bioihbjkbjnl/mcl2 huggingface dataset:
L-arginine in Treatment as Usual in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      STUDY OBJECTIVES: To determine whether the addition of L-arginine to treatment as usual (TAU)
      in schizophrenia further improves and enhances therapeutic efficacy (positive, negative and
      depressive symptoms) and effectiveness of antipsychotic treatment

      STUDY POPULATION: Patients diagnosed (DSM-IV criteria) with schizophrenia or schizoaffective
      disorder

      Total expected number of patients: 14

      INVESTIGATIONAL COMPOUND: L-arginine capsules, 3 grams of L-arginine given twice a day (total
      daily dose of 6 grams/day)

      DURATION OF ACTIVE TREATMENT: 3 weeks followed by wash-out phase of 5 days and 3 weeks of
      second treatment phase (cross-over design)

      EVALUATION CRITERIA: Primary (efficacy) outcomes: PANSS scores. Secondary outcomes: Calgary
      Depression Scale for schizophrenia, CGI; AIMS, UKU-assessment of side-effects

      ASSESSMENT SCHEDULE: Treatment arm 1: Baseline, weeks: 1,2,3, wash-out phase; week 4,
      cross-over phase: treatment phase-2; weeks 5,6,7

      STATISTICAL CONSIDERATIONS: Analysis of variance of outcome measures with treatment as the
      between-subject factor and pre- and post-treatment scores as within- subjects factors.

      DURATION OF STUDY PERIOD: Patient recruitment to be completed in 12 months, study full
      completion 18 months.
    

Detailed description: 
      In the current study, our goals were to examine the clinical benefits of the nitric oxide
      (NO) donor and main precursor of NO, L-arginine, to further improve the symptoms of
      schizophrenia with minimum or no additional side-effects. L-Arginine is classified as a
      semi-essential or conditionally essential amino acid depending on the developmental stage and
      health status of the individual. Glutamate N-methyl-D-aspartate (NMDA) receptors have
      functional connections to the NO system in the brain. Dysfunction of connectivity of the
      neuroregulators glutamate and NO have been implicated in mechanisms of psychosis. Therefore,
      any downstream effects of NMDA dysfunction in schizophrenia may be ultimately mediated by the
      NO system at a cellular level. As an augmenting treatment to antipsychotic therapy, we
      examined the ability of L-arginine to further improve residual symptoms in the illness.
    

Intervention name(s): L-Arginine
Intervention type(s): Drug
Intervention description(s): 3 grams, twice daily, oral administration
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Nutritional Counseling to Change Eating Behavior, Metabolism and Anthropometry in Adults With Abdominal Obesity
Condition: Obesity, Abdominal
MeSH terms: Obesity; Obesity, Abdominal
Study type: Interventional

Summary: 
      This study evaluates the impact of changes in eating behavior through nutritional counseling,
      after nine months of intervention, on body composition and metabolism in adult workers with
      abdominal obesity
    

Detailed description: 
      This study is a nutritional intervention in voluntary workers with abdominal obesity (waist
      circumference ≥102cm and ≥88cm). The intervention is divided into two phases: the intensive
      one has a duration of 6 months and consisted in a 4 face-to-face sessions with 9 online or
      telephone contacts based on the use of nutritional counseling [Academy of Nutrition and
      Dietetics, 2013] and the second phase: consisted in a 3 months' follow-up with 2 telephone
      contacts and a final visit face-to-face. The investigators used the Cognitive Behavior
      Therapy process as a theoretical framework, and also used the intervention comprised sessions
      designed to promote motivation, social support, self-regulation to promote the eating
      behavior change process. The participants were measured weight loss, waist circumference, and
      the lipid profile change, pre-intervention, and after six and nice months post-intervention.
    

Intervention name(s): Nutritional counseling
Intervention type(s): Other
Intervention description(s): Intervention based on nutritional counseling under Cognitive Behavioral Theory and the used of strategies like self-monitoring, goals, cognitive restructuring and social support.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: obesity; nutritional counseling; weight loss; eating behaviors; abdominal obesity
Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant IBS and UC in Remission
Condition: Gut Health
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      Short chain fatty acids (mainly butyrate, acetate, and propionate) are produced in the large
      intestine by bacterial fermentation of undigested carbohydrates, such as dietary fibres.
      Butyrate is an important energy source of the intestinal epithelium and has a pivotal role in
      the regulation of epithelial cell proliferation and differentiation, immune function and
      mucosal protection.

      Non-digestible carbohydrates (prebiotics) increase the concentrations of colonic butyrate,
      which has been proposed to be responsible for its beneficial effects. Furthermore, butyrate
      enemas have been proven to be effective in the treatment of active ulcerative colitis.

      In the present study, the direct effects of butyrate on inflammation and parameters of
      colonic defence and mucosal integrity of the distal colon will be studied in 40 patients with
      diarrhoea predominant IBS (D-IBS) and 40 patients with ulcerative colitis in remission
      (UCrem) using rectal enemas. These patients groups were chosen because they have a low-grade
      inflammation in the large intestine, and can therefore be used as a model to study the
      mechanistic effects of butyrate. The design used to study the effects of butyrate in both
      patient groups will be a double blind randomized placebo-controlled parallel design.
    


Intervention name(s): sodium butyrate; NaCl
Intervention type(s): Other; Other
Intervention description(s): 1 enema (60 ml) once daily containing 100mM; 1 enema (60 ml) once daily containing 0.9%NaCl
Intervention MeSH terms: Butyric Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Immediate Functional Versus Non Functional Implant Loading in the Mandible
Condition: Dental Implants; Edentulous Alveolar Ridge
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      comparing immediate functionally loaded implants and immediate non functionally loaded
      implants in the posterior mandibular region on bases of bone density and bone loss evaluated
      by cone-beam computed tomography (CBCT).
    

Detailed description: 
      Patients are more demanding after the revolution in immediate implant dentistry which reduces
      implant procedure nowadays according to literature and research. In response to patients'
      demands not only implants are immediately placed but also immediately loaded within 72 hours
      reducing the time for prosthetic loading and also improving bone formation according to some
      studies. The debate in modern implant dentistry is whether to immediately load the implants
      in functional occlusion or non-functional occlusion and which will improve the
      osseointegration and reduce crestal bone loss.

      Implants of the BioInfinity system were placed in 16 subjects divided into two groups.

      Group (A): 8 patients with missing posterior mandibular teeth whom will be rehabilitated with
      immediate functionally loaded implants.

      Group (B): 8 patients with missing posterior mandibular teeth in whom immediate
      non-functionally loaded implants were used.

      The two groups were evaluated at baseline, immediately after implant placement and 4 months
      postoperative to evaluate crestal bone level and quantitative radiographic bone density using
      CBCT.
    

Intervention name(s): immediate functional implant loading; immediate non functional implant loading
Intervention type(s): Other; Other
Intervention description(s): Patients will undergo implant placement and a minimum of 35 Ncm reading with the graded torque wrench. Temporary crowns in functional occlusion were cemented.; implant will be placed into the site following the manufacturer's protocol making sure to have a minimum of 35 Newton centimeter reading with the degraded torque wrench. Non-functional temporary crowns were cemented.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)
Condition: Sjögren's Syndrome; Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To evaluate the therapeutic efficacy of one dose level of SAR441344 versus placebo over 12
      weeks in adult patients with primary Sjögren's syndrome (pSjS), assessed by the change of the
      European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI)

      Secondary Objectives:

        -  To evaluate the therapeutic efficacy of one dose level of SAR441344 versus placebo over
           12 weeks in adult patients with pSjS

        -  To evaluate the therapeutic efficacy on fatigue of one dose level of SAR441344 versus
           placebo over 12 weeks in adult patients with pSjS

        -  To evaluate the pharmacokinetic (PK) exposure of one dose level of SAR441344 over 12
           weeks in adult patients with pSjS

        -  To evaluate the safety and tolerability of one dose level of SAR441344 versus placebo in
           adult patients with pSjS as determined by adverse events (AEs)

        -  To evaluate the local tolerability of one dose level of SAR441344 versus placebo over 12
           weeks in adult patients with pSjS

        -  To evaluate the safety and tolerability of one dose level of SAR441344 versus placebo
           over 12 weeks in adult patients with pSjS determined by electrocardiogram, vital signs,
           and laboratory evaluations

        -  To measure the immunogenicity of one dose level of SAR441344 versus placebo over 12
           weeks in adult patients with pSjS

      This is a multicenter, randomized, double blind, placebo controlled, parallel group proof of
      concept Phase 2 study to evaluate the therapeutic efficacy of SAR441344 in adult patients
      with primary Sjögren's syndrome (pSjS), as well as safety, tolerability, pharmacokinetics
      (PK), and pharmacodynamics (PD).

        -  Study visit frequency: every 2 weeks in the treatment period and every 4 weeks in the
           follow-up period.

        -  The total duration of the study will be 24 weeks (28 weeks including maximum screening
           duration) for each participant, including a 12-week treatment period and a 12-week
           follow-up period.
    


Intervention name(s): SAR441344; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: solution for injection
Route of administration: intravenous or subcutaneous; Pharmaceutical form: solution for injection
Route of administration: intravenous or subcutaneous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of the study drug tirzepatide in
      participants with type 2 diabetes mellitus.
    


Intervention name(s): tirzepatide; Dulaglutide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered SC; Administered SC; Administered SC
Other intervention name(s): LY3298176; LY2189265
Intervention MeSH terms: Dulaglutide; Tirzepatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Erector Spinae Plane Block Versus Intraarticular Injection for Postoperative Analgesia in Shoulder Arthroscopy
Condition: Shoulder Arthroscopy; Postoperative Analgesia; Erector Spinae Plane Block; Intraarticular Injection
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      To improve the outcome after surgery, effective pain control is needed. The aim of the
      current study was to compare the efficacy of ultrasound guided erector spinae plane block
      versus the intra articular injection of local anesthetic for post-operative analgesia in
      patients undergoing shoulder arthroscopy.
    

Detailed description: 
      Sample size calculation:

      Calculation of sample size was done to detect a 15% difference in the VAS score between two
      groups detected that at least 27 patients were needed at an α error of 0.05 and 80 % power of
      the study. The number will be increased to 30 patients to avoid a 10% dropped out patients.

      Statistical analysis Statistical analysis will be done by Statistical Package for the Social
      Sciences (SPSS) v25 (IBM Inc., Chicago, USA). Normality of data will be checked with
      Shapiro-Wilks test and histogram. Quantitative variables will be presented as mean and
      standard deviation (SD) and will be compared by unpaired student T test. Categorical
      variables will be presented as frequency and percentage (%) and will be analysed by the
      Chi-square test. P value < 0.05 will be considered statistically significant.
    

Intervention name(s): Erector Spinae Plane Block; Intraarticular Injection
Intervention type(s): Procedure; Procedure
Intervention description(s): The patient will be placed in the lateral position. Following skin disinfection, counting down from the C7 spinous process and using ultrasound guidance, the level of T2 transverse process will be identified. A 2-5 MH2 curved array transducer (sono site Edge, Bothell, Will behington) will be positioned transversely to visualize the lateral tip of T2 transverse Process. A longitudinal parasagittal orientation will be obtained over the transverse process using a 22 - gauge 8 cm block needle (visioplex, Vygon , France) will be inserted in plane to US beam in a caudal to cranial direction to place the needle tip between the posterior fascia of the erector spinae muscle and the T2 transverse process.
Position of the needle tip in the ESP deep to the erector spinae muscle will be confirmed using hydrodissection with 0.5 - 1 ml of normal saline and visualization of the linear fluid spread deep to the erector spinae muscle following which 20 ml of 0.25% bupivacaine will be injected.; Intraarticular injection of local anesthetic through the surgical port
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      The investigators hypothesize that the inhibition of endogenous reverse transcriptase would:
      (1) reduce excess cytosolic DNA, stress initiating the inflammatory loop at the origin of
      psoriatic lesions, and (2) interrupt the loop and lighten lesions
    


Intervention name(s): Generic antiretroviral
Intervention type(s): Drug
Intervention description(s): 200mg emtricitabine plus 245mg tenofovir diisopropyl fumarate for 7 days
Intervention MeSH terms: Anti-Retroviral Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Non-thermal Plasma for Sebum Reduction in Oily Facial Skin
Condition: Oily Skin
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy and safety of argon-and nitrogen-
      non-thermal, atmospheric-pressure plasma (NTAPP) for reduction of sebum excretion in healthy
      volunteers with oily facial skin.
    

Detailed description: 
      Excessive secretion of sebum contributes to several skin diseases associated with sebum
      glands, including acne. Excessive sebum secretion can damage the skin barrier function by
      changing the composition of skin surface lipids, leading to the abnormal keratinocyte
      differentiation and hyperkeratosis in the follicular ostia. Follicular hyperkeratosis can
      create anaerobic environment, leading to the proliferation of Propionibacterium acnes.

      Recently, several energy devices targeting sebaceous glands have been developed, but there is
      still a need for an effective and safe therapeutic tool for hyperseborrhea. Non-thermal,
      atmospheric-pressure plasma (NTAPP) has various biological effects. A recent study
      demonstrated NTAPP-induced microscopic tissue reactions in the sebaceous glands from rat skin
      in vivo, suggesting that the potential effect of NTAPP on the human sebaceous gland
      physiology, but the relevant data are lacking. In this study, investigators aim to assess the
      safety and efficacy of argon- and nitrogen-NTAPP for reduction of sebum excretion in oily
      human facial skin.
    

Intervention name(s): PLADUO(PX1000)
Intervention type(s): Device
Intervention description(s): Three sessions of argon- and nitrogen- NTAPP treatment at 1-week interval. Two passes of argon-NTAPP treatment and two passes of nitrogen-NTAPP treatment were sequentially performed in each session. Argon plasma at a pulse energy of 0.8 J/pulse with a 12 msec of pulse duration and nitrogen-plasma at a pulse energy of 0.75 J/pulse delivered with a 7 ms of pulse duration.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1 Study(Additional) of URC102 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, PK and PD of URC102 in
      healthy subjects.
    

Detailed description: 
      Tolerability, safety, and pharmacokinetics (PK) of URC102 will be assessed after 7-day
      repeated oral dose in healthy adult Korean males. In addition, pharmacodynamic (PD) response
      of blood and urinary uric acid levels will be assessed.
    

Intervention name(s): Placebo; URC102
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial
Condition: Atrial Fibrillation; Arrhythmia
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The CABANA pilot study is designed to test the hypothesis that the treatment strategy of
      percutaneous left atrial catheter ablation for the purpose of the elimination of atrial
      fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or
      anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.
    

Detailed description: 
      The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of
      age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug
      therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application
      of radio-frequency catheter ablation without appropriate evidence-based validation, and 4)
      the expanding impact of AF on health care costs.
    

Intervention name(s): Rate Control; Ablation Therapy; Rate Control; Rate control; Rate control; Rate control; Rate Control; Rate Control; Rate Control; Rhythm Control; Rhythm control; Rhythm control; Rhythm control; Rhythm control; Rhythm control
Intervention type(s): Drug; Device; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Metoprolol 50-100mg; Atenolol 50-100mg,; Propranolol 40-80mg; Acebutolol 200mg; Carvedilol 6.25mg; Diltiazem 180-240mg; Verapamil 180-240mg; Digoxin 0.125mg; Propafenone 450mg; Flecainide 200mg; Sotalol 240mg; Dofetilide 500mcg; Amiodarone 200mg; Quinidine 600-900mg
Other intervention name(s): Toprol; St. Jude: Livewire; Tenormin; Inderal; Sectral; Coreg; Cardizem; Calan; Lanoxin; Rhythmol; Tambacor; Betapace; Tykosin; Cordarone; Quini-glute/dex
Intervention MeSH terms: Amiodarone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial fibrillation; Left Atrial Ablation; Pulmonary Vein Isolation; Catheter Ablation; Antiarrhythmic Drug Therapy
Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain
Condition: Acute Pain; Postoperative Pain
MeSH terms: Pain, Postoperative; Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the present phase IIb clinical trial was to compare the safety and efficacy of
      the fixed-dose combination etoricoxib-tramadol 120mg/100mg tablet (once a day, for three
      days) versus naproxen 220mg tablet plus tramadol 50 mg capsule in patients with acute
      postoperative pain after impacted third molar extraction. The main research question was: Is
      the analgesic efficacy of etoricoxib-tramadol 120mg/100mg tablet non-inferior to naproxen 220
      mg tablet + tramadol 50 mg capsule in a clinical model of moderate to severe acute pain?
      After informed consent, patients were randomly assigned to one of the two arms: test product
      (etoricoxib-tramadol 120mg/100mg tablet) or active comparator (naproxen 220mg tablet +
      tramadol 50 mg capsule). After surgery, patients were requested to start the treatment with
      study drugs (test product was administered once daily for three days; meanwhile reference
      drug was administered twice a day for three days).

      Investigators compared the effects of both treatments on pain intensity at different time
      frames using the visual analogue scale. Furthermore, the safety of investigational drugs was
      assessed during the study.
    


Intervention name(s): etoricoxib-tramadol; Naproxen; Tramadol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral administration (with or without food); Oral administration (with or without food); Oral administration (with or without food)
Intervention MeSH terms: Naproxen; Etoricoxib; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Etoricoxib-tramadol; Third molar extraction; Analgesia