bioihbjkbjnl/mcl2 huggingface dataset:
Internet-Delivered CBT for Children With Functional Abdominal Pain Disorders
Condition: Functional Abdominal Pain Disorders
MeSH terms: Abdominal Pain; Somatoform Disorders
Study type: Interventional

Summary: 
      This randomized controlled study aims to evaluate the efficacy of exposure-based
      Internet-delivered cognitive behavior therapy for children 8-12 years with Functional
      Abdominal Pain Disorders. The children participate along with their parents, who will also
      receive specific modules with information on how to support their children in the treatment.
      Predictors and mediators for treatment effects will be studied as well as the cost
      effectiveness of the intervention.
    


Intervention name(s): Internet-delivered Cognitive behavior therapy
Intervention type(s): Behavioral
Intervention description(s): The treatment is delivered via an online platform and is based on interventions for adults, adolescents and children tested in previous trials. Therapists are CBT-psychologists och students in clinical psychology under supervision.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase II Study for Solid Metastatic Tumors
Condition: Breast Cancer; Metastatic Breast Cancer; Solid Tumor
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      1. To induce immunity-mediated tumor response outside the radiation field (abscopal effect)
           after chemo-radiation of a metastatic site in metastatic breast cancer patients.

        2. To monitor the induction of a T cell response.

        3. To explore the role of PET scanning to assess tumor responses/abscopal effect.
    

Detailed description: 
      1. To induce immunity-mediated tumor response outside the radiation field (abscopal effect)
           after chemo-radiation of a metastatic site in a pilot study of metastatic breast and
           other metastatic solid tumors.

        2. To monitor the induction of a T cell response in patients with metastatic breast cancer.

        3. To explore the role of PET scanning to assess tumor response/abscopal effect.

      Eligible are women with metastatic breast cancer and patients with other metastatic solid
      tumors who have achieved stable disease or have disease progression after systemic therapy
      and have at least three separate measurable sites of disease. Extent of metastatic disease is
      recorded both at CT and PET scanning. Radiation is given during systemic therapy to one of
      the lesions, 35 Gy in ten fractions over a two week interval, conformally to maximally spare
      normal tissue. GM-CSF treatment is given daily for fourteen days. At day 22 radiation is
      re-started and the same radiation dose is delivered to a second metastatic site, again with
      GM-CSF. Abscopal response is evaluated by assessing clinical and PET response in the
      non-irradiated measurable metastatic sites. A Phase II clinical trial based on an optimum
      two-stage Phase II Simon design is used to conduct this pilot study. Ten patients will be
      treated in Stage one; if there are no abscopal responses, the trial will be terminated. If
      there are one or more abscopal responses in Stage One, the trial will proceed to enroll an
      additional 19 patients.
    

Intervention name(s): Radiation therapy; Xeloda; paclitaxel
Intervention type(s): Radiation; Drug; Drug
Intervention description(s): Patients with metastatic breast cancer and other metastatic solid tumors receiving single-agent chemotherapy will receive 3.5 Gy/fraction to a total dose of 35 Gy/10 fractions over 2 weeks with concurrent systemic therapy; chemotherapy agent daily for two weeks; chemotherapy agent weekly for two weeks
Other intervention name(s): Radiotherapy; capecitabine; docetaxel; taxol
Intervention MeSH terms: Paclitaxel; Docetaxel; Capecitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast; cancer; metastatic; breast cancer; metastatic breast cancer; radiation; radiotherapy; radiation therapy; abscopal; abscopal effect; T-cell; GM-CSF; anti-tumor; immune; immune response; capecitabine; xeloda; taxol; paclitaxel; other solid metastatic tumor
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy Participants
Condition: Non-alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I Randomised Single-blind Placebo-controlled Study to Assess the Safety,
      Tolerability, and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration
      to Healthy Participants.
    

Detailed description: 
      This study will be a Phase I, First-In-Human (FIH), randomised, single-blind,
      placebo-controlled, single ascending dose (SAD), sequential group study in healthy male and
      female participants of non- childbearing potential performed at a single study centre.

      The study consists of 3 parts:

        -  Part A: SAD (up to 5 dose levels) of AZD9550 administered subcutaneous (SC) in healthy
           participants.

        -  Part B: 1 dose level of AZD9550 administered SC in healthy participants of Japanese
           descent.

