bioihbjkbjnl/mcl2 huggingface dataset:
Specialized Treatment Early in Psychosis (STEP)
Condition: Schizophrenia and Disorders With Psychotic Features
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to understand the effectiveness of a specialized package of
      phase-specific treatments for individuals in the midst of their first episode of psychosis.
      The pharmacologic and psychosocial treatments will be delivered within a state public mental
      health center.
    

Detailed description: 
      We propose to conduct a clinical trial for first episode psychosis patients not eligible for
      CMHC services that will compare randomized access to care at CMHC versus the usual procedure
      of referral to community providers outside CMHC. Patients randomized to access to CMHC
      services will receive multifaceted, intensive, phase-specific care delivered by a specialized
      clinical team. This care will include five principal components: antipsychotic prescription,
      multi-family group therapy, group cognitive behavioral therapy, cognitive remediation and
      individual case management including supportive, problem solving approaches and a focus on
      resumption of movement towards educational and/or employment related goals. All consenting
      subjects will undergo research evaluations every six months for up to five years. Outcomes
      will be assessed in the domains of re-admission (primary outcome), relapse, symptoms, overall
      functioning, quality of life, education and employment, treatment satisfaction, adherence,
      substance use, adverse events (including self-harm) and economic measures including service
      use, cost of care and forensic data.
    

Intervention name(s): Cognitive Behavioral Group Therapy; Cognitive remediation; Medications; MFG; Assertive case management; Treatment as Usual in the community
Intervention type(s): Behavioral; Behavioral; Drug; Behavioral; Behavioral; Other
Intervention description(s): once per week; as needed; Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.; Multi-Family psychoeducation Group based on the model published by McFarlane et al.; Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports.; Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: First episode psychosis; Specialized care; Phase-specific treatment; Schizophrenia; Disorders with psychotic features
Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the performance of two toothpastes in controlling
      established gingivitis and dental plaque in adults.
    


Intervention name(s): Triclosan, fluoride; Fluoride
Intervention type(s): Drug; Drug
Intervention description(s): Six Month study, brush twice daily; twice daily usage
Other intervention name(s): Colgate Total Advanced Freshening toothpaste; Crest Cavity Protection toothpaste
Intervention MeSH terms: Triclosan; Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gingivitis and Plaque
Metta Meditation Training on Prosocial Behavior
Condition: Social Behavior
Study type: Interventional

Summary: 
      The purpose of the study is to look at the impact of a metta meditation training on prosocial
      behavior and socio-affective brain responses. The training involves an 8-week, online
      administration of guided metta meditation practices aimed at generating feelings of kindness
      and compassion for other people. The study examines how participants respond to thinking
      about familiar others and strangers using behavioral and brain-imaging measures. This study
      will be important for understanding how people develop the capacity to be prosocial towards
      other individuals, which is a key component of adaptive social behavior.
    


Intervention name(s): Metta meditation
Intervention type(s): Behavioral
Intervention description(s): Administered 5 days per week for 8 weeks.
Other intervention name(s): Loving-kindness meditation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy subjects; prosocial; metta meditation; fMRI
Brain Effects of Opiate Agonist and Antagonist
Condition: Chronic Low-back Pain
MeSH terms: Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will look at the short-term effect of morphine on brain response to food.
    

Detailed description: 
      Chronic low back pain patients and healthy controls will be recruited for this study.
      Participants' brain will be scanned at baseline and then again on a different day after the
      administration of an oral dose of 30 mg morphine in an open label design. Participants will
      receive morphine 60 minutes prior to the start of the second scanning session. The brain
      scans will include structural scans, functional scans at rest and functional scans during the
      ingestion of a highly caloric drink.
    

Intervention name(s): Morphine
Intervention type(s): Drug
Intervention description(s): 30 mg oral tablet
Intervention MeSH terms: Morphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Tri Staple Technology Stapler Used in Gastric Bypass
Condition: Sleep Apnea; Hypertension; Hyperlipidemia; Coronary Artery Disease; Gastroesophageal Reflux Disease; Osteoarthritis; Diabetes
MeSH terms: Gastroesophageal Reflux; Coronary Artery Disease; Hyperlipidemias
Study type: Interventional

Summary: 
      The objectives of this clinical trial are to assess in a pilot setting the overall
      performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™
      Technology when used in a gastric bypass procedure.
    


