bioihbjkbjnl/mcl2 huggingface dataset:
Tolerability of Suprascapular and Median Nerve Blocks for the Treatment of Shoulder-hand Syndrome
Condition: Shoulder Hand Syndrome; Complex Regional Pain Syndromes
MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome
Intervention: Suprascapular and median nerve blocks
Intervention description: Ultrasound guided injection of the median and suprascapular nerve of the affected side.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Intervention model description: Open label preliminary study testing the tolerability of the procedure.
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Suprascapular nerve block; Median nerve block; CRPS; Shoulder hand syndrome

Summary:

      Shoulder-hand syndrome (SHS) in stroke patients is painful and lowers quality of life.
      Unfortunately, the cause of SHS is not known, diagnosing SHS can be difficult, and treating
      it can be hard. Recent research has shown that certain nerve blocks are good for treating
      shoulder pain for stroke patients, but no one has looked specifically as SHS. Investigators
      think that specific nerve blocks involving a shoulder nerve (the suprascapular, or SSc nerve)
      and a hand nerve (the median nerve) will be helpful in reducing SHS pain. Investigators will
      use ultrasound guidance to accurately inject these nerves. These injections have never been
      described for SHS patients however, so investigators want to make sure people with SHS can go
      through with the injections without too much pain or discomfort. That is, the investigators
      want to test the tolerance of these injections for people with SHS. Investigators are also
      hoping to better understand how consistent a set of diagnostic criteria, called the Budapest
      criteria, are at diagnosing SHS in order to be able to accurately diagnose this condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects are required to be 18 years of age or older and have a presumptive diagnosis
             of SHS post-stroke with a minimum visual analog scale of 40mm (greater than 40mm is
             considered moderate pain).

        Exclusion Criteria:

          -  Subjects will be excluded from the study if they have significant cognitive impairment
             (mini-mental state examination <23) and language deficits (difficulty cooperating due
             to aphasia) as this may affect their response to the outcome measures. Subjects with
             uncontrolled hypertension (>180/110), septicemia, and brachial plexus injuries will be
             excluded. Patients who are blind and deaf will also be excluded, as they will be
             unable to adequately complete the post-procedure survey and VAS. Patients on
             anticoagulation medications will also be excluded on a case-by-case basis and
             medications will be held prior to injection if required for safety. Patients with INR
             >1.5 will be excluded.
Spironolactone After Liver Transplant
Condition: Transplant, Liver
Intervention: Spironolactone
Intervention description: spironolactone 25 mg up to 50 mg
Intervention MeSH terms: Spironolactone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To study spironolactone to prevent calcineurin inhibitor (CNI) kidney injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  liver transplant

        Exclusion Criteria:

          -  dual organ transplant
Valproate Versus Ketorolac Versus Metoclopramide
Condition: Acute Migraine
MeSH terms: Migraine Disorders
Intervention: Metoclopramide; Ketorolac; Valproate
Intervention description: 10mg IVSS; 30g IVSS; 1gm IVSS
Intervention MeSH terms: Ketorolac; Valproic Acid; Metoclopramide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 330.0
Sex: All
Minimum age: 21 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: migraine; emergency; metoclopramide; ketorolac; valproate

Summary:

      This randomized study is testing 3 different intravenous medications to see which one is best
      for acute migraine. The three medications are metoclopramide, valproate, and ketorolac.
    

Eligibility criteria:

        Inclusion Criteria:

          -  IHS migraine without aura

          -  IHS probable migraine (all migraine without arua criteria must be met except duration
             may be >72 hours or <4 hours)

        Exclusion Criteria:

          -  Allergy or contra-indication to investigational medication
An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Severe Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: TTS-fentanyl
Intervention description: TTS-fentanyl patches releasing drug at the rate of 12.5 microgram (µg) per hour for 3 days. The patches will be replaced every 3 days until 30 days.
Intervention MeSH terms: Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Low Back Pain; TTS-fentanyl; Durogesic

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic
      System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so
      the drug will enter the body through the skin) in severe (very serious, life threatening)
      chronic (lasting a long time) low back pain in Thai participants.
    

