bioihbjkbjnl/mcl2 huggingface dataset:
Guideline for Hometitration With Duodopa for Parkinson Patients
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The purpose of this study is to

        1. Create a guide for hometitration of Duodopa for patients with Parkinson's disease

        2. Outline which patients could be considered for "hometitration"
    

Detailed description: 
      To start treatment with continuous intestinal levodopa infusion to the duodenum
      (Duodopa-pump) in patients with Idiopathic Parkinson Disease (IPD), it is usually required
      that the patient is hospitalised to test if Duodopa works for the patient and for the
      titration process to find the relevant dosage before operation and connection of the pump.

      A hospitalisation is very costly. Experience shows, that this group of patients are often
      very stressed during hospitalisation because of noise, impaired sleep and unfamiliar
      surroundings. These conditions make fast and effective dosage titration very difficult, and
      experience also shows that the dosage often needs to be recalibrated once the patient is back
      home in familiar surroundings.

      The use of TeleMedicin (TM) is on the rise in Denmark as well as other international health
      care systems.

      These factors were the basis for the home-titration study where patients have their initial
      dosage titration done in their own home, supported by one visit from nursing staff, and one
      TM (video consultation) a day. The goal is to make the titration process more effective,
      reduce cost by treating the patient in their own home and making the patient more satisfied
      with the titration process.
    

Intervention name(s): Home titration
Intervention type(s): Other
Intervention description(s): Patients have their initial dosage titration of duodopa done in their own home, supported by one visit from nursing staff, and one video consultation a day
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with advanced parkinson, reffered to Duodopa treatment.
      
Keywords: Parkinson disease; duodopa; pump; tele-medicine
Evaluating HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus Erythematosus
Condition: HIV Infections; Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the breadth and potency of HIV-1 neutralizing
      antibody (nAb) responses and examine the safety and tolerability of an HIV gp120 protein
      vaccine (AIDSVAX® B/E) in HIV-uninfected adults diagnosed with Systemic Lupus Erythematosus
      (SLE) who have stable disease.
    

Detailed description: 
      This study will evaluate the breadth and potency of HIV-1 neutralizing antibody (nAb)
      responses and examine the safety and tolerability of an HIV gp120 protein vaccine (AIDSVAX®
      B/E) in HIV-uninfected adults diagnosed with Systemic Lupus Erythematosus (SLE) who have
      stable disease.

      All participants will receive 600 mcg/mL of AIDSVAX® B/E at Months 0, 1, and 6.

      Study visits will occur at Months 0, 0.25, 0.5, 1, 1.25, 1.5, 3, 6, 6.25, 6.5, 7.5, 8.5, and
      12. Visits may include physical examinations, blood and urine collection, pregnancy testing,
      HIV testing, risk reduction counseling, assessments, and questionnaires.
    

Intervention name(s): AIDSVAX® B/E
Intervention type(s): Biological
Intervention description(s): Administered by intramuscular injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Aripiprazole Open-Label, Safety and Tolerability Study
Condition: Schizophrenia; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the long-term safety and tolerability of aripiprazole in
      adolescent patients with schizophrenia, and child and adolescent patients with bipolar I
      disorder, manic or mixed episode.
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): 2 to 30 mg/day orally (2, 5, 10, 15, 20, 25, or 30 mg/day); tablets in strengths of 2, 5, 10, and 15 mg were used to achieve desired doses
Other intervention name(s): OPC-14597
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Open Label; Aripiprazole; Bipolar I Disorder, Manic or Mixed Episode
Physical Activity Pathological Gamblers
Condition: Gambling Disorder
MeSH terms: Gambling
Study type: Interventional

Summary: 
      Gambling Disorder (GD) is defined as the recurrent and persistent act of betting which leads
      to clinical impairments,. The latest edition of the Diagnostic and Statistical Manual of
      Mental Disorders (5th edition) conceptualizes GD as a behavioral addiction due to the
      similarities between GD and substance addictions in clinical presentation, association with
      personality factors, genetic transmission and treatment options. Previous studies found
      potential benefits of physical activity in treatment of addictions in general and GD in
      particular, such as reducing desire to play, betting and depressive and anxious symptoms.
    

