bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Patients With Multiple Sclerosis (MS)
Condition: Herpesviridae Infection; HTLV-I Infection; Multiple Sclerosis; Tropical Spastic Paraparesis; Vasculitis
MeSH terms: Infections; Communicable Diseases; Paraparesis, Tropical Spastic; HTLV-I Infections; Herpesviridae Infections; Muscle Spasticity; Multiple Sclerosis; Paraparesis; Paraparesis, Spastic; Vasculitis; Sclerosis
Study type: Observational

Summary: 
      Multiple sclerosis (MS) is a disease of the nervous system. The exact cause of MS is unknown,
      but it is believed to be an autoimmune condition. Autoimmune conditions are diseases that
      cause the body's immune system and natural defenses to attack healthy cells. In the case of
      MS, the immune system begins attacking myelin, the cells that make up the sheath covering
      nerves. Without myelin, nerves are unable to transmit signals effectively and symptoms occur.

      This study is directed toward a better understanding of the cause of Multiple Sclerosis (MS).
      Researchers will evaluate patients with a tentative diagnosis of MS or other neurological
      diseases possibly caused by a immunological reaction. Patients will undergo a series of three
      MRIs, taken once a month for three months and submit blood samples for immunological studies.
    

Detailed description: 
      The Neuroimmunology Branch (NIB) conducts research into the cause of immunologically mediated
      diseases of the nervous system such as multiple sclerosis (MS). The studies in the NIB range
      for studies of the natural history of MS to trials of new experimental therapies. In order to
      recruit patients into the various NIB research studies, patients with a tentative diagnosis
      are initially seen by the NIB to assess the accuracy of the diagnosis and to assess the level
      of disease activity occurring in the patient. Patients seen under the NIB screening protocol
      are evaluated in clinic with a complete neurological examination. Blood studies necessary to
      eliminate the possibility of many other causes of disease that may resemble MS are performed.
      Spinal fluid examination may be preformed if uncertainty exists with respect to the
      diagnosis. Finally, patients will have at least one MRI preformed to assess the consistency
      with MRI findings expected in MS. Most patients will have a series of three MRIs done
      approximately one month apart in order to assess the frequency of new contrast enhancing
      lesions occurring in the patient. The level of disease on MRI is important both from the
      standpoint of diagnosis as well as determining if the patient may be eligible for any other
      NIB protocols. To assess the patient's eligibility for other NIB studies, the NIB may
      periodically follow patients in whom the diagnosis is uncertain or in whom the level of
      disease activity is not clear for the initial evaluation.
    

Keywords: Immunogenetics; Tropical Spastic Paraplegia; Twins; Epstein-Barr Virus; HTLV-I; Vasculitis; Cerebrospinal Fluid; Immunity to Viruses; Multiple Sclerosis; Magnetic Resonance Imaging
COVID-19 Phobia in Patients With Bronchiectasis During Covid-19 Pandemic
Condition: Covid19; Bronchiectasis
MeSH terms: COVID-19; Bronchiectasis
Study type: Observational

Summary: 
      In the literature, there are no studies evaluating COVID-19 phobia, quality of life, health
      anxiety, physical activity level and quality of sleep in patients with bronchiectasis during
      COVID-19 pandemic. The investigators will evaluate these parameters in patients with
      bronchiectasis and compare the findings of healthy individuals during COVID-19 pandemic
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients and healthy individuals between 18-60 years old, who are diagnosed with non-cystic
        fibrosis bronchiectasis, and whose local language is Turkish will be included in the study.
      
Keywords: phobia; quality of life; health anxiety
A Phase I Safety and Immunogenicity Trial of UBI Multivalent HIV-1 Peptide Immunogen in HIV-1 Seronegative Human Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate, in healthy adult volunteers, the safety and immunogenicity of multivalent HIV-1
      peptide immunogen, a formulation of HIV-1 gp120 principal neutralizing domain (PND) branched
      synthetic peptides from 15 viral strains representative of diverse worldwide isolates.

      Because there is considerable variation among HIV-1 virus strains from differing geographical
      locations worldwide, a multivalent peptide vaccine has been constructed to include prevalent
      and divergent isolates, potentially providing for wide coverage of geographically isolated
      epidemics.
    

Detailed description: 
      Because there is considerable variation among HIV-1 virus strains from differing geographical
      locations worldwide, a multivalent peptide vaccine has been constructed to include prevalent
      and divergent isolates, potentially providing for wide coverage of geographically isolated
      epidemics.

      Fourteen volunteers are entered at one of two dose levels of multivalent candidate vaccine.
      At each dose level, 12 volunteers receive vaccine and two receive placebo. At least eight
      volunteers at the low dose level must be monitored for 2 weeks before subsequent volunteers
      are entered at the high dose. Intramuscular injections are given on days 0, 28, and 168, and
      patients are followed for a minimum of 48 weeks after the initial immunization. Approximately
      13 clinical visits are required.
    

Intervention name(s): HIV-1 Peptide Immunogen, Multivalent
Intervention type(s): Biological
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; HIV-1; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
Coagulation Profile of Patients Undergoing CRS(Cytoreductive Surgery) and Hyperthermic Intraperitoneal Chemotherapy
Condition: Haematological Abnormality
MeSH terms: Hyperthermia; Fever
Study type: Observational

Summary: 
      To study the changes in coagulation profile in patients undergoing cytoreductive surgery and
      Hyperthermic intraperitoneal chemotherapy. The objective of the study is to determine the
      utility of thromboelastography in comparison to standard coagulation tests in assessing the
      coagulopathy in patients undergoing CRS with HIPEC.
    

Detailed description: 
      This is a prospective observational study conducted in 60 patients undergoing CRS with HIPEC
      in RGCIRC from march 2015- march2016 after taking permission from the institutional review
      board and informed written consent from the patients.

      Arterial blood samples were collected before and after HIPEC and on first and second
      postoperative day for PT,APTT INR,TEG and ABG. Statistical analysis was done using chi square
      test and unpaired t- test for categorical and continuous variables. Pearson's correlation
      coefficient was calculated for analysing the correlation between the variables .P - value
      <0.05 was considered statistically significant.
    

Intervention name(s): thromboelastography
Intervention type(s): Other
Intervention description(s): thromboelastography was done pre HIPEC ,post HIPEC and first and second postoperative days
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        thromboelastography was done in 60 patients undergoing CRS with HIPEC in RGCI FROM
        MARCH2015- MARCH 2016
      
Keywords: Thromboelastography, chemotherapy,hyperthermic
Multi-center Research Project for Glioma Molecular Pathology Intraoperative Rapid Detection
Condition: Glioma, Malignant
MeSH terms: Glioma
Study type: Observational

Summary: 
      We explores the accuracy and sensitivity of rapid intraoperative detection of IDH, TERT, BRAF
      indicators through a prospective clinical multi-center study. This part includes a total of
      300 fresh tissue samples, paired blood samples, relevant clinical information and follow-up
      information from 300 patients with different grades of adult glioma. By comparing with the
      postoperative sequencing results, the specificity and sensitivity of intraoperative IDH and
      TERT rapid detection results are clear.
    


Intervention name(s): Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e
Intervention type(s): Diagnostic Test
Intervention description(s): Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1. Glioma patients with Informed Consent Form

          2. Glioma patients with intact clinical information
Efficacy of Different Doses of Amino Acids in 5AA+CrPic Water on Glucose Homeostasis in a Healthy Population.
Condition: Healthy
Study type: Interventional

Summary: 
      It has previously been shown that a carbonated water including a defined amount of amino
      acids and chromium can decrease the postprandial glucose response. In this study, the effect
      of three different doses of amino acids on glucose excursions after a standardized test meal
      will be evaluated in healthy subjects. The study will be conducted in a randomized, single
      center, crossover, double-blinded, placebo controlled design including 25 participants. The
      primary endpoint of the study is the incremental area under the curve for capillary blood
      glucose (iAUC) within 180 minutes after ingestion of the meal.
    


Intervention name(s): 5AA+CrPic Water; Placebo drink
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Dietary supplement drink with carbonation, aroma, amino acids and chromium picolinate; Placebo water with carbonation and aroma
Other intervention name(s): Good Idea
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diabetes; Prediabetes; Blood sugar regulation
Tissue Factor Pathway Inhibitor (TFPI) and Haemorrhagic Manifestations in Haemophilia A and B Patients
Condition: Hemophilia
MeSH terms: Hemophilia A
Study type: Observational

Summary: 
      Haemophilia is a rare and serious congenital defect of blood coagulation due to a genetic
      mutation on a sexual chromosome. It affects quasi-essentially the men and it is responsible
      for bleeding. There are two types of haemophilia: Haemophilia A, (85 % of cases), due to a
      factor VIII (FVIII) deficiency and Haemophilia B (15 % of cases) due to factor IX (FIX)
      deficiency. According to the intensity of the defect, there are three forms of haemophilia:
      severe (FVIII or FIX lower than 1 %), moderate (factor level between 1 and 5 %), minor
      (factor level between 5 and 40 %). For a same level of factor VIII or IX, hemorrhagic
      manifestations are variable from one patient to the other. Moreover, several studies showed
      that haemophilic B patients bleed less and consume fewer anti-hemophilic concentrate that
      haemophilic A patients.

      The main inhibitors of the coagulation are antithrombin, Protein C-Protein S-Thrombomodulin
      system, and tissue factor pathway inhibitor (TFPI). TFPI is the specific and exclusive
      inhibitor of tissue factor pathway that is the main way by which plasmatic coagulation
      starts. TFPI is a potent direct inhibitor of factor Xa and Xa-dependent inhibitor of the
      VIIa-Tissue Factor (TF) complex. In hemophilic patient, the production of Xa by the
      amplification pathway being strongly altered because of factor VIII or IX deficiency,
      thrombin generation (via Xa) comes exclusively from TFPI regulated tissue factor pathway. We
      can thus say that if haemophilic patients bleed, it is also because of the presence of TFPI
      that inhibits at the same time Xa and the complex TF-VIIa as soon as factor Xa is generated.
    


Intervention name(s): blood specimen
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Haemophilia A and B patients between 18 and 65 years old, whatever the severity of their
        disease
      
Biospecimen description: 
      blood specimen
    
Keywords: haemophilia; TFPI; thrombin generation; hemorrhagic score
Study Evaluating Vabicaserin in Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this protocol is to establish the efficacy, safety, and tolerability
      of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of
      schizophrenia.
    


Intervention name(s): vabicaserin; risperidone; placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): This study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Milk Plus Exercise: A Novel Strategy to Treat Diabetes.
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether combining interval training with skim
      milk supplementation will result in improved glucose control and markers of cardiovascular
      health in people with type 2 diabetes. Participants will complete supervised interval
      training three times a week over a 12 week training period while consuming skim-milk,
      whey/casein protein drink, or a placebo beverage that does not contain any calories or
      vitamins/minerals immediately and 1 hour after each training session. After twelve weeks
      participants will repeat baseline tests to examine any effects of the intervention on their
      glucose control, fitness, blood vessel function, body composition, and blood markers of
      inflammation.
    


Intervention name(s): Skim Milk; High intensity interval training; Placebo; Macronutrient isoenergetic control
Intervention type(s): Dietary Supplement; Behavioral; Other; Dietary Supplement
Intervention description(s): 250 ml skim milk will be consumed by participants immediately and 1 hour after each of the 36 sessions of high-intensity interval training over a 12 week period.; All participants will undergo a 12 week high intensity interval training program consisting of 3 supervised sessions a week of 4-10 x 1 min high intensity interval alternating with 1 min of recovery.; 250 mL water will be consumed by participants immediately and 1 hour after each of the 36 sessions of high-intensity interval training over a 12 week period.; 250 mL of protein+cho matched drink will be consumed by participants immediately and 1 hour after each of the 36 sessions of high-intensity interval training over a 12 week period.
Other intervention name(s): Fat-free milk; water; Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Hormone Replacement Therapy (HRT) Website Tool
Condition: Communication; Menopause; Hormone Replacement Therapy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate a prototype web-based module for patients to
      generate appropriate and focused health information along with a customized set of questions
      to take to their health care provider for discussion on hormone replacement therapy.
    

Detailed description: 
      Patient-centered care may be enhanced by medically accurate, personalized health information
      generated by specialized software on the Internet. This study assessed the effect of a
      web-based interactive tool about menopausal hormone therapy (HT) on patient and provider
      communication and satisfaction.