Eligibility criteria:

        Inclusion Criteria: -Chronic low back pain with moderate to severe pain at least 3 months
        -Participants needed to be treated with strong opioid and haven't been treated with strong
        opioid in the past -Participants who still had moderate to severe pain (Visual Analog Scale
        [VAS] >= 4), which was not adequately controlled by weak opioids such as tramadol or
        codeine at optimal doses (at least 120 milligram [mg] per day for tramadol or 200 mg per
        day for codeine) for at least 7 consecutive days

        -Participants who failed from other treatments such as operation or lack of efficacy of
        current treatment -Participant who has signed the informed consent form Exclusion Criteria:
        -Skin disease that prevent the use of the transdermal system or which could affect the
        absorption of fentanyl or local tolerability -History or suspicion of alcohol or drug abuse
        within the past 5 years -History of cardiac, nervous system or respiratory disease which in
        the investigator's judgment precludes participation in the study because of the potential
        for respiratory depression -Concomitant use of Non Steroidal Anti-Inflammatory Drugs
        (NSAIDs), Cyclooxygenase - 2 (COX-2), muscle relaxant, topical analgesic during the
        previous week (unless on stable drug dose for at least 1 month before study entry)
        -Pregnancy or breast-feeding female; female participants of childbearing potential without
        adequate contraception
Comparison of Two Lidocaine Administration Techniques
Condition: Pain
Intervention: lidocaine; lidocaine
Intervention description: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection; 1% lidocaine subcutaneous injection alone
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 481.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: procedural

Summary:

      The objective of our study is to determine if technique of lidocaine administration can
      decrease pain perception.

      Hypothesis: There will be a significant difference in pain perception between patients who
      are given lidocaine on the skin surface prior to subcutaneous injection and patients who are
      given only subcutaneous injection by standard approach.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients refered to the University of Chicago Medical Centers Procedure Service
             for a planned medical procedure requiring local injection of lidocaine.

        Exclusion Criteria:

          -  Patient who lack decisional capacity to consent

          -  Patients who lack the ability to answer questions in english using pain scales
Pain Control In First Trimester Medical Abortion: A Randomized Trial
Condition: Pain
Intervention: Ibuprofen
Intervention description: Ibuprofen
Intervention MeSH terms: Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 250.0
Sex: Female
Healthy volunteers: No
Keywords: pain; medical abortion

Summary:

      This trial will compare two oral analgesic regimens in women undergoing first trimester
      medical abortion with mifepristone and misoprostol. The primary study outcome is pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women with a gestational age of 63 days or less

          -  Desire a medical abortion with mifepristone and misoprostol

        Exclusion Criteria:

        - Have contraindications to ibuprofen
Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain
Condition: Ankle Sprain
MeSH terms: Acute Pain; Sprains and Strains; Ankle Injuries
Intervention: Non-selective NSAIDS; Celecoxib
Intervention description: Non-selective NSAIDs administered at usual (standard) doses.; celecoxib with an initial loading dose of 400 mg followed by 200 mg twice daily (BID) for up to 7 days.
Intervention MeSH terms: Celecoxib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 278.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankle sprain, acute pain, NSAID, celecoxib,

Summary:

      To assess the efficacy of celecoxib loading dose of 400mg followed by 200 mg twice a day
      (BID) versus oral non-selective NSAIDs in acute pain due to ankle sprain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with first acute ankle sprain episode in the last six months classified as
             grade I or II, confirmed by X-rays, according to the following definitions:

          -  Grade I: When the ligament is stretched but not torn and the anterior talofibular
             ligament is usually involved. The anterior draw test is negative.

          -  Grade II: Moderate sprains which usually result in partial tears af the ligaments,
             primarily the anterior talofibular and possibly the calcaneofibular ligament.
             Ligamentous laxity may be present and there is moderate swelling.

