norwegian elderly population 70-77 years of age
      
Keywords: physical activity; maximal oxygen uptake
A Food Effect Study of TAK-385 Final Formulation
Condition: Japanese Premenopausal Healthy Adult Women
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate food effects on the pharmacokinetics of a single
      oral dose of TAK-385 in Japanese premenopausal healthy adult women.
    

Detailed description: 
      This is a phase 1 clinical pharmacological study of TAK-385 in Japanese premenopausal healthy
      adult women.

      Using an open-label crossover design, food effects on the pharmacokinetics and safety of
      TAK-385 will be evaluated in participants receiving a single oral dose of TAK-385 40 mg in
      fasted condition without breakfast, before breakfast, or after breakfast.

      Participants determined to be eligible will be randomly assigned to one of Groups A to F
      prior to study medication administration in Period 1; subsequently, participants will receive
      one TAK-385 40 mg tablet in fasted condition without breakfast (following a minimum 10-hour
      overnight fast), before breakfast (30 minutes before starting breakfast), or after breakfast
      (30 minutes after starting breakfast) in Periods 1, 2, and 3.
    

Intervention name(s): TAK-385 40 mg
Intervention type(s): Drug
Intervention description(s): TAK-385 40 mg tablet
Intervention MeSH terms: Relugolix
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy
The Effect of Inhaled Lavender and Bergamot Oil on Anxiety and Sleep Quality in Intensive Care Patients.
Condition: Patient Undergoing Surgery
Study type: Interventional

Summary: 
      This study was carried out as a randomized controlled experimental study to determine the
      effect of inhaled lavender and bergamot oil on anxiety and sleep quality in patients
      hospitalized in the intensive care unit who had undergone surgical intervention.

      The universe of the research; Patients who were hospitalized in an Intensive Care Unit in
      Istanbul between May 2021 and October 2021, and the sample consisted of patients who met the
      criteria for inclusion in the study. Fifty-four patients who agreed to participate in the
      study and met the inclusion criteria were included. Lavender oil or bergamot oil or distilled
      water was administered to the patients 2 evenings by inhalation.
    

Detailed description: 
      The universe of the research; Patients who were hospitalized in the Intensive Care Unit of a
      university hospital in Istanbul between May 2021 and October 2021, and the sample consisted
      of patients who met the inclusion criteria of the study. Data collection started after
      obtaining the ethics committee permission, institutional permission, and research permission
      from the Ministry of Health GETAT Clinical Research Department. A simple computer-assisted
      randomization method was used to distribute the groups homogeneously. Fifty-four patients who
      were hospitalized in the reanimation intensive care unit and accepted to participate in the
      study and met the inclusion criteria were included. The patients were randomly assigned to 3
      groups of 18 people, each with distilled water, lavender oil, and bergamot oil. "Patient
      Information Form", "Patient Follow-up Form", "State-Trait Anxiety Inventory" and
      "Richard-Campbell Sleep Scale (RCUS)" were used to collect data.
    

Intervention name(s): aromatherapy; Placebo
Intervention type(s): Other; Other
Intervention description(s): essential oil application by inhalation; Placebo essential oil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: - Having pain, having smell problems, having systolic blood pressure below 100 mm Hg, having lung cancer, asthma and chronic obstructive pulmonary disease, allergic to known plants, flowers and related essential oils, using any medication for anxiety and sleep problems Lavender and bergamot oil were not administered to the patients by inhalation.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Intensive care unit,; sleep quality,; anxiety; aromatherapy,; lavender oil,; bergamot oil
Relative Bioavailability and Food Effect Study for GSK163090 in Healthy Male and Female Volunteers
Condition: Depressive Disorder and Anxiety Disorders
MeSH terms: Depressive Disorder; Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will consist of a screening period, 3 treatment periods and a post-treatment
      follow-up. In each of the 3 treatment periods, subjects will receive a single oral dose of
      GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose
    


Intervention name(s): GSK163090 capsule, fasted; GSK163090 Tablet, fasted; GSK163090 Tablet, fed
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK163090 will be available as 1 mg hard gelatine white/white opaque capsules. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with approximately 240 milliliters (mL) of water.; GSK163090 will be available as 1 mg white coated round tablet. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with approximately 240 mL of water.; GSK163090 will be available as 1 mg white coated round tablet. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with Food and Drug Administration (FDA) high fat breakfast.
Other intervention name(s): GSK163090
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relative Bioavailability; Randomised; GSK163090; Food Effect
Autoregulation of Glomerular Filtration Rate in Patients With Type 1 Diabetes During Spironolactone Therapy
Condition: Hypertension
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the impact of spironolactone treatment on renal autoregulation in hypertensive
      type 1 diabetic patients.
    

Detailed description: 
      Double-masked, randomized, crossover trial. In random order, patients will be treated with
      spironolactone 25 mg o.d. and matched placebo for 28 days.

      On the last day of treatment, GFR will be determined twice on the same day: first without
      clonidine and secondly after injection of clonidine (clonidine induces a transient reduction
      in blood pressure, with no influence on renal plasma flow and GFR), in order to evaluate the
      effect of antihypertensive treatment with spironolactone on renal autoregulation of GFR.

      The study will be preceded by a wash-out period of 1 month for patients receiving
      antihypertensive medication. Patients will be instructed to measure blood pressure twice
      daily, three days a week during this period. If, during the washout period, blood pressure
      exceeds 170/105 mm Hg or persistent edemas develop, treatment with long-acting loop diuretics
      will be initiated and continued throughout the rest of the study. If blood pressure despite
      diuretic treatment still exceeds 170 mm Hg systolic and/or 105 mm Hg diastolic, the patient
      will be excluded from the study and previous/appropriate antihypertensive treatment will be
      restarted.
    

Intervention name(s): Spironolactone
Intervention type(s): Drug
Intervention MeSH terms: Spironolactone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Renal autoregulation; Glomerular filtration rate; Type 1 diabetes
Enhancement of Cerebral Vasoreactivity and Cognition by Intranasal Insulin in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Our goal is to determine the acute effects of intranasal insulin on regional perfusion and
      cognition of older adults. We propose a pilot study to examine the effect of a single dose of
      intranasal insulin on regional vasoreactivity and cognitive functions in 30 subjects with
      T2DM and 30 healthy controls >50 years old using a double blinded, placebo-controlled,
      cross-over design.

      Hypothesis 1: Intranasal insulin improves acutely regional perfusion and vasoreactivity in
      older patients with T2DM as compared with placebo and compared with the control group.

      Hypothesis 2: Intranasal insulin improves cognitive functioning including attention, memory
      and executive function in diabetic patients as compared with placebo and compared with
      control group.
    

Detailed description: 
      Type 2 diabetes mellitus (T2DM) is a major risk factor for vascular dementia. DM alters
      insulin transport across blood-brain barrier affecting perfusion and neuronal function.
      Intranasal administration enables effective delivery of insulin to the brain. Clinical
      studies demonstrated improvement of cognitive function and memory in healthy and cognitively
      impaired people.

      Aim 1: To determine the acute effects of a single 40-IU dose of intranasal insulin vs.
      placebo on regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous
      arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups. We will use
      transcranial Doppler to determine the effects on intranasal insulin vs. placebo on cerebral
      autoregulation based on measurements of beat-to-beat pressure flow velocity relationship.

      Aim 2: To determine whether intranasal insulin improves cognitive functioning in older T2DM
      patients as compared with placebo and the control group.

      This translational study will address an important area about the effects of intranasal
      insulin on cerebral blood flow regulation and cognition in older diabetics that has not been
      studied. Intranasal insulin administration may provide a novel therapeutic target for
      prevention and treatment of microvascular disease and cerebrovascular complications of T2DM.
      If successful, this approach may have significant impact on the clinical management of large
      population of older adults with T2DM.
    

Intervention name(s): Intranasal insulin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The acute effects of a single 40-IU dose of intranasal insulin; The acute effects of intranasal sterile saline.
Other intervention name(s): Novolin R
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: diabetes, blood flow, brain perfusion, cognitive function