bioihbjkbjnl/mcl2 huggingface dataset:
A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy
Condition: Muscle Weakness | Patient; Pain
MeSH terms: Muscle Weakness
Intervention: Peripheral Nerve Block; Sham Block
Intervention description: Regional Anesthesia by Local Anesthetic Injection; Sham Block by saline injection
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      Patients undergoing arthroscopic hip surgery have been shown to have significant
      post-operative pain that may delay discharge, recovery, and early mobilisation. A
      pre-operative regional anesthesia technique, the fascia iliaca block may be an effective
      method for acute post-operative analgesia.

      This is a prospective, randomized controlled study of the preoperative fascia iliaca block
      for patients undergoing hip arthroscopy.

      The enrolled patients will be randomized to receive either a fascia iliaca block with the
      local anesthetic ropivacaine or to have a sham block. All patients will receive a general
      anesthetic for the hip arthroscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age at least 18 years old

          -  American Society of Anesthesia physical classification I - III, scheduled for
             arthroscopic hip surgery

        Exclusion Criteria:

          -  Age younger than 18 years old

          -  Non-English speaking

          -  Contraindicated for regional nerve block (such as, but not limited to: coagulopathy,
             infection at site, allergy to local anesthetic)

          -  Preexisting neurologic deficits of operative limb

          -  Need for postoperative nerve function test

          -  Inability to consent due to cognitive dysfunction

          -  Chronic pain

          -  Patient refusal.
Effectiveness of Antibiotic Therapy for Exacerbations of Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Placebo; Amoxicillin and clavulanic acid
Intervention description: One pill to be taken every eight hours for 8 days; 500-125 mg to be taken every eight hours for 8 days
Intervention MeSH terms: Amoxicillin; Clavulanic Acids; Clavulanic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 318.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Antibiotics

Summary:

      The purpose of this study is to determine the effectiveness of antibiotic therapy for
      patients with acute exacerbations of mild-to-moderate chronic obstructive pulmonary disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute exacerbations (at least one criterion present: increase of dyspnoea, increase of
             sputum production and/or increase of purulence) of

          -  patients older than 40 years old,

          -  smokers or ex-smokers of more than 10 pack-years,

          -  with COPD and FEV1 greater than 50%, diagnosed by spirometry and a predicted ratio
             FEV1/FVC<0.7%.

        Exclusion Criteria:

          -  Severe COPD (FEV1<50%)

          -  Pneumonia

          -  Active neoplasm

          -  Tracheotomy

          -  Criteria for hospitalisation

          -  Patients previously being on antibiotics

          -  Immunodepressed patients

          -  History of hypersensitivity to beta-lactams or intolerance to clavulanate

          -  Enrollment in other clinical trials

          -  Patients who refuse to take part in this study

          -  Patients who have not had a spirometry test for the past two years
Analgetic and Anxiolytic Effect of Preoperative Pregabalin
Condition: Intervertebral Disk Displacement; Disk Prolapse
MeSH terms: Intervertebral Disc Displacement; Prolapse
Intervention: pregabalin; Placebo; morphine
Intervention description: capsule 150 mg x 1 per orally one hour before surgery; One capsule of saccharose (placebo) was administered about one hour before surgery; All patients were equipped with a PCA (patient controlled analgesia) for 24 hours after surgery. The sum of morphine used was registered (milligram).
Intervention MeSH terms: Pregabalin; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Intervertebral disk displacement; disk prolapse; pregabalin

Summary:

      The purpose of this study is to determine whether the use of oral pregabalin 150 mg as
      premedication reduces the amount and degree of postoperative pain.

      Furthermore the purpose of this study is to determine whether the use of oral pregabalin 150
      mg as premedication reduces anxiety prior to anaesthesia in these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of disc prolapse

          -  Age 18+

          -  ASA (American Association in Anesthesiology) I-III

          -  written consent

        Exclusion Criteria:

          -  Age < 18

          -  ASA > III

          -  liver failure

          -  renal failure

          -  allergic reaction against gabapentin and/or pregabalin

          -  pregnancy
Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery
Condition: Major Depressive Disorder; Surgery; Orthopedic Disorder
MeSH terms: Musculoskeletal Diseases; Depressive Disorder; Depressive Disorder, Major
Intervention: Ketamine; Normal saline (placebo)
Intervention description: 0.5 mg/kg over 40 minutes, intravenous.; Normal saline infusion over 40 minutes, equivalent volume to ketamine infusion.
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Masking is for double blind phase only.
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: depression; ketamine; anesthesia; total joint arthroplasty

Summary:

      This study evaluates whether ketamine, given as part of an anesthetic, improves depression
      symptoms in depressed patients undergoing non-cardiac surgery. Half of participants will
      receive a ketamine infusion during surgery, while the other half will receive a placebo
      (normal saline) during surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient presenting for non-cardiac, non-intracranial surgery

          -  Major Depressive Disorder

        Exclusion Criteria:

          -  Pregnant of breastfeeding women
Efficacy and Safety of Peg-Interferon Alpha-2a Plus Ribavirin in Genotype 1 Chronic Hepatitis C Participants Co-Infected With Human Immunodeficiency Virus
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Acquired Immunodeficiency Syndrome; HIV Infections; Hepatitis
Intervention: Peg-Interferon Alpha-2A; Ribavirin
Intervention description: Peg-IFN-Alpha-2A will be administered at 180 micrograms (mcg) once weekly via subcutaneous injection.; Ribavirin will be administered as either 1000 milligrams (mg) (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing less than (<) 75 kilograms (kg) or as 1200 mg (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing greater than or equal to (>/=) 75 kg.
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, multi-center, Phase IV, comparative study will assess the efficacy and
      safety of combined peg-interferon alpha-2a (Peg-IFN-Alpha-2A) and ribavirin therapy for 48 or
      72 weeks of treatment and 24 weeks of follow-up in participants with Genotype 1 chronic
      hepatitis C (CHC), co-infected with human immunodeficiency virus type 1 (HIV-1).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Serological evidence of chronic hepatitis C infection by anti-hepatitis C virus (HCV)
             test

          -  Detectable HCV-ribonucleic acid (RNA) plasma level testing by Roche AMPLICOR HCV (<50
             International Units per milliliter [IU/mL]) (qualitative test)

          -  Chronic liver disease consistent with infection of CHC

          -  Compensated liver disease (Child-Pugh Grade A)

          -  Serological evidence of infection by HIV-1 test, anti-HIV-1 or HIV-1 RNA detection

          -  Negative pregnancy urine or blood test (for women in childbearing age); additionally,
             all men and women of childbearing potential must agree to use two effective forms of
             contraception during the treatment and during the 6 months after the end of treatment

        Exclusion Criteria:

          -  Pregnant or nursing women and male partners of pregnant women

          -  Prior therapy with interferon (IFN) or ribavirin and any investigational medication
             less than or equal to (</=) 6 weeks before the first dose of the study drug

          -  History or other evidence of a medical condition associated with chronic liver disease
             further than HCV

          -  Active opportunistic infection associated with HIV and / or cancer requiring systemic
             therapy

          -  History of any other significant illness which in the investigator's opinion, could
             result in the participant's inability to meet the Protocol requirements
The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance
Condition: Ptosis, Eyelid; Conjunctiva Inflamed; Eye Manifestations
MeSH terms: Blepharoptosis; Eye Manifestations; Conjunctivitis
Intervention: Oxymetazoline hydrochloride 0.1% ophthalmic solution; Placebo
Intervention description: One drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye.; One drop of placebo (balanced saline solution) will be applied to the ocular surface of each eye.
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the research is to see if Upneeq ( oxymetazoline 0.1% ophthalmic solution) has
      an effect on eyelid position, eye redness, or patient-perceived appearance of the eyes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults age 18 and above able to provide informed consent to participate

          -  Subject with stable ocular health, defined as no ocular conditions requiring ongoing
             topical therapy or recent surgical intervention

        Exclusion Criteria:

          -  Adults unable to consent

          -  Individuals less than 18 years of age

          -  Prisoners

          -  Pregnant women.

          -  Known contradictions or sensitivities to study medication (oxymetazoline)

          -  Ocular surgery within the past 3 months or refractive surgery within the past six
             months

          -  Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital
             surgery

          -  Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or
             blepharospasm)

          -  Any ocular or systemic condition that, in the opinion of the investigator, would
             confound study data, interfere with the subject's study participation, or affected the
             subject's safety or trial parameters

          -  Presence of an active ocular infection

          -  Prior (within 5 days of beginning study treatment) use of eye whiteners (eg,
             vasoconstrictors), decongestants, antihistamines (including over the counter and
             herbal topical ophthalmic medications), phenylephrine dilating drops, any other
             topical ophthalmic agents

          -  Inability to sit comfortably for 15 - 30 minutes
Ultrasound-guided Axillary Plexus Block - Dose Reduction of Prilocaine
Condition: Other Surgical Procedures
Intervention: midazolam; prilocaine 1%; prilocaine 1%; prilocaine 1%
Intervention description: Prior to performing the regional anesthesia the investigators administered midazolam as a premedication by mouth (3,75-7,5mg) or intravenously (2-3mg).; 40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block; 40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block; 40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
Intervention MeSH terms: Midazolam; Prilocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ultrasound; methaemoglobin; prilocaine; regional anesthesia; ASA risk groups I-II; adult outpatients; surgical spectrum covered procedures; distal forearm; hand

Summary:

      Clinical aim: Does reducing the dose of local anesthetic in ultrasound-guided axillary plexus
      anesthesia have any effect on the success rate and additional parameters of block quality?
      Methodology: In this prospective cohort study three groups of 40 outpatients each were
      administered dosages of 1% prilocaine of either 40mL, 30mL or 20mL for axillary plexus
      anesthesia. Met-Hb was measured prior to administration of the block and then hourly until
      the Met-Hb concentration fell. Parameters of block quality and any adverse effects were
      recorded. The level of significance was defined with α ≤ 0.05.
    

Eligibility criteria:

        Inclusion Criteria:

          -  elective surgery on the distal forearm or the hand

          -  adult outpatients, age 18-75 years old

          -  ASA-risk groups I-II (American Society of Anesthesiologists)

          -  Body Mass Index 17-35

          -  informed consent

        Exclusion Criteria:

          -  severe coagulopathy

          -  local or systemic inflammatory response

          -  ASA-risk groups ≥ Grad III

          -  severe anemia

          -  heart failure

          -  manifest shock

          -  other drugs with influence on methaemoglobinemia (nitrates, sulfonamides etc.)

          -  domestic care after surgery not ensured

          -  drug allergy : local anesthetics

          -  severe polyneuropathy

          -  pregnancy, lactation period

          -  participation in other studies

          -  non-cooperative patients

          -  addiction to drugs or alcohol
Carbamazapine for Inherited Erythromelalgia Patients With NaV1.7 Mutations
Condition: Erythromelalgia
MeSH terms: Erythromelalgia
Intervention: Carbamazepine; Placebo
Intervention description: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.
Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days.
Intervention MeSH terms: Carbamazepine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This research study is designed to investigate brain response using fMRI scan, and behavioral
      responses, to treatment with the drug carbamazepine (CBZ) in patients with the painful sodium
      channelopathy inherited Erythromelalgia (IEM). This study is designed to identify the central
      nervous system (CNS) regions that are activated during ongoing or evoked pain attacks, and
      the altered CNS response to CBZ treatment. This will advance our understanding of how IEM
      affects the brain. We also hope to validate a pharmacogenic approach to the study of IEM by
      use of an FDA approved drug. We hope, but cannot be sure, that subjects will directly benefit
      from this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis/symptoms of EM

          -  specific NaV1.7 sodium channel mutations (including S241T)

        Exclusion Criteria:

          -  patients with no identified NaV1.7 mutation
A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)
Condition: Cataract
MeSH terms: Cataract; Presbyopia
Intervention: ReSTOR +3; Tecnis MF
Intervention description: Bilateral implantation of ReSTOR +3 Intraocular Lenses (IOLs) after cataract extraction; Bilateral implantation of Tecnis Multifocal (MF) Intraocular Lenses (IOLs) after cataract extraction
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 65.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: presbyopia; intraocular lens

Summary:

      The purpose of this study is to prospectively evaluate postoperative visual and refractive
      parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3
      versus those bilaterally implanted with the Tecnis Multifocal 1-piece.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosed with bilateral cataracts

          -  candidate for presbyopic lens

        Exclusion Criteria:

          -  >1 Diopter (D) preoperative astigmatism by Keratometry (K)readings

          -  pre-existing conditions that could skew the results
Effectiveness of Rebif® in Clinically Isolated Syndrome and Relapsing Multiple Sclerosis Using RebiSmart™
Condition: Relapsing Multiple Sclerosis; Clinically Isolated Syndrome
MeSH terms: Multiple Sclerosis; Syndrome; Sclerosis
Intervention: Rebif
Intervention description: Rebif will be administered at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Relapsing multiple sclerosis; Clinically isolated syndrome; RMS; CIS; RebiSmart™; Rebif®; Interferon beta-1a

Summary:

      This is a Phase 4, interventional, multicenter study of subcutaneous Rebif® (interferon
      beta-1a) using RebiSmart™ device to assess effectiveness and adherence of treatment in
      subjects with clinically isolated syndrome (CIS) or relapsing multiple sclerosis (RMS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects between 18 to 65 years of age

          -  Female subjects must be neither pregnant nor breast-feeding and must lack
             child-bearing potential as defined in the protocol

          -  Subjects diagnosed with CIS or RMS according to the revised McDonald criteria (2010)

          -  Treatment-naive subjects or subjects treated with Rebif® multi-dose injected by
             RebiSmart™ for no longer than 6 weeks prior to Baseline visit

          -  Subjects that are able to self-inject with RebiSmart™ (in the opinion of the
             physician)

          -  Subjects with Expanded Disability Status Scale (EDSS) score less than (<) 6
             (inclusive) at Baseline

          -  Signed informed consent and subject data collection form

        Exclusion Criteria:

          -  Subjects experiencing a relapse within 30 days before Baseline

          -  Participation in other studies within 30 days before Baseline

          -  Received any MS therapy within 6 months prior to study enrolment (for example, other
             disease-modifying drugs: immunomodulatory, immunosuppressive agents or combination
             therapy) with the exception of Rebif® multi-dose injected by RebiSmart™

          -  Any visual or physical impairment that precludes the subject from self-injecting the
             treatment using the RebiSmart™

          -  Pregnancy and breast-feeding

          -  Serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled
             angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure, as per
             investigator opinion

          -  Current or past (within the last 2 years) history of alcohol or drug abuse

          -  Have any contra-indications to treatment with interferon beta-1a according to Summary
             of Product Characteristics