bioihbjkbjnl/mcl2 huggingface dataset:
Brain Mechanisms of Acupuncture Treatment in Chronic Low Back Pain
Condition: Chronic Low Back Pain; Low Back Pain; Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      We are doing this study to investigate the effects of acupuncture on chronic low back pain.
      We are interested in learning about brain activity during pain. We plan to look at brain
      activity at the beginning and the end of the study, after 6 sessions of acupuncture
      treatment. You will be randomly assigned to one of two groups to receive either real or
      placebo acupuncture.

      Acupuncture has been used for many years to help relieve pain. However, it is not clear how
      acupuncture works. Acupuncture may relieve pain by changing activity in the nervous system.
      Some studies indicate that acupuncture may relieve the low back pain. However, we need more
      research to see how well acupuncture works to relieve pain for people with this condition.

      In this study, we will measure your brain activity before and after you do exercises to make
      your back pain worse. We will also measure your brain activity while inflating a pressure
      cuff device on your lower leg. We will measure this brain activity using a research tool
      called functional MRI (fMRI). Functional MRI is a very fast MRI that uses radio waves and a
      magnet, and allows the study investigators to look at changes in blood flow to different
      parts of the brain when there are changes in brain activity.
    


Intervention name(s): Acupuncture
Intervention type(s): Procedure
Intervention description(s): A licensed acupuncturist will perform acupuncture for six, 30 minute treatment sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acupuncture; Back Pain; Lower Back Pain; Brigham and Women's Hospital; Massachusetts General Hospital; Effects of Acupuncture
Watching Live VIA/VILI Examinations on a Digital Screen May Reduce Patients' Anxiety
Condition: Cervical Cancer; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether the degree of anxiety experienced by women
      undergoing visual inspection with acetic acid (VIA) and Lugol's iodine (VILI) can be reduced
      by watching the procedure in real-time on a digital screen.
    

Detailed description: 
      The study took place in the District of Dschang, Cameroon. Women aged between 30 and 49
      years, addressed to undergo a pelvic examination with VIA and VILI, were invited to
      participate. Throughout the examination, one part of the women underwent the routine
      VIA/VILI, with no visual support (control group), whereas the other part of patients were
      shown the pictures of the cervix in real-time on a digital screen (study group). At the end
      of the procedure, all women had the possibility to see the pictures retrospectively.
      Randomization determined the women's distribution between the two groups. Their anxiety level
      was measured by asking them to complete the Spielberg's State Anxiety Inventory (STAI) both
      prior to and immediately after the procedure.
    

Intervention name(s): Real-time view; No visual support
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Weight Maintenance With Dipeptidyl Peptidase 4 (DPP4) Inhibitor Sitagliptin in Combination With Metformin After Liragludite Induced Weight Loss
Condition: Polycystic Ovary Syndrome; Body Weight
MeSH terms: Polycystic Ovary Syndrome; Body Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      Weight reduction is the most important treatment target in obese women with polycystic ovary
      syndrome (PCOS), yet it is usually hardly achievable with lifestyle intervention alone.
      Glucagon-like peptide 1 (GLP-1) receptor agonist (RA) liraglutide was recently approved as an
      anti-obesity drug but with some limitations, which include high cost and the lack of
      long-term efficacy and safety data regarding weight reduction. In addition, weight loss
      achieved with liraglutide is often non-sustainable after treatment cessation. Although DPP-4
      inhibitors are weight neutral, they reduced weight regain in animals previously treated with
      GLP-1 RAs if they were switched to DPP-4 inhibitor rather than placebo. The aim is to
      evaluate whether DPP-4 inhibitor sitagliptin in combination with metformin reduce body weight
      regain more effectively than metformin alone in obese PCOS who had been previously treated
      with liraglutide.
    


Intervention name(s): sitagliptin and metformin; Metformin
Intervention type(s): Drug; Drug
Other intervention name(s): Janumet; Glucophage
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DPP4-inhibitors
Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors
Condition: Solid Tumor; Metastatic Cancer; Advanced Cancer
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety,
      tolerability, MTD or MAD, PK, and PD of TJ210001 in subjects with relapsed or refractory
      advanced solid tumors. Beginning with Dose Level 1, TJ210001 will be given every week
      starting on Cycle 1 Day 1 (C1D1). The criteria for dose escalation/de-escalation will be
      based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts. The
      BOIN design is implemented in a simple way similar to the traditional 3+3 design but is more
      flexible and possesses superior operating characteristics that are comparable to those of the
      more complex model-based designs, such as the continual reassessment method (CRM).
    


Intervention name(s): TJ210001
Intervention type(s): Drug
Intervention description(s): human anti-C5aR monoclonal antibody
Other intervention name(s): MOR210; MOR044254; WBP2191
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: monoclonal antibody; anti-C2aR
Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary:

        -  To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects
           with type 1 or type 2 diabetes mellitus.

        -  To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro.

      Secondary:

        -  To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks
           12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with
           type 1 or type 2 diabetes mellitus
    


Intervention name(s): Insulin Glulisine; Lispro; Insulin Glargine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3 times a day before each meal; 3 times a day before each meal; once daily
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery
Condition: Anesthesia; Surgery; Neurogenic Inflammation; Cognitive Disorders
MeSH terms: Neurogenic Inflammation; Inflammation; Cognitive Dysfunction; Cognition Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to assess the induction of neuroinflammation in brain
      regions of interest for learning and memory in adult patients undergoing urological surgery
      under general anesthesia
    

Detailed description: 
      The investigators aim to study immune cell activation as a biomarker for neuroinflammation
      using the cell specific [11C]PBR28 probe as detected by PET imaging techniques.
    

Intervention name(s): Positron emission tomography (PET) using [11C]PBR28
Intervention type(s): Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Neuroinflammation; Postoperative cognitive dysfunction
Comparison of Phenprocoumon and Acetylsalicylic Acid (ASA)
Condition: Valvular Calcification; Coronary Calcification
MeSH terms: Calcinosis
Study type: Observational

Summary: 
      In this open, prospective, non-randomised, parallel group, unicentric pilot-study will be
      compared the progress of valvular and coronary calcification with regard to the therapy with
      either acetyl-salicylic acid or phenprocoumon. The progress of calcification is documented by
      comparison of cardial stratified computed tomography. It is supposed that treatment with
      phenprocumon leads to increased coronary and valvular calcification as well to decreased
      blood levels of carboxylated matrix-GLA-protein
    

Detailed description: 
      Patients will be allocated to two groups with either

        1. anticoagulation with phenprocoumon (needed for at least 1 year)

        2. therapy with ASA

      Both treatment groups should include to 50% patients with a glomerular filtration rate (GFR)
      < 60 ml/min and > 15 ml/min.

      All patients will undergo a screening procedure with evaluation of calcium regulating
      proteins, echocardiography and stratified computed tomography of the heart. Medical check
      up's are planned after 1,3,6, 12 and 18 months.

      Prior investigations concern diastolic ventricular function under long lasting therapy with
      phenprocoumon and the influence of long lasting therapy with phenprocoumon in patients
      suffering from aortic valve sclerosis.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with required therapy with either ASS or phenprocoumon
      
Biospecimen description: 
      Biomarkers for inflammation, measuring of inhibitors of calcification
    
Keywords: phenprocoumon; anticoagulation; acetylic salicylic acid; Need for new anticoagulation treatment
Co-Sér: Serological Analysis and Viral Neutralization in People With a Documented COVID-19 Infection
Condition: SARS-CoV Infection; Immune System Disorder
MeSH terms: Infections; Severe Acute Respiratory Syndrome; Immune System Diseases
Study type: Interventional

Summary: 
      In light of the current coronavirus disease 2019 (COVID-19) pandemic, the investigators want
      to better study the immunological characteristics of Severe Acute Respiratory
      Syndrome-Coronavirus 2 (SARS-CoV2) infections in adults. The investigators invite volunteers
      to participate in a clinical study to better understand what happens after an infection with
      SARS-CoV2. By collecting and analysing blood samples of people that were infected, the
      investigators want to evaluate whether or not the participants had an adaptive immune
      response with the producting of immunoglobulin. The investigators will evaluate the quality
      of the antibodies and their neutralising capacity. In a selected patient group with strong
      antibody response, the investigators will try to reproduce them in the lab after the
      collection of a larger blood sample (max 72 mL) of, in case of insufficient B-cells, a
      leucapheresis (after consent of the patient). These antibodies can be used in clinical trials
      to evaluate whether the investigators can cure patients faster or prevent disease by the
      utilisation of these antibodies.

      Aside from the aforementioned information the investigators will also collect clinical data
      such as: demographic information, medical history, routine lab results, radiographic imaging
      and medication use.

      After the completion of the study, the samples will be stored for 30 years with consent of
      the participants.
    


Intervention name(s): Blood sample
Intervention type(s): Diagnostic Test
Intervention description(s): Analysing blood samples for the presence of antibody against SARS-CoV2. When impossible to collect sufficient B-cells for further typing, leucapheresis will be performed if the patient agrees.
Intervention model: Single Group Assignment
Intervention model description: (serial) blood samples in patients with proven SARS-CoV2
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: immunology; SARS-CoV2; Antibodies
Beneficial Effects of a Polyphenol Enriched Beverage on Type 2 Diabetes Prevention and on Cardiovascular Risk Profile of Men and Women With Insulin Resistance.
Condition: Diabetes; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus; Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to measure the beneficial effects of an optimized berries
      extracts on diabetes and cardiovascular diseases prevention. Our hypothesis is that including
      a polyphenol rich berries extract in daily feeding will improve insulin sensitivity, glucose
      tolerance, pancreatic β-cells function, lipids and inflammatory profile, and oxidative stress
      markers.
    

Detailed description: 
      Type 2 diabetes is an up rising disease that makes it a major public health problem. While
      221 millions cases were estimated in 2010, the prevalence would be 366 millions in 2030. It
      is well recognized that regular consumption of fruits and vegetables can lower the incidence
      of chronic diseases such as cancer, cardiovascular diseases, diabetes and inflammatory
      diseases. Recently, Drs Desjardins, Abrams and Marette's research team discovered a high
      amount of a sesquiterpene in berries. This molecule is recognized for its ability to improve
      glucose tolerance and insulin sensitivity, and to lower pro-inflammatory profile of obese
      mice. The aim of this study is to determine the effect of a polyphenol rich berries extract
      mix on insulin sensitivity, glucose tolerance, pancreatic β-cells function, lipids and
      inflammatory profile, and oxidative stress markers, on human obese subjects that have insulin
      resistance.
    

Intervention name(s): Uncontrolled nutritional intervention with a supplemental beverage; Placebo
Intervention type(s): Other; Other
Intervention description(s): Men and women are assigned to an uncontrolled nutritional intervention where they have to consume every day one of the beverage. Half of the subjects consume the experimental beverage containing polyphenols from berries extracts, the other half consume a placebo beverage without polyphenols. The polyphenol containing beverage daily supply 1,84 g of a strawberry and cranberry extract. This amount give the equivalent of 333 mg of polyphenols, thus corresponding to a daily consumption of one cup of berries. The placebo beverage is also a fruit taste beverage, but without polyphenols. Both beverage are isocaloric, with same appearance and taste. A 2 weeks stabilisation period precede the 6 weeks experimental period. During these two periods, subjects are advise to maintain their habitual caloric intake and their habitual activity level, and to avoid consumption of particular food with a high polyphenol content.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: insulin sensitivity,; glucose tolerance,; inflammatory markers,; lipid profile,; oxidative stress,; pancreatic β-cell function
Observational Study Evaluating the Potential Impact of Procalcitonin Testing on Care of Stemcell Transplant Recipients
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma
Study type: Observational

Summary: 
      An observational study in evaluating the clinical impact of procalcitonin on the care of Stem
      cell transplant recipient and its performance as an adjunct in the diagnosis and
      prognostication of Infectious processes
    

Detailed description: 
      The overall goal of this project will be to provide new insights into the use of biomarkers
      in surveillance for infectious processes in Stem Cell Transplant recipients by evaluating the
      added impact of procalcitonin testing on detection of infectious processes
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Multiple Myeloma at UAMS receiving Stem Cell transplantation
Efficacy of Proprioceptive Neuromuscular Facilitation in Pain Relief
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the contract-relax technique of
      proprioceptive neuromuscular facilitation, and the static stretching exercise are effective
      in reducing the frequency, intensity and duration of headache and in improving the perception
      of quality of life in women with migraine.
    

Detailed description: 
      This is an randomized clinical trial, double blind, comparing two interventions in women with
      migraine, whose diagnosis was confirmed by a neurologist.
    

Intervention name(s): PNF contract-relax; Static stretching
Intervention type(s): Other; Other
Intervention description(s): Proprioceptive neuromuscular facilitation, using the technique of contract-relax on neck diagonal.; Static stretching of neck muscles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Migraine disorders; Muscle stretching exercises
Allogeneic Bone Marrow Mesenchymal Stem Cells for Patients With Interstitial Lung Disease (ILD) & Connective Tissue Disorders (CTD)
Condition: Interstitial Lung Disease; Connective Tissue Diseases
MeSH terms: Lung Diseases; Lung Diseases, Interstitial; Connective Tissue Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers are trying to find out more about the safety of a new treatment, Allogeneic
      (coming from a healthy donor) Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs) which is
      still experimental, for Interstitial Lung Disease (ILD) associated with Connective Tissue
      Disorder (CTD).
    


Intervention name(s): Allogeneic Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs)
Intervention type(s): Biological
Intervention description(s): Subjects will be treated with regular standard of care plus 0.5-1 million MSC/Kg intravenously.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348(2)
Condition: Hypertension and Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-348(2)
    

Detailed description: 
      An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to
      evaluate the pharmacokinetics and tolerability of CKD-348(2) with coadministration of
      CKD-828, D097 and D337 in healthy adult volunteers
    

Intervention name(s): CKD-348(2); CKD-828, D097, D337
Intervention type(s): Drug; Drug
Intervention description(s): QD, PO; QD, PO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Radiomics Study for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      The goal of this prospective study is to develop MRI-based models representing tumor
      microenvironment in participants with invasive breast cancer.

      The main purpose of this study is to analyze the association of diffusion-, T2-, and dynamic
      contrast-enhanced T1-weighted images of 3T MRI before treatment with the immunohistochemical
      reactivity of tumor microenvironment including the extracellular matrix and immune cells of
      core-needle biopsy specimens For this purpose, investigators extract 16145 radiomic features
      from the intratumoral and peritumoral regions on MRI of participants with invasive breast
      cancer before treatment.
    

Detailed description: 
      The written informed consents for the participation into this prospective study is done in
      participants who are diagnosed with invasive breast cancer before surgery with curative
      intent. After enrollment, breast MRI is done for particpants and diffusion-, T2-, and dynamic
      contrast-enhanced T1-weighted images are extracted from the results of MRI of participants.
      The tumor tissue samples are archived from participants before surgery through core-needle
      biopsy and the immunohistochemistry is done to assess the components of tumor
      microenvironment including intraturmoal and peritumoral components through volume
      histochemical assessment. Radiomic feature selection and prediction model building are
      performed using the least absolute shrinkage and selection operator and linear regression
      analysis, respectively. The investigators apply fivefold cross-validation to prevent
      overfitting, and the performance is evaluated using the area under the receiver operating
      characteristic curve (AUC) and the DeLong test.
    

Intervention name(s): MRI
Intervention type(s): Diagnostic Test
Intervention description(s): MRI based assessment of tumor microenvironment in breast cancer mass
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population should fulfill the following criteria as follows:(a) histologically
        confirmed invasive breast cancer, (b) participant consent, and (c) MRI performed before
        treatment