Detailed description: 
      Detailed Description: The purpose of this study is to investigate the effects of regular
      physical activity controlled and supervised in the treatment of gambling disorder with focus
      on gambling severity, psychiatric comorbidity and impulsiveness. Patients will undergo
      physical activity either running (experimental) or stretching (control) groups,. Physical
      activity sessions will be lead by a physical educator., Both groups will receive treatment
      for psychiatric comorbidities and cognitive behavioral psychoeducation.
    

Intervention name(s): Aerobic; Stretching
Intervention type(s): Other; Other
Intervention description(s): Aerobic exercise Patients performs 8 sessions of aerobic exercise (walking / running),with monitoring and 8 sessions without monitoring totaling 16 sessions and patients have medical appointment with psychiatrist and make psychotherapy sessions.; Stretching Patients performs 8 sessions of stretching, with monitoring and 8 sessions without monitoring totaling 16 sessions and patients have medical appointment with psychiatrist and make psychotherapy sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Intracardiac CD133+ Cells in Patients With No-option Resistant Angina
Condition: Stable Angina
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy of therapy with autological CD133+ cells
      in patients with angina resistant to pharmacological treatment and without the possibility of
      effective revascularization. Cells will be isolated from patients bone marrow and
      administered directly into the muscle of left ventricle. The main objective is to assess the
      treatments' influence on improvement of myocardial perfusion and function, and on decrease of
      occurrence of symptomatic angina.
    

Detailed description: 
      Patients with a Stable angina pectoris (CCS II-IV) can potentially benefit from treatment
      with autological CD133+ cell populations, which include cells with a higher expression of
      cardiac and endothelial differentiation markers.

      REGENT VSEL Trial will include Patients with Angina resistant to pharmacological treatment
      and without the possibility of effective revascularization.

      The main objective of the study is to assess the treatments influence on:

        -  improvement of myocardial perfusion

        -  global and segmental contractility (LVEF)

        -  occurrence of symptomatic angina

        -  quality of life

      Regent Vsel is a prospective, randomized, double blind, placebo-controlled study with a
      planned number of 60 Patients.

      Randomization will be carried out according to a 1:1 mode. Every Patient will undergo a bone
      marrow aspiration. CD133+ cells will be isolated from bone marrow aspirates. Patients
      randomized to experimental group will receive isolated cells (direct left ventricular muscle
      administration). Patients enrolled to control group will get only a placebo solution injected
      into the muscle.
    

Intervention name(s): intramyocardial injection (electromechanical mapping based); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Patient will undergo 3D electric and mechanical intracardiac mapping; based on maps generated intramyocardial administration of autologous CD133+ cells or placebo will be performed.; Patients in the placebo group receive 0.9% NaCl solution with 0.5% solution of the patient's own serum.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CD133+; stem cells; Coronary Artery Disease; Stable Angina Pectoris
Phase 1 Safety Study of ALK-001 in Healthy Volunteers
Condition: Stargardt Disease; Age-related Macular Degeneration; Other Retinal Dystrophies
MeSH terms: Macular Degeneration; Retinal Dystrophies; Stargardt Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This protocol is a phase 1 clinical study to assess the safety and pharmacokinetics of
      ALK-001 in healthy volunteers. Please contact trials@alkeus.com for any questions.
    


Intervention name(s): ALK-001 (No generic name)
Intervention type(s): Drug
Intervention description(s): Daily, oral administration of ALK-001 capsules.
Other intervention name(s): C20-D3-Retinyl Acetate; C20 Deuterated vitamin A
Intervention MeSH terms: Vitamin A; Retinol acetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Copeptin as a Biomarker for Central Diabetes Insipidus Development Following Pituitary Surgery
Condition: Sellar and Suprasellar Masses; Pituitary Tumor
MeSH terms: Pituitary Neoplasms; Pituitary Diseases; Diabetes Insipidus; Diabetes Insipidus, Neurogenic
Study type: Observational

Summary: 
      1. Access the optimal cut point value of copeptin which predicts development of central
           diabetes insipidus postoperatively with highest accuracy.

        2. Access the optimal cut point value of copeptin which predicts the lack of central
           diabetes insipidus postoperatively with highest accuracy

        3. Access the relative change in copeptin values between baseline and post-surgery as a
           predictor for diabetes insipidus development.
    

Detailed description: 
      Patient serum levels of copeptin would be measured after phlebotomy of 3 ml of blood in EDTA
      tube twice a) within 1-4 hours of extubation and b) within 4-24 hours of extubation (the
      morning following surgery).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with sellar and suprasellar masses.
Study to Characterize the Effect of Heparin on Palifermin Activity
Condition: Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of a continuous intravenous infusion of
      unfractionated heparin on the multiple-dose pharmacodynamics of palifermin in healthy adult
      subjects.
    

Detailed description: 
      The planned study is designed to characterize the impact of heparin on the biologic activity
      of palifermin and assess the impact of the combination of palifermin and heparin on
      tolerability. Approximately forty-three (43) eligible healthy adult men and oophorectomized
      or postmenopausal women between 18-45 years of age will be assigned to one of three treatment
      groups where treatment group A will receive a daily dose of palifermin 40 µg/kg for three
      consecutive days as intravenous (IV) bolus injections and continuous heparin IV infusion,
      treatment B will receive a daily dose of palifermin 40 µg/kg for three consecutive days as IV
      bolus injections and treatment C will be a control group without any treatment administered.
      The subjects will be randomized in a 20:15:8 ratio (Treatment A:B:C).

      The study consists of a up to 21-days screening period, a 5-days treatment period and a up to
      45-days follow-up period.
    

Intervention name(s): Palifermin; Heparin
Intervention type(s): Drug; Drug
Intervention description(s): 40 µg/kg IV bolus injections for three consecutive days; Heparin continuous IV infusion
Intervention MeSH terms: Heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trazodone for Sleep Disturbance in Early Alcohol Recovery
Condition: Alcoholism
MeSH terms: Dyssomnias; Parasomnias; Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomized, double-blind clinical trial comparing trazodone (Desyrel) and
      placebo among sleep-disturbed, alcohol-dependent individuals shortly after discharge from an
      inpatient detoxification program. Subjects will undergo a baseline assessment and random
      assignment to trazodone or identical placebo for 12 weeks. All persons completing the alcohol
      detoxification at Stanley Street Treatment and Resources (SSTAR) will be screened. (SSTAR of
      Rhode Island provides detoxification services to non/underinsured persons of Rhode Island.)
    


Intervention name(s): Trazodone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 to 150 mg qhs
Intervention MeSH terms: Trazodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: alcoholism; alcohol dependence; trazadone; sleep
Carbohydrate Feeding Frequency, Muscle Glycogen and Exercise Capacity in Runners
Condition: Exercise
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of regular sucrose feeds compared to a
      single large bolus given late in exercise, on muscle glycogen utilisation, exercise capacity
      and other markers of metabolism during running
    


Intervention name(s): Regular carbohydrate feeding; Single carbohydrate bolus
Intervention type(s): Other; Other
Intervention description(s): 60 ml of water with 5 g sucrose given every 5 minutes 14 times up until 70 minutes followed by 5 g sucrose after 75 minutes in a 250 ml solution; 60 ml of water given every 5 minutes 14 times up until 70 minutes followed by 75 g sucrose after 75 minutes in a 250 ml solution
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium
Condition: Sinusitis
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety and performance of the SinuSys Dilation System
      for dilation of the maxillary sinus ostium.
    

Detailed description: 
      A multicenter, single-arm, prospective study conducted to assess the safety and effectiveness
      of a new osmotically-driven, low-pressure expansion device for dilation of maxillary sinus
      ostia in patients with (CRS) Chronic Rhinosinusitis
    

Intervention name(s): SinuSys Dilation System
Intervention type(s): Device
Intervention description(s): Sinuplasty
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Infrared Laser Moxibustion on Cancer-related Fatigue in Breast Cancer Patients
Condition: Cancer-related Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Cancer-related fatigue (CRF) is the most common and distressing symptom associated with tumor
      or cancer treatment that breast cancer survivors (BCS) experience.The investigators
      previously found the laser moxibustion was potentially efficacious for CRF; however, more
      rigorously designed study is needed to confirm its benefit. The primary aim of this study is
      to determine the efficacy of 10.6µm infrared laser moxibustion and its long-term effects on
      CRF. Secondary aims are to evaluate the effect of infrared laser moxibustion on co-existing
      symptoms such as among BCS experiencing CRF.
    

Detailed description: 
      The randomized, placebo-controlled, three-arm trial will be conducted to evaluate the
      efficacy of infrared laser moxibustion (ILM) and sham ILM (SILM) compared to waitlist control
      (WLC) for moderately to severely fatigued BCS. The two intervention groups will receive
      real/sham infrared laser moxibustion on four acupoints (e.g. ST36 (bilateral), CV4, and CV6)
      for 20 minutes each session for six weeks (two times per week). The primary endpoint is the
      change in fatigue scores from Baseline to Week 6 as measured by the Chinese version of the
      Brief Fatigue Inventory (BFI-C). Our secondary aims are to compare the severity of
      comorbidities (e.g. depression, insomnia, and pain) and biological outcomes (e.g. telomere
      length) among the three groups.
    

Intervention name(s): Infrared Laser Moxibustion; Sham Infrared Laser Moxibustion
Intervention type(s): Device; Device
Intervention description(s): We will use SX10-C1 laser moxibustion devices (Shanghai Wonderful Opto-Electrics Tech Co Ltd, Shanghai, China) for the ILM and SILM groups. Four laser probes will be synchronously aligned with 4 points (tST36 (bilateral), CV4, and CV6 acupoints) and we will irradiate each acupoint 2 cm away from the skin surface for 20 minutes. Each patient will receive this treatment twice per week for six weeks (12 sessions total).; The sham laser moxibustion instrument appears to be identical as the real one.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: infrared laser moxibustion; cancer-related fatigue; breast cancer
Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms
Condition: Abdominal Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if telmisartan is effective in slowing the
      progression of abdominal aortic aneurysms and reducing circulating concentrations of
      Abdominal Aortic Aneurysms (AAA) biomarkers.
    

Detailed description: 
      Currently, the only management options for AAA are surgical (open or endovascular) based on
      ongoing follow-up with imaging at regular intervals. Telmisartan is currently approved for
      use in the United States by the Food and Drug Administration for management of hypertension.
      If telmisartan is found to be effective in slowing the progression of abdominal aortic
      aneurysms, this would provide a new treatment option for patients with AAA disease.
    

Intervention name(s): Telmisartan; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Abdominal Aortic Aneurysm; AAA; telmisartan
Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      State the scientific aim(s) of the study, or the hypotheses to be tested. The purpose of the
      current study is to evaluate the usage and acceptability of the Soberlink's blood alcohol
      concentration (BAC) unit in collaboration with Aware treatment to assess increased sobriety
      within patients suffering from alcohol use disorder (AUD).

      The specific AIMS will be:

        1. To determine the effectiveness of Soberlink's ability to increase abstinence

        2. To evaluate the impact of Soberlink's device on the participant based on their quality
           of health and sobriety.

        3. To evaluate the extent to which need for higher levels of follow-up care and treatment
           is reduced for individuals who have had access to the Soberlink device.
    


Intervention name(s): Soberlink
Intervention type(s): Device
Intervention description(s): Soberlink is a comprehensive alcohol monitoring system designed to remotely monitor a person's Blood Alcohol Concentration (BAC). Combining a professional grade handheld breathalyzer with wireless connectivity, the technology includes real-time facial recognition, robust tamper detection and real-time alerting.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, open label, single dose, 3 way crossover study to evaluate the bioavailability of a
      solid dose formulation of PF 04965842 relative to a suspension formulation under fasting
      conditions and the effect of food on the bioavailability of the solid dosage formulation of
      PF 04965842 in healthy subjects.
    


Intervention name(s): PF-04965842; PF-04965842; PF- 04965842
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive 4 x 100 mg PF 04965842 tablet under fasted conditions; Subjects will receive 400 mg PF 04965842 oral suspension under fasted conditions; Subjects will receive 4 x 100 mg PF 04965842 tablet under fed conditions
Intervention MeSH terms: Abrocitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; Open Label; Single dose; Crossover; Bioavailability; Fasting; Fed; PF-04965842; Healthy
Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules in Treating Symptomatic Non-Erosive Gastroesophageal Reflux Disease in Adolescents
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to assess the safety and effectiveness of once daily oral
      administration of dexlansoprazole delayed-release capsules in adolescent participants with
      symptomatic non-erosive gastroesophageal reflux disease (GERD).
    


Intervention name(s): Dexlansoprazole
Intervention type(s): Drug
Intervention description(s): Dexlansoprazole delayed-release capsules.
Other intervention name(s): Dexilant; TAK-390MR
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy