bioihbjkbjnl/mcl2 huggingface dataset:
Local Application of Combined Optical and Magnetic Stimulation (COMS) for Treatment of Chronic Wounds: Safety Evaluation
Condition: Leg Ulcers Venous; Leg Ulcer Arterial; Leg Ulcer Mixed
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Study type: Interventional

Summary: 
      The demographic shift and the increasing prevalence of chronic wounds represent major
      challenges for modern health care systems. Classic chronic wounds (venous ulcer, arterial
      ulcer, mixed ulcer) persist for months or years with a very slow or even no healing progress.
      Patients suffer from pain and immobility, which dramatically reduces their quality of life.
      Complications such as infections or tissue necrosis can lead to a bad outcome and amputation
      of extremities.

      The Pio device offers a non-invasive and non-toxic therapeutic approach. The system combines
      the technologies of pulse modulated magnetic fields and light emission locally applied to the
      wound area. The investigational medical device represents a promising combinational
      therapeutic approach to synergistically increase the tissues regenerative potential. By
      stimulating electrophysiological processes at the site of injury, the cells regain its
      capacity to efficiently regenerate the injured or diseased tissue. It is expected that the
      patient benefits from a faster healing process, reduced inflammation as well as an improved
      overall treatment outcome.
    


Intervention name(s): Pio Medical Device
Intervention type(s): Device
Intervention description(s): The Pio device combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Description of Tolerability of LCZ696 (Sacubitril / Valsartan) in Heart Failure With Reduced Ejection Fraction (HFrEF) Treated in Real Life Setting
Condition: Hearth Failure With Reduced Ejection Fraction (HFrEF)
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of the study was to describe the tolerability of treatment with the
      optimal dose of LCZ696 (97 mg sacubitril / 103 mg valsartan bid), over six (6) months, in
      patients with heart failure with reduced ejection fraction (HFrEF) in Canada.

      The study was also to describe the overall tolerability, effectiveness and safety of LCZ696
      for the management of HFrEF over 12 months of treatment, as well as describe the patterns of
      LCZ696 up and down dose titrations occurring during the management of patients with HFrEF.
    


Intervention name(s): LCZ696 (sacubitril/valsartan)
Intervention type(s): Drug
Intervention description(s): All patients were treated with the LCZ696 (sacubitril and valsartan) tablets
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: HFrEF,; ACEi,; ACE inhibitor,; ARBs,; systolic heart failure,; chronic heart failure,; CHF,; reduced EF,; Ejection Fraction
Computerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to determine whether the Cogstate testing battery can detect improvements in
      cognitive function in participants with mild AD. The primary hypothesis is that for one of
      the Cogstate battery tests, One Card Learning (OCL), the standard deviation associated with
      the change from baseline in OCL measurements after 12 weeks of donepezil and placebo
      treatments is =<0.1
    


Intervention name(s): Placebo; Donepezil; Donepezil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo for donepezil hydrochloride capsule; 5 mg donepezil hydrochloride capsule.; 10 mg donepezil hydrochloride capsule.
Other intervention name(s): Aricept; Aricept
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Prospective Study of TW in the Treatment of LN Type V With Gross Proteinuria
Condition: Lupus Nephritis; Proteinuria; CTX
MeSH terms: Nephritis; Lupus Nephritis; Proteinuria
Study type: Interventional

Summary: 
      The purpose of this study is to analyze the clinical effects and adverse reactions of
      tripterygium glycosides (TW) and CTX in LN-V patients with gross proteinuria.
    

Detailed description: 
      Compared with cyclophosphamide(CTX), to analyze the clinical effects and adverse reactions of
      tripterygium glycosides (TW) in LN-V patients with gross proteinuria.
    

Intervention name(s): tripterygium glycosides
Intervention type(s): Drug
Intervention description(s): The onset dosage should be 30mg/q.d. and can be reduced into 20mg b.i.d if CR obtained in 3 months. Without CR in 3 months, the dosage of 90mg/d will last for another 3 months and then reduced to 60mg/d.
Other intervention name(s): TW
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain
Condition: Lumbosacral Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional
Phase: Phase 2

Summary: 
      Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain
    

Detailed description: 
      A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy
      and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain
    

Intervention name(s): ETX-018810; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study Drug; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo Controlled
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Prevalence of Geophagy and Knowledge About Its Health Effects Among Native Sub-Saharan Africa, Caribbean and South America Healthy Adults Living in France
Condition: Geophagia
MeSH terms: Pica
Study type: Observational

Summary: 
      Since geophagy is widespread among women from Sub-Saharan Africa, South America and the
      Caribbean, we aimed to determine the frequency of geophagy and the level of knowledge about
      its health effects among healthy adults originating from these countries and attending a
      travel medicine and international vaccination consultation in France.
    

Detailed description: 
      Since geophagy is widespread among women from Sub-Saharan Africa, South America and the
      Caribbean, we aimed to determine the frequency of geophagy and the level of knowledge about
      its health effects among healthy adults originating from these countries and attending a
      travel medicine and international vaccination consultation in France.

      A cross-sectional study was performed in the consultation for travel medicine and
      international vaccination in Reims University Hospital, France. All adult travellers who were
      natives of Sub Saharan Africa, South America and the Caribbean or born in France of parents
      from these countries were eligible to complete a confidential questionnaire about geophagy,
      which was defined as eating soil or clay. Descriptive analysis was performed.
    

Intervention name(s): Questionnaire about geophagia (knowledge about soil/clay consumption and knowledge of the health effects of geophagy)
Intervention type(s): Other
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults originating from Sub-Saharan Africa, South America and the Caribbean and
        attending a travel medicine and international vaccination consultation in France.
      
Keywords: geophagia
Surufatinib Hepatic Impairment Study
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, multicenter, single-dose, single-period, sequential study to determine the
      effect of hepatic impairment on the PK of surufatinib.
    

Detailed description: 
      This is a phase 1, open-label, multicenter, single-dose, single-period, sequential study with
      the primary objective of determining the effect of moderate and mild hepatic impairment on
      the PK of surufatinib. The secondary objective is to evaluate the safety in subjects with
      moderate and mild (if enrolled) hepatic impairment and subjects with normal hepatic function.
    

Intervention name(s): Surufatinib; Surufatinib
Intervention type(s): Drug; Drug
Intervention description(s): Subjects to receive Surufatinib 250 mg on Day 1; Subjects to receive Surufatinib 250 mg on Day 1
Other intervention name(s): HMPL-012; HMPL-012
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Alternate Dosing Strategies for Beta-hydroxy-beta-methylbutyrate (HMB) Supplementation: Effect on Plasma HMB Responses
Condition: Focus of the Study is to Examine Plasma HMB Levels After Oral HMB Supplementation
Study type: Interventional

Summary: 
      The purpose of this study is to examine the rise in plasma Beta-hydroxy-beta-methylbutyrate
      (HMB) after the dietary supplement has been administered in different forms. Prior studies
      have indicated that form of administration affects bioavailability of the HMB supplement.
      Therefore the current study will examine the bioavailability of a single dose of HMB given
      as:

        -  1.0g CaHMB in gelatin capsule

        -  0.8 g HMB free acid in a gelcap

        -  0.8 g HMB free acid in water

        -  1.0 g CaHMB in water

        -  0.8 g HMB free acid

      The randomized study will be a crossover design and each study subject will undergo the
      experimental protocol for each of the supplementation forms. Because of the different
      administration forms, the study will be an open label study. Briefly, the fasted participants
      will report to the laboratory in the morning. After an initial blood sample is taken, the
      dose of HMB will be administered. Blood will then be samples at 2, 5, 10, 15, 25, 35, 45, 60,
      90, 120, 180, 360, 720, and 1440 min post administration. A 24 h complete urine collection
      will also be performed. Participants will be given a light sack lunch 4 h after
      administration of the dosage and will remain at the laboratory through the 360 min sampling.
      Participants will then be allowed to leave the laboratory and return for the 720 min sampling
      after which the participants can eat an normal evening meal. Participants will return to the
      laboratory fasted the next morning for the final sample. A minimum 48 h washout period will
      be required before the next dosage form is administered and the process repeated.
    


Intervention name(s): CaHMB capsule; HMB free acid gelcap; HMB free acid mixed in water; CaHMB in water; HMB free acid
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1.0 gram of CaHMB powder in a gelatin capsule; 0.8 g HMB free acid is a soft gel capsule; 0.8 g HMB free acid in water; 1.0 g CaHMB powder mixed in water; 0.8 g HMB free acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: CaHMB; HMB free acid; HMB
DU and BOO in Women With and Without Symptoms of VD
Condition: Detrusor Underactivity; Bladder Outlet Obstruction
MeSH terms: Hypokinesia; Urinary Bladder Neck Obstruction; Urinary Bladder, Underactive
Study type: Observational

Summary: 
      Women with symptoms of voiding dysfunction may be associated with detrusor underactivity or
      bladder outlet obstruction. However, the prevalence of detrusor underactivity and bladder
      outlet obstruction remained obscure. Thus, the aim of this study was to elucidate the
      prevalence of detrusor underactivity and bladder outlet obstruction in women with and without
      symptoms of voiding dysfunction.
    

Detailed description: 
      Between February 2005 and December 2020, all women with lower urinary tract symptoms but
      without cystocele who visited the urogynecological department of a medical center for
      urodynamic evaluation were reviewed. Those women who have no complete data of maximum flow
      rate, voided volume, post-void residual volume and detrusor pressure at maximum flow rate
      were excluded from this study. Detrusor underactivity was defined when the detrusor pressure
      at maximum flow rate was less than 20 cmH2O, the maximum flow rate was less than 15 mL/s, and
      the bladder voiding efficiency was less than 90 %. Bladder outlet obstruction was defined
      when the the detrusor pressure at maximum flow rate was not less than 40 cmH2O, and the
      maximum flow rate was less than 12 mL/s. Those women without detrusor interactivity or
      bladder outlet obstruction were allocated to the non-DU/BOO group.

      STATA software was used for statistical analysis. Chi2 test, univariate and multivariable
      logistic regression test were used for statistical analysis as appropriate. A p < 0.05 was
      considered as statistically significant.
    

Intervention name(s): Urodynamic study
Intervention type(s): Diagnostic Test
Intervention description(s): The urodynamic assessment, including noninstrumented uroflowmetry, filling cystometry with 35°C distilled water at a rate of 60 mL/sec, a pressure flow study, and urethral pressure profilometry, was performed with the patient in a sitting position according to the recommendations by the International Continence Society.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        women with lower urinary tract symptoms but without cystocele who visited the
        urogynecological department of a medical center for urodynamic evaluation
      
Keywords: detrusor underactivity; bladder outlet obstruction; voiding dysfunction
Efficacy, Safety, and Pharmacokinetics of QAW039
Condition: Persistent Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free
      patients with mild to moderate persistent asthma.
    


Intervention name(s): QAW039 capsules once daily for 28 days; Placebo to QAW039 capsules once daily for 28 days; Fluticasone propionate inhaler twice daily for 28 days
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Fluticasone; Xhance; Indoleacetic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma
Association of Physical Activity Levels and Inflammatory Markers Following Pulmonary Rehabilitation
Condition: COPD
Study type: Observational

Summary: 
      COPD is characterised by irreversible airflow limitation that is usually progressive and
      associated with an enhanced chronic inflammatory response. This inflammation can be amplified
      with flare-ups that are commonly seen in COPD patients. Pulmonary rehabilitation is one of
      the most effective methods of managing chronic obstructive pulmonary disease (COPD).
      Pulmonary rehabilitation has been seen to induce improvements in functional capacity and
      quality.

      In healthy individuals, exercise has been shown to induce an anti-inflammatory response when
      performed regularly. However, the effects of exercise on inflammation in COPD are unclear.
      Our initial CIMPRES-COPD study has looked into the effects of short-term exercise, as part of
      pulmonary rehabilitation, on inflammation. However, this trial will examine the inflammatory
      response in COPD patients who are most active following pulmonary rehabilitation against
      those who are least active.

      This study will split participants into 2 groups according to physical activity level
      following pulmonary rehabilitation. We will recruit 40 COPD patients who provided a sample in
      the initial CIMPRES-COPD study to explore inflammatory responses in those who are most active
      and least active. By better understanding the mechanisms of how long-term physical activity
      levels affects inflammation in COPD, we could design better interventions to increase
      physical activity levels following pulmonary rehabilitation.
    


Intervention name(s): Physical activity monitoring
Intervention type(s): Other
Intervention description(s): COPD patients will wear an accelerometer and complete questionnaires related to daily physical activity levels for 7 days before returning for a clinic visit.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COPD patients who have enrolled on pulmonary rehabilitation and took part in the initial
        CIMPRES-COPD study.
      
Biospecimen description: 
      Whole blood samples will be used on the day of collection and analysed before being
      appropriately disposed of on the same day. Blood samples will be centrifuged with separated
      acellular plasma to be frozen at -80c for later analysis of cellular content.
    
Keywords: Pulmonary Rehabilitation; Neutrophils
The Value of Diagnosis and Outcome Prediction in CTC for Metastatic NPC Patients
Condition: Nasopharyngeal Neoplasms
MeSH terms: Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms
Study type: Observational

Summary: 
      A circulating tumor cell (CTC) count is an established prognostic factor in some malignancies
      such as metastatic breast cancer. However, the value of CTC in diagnosis and outcome
      prediction of metastatic nasopharyngeal carcinoma (mNPC) patients is not unknown. Through the
      observational prospective clinical trial, sensitivity, specificity, positive and negative
      predictive values of CTC in diagnosis of mNPC patients will be gained. Further, the value of
      CTC in outcome prediction of mNPC patients will be uncovered.
    


Intervention name(s): the number of circulating tumor cells
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        NPC patients with distant metastasis
      
Biospecimen description: 
      The blood after separation and purification along with or without CTC.
    
Keywords: nasopharyngeal carcinoma; distant metastasis; circulating tumor cells; outcome prediction
A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients
Condition: Liver Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release
      tacrolimus with Myfortic® in de novo liver transplant recipients.
    


Intervention name(s): Prograf; Advagraf; Myfortic
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral; oral; oral
Other intervention name(s): Tacrolimus; FK506; Extended release tacrolimus; FK506E; MR4; Mycophenolate sodium
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prograf; Advagraf; Myfortic
Study of OPA-15406 Ointment in Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of OPA-15406 ointment in
      patients with atopic dermatitis.
    


Intervention name(s): OPA-15406; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.; Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Heat Stress in Wheelchair Sports
Condition: Heat Stress; Body Temperature Changes
MeSH terms: Body Temperature Changes; Heat Stress Disorders
Study type: Observational

Summary: 
      The aim of the study is to study the thermoregulatory responses under real life conditions,
      such as during wheelchair rugby and basketball matches. A further goal is to develop and
      validate a standardised field-based protocol, which induces the same thermoregulatory
      response as during a wheelchair rugby and basketball match. This knowledge allows to
      investigate strategies to reduce heat stress and to enhance exercise performance (e.g.
      pre-cooling) in the future, based on standardised conditions.
    

Detailed description: 
      A spinal cord injury leads to several physiological changes and complications, which might
      influence exercise performance (Perret and Abel, 2016). One major problem is the limited
      thermoregulation, especially in subjects suffering from a tetraplegia (Griggs et al., 2015;
      Price et al., 2006). There are only few studies, which investigated the thermoregulatory
      response during real life conditions in wheelchair athletes such as during a wheelchair rugby
      match (Griggs et al., 2017). However, to implement strategies to reduce heat stress (e.g.
      precooling methods) or to determine the influence of heat stress on exercise performance and
      to determine the effects of specific interventions the following two issues seem to be a
      prerequisite: First of all, we need to understand, which thermoregulatory response is induced
      under real life conditions, e.g. by a wheelchair rugby or basketball match. Second, if we
      want to study the effects of potential interventions, a standardised and reliable study
      protocol has to be available, which closely mimics match conditions and induces a similar
      amount of heat stress. Thus, the aim of the study is to measure thermoregulatory and physical
      performance outcomes during a real life wheelchair rugby and basketball match. A further goal
      is to develop and validate a standardised field-based protocol, which induces a similar
      thermoregulatory response as during a wheelchair rugby or basketball match. These knowledge
      builds the basis for future thermoregulatory studies based on a reliable and standardised
      field-based testing protocol.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        well trained spinal cord injured wheelchair rugby and basketball players