bioihbjkbjnl/mcl2 huggingface dataset:
Combination of Probiotic and Calcium in Healthy Adults
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The study was conducted to investigate the effect of the probiotic L. paracasei LPC 37 alone
      or in combination with a calcium supplement of the human microbiota and further physiological
      parameters.
    

Detailed description: 
      Animal studies suggest that calcium beneficially influence the microbiota in the gut. This
      effect of calcium is due to the formation of amorphous calcium phosphate, which has the
      ability to bind bile acids and other cytotoxic substances in the gut. The precipitation of
      the cytotoxic substances leads to a less aggressive environment in the gut and might be
      stimulate the adhesion of the microbiota.

      Thirty-two healthy men and women participated in a placebo-controlled, double-blind and cross
      over human study. The participants were randomly divided into two groups. All probands
      consumed a probiotic drink for four weeks (10e+10 CFU/d). Additionally, one group consumed a
      pentacalcium phosphate-enriched bread (1 g Ca/d) and the other group consumed a bread without
      pentacalcium phosphate. After a two-week wash-out and a two-week placebo period the invention
      changed for another four weeks (cross over). At the end of each intervention and placebo
      period, subjects consumed a defined diet for three days. Furthermore, there was a three-day
      quantitative stool and urine collection and a fasting venous blood sample was taken.
    

Intervention name(s): calcium and probiotic; probiotic; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): the subjects consumed for 4 weeks a yoghurt drink enriched with 10e+10 cfu/d L. paracasei LPC 37 and a bread enriched with 1 g pentacalcium phosphate per day; the subjects consumed a yoghurt drink enriched with 10e+10 cfu/d L. paracasei LPC 37 for 4 weeks; the subjects consumed a yoghurt drink without L. paracasei LPC 37 and a bread without pentacalcium phosphate
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: probiotic; lactobacillus paracasei; calcium; faecal microbiota; cholesterol metabolism
Pioglitazone Treatment in Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, the investigators wish to investigate how pioglitazone treatment effects
      hirsute women. Hirsute women are often overweight and have an increased amount of male sex
      hormone in their blood. Their blood tests show frequent changes corresponding to the changes
      seen in diabetic patients.

      Pioglitazone is a drug used for increasing the insulin sensitivity in diabetic patients.
      Previous studies showed that this drug is able to decrease the level of insulin in blood in
      hirsute women. Moreover, the level of male sex hormones is reduced during this treatment. The
      drug has only been marketed for few years, and no investigations have been carried out as to
      the reaction of other hormones, e.g. growth hormone and stress hormone, using this treatment.

      This clinical trial includes 30 strongly hirsute women. The patients are randomized to either
      placebo or an active drug. The treatment period is 16 weeks. The patients included must be
      healthy and take no medicine possibly changing the results of the study. The patients must
      take no contraceptive pills or receive any other hormone treatment.

      In connection with the investigation, the following will be carried out on all patients:
      glucose tolerance test, clinical examination, blood tests, measurement of stress hormones and
      sex hormones, hyperinsulinaemic euglycaemic clamp test, muscle biopsies and bone scan.

      This examination programme will be carried out before start of pioglitazone or placebo
      treatment and again after 16 weeks of treatment. The examinations require 2½ days of
      hospitalization.

      The purpose of the study is to gain more knowledge of the reasons for hirsute women to grow
      more hair than normal women. The study will show whether pioglitazone treatment can reduce
      the amount of male sex hormone in blood and how the level of stress hormone and growth
      hormone is changed when reducing the amount of insulin in blood.
    


Intervention name(s): pioglitazone
Intervention type(s): Drug
Intervention description(s): 30 Mg/day
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: polycystic ovary syndrome (PCOS); PPARgamma; growth hormone; insulin resistance; pioglitazone; glucose metabolism; microarray
Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Monoclonal antibodies can block tumor growth in different ways. Some block the
      ability of tumor cells to grow and spread. Others find tumor cells and help kill them or
      carry tumor-killing substances to them.

      PURPOSE: This clinical trial is studying the side effects and best dose of a monoclonal
      antibody in treating patients with stage IV melanoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the safety/toxicity of a single dose of B7-dendritic cell cross-linking
           antibody containing plasma in treating patients with stage IV melanoma.

      Secondary

        -  Describe the immunological changes (Th1/Th2 balance, frequency of tumor specific
           cytotoxic T lymphocytes, and plasma cytokine profiles) in the treated patients.

        -  Determine the treatment impact on tumor growth (e.g., objective response, time to
           progression).

      OUTLINE: Patients receive B7-dendritic cell cross-linking antibody IV once on day 1.

      Patients undergo peripheral blood collection at baseline and periodically after infusion for
      analysis of dendritic cell activation, cytotoxic T-lymphocyte activity, immune cell impact,
      and serum cytokine changes using immunophenotyping and flow cytometry.

      After completion of study treatment patients are followed every 2 months for 5 years.
    

Intervention name(s): B7-DC cross-linking antibody rHIgM12B7; flow cytometry; immunologic technique; laboratory biomarker analysis
Intervention type(s): Biological; Other; Other; Other
Intervention MeSH terms: Antibodies
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent melanoma; stage IV melanoma
Ambulatory Blood Pressure Reduction After Rosiglitazone Treatment In Normotensive Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to determine the effects of rosiglitazone in normotensive type
      2 diabetic patients with regard to its blood-pressure-reducing effects.
    

Detailed description: 
      The first study to evaluate the effects of troglitazone on blood pressure in humans was
      published recently, which demonstrated a 5/4 mm Hg reduction in ambulatory blood pressure in
      18 nondiabetic obese subjects after 12 weeks' treatment. Another study in 18 hypertensive
      subjects with diabetes mellitus showed an 18/12 mm Hg decline in office blood pressure after
      8 weeks of treatment.
    

Intervention name(s): rosiglitazone(drug), blood pressure lowering effect
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blood Pressure,; rosiglitazone,Diabetes Mellitus, Type 2,
Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus-2
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The purpose of this study is to improve blood glucose control in Type 2 Diabetes mellitus
      patients.
    

Detailed description: 
      We hypothesize that Autologous bone marrow derived stem cell transplantation(ABMSCT)into the
      pancreas of patients with T2DM, aged 30 - 70 years with triple oral hypoglycemic agent
      failure and on insulin(>0.4 U/ kg body weight/day) will lead to abolition or reduction of
      insulin requirement by more than or equal to 50% in these patients over a period of 6 months.
      It is assumed that ABMSCT in these patients leads to increased angiogenesis, secretion of
      various cytokines and upregulation of pancreatic transcription factors and Vascular
      endothelial growth factor(VEGF) and creates a microenvironment which supports beta
      cell/resident stem cell activation and survival.
    

Intervention name(s): stem cell transplantation
Intervention type(s): Biological
Intervention description(s): Group 1: 200 - 250 ml of bone marrow will be aspirated and layered on density gradient medium (Ficoll - Hyperaque) and stem cells will be separated. Separated MNC's will be tagged with FDG-PET and injected into superior pancreatico duodenal artery and an PET scan will be done 2 hours later to see the percentage of stem cells homing in to pancreas. After 8 weeks G-CSF(10mcg/Kg/day) will be given subcutaneous for 5 days to achieve a Leucocyte count of >40,000/mm3. Patients will be urged to monitor and document blood glucose readings for next 6 months. Glucagon stimulated C - peptide, plasma Insulin, HOMA-IR , HOMA-B ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months .
Other intervention name(s): Autologous Bone marrow derived stem cell transplantation
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with type 2 Diabetes mellitus with triple Oral hypoglycemic failure and on Insulin
        for glycemic control
Study to Evaluate the Drug Interaction Between CKD-519 and Rosuvastatin in Healthy Male Subjects
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug interaction between CKD-519 and
      rosuvastatin in healthy male subjects.
    

Detailed description: 
      An open-label, multiple dose, fixed-sequence, 3-period study to evaluate the drug interaction
      between CKD-519 and rosuvastatin in healthy male subjects.
    

Intervention name(s): Rosuvastatin 20 mg; CKD-519 200 mg; Rosuvastatin 20 mg & CKD-519 200 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treatment A: Rosuvastatin 20 mg(20 mg X 1 tablet) for Day1~Day5; Treatment B: CKD-519 200 mg(100 mg X 2 tablets) for Day9~Day21; Treatment C: Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets) for Day22~Day26
Other intervention name(s): Rosuvastatin 20 mg(20 mg X 1 tablet); CKD-519 200 mg(100 mg X 2 tablets); Rosuvastatin 20 mg(20 mgX1 tablet), CKD-519 200 mg(100 mgX2 tablets)
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dyslipidemia; CKD-519; Rosuvastatin; Drug-Drug Interaction
Brain Activation During Accommodation to Painful Stimulation With FMRI
Condition: Pain
Study type: Observational

Summary: 
      Blood oxygen level dependant (BOLD) functional magnetic resonance imaging (FMRI)
      investigations of pain have provided substantial insight into the workings of the human
      brain. To date, however, the vast majority of studies have dealt with short painful
      stimulations. This work will expand the investigators knowledge of how longer stimulations
      are processed by comparing the activation pattern from a two minute painful stimulation with
      that of an 30-second painful stimulus. The investigators hypothesis that accommodation to the
      longer stimulation will be evident by either decreases in signal intensity in brain areas
      known to process pain, or by increasing activity in brain areas thought to be responsible for
      the modulation of painful perception.
    

Detailed description: 
      Background: Over the past 14 years, BOLD FMRI studies have non-invasively shown that pain
      activates a matrix of areas, but that this activation decays during stimulation, possibly
      reflecting the body's ability to "accommodate" to the stimulation. The majority of these use
      short applications of pain lasting 1 to 30 seconds. However, investigators are now using
      stimulations much longer than the periods that were typical a few years ago. The effect of
      signal decay on the activation maps generated by these longer tasks is not known. Because the
      signal change in many of the subcortical areas involved in pain processing is low, errors in
      analysis due to neglecting the signal decay may induce significant artifact.

      Materials and Methods: Using transcutaneous electrical nerve stimulation, 20 healthy
      volunteers will experience two different painful stimulations: a repeating 30-second long
      stimulation and a constant 2 minute stimulation. The brain activity for each will be
      determined and compared. In addition, the signal decay during each painful stimulation will
      be quantified and compared.

      Significance: Investigators are using longer stimulations periods in an attempt to understand
      how the brain processes "real- life" pain instead of the artificial on-off pattern of earlier
      studies. However, significant attention has not been paid to the possible effect of
      accommodation on the stimulus and how this may impact the activity pattern found. In
      addition, proof of activation of pain-control areas like the periaquaductal gray while
      inverse changes are occurring in pain-perceiving areas has not been sought. This study will
      address both of these issues with a single BOLD FMRI experiment.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Subjects will come from the general surrounding community.
      
Keywords: Pain; Functional Magnetic Resonance Imaging
Proof-of-concept Study for Bioimpedance Based Monitoring of Venous Ulcers During Galvanic Stimulation
Condition: Patients With Lower Extremity Venous Ulcers; Patients With Localized Edema
MeSH terms: Varicose Ulcer; Ulcer
Study type: Interventional

Summary: 
      The research group will choose no more than 10 patients having a lower extremity venous
      ulcer(s), less than 5cm diameter and with an estimated one month time of re-epithelization.
      In this study the investigators will follow and monitor the healing of the wound and
      effectiveness of compression therapy using bioimpedance measurement based method. The
      investigators will also treat the wounds using periodical low intensity direct current (LIDC)
      stimulation therapy.

      Bioimpedance monitoring and wound stimulation functionalities are provided by a purpose built
      wound patch. The patch features a printed 4 x 4 stimulation and impedance measurement
      electrodes array (in contact with wound surface) surrounded by a 4-part dual purpose counter
      and impedance reference electrodes (in contact with the intact skin surrounding the wound
      area).
    

Detailed description: 
      Objectives of the study

      Primary: Proof-of-concept study of bioimpedance measurement based method for monitoring of
      chronic wound healing and assessment of efficacy of compression therapy. Gathering
      bioimpedance data from the patients with a lower extremity ulcer of venous etiology over
      their healing process. The investigators will seek methods for processing the collected data
      to find the best correlation with visually observed healing of the wound.

      Secondary: Proof-of-concept study of periodical LIDC wound stimulation. The investigators
      will compare the LIDC enhanced healing outcome with appropriate archived data of previous
      studies performed in TAYS.

      Other: Analysis of the received data and reliability evaluation of the methods. Gathering
      relevant user feedback from medical personnel and patients.
    

Intervention name(s): Periodical low intensity direct current (LIDC) stimulation of wound.; Compression therapy of swollen limbs.
Intervention type(s): Procedure; Procedure
Intervention description(s): Wound is stimulated using LIDC current. Stimulation current magnitude is in micro-ampere range. Stimulation sequence is 1 hour on and 1 hour off for 72 hours or 96 hours.; Compression bandage is used for reducing swelling of the limbs.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Bioimpedance; Venous ulcer; Edema; LIDC; Electrical stimulation
A Smoking Cessation Study to Understand the Biological and Functional Changes After One Year of Smoking Cessation
Condition: Cigarette Smoking
Study type: Observational

Summary: 
      The purpose of this study was to understand the biological and functional changes after one
      year of smoking cessation and to collect data on a broad range of biomarkers of exposure
      (BoExp) and biomarkers of effect (BoE).
    

Detailed description: 
      This was a 12 month, multi-region, multi-center, ambulatory study conducted in the US, Japan
      and Europe. Smokers who were willing to quit smoking within the next 30 days at the Screening
      Visit were enrolled to reach approximately 950 subjects continuously abstinent from smoking
      from Actual Quit Date (AQD) onwards at week 2, in order to achieve at least 190 successful
      quitters expected to complete the study. Once approximately 950 subjects reached week 2,
      screening and enrollment were stopped.

      Compliance with smoking abstinence was verified by self-reporting, CO breath tests, and urine
      cotinine tests. Smokers who were not continuously abstinent from smoking [i.e., free from
      tobacco product use (e.g., CC, pipes, cigars, snus) or any nicotine-containing product
      (including electronic cigarettes) other than nicotine replacement therapy (NRT)] from their
      AQD onwards were discontinued from the study. At the end of the study, 358 subjects were
      verified as continuously abstinent from their AQD.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult, smoking subjects willing to quit smoking with no restriction on race and ethnicities
        will be enrolled in this study.
      
Biospecimen description: 
      Blood and urine bio-banking samples
    
Keywords: smoking cessation; smoking abstinence; clinical, biological and functional changes; one year; healthy smokers; quit smoking
The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine if there is improvement or measurable change in
      cognition after only one month of treatment with donepezil when using a computerized test
      battery. The results at one month will be compared with the results at 3 months to evaluate
      this.
    


Intervention name(s): Donepezil; Donepezil; Placebo to match Aricept
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5 mg capsule, orally, once daily, first 14 days of treatment; 10 mg, orally, once daily, for remaining 70 days of treatment; Placebo capsule, orally, 84 days of treatment
Other intervention name(s): Aricept; Aricept
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Patients with Mild to Moderate Alzheimer's Disease
Pramipexole as a Treatment for Cocaine Dependence
Condition: Cocaine Addiction; Cocaine Abuse; Cocaine Dependence; Substance Abuse
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are as follows: 1. To assess the cardiovascular and subjective
      effects of cocaine during treatment with pramipexole and placebo. 2. To assess the
      reinforcing effects of cocaine, measured using choice procedures, during treatment with
      pramipexole and placebo.
    

Detailed description: 
      In this protocol we propose to assess the impact of treatment with higher doses of the potent
      D2/3 agonist pramipexole, using the extended release preparation that has been shown to
      produce continuous DA receptor stimulation. Pramipexole is a non-ergot DA 3
      receptor-preferring agonist. In contrast to pergolide, bromocriptine and cabergoline, it does
      not stimulate 5-HT2B receptors and therefore does not cause cardiac valvulopathy. It can
      therefore be safely used chronically at higher doses, whereas pergolide has been withdrawn
      from the market for causing cardiac valvulopathy.
    

Intervention name(s): Pramipexole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive pramipexole ER 0.375, .075, 1.5, 2.25, and 3mg/d in an ascending-dose pattern.; Participants will receive matching placebo pills. The placebo group is included to maintain the blind, rather than as a comparison group.
Other intervention name(s): Mirapex; Sugar pill
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Pramipexole; Mirapex; Cocaine
Decrease in Circulating Tumour Cell Count Reflects the Effectiveness of Postoperative Adjuvant Transarterial Chemoembolization (TACE) in Preventing Hepatocellular Carcinoma Recurrence
Condition: Circulating Tumor Cell;; Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Neoplastic Cells, Circulating; Recurrence
Study type: Interventional

Summary: 
      Circulating tumour cell (CTC) count could reflect the effect of postoperative transarterial
      chemoembolization (TACE) on hepatocellular carcinoma (HCC) recurrence.
    

Detailed description: 
      Early metastases of hepatocellular carcinoma (HCC) may be detected by the isolation of
      circulating tumor cells (CTCs) in the bloodstream. During the course of therapeutic attempts,
      monitoring CTC changes in patients with HCC is helpful for the efficacy assessment.
      Nevertheless, the markers used for the detection, such as a-feto protein, asialoglycoprotein
      receptor or epithelial cell adhesion molecule, CD133 or CD90, are not specific for HCC CTCs.
      In spite of these limitations, a timely determination of the existence of CTCs will be
      beneficial for the monitoring of distant metastases, the evaluation of therapeutic attempts,
      and the prediction of prognosis.
    

Intervention name(s): transarterial chemoembolization (TACE)
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Screening
Keywords: circulating tumour cell;; transarterial chemoembolization;; hepatocellular carcinoma;; recurrence