bioihbjkbjnl/mcl2 huggingface dataset:
Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      This Clinical Trial is being conducted to study an adjunctive treatment for rotator cuff
      repair; bone trephination."Trephination" is a procedure that involves making small
      perforations in the bone that the tendon is repaired to.The rotator cuff is repaired by
      sewing the tendon down to the bone in the shoulder. Trephination is a new technique that is
      used in addition to the standard method of repairing the rotator cuff tendon. The control
      group will undergo the standard repair for rotator cuff tears.

      It is the investigators' hypothesis that healing rates in patients who undergo bone
      trephination will be higher compared with surgery without trephination in arthroscopic
      rotator cuff repair at 24 months post-operatively.
    

Detailed description: 
      Rotator cuff repair carried out with current techniques has shown favourable results in terms
      of pain relief. However the re-tear rates remain high and are associated with significant
      morbidity in terms of functional outcome and shoulder strength. As rotator cuff disease
      becomes ever more prevalent with our aging population, it is imperative to determine if
      healing rates can be improved with autologous stem cell enhancement with pre-surgical
      preparation of the tendon insertion site through trephination. This trial is necessary both
      to provide optimal care of our patients, and to do so in a fiscally responsible fashion.

      The primary outcome measure the re-tear rate as measured by ultrasound at 24 months
      post-operatively.

      The secondary outcome measures are Western Ontario Rotator Cuff Index (WORC), Constant Score,
      and the American Shoulder and Elbow surgeons standardized assessment of shoulder function
      (ASES).
    

Intervention name(s): Bone Trephination; Control
Intervention type(s): Procedure; Procedure
Intervention description(s): For the bone trephination, the wire will be advanced into the insertion site through the cortex and into the metaphyseal bone of proximal humerus.; The control group will undergo standard rotator cuff repair.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cuff repair; arthroscopic; Trephination; Bone; cuff tear
Safety, Tolerability, and Efficacy Study of MB07803 Administered to Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to collect important information regarding the safety,
      tolerability, and efficacy of MB07803 when administered for 28 days in patients with type 2
      diabetes mellitus
    


Intervention name(s): MB07803; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Daily oral administration; Daily oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Low Dose Versus Aggressive Inhibition of the Renin-Angiotensin-Aldosterone (RAS) to Treat Microalbuminuria
Condition: Microalbuminuria
Study type: Interventional

Summary: 
      The objective of the study is to assess the effect of standard versus aggressive inhibition
      of the renin-angiotensin system (RAS)in type 2 diabetic patients with microalbuminuria (MA)
      on; a)progression of microalbuminuria, b)estimated glomerular filtration rate (eGFR),
      c)endothelial dysfunction (measured by post-hyperemia arterial tonometry) and d)the slowing
      of the progression of atherosclerotic disease (measured by carotid intima media thickness
      [CIMT]).
    

Detailed description: 
      Diabetic patients with confirmed MA (50-300 mg albumin per g creatinine) on a morning spot
      urine sample were entered into a one to three month run-in phase before randomization. (50
      mg/g was used as the lower limit to allow room for improvement to reach normal.) Since
      hypertension and uncontrolled hyperglycemia will cause MA, blood pressure (BP) and hemoglobin
      A1c (AIC) levels were reduced to <130/80 mm Hg and <8.0%, respectively, during this period.
      All patients had been on various doses of an angiotensin converting enzyme inhibitor (ACE-I)
      which were reduced to 10 mg benazepril and BP controlled with other classes of
      anti-hypertensive drugs (except for angiotensin receptor blockers [ARB's]). Glycemia was
      treated with intensification of their current therapy. MA and BP were measured monthly.

      When goal levels of BP and AIC were achieved and MA was still present, patients were
      randomized to either low dose RAS inhibition (10 mg benazepril) (Standard) or aggressive
      inhibition of the RAS (Aggressive). MA continued to be measured monthly and the progressive
      increase in doses of an ACE-I and an ARB was as follows. Benazepril (the ACE-I) - 10 mg to 20
      mg to 40 mg to adding losartan (the ARB) -25 mg to 50 mg to 100 mg to increasing benazepril
      to 80 mg with the goal of returning albumin excretion to normal. Other classes of drugs were
      reduced as necessary to keep systolic BP > 100 mm Hg. Serum creatinine and potassium[K+] were
      measured monthly, AIC levels every 3 months and CIMT by ultrasound and endothelial function
      by post hyperemia and nitroglycerine (NTG) - induced peripheral artery tonometry (PAT) via
      finger plethysmography every six months.
    

Intervention name(s): benazepril; benazepril
Intervention type(s): Drug; Drug
Intervention description(s): benazepril 10 mg orally once daily; 40-80 mg benazepril plus 25-100 mg losartan orally once or twice daily
Other intervention name(s): Lotensin; Lotensin; Cozaar
Intervention MeSH terms: Benazepril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Microalbuminuria; Carotid intima media thickness; Endothelial dysfunction; Renin angiotensin system; Diabetic nephropathy
An Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the absorption, metabolism and excretion of [14C]
      PD 0332334 to characterize plasma, fecal and urinary radioactivity and identify any
      metabolites of [14C] PD 0332334.
    


Intervention name(s): PD 0332334
Intervention type(s): Drug
Other intervention name(s): imagabalin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
the Effect of Spray on Propofol Injection Pain
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      While propofol is widely used an anesthetic induction medication, it causes the mild to
      moderate pain. Investigators will investigate the effect of ethyl chloride spray on propofol
      injection pain.
    


Intervention name(s): ethyl chloride spray; lidocaine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): apply the spray for 5 seconds on the dorsal hand before propofol iv injection; apply lidocaine under the tourniquet state before propofol iv injection; apply normal saline before propofol iv injection
Other intervention name(s): spray; normal saline
Intervention MeSH terms: Lidocaine; Ethyl Chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      This study aimed to evaluate the feasibility of dual sentinel node staining method using
      mixture of indocyanine green(ICG) and radioisotope (RI) in breast cancer patients who receive
      neoadjuvant chemotherapy.

      Over the past few years, several studies have found using methylene blue, isosulfan blue,
      indocyanine green or radioisotope alone by detection method had several disadvantages.

      In this study we expects using mixture of indocyanine green (ICG) with radioisotope (RI) has
      potential to improve sentinel lymph node (SLN) mapping in breast cancer patients who receive
      neoadjuvant chemotherapy.
    

Detailed description: 
      -  5 patients who receive neoadjuvant chemotherapy with cN1-cN2 or cT2 on TNM staging

        -  sentinel lymph node biopsy(SLNB) by sentinel lymph node staining method using mixture of
           indocyanine green (ICG) with radioisotope (RI).

        -  indocyanine green (ICG) penetrates human tissue to depths of several millimeters to 2cm,
           and the fluorescence can be detected percutaneously in real time.

        -  using RI only has several disadvantages such as invisibility,interference. RI only
           detect sound or confirm numerical value through gamma probe.

        -  ICG can be visualized with a fluorescence imaging system

        -  confirm Identification rate of sentinal lymph node biopsy, and duration of sentinel
           lymph node biopsy
    

Intervention name(s): sentinel lymph node biopsy(SLNB)
Intervention type(s): Procedure
Intervention description(s): incision will be made over the skin site that had fluorescence lymphatic flow which visualized using fluorescence imaging camera and gamma probe.
double check after removal of the sentinel lymph node
sending frozen biopsy
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Breast cancer patients who receive neoadjuvant chemotherapy
      
Keywords: Neoadjuvant chemotherapy; Indocyanine green (ICG); Radioisotope (RI); Near infrared fluorescence camera
Evaluation of the Relationship Between Neck Pain and Ergonomic Factors in Office Workers
Condition: Disability Physical; Neck Pain; Ergonomic Factors
MeSH terms: Neck Pain
Study type: Observational

Summary: 
      The current study aimed to explore the associations between disability levels and
      occupational risk factors in computer-using office workers with neck pain.
    

Detailed description: 
      This is a cross-sectional study. All participants will provide informed consent before
      participating in the study. The study will be conducted in accordance with the Helsinki
      Declaration criteria. Data will be collected using questionnaires, which include information
      on demographic, clinical, and occupational ergonomic conditions.

      Patients will be divided into 2 groups as mild-moderate and severe disabled according to
      their neck disability index values and will be analyzed statistically.
    

Intervention name(s): A self-administered questionnaire
Intervention type(s): Diagnostic Test
Intervention description(s): A self-administered questionnaire will be used to screen Neck disability index, demographic information and ergonomic risk factors.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        aged between 18 and 55, working on computer, having neck pain at least three months
      
Keywords: neck pain office workers ergonomic factors
GLASSIA Infusion Rate Study
Condition: Alpha1-antitrypsin Deficiency; Healthy Volunteers
MeSH terms: Alpha 1-Antitrypsin Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to generate sufficient safety and tolerability information in
      support of an increase in the infusion rate of intravenous GLASSIA in the prescribing
      information from 0.04 to 0.2 mL/kg/min.
    

Detailed description: 
      To achieve proper masking, 30 participants were randomly assigned to receive either GLASSIA
      at 0.04 mL/kg/min with a simultaneous administration of placebo (2.5% human albumin in normal
      saline) at 0.2 mL/kg/min (Cohort 1) or GLASSIA at 0.2 mL/kg/min with a simultaneous
      administration of placebo at 0.04 mL/kg/min (Cohort 2) on Day 1.

      Two weeks later (Day 15), the same participants received the second infusion with the
      opposite rate of GLASSIA infusion and the corresponding masking placebo infusion.
    

Intervention name(s): Alpha1-proteinase inhibitor; Placebo: Human albumin 2.5%
Intervention type(s): Biological; Biological
Intervention description(s): GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration.; Intravenous administration
Other intervention name(s): GLASSIA
Intervention MeSH terms: Protease Inhibitors; Alpha 1-Antitrypsin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: for this study; volunteers; Focus; Condition:
Assessment of Bronchial Obstruction in Adolescents With HIV
Condition: HIV
Study type: Interventional

Summary: 
      In children, data from the literature find a higher prevalence of asthma in the population
      treated for HIV. Bronchial hyperreactivity, indicative of chronic inflammation and bronchial
      obstruction, is also present.

      Screening for early peripheral obstruction could therefore make it possible to initiate
      appropriate anti-inflammatory treatment, if necessary, and early preventive management.
    

Detailed description: 
      In adults chronically infected with HIV, there is an increased prevalence impaired
      respiratory function, with a greater occurrence of COPD than in the uninfected population. In
      children, data from the literature find a prevalence of greater atopy in the HIV-infected
      pediatric population. Furthermore, a bronchial hyperreactivity or even peripheral bronchial
      obstruction, indicative of a local chronic inflammation has been found in young adolescents
      treated since the birth for HIV infection in utero. Screening for early peripheral
      obstruction in HIV-infected adolescents could therefore make it possible to initiate, if
      necessary, a anti-inflammatory treatment, and early management to prevent the occurrence of
      impaired respiratory function in adulthood For this this single-center prospective study
      chose to perform respiratory function explorations with forced oscillometry with the Endpoint
      main factor of the peripheral obstruction the R5HZ parameter expressed in % predicted.
      Patients from 11 to 25 years to whom it was proposed added to that to answer a questionnaire
      of respiratory quality of life
    

Intervention name(s): pulmonary function tests
Intervention type(s): Diagnostic Test
Intervention description(s): pulmonary function tests
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: antiretrovirals
Serum AMH Levels in Patients Who Underwent Hypogastric Artery Ligation
Condition: AMH
Study type: Observational [Patient Registry]

Summary: 
      To observe the effects of hypogastric artery ligation on serum antimullerian hormone levels.
    

Detailed description: 
      To measure and compare serum antimullerian hormone levels in patients who underwent
      hypogastric artery ligation/ hypogastric artery ligation+ hysterectomy and postpartum
      control. The procedures performed as an emergency life saving method during delivery. The
      reasons for hypogastric artery ligation/ hypogastric artery ligation+ hysterectomy were
      obstetric hemorrhage mainly uterine atony.

      The serum levels of antimullerian hormone were measured 6 months after the operations and
      compared with matching postpartum controls. Serum levels of FSH, LH, PRL and TSH were also
      measured 6 months after the operation. Further, antral follicle count measured along with the
      aforementioned blood tests.
    

Intervention name(s): hypogastric artery ligation
Intervention type(s): Procedure
Intervention description(s): hypogastric artery ligation is the ligation of the internal iliac artery to stop bleeding related to obstetrics obstetric hemorrhage Hysterectomy is the removal of the uterus if bleeding can't stop by hypogastric artery ligation
Other intervention name(s): hysterectomy
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who had hypogastric artery ligation and/or hysterectomy during their delivery.
        Control group is age-matched postpartum patients.
      
Keywords: hypogastric artery; anti-mullerian hormone; ovarian reserve; postpartum
Biomechanical Effects of Duloxetine on Bladder and Sphincter Muscle Function in Women in Pure Genuine Stress Incontinence
Condition: Urinary Stress Incontinence
MeSH terms: Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 2

Summary: 
      Double-blind placebo-controlled study of the biomechanical effects of duloxetine compared
      with placebo in the treatment of women with pure genuine stress incontinence
    


Intervention name(s): duloxetine; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Hormonal Effects on Pain Perception
Condition: Pregnancy; Progesterone Levels; Pregnancy Associated Analgesia
Study type: Observational

Summary: 
      To investigate if labor pain is affected by mother's hormone levels.

      The hormonal effects of pregnancy are well documented. Although differences in pain
      sensitivity between women and men are partly attributable to social conditioning and to
      psychosocial factors, many laboratory studies of humans have described sex differences in
      sensitivity to noxious stimuli, suggesting that biological mechanisms underlie such
      differences. Some animal studies have suggested that sensitivity to pain decreases during
      pregnancy because of the progressive activation of endogenous pain inhibitory systems. This
      effect may be mediated by pregnancy-associated hormones, in particular progesterone.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy term pregnant women
      
Biospecimen description: 
      Plasma for progesterone levels
Safety Study of Bone Marrow Cell Concentrate Prepared Using the Magellan System to Treat Critical Limb Ischemia (CLI)
Condition: Critical Limb Ischemia (CLI); Peripheral Vascular Disease (PVD)
MeSH terms: Vascular Diseases; Chronic Limb-Threatening Ischemia; Peripheral Vascular Diseases; Peripheral Arterial Disease; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of administration of marrow-derived
      autologous hematopoietic stem cells (HSC) concentrate and platelet-rich plasma (PRP) gel for
      the treatment of Critical Limb Ischemia (CLI).
    

Detailed description: 
      Critical limb ischemia (CLI) continues to be an important cause of atherosclerotic morbidity
      and mortality despite conventional therapies. Modulation of angiogenesis is a promising
      alternative to surgical revascularization. Trials of isolated angiogenic growth factor
      therapies using recombinant proteins or gene transfer have been conducted, but with
      disappointing results because it is unlikely that a single angiogenic factor is solely or
      even primarily responsible for angiogenesis. Emerging stem cell therapies represent a new
      approach to the modulation of angiogenesis. Pluripotent hematopoietic stem cells (HSC) hold
      promise because they can reproduce a pro-angiogenic milieu in the ischemic limb rather than
      upregulate a single angiogenic factor.

      For this CLI study, the Magellan® System is utilized for the preparation of autologous cell
      concentrate at the point of care. The bone marrow aspirate is obtained from the patient and
      concentrated with the cell concentration kit, and delivered intramuscularly to the affected
      limb for the treatment of impaired ischemic tissue in order to improve perfusion, reduce pain
      and revascularize tissues in patients who have inadequate tissue blood flow, prohibitive
      medical comorbidities, or failed previous treatments for revascularization for the prevention
      of amputation.
    

Intervention name(s): Magellan®
Intervention type(s): Device
Intervention description(s): Autologous Bone Marrow Cell Concentrate Prepared Using the Magellan System to be injected into the ischemic muscle tissue at 0.5 cc/injection for a total of 12-20 cc.
Other intervention name(s): autologous cell concentrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Critical limb ischemia; Peripheral vascular disease; platelet-rich plasma
A Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-03882845 In Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of PF-03882845 in Healthy Volunteers. To evaluate the
      pharmacokinetics of PF-03882845 in Healthy Volunteers. To evaluate the pharmacodynamics of
      PF-03882845 in Healthy Volunteers.
    


Intervention name(s): PF-03882845 or Placebo; PF-03882845 or Placebo; PF-03882845 or Placebo; PF-03882845 or Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PF-03882845 20 mg or Placebo, daily for 10 days.; PF-03882845 60 mg or Placebo, daily for 10 days.; PF-03882845 120 mg or Placebo, daily for 10 days.; PF-03882845 185 mg or Placebo, daily for 10 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Ultrasound-Guided Stellate Ganglion Block With Botulinum
Condition: Change From Baseline House-Brackmann
MeSH terms: Ganglion Cysts
Study type: Interventional

Summary: 
      the local stellate ganglion block with bupivacaine and corticosteroid treatment for acute
      peripheral facial nerve palsy in patients can induce hyperglycemia, and an alternative local
      therapy may be necessary and some time may ve ineffective. Our purpose in this study is to
      evaluate therapeutic effects of stellate ganglion block (SGB) Botulinum Toxin on referactory
      facial nerve palsy
    

Detailed description: 
      :Idiopathic facial nerve palsy (Bell's palsy) is caused by damage to the facial nerve at any
      site of the peripheral branches after the facial nucleus.Stellate ganglion block is inteneded
      to increase blood flow and promotes nerve regeneration. the local stellate ganglion block
      with bupivacaine and corticosteroid treatment for acute peripheral facial nerve palsy in
      patients can induce hyperglycemia, and an alternative local therapy may be necessary and some
      time may ve ineffective. Our purpose in this study is to evaluate therapeutic effects of
      stellate ganglion block (SGB) Botulinum Toxin on referactory facial nerve palsy
    

Intervention name(s): Botox; triamcinolonacetonide
Intervention type(s): Drug; Drug
Intervention description(s): injected 10 mL of 0.1% bupivacaine with 100 Botox units (BOTOX®, Allergan Inc., Irvine, CA, USA); triamcinolonacetonide stellate ganglion injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment