bioihbjkbjnl/mcl2 huggingface dataset:
Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation
Condition: Sedation
Intervention: Propofol; Alfentanil
Intervention description: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation; Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation
Intervention MeSH terms: Alfentanil; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: propofol; alfentanil; nitrous oxide; moderate procedural sedation; Moderate Procedural Sedation in the Emergency Department

Summary:

      This is a clinical trial of propofol and alfentanil as agents for moderated procedural
      sedation in patients undergoing sedation in the emergency department (ED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults undergoing moderate procedural sedation in the Emergency Department

        Exclusion Criteria:

          -  Age <18 years

          -  Pregnancy

          -  Intoxication

          -  Cannot give informed consent

          -  Allergy to any of the three study medications

          -  ASA physical status score > 2

          -  Patients who require deep procedural sedation
Usefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial Cystitis
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial; Pain, Postoperative
Intervention: Dexmedetomidine; Normal Saline
Intervention description: 1 mcg/kg/hour; 1mcg/kg/hr
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post-operative pain management; Pain Management; Painful bladder syndrome; frequency and urgency; Dexmedetomidine; hydrodistension

Summary:

      The purpose of this study is to assess the effects of dexmedetomidine while patients undergo
      treatment for Interstitial Cystitis (IC). The investigators goal is to demonstrate in
      patients with IC undergoing bladder hydrodistension that the use of dexmedetomidine as a
      supplemental anesthetic agent will result in better postoperative pain management.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a clinical diagnosis of IC scheduled for cystoscopy and hydrodistension
             for both diagnostic and therapeutic indications.

          -  2. Gender of Patients: Male & female,Age of Patients: 18 and older

        Exclusion Criteria:

          -  Conduction disturbance (second degree AV block or greater), or previous reaction to
             medications used in this study. Patients receiving spinal anesthesia will not be
             included.
A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum
Condition: Colorectal Cancer
MeSH terms: Neoplasm Metastasis; Colonic Neoplasms
Intervention: 5-Fluorouracil; Bevacizumab; Irinotecan; Oxaliplatin
Intervention description: Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor.; Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study.; Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study.; Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.
Intervention MeSH terms: Bevacizumab; Fluorouracil; Oxaliplatin; Irinotecan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This expanded access study will assess the efficacy and safety of intravenous (IV)
      bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic
      cancer of the colon or rectum. The anticipated median time on study treatment is
      approximately 10 months, and the target sample size is 40 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously untreated metastatic colon or rectal cancer

          -  Scheduled to begin IV 5-fluorouracil-based chemotherapy as a first-line treatment

        Exclusion Criteria:

          -  Prior chemotherapy for metastatic colon or rectal cancer

          -  Planned radiotherapy for underlying disease

          -  Central nervous system metastases

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to study start

          -  Treatment with any investigational drug, or participation in another investigational
             study, within 30 days prior to enrollment
A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture
Condition: Osteoporosis
MeSH terms: Osteoporosis; Hip Fractures
Intervention: Teriparatide; Risedronate; Placebo; Calcium; Vitamin D
Intervention description: Administered subcutaneously; Administered orally; Weekly: Administered orally
Daily: Administered subcutaneously; Approximately 500 to 1000 mg/day administered orally throughout study.; Approximately 800 International Units per day (IU/day) administered orally throughout study.
Intervention MeSH terms: Vitamin D; Teriparatide; Risedronic Acid; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 224.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Low bone mass; Recent pertrochanteric hip fracture

Summary:

      This study will evaluate whether teriparatide is superior to the active comparator in the
      change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal
      women with low bone mass and a recent pertrochanteric hip fracture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and postmenopausal women aged ≥50 who have sustained a unilateral, fracture of the
             trochanteric region

          -  Lumbar spine BMD and/or femoral neck BMD and/or total hip BMD measurement of the
             contra lateral hip at least 2.0 SDs (standard deviation) below the average bone mass
             for young women and men

        Exclusion Criteria:

          -  Clinically significant abnormal laboratory values

          -  History of unresolved skeletal diseases that affect bone metabolism

          -  Polytrauma participants and participants with fractures at more than one site
Parastomal Reinforcement With Strattice
Condition: Parastomal Hernia
MeSH terms: Hernia
Intervention: Strattice Reconstructive Matrix; Standard ostomy creation
Intervention description: Strattice will be placed as a fascial inlay to support stoma sites; Ostomy will be created as routinely performed
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ostomy creation; Parastomal hernia

Summary:

      The purpose of this study is to compare the clinical outcomes of patients undergoing surgery
      for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay,
      as measured by postoperative occurence of parastomal hernia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults

          -  need for permanent ileostomy or colostomy

        Exclusion Criteria:

          -  history of hernia at new ostomy site

          -  has previously implanted surgical mesh at site of planned ostomy

          -  requires a temporary ostomy

          -  has need for multiple ostomies

          -  is receiving chronic immunosuppression therapy, has MELD score of > 17, has severe
             COPD, systemic infection, or known collagen disorder

          -  is bedridden or otherwise non-ambulatory
TXA vs. Amicar in Total Knee and Hip Arthroplasty
Condition: Blood Loss; Hip Arthritis; Knee Arthritis
MeSH terms: Arthritis
Intervention: Amicar; TXA
Intervention description: Subjects randomized to receive Amicar will receive this during surgical intervention; Subjects randomized to receive TXA will receive this during surgical intervention
Intervention MeSH terms: Tranexamic Acid; Aminocaproic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 246.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the relative effectiveness of two drug agents,
      Tranexamic acid (TXA) and aminocaproic acid (Amicar), that act through a similar mechanism of
      action. These agents are used to decrease blood loss that is a result of major surgery, like
      total joint arthroplasty. A secondary goal will be investigate the cost-analysis of total
      hospitalization. Both TXA and Amicar are both currently used in the care of patients
      undergoing total joint arthroplasty.

      Subjects will be randomly assigned to the TXA or Amicar arm. All data needed for this study
      including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit
      and hemoglobin, and complications will be collected during the hospitalization stay.

      Our Hypothesis is that TXA and Amicar will have similar effectiveness in preventing
      intraoperative blood loss and the need for transfusion post-op than Amicar.

      A detailed cost analysis will show that the overall cost of performing the operative
      procedure, including transfusions, OR time, and total costs associated with admission cost
      will be more decreased with Amicar as compared to TXA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients electing to undergo primary total hip or knee arthroplasty

        Exclusion Criteria:

          -  History of stents

          -  Myocardial infarction,

          -  Cerebrovascular accident or stroke

          -  Deep venous thrombus

          -  Pulmonary embolus

          -  Late onset color blindness

          -  Hypercoagulable state
Minimally-Invasive Cardiovascular Hemodynamic Optimization (MiCHO) Versus Early Goal-Directed Therapy (EGDT) in the Management of Septic Shock
Condition: Severe Sepsis; Septic Shock
MeSH terms: Shock, Septic; Sepsis; Shock
Intervention: Esophageal Doppler monitoring - CardioQ, Deltex Inc; Central line with CVP and continuous ScvO2 monitoring
Intervention description: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM; 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Emergency Department; Hemodynamic Optimization; Esophageal Doppler monitoring; Early Goal-Directed Therapy

Summary:

      Early intervention in the treatment of septic shock, including early goal-directed therapy
      (EGDT) in the first 6 hours of disease presentation, has been shown to significantly decrease
      mortality. However, this approach requires invasive hemodynamic monitoring, thus limiting its
      widespread application in the emergency department setting. A minimally invasive protocol
      utilizing esophageal Doppler monitoring (EDM) may be of benefit and practical if it is shown
      to result in similar outcome as EGDT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients >= 18 years old

          -  Source of infection

          -  Two or more of systemic inflammatory response syndrome criteria

          -  Systolic blood pressure < 90 mmHg after a fluid bolus OR lactate >= 4 mmol/L

          -  A central line has been placed for CVP/ScvO2 monitoring

        Exclusion Criteria:

          -  Pregnancy

          -  Acute stroke

          -  Acute cardiogenic pulmonary edema

          -  Status asthmaticus

          -  Unstable cardiac dysrhythmia

          -  Active hemorrhage

          -  Acute seizure

          -  Drug overdose

          -  Trauma

          -  Requiring immediate surgery

          -  Do-not-resuscitate status
A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
Condition: Perinatal Depression; HIV-1-infection
MeSH terms: Asphyxia Neonatorum; Depression; Depressive Disorder
Intervention: Sertraline; Interpersonal therapy
Intervention description: daily SSRI (Sertraline 25mg); 11 sessions over a 24-week period
Intervention MeSH terms: Sertraline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline initial dose of 25 mg tablet versus IPT in a 1:1 ratio commenced between six and 8 weeks postpartum and continued through 30 weeks postpartum.
Masking: None (Open Label)
Enrollment: 80.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: perinatal depression; HIV; Antiretroviral Treatment; Interpersonal psychotherapy

Summary:

      This pilot study will evaluate, through quantitative and qualitative methods, whether
      different treatments for postpartum depression are feasible and acceptable in postpartum HIV
      infected women on antiretrovirals (ART). The study will take place at several clinics in
      Lusaka, Zambia.
    

Eligibility criteria:

        Inclusion criteria:

          -  18 years of age or older

          -  Documentation of confirmed HIV-1 infection

          -  Six to eight weeks postpartum

          -  Currently taking ART treatment

          -  Able and willing to provide written informed consent

          -  Willing to adhere to study visit schedule

          -  PND diagnosis confirmed by Mini-International Neuropsychiatric Interview

        Exclusion criteria:

          -  Taking an ADM in the prior 12 months prior to enrollment

          -  Actively suicidal

          -  Known or suspected allergy or contraindication to first line Sertraline

          -  Any other condition (social or medical) which, in the opinion of the study staff,
             would make trial participation unsafe or complicate data interpretation.
A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Platinum-based chemotherapy; Bevacizumab [Avastin]
Intervention description: As prescribed; 15 mg/kg IV on Day 1 of each 3 week cycle
Intervention MeSH terms: Bevacizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2252.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the safety and efficacy of Avastin combined with
      platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous
      non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in
      combination with platinum-based chemotherapy or in combination with any standard of care
      NSCLC first-line chemotherapy used in line with the licensed national prescribing
      information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week
      cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of
      chemotherapy cycles until disease progression, and the target sample size is 500+
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  histologically or cytologically documented inoperable, locally advanced ( stage III),
             metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed
             histology should be categorized by the predominant cell type);

          -  ECOG PS status 0-2;

          -  life expectancy >= 12weeks;

          -  adequate renal, liver and hematological function.

        Exclusion Criteria:

          -  mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a
             predominant squamous component;

          -  hemoptysis (>=1/2 teaspoon of bright red blood) in previous 3 months;

          -  evidence of tumor invading major blood vessels on imaging;

          -  evidence of CNS metastases, even if previously treated.

          -  major surgery (including open biopsy), significant traumatic injury within 28 days
             prior to enrolment, or anticipation of need for major surgery during study treatment;

          -  prior chemotherapy for stage IIIb/IV disease.
Azithromycin - Ivermectin Mass Drug Administration for Skin Disease
Condition: Scabies; Yaws; Impetigo
MeSH terms: Scabies; Impetigo
Intervention: Ivermectin; Azithromycin; Permethrin
Intervention description: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.; Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.; Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead.
Intervention MeSH terms: Azithromycin; Ivermectin; Permethrin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1291.0
Sex: All
Healthy volunteers: No

Summary:

      This is an open-label prospective community intervention trial to assess the impact of
      community mass treatment with azithromycin for yaws and ivermectin for scabies, on non-yaws
      bacterial skin infections.

      Communities will be randomised to receive standard treatment for both yaws and scabies either
      in parallel (site 1) or in sequence (site 2).

      Treatment of yaws:

      Single dose of Azithromycin (30mg/kg, max 2G).

      Treatment of scabies:

      Either an oral dose of Ivermectin (200μg/kg) or permethrin cream for those with a
      contraindication to Ivermectin (WT<15kg, pregnant or breastfeeding women) given in 2 doses
      7-14 days apart.

      Investigators will complete a clinical and microbiological assessment of bacterial skin
      disease at baseline and at 12 months to assess the impact of treatment on the prevalence of
      bacterial infection and the emergence of antimicrobial resistance.

      Primary Outcome

        1. Difference in the change in prevalence of impetigo between baseline and 12- months
           between the parallel and the sequential treatment arms.

           Secondary Outcomes

        2. Change in the proportion of swab samples from which S. pyogenes is cultured between
           baseline and follow-up in the two arms

        3. The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured
           in the two arms
    

Eligibility criteria:

        Inclusion Criteria:

          -  All community members are able to be included in the study.

        Exclusion Criteria:

          -  Allergy to any of the components of the allocated drug regimen
Orphenadrine and Methocarbamol for LBP
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Orphenadrine; Methocarbamol; Naproxen; Placebo
Intervention description: Orphenadrine 100mg PO BID x 7 days; Methocarbamol 750mg 1-2 tabs po TID x 7 days; Naproxen 500mg PO BID x 7 days; 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days
Intervention MeSH terms: Naproxen; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Orphenadrine; Methocarbamol; Cholinergic Antagonists
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No

Summary:

      Low back pain is a common cause of visit to emergency department. It is not clear if skeletal
      muscle relaxants are of benefit for patients with acute low back pain. This is a randomized
      study to determine if skeletal muscle relaxants, when combined with naproxen, improve
      outcomes more than naproxen alone
    

Eligibility criteria:

        Inclusion Criteria:

          -  LBP duration <= 2 weeks

          -  No trauma to low back within previous month

          -  No radicular symptoms

          -  No history of low back pain or history of only infrequent episodes

        Exclusion Criteria:

          -  Medication allergies or contra-indications

          -  Not available for follow-up

          -  Chronic pain syndrome