        -  Part C: 1 dose level of AZD9550 administered intravenous (IV) in healthy participants.

      The study will comprise of:

        -  A Screening Period of maximum 28 days.

        -  A Treatment Period during which participants will be resident at the Clinical Unit from
           2 days before (Day -2) investigational medicinal product (IMP]) administration (Day 1)
           until at least 7 days (168 hours; Day 8) after IMP administration.

        -  Weekly out-clinic visits on Days 15, 22, 29, and 36.

        -  A Follow-up Visit 6 weeks (Day 43) after the IMP dose.
    

Intervention name(s): AZD9550; AZD9550; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will be administered AZD9550 subcutaneously.; Participants will be administered AZD9550 intravenously.; Participants will be administered matching volumes of placebo subcutaneously or intravenously.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Placebo-control
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Non-alcoholic steatohepatitis (NASH); Liver disease
A Study Designed to Compare the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 and GC4419 in Healthy Volunteers
Condition: Healthy Volunteers; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be a double-blind, randomized, crossover, single-dose assessment of
      IV-administered GC4711 compared to GC4419 in healthy volunteers.

      Consenting subjects will undergo screening procedures within 28 days of the start of dosing.
      Pharmacokinetics (parent drug and major metabolites) will be assessed in plasma and urine
      from all subjects.

      Initially, a sentinel cohort of 4 subjects, will be enrolled; each eligible subject will
      receive single dose of GC4711 IV at dose of 30 mg over one hour. Following a clinical safety
      review by the Galera study team , if no safety concerns are identified after the last subject
      completes study participation, enrollment will continue in 2 stages to a crossover study
      design. In stage 1, 12 subjects will be enrolled and in stage 2, if no safety concerns are
      identified in stage 1 following a clinical safety review by the Galera study team, 20
      subjects will be enrolled. In both enrollment stages, eligible subjects in the crossover
      design will be randomized in 1:1 ratio to one of two treatment sequences: Test (GC4711) ->
      Ref (GC4419) or Ref (GC4419) -> Test (GC4711). On Day 1, subjects will receive the first
      treatment they were randomized to, and on Day 4 (following a washout), they will receive the
      second treatment. Subjects will be followed up for 2 days after the second treatment.
    


Intervention name(s): GC4711 30 mg IV; GC4711 50 mg IV; GC4419 45 mg IV
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GC4711 will be infused IV as a single dose of 30 mg (3 mL GC4711 at 10 mg/mL) in 245 mL normal saline, totaling 250 mL, over a 60-minute period using a programmable pump; GC4711 will be infused IV as a single dose of 50 mg (5 mL GC4711 at 10 mg/mL) in 245 mL normal saline, totalling 250 mL, over a 60-minute period using a programmable pump.; GC4419 will be infused IV as a single dose of 45 mg (5 mL GC4419 at 9 mg/mL) in 245 mL normal (0.9%) saline, totalling 250 mL, over a 60-minute period using a programmable pump.
Intervention MeSH terms: Avasopasem manganese
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Adult; Superoxide Dismutase; First in Human; Free Radical Dismutase
Non- Essential Amino Acid Requirements and Metabolism in Humans
Condition: Healthy Adult Males
Study type: Observational

Summary: 
      Protein is a major structural component of all cells in the body. The nutritional importance
      of protein is because of their amino acids. 9 are called essential and 11 are called
      non-essential, based on whether we need to get them from diet. This classification is based
      on studies done using older techniques. Recent studies suggest that these so called
      non-essential amino acids play important roles in our body's health. For the first time, this
      proposal defines an experimental design to examine non- essential amino acid/nitrogen
      requirements and metabolism in humans using the Indicator Amino Acid Oxidation (IAAO)
      technique.

      The objective of the current study is to examine the application of IAAO technique to
      determine the non-essential amino acid/nitrogen requirement in adult humans.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Physiologically Healthy Adult males, 20-40 years of age
      
Biospecimen description: 
      Breath and urine samples
    
Keywords: Indicator Amino Acid Oxidation; Non essential Amino acids; Protein; Amino acid
Prediction of Cognitive Decline by Neuroimaging Techniques and the Application in Diagnosis and Treatment of Preclinical AD
Condition: Subjective Cognitive Decline; Preclinical Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Observational

Summary: 
      This study is affiliated to Sino Longitudinal Study on Cognitive Decline, SILCODE. To
      establish models of normal and pathological cognitive aging.To collect the longitudinal data
      of SCD population, to study the dynamic changes of brain networks so as to explore the
      progressive mechanisms of AD on brain networks and to construct a high-precision multi-modal
      model for early diagnosis.
    

Detailed description: 
      This study is affiliated to Sino Longitudinal Study on Cognitive Decline, SILCODE.
      Alzheimer's disease (AD) is the most common cause of dementia, which severely injures
      multiple domains of cognitive functions in the aging people, bringing heavy burden to the
      society and families. Studying the cognitive brain damage mechanism of subjective cognitive
      decline (SCD), the preclinical stage of AD, would provide great opportunities for
      understanding the pathogenesis of AD and clinical value for early diagnosis and intervention
      in AD. The project intends to utilize amyloid-PET and FDG-PET for screening and then employ
      the comprehensive neuropsychological examination combined with multi-modal MRI neuroimaging
      techniques to study the brain functions and structures of the normal aging and SCD. The
      imaging data would be analyzed from several levels, including the cognitive dimensions, brain
      activation patterns, and especially functional and structural networks to establish the
      models of normal and pathological cognitive aging, which mainly be modulated by
      frontal-parietal control system. We aim to establish models of normal and pathological
      cognitive aging. Furthermore, the longitudinal data of SCD population would be collected to
      study the dynamic changes of brain networks so as to explore the progressive mechanisms of AD
      on brain networks and to construct a high-precision multi-modal model for early diagnosis
    

Intervention name(s): Neuropsychological scale
Intervention type(s): Diagnostic Test
Intervention description(s): Neuropsychological scale, including mini-mental state examination (MMSE), Montreal cognitive assessment (MoCA), clinical dementia rating scales (CDR) and so on
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Volunteers recrewed from communities, and signed up with informed consent.
      
Keywords: subjective cognitive decline; brain network; multi-modality; magnetic resonance imaging
A Study To Evaluate The Effects Of Repeat Dosing Of Esomeprazole On The Pharmacokinetics Of SB-751689 In Healthy People
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the effects of altering gastric pH in healthy volunteers on the
      pharmacokinetics of SB-751689 with or without food.
    


Intervention name(s): SB-751689
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetic study,; gastric pH
Dronabinol Versus Placebo in Treatment and Prevention of Highly Active Anti-Retroviral Therapy (HAART)-Related Nausea and Vomiting
Condition: Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting; HIV Infections
MeSH terms: HIV Infections; Nausea; Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to determine if dronabinol is effective in preventing or
      treating nausea caused by HAART (highly active anti-retroviral therapy) in HIV and AIDS
      patients
    


Intervention name(s): Dronabinol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2.5 mg to 40 mg; placebo
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HIV; AIDS; nausea; vomiting; HAART; Treatment Experienced; HIV Infections
Enalapril After Anthracycline Cardiotoxicity
Condition: Cardiovascular Diseases; Heart Diseases; Heart Failure; Myocardial Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Cardiomyopathies
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine if the chronic administration of enalapril, an inhibitor of angiotensin
      converting enzyme (ACE), reduces progression of cardiac dysfunction in pediatric oncology
      patients who have received anthracyclines, and who are not currently on digoxin, diuretics,
      or vasodilators for heart failure.
    

Detailed description: 
      BACKGROUND:

      Pediatric oncology patients who have been treated with anthracycline therapy as a part of
      their chemotherapeutic regimen often subsequently develop left ventricular failure. The
      optimal medical management is not known. This trial will be the first to provide
      comprehensive data on a well characterized population regarding the role of afterload
      reduction using enalapril to treat ventricular dysfunction after anthracycline chemotherapy

      DESIGN NARRATIVE:

      Randomized, double-blind. Randomization was stratified by total anthracycline dose, follow-up
      time from treatment, and age at time of treatment. All patients received the following
      baseline tests: Maximal Cardiac Index (MCI) on cycle ergometry; echocardiogram/Doppler
      determined left ventricular end systolic wall stress (ESWS); gated nuclear angiography (GNA)
      to determine left ventricular ejection fraction; Holter monitoring for 24 hour ECG
      monitoring. Patients were randomized to either enalapril or placebo. Follow-up visits were
      conducted to ensure compliance and screen for side effects. MCI and ESWS were measured twice
      yearly, while all four tests were repeated at the conclusion of the trial, after four to five
      years of treatment. The primary outcome variables were the rate of decline in MCI and the
      rate of increase in ESWS. Secondary outcomes were the change in left ventricular ejection
      fraction and the incidence of arrhythmias. A second aim of the study was to develop an
      algorithm to determine indications for enalapril use if the study succeeded in showing a
      treatment effect. This required modeling the probability of cardiac dysfunction given patient
      characteristics at treatment, treatment type, cardiac status during treatment and at
      follow-up, and the development of cost effectiveness and medical decision making models
      testing the proposed algorithm.

      The study completion date listed in this record was obtained from the "Completed Date"
      entered in the Query View Report System (QVR).
    

Intervention name(s): enalapril
Intervention type(s): Drug
Intervention MeSH terms: Enalapril
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome
Condition: SARS-CoV 2; COVID19; SARS (Severe Acute Respiratory Syndrome); Cytokine Release Syndrome; Cytokine Storm
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome; Syndrome; Cytokine Release Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The administration of Calcifediol in patients with COVID-19, will reduce the development of
      SARS and the worsening of the various phases of the syndrome. Reducing at least 25% in ICU
      admission and death from the process, reducing days of hospitalization, facilitating the
      recovery of the same, acting significantly and positively, in any of its phases throughout
      the natural history of illness.

      As a treatment with extensive experience of clinical use, safe, inexpensive, and potentially
      very effective, it will have a highly efficient cost-benefit impact on the prevention of
      SARS.
    


Intervention name(s): BAT + Calcifediol; BAT
Intervention type(s): Drug; Drug
Intervention description(s): The subject will be treated with the best available therapy, which will include any combination of drugs included in the current protocol of the Ministry of Health and/or complementary notes issued by the Spanish Agency of Medicines and Health Products (AEMPS) plus Calcifediol caps. 266 µg. According to the pharmacokinetics of Calcifediol evaluated in an inflammatory model, the posology will be
Start: 2 capsules Days 3, 7, 14, 21, 28: 1 capsule; The subject will be treated with the best available therapy, which will include any combination of drugs included in the current protocol of the Ministry of Health and/or complementary notes issued by the Spanish Agency of Medicines and Health Products (AEMPS).
Intervention MeSH terms: Calcifediol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Induced Hypoxia Study for Validation of SpO2 Accuracy
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      Validate Non-Motion SpO2 Accuracy from 70%-100% of various pulse oximeter/ sensor
      combinations and various OEM pulse oximeter modules and sensor combinations during induced
      hypoxia (desaturation).
    

Detailed description: 
      The testing is conducted on 12 healthy, consenting, non-smoking subjects in accordance with
      the IRB approved Protocol. The subjects shall be distributed across both genders and a range
      of skin tones as equally as practical.

      An arterial line will be placed in the radial artery of each subject's right arm, and sensors
      will be attached to each subject. The subjects will be placed in a semi-supine position and
      allowed to breathe through a mouthpiece while the nose is blocked with a nose-clip.

      Hypoxia will be induced by on each subject, as levels of oxyhemoglobin saturation (between
      70% and 100%) are achieved by breathing mixtures of nitrogen, room air and carbon dioxide.
      Inspired O2 concentration will be adjusted breath-by-breath using a computed saturation,
      based on end-tidal PO2 and PCO2, as sampled by a mass spectrometer. Predicted levels of
      oxyhemoglobin saturations will be attained and held stable. At a minimum of sixty seconds
      into each plateau, a 0.5cc waste blood draw through the arterial line, followed by the first
      1.0cc sample blood draw. After approximately thirty additional seconds, the second 1.0cc
      sample blood draw will be taken. The samples will immediately be analyzed by a Radiometer
      OSM-3 multi-wavelength co-oximeter and recorded. The SpO2 data from the oximeters will be
      collected via a laptop computer. Concurrent with the end of each blood draw, a marker will be
      generated on the laptop computers to identify the event.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy, consenting, non-smoking subjects, 18 years or greater, both genders and a range of
        skin tones
      
Keywords: Induced hypoxia; Pulse oximeter; Nonin Medical; Verification of SpO2 accuracy