bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Intra-uterine Slow-Release Insemination on Pregnancy Rate in Women Designated for Artificial Insemination
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      A couple that does not achieve pregnancy though regular attempts for a year are defined
      infertile couple. This condition is caused by faulty functioning of the reproduction system
      of the husband or wife or both. If there are no organic defects and there is no definite
      injury to the reproductive system (ova or spermatozoa), the specialist doctor generally
      decides to put the couple into a fertility treatment program. Artificial insemination is one
      of the important ways of achieving pregnancy.

      Three common methods of artificial insemination:

        1. Placement of a diaphragm that contains raw spermatozoa or isolated improved spermatozoa
           in an appropriate liquid solution (Cup insemination, CI) upon the cervix.

        2. Spermatozoa injection (after improvement) through the vagina to the cervix
           (Intra-Cervical Insemination, ICI).

        3. Spermatozoa injection (after improvement) directly into the uterus (IUI-Intra-Uterine
           Insemination).

      The EVIE - Slow Release Insemination method:

      The slow release insemination is utilizing a Grasby type MS16 pump for 3 hours. The release
      rate for motile spermatozoa is 50X103 per minute.

      Advantages:

        -  Very close approximation of the natural procedure in which the spermatozoa arrive to the
           fertilization site over a long period.

        -  An extended "window of opportunities" for meeting between the ovum and spermatozoa will
           be longer.

        -  There is no loss of spermatozoa due to leaking as sometimes happens with single-time
           injection practiced in the IUI method.

      Primary Endpoint:

      Accumulation of 50 cycles of SRI- slow release insemination (study group) in addition to 50
      cycles of regular IUI (control group). Two weeks after insemination Beta hCG test

      Secondary Endpoints:

      Four weeks after insemination - US Viability scan

      Procedure:

      Subjects will be women with fertility difficulties who are designated for IUI treatment. 100
      insemination cycles will be conducted. (50 regular IUI and 50 EVIE-SRI). Subjects that were
      treated with the IUI method and who does not become pregnant will then be treated with the
      EVIE-Slow Release method and vice versa.
    


Intervention name(s): Fertiligent
Intervention type(s): Device
Intervention description(s): Fertility treatment by using the EVIE - Slow Release Insemination method
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infertility; insemination; slow release
Islet Transplantation Using Campath-1H and Infliximab Induction
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Islet transplantation has been investigated as a treatment for Type 1 diabetes mellitus in
      selected patients with inadequate glucose control despite insulin therapy. However, the
      perennial hope that such an approach would result in long-term freedom from the need for
      exogenous insulin, with stabilization of the secondary complications of diabetes, has failed
      to materialize in practice. The goal of the present study is therefore to improve the safety
      and efficacy of clinical islet-alone transplantation by minimizing dependence on
      calcineurin-inhibitor therapy - thereby avoiding potential nephrotoxicity, and furthermore
      improving success with single-donor islet infusions by avoiding all diabetogenic
      immunosuppression. Campath-1H, combined with Infliximab induction therapy provides a unique
      opportunity to minimize dosing of maintenance long-term immunosuppression while further
      promoting islet engraftment.
    

Detailed description: 
      This is a single-centre, prospective, open-label study in Type 1 diabetic participants
      receiving an islet cell transplant; all participants will receive Campath-1H + Infliximab
      induction therapy followed by sirolimus and ultra-low dose tacrolimus maintenance therapy.

      The primary objective of this protocol is to assess the safety of this treatment regimen in
      adult Type 1 diabetic participants receiving their first islet transplant.
    

Intervention name(s): alemtuzumab; islet transplant; infliximab
Intervention type(s): Drug; Procedure; Drug
Intervention MeSH terms: Infliximab; Alemtuzumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: islet; transplantation
Acellular Dermal Matrix in Primary Palatoplasty
Condition: Cleft Palate
MeSH terms: Cleft Palate
Study type: Observational

Summary: 
      The goal of the present study is to definitely determine whether the use of acellular dermal
      matrix (ADM) during primary cleft palate repair decreases the rate of fistula formation.
      Although individual studies have described promising advantages to its use in cleft palate
      surgery, no consensus currently exists. Without concrete evidence, one must question the
      whether the increased cost, time and potential patient risk (human derived tissue) to
      patients justifies its use in primary cleft palate repair.
    

Detailed description: 
      There has been a change in the standard practice at the Montreal Children's Hospital where
      the senior author has shifted from selected application of ADM in certain cases to routine
      use of ADM in all cleft palate cases. This study is an observational study comparing a
      prospective cohort group receiving ADM routinely to a retrospective historical cohort group
      without routine use of ADM.

      Objectives of the study:

      Primary objectives:

      The primary objective of this study is to determine whether routine use of ADM would lower
      the incidence of palatal fistula in patients undergoing primary cleft palate repair.

      Secondary objectives:

        1. Incidence of wound dehiscence

        2. Incidence of wound infection

        3. Hospital length of stay
    

Intervention name(s): Acellular Dermal Matrix
Intervention type(s): Device
Other intervention name(s): DermaMatrix
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Children who present to the Montreal Children's Hospital with a cleft palate (Veau II-IV)
        that undergo surgical repair between the age of 3 months and 3 years.
      
Keywords: Palatoplasty; Acellular Dermal Matrix
Early Phase II Trials for Cocaine Medication Development - 1
Condition: Cocaine-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to develop models for early Phase II testing of potential
      medications for cocaine dependence: amoxapine, risperidone and other agents.

      The study was a controlled pilot trial of risperidone in opiate-dependent patients on
      methadone maintenance. The study explored whether risperidone reduced cocaine use, cocaine
      craving, and cocaine subjective effects in patients on methadone maintenance who abused
      cocaine and whether it had an acceptable side effect profile. This
    

Detailed description: 
      This was an 18-week prospective, randomized, placebo-controlled crossover design with placebo
      lead-in phase and terminal placebo phase. After two weeks of single-blind placebo, patients
      were randomly assigned to one of two schedules of medication:

      2 Week Baseline Weeks 1-6 Weeks 7-12 Weeks 13-18 Group 1 placebo risperidone placebo placebo
      Group 2 placebo placebo risperidone placebo

      The first 6-week phase provided an initial double-blind medication-placebo comparison. In the
      second six-week phase (weeks 7-12), patients crossed over to the opposite treatment. During
      weeks 13-18, Group 1 patients remained on placebo while Group 2 patients were tapered from
      risperidone to placebo. For six weeks after the end of the trial, patients were offered
      routine clinical treatment with counseling and psychiatrist visits as needed. Medication
      dosage was titrated upwards on a fixed-flexible schedule to a maximum dose of 4 mg per day.
      Medication began at ½ mg risperidone for 3 days, then 1 mg for four days, 2 mg per day during
      week 2, 3 mg per day during week 3, and 4 mg per day during weeks 4-6. The titration schedule
      for risperidone in weeks 7-12 was the same as for weeks 1-6. In addition to treatment as
      usual, patients received a modified manual-guided relapse prevention counseling program in
      weekly meetings lasting approximately 20 minutes; these sessions provided cognitive and
      behavioral skills that were found to be helpful to patients in reducing cocaine use.
    

Intervention name(s): Risperidone; Placebo; Relapse prevention counseling
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Risperidone (4mg/day); Placebo; Modified manual guided relapse prevention counseling. Weekly 20 minute sessions consisting of cognitive behavioral skills. Both arms will receive this intervention.
Other intervention name(s): Risperidal; RPT-CBT
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cocaine; METHADONE PATIENTS; RISPERIDONE
Studies Examining the Importance of Smoking After Being Diagnosed With Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      A large project consisting of:

      a) an observational trial where smoking status is recorded on 1400 consecutive people newly
      diagnosed with lung cancer. Smoking status is biologically validated with exhaled carbon
      monoxide (eCO) levels every 3 months. Survival, cancer progression and treatment
      complications will be recorded and compared in smokers, ex-smokers and never smokers.
    

Detailed description: 
      Smoking causes around 85% of lung cancer. Continued smoking after diagnosis probably worsens
      survival and increases treatment complications but prospective well-designed studies are
      lacking.

      This project is an observational cohort study recording outcomes in smokers, never-smokers,
      and ex-smokers, using exhaled carbon monoxide to validate smoking status when they attend for
      further lung cancer clinics.

      This project is unique, as every patient with a clinical diagnosis of lung cancer will have
      their smoking status biologically validated by a quick and easy test, and those enrolled in
      the smoking cessation treatments or not will also complete a generic quality of life
      questionnaire at regular intervals. These appointments will coincide with other hospital
      appointments wherever possible, and survival status will reported up to 24 months after
      enrolment.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with newly diagnosed lung cancer
      
Keywords: smoking; cessation; mortality; quality of life
In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline
Condition: Myelomeningocele; Terbutaline Adverse Reaction; Pregnancy; Malformation Central Nervous System
MeSH terms: Meningomyelocele; Spina Bifida Cystica
Study type: Observational

Summary: 
      Myelomeningocele is a malformation with high incidence, and it consists in a neural tube
      defect. Fetal intrauterine surgery is an alternative for correction, and it improves the
      prognosis of the fetus, but has an increased risk of maternal complications and premature
      labor, as it can occur due to uterine stimulation. It is therefore essential that tocolysis
      is performed before, during and after surgery, and the most commonly used tocolytics are
      terbutaline and atosiban. Terbutaline has no specificity and may have several adverse effects
      such as maternal acidosis.
    

Detailed description: 
      The objective of the study was to evaluate maternal blood gas alterations among cases that
      used atosiban tocolytic agent and cases with terbutaline in in utero repair of
      myelomeningocele. It consists of a retrospective cohort study. It included 25 patients, who
      were divided into two groups, depending on which agent they received as main tocolytic agent
      during the intrauterine fetal myelomeningocele repair: terbutalineor atosiban. The primary
      outcome was maternal arterial pH at the end of surgery.
    

Intervention name(s): Atosiban; Terbutaline
Intervention type(s): Drug; Drug
Intervention description(s): Atosiban intravenous. Dose: attack of 6.75 mg, and maintenance of 300 mcg / min for 3 hours, and 100 mcg / min for 21 hours.; Terbutaline intravenous. Dose: 2.5 mg in 500 mL saline, infusion rate of 30 mL / hr (150 mcg / h) during the surgery and for 24 hours.
Intervention MeSH terms: Terbutaline; Atosiban
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who underwent intrauterine myelomeningocele surgical repair in a tertiary
        obstetrical center (Hospital das Clínicas da Faculdade de Medicina da Universidade de São
        Paulo), from November of 2017 to January of 2020.
Effect of the Neck Extension on Blind Intubation Via Ambu® AuraGain™
Condition: Intubation; Difficult or Failed; Intubation Complication
Study type: Interventional

Summary: 
      In a previous study, NCT03147469, the investigators found that the vocal cords were more
      easily visualized by fiberoptic bronchoscopy with neck extension positioning. On the basis of
      this finding, the investigators are going to conduct a randomized controlled trial to
      evaluate the effect of neck extension on the success rate of blind intubation through
      laryngeal mask.

      Participants undergoing general anesthesia will be randomly assigned to group E (with neck
      extension) or group C (with neutral position). Ambu® AuraGain™ laryngeal mask will be placed
      first, and then, a lubricated endotracheal tube will be gently intubated through the
      laryngeal mask. The participants will be mechanically ventilated with an endotracheal tube if
      blind intubation succeed. Blind intubation will be performed with a maximum of two attempts.
      If all attempts failed, the laryngeal mask will be removed and the tube will be intubated
      using a direct laryngoscopy.

      The primary outcome of this study is the success rate of blind intubation within a first
      attempt. Secondary outcomes included overall success rate of blind intubation within a
      maximum of two attempts, time for blind intubation, the incidence of postoperative
      hoarseness, cough, and sore throat, and any obvious complications related to airway
      management such as bleeding, airway trauma, dental fracture, aspiration, or bronchospasm.
    


Intervention name(s): Ambu® AuraGain™; neck extension
Intervention type(s): Device; Procedure
Intervention description(s): Ambu® AuraGain™ laryngeal mask will be placed first, and then, a lubricated endotracheal tube will be gently intubated through the laryngeal mask under each position according to the assigned group.; Patients' neck will be maximally extended (~60°) during blind intubation.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Prevention of Intrathecal Morphine Induced Pruritus: Comparison of Ondansetron and Palonosetron
Condition: Morphine Adverse Reaction
MeSH terms: Pruritus
Study type: Interventional

Summary: 
      Intrathecal administration of morphine is often used for control of postoperative pain.
      However, pruritus is one of the most common side effects of intrathecal morphine . Specific
      serotonin receptor antagonists could be an effective prophylactic treatment of neuraxial
      opioid-induced pruritus. It was reported that palonosetron is more effective than ondansetron
      for prevention of postoperative nausea and vomiting. Therefore, the investigators evaluated
      the efficacy of prophylactic administration of ondansetron and palonosetron for the
      prevention of intrathecal morphine-induced pruritus.
    

Detailed description: 
      Intrathecal administration of morphine is often used for relief of postoperative pain.
      However, pruritus is one of the most common side effects associated with intrathecal
      morphine. Specific serotonin receptor antagonists such as ondansetron could be an effective
      prophylactic treatment of neuraxial opioid-induced pruritus. It was reported that
      palonosetron is more effective than ondansetron for prevention of postoperative nausea and
      vomiting. Therefore, the investigators evaluated the efficacy of prophylactic administration
      of ondansetron and palonosetron for the prevention of intrathecal morphine-induced pruritus.
    

Intervention name(s): Ondansetron; Palonosetron
Intervention type(s): Drug; Drug
Intervention description(s): intravenous injection; intravenous injection
Other intervention name(s): zofran; aloxi
Intervention MeSH terms: Ondansetron; Palonosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: intrathecal; morphine; ondansetron; palonosetron; pruritus
The Ideal LiST Session Frequency Protocol for CPPS Treatment
Condition: Chronic Pelvic Pain Syndrome; Chronic Non-bacterial Prostatitis Type IIIB
MeSH terms: Prostatitis; Syndrome; Pelvic Pain
Study type: Interventional

Summary: 
      The study will include 50 chronic pelvic pain syndrome (CPPS) patients who will be randomised
      in 2 groups.

      Group A (25 patients )will receive 6 LiST sessions with a frequency 1 session / week.

      Group B (25 patients) will receive 6 LiST sessions with a frequency 2 sessions / week.

      National Institutes of Health Chronic Prostatitis Symptom Index(NHI-CPSI), International
      Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF-ED)
      questionnaires will be answered before and at 1 and 3 month follow up visit.

      Adverse events will be reported during the treatment and follow up period.
    


Intervention name(s): Low intensity shockwave therapy
Intervention type(s): Device
Intervention description(s): LiST will be applied in the perineum of the patients by using Dornier Aries 2 shockwave machine (5000shockwaves per session, energy level 7)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Use of an Oral Beta-2 Agonist in Persons With Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary purpose of this study is to determine the effect of administration of the oral
      beta-2 adrenergic agonist, albuterol, on respiratory muscle strength in individuals with
      cervical (neck) and high thoracic (upper back) spinal cord injury and to compare findings
      with those obtained in a demographically matched group that will receive placebo.
      Participation in this study will involve 12 weeks of pharmacological intervention during
      which participants will be randomized to receive either oral albuterol 4mg twice daily or
      placebo. All investigators and study participants will be blinded to randomization by our
      research pharmacy. Participation in the study will require study subjects to come to our lab
      for the total of 2 visits (at baseline and after week 12), during which a series of tests
      will be performed to assess their respiratory muscle strength and pulmonary function.
    


Intervention name(s): extended release beta-2 adrenergic agonist; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles.; An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.
Intervention MeSH terms: Adrenergic Agents; Adrenergic Agonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: spinal cord injury; beta-2 agonist; respiratory muscle strength; pulmonary function test
3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency
Condition: Ureter Injury
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine whether the use of 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium
      0.8% Solution for injection provides a visualization advantage compared to saline when used
      as an aid in the determination of ureteral patency
    

Detailed description: 
      This is an open-label, randomized, multicenter study to evaluate the efficacy, safety, and
      pharmacokinetics of two doses (2.5 mL and 5.0 mL) of
      3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium solution for injection when used as
      an aid in the determination of ureteral patency. Study will enroll up to 116 subjects from
      approximately 10 study centers in the United States.
    

Intervention name(s): 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%; Saline spray
Intervention type(s): Drug; Drug
Intervention description(s): Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination
      alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in
      the treatment of Hepatitis C in patients who have not responded to prior therapy.
    


Intervention name(s): BMS-790052; BMS-650032; BMS-650032; BMS-650032; Pegylated-interferon alfa-2a; Ribavirin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 60 mg, once daily, 24 weeks; Tablets, Oral, 600 mg, twice daily, 24 weeks; Tablets, Oral, 200mg, twice daily, 24 weeks; Tablets, Oral, 200 mg, once daily, 24 weeks; Syringe, Subcutaneous Injection, 180 µg, once weekly; Tablets, Oral
For subjects weighing < 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg
Twice daily (< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks
Other intervention name(s): Pegasys; Copegus
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; Asunaprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment