bioihbjkbjnl/mcl2 huggingface dataset:
Matrilysin Expression in Different Stages of Colorectal Tumors
Condition: Colorectal Cancer Stage 0; Colorectal Cancer Stage I; Colorectal Cancer Stage II; Colorectal Cancer Stage III; Colorectal Cancer Stage IV
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Matrix metalloproteinases (MMPs) have been shown to be involved in cancer biology.
      Significant expression of MMP-7 (matrilysin) in colorectal cancer is mainly associated with
      metastatic disease even though it is expressed in most tumor states. Our purpose is to
      analyse MMP-7 in bowel and lymph nodes of different tumor stages and to evaluate its
      expression as a potential biomarker of cancer disease in patients surgically treated for
      benign and malignant colorectal tumors. Tumoral tissue, lymph nodes and serum samples from
      recruited Patients plus serum samples from healthy volunteers are analysed for matrilysin
      expression by histology, immunohistochemistry, ELISA and Western blotting.

      If Matrilysin increases with increasing dysplasia and cancer disease stage in tumor tissue as
      well as in the regional lymph nodes it might be used as a complement in investigating
      suspected locally advanced cancer.
    


Intervention name(s): colonic or colorectal resection
Intervention type(s): Procedure
Intervention description(s): standard laparotomic resection of colon-rectum including right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients affected by colorectal neoplasm admitted to our department of surgery
      
Biospecimen description: 
      normal mucosa, cancer tissue, lymph nodes and serum from cancer patients serum from healty
      volunteers
    
Keywords: matrilysin; MMP-7; colorectal cancer; adenoma; lymph nodes
Hepcidin Levels in Preterm Infants
Condition: Preterm Infants; Anemia of Prematurity; Neonatal Sepsis
MeSH terms: Sepsis; Neonatal Sepsis; Premature Birth
Study type: Observational

Summary: 
      A recently isolated peptide hormone, hepcidin, is thought to be the principal regulator of
      iron homeostasis. Hepcidin acts by limiting intestinal iron absorption and promoting iron
      retention in reticuloendothelial cells. The aims of this study were to determine serum
      hepcidin levels in preterm infants who receive blood transfusion and preterm infants having
      sepsis, in order to assess possible relationships between hepcidin and serum iron, serum
      ferritin,in iron load situations.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm < 38 weeks gestation Need of blood transfusion according to local Protocol. or
        signs and symptoms of sepsis
      
Keywords: Hepcidin; Preterm Infants; Anemia; Sepsis; Ferritin
IM and IV SPL026 Drug Product in Healthy Participants
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical trial is to test SPL026 given via injection into a muscle in
      healthy volunteers.
    

Detailed description: 
      Part A: Crossover IM then IV dosing with SPL026 in psychedelic experienced, healthy
      volunteers.

      PART B: IM dosing only with SPL026 in less experienced/psychedelic naive, healthy volunteers.
    

Intervention name(s): SPL026 IV; SPL026 IM
Intervention type(s): Drug; Drug
Intervention description(s): IV dosing; IM dosing
Other intervention name(s): DMT; DMT
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Is ESWT Better in Plantar Fasciitis Treatment?
Condition: Plantar Fascitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      It was aimed to compare the pain and functional results of ESWT, kinesiotherapy and
      corticosteroid injection in patients with treatment-resistant plantar fasciitis.
    

Detailed description: 
      The groups were randomized in patients with chronic plantar fasciitis who did not benefit
      from conservative treatment. A questionnaire study was conducted at the first visit, sixth
      week, third month, and sixth month. Visual analog scale (VAS) and The American Orthopedic
      Foot and Ankle Society (AOFAS) score were applied as a questionnaire at each control visit of
      the patients.
    

Intervention name(s): extracorporeal Shock wave therapy; Corticosteroid injection; Kinesiotaping
Intervention type(s): Device; Drug; Device
Intervention description(s): Two thousand pulses with a frequency of 6 Hz and a pressure of 3 bar were applied to patients with an Auto Wave 695 (Mettler electronics, USA) brand device. Patients underwent two sessions of ESWT per week, for two weeks, adding up to a total of 4 sessions.; 40mg/1ml methylprednisolone, two sessions once a week; The first strip was adhered along the plantar fascia from the calcaneus to the toes using maximum stretch. The other four strips of tape were attached medially and laterally to support the medial longitudinal arch with a 45° inclination. While maximum stretching was applied to the middle 1/3 of all bands, no stretching was applied to the ends. Once a week, three times
Other intervention name(s): an Auto Wave 695 (Mettler electronics, USA) brand device; methylprednisolone; KinesioTex, KinesioTaping, US
Intervention MeSH terms: Methylprednisolone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ESWT; Kinesiotaping; corticosteroid injection
Study of Bacteria on Mood and Bowel Symptoms in Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome; IBS
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether probiotic bacterium Bifidobacterium longum
      (B. longum) can improve mood and bowel symptoms in patients with Irritable bowel syndrome
      (IBS). The patients will be treated with probiotic or placebo for 6 weeks. Their mood,
      memory, general well-being and bowel symptoms will be assessed before, at the end of the
      treatment and 4 weeks later. Brain activation pattern, changes in gut bacteria, metabolic
      profile and inflammatory markers will be also measured.
    


Intervention name(s): Bifidobacterium longum; Maltodextrin
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Powder containing Bifidobacterium longum in maltodextrin.; Powder containing only maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Treosulfan Pharmacokinetics in Children Undergoing Allogeneic HSCT
Condition: Allogeneic Haematopoietic Stem Cell Transplantation
Study type: Observational

Summary: 
      Every year around 70 children affected by cancer or life-threatening genetic diseases undergo
      haematopoietic cell transplantation (HCT) within the Blood and Marrow Transplant (BMT) unit
      at Great Ormond Street Hospital (GOSH).

      One of the main goals of the BMT unit over the last decade has been to reduce the morbidity
      and mortality related to HCT, and the group has become a world-leader in pioneering less
      toxic transplants.

      Fixed high doses of chemotherapy drugs are generally used to prepare children for HCT but
      several studies have shown a correlation between the concentration of these drugs achieved in
      the patient's blood, and the success or failure of the HCT procedure.

      Recently a new drug, Treosulfan, has become available for use in patients undergoing HCT, and
      GOSH has pioneered its introduction in children undergoing HCT. With promising early results,
      Treosulfan has become the pre-HCT drug of choice, however, very little is currently known
      about how the drug is metabolised and cleared from the body, particularly in children.

      The investigators therefore plan to investigate the pharmacokinetic (PK) profile of
      Treosulfan in children undergoing HCT at GOSH and define which parameters affect its
      metabolism and clearance, and what blood levels are associated with a favourable outcome
      (graft take without toxicity) or a poor result (graft rejection and/or toxicity).
    


Intervention name(s): Treosulfan
Intervention type(s): Drug
Intervention description(s): Treosulfan will be administered over 3 days prior to HSCT at the following dose: 10 g/m2 (children aged < 3months) or 12 g/m2 (children aged 3/12 months) or 14 g/m2 (children aged > 12 months)
Intervention MeSH terms: Treosulfan
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children affected by malignant or non-malignant diseases with an indication to allogeneic
        HSCT.
      
Biospecimen description: 
      Plasma will be stored for Treosulfan PK analysis.
    
Keywords: Treosulfan pharmacokinetics; Children; Any condition that requires an allogeneic HSCT
Pharmacokinetics of Lanraplenib in Adults With Impaired Renal Function
Condition: Inflammatory Disease
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetics (PK) of lanraplenib
      in participants with impaired renal function relative to matched healthy controls.
      Participants in this study will be enrolled using an adaptive design that includes up to 3
      enrolled cohorts. Based on safety and/or PK data in Cohort 1, participants will be enrolled
      in adaptive Cohorts 2 and/or 3.
    


Intervention name(s): Lanraplenib.
Intervention type(s): Drug
Intervention description(s): 20 mg (2 X 10 mg) tablets administered orally in a fasted state on Day 1
Other intervention name(s): GS-9876
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Telehealth System to Improve Quality of Life in Breast Cancer Survivors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Background: Cancer is increasingly viewed as a chronic disease and therefore there is a
      growing need for long-term treatments. Breast cancer survivors suffer physical impairment
      after oncology treatment. This impairment reduces quality of life (QoL) and increases the
      prevalence of conditions associated to unhealthy life-style.

      Objective: The overall objective of e-Cuidate telerehabilitation will be to evaluate short
      and long-term effects telehealth program.

      Methods: Seventy-two breast cancer survivors (age range: 18-65 years) will be recruited
      through oncology and breast units at the Virgen de las Nieves Hospital and San Cecilio
      Hospital and associations of breast cancer patients in Granada. Patients will be randomized
      to receive the online rehabilitation group (n=36) or usual care (control) group (n=36).
      Telerehabilitation group will receive an eight-week online intervention and control group
      receive recommendations about usual care.

      Discussion: The investigators study attempts to increase the level of fitness and reduce
      musculoskeletal disorders in breast cancer patients through a strategy for care based on
      telerehabilitation to promote therapeutic exercise.
    


Intervention name(s): Telerehabilitation group
Intervention type(s): Behavioral
Intervention description(s): Interventions will be based on to provide cardiovascular, mobility, strength and stretching exercises through telerehabilitation system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Telehealth; Fatigue; Breast cancer; Exercise; Quality of life; Telerehabilitation
Efficacy and Safety of Donepezil Hydrochloride (Aricept) in Vascular Dementia
Condition: Vascular Dementia
MeSH terms: Dementia; Dementia, Vascular
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the efficacy and safety of cholinesterase inhibitor
      (donepezil hydrochloride) Aricept in patients with vascular dementia (VaD).
    

Detailed description: 
      Vascular dementia is a significant cause of intellectual and functional impairment in young
      patients consequent to cerebrovascular disease. Post-mortem studies show that VaD patients
      have a cholinergic deficiency like in Alzheimer's disease (AD). Cholinesterase inhibitors are
      now standard treatment for mild to moderate AD. This study aims to determine if donepezil, a
      cholinesterase inhibitor, would benefit patients with VaD by decreasing their scores in the
      VaDAS-cog and improvement in their CIBIC rating over a period of 24-weeks treatment. Adverse
      events will also be monitored.
    

Intervention name(s): donepezil hydrochloride (Aricept)
Intervention type(s): Drug
Intervention description(s): 5 mg donepezil HCl given once a day and increased to 10 mg per day if side effects, when present, are tolerated.
Other intervention name(s): Aricept
Intervention MeSH terms: Donepezil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vascular Dementia
A Study to Assess the Pharmacokinetics of CC-122 in Subjects With Mild, Moderate, and Severe Renal Impairment
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Multi-center, open-label, single-dose study to assess the PK of a single oral dose of 3 mg
      CC-122 in subjects with mild, moderate, and severe renal impairment as compared to sex, age
      (± 15 years), and weight (± 20%) matched control subjects with normal renal function.
    

Detailed description: 
      This will be a multi-center, open-label, single-dose study to assess the PK of a single oral
      dose of 3 mg CC-122 in subjects with mild, moderate, and severe renal impairment as compared
      to sex, age (± 15 years), and weight (± 20%) matched control subjects with normal renal
      function. Estimated renal function for the purpose of group assignment will be determined at
      screening. Matched control subjects will have normal renal function, defined using the
      Cockcroft-Gault (C G) equation, as an estimated creatinine clearance (CLcr) of ≥ 90 mL/min.
      Subjects with impaired renal function will be classified by stage of renal impairment (mild,
      moderate, or severe) using estimated glomerular filtration rate (eGFR), calculated by the
      Modification of Diet in Renal Disease (MDRD) equation. Each group will enroll at least 2
      subjects of each sex

      During the course of the study, each subject will participate in a Screening period (Days -
      21 to -2), Treatment Period (including baseline visit), and a follow-up telephone call
      between Days 11 to 18. Subjects will be screened for eligibility. Eligible subjects will
      return to the clinical site on Day 1 for baseline assessments, and will be domiciled at the
      clinical site from Day 1 to Day 4. PK samples will be collected through 72 hours post dose.
      Safety will be monitored throughout study.

      The study will be conducted in compliance with the International Council on Harmonisation
      (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good
      Clinical Practice (GCP) and applicable regulatory requirements.
    

Intervention name(s): CC-122
Intervention type(s): Drug
Intervention description(s): All subjects will receive one 3 mg CC-122 capsule the morning of Day 1 which will be administered in the fasted state.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal Impairment; Pharmacokinetics; CC-122; Mild; Moderate; Severe
Single-blind RCT Comparing Smartphone vs. Paper-based HEP in Pelvic Floor PT
Condition: Pelvic Floor Muscle Weakness
MeSH terms: Muscle Weakness; Paresis; Asthenia
Study type: Interventional

Summary: 
      The goal of this randomized clinical trial is to investigate the impact of a smartphone-based
      application on patient-reported outcomes for patients with pelvic floor muscle weakness, and
      the relationship of patient adherence to outcomes in pelvic floor physical therapy compared
      to the paper-based standard of care.

      An additional aim is the exploration and development of two patient-reported questionnaires
      to enhance understanding of exercise adherence in outpatient pelvic floor physical therapy
      and smartphone application self-efficacy. These goals will serve to improve practice
      recommendations for home exercise prescriptions in this patient population.

      Participants will be asked to complete 6 patient-reported outcome measures after they
      complete four, 60-minute long physical therapy treatment sessions conducted one time per week
      according to the current standard of care for pelvic floor physical therapy.

      The experimental group will be given a free pelvic floor muscle exercise application while
      the control group will be provided with the paper-based standard of care for their home
      exercise program.
    


Intervention name(s): A smartphone based application free to download from the google play and iphone store to provide auditory and visual cues and counting for number of perscribed pelvic floor muscle contractions; Paper-based home exercise program for pelvic floor muscle exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Use of a smartphone-based home exercise application for pelvic floor muscle exercises with visual and auditory feedback for 10 repetitions of pelvic floor contraction endurance holds and 10 repetitions of pelvic floor quick contractions performed three times per day.; Written instructions on a piece of paper for 10 repetitions of pelvic floor contraction endurance holds and 10 repetitions of pelvic floor quick contractions performed three times per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Smartphone Applications; Home exercise program; Adherence
Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Absorption of inhaled tiotropium is compared between three Tiotropium Easyhaler products and
      Spiriva capsules inhaled via HandiHaler. All subjects will receive all products as a single
      dose.
    


Intervention name(s): Tiotropium Bromide Monohydrate; Tiotropium Bromide Monohydrate; Tiotropium Bromide Monohydrate; Tiotropium Bromide Monohydrate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tiotropium Easyhaler 10 mcg/dose Product A; Tiotropium Easyhaler 10 mcg/dose Product B; Tiotropium Easyhaler 10 mcg/dose Product C; Spiriva 18 Mcg/capsule inhaled via HandiHaler
Intervention MeSH terms: Bromides; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oxidized Regenerated Cellulose to Decrease Vaginal Cuff Complications
Condition: Vaginal Cuff Complications
Study type: Observational

Summary: 
      The goal of the investigators study is to determine whether the use of oxidized regenerated
      cellulose reduces the risk of vaginal cuff cellulitis, pelvic abscess, or vaginal cuff
      dehiscence in patients undergoing laparoscopic hysterectomy. The investigators hypothesize
      that the use of oxidized regenerated cellulose will reduce the risk of vaginal cuff
      cellulitis, pelvic abscess, and vaginal cuff dehiscence in patients undergoing laparoscopic
      hysterectomy.
    

Detailed description: 
      Structured non-woven absorbable hemostat (or oxidized regenerated cellulose) was designed and
      marketed for its hemostatic properties. It is used in our practice to achieve hemostasis at
      the site of the vaginal cuff closure during laparoscopic hysterectomy. While the hemostatic
      properties of oxidized regenerated cellulose are well known and documented, there is newer
      research to suggest that oxidized regenerated cellulose may have antimicrobial activity. One
      In vitro study investigated the antimicrobial activity of oxidized regenerated cellulose
      products against multiple antibiotic resistant microorganisms and found that the
      antimicrobial affect of the oxidized regenerated cellulose products was significantly greater
      than that of the controls. There are a limited number of studies investigating the
      antimicrobial activity of oxidized regenerated cellulose products in vivo (and none in
      gynecologic surgery).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        women, age 20-80, undergoing laparoscopic hysterectomy
Genetic Testing for Type 2 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      In this 6-month randomized, controlled trial, we examined whether providing participants with
      genetic test results and counseling regarding their risk for type 2 diabetes would motivate
      them to improve their health behaviors and lose weight to reduce their diabetes risk. We
      hypothesized that participants who received conventional diabetes counseling plus genetic
      test results and counseling would have at least 6 lb greater weight loss at 3 months than
      participants who received conventional diabetes counseling without genetic test results.
    

Detailed description: 
      In this 6-month randomized, controlled trial, we evaluated the impact of genetic testing for
      type 2 diabetes on psychological, health behavior, and clinical outcomes. Eligibility
      criteria included age 21 to 65 years, overweight or obese (body mass index [BMI] >27 kg/m2),
      and no prior diagnosis of type 2 diabetes. At baseline, participants (N=601) had conventional
      risk factors assessed, including demographics, fasting plasma glucose (FPG), and family
      history. They also provided blood samples for genetic testing of TCF7L2, PPARG, and KCNJ11,
      three genes that confer elevated risk for development of type 2 diabetes. Participants were
      then randomized to receive conventional counseling plus control eye disease counseling
      (CR+EYE) or conventional counseling plus genetic test results (CR+G). Two to four weeks
      following the baseline visit, when the genetic test results were available, participants
      returned for a visit with a genetic counselor. All participants received conventional risk
      counseling based on their lifetime population risk, FPG results, and family history. Next,
      participants were informed of their randomization assignments; CR+EYE participants received
      counseling on eye diseases, whereas CR+G participants received genetic counseling. Then
      perceived risk, affect, self-efficacy, and readiness to change were assessed. All other
      outcomes were also assessed at 3 and 6 months.
    

Intervention name(s): genetic testing for type 2 diabetes; Conventional risk counseling; eye disease counseling
Intervention type(s): Genetic; Behavioral; Behavioral
Intervention description(s): TCF7L2, PPARG, or KCNJ11; Risk based on lifetime risk, fasting plasma glucose results, and family history.; addresses risk for age-related macular degeneration, glaucoma, cataracts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: genetic screening