      The controlled, randomized evaluation of the TalkToYourDoc(sm) (TTYD) interactive website
      module on communication, satisfaction and efficiency of office visits involved 288 women born
      between 1930 and 1960 and 26 health care providers in an outpatient, academic setting. Women
      were randomized after stratification by HT use to usual care or access to the TTYD website.
      The TTYD website built a personalized series of questions based on participant input
      regarding health status and generated a printout of health issues, medications and questions
      about HT for participants to bring to the visit with their health care provider.

      Results of the study found that women who participated in the intervention were more likely
      to come prepared to the clinic appointment with appropriate questions (80% vs. 96%) than
      women receiving usual care. Participants found the website easy to use, the questions
      generated were useful in the discussion of HT, and they felt that providers had a positive
      response to the printout. Providers felt that women who participated in the intervention were
      more engaged in the discussion and asked more relevant questions regarding HT. Providers had
      a higher level of satisfaction with the discussion with intervention participants, and felt
      that these office visits were more efficient.

      Therefore, it was determined that the TalkToYourDoc(sm) module enhanced communication between
      women and their providers, led to greater visit satisfaction for both patient and provider,
      and improved visit efficiency.
    

Intervention name(s): TalkToYourDoc(sm) hormone therapy module
Intervention type(s): Behavioral
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Educational/Counseling/Training
Safety and Efficacy Study of Mepolizumab in Churg Strauss Syndrome
Condition: Churg Strauss Syndrome
MeSH terms: Churg-Strauss Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Churg-Strauss syndrome is a rare type of systemic vasculitis which occurs almost exclusively
      in patients with asthma and which is characterized by prominent blood and tissue
      eosinophilia. The disease has a chronic smoldering course with a permanent need for medium to
      high corticosteroid doses. Available unselective immunosuppressive agents are often
      insufficient to reduce corticosteroid doses, to induce complete remission and to protect
      patients from disease flares which occur in more than 50 % of cases.

      Interleukin-5 is the most potent cytokine regulating the production of eosinophil
      granulocytes which are the major effector cells in Churg-Strauss syndrome. Recently, an
      increased production of interleukin-5 was demonstrated in Churg-Strauss syndrome. Mepolizumab
      is a monoclonal IgG antibody targeting interleukin-5 and is effective in the treatment of the
      HES. The hypothesis of this study is, that mepolizumab will induce remission and allow for
      steroid reduction.
    


Intervention name(s): mepolizumab
Intervention type(s): Drug
Intervention description(s): 750 mg mepolizumab iv q4wk until week 32
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Near Normalisation of BG Improves the Potentiating Effect of GLP-1
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The ability of glucagon-like peptide 1 to enhance beta-cell responsiveness to I.v. glucose is
      impaired in patients with type 2 diabetes mellitus compared with healthy individuals. We
      investigated whether 4 weeks of near-normalisation og blood glucose improves the potentiation
      of glucose-stimulated insulin secretion by GLP-1
    


Intervention name(s): glucagon-like peptide-1; Saline
Intervention type(s): Drug; Drug
Intervention description(s): continuous infusion of GLP-1 (1½ pmol/kg/min); continuous infusion of saline
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Influence of Interferential Current Therapy in the Treatment of Individuals With Shoulder Impact Syndrome: A Randomized, Placebo Controlled Clinical Trial.
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome
Study type: Interventional

Summary: 
      This project will analyze the influence of interferential current therapy in an exercise
      program for individuals with a unilateral impact syndrome diagnosis. To that end, volunteers
      of both genders, aged 18-59 years, had an unilateral, unilateral pain in the shoulder with
      more than 3 months duration, at least grade 4 pain by the numerical scale of pain assessment,
      positivity In at least 2 of 3 orthopedic tests for impact syndrome, will be randomized into
      the following groups: exercise group, exercise + ultrasound group, exercise group +
      interferential current. Sixteen consecutive treatment sessions will be performed, and the
      volunteers will be evaluated before and after, by means of the following instruments:
      Numerical scale of evaluation of pain, Shoulder pain and disability index (SPADI),
      Pain-Related Catastrophizing Thoughts Scale, being applied the Numerical scale of evaluation
      of pain at the end of Each session and one month after the end of treatment.
    


Intervention name(s): exercise; Interferential current therapy; Therapeutic Ultrasound
Intervention type(s): Other; Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment