bioihbjkbjnl/mcl2 huggingface dataset:
Sleep Disordered Breathing in Acute Congestive Heart Failure
Condition: Obstructive Sleep Apnea; Heart Failure; With Decompensation
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Heart Failure
Study type: Observational

Summary: 
      The goal of this study is to determine if sleep disordered breathing results in a measurable
      degree of overnight myocardial stress/injury in patients with acutely decompensated
      congestive heart failure. A secondary goal is to determine of a period of medical management
      attenuates this sleep disordered breathing-induced cardiac injury in this patient population.
    

Detailed description: 
      Consecutive patients admitted to the hospital with acutely decompensated heart failure will
      be identified for potential enrollment in this study. Enrolled patients will first be asked
      to complete questionnaires to assess their symptoms and risk of having sleep apnea.

      Relevant information will be obtained from the electronic medical record (age, gender, body
      mass index, co-morbidities, medications, prior echocardiography results). Subjects will then
      undergo a "type III" portable monitoring sleep study on the first or second night of their
      hospital admission, which measures respiratory effort, nasal airflow, oxyhemoglobin
      saturation, and heart rate. Blood samples will be collected on the evening before (08:00 PM
      +/- 2 hours), and the morning after (06:00 AM +/-2 hours) sleep apnea testing. If not
      otherwise obtained clinically, echocardiography will be obtained within 48 hours of
      admission. After a period of medical management for acutely decompensated heart failure,
      subjects will then have a second portable sleep apnea study (with associated pre and
      post-sleep blood draws) on the evening prior to discharge (approximately hospital day 5 or
      6). Later, clinical outcomes such as incidence of renal dysfunction, hospital length of stay
      etc. will be collected from the electronic medical record. Blood samples will be processed,
      stored, and subsequently analyzed for high-sensitivity cardiac troponin T and I.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive patients admitted to University of California San Diego Sulpizio Cardiovascular
        Center, Jacobs Medical Center, and Thornton Hospital with acutely decompensated heart
        failure will be identified in the emergency department, or upon admission to the cardiology
        or hospitalist (general medical) service.
      
Biospecimen description: 
      Serum retention
    
Keywords: Sleep; OSA; CSA; CHF; Heart Failure; Troponin
Mailed Reminders Plus Fecal Immunochemical Testing
Condition: Colorectal Cancer Screening; Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Purpose: The investigators propose to test the effectiveness, feasibility, and
      cost-effectiveness of a mailed reminder with and without FIT kits in a population of Medicaid
      enrollees in Mecklenburg County.
    

Detailed description: 
      Purpose: The investigators propose to test the effectiveness, feasibility, and
      cost-effectiveness of a mailed reminder with and without FIT kits in a population of Medicaid
      enrollees in Mecklenburg County.

      Participants: Medicaid beneficiaries who are enrolled in Community Care of North Carolina,
      ages 52-64, currently living in Mecklenburg County, at average risk for colorectal cancer
      (CRC), with no record of recent CRC screening (FOBT within 12 months, colonoscopy within 10
      years).

      Procedures (methods): Participants will be identified through the state Medicaid database and
      randomized to receive either: 1) a mailed reminder to complete CRC screening including a FIT
      kit, instructions for completion, and a return mailer, OR 2) a mailed reminder to complete
      CRC screening only.

      Any recipients testing positive will be guided by care managers from Community Care of North
      Carolina to ensure a follow-up colonoscopy is completed.
    

Intervention name(s): Mailed Reminders with Fecal Immunochemical Testing kits; Reminder letter only
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: colorectal cancer screening; colorectal cancer
Study Investigating Immunological Effects of Treatment for Chronic Hepatitis C Patients.
Condition: Hepatitis C; Liver; Immunology; Regulation
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Observational

Summary: 
      Aim

      To evaluate the effects of peginterferon and ribavirin therapy on the immune response in
      chronic HCV genotype 1,2 or 3 patients before, during and after treatment.

      Background

      Treatment of chronic hepatitis C (HCV) has shown a remarkable success. However, genotype 1
      patients have reduced response rates. A better understanding and improvement of these results
      can now be considered the greatest challenge.

      In chronically infected patients, HCV-specific immune responses are generally weak, narrowly
      focused, and often dysfunctional. The presence of HCV-specific cells suppressing the immune
      response (regulatory T-lymphocytes=Treg) are able to suppress the immune response. These Treg
      are possibly responsible for the impaired immune response.

      Previous studies have indicated increased Treg frequency and activity of immune regulating
      mechanisms, locally in the liver, as a result of HCV re-infection. Hence, these Data
      highlight the importance of monitoring intrahepatic immune responses in addition to
      peripheral immune responses. Using the minimally-invasive technique of fine-needle aspiration
      biopsy (FNAB), it is now possible to obtain safe and frequent liver samples to monitor local
      antiviral immune responses in chronic HCV patients during antiviral therapy.

      Rationale and hypothesis of the study

      Our previous studies and current literature support the concept that Treg may contribute to
      HCV persistence by suppressing HCV-spec immune responses. The current study is designed to
      examine if peginterferon and ribavirin therapy affects the activity of Treg and DC, and if
      this results in enhanced HCV-specific immune responses.

      Design

      Single centre, translational and observational open label study with one arm of 20 genotype 1
      patients and one arm of 7 genotype 2/3 patients.
    


Intervention name(s): fine-needle aspiration biopsy
Intervention type(s): Procedure
Intervention description(s): aspiration of intrahepatic cells
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients chronically infected with HCV-genotype 1,2 or 3
      
Biospecimen description: 
      PBMC Serum RNA Liver infiltrating lymphocytes
    
Keywords: Hepatitis C; Liver; immunology; regulation; Genotype 1,2,3; Treatment; Chronic; Pegylated interferon; Ribavirin
EryDex Pharmacokinetics in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the pharmacokinetic properties of two different doses of EryDex (dexamethasone
      sodium phosphate encapsulated in erythrocytes) given as a single infusion in healthy
      volunteers, based on plasma concentrations of dexamethasone.
    


Intervention name(s): EryDex (dexamethasone sodium phosphate encapsulated erythrocytes)
Intervention type(s): Drug
Intervention description(s): erythrocytes encapsulated with dexamethasone sodium phosphate (EryDex System)-corresponding to either 50 mg OR 125mg of experimental study drug
Other intervention name(s): EryDex System (dexamethasone sodium phosphate encapsulated erythrocytes)
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Dexamethasone 21-phosphate; BB 1101
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic analysis; EryDex
Metabolic Syndrome in Psoriasis and Psoriatic Arthritis and Correlation With Serum Omentin and Visfatin Levels
Condition: Psoriasis Vulgaris; Psoriatic Arthritis; Metabolic Syndrome
MeSH terms: Arthritis; Arthritis, Psoriatic; Psoriasis; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      In this study, the prevalence of metabolic syndrome in psoriatic and psoriatic arthritis
      patients as well as the parameters of metabolic syndrome will be examined. At the same time,
      the levels of omentin and visfatin adipokines associated with metabolic syndrome and obesity
      will be measured by measuring the disease severity (by PASI psoriasis, clinical activity
      score for psoriatic arthritis). The patients who accepted to participate in the study , who
      were admitted to the dermatology outpatient clinic were included in the study. For the blood
      tests required after the examination, 2 tubes of blood will be taken for the measurement of
      omentin and visfatin. 80 psoriasis, 40 psoriatic arthritis and 60 healthy volunteers were
      planned to be studied. AHA / NHLBI, 2005 (revised ATP III criteria) criterion for the
      diagnosis of metabolic syndrome will be used. Omentin and visfatin levels are compared with
      the severity of the disease for psoriasis and psoriatic arthritis, and it will be examined
      whether it is proinflammatory or antiinflammatory.
    


Intervention name(s): omentin, visfatin
Intervention type(s): Diagnostic Test
Intervention description(s): diagnostic blood test
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: psoriasis vulgaris; psoriatic arthritis; metabolic syndrome; omentin; visfatin
Haplo HCT vs Haplo-cord HCT for Patients With AML
Condition: Hematopoietic Stem Cell Transplantation; Haplo-identical Donor; Cord Blood Unit; Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients who have acute myeloid leukemia and will undergo haplo-identical donor hematopoeitic
      cell transplantation (haplo HCT) are potential candidates of this trial. Participants will
      randomized into two arms: Arm A will undergo a typical haplo HCT, while Arm B will receive an
      coinfusion of an unrelated cord blood unit (haplo-cord HCT) in addition to Arm A.
      Progression-free survival, overall survival, cumulative incidence of relapse and nonrelapse
      mortality will be recorded as endpoints.
    


Intervention name(s): haplo-HCT; haplo-cord HCT
Intervention type(s): Procedure; Procedure
Intervention description(s): HCT will be performed with a haploidentical donor; Haploidentical donor HCT will be performed with coinfusion of unrelated cord blood unit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Safety, Tolerability, and Distribution of a Microdose of Radiolabeled BIIB067 (99mTc-MAG3-BIIB067) Co-administered With BIIB067 (Tofersen) to Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the distribution in the central nervous
      system (CNS) of a microdose 99mTc-MAG3-BIIB067 co-administered with unlabeled BIIB067
      (Tofersen). The secondary objective of the study is to assess the safety and tolerability of
      unlabeled BIIB067 co-administered with a microdose of 99mTc-MAG3-BIIB067 to healthy
      participants.
    


Intervention name(s): Tofersen; 99mTc-MAG3-BIIB067
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm.; Administered as specified in the treatment arm.
Other intervention name(s): BIIB067; QALSODY
Intervention MeSH terms: Technetium Tc 99m Mertiatide
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether anorectal application of Nasha Dx is safe
      and effective for treatment of anal incontinence.
    

Detailed description: 
      Patients not fully improved after 1:st injection were offered reinjection after 4-6 weeks.
    

Intervention name(s): Anal injection of Nasha Dx
Intervention type(s): Procedure
Intervention description(s): Submucous injection of Nasha Dx 5-10 mm above dentate line
Other intervention name(s): Solesta
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fecal incontinence; Treatment; Surgery
A Study to Evaluate the Safety, Tolerability and Efficacy of Multiple Doses of JS002 in Patients With Hyperlipidemia..
Condition: Hyperlipemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.
    


Intervention name(s): Biological：JS002; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Blood Flow Restriction on Football-Related Performance Parameters
Condition: Vascular Occlusion; Soccer; Exercise; EMG
Study type: Interventional

Summary: 
      The blood flow restriction method can have similar or superior effects to high-intensity
      exercises even in a short duration, which can positively affect some performance parameters,
      can be applied with low-intensity load and cause hypertrophy in the muscle by providing high
      metabolic stress, facilitating muscle growth without significantly changing the total
      training dose. The aim of this study is to investigate whether adding the blood flow
      restriction method to the classical training program can be more effective than the classical
      training applied alone in the development of football-related performance parameters.
    


Intervention name(s): Blood Flow Restriction; Classical Training Alone
Intervention type(s): Other; Other
Intervention description(s): Blood flow restriction with low load (30-50% 1RM) for 2 sessions in a week for 6 weeks during classical training will be applied.; Classical training same as Group 1with moderate to high load (70-90% 1RM) for 2 sessions in a week for 6 weeks will be applied without blood restriction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
The Effects of Naltrexone on Active Crohn's Disease
Condition: Inflammation; Crohn's Disease
MeSH terms: Crohn Disease; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      It is hypothesized that the opioid antagonist naltrexone will improve inflammation of the
      bowel and quality of life in subjects with active Crohn's disease compared to placebo. In
      order to test this hypothesis the following specific aims are proposed:

        1. Evaluate the effects of low dose naltrexone compared to placebo on the activity of
           Crohn's disease by the following end points: Crohn's Disease Activity Index (CDAI), pain
           assessment, laboratory values (CRP and ESR), endoscopic appearance, histology, and
           quality of life surveys;

        2. Examine the effects of naltrexone given over 3 months compared to 6 months for
           durability of response;

        3. Determine the safety and toxicity of low dose naltrexone in subjects with active Crohn's
           disease, and

        4. Study the mechanism by which naltrexone exerts its effect by measuring plasma enkephalin
           levels of subjects on therapy.

      Purpose statement: The purpose of this study is to evaluate the effects of low dose
      naltrexone in a blinded placebo controlled study to determine the safety and efficacy of this
      compound in those with active Crohn's disease.
    

Detailed description: 
      Study design : The study is designed as a double-blind placebo controlled study for 3 months
      followed by a pseudo cross-over such that all subjects receiving placebo the first 3 months
      will receive active drug the second 3 months and all receiving naltrexone the first 3 months
      remain on the drug the last 3 months of this 6 month study.
    

Intervention name(s): Naltrexone-HCl; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): naltrexone 4.5 mg; Placebo
Other intervention name(s): LDN; Revia; sugar pill
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: naltrexone; LDN; IBD; Inflammatory bowel disease
Fluid Responsiveness Predicted by PtcO2 in Critically Ill Patients
Condition: Circulatory Failure
MeSH terms: Shock
Study type: Observational

Summary: 
      Our goal was to study the feasibility of predicting fluid responsiveness by transcutaneous
      partial pressure of oxygen (PtcO2) in the critically ill patients.
    

Detailed description: 
      The clinical determination of the intravascular volume can be extremely difficult in
      critically ill patients. Although hemodynamic maximization was proposed, this approach was
      associated with a risk of fluid overload and excessive inotropic support. Therefore, fluid
      optimization was seen as a significant step forward and has been shown to decrease
      complications. Significant effort has been devoted to defining and developing simple means
      for predicting fluid responsiveness, i.e. whether the patient will benefit from fluid
      administration. Passive leg raising (PLR), a bedside performed test, could be used to
      accurately predict fluid responsiveness in most conditions.

      However, most parameters that provide information about fluid responsiveness during volume
      expansion and PLR are invasive and time-consuming. A completely noninvasive and atraumatic
      parameter to predict fluid responsiveness might be need urgently. Transcutaneous partial
      pressure of oxygen (PtcO2), a measure to detect tissue ischemia or inadequate perfusion,
      might reflect the change in cardiac output, thus predict fluid responsiveness. The purpose of
      this study was to study the feasibility of predicting fluid responsiveness by transcutaneous
      partial pressure of oxygen in the critically ill patients.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients for whom the attending physician decided to perform a fluid challenge or presence
        of at least one clinical sign of inadequate tissue perfusion in the absence of
        contraindication for fluid infusion for less than 24 hours were eligible to participate in
        the study.
      
Keywords: Fluid responsiveness; Passive leg raising
Cannabidiol Treatment in Patients With Early Psychosis
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Cannabidiol (CBD) is a component of herbal cannabis that is present in varying concentrations
      in cannabis extracts. CBD has been shown to produce central effects including hypnotic,
      anticonvulsive, anxiolytic and neuroprotective effects.The investigators hypothesize that
      treatment with CBD will result in: 1) Improvement evidenced by a reduction in scores on the
      Positive and Negative Syndrome Scale for Schizophrenia (PANSS), 2) Improvement evidenced by a
      reduction in the Clinical Global Impression of Severity scale (CGI); Secondary Hypothesis: 1)
      Greater improvement in functioning as measured on the "Patient Assessment of Own Functioning
      Inventory: (PAOFI) and the Quality of Life Scale (QLS) In this 2 period cross over design,
      subjects will be randomized in a 1:1 ratio to receive either: Order 1: CBD (Period 1)
      followed by placebo (Period 2) or Order 2: Placebo (Period 1) followed by CBD (Period 2)
      under double-blind conditions. The 2 study periods will be separated by a washout of at least
      2 weeks. During each period subjects will receive study medications (CBD [total 800mg/day] or
      placebo) for a period of 4 weeks.
    


Intervention name(s): Cannabidiol; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): CBD
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Second Open Label Extension to Bridging Study CTBM100C2303
Condition: Pulmonary Infections; Pseudomonas Aeruginosa
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This was an open-label, single arm (uncontrolled) study in participants suffering from cystic
      fibrosis, who have completed their study participation in CTBM100C2303 and extension study
      one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at
      enrollment into CTBM100C2303.
    


Intervention name(s): Tobramycin inhalation powder
Intervention type(s): Drug
Intervention description(s): Tobramycin dry powder for inhalation in capsules administered by the T-326 inhaler.
Intervention MeSH terms: Tobramycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tobramycin Inhalation Powder; Cystic fibrosis; Lung diseases; Anti-Bacterial Agents; Treatment of pulmonary infections with P. aeruginosa in cystic fibrosis participants