bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Escitalopram Doses up to 50mg in Treatment of MDD
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be an open label study of escitalopram. Patients not responsive to citalopram will
      be switched directly to escitalopram.

      Patients will receive escalating doses of escitalopram up to a maximum of 50 mg until they
      either achieve remission (MADRS <9) or fail to tolerate the dose.
    

Detailed description: 
      Patients will receive escalating doses of escitalopram up to a maximum of 50 mg until they
      either achieve remission (MADRS <9) or fail to tolerate the dose.

      Visit 1 - (Initial visit) - escitalopram 10 mg Visit 2 - (Week 2) - escitalopram 20 mg Visit
      3 - (Week 4) - review visit Visit 4 - (Week 6) - MADRS <12 - continue 20 mg MADRS >12 -
      escitalopram 30 mg Visit 5 - (Week 8) - MADRS <8 - continue current dose MADRS >8 - escalate
      dose (20 mg to 30 mg or 30 mg to 35mg)

      Thereafter, Patients who have achieved remission will be maintained on the remission dosage
      and reviewed at four weekly intervals. At any subsequent visit where the MADRS is >8 they
      will have a dosage increase

      Patients who have not achieved remission will have dosage escalated by 5 mg at two weekly
      intervals until remission, a maximum dose of 50 mg is achieved or the dosage is intolerable
      when they will be reduced to the previous tolerable dose.

      Patients will be followed up until eight months from their initial visit.
    

Intervention name(s): escitalopram
Intervention type(s): Drug
Intervention description(s): Dose ranging up to 50mg
Intervention MeSH terms: Escitalopram
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MDD; escitalopram
Neurofeedback Treatment of Pain in Persons With Spinal Cord Injury (SCI)
Condition: Spinal Cord Injury; Pain
MeSH terms: Spinal Cord Injuries
Study type: Observational

Summary: 
      There has been little research on how chronic pain is related to brain activity. The purpose
      of this study is to learn more about pain and brain activity by finding any differences in
      brain activity among people who have moderate to severe chronic pain and a spinal cord
      injury, those who have a spinal cord injury but do not experience chronic pain, and people
      who have neither a spinal cord injury nor chronic pain (please note: subjects do not have to
      have pain to participate in this study). The information we collect will help the
      investigators get a better understanding of chronic pain.
    

Detailed description: 
      Research staff will record the brain activity of subjects by using an electroencephalogram
      (EEG), a device that measures the electrical activity in the brain through electrodes put on
      the scalp. There is no risk of electrical shock. Research staff will put a cap on the
      subject's head that has electrodes that will measure your brain activity. In addition to the
      electrodes in the cap, two electrode clips will be put on your ears. EEG activity will be
      collected for 20 minutes: subjects will have their eyes open for ten minutes, and then eyes
      closed for ten minutes.

      Before the assessment, subjects will be asked how much pain they are currently in. Once the
      20-minute assessment has ended, the research staff member will again ask subjects how much
      pain they are currently in, and how much pain they had during the EEG assessment. Subjects
      with SCI-related pain on a daily basis may also be contacted in the future to see if they
      want to participate in the second phase of this study that will involve learning to directly
      change their brain activity.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited primarily from a previous survey study conducted by the
        principal investigator, as well as a data registry maintained by the principal
        investigator. Individuals recruited for these studies were recruited primarily from
        rehabilitation clinics. Interested individuals may also learn about the study from
        advertisements in newsletters and magazines from consumer organizations, physician
        referrals, recruitment descriptions on University of Washington websites, and study
        brochures in clinics.

        In addition, SCI subjects participating in the study will give friends and relatives who do
        not have a spinal cord injury or chronic pain a brochure informing them about the study.
Variations of Cognitive Behavior Therapy for Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of two variants of cognitive behavioral
      therapy (CBT) (cognitive therapy (CT) and acceptance and commitment therapy (ACT)), for the
      treatment of generalized social anxiety disorder.
    

Detailed description: 
      We are recruiting a clinical sample of patients who meet diagnostic criteria (per DSM-5) for
      the generalized subtype of social anxiety disorder. Participants are randomly assigned to the
      two active intervention conditions; no placebo or sham treatments will be employed.
      Assessments take place at baseline, pre-treatment, mid-treatment, post-treatment, and at 3-
      and 12-months follow-up; participants also complete a brief weekly assessment of functioning.
      Treatment is administered individually by trained graduate students in clinical psychology,
      directly trained and supervised by the PI and Co-PI. Participants receive 12 weekly 1-hour
      long sessions. The study design is a 2 (treatment condition) by 5 (assessment occasion) mixed
      factorial design.
    

Intervention name(s): Cognitive Therapy; Acceptance and Commitment Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive therapy (CT) highlights the identification and reappraisal of distorted or dysfunctional cognitions in the treatment of psychopathology. For example, socially anxious patients are taught to identify the thoughts and underlying beliefs that trigger strong emotional reactions (e.g., "if I attempt to initiate a conversation I'll humiliate myself"), and then replace these with more accurate, functional thoughts. There is a large body of research supporting the efficacy of CT for mood and anxiety disorders, and for social anxiety disorder in particular (Beck, 2005).; ACT does not attempt to modify cognitions directly, but rather seeks to foster a mindful acceptance of whatever thoughts or feelings arise, while still pursuing specific behavioral goals. For example, the individual would be taught simply to notice the thoughts as if from a distance without attempting to modify them, and initiate a conversation. Like other newer mindfulness and acceptance-based models of CBT, ACT also expands the traditional focus on symptom reduction to include an emphasis on broader life goals. The scientific literature on ACT has expanded rapidly over the past ten years. Recent reviews conclude that it appears to be at least as effective as CT, and may work at least in part via distinct treatment mechanisms (Powers, Zum Vörde Sive Vörding, & Emmelkamp, 2009).
Other intervention name(s): CT; ACT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: social anxiety; treatment; Cognitive Behavioral Therapy; Acceptance and Commitment Therapy; Cognitive Therapy
Descriptive Study of Cardiac Output During Rehydration With Recombinant Human Hyaluronidase in Pediatrics
Condition: Dehydration; Cardiac Output; Pediatrics
MeSH terms: Dehydration
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to non-invasively study the reflective changes in cardiac output
      as response to fluid therapy in the pediatric moderate hypovolemia/dehydrated pediatric
      patients using sub-q rehydration using Hylenex augmented subcutaneous infusion of fluids and
      electrolytes compared to intravenous methods.
    

Detailed description: 
      This is an open-labeled, single-center Phase IV clinical trial. The study will consist of
      patients with moderate hypovolemia/dehydration requiring parenteral rehydration. It is
      expected that this study will describe the onset or change in cardiac output using Hylenex
      augmented subcutaneous rehydration from ages 2 months up to 3 years and at a flow rate
      satisfying clinical needs, especially in reference to changes in cardiac output observed in
      standard intravenous rehydration.
    

Intervention name(s): Hylenex
Intervention type(s): Drug
Intervention description(s): 1ml subcutaneous with initiation of intravenous fluids then every 24 hrs with a maximum dose of 3 injections in 72 hours
Other intervention name(s): hyaluronidase human injection
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: cardiac output; dehydration; pediatrics
Platelet Rich Plasma for Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with
      involving compression of the median nerve in the carpal tunnel. Although many conservative
      managements of CTS, the effectiveness of these methods is insignificant or only persist for a
      short duration. The platelet rich plasma (PRP) is a new and potential treatment for patients
      with kinds of musculoskeletal disorders and recent reports showed being beneficial for
      peripheral neuropathy in animal studies. Since 2014, four small clinical trials showed the
      positive effect of PRP in peripheral neuropathy. Among these studies, two small trials showed
      beneficial effect of PRP for patients with mild CTS. However, the definite clinical effect of
      PRP for peripheral neuropathy from currently published studies is unclarified because these
      studies enrolled a few patients and lacked long-term follow-up (no more than 6 months
      follow-up).
    

Detailed description: 
      After obtaining written informed consent, patients of clinically diagnosed with bilateral CTS
      were randomized into intervention and control side. Intervention group received one-dose
      ultrasound-guided PRP injection and control group received one-dose ultrasound-guided normal
      saline injection. No additional treatment after injection through the study period. The
      primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes
      include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory
      nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was
      performed pretreatment as well as on the 2nd week, 1st, 3rd, 6th month and one year after the
      treatment.
    

Intervention name(s): platelet rich plasma; Normal saline
Intervention type(s): Procedure; Drug
Intervention description(s): Ultrasound-guided PRP injection between proximal carpal tunnel and median nerve.; Ultrasound-guided normal saline injection between proximal carpal tunnel and median nerve.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: platelet rich plasma; Perineural injection therapy; hydrodissection
Bone Marrow Autotransplantation in Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This project evaluates the effectiveness of the administration of autologous bone marrow
      blood in patients with brittle type 1 diabetes mellitus to restore insulin secretion. After
      mobilization of hematopoietic progenitors (G-CSF) during 3 days, 50 to 90 mL of bone marrow
      blood will be obtained by multifunction in the posterior iliac crest. The material obtained
      will be implanted into the pancreas through the magna pancreatic artery after femoral
      catheterization.
    


Intervention name(s): administration of autologous bone marrow blood
Intervention type(s): Biological
Intervention description(s): administration of autologous bone marrow blood through magna pancreatic artery after femoral catheterization once during 12-month study period
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes type 1; bone marrow transplantation
HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease
Condition: Celiac Disease; Gluten
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators will evaluate the use of an HLA-DQ2-gliadin tetramer for staining of gluten
      specific T cells in the diagnostics of uncertain celiac disease. Some patients have started
      on a gluten free diet without a diagnosis of celiac disease. Subsequent later investigation
      in special care is difficult as the patients often are reluctant to prolonged gluten
      challenge. The investigators use the HLA-DQ2-gliadin tetramers for detection of gluten
      specific T cells after a short gluten challenge. By this method the investigators search to
      discriminate between true celiac disease and clinical gluten intolerance without celiac
      disease, in a population of HLA-DQ2+ persons already on a gluten free diet without a formal
      diagnosis of celiac disease.
    


Intervention name(s): Gluten challenge.
Intervention type(s): Dietary Supplement
Intervention description(s): The study population consists of 50 HLA-DQ2+ patients on a gluten free diet, both celiacs and uncertain celiacs. The patients will undergo a oral gluten challenge with four slices of bread daily for three days. Before challenge blood samples will be drawn for tetramer staining of gluten-specific T-cells. The analysis is done at the Institute of Immunology at Rikshospitalet, using FACS analysis. Small intestinal biopsies will be examined for morhological changes and inflammatory gene expression. These procedures with blood samples and biopsies will be repeated after gluten challenge. Registration for clinical symptoms and personality traits will be done by standardised and validated forms. A dietist will perform an interview of the patients.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Celiac disease.; Food intolerance.; Gluten intolerance without celiac disease.
Phase I Double-blind, Placebo-controlled Study of AZD7442
Condition: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      AZD7442 mAbs are being evaluated for administration to prevent or treat COVID-19. This Phase
      I study will gather important information on the safety and tolerability of AZD7442.
    

Detailed description: 
      Severe acute respiratory coronavirus 2 is a novel coronavirus that appears to have first
      emerged in China in November 2019 causing cases of atypical pneumonia. Since then, the
      COVID-19 pandemic has caused major disruption to healthcare systems with significant
      socioeconomic impacts. As of 22 December 2020, the virus had spread to all corners of the
      globe, involving 218 countries/regions with over 78.00 million confirmed cases reported and
      more than 1.71 million associated deaths. As a response to the ongoing pandemic, AstraZeneca
      is developing mAbs to the SARS-CoV-2 spike protein. The SARS-CoV-2 spike protein contains the
      virus's receptor binding domain, which enables the virus to bind to receptors on human cells.
      By targeting this region of the virus's spike protein, antibodies can block the virus's
      attachment to human cells, and, therefore, are expected to block infection. AZD7442, a
      combination of 2 of these mAbs (AZD8895 and AZD1061), is being evaluated for administration
      to treat or prevent COVID-19. There are currently one ongoing Phase I study and two ongoing
      Phase III studies with AZD7442, in addition to this treatment study.

      Randomization of approximately 40 Japanese participants is planned.
    

Intervention name(s): AZD7442 300 mg IM(male); AZD7442 600 mg IM (male); AZD7442 300 mg IV (male and female); AZD7442 1000 mg IV (male)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Single dose of 300 mg of AZD7442 or saline placebo on Day 1.; Single dose of 600 mg of AZD7442 or saline placebo on Day 1.; Single dose of 300 mg of AZD7442 or saline placebo on Day 1.; Single dose 1000 mg of AZD7442 or saline placebo on Day 1.
Intervention MeSH terms: Cilgavimab and tixagevimab drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Feasibility Trial for Detecting Drug-induced Respiratory Depression and Prompting for Self-rescue
Condition: Healthy
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      This is a small trial to test feasibility of an idea for a potential device. The
      investigators tested the feasibility of prompting a volunteer to breathe when their breathing
      had slowed down during administration of anesthetic drugs.
    


Intervention name(s): Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany
Intervention type(s): Device
Intervention description(s): Prompt volunteer to breathe using device to play recorded voice, massage the body, and/or apply muscle tetany
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Feasibility trial
Effects of Steroid Replacement Therapy on Metabolic, Cardiovascular and Bone Outcomes in Adrenal Insufficiency
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The current study is a randomized, open study aimed to compare the effects of conventional
      glucocorticoid replacement treatment and dual-release hydrocortisone on anthropometric,
      metabolic, cardiovascular and bone outcomes in treatment-naïve patients with primary adrenal
      insufficiency and secondary adrenal insufficiency in a 10 year-observation period.
    

Detailed description: 
      Adrenal insufficiency (AI) can be caused by a disease involving the adrenal gland resulting
      in inadequate secretion of adrenal cortex hormones, primary adrenal insufficiency (PAI).
      Secondary adrenal insufficiency (SAI) results from a decreased level of adrenocorticotrophin
      hormone (ACTH) released from the pituitary gland.

      The mainstay of treatment of PAI and SAI is glucocorticoid (GC) replacement therapy.
      Conventional steroid replacement therapy includes cortisone acetate and hydrocortisone
      administered 2-3 times a day with the highest dose in the morning and the lowest dose in the
      afternoon. These dosing regimens have been designed to mimic the peak of cortisol secretion
      in the morning and avoid overdosing during the night hours, even though a higher risk of
      developing comorbidities has been shown, notably in patients treated with higher evening
      doses.

      In patients with AI on conventional steroid replacement therapy, mortality remains higher
      than in the general population, mainly due to non-physiological daily GC overexposure and to
      inadequate cortisol exposure during stress-related events and illness.

      Studies aiming to evaluate the long-term clinical outcomes of patients with AI on
      conventional steroid replacement therapy clearly showed increased comorbidities, mainly
      related to the dose used.

      By contrast, dual-release hydrocortisone (DR-HC) is characterized by once-daily
      administration with high release of hydrocortisone immediately after intake and a very low
      release in the evening and nocturnal hours. The switch from conventional GC therapy to DR-HC
      has been shown to be associated with improvement in BMI, hepatic, bone and glucometabolic
      parameters and QoL. However, long-term clinical outcomes of patients treated with DR-HC in
      patients naïve to steroid treatment are not known.
    

Intervention name(s): dual-release hydrocortisone; Conventional glucocortidois
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets 20-25-30-40 mg/day; Oral tablets 10-15-20-25-37,5-50-62,5 mg/day
Other intervention name(s): Plenadren; hydrocortisone; cortisone acetate
Intervention MeSH terms: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Cortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Post-exercise Food Intake Regulation in a Hot Environment
Condition: Healthy and Physically Active Young Men
Study type: Interventional

Summary: 
      The potential of physical activity and other non-medicinal methods for the care and
      prevention of metabolic and cardiovascular disorders has been insufficiently used. There is a
      potential influence of environmental heat in energetic balance regulation. However, the
      existing knowledge is insufficient to optimize physical activity programs based on the impact
      of exercise on energy intake regulation in hot climates. The aim of the present study is to
      define the major physiological determinants of short-term food intake regulation in young
      active and healthy men, when exposed to different levels of metabolic activity and
      environmental temperatures. We will thus explore the biological mechanisms related to
      post-exercise relative energy intake. Post-rest and post-exercise energetic compensation will
      be analysed in these different environmental conditions, with a special focus on the effect
      of the birth weight. This study should open interesting ways to define adequate nutritional
      and exercising programs in hot environments.
    


Intervention name(s): Rest; Exercise
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science