Intervention name(s): Tri Staple Technology stapler
Intervention type(s): Device
Intervention description(s): This is a single arm study.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastric bypass; Gastric bypass surgery
Woebot for Substance Use Disorders
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 of this study aims to develop a digitally-delivered substance use disorder program
      through the Woebot app-based platform (W-SUDs) and evaluate the effectiveness of, patient
      satisfaction with and the acceptability of W-SUDs as a substance use management tool.
    


Intervention name(s): Woebot-SUDs (W-SUDs)
Intervention type(s): Device
Intervention description(s): Woebot-SUDs (W-SUDS), an artificially intelligence-powered conversational agent on a smartphone app, eliminates most current SUDs treatment barriers while simultaneously leveraging technology to enhance user experience and engagement. W-SUDs expands and refines existing SUDs treatments by adapting skills from cognitive behavioral therapy, motivational interviewing, and dialectical behavior therapy.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500 Post-Meal Glucose Control in Patients With Severe Insulin Resistance
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is designed to compare meal time glucose control associated with BIOD-531, a
      rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R
      U-500 in patients with diabetes and severe insulin resistance.
    


Intervention name(s): BIOD-531; Humalog Mix 75/25; Humulin R U-500; BIOD-531
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
"Efficacy Of 1.2% Rosuvastatin Gel In The Management Of Infrabony Defects"
Condition: Adult Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Study aims to evaluate clinical and radiographic effectiveness of 1.2% Rosuvastatin gel in
      the treatment of Infrabony defects in chronic periodontitis patients.
    

Detailed description: 
      Source from where the patients will be selected:

      10 patients with chronic periodontitis having two or more infrabony defects will be selected
      from the Outpatient section of Dept. of Periodontology, Dr. D. Y. Patil Dental College and
      Hospital, Pimpri, Pune - 18.

      A detailed clinical examination, case history and written consent will be obtained from all
      the participants.

      Before surgery, each patient will be given careful instructions regarding proper oral hygiene
      measures. A full-mouth phase I therapy will be performed. A periodontal re-evaluation will be
      performed after 4 to 6 weeks of phase 1 therapy to confirm the desired sites for the study.
      The selected sites will be divided randomly by using a Sequentially numbered, opaque, sealed
      envelopes (SNOSE) randomization into control and test sites. The control site will be treated
      with Access Flap Surgery (AFS), whereas test sites will be treated with AFS and 1.2%
      Rosuvastatin gel. Suitable antibiotics and analgesics will be prescribed along with
      Chlorhexidine digluconate rinses (0.2%) twice daily for 14 days. Patients will be examined at
      4 weeks, 3 and 6 month after surgery.
    

Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention description(s): Test sites were treated with access flap surgery and 1.2% Rosuvastatin gel
Other intervention name(s): No intervention used on Control site
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Intervention Study; Rosuvastatin; Periodontitis
Improving Insulin Sensitivity by Non-invasive Brain Stimulation
Condition: Insulin Resistance; Transcranial Direct Current Stimulation; Obesity; Diabetes; Magnetic Resonance Imaging
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Efforts in curing and preventing obesity and type 2 diabetes (T2D) have been elusive thus
      far. One reason for that is the lack of understanding of the role of the brain in the
      development and treatment of the disease. In recent studies, the hypothalamus was identified
      as part of a brain network including higher cognitive regions that is particularly vulnerable
      to insulin resistance. Furthermore, the central insulin response in this network predicted
      food craving and hunger. In this project, transcranial direct current stimulation (tDCS) is
      implemented as a tool to stimulate brain networks. The investigators hypothesize that
      stimulating the hypothalamus-cognitive network will enhance insulin sensitivity and reduce
      food intake, food craving and hunger. Furthermore, the project will provide the unique
      opportunity to investigate novel mechanisms of insulin resistance in participants who have
      been extensively metabolically characterized.
    

Detailed description: 
      Objectives The overarching aim of the study is to stimulate the hypothalamus-cognitive brain
      network to improve insulin sensitivity and eating behavior.

      Specific Objectives

        1. Implement tDCS stimulation compared to sham stimulation in overweight and obese adults
           to assess the impact on eating behavior, cognition and metabolism.

        2. Evaluate whether 3-day non-invasive brain stimulation of the hypothalamus-cognitive
           network has a causal effect on metabolism.

        3. Evaluate whether 3-day non-invasive brain stimulation has a significant effect on brain
           functional connectivity and diffusion parameters.
    

Intervention name(s): transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): anodal or cathodal transcranial direct current stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Use of Positive Pressure in Morbidly Obese Patients Undergoing Reduction Stomach Surgery
Condition: Pulmonary Atelectasis; Respiratory Tract Diseases; Pathological Conditions, Signs and Symptoms
MeSH terms: Pulmonary Atelectasis; Respiratory Tract Diseases
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effects of using positive pressure in the
      preoperative, intraoperative and postoperative morbidly obese individuals undergoing
      gastroplasty.

      It is believed that the application of these devices before, during or after surgery can help
      to improve the lungs and reduce pulmonary complications after surgery to reduce the stomach.
    

Detailed description: 
      The aim of this study was to investigate the effects of using positive pressure in the
      preoperative, intraoperative and postoperative morbidly obese individuals undergoing
      Roux-en-Y gastric bypass with regard to: lung volumes and capacities, the prevalence of
      atelectasis, duration of surgery and diaphragmatic mobility.

      Individuals with BMI between 40 and 55 kg/m2, aged between 25 and 55 years, were submitted to
      Roux-en-Y type gastric bypass by laparotomy. Patients showing a normal preoperative pulmonary
      function test were included, but those with hemodynamic instability, a hospital stay longer
      than three days or the presence of postoperative complications were excluded.

      The volunteers were divided into four different groups:

      Gpre: subjects treated with positive pressure in the BiPAP mode (Bi-Level Positive Airway
      Pressure) for one hour before surgery; Gpos: individuals treated with positive airway
      pressure (BiPAP) for one hour after surgery; Gpeep: individuals treated with 10 cm H2O of
      PEEP (Positive End Expiratory Pressure) during the surgical procedure.

      Gcont: individuals treated with conventional physiotherapy (CP) according to the routine
      service of physiotherapy of the hospital, including the techniques of pulmonary re-expansion,
      breathing exercises (deep breaths or fractional), the use of incentive spirometry
      (Respiron®), bronchial hygiene resources if necessary (Flutter® and cough active or assisted)
      and assisted ambulation. It should be noted that the physiotherapist was blinded to the
      individual's participation in the groups, and all patients received conventional
      physiotherapy, independent of the group in which they were included.

      The respiratory evaluation (preoperative and second postoperative days) consisted of
      collecting the anthropometric data, a pulmonary function test and a chest radiography
      (inspired and expired).
    

Intervention name(s): Positive pressure
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Morbid obesity; Bariatric Surgery; Pulmonary Atelectasis; Spirometry; Continuous Positive Airway Pressure; Physical Therapy Specialty
Safety and Pharmacokinetics of Phaffia Rhodozyma Astaxanthin
Condition: Absorption; Chemicals
Study type: Interventional

Summary: 
      Astaxanthin is a xanthophyll carotenoid, a naturally occurring lipid-soluble red pigment.
      Apart from its coloring ability it is also a strong antioxidative ingredient and contains
      health-promoting properties.

      Study aim is to monitor the safety and tolerability of AstaFerm™, an astaxanthin dietary
      supplement derived from the yeast Phaffia rhodozyma. Pharmacokinetics profile is tested in 12
      healthy male adults who received a single dose of AstaFerm™ in a single-center, open-label,
      non-randomized, single-dose study. Subjects are admitted to the clinical research center on
      the evening before dosing. On the next morning, after overnight fast, pre-dosing plasma
      sampling is performed, then they receive a fat balanced breakfast followed by a single
      administration of AstaFerm™ capsules. The capsules contain 50 milligram astaxanthin derived
      from Phaffia rhodozyma. Following dosing, blood sampling is performed for 24 hours in-house
      (2, 4, 6, 8, 10, 12 and 24-hours post-dose) and ambulatory at 48, 72- and 168-hours
      post-dose. Blood for antioxidant activity assessment is also drawn.
    


Intervention name(s): Astaxanthin
Intervention type(s): Dietary Supplement
Intervention description(s): Capsules containing astaxanthin derived from the yeast Phaffia rhodozyma .
Other intervention name(s): AstaFerm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics
Myocardial Perfusion in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators aimed to evaluate microvascular circulation with novel method: real-time
      myocardial contrast echocardiography in patients with type 2 diabetes and normal coronary
      arteries.

      Myocardial blood flow reserve will be determined by quantitative contrast Stress
      echocardiography. Diabetic individuals will be evaluate in a decompensated state (Phase 1)
      and after optimization of medical treatment four months later (Phase 2).
    

Detailed description: 
      Early stages of epicardial atherosclerosis in patients with type 2 diabetes are associated
      with an impairment in endothelium-dependent dilation of the coronary microvasculature,
      indicating that the pathophysiological consequences of atherosclerosis may extend into the
      coronary microcirculation.

      The investigators will evaluate three parameters of myocardial quantification with contrast
      Stress echocardiography and correlate with HbA1C levels.
    

Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): Metformin 850mg
Other intervention name(s): Glucophage
Intervention MeSH terms: Metformin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Diabetes Mellitus; Myocardial perfusion imaging; Heart diseases; Echocardiography; Endothelium
What is the Optimal Stiffness and Height of a Running-specific Prosthesis?
Condition: Amputation, Traumatic; Traumatic Amputation of Lower Extremity; Wounds and Injuries
MeSH terms: Wounds and Injuries; Amputation, Traumatic
Study type: Interventional

Summary: 
      The proposed study aims to characterize the effects of running-specific leg prosthetic
      stiffness and height during on performance during running and sprinting to optimize
      running-specific prosthesis prescription. The investigators will collect biomechanical and
      metabolic data from participants with unilateral and bilateral below the knee amputations
      while they run at different speeds on a treadmill. This data will be used to understand the
      effects of running prostheses. Then, these parameters will be used to develop prosthetic
      prescription techniques for people with below the knee amputations.
    


Intervention name(s): Otto Bock prosthesis; Ossur prosthesis; Freedom Innovations prosthesis
Intervention type(s): Device; Device; Device
Intervention description(s): Participants will run using the Otto Bock prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.; Participants will run using the Ossur prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.; Participants will run using the Freedom Innovations prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 10 athletes with a unilateral and 5 athletes with bilateral transtibial amputations used 15 different running-specific prosthetic configurations while they ran at one speed and we measured metabolic rates and biomechanics. 10 athletes with a unilateral and 5 athletes with bilateral transtibial amputations used 15 different running-specific prosthetic configurations while they ran at multiple speeds and we measured top speeds and biomechanics.
Masking: None (Open Label)
Primary purpose: Basic Science
Anterior Segment Anatomic Parameters for Risk Profiling of Primary Angle-closure Glaucoma
Condition: Glaucoma, Angle-Closure
MeSH terms: Glaucoma; Glaucoma, Angle-Closure
Study type: Observational

Summary: 
      The goal of this observational study is to examine the anterior segment anatomical parameters
      associated with the scleral spur and cornea for risk profiling of primary angle-closure
      glaucoma (PACG). The main question it aims to answer is:

      • Are there new anatomical parameters of the anterior segment of the eye that can be used
      early for risk profiling for PACG? Researchers will compare PACG and narrow angle groups to
      see if there are some anatomical parameters that can distinguish the two.
    

Detailed description: 
      We aimed to examine the anterior segment anatomical parameters associated with the scleral
      spur and cornea for risk profiling of primary angle-closure glaucoma (PACG).

      This retrospective study included 84 patients with PACG and 84 patients with narrow angles
      (NA). We collected parametric measurements obtained using anterior-segment optical coherence
      tomography and IOLMaster 700. Univariate and multivariate logistic regression models were
      used to compare the ocular parameters between the NA and PACG groups as well as to identify
      risk factors for PACG. The predictive performance of each parameter was evaluated using the
      area under the receiver operating characteristic curve (AUROC) analysis.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with PACG and anterior chamber angle stenosis were enrolled in this study and
        excluded from other diseases affecting the structure of the anterior segment of the eye, as
        well as a history of intraocular surgery.