bioihbjkbjnl/mcl2 huggingface dataset:
Investigating the Role of Brain-derived Neurotrophic Factor (BDNF) Between Pain and Other Neuronal Disease
Condition: Pain
Study type: Observational [Patient Registry]

Summary: 
      Measure the cytokines, transforming or neurotrophic factors in CSF and plasma as the pain
      markers and as a new therapeutic target for pain control.
    

Detailed description: 
      The research protocol was approved by the Institutional Review Board (IRB) for the Protection
      of Human Subjects at National Cheng Kung University Hospital (NCKUH/B-ER-104-070). The study
      procedures were performed according to the rules of IRB and fully explained to the
      participants. Blood and CSF samples were collected and compared the difference in no pain
      group, acute pain group, and chronic pain group.
    

Intervention name(s): pain evaluation
Intervention type(s): Behavioral
Intervention description(s): collect CSF during spinal anesthesia
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients undergo spinal anesthesia
      
Biospecimen description: 
      Whole blood (10 ml) was collected before surgery using venipuncture: the blood was drawn into
      a test tube that contained the anticoagulant ethylenediamine tetraacetic acid (EDTA). Blood
      and CSF samples were ice bathed and then transported to laboratory for biological molecule
      analysis. White blood cells and platelets were also counted before operation as a routinely
      pre-operative check
    
Keywords: pain
Gender Discrimination Against Female Surgeons A Study in a Lower-Middle-Income Country
Condition: Gender Issues
Study type: Observational

Summary: 
      our study explores how GD is perceived and reported by surgeons in Pakistan.
    

Detailed description: 
      Due to an increasing spotlight, gender discrimination (GD) is identified and reported in many
      aspects of surgical training and practice in the developed world 1, 2. In contrast,
      lower-middle-income countries like Pakistan lack awareness and strategies to counteract GD,
      which manifests as a lack of females in leadership and academic positions, and pay
      inequities. GD often occurs insidiously, as a result of complex interplay between societal
      norms, gender stereotypes and learned behaviors. Thus, our study identifies how GD is
      perceived and reported by surgeons in Pakistan.
    

Intervention name(s): no intervention carried out
Intervention type(s): Other
Intervention description(s): no intervention was done
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        all consultants

          -  fellows

          -  instructors

          -  medical officers

          -  residents working in the Department of Surgery
Influences of Multivitamin Supplementation on Health Parameters
Condition: Health Behavior
Study type: Interventional

Summary: 
      In this study the investigator will evaluate whether a liquid multivitamin supplement
      influences blood and vital parameters. Furthermore the investigator will establish the
      effects on life quality, mood and perception of stress and will characterize changes on
      immune system.
    

Detailed description: 
      The double-blind, randomized intervention study is conducted for 12 weeks and includes two
      groups (placebo versus verum) with same number of participants.

      The investigator aims to determine the effects of multivitamin supplement on blood and vital
      parameters which includes blood pressure, pulse, heart rate, variability of heart rate,
      vitamin D, vitamin B12, folic acid, homocysteine, HbA1c. Furthermore the investigator will
      access life quality, mood and perception of stress through the following questionnaire POMS,
      PSS-10, SF12 & SF36. The investigator will evaluate whether the multivitamin supplement
      changes the frequency of diseases like cold which represents the function of the immune
      system.
    

Intervention name(s): multivitamin supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): supplement includes 97 natural extracts; liquids with similar appearance and taste like multivitamin supplement for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and
      may have fewer side effects and improve recovery.

      PURPOSE: This phase II trial is studying different breast-conserving surgery techniques in
      treating women with breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the percentage of histologically healthy margins maintained during resection in
           women with breast cancer.

      Secondary

        -  Evaluate local recurrence at 5 years.

        -  Evaluate aesthetic results.

        -  Evaluate quality of life using the QLQC30 and BR23 questionnaires.

      OUTLINE: This is a multicenter study.

      Patients undergo oncoplastic conservative surgery according to defined modalities across the
      various centers.

      Quality of life is assessed periodically.

      After completion of study treatment, patients are followed every 6 months for 2 years and
      then for at least 3 years.
    

Intervention name(s): quality-of-life assessment; therapeutic conventional surgery
Intervention type(s): Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIC breast cancer; ductal breast carcinoma; invasive ductal breast carcinoma
KN046 in Subjects With Late Stage Esophageal Squamous Cell Carcinoma
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, multi-center, single arm study to evaluate the efficacy, safety and
      tolerability of KN046 in subjects with advanced unresectable or metastatic esophageal
      squamous cell carcinoma (ESCC).

      The study is composed of 3 stages. Stage 1 (Safety run-in period) will enroll approximately 6
      subjects with KN046 3 mg/kg Q2W IV, for at least 4 cycles; thereafter, Scientific Monitoring
      Committee (SMC) will held to review the safety profiling data and decide whether proceed to
      stage 2 (Expansion period). Stage 2 will enroll up to 30 subjects. After completion of the
      enrollment from Stage 2 and all subjects have completed at least two post baseline tumor
      evaluation, an interim analysis will be performed for efficacy evaluation. SMC will
      continuously review the safety and clinical efficacy during the study and at the interim
      analysis and be responsible for the decision of proceeding to Stage 3 (Biomarker enrich
      period).
    


Intervention name(s): KN046
Intervention type(s): Drug
Intervention description(s): Eligible subjects will be enrolled and receive KN046 (3 mg/kg) monotherapy treatment until progressive disease according to RECIST 1.1, unacceptable toxicity, completion of 2 years' KN046 treatment, or withdrawal of informed consent, whichever comes first
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Biodegradable Versus Titanium Nailing in Forearm Shaft Fractures in Children
Condition: Forearm Fracture
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      There are disadvantages in Elastic Stable Intramedullary Nailing (ESIN) of forearm shaft
      fractures, such as soft tissue irritation and the need of implant removal. A new
      mini-invasive technique of intramedullary nailing with biodegradable material (BESIN) has
      been developed. The nails are tapped into the medullary cavity and left in place. The aim of
      this study was to compare BESIN technique with ESIN.

      This is a prospective, randomized, controlled clinical trial including the patients (aged
      5-15 years) who required operative treatment for forearm shaft fractures in two pediatric
      trauma centers, in Finland. The patients were randomized to be treated by BESIN or ESIN.
      Thirteen patients were required for each group, according to power analysis but altogether 35
      were enrolled for potential drop-outs. Biodegradable polylactide-co-glycolide (PLGA) nails
      (ActivaNail ®, Bioretec ltd, Finland) were used in 19 and titanium nails (TEN ®, Synthes ltd,
      USA) in 16 patients. Pain and the range of motion (ROM) of forearm, elbow and wrist were
      primary outcomes. Radiographs and potential complications were analyzed of all and magnetic
      resonance imagines (MRI) of a randomly selected subgroup in BESIN group (N=13).
    


Intervention name(s): PLGA implant, Bioretec ltd. Finland; Titanium elastic stable nail
Intervention type(s): Device; Device
Intervention description(s): The investigational implant is an ultra-high-strength biodegradable intramedullary (IM) nail of poly(lactide-co-glycolide) (PLGA)/tricalcium-phosphate (β-TCP) which was manufactured by Bioretec Ltd. (Hartmaninkatu 2, Tampere, Finland); Elastic stable intramedullary nail to stabilize unstable forearm shaft fractures in children
Other intervention name(s): Biodegradable elastic stable intramedullary nail; elastic stable intramedullary nail
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients were randomised to 2 groups, titanium nailing or biodegradable nailing.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intramedullary nailing; randomised controlled trial; biodegradable; children; forearm shaft fractures
A Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VEL-101
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is primarily designed to assess the safety and tolerability of single doses of
      VEL-101 when administered subcutaneously (via injection into an area under the skin) or
      intravenously (via infusion into a vein). As each new group of participants is enrolled into
      the study, the dose administered to that group may be higher than a previous dose shown to be
      safe in other participants. The study is also designed to determine blood levels of VEL-101
      and some substances produced by the immune system following VEL-101 administration. This
      information can provide insight into how quickly VEL-101 is eliminated from the body and some
      if its effects on the body.
    


