bioihbjkbjnl/mcl2 huggingface dataset:
Combination Stem Cell Therapy for the Treatment of Severe Coronary Ischemia
Condition: Coronary Ischemia; Coronary Disease; Coronary Artery Disease; Coronary Atherosclerosis; Coronary Arteriosclerosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis; Arteriosclerosis; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to determine if the infusion of a combination of stem
      cells obtained from the bone marrow of the same patient will contribute to the formation of
      new blood vessels in patients with symptomatic severe coronary ischemia. In this trial we
      will study the safe use of this therapy and its effects on making new blood vessels will be
      evaluated.

      Coronary ischemia is intractable angina due to severe coronary artery disease which can
      seriously decrease blood flow to the heart.

      CI needs a comprehensive treatment since the condition will not improve on its own. The
      overall goal of the treatment is to increase blood flow to the heart and improve symptoms of
      angina.

      The study hypothesis is based on the concept that the process of formation of new blood
      vessels is complex and requires the participation of several types of stem cells and growth
      factors. The lack of any of these components will produce vessels which are immature and
      unable to provide appropriate blood supply to the heart.

      Patients eligible to participate in this study are those suffering from severe blockages to
      the vessels of the heart and are not candidates for percutaneous revascularization or
      surgical procedures.

      Once the final mixture of stem cells is prepared, the cells will be intracoronary infused
      through a catheter into the blocked vessel of the heart.

      Studies will be performed to evaluate if the intracoronary infusion of stem cells is safe,
      feasible and works.

      Patients will be evaluated for 6 months after cell transplant.
    


Intervention name(s): MESENDO
Intervention type(s): Biological
Intervention description(s): 2 ml of the "final cell mixture" will be injected through the lumen of an intracoronary percutaneous balloon designed for angioplasty into the ishcemic vessel.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reduced Exposure Study in Smokers Using the Tobacco Heating System 2.2 (THS 2.2) for 5 Days in a Confinement Setting
Condition: Smoking
Study type: Interventional

Summary: 
      The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating
      System 2.2 (THS 2.2) for 5 consecutive days by adult Japanese healthy smokers affects the
      levels of biomarkers of exposure for selected harmful and potentially harmful constituents
      (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).
    


Intervention name(s): Tobacco Heating System (THS 2.2); Smoking abstinence (SA); Conventional cigarette (CC)
Intervention type(s): Other; Other; Other
Intervention description(s): THS 2.2 ad libitum for 5 days in confinement; SA for 5 days in confinement; Subject's own preferred brand of CC ad libitum for 5 days in confinement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Candidate modified risk tobacco product; Conventional cigarette; Reduced exposure; HPHCs; Confinement
Patient Perceptions and Physician Assessment of Benefits and Risks of Oral Anticoagulation Due to Non-valvular AF
Condition: Atrial Fibrillation; Health Literacy
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      The risk of stroke is markedly elevated in patients with atrial fibrillation (AF). Oral
      anticoagulation (OAC) is indicated in individuals with moderate and high risk of stroke to
      the disadvantage of an increased burden from bleeding. Adequate knowledge of this disorder
      and understanding the benefits and hazards of antithrombotic treatment are essential to
      incorporate patient´s values and preferences in these decisions. This will further improve
      acceptance of recommended therapy and augment compliance with OAC.

      The objective of this investigation is to compare patient´s perceptions and physician´s
      assessments of benefits and risks of OAC.
    


Intervention name(s): Questionnaire
Intervention type(s): Other
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with atrial fibrillation with new indication for anticoagulation.
Methods for Objective Selection of Competent Sperm
Condition: Sperm Selection
Study type: Interventional

Summary: 
      In spite of the achievements and developement of the assisted reproduction techniques in the
      last years, there is still an elevated percentage of unsuccessful treatments, needing
      sometimes repeated attempts to reach pregnancy.

      The molecular physiology of sperm is being better characterized, and some reports have
      demonstrated the implication of different molecular processes in the pathophysiology of male
      infertility.

      Recently, different sperm selection methods have been based on these molecular differences,
      showing a better quality of the sperm population after selection.

      The main objective of this research project is to clinically apply these techniques in order
      to increase the pregnancy rates per cycle in infertile couples attending assisted
      reproduction treatments.
    


Intervention name(s): Negative selection
Intervention type(s): Other
Intervention description(s): Sperm selection to continue the treatment with healthy sperm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Study of the Effects of Chinese Herbal Medicine on Chronic Urticaria
Condition: Chronic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 3

Summary: 
      Urticaria is a common dermatology disease. Urticaria affects nearly 25% of the population at
      some time in their lives. Recurrent skin itch, insomnia, daily activities limitation greatly
      affect the quality of life. Some patient with chronic urticaria who had poor response to
      antihistamine may need second line medication. In United States, up to 54% chronic urticarial
      patient use oral corticosteroid to control. However, long-term use of oral steroids still
      needs to consider the impact of its side effects. Therefore, patients may seek for
      alternative medicine as an adjuvant therapy.

      It is still lack large-scale clinical trials in Traditional Chinese Medicine research of
      chronic urticarial. The aim of this study is to conduct a double-blind, randomized clinical
      trial to analyze the effectiveness of Chinese medicine in chronic urticaria and its possible
      mechanisms.
    

Detailed description: 
      Traditional Chinese medicine has been used widely in Taiwan for several diseases, such as
      allergic rhinitis, atopic dermatitis. For urticaria,certain antipruritic Chinese herbal
      medicine, such and Xiao-feng-san (XFS), Qing-shang-fang-fen-tang (QSFFT), have been commonly
      used in clinical practice, yet no clinical trials have been done to prove the effectiveness.

      In this study, a double-blinded, randomized, placebo control trial is designed and total 100
      chronic urticaria patients will be enrolled. All subjects will be divided into Chinese herbal
      medicine (CHM) and placebo control groups, in 1:1 allocation ratio. CHM group will receive
      capsule of mixture of XFS and QSFFT, 4gm four times a day, total 16 gm in a single day; while
      control group will receive placebo capsule with similar look, smell, and taste with same
      scheme. Total 1 month treatment course with 1 month follow-up study course will be done.
      Changes in symptom severity is the primary outcome, while improvement in sleep disturbance,
      and serologic marker evolution are the secondary outcome.
    

Intervention name(s): Chinese Herbal Medicine (CHM); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each CHM capsule, weighing 500mg, consists of XFS 250 mg and QSFFT 250 mg.; Encapsulated powder with similar taste, color, odor to intervention Chinese herbal medicine
Other intervention name(s): XFS (Xiao-feng-san):; - Hsiao-feng-san; - yokukansan; - Eliminate Wind Powder; QSFFT (Qin-shang-fang-fen-tang); - Qing-shang-fang-feng-tang
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Chinese herbal medicine; Urticaria; Antipruritics; Phase III clinical trial
Genetic Study of Patients and Families With Diaphyseal Medullary Stenosis With Malignant Fibrous Histiocytoma of the Bone
Condition: Stenosis; Histiocytoma
MeSH terms: Histiocytoma; Histiocytoma, Benign Fibrous; Histiocytoma, Malignant Fibrous; Constriction, Pathologic
Study type: Observational

Summary: 
      OBJECTIVES: I. Identify and characterize the gene causing diaphyseal medullary stenosis with
      malignant fibrous histiocytoma of the bone.

      II. Determine the clinical manifestations of this disease in these patients.
    

Detailed description: 
      PROTOCOL OUTLINE: Blood samples are obtained from affected individuals and their family
      members after genetic counseling. Genetic linkage analysis is performed on these blood
      samples. Unaffected individuals undergo x-rays and technetium bone scans to detect the
      presence of bone disease. Affected individuals undergo bone densitometry, MRI studies,
      thallium scans, ophthalmologic examination, electrocardiogram, echocardiogram, and skin
      biopsies.

      Affected family members identified after radiologic studies receive additional genetic
      counseling.
    

Keywords: arthritis & connective tissue diseases; bone cancer; diaphyseal medullary stenosis; genetic diseases and dysmorphic syndromes; malignant fibrous histiocytoma of bone; musculoskeletal/mesodermal cancer; oncologic disorders; rare disease
Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin
Condition: Obesity
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      Study DFA102E is an extension of Study DFA102, which included a 28-week treatment period with
      randomized study medication. The purpose of the extension study is to examine the long-term
      (up to 1 year) safety, tolerability, and effect on body weight of treatment with pramlintide
      and metreleptin, administered as separate subcutaneous (SC) injections, in obese and
      overweight subjects.
    


Intervention name(s): Placebo; Pramlintide and Metreleptin
Intervention type(s): Drug; Drug
Intervention description(s): placebo pramlintide and placebo metreleptin twice daily; Subcutaneous injection, twice daily
Other intervention name(s): Symlin
Intervention MeSH terms: Pramlintide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Leptin; Pramlintide; Obese; Symlin; Amylin
Convalescent Plasma in the Treatment of COVID 19
Condition: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); COVID; Coronavirus
MeSH terms: Coronavirus Infections; Severe Acute Respiratory Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to collect blood from previously COVID-19 infected persons who
      have recovered and use it as a treatment for those who are currently sick with a severe or
      life-threatening COVID-19 infection.
    

Detailed description: 
      The purpose of this prospective interventional study is to gain clinical experience using
      convalescent plasma transfusion administered to critically ill patients with COVID-19.

      1 To study the efficacy of plasma from patients recovered from COVID-19 infection with a high
      neutralizing antibody titer (NAT) as treatment for individuals who are critically ill with
      COVID-19.

      2. Determine if the antibodies from convalescent plasma will suppress virus load in
      critically ill patients with COVID-19.
    

Intervention name(s): Convalescent Plasma
Intervention type(s): Biological
Intervention description(s): treatment with 2 Units of convalescent plasma
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SARS-CoV-1, COVID, Coronavirus, convalescent plasma, plasma
Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the efficacy of irbesartan on the progression of
      liver fibrosis in adult patients with chronic hepatitis C.

      The expected total enrollment is 200 patients. Patients who meet the study criteria and
      accept to participate at this study will take by day one tablet of 150 mg of treatment
      (irbesartan or placebo) during two years. The assessment of efficacy will be make by
      evaluation of area of liver fibrosis and blood markers of liver fibrosis
    

Detailed description: 
      The results of several studies suggests than the AT1 receptor antagonists of angiotensin II
      have inhibitory effects on TGF-beta 1 production and can limit the progression of liver
      fibrosis.

      Therefore, the angiotensin II could be another mediator of the synthesis of the
      extra-cellular matrix at the hepatic level, opening new perspectives with the antagonists of
      angiotensin II receptors drugs (ARA2/sartans).

      This study is a randomized, double blind, multi-center, parallel assignment, and efficacy
      study.
    

Intervention name(s): Irbesartan; placebo
Intervention type(s): Drug; Drug
Intervention description(s): one tablet of 150 mg/d during 2 years; one tablet per day during 2 years
Intervention MeSH terms: Irbesartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis C, Chronic; irbesartan
FLAVIOLA Health Study
Condition: Vascular Health
Study type: Interventional

Summary: 
      Atherosclerosis progressively occurs with increasing age in the general population. So far
      most dietary intervention studies with flavanols were performed over short time frames and in
      small groups of young healthy and older patients with manifest cardiovascular disease,
      respectively. Vascular health is defined as absence of vascular disease and the presence of
      optimal parameters that determine the development and progression of arteriosclerosis
      (endothelial function, blood pressure, plasma lipids, and glucose). It is not clear whether
      flavanols can improve parameters of vascular health, most importantly endothelial function,
      when given repetitively to healthy middle aged and which factors affect the efficacy of
      flavanol interventions.
    


Intervention name(s): Flavanol (410 mg); Control (no flavanols)
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Ingestion of intervention drink containing 410 mg flavanols twice a day for 30 days; Ingestion of a macro- and micronutrient matched control drink that is free of flavanols twice per day
Intervention MeSH terms: Micronutrients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: flavanols; diet; endothelial function; blood pressure; FLAVIOLA
Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool
Condition: Essential Tremor; Parkinson's Disease
MeSH terms: Parkinson Disease; Essential Tremor
Study type: Interventional

Summary: 
      The objective of this clinical investigation is to characterize the clinical performance of
      Abbott's Clinician Programmer Electrode Screening Mode tool (InformityTM tool) in programming
      InfinityTM deep brain stimulation (DBS) systems for patients with Parkinson's disease (PD) or
      essential tremor (ET).
    

Detailed description: 
      This is a prospective, non-randomized, single-arm, multi-center, post-market clinical
      investigation designed to evaluate Abbott's Informity tool for Infinity DBS systems.

      This clinical investigation will be conducted at up to 5 centers in the United States.

      Up to 40 patients were intended to enroll in the study. However the study was stopped after
      enrolling 8 subjects at 3 sites.

      Subjects participating in this clinical investigation will be followed for 6 months. The
      expected duration of enrollment is 6 months. The total duration of the clinical investigation
      is expected to be 18 months. The primary and secondary endpoints will be evaluated when all
      subjects have completed their 6 month follow-up visits
    

Intervention name(s): Clinician programmer electrode screening mode tool
Intervention type(s): Device
Intervention description(s): Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Other intervention name(s): Informity tool
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Headache Provocation of People Who Are Unable to Have Headache
Condition: Headache; Healthy
MeSH terms: Headache
Study type: Interventional

Summary: 
      Headaches are extremely common illnesses with a combined lifetime prevalence of 90-99% in
      Europe. Despite this high prevalence, there are persons who have never, in their whole life,
      encountered a headache.

      The aim of the study is to identify factors that protect against headache by studying
      headache after provocation in people who never have had a headache (headache resistant)
      versus non-resistant controls.

      The investigators will use isosorbide mononitrate as a pharmacological trigger of headache.
      The provocation is performed by investigators who are blinded to the grouping of the
      participants.

      The investigators hope to contribute with novelty to the current understanding of headache
      pathophysiology and development of more efficient treatment of headache.
    


Intervention name(s): Isosorbide Mononitrate 60 MG
Intervention type(s): Drug
Intervention description(s): 1 tablet Isosorbide Mononitrate 60 mg administrated orally.
Other intervention name(s): Imdur
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Intervention model: Single Group Assignment
Intervention model description: Blinded case-control study
Masking: None (Open Label)
Primary purpose: Other
Biomarker Assessment of Glutamatergic Target Engagement
Condition: Healthy Controls
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the relative feasibility of 2 potential functional
      measures of target engagement (Glx MRS, BOLD fMRI) to systematically assess mGluR 2/3 in drug
      development for psychotic spectrum disorders.
    

Detailed description: 
      This is a pilot study of healthy subject to assess the feasibility of Glx MRS and BOLD fMRI
      to measure ketamine induced changes in glutamatergic indices. The investigators will
      randomize 18 subjects at each site. Subjects will be randomized to ketamine or placebo in a
      2:1 ratio and receive two drug challenges separated by at least two weeks. Ketamine challenge
      is used to induce a "glutamate surge" within prefrontal brain regions that can be detected
      using neurochemical and functional imaging techniques. Each subject will receive MRS and BOLD
      fMRI during each challenge day. The goal of the pilot study is to assess the feasibility of
      both the proposed ketamine challenge paradigm and of the proposed imaging-based biomarkers.
      Specific indices to be used in assessing feasibility will include effect size, cross-site and
      cross-subject reliability, safety, and subject tolerability as similar studies will be
      performed independently at Yale and UC Davis. Second this information will be used to select
      and refine final study parameters for a subsequent full proof-of-clinical mechanism (POCM)
      study investigating the effect of Pomaglumetad on ketamine-induced MRS and fMRI effects.
    

Intervention name(s): Ketamine; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): intravenous infusion of saline solution with ketamine; Normal saline will be used for placebo in this group
Other intervention name(s): ketamine hydrochloride; saline
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study Exploring Efficacy of Peginterferon in Patients With Herpes Zoster
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy, optimal dose and efficacy trend of multiple subcutaneous injections
      of peginterferon α1b in patients with herpes zoster, and provide support for phase III
      clinical trials.
    

Detailed description: 
      This trial is a multicenter, randomized, active drug-controlled, dose-finding phase II
      clinical study. A total of 5 experimental groups and 1 positive drug control group were set
      up to evaluate the efficacy, optimal dose and efficacy trend of multiple subcutaneous
      injections of peginterferon α1b in patients with herpes zoster, and provide support for phase
      III clinical trials.
    

Intervention name(s): Peginterferon α1b; Peginterferon α1b with valacyclovir; Valacyclovir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Injecting different doses of the peginterferon α1b into different groups of subjects.; Both valacyclovir tablets and different dose of peginterferon α1b plan to be used in different groups of subjects.; Valacyclovir is a positive control drug.
Intervention MeSH terms: Valacyclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multicenter, randomized, active drug-controlled, dose-finding phase II clinical study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Herpes zoster; peginterferon; efficacy; safety; postherpetic neuralgia