        Exclusion Criteria:

          -  Patients who have a similar injury of the same joint within the last six months; or

          -  clinical evidence of complete rupture of ankle ligaments (third degree sprain), or

          -  requirements for bed rest, hospitalization, surgical intervention for the ankle
             injury; or

          -  evidence of fractures; or non-removable full cast of any tipe; or

          -  presence of bilateral occurrence of ankle injury or ipsilateral ankle and knee injury.
Pre-emptive Analgesics in Orthodontic Treatment
Condition: NSAID; Pain Management
Intervention: Acetaminophen; Ibuprofen
Intervention description: Acetaminophen gel capsule; Ibuprofen gel capsule
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients of the University of Washington Graduate Orthodontics Clinic
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The medications were prepared by the Kelley-Ross Compounding Group (Seattle, WA) and were identical in appearance. The bottles were labeled as "A", "B", or "C" and the identity of the medications were not revealed until after the data analysis was completed.
Enrollment: 73.0
Sex: All
Minimum age: 12 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pre-emptive analgesics; Acetaminophen; Ibuprofen

Summary:

      This study is designed to determine if the preemptive use of a combination of acetaminophen
      and ibuprofen is more effective in reducing pain following orthodontic tooth movement when
      compared to the use of acetaminophen and ibuprofen alone.
    

Eligibility criteria:

        Inclusion Criteria:

        -Orthodontic patient presenting for orthodontic treatment

        Exclusion Criteria:

          -  History of taking an analgesic in the past six hours

          -  Hypersensitivity to ibuprofen or acetaminophen

          -  Aspirin-sensitive asthma

          -  Renal or liver impairment

          -  History of GI bleeding or ulcers

          -  Cardiovascular disease, recent myocardial infarction, heart failure, or coronary
             artery bypass graft surgery

          -  Currently taking antibiotics or other medications for a chronic systemic disease

          -  Bleeding disorder

          -  Pregnant or nursing
A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls
Condition: Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Intervention: Valganciclovir
Intervention description: Participants will receive valganciclovir 900 milligrams (mg) orally once daily for up to a maximum of 200 days post-transplant.
Intervention MeSH terms: Valganciclovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Masking: None (Open Label)
Enrollment: 59.0
Sex: Male
Minimum age: 20 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This observational study will compare spermatogenesis in male adult renal transplant
      recipients receiving valganciclovir versus untreated matched controls. Data will be collected
      from each participant for up to 52 weeks post transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  First renal transplant

          -  Participant eligible to receive valganciclovir prophylaxis as determined by the
             treating physician in accordance with the local approved product prescribing
             information (Cohort A only) or the participant is not expected to require any
             valganciclovir prophylaxis (Cohort B only) post-transplant

          -  Participant has no history of known infertility

          -  Participant is able and willing to provide semen samples

          -  Participant agrees to utilize a barrier contraceptive throughout the study or for at
             least 90 days after cessation of valganciclovir treatment

        Exclusion Criteria:

          -  Prior ganciclovir or valganciclovir within 3 months of enrollment

          -  Organ transplant other than kidney

          -  Participant has received an investigational new drug in the 3 months prior to
             transplant

          -  Participant hs received an alkylating agent or other medications known to affect
             fertility/spermatogenesis

          -  Participant is unlikely to be available for follow-up for the entire duration of the
             study (up to 52 weeks)
The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients
Condition: BPH
MeSH terms: Urinary Bladder Neck Obstruction
Intervention: Alfuzosin; Alfuzosin; Alfuzosin; Alfuzosin
Intervention description: 10mg, once daily, 12months; 10mg, once daily, 12months; 10mg, once daily, 12months; 10mg, once daily, 12months
Intervention MeSH terms: Alfuzosin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 232.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No
Keywords: LUTS; BPH; bladder outlet obstruction; bladder contractility

Summary:

      Benign prostatic hyperplasia (BPH) is a common condition among older men. The efficacy of
      α1-blockers for treating BPH has been well documented and they are recommended for the
      treatment of BPH by clinical guidelines.

      It is not well known if a stratification based on the grade of BOO and bladder contractility
      has any predictive value for patients who are treated with an α1-selective blocking agent. In
      our study, we investigated possible differences in treatment outcome between patients with
      and without BOO, and with or without proper contractility who are treated with alfuzosin. So
      we will compare the quantified improvements 12 months after alfuzosin medication in LUTS/BPH
      patients by the grade of BOO and/or bladder contractility.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH

          -  Patients satisfying all of the following:

          -  Moderate to severe LUTS :

          -  international prostate symptom score (IPSS)≥ 8

          -  An enlarged prostate (≥25 mL)

          -  Decreased peak flow rate : Qmax ≤15 mL/s (volume voided ≥ 120 mL)

        Exclusion Criteria:

          -  Post voided residual urine ≥ 200 mL

          -  Patients performing catheterization

          -  Urinary tract infection patients

          -  Patients taking 5 alpha reductase inhibitor

          -  Known hypersensitivity to alfuzosin

          -  History of postural hypotension or syncope

          -  Hypertension patients treated with other alpha1-blockers

          -  Patients newly taking anticholinergic medication within 1 month

          -  Hepatic insufficiency (Aspartate transaminase /alanine aminotransferase ≥ 2 times of
             normal range)

          -  Renal insufficiency (s-Cr ≥ 2mg/dL)

          -  Unstable angina pectoris

          -  Uninvestigated hematuria

          -  Serum Prostate specific antigen ≥ 4 ng/mL (biopsy proven no cancer patients can be
             included)

          -  Interstitial cystitis patients

          -  Severe concomitant condition threatening life.

          -  Patient who is unable to make voiding diary

          -  Bladder or prostate cancer patients

          -  Patients receiving prostate or bladder surgery
Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX
Condition: Encephalitis
MeSH terms: Encephalitis
Intervention: Live attenuated chimeric Japanese Encephalitis vaccine; Inactivated Hepatitis A vaccine
Intervention description: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh; 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 1 Year
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Live attenuated Japanese Encephalitis vaccine; IMOJEV; CD.JEVAX; Booster; Thai children; Immunogenicity; Safety; Interchangeability; Hepatitis A vaccine; Vaccination or Other Immunization Procedure

Summary:

      This study was undertaken to assess the immunogenicity and safety of a booster dose of a live
      attenuated chimeric Japanese Encephalitis vaccine (JE-CV) after primary vaccination with
      SA14-14-2 in Thai children aged 1 to <5 years. In addition, to assess the impact of the
      duration interval after primary vaccination on subsequent booster response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 1 to <5 years on the day of inclusion

          -  History of received 1 dose of CD.JEVAX at 9-15 months prior to enrollment

          -  In good general health at the time of inclusion

          -  Provision of informed consent by the parent(s) or legal guardian(s)

        Exclusion Criteria:

          -  Receipt of blood or blood products in the past 3 months

          -  Acute febrile illness on the day of vaccination (Body Temperature ≥ 38 ◦C)

          -  Previous receipt of 2 doses of any vaccine against JE virus

          -  Known hypersensitivity to any of the vaccine components

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination

          -  Planned receipt of any live attenuated vaccine within 4 weeks following the trial
             vaccination
A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Intervention: agalsidase beta
Intervention description: 1.0 mg/kg every 2 weeks
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: alpha-galactosidase A; a-GAL; r-haGAL; Fabry; GL-3; Fabrazyme

Summary:

      People with Fabry Disease have an alteration in their genetic material (DNA) which causes a
      deficiency of the alpha-galactosidase A enzyme. Fabrazyme (agalsidase beta) is a drug that
      helps to break down and removes certain types of fatty substances called "glycolipids". These
      glycolipids are normally present within the body in most cells. In Fabry disease, glycolipids
      build up in various tissues such as the liver, kidney, skin, and blood vessels because
      a-galactosidase A is not present, or is present in small quantities. The build up of
      glycolipid (globatriaosylceramide or GL-3) levels in these tissues in particular is thought
      to cause the clinical symptoms that are common to Fabry disease. This study analyzed the
      safety and efficacy of Fabrazyme in the treatment of patients with Fabry disease that
      previously participated in the AGAL-008-00 (NCT0074984) study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have successfully completed the previous double-blind study AGAL-008-00
             (NCT00074984)

          -  Patients must provide written informed consent prior to study participation

          -  Female patients of childbearing potential must have a negative pregnancy test prior to
             each dosing and all female patients must use a medically accepted form of
             contraception throughout the study

        Exclusion Criteria:

          -  The patient was unable to complete AGAL-008-00 (NCT00074984)

          -  The patient has undergone kidney transplantation or is currently on dialysis

          -  The patient has diabetes mellitus or presence of confounding renal disease

          -  The patient has a clinically significant organic disease or an unstable condition that
             precludes participation

          -  The patient is unwilling to comply with the protocol requirements