Intervention name(s): VEL-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intervention administered via subcutaneous injection or 1-hour intravenous infusion on Day 1; Intervention administered via subcutaneous injection or 1-hour intravenous infusion on Day 1
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
The Correlation Between CITED2 and Collateral Circulation in Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Observational

Summary: 
      Evaluating the collateral circulation of acute ischemic stroke (AIS) mainly depends on the
      imaging examination. At present, there is no effective and sensitive biomarker for collateral
      circulation. Thus, the research objective was to evaluate the predicting role of the
      CBP/P300-interacting transactivator with Glu/Asp-rich C-terminal domain 2 Ratio (CITED2) from
      peripheral blood mononuclear cells in the collateral circulation of AIS. We classified the
      AIS patients into two groups (the good collateral group and the poor collateral group) by
      DWI-ASPECTS score. The western blot was applied to test the protein expression of vascular
      endothelial growth factor (VEGF) and CITED2. Then, we collected other clinical data. Binary
      logistic regression analysis between collateral circulation and clinical data was performed.
      Finally, Receiver operating characteristic (ROC) curve analysis was used to explore the
      predictive value of the CITED2.
    


Intervention name(s): non-applicable
Intervention type(s): Other
Intervention description(s): non-applicable
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients were diagnosed with acute ischemic stroke in the neurology department of our
        hospital from November 2020 to November 2021.
Characterization of Exposure From Topical Administration of [14C] Umeclidinium to Axilla or Palm of Healthy Male Subjects
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the pharmacokinetics (PK), safety and
      tolerability of topically applied umeclidinium following single dose topical administration.
      The results from this study will be used to 1) improve our understanding of the risk of
      systemic accumulation upon chronic administration, 2) support dosing recommendations in a
      2a/2b study for axillary administration and, potentially, a separate combined 2a/2b study for
      palmar administration, and 3) confirm whether the same formulation can be used for axillary
      and palmar application for the next studies.
    


Intervention name(s): [14C]Umeclidinium 18.5 mg
Intervention type(s): Drug
Intervention description(s): Umeclidinium will be supplied as clear, colorless solution, free from visible particulates, single dose, topical solution in clear glass jars. Dosage of 18.5 mg of Umeclidinium per gram is equivalent to 22 mg per gram of the bromide salt.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hyperhidrosis; topical; [14C] radiolabel; palm; GSK573719; axilla; Umeclidinium
A Efficacy and Safety of Duac™Compared With Clindamycin Phosphate Gel in the Treatment of Mild to Moderate Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicentre, randomized, assessor-blind, comparator-controlled evaluation of the
      efficacy, safety, and tolerability of Duac™Once Daily Gel and clindamycin phosphate gel in
      the topical treatment of mild to moderate facial acne vulgaris. A total of 1020 subjects will
      be enrolled, 510 per study arm. The subjects will be males and females between 12 and 45
      years of age, inclusive, at the time of consent, who have mild to moderate facial acne
      vulgaris.

      Subjects will use Duac™Once Daily Gel (once daily in the evening) or clindamycin phosphate
      gel twice daily (once in the morning and once in the evening) for 12 weeks. The subjects will
      be evaluated for change in lesion counts, investigator's static global assessment (ISGA),
      subject's global assessment (SGA), local tolerability and AEs/SAEs at Weeks0, 1, 2, 4, 8, and
      12 (or at early withdrawal). In addition, quality of life measures will be performed at every
      study visit.
    


Intervention name(s): Duac™Once Daily Gel; 1% clindamycin phosphate gel
Intervention type(s): Drug; Drug
Intervention description(s): 1% clindamycin as clindamycin phosphate and 5% benzoyl peroxide; 1% clindamycin as clindamycin phosphate
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Is Augmentation of PORH by Rosuvastatin Adenosine-receptor Mediated?
Condition: Atherosclerosis; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Rationale:

      Statins form a class of drugs that is widely prescribed for hypercholesterolaemia,
      specifically to reduce the risk on atherosclerosis by lowering LDL-cholesterol. Next to the
      effect for which the drug was originally developed, it became obvious that statins have
      several other beneficial effects. Such pleiotropic effects include the activation of
      ecto-5'-nucleotidase which can increase endogenous adenosine production (by dephosphorylation
      adenosine monophosphate into adenosine) and subsequently cause vasodilation. A recent study
      of Meijer et al (not yet published) showed that rosuvastatin significantly augments
      vasodilation after a brief period of ischemia (post occlusive reactive hyperaemia). However,
      it is not yet verified whether this increase in post occlusive reactive hyperaemia is truly
      caused by a rise of extracellular adenosine and subsequent adenosine receptor stimulation. In
      this study, the mechanism by which rosuvastatin augments post occlusive reactive hyperaemia
      will be investigated by blocking adenosine receptors with caffeine, a competitive A1 and A2
      adenosine receptor antagonist. Caffeine is a substance that can be safely used in normal
      concentrations to block the adenosine receptor.

      Hypothesis:

      The augmenting effect of rosuvastatin on PORH is caused by an increase of extracellular
      adenosine formation and this effect can be diminished by blocking the adenosine receptor
      using caffeine.

      Objective:

      To study the influence of caffeine on post occlusive reactive hyperaemia before and after 7
      days treatment with rosuvastatin.

      Study design:

      Open label cross-over design Study population: Healthy volunteers, 18-50 years of age

      Intervention:

      Eight volunteers will receive a 7 day treatment with rosuvastatin 20 mg daily before and
      after rosuvastatin treatment caffeine will be administrated intra-arterially.

      Main study parameters/endpoints:

      Forearm blood flow (FBF) will be measured as an indicator for post occlusive reactive
      hyperaemia (PORH).
    


Intervention name(s): rosuvastatin; caffeine
Intervention type(s): Drug; Drug
Intervention description(s): 7 day treatment with rosuvastatin 1dd 20mg; intra-arterial (brachial artery of non dominant arm) administration of caffeine(90 ug/min/100ml forearm volume)for approximately 60 minutes
Intervention MeSH terms: Caffeine; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of a Motion-Activated Refusal-Skills Training Video Game for Prevention of Substance Use Disorder Relapse
Condition: Relapse; Opioid Use; Marijuana Usage
MeSH terms: Recurrence; Substance-Related Disorders
Study type: Interventional

Summary: 
      The project proposes to continue the development of an intervention for relapse prevention in
      the form of a professional quality video game which rewards drug-rejecting physical motions
      and spoken refusal phrases. Phase I research findings showed that youth in recovery
      experienced increased low craving levels, strong levels of satisfaction, and interest in
      attending treatment sessions where the intervention is available - an important outcome since
      failure to attend treatment is highly correlated with relapse. In Phase II, the investigators
      propose to modify and expand the prototype based on customer feedback from treatment centers,
      counselors and patients. The investigators will test the effectiveness of the motion and
      voice-controlled game in a randomized controlled trial of youths in treatment for opioid use
      disorder who have access to the game for a month. The investigators will measure the effect
      of gameplay on successful completion of detoxification/inpatient treatment and rates of
      linkage to next level of outpatient treatment. The investigators will also measure the effect
      of gameplay compared to treatment as usual (TAU) during a subsequent episode of outpatient
      treatment (following inpatient), on rates of treatment attendance, treatment retention, urine
      drug test results, substance use self-report, treatment alliance, drug craving, and treatment
      satisfaction.
    


Intervention name(s): RecoveryWarrior 2.0
Intervention type(s): Behavioral
Intervention description(s): RecoveryWarrior 2.0 was developed for use with Microsoft Kinect running on a Windows personal computer. All games made use of whole-body motion detection and the same voice-recognition feature. Body motions included a variety of arm, leg, and whole-body movements to physically enact the motions of destroying or evading images of drugs and drug paraphernalia. Voice features consisted of recognition of the refusal phrase "I'm Clean" Players could say or shout "I'm Clean" in order to gain additional strength for their game play avatar. All game art was created in a hyperrealistic, idealized, heroic style.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Pulmonary Perfusion Heterogeneity in Patients With CTEPH Using Functional PET Imaging
Condition: Chronic Thromboembolic Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Observational

Summary: 
      This study with evaluate blood flow in the lungs of patients prior to and after surgery for
      treatment.
    

Detailed description: 
      Specifically, we will evaluate the length-scale or size of blood flow alterations using
      filtering techniques with the objective of identifying the size of blood vessels that are
      obstructed by clot (large vessels versus small vessels).
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Chronic thromboembolic pulmonary hypertension
Evaluation of 1440nm Laser Assisted Selective Photothermolysis for Treatment of Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the Nd:YAG 1440 nm
      wavelength laser for the treatment of primary hyperhidrosis of the axilla.
    


Intervention name(s): Nd:YAG 1440 nm laser
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment