bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Effect of SCY-078 (Ibrexafungerp) on the PK of Pravastatin in Healthy Subjects
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Effect of Oral
      Doses of SCY-078 (Ibrexafungerp) on the Pharmacokinetics of Pravastatin Administered Orally
      to Healthy Subjects
    

Detailed description: 
      The two period crossover study will consist of two treatments administered in random order
      separated by a minimum 10 day washout interval (between the last dose in the first period and
      the first dose in the subsequent period).

      28 healthy adult male and female subjects will be enrolled to determine the effects of
      SCY-078 on the pharmacokinetics of a single-dose of PRA.

      Subjects will undergo a screening visit 4 weeks prior to dosing.

      Subjects will be randomized to a treatment sequence (AB or BA) in a crossover fashion:

      Treatment A = Single oral 20-mg dose of PRA on Day 1 AM.

      Treatment B = Twice daily (BID) oral doses of SCY-078 750 mg (5 X 150-mg tablets) on Day 1
      and Day 2; and on Day 3 a single AM dose of oral SCY 078 750 mg followed one hour later by a
      single 20-mg oral dose of PRA.

      All subjects will be admitted to the clinical site on Day -1 in each period and will then
      fast overnight and will stay in the clinical site until the final procedures are performed in
      that treatment period, and then they may be discharged.

      For Treatment B, on Day 1, 2, and 3, limited PK blood samples will be collected for SCY 078
      assays.

      For Treatments A on Days 1 and 2, and Treatment B on Day 3, serial PK blood samples will be
      collected for PRA assays.
    

Intervention name(s): PRA; SCY-078 plus PRA
Intervention type(s): Drug; Drug
Intervention description(s): Single oral 20-mg dose of PRA on Day 1 AM; Twice daily (BID), every 12 hours (Q12H) oral doses of SCY-078 750 mg on Day 1 and Day 2; and on Day 3 a single AM dose of oral SCY 078 750 mg followed by a single 20-mg dose of PRA administered one hour later
Intervention MeSH terms: Ibrexafungerp
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will be randomized to a treatment sequence (AB or BA) in a crossover fashion with a minimum 10-day washout period between treatments
Treatment A = Single oral 20-mg dose of PRA on Day 1 AM. Treatment B = Twice daily (BID), every 12 hours (Q12H) oral doses of SCY-078 750 mg on Day 1 and Day 2; and on Day 3 a single AM dose of oral SCY 078 750 mg followed by a single 20-mg dose of PRA administered one hour later.
Masking: None (Open Label)
Primary purpose: Other
Keywords: SCY-078; Ibrexafungerp; Pravastatin; Healthy Subjects; Pharmacokinetics
Analgesic Effect Of Intra-articular Bupivacaine Fentanyl for Postoperative Pain Relief in Knee Arthroscopic Surgery
Condition: Knee Arthroscopic Surgery
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      However, local anesthetic agents can produce analgesia for a limited time when used as a
      single injection. Bupivacaine is a local anesthetic that has an immediate action on pain by
      blocking peripheral afferents. However, as the ideal analgesic, the drug must cover the whole
      postoperative period (≥ 24 hours); therefore, bupivacaine is usually combined with many
      adjutants to provide long-lasting post-arthroscopy analgesia.
    

Detailed description: 
      Intr-articular drug administration has gained popularity because of its simplicity and
      efficacy in achieving anesthesia for diagnostic and operative arthroscopy and for providing
      postoperative analgesia .although the knee joint has been examined most commonly, arthroscopy
      of other joints such as shoulder, ankle, wrist, metatarsophalangeal and temporomandibular
      joints is being increasingly used.

      Intra-articular installation of local anesthesia during arthroscopic procedures has been used
      by many orthopedic surgeons to provide pain relief after surgery.The aim of this study was to
      evaluate the analgesic efficacy of intra-articular dexamethasone versus fentanyl added as an
      adjuvant to bupivacaine in patients undergoing knee arthroscopic surgery
    

Intervention name(s): Group DB/Dexamethasone-Bupivacaine; Group FB /Fentanyl-Bupivacaine; Group PB/Placebo-Bupivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The patient were received an intra-articular injection of 18ml bupivacaine 0.25% added to 8mg dexamethasone.; The patient were received an intra-articular injection of 1 ug/kg fentanyl added to 18ml of 0.25% bupivacaine.; Patients were received an intra-articular injection of 2ml isotonic saline added to 18ml of 0.25% bupivacaine.
Intervention MeSH terms: Dexamethasone; Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Pharmacokinetic Study Comparing Nicotine Delivery From E-cigarettes and a Conventional Cigarette in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will compare nicotine delivery, heart rate, puffing parameters and product
      satisfaction in healthy subjects either using several different types of electronic
      cigarettes or smoking a conventional cigarette.
    


Intervention name(s): Use electronic cigarette or smoke conventional cigarette
Intervention type(s): Other
Intervention description(s): Use of electronic cigarette or smoking conventional cigarette ad libitum for 5 minute period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A 3 Year Follow-up Prospective Open Randomized Trial of TVT Versus Colposuspension for Primary Stress Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: To compare TVT with COLPOSUSPENSION (CS) as primary treatment for stress
      incontinence (SUI).

      Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive
      35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district
      general hospital at Leganés (Madrid), Spain.

      Intervention: 24 patients randomised to TVT and 25 to CS.
    

Detailed description: 
      Background: Evidence comparing effectiveness of tension-free vaginal tape (TVT) and Burch's
      colposuspension (CS) in the long term follow-up is weak.

      Objective: To compare TVT with CS as primary treatment for stress incontinence (SUI).

      Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive
      35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district
      general hospital at Leganés (Madrid), Spain.

      Intervention: 24 patients randomised to TVT and 25 to CS. Measurements: Main outcome:
      Assessment before treatment and at 6-months, 1-year and 3-years postoperatively with the
      incontinence severity symptoms index (ISS) and the incontinence impact symptoms index (IIS)
      Secondary outcome: 3 groups to asses cure rates: cured, improved and failure.
    

Intervention name(s): Surgical treatment: TVT; Surgical treatment: colposuspension
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stress urinary incontinence; female incontinence; surgical treatment; Female stress urinary incontinence
Booster Dose of HCG for Unruptured Follicle in Non IVF/ICSI Cycles
Condition: LUF - Luteinised Unruptured Follicle Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will be conducted to assess the effect of booster dose of hCG on the unruptured
      follicles in non IVF/ICSI cycles.
    

Detailed description: 
      In this study enrolled patients (n=160) who underwent controlled ovarian stimulation and
      timed intercourse with unruptured mature graffian follicle 48 hours after IM 10,000 IU HCG
      dose. Patients were allocated randomly into intervention group and control group. In the
      intervention group another booster dose (10,000 IU of hCG) was given IM while in the control
      group 2 ml normal saline was given IM leaving follicles for spontaneous rupture
    

Intervention name(s): hCG; Saline Solution
Intervention type(s): Drug; Drug
Intervention description(s): A booster dose (10,000 IU of hCG) was given IM 48 hours after first triggering dose; 2 ml of normal saline will be injected 48 hours after first triggering dose
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cohort groups with parallel allocation
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: LUF; HCG; Booster dose; Ovulation rate; pregnancy rate
A Study Comparing the Impact of Mini-exchange-room and Usual Care on Physical Activity and Quality of Life in Peritoneal Dialysis Patients
Condition: Physical Activity; Quality of Life
Study type: Interventional

Summary: 
      To compare the effect of mini-exchange-room and usual care on physical activity and quality
      of life in peritoneal dialysis (PD) patients through a randomized controlled study. A total
      of 80 incident CAPD patients with age of 18~80 years old will be enrolled, who are medically
      stable and regularly followed up. The one group perform traditional PD procedure (G1), and
      the other group will utilize disposable mini-exchange-room group (G2). Two groups will be
      followed for 6 months. Biochemistry data, types of space for bag exchange, physical activity
      and quality of life will also be collected for all subjects at the 3rd and 6th month. During
      the study period, peritonitis episode, acute comorbidity and hospitalization will be
      recorded. The change of physical activity, quality of life and peritonitis rate will be
      compared between the two groups.
    


Intervention name(s): mini-exchange-room
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: mini-exchange-room; physical activity; quality of life; peritoneal dialysis
Safety Study of GNbAC1 in Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and tolerability of single ascending doses,
      as well as of repeated administrations of GNbAC1 in MS patients.

      Scientific research has shown that the expression of genes of a virus which is integrated in
      the Human genetic material, the Multiple Sclerosis associated RetroVirus (MSRV) could play a
      critical role in the causation of multiple sclerosis.

      GNbAC1 is an experimental medication, which neutralizes (i.e. inactivates) a protein of MSRV
      that might contribute to the development or deterioration of multiple sclerosis.
    


Intervention name(s): GNbAC1; GNbAC1 placebo
Intervention type(s): Biological; Biological
Intervention description(s): Single dose intravenous (IV) GNbAC1 2mg/kg or 6mg/kg; Single dose intravenous (IV) GNbAC1 placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Relapsing Forms of Multiple Sclerosis; Progressive Forms of Multiple Sclerosis; GNbAC1; Monoclonal antibody; Multiple Sclerosis Associated Retrovirus (MSRV); Temelimab
Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III
Condition: Leukemia, Lymphocytic, Acute
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 3

Summary: 
      Improved outcome of high risk lymphoblastic leukemia (ALL) with laite high dose therapy.

      High dose versus conventional therapy for adult low risk T-ALL and Lymphoblastic lymphoma
      (LBL).
    

Detailed description: 
      Comparison between two autograf therapeutic strategies in high risk patients Ramdomised
      comparison between maintenance treatment with or not interferon alpha 2 a
    

Intervention name(s): interferon alpha 2a
Intervention type(s): Drug
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Zepatier For Treatment Of Hepatitis C-Negative Patients Who Receive Heart Transplants From Hepatitis C-Positive Donors (HCV)
Condition: Heart Failure
MeSH terms: Hepatitis C; Hepatitis; Heart Failure
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is being conducted to determine safety and effectiveness of transplanting hearts
      from Hepatitis C-positive donors into Hepatitis C-negative patients on the heart transplant
      waitlist, who will then be treated with Zepatier after transplantation.
    

Detailed description: 
      Open-labelled pilot clinical trial of Zepatier (MK-5172 and MK-8742/Grazoprevir + Elbasvir)
      in at least 20 HCV-negative subjects receiving a heart transplant from a HCV-positive donor.
      Eligible subjects will receive a heart transplant from a deceased-donor with genotype 1 or 4
      HCV, and then will receive 12 weeks of Zepatier after heart transplantation when infection
      with HCV is confirmed in these heart transplant recipients. Treatment will be complete after
      12 weeks.
    

Intervention name(s): Zepatier
Intervention type(s): Drug
Intervention description(s): Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected. In this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.
Intervention MeSH terms: Elbasvir-grazoprevir drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart Failure
MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to
      determine if motavizumab is more effective than placebo in reducing RSV hospitalization in
      otherwise healthy Native American Infants in the Southwestern United States during their
      first RSV season.
    

Detailed description: 
      MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to
      determine if motavizumab is more effective than placebo in reducing RSV hospitalization in
      otherwise healthy Native American infants during their first RSV season.

      Participants were randomized in a 2:1 ratio to receive either 15 mg/kg motavizumab or placebo
      by intramuscular (IM) injection every 30 days during the RSV season for a maximum of 5
      injections.

      During their first RSV season, participants were evaluated monthly just prior to each
      injection of study drug for adverse events (AEs) (including medically attended otitis media),
      with a final post-dosing follow up evaluation at Study Day 150. During Seasons 1, 2, and 3,
      blood was to be collected prior to the first and last dose of study drug for serum chemistry
      evaluations, motavizumab serum concentrations, and anti-motavizumab antibodies. Efficacy and
      safety outcomes were examined through Study Day 150 and wheezing outcomes were evaluated from
      the time of randomization until the third birthday.
    

Intervention name(s): Motavizumab; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Intramuscular dose of motavizumab 15 mg/kg will be administered every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.; Intramuscular dose of placebo matched to motavizumab will be administered every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the the RSV season.
Other intervention name(s): MEDI-524
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: RSV, infants, Native American Indians
Inflammation and the Metabolic Syndrome in Humans
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Syndrome; Inflammation
Study type: Interventional

Summary: 
      People who are overweight are at increased risk of heart disease. Being overweight and having
      heart disease are linked in that both involve inflammation. Inflammation refers to the body's
      first line of defense against infection and injury. Metabolic changes in cholesterol,
      triglycerides (fat in the blood) and sugar in the blood caused by inflammation are similar to
      that in some people who are overweight. The investigators wish to examine the effects of
      inflammation on these metabolic changes that may lead to heart disease.
    

Detailed description: 
      This study is a single site, open-label, "baseline-controlled" (pre LPS saline period) study
      examining the pro-atherosclerotic metabolic responses and safety responses to a single
      administration low-dose (3 ng/kg) endotoxin (LPS) in 20 additional non-metabolic syndrome
      participants: 10 healthy overweight and 10 healthy lean counterparts (20 non-metabolic
      syndrome participants were studies in first phase), and 40 subjects with the metabolic
      syndrome. We are continuing to use an approach whereby "metabolic syndrome" subjects will be
      recruited to have key metabolic syndrome abnormalities that are sensitive to insulin
      resistance compared to the non-metabolic syndrome groups, although all of these "metabolic
      syndrome" subjects may not fulfill traditional NCEP criteria for the syndrome.
    

Intervention name(s): Endotoxin (LPS)
Intervention type(s): Biological
Intervention description(s): Single administration low-dose (3 ng/kg) endotoxin (LPS).
Other intervention name(s): LPS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
New Biopsy Needle - Evaluation of Prostate Biopsy Quality
Condition: Prostate Cancer (Diagnosis)
MeSH terms: Prostatic Neoplasms; Neoplasms
Study type: Interventional

Summary: 
      Patient blinded randomized prospective trial evaluating prostate biopsy quality of a novel
      biopsy needle.
    

Detailed description: 
      Prostate biopsy is the golden standard for diagnose of prostate cancer. Transrectal prostate
      biopsy (TRUSbx) is the most widely used technique. Due to the transrectal path the biopsy
      needle will bring bacteria from the colon into tissue. The patent should always receive
      prophylactic antibiotics to reduce the risk of clinical infection. Infections related to
      transrectal prostate biopsy (TRUSbx) are increasing in parallel with rising antibiotic
      resistance.

      The investigators have in an ex-vivo setting previously shown a drastic reduction in
      bacterial transfer across the colon wall using a novel biopsy needle designed to minimize
      bacterial transfer. Biopsy of prostatectomy specimen using the novel needle has shown biopsy
      quality equal to the tru cut biopsy needle used today.

      This is the first human pilot aiming to evaluate if biopsy quality of the novel needle is
      equal to the reference tru cut biopsy needle in prostate biopsy.
    

Intervention name(s): TRUSbx
Intervention type(s): Device
Intervention description(s): Trans Rectal UltraSound guided Prostate Biopsy
Other intervention name(s): prostate biopsy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 20 patients eligible for prostate biopsy are randomized into 2 arms (10+10 patients) using either the novel needle and actuator device or standard tru cut needle and actuator device used in the clinic today. On average 12 biopsies are taken from each patient. Biopsy quality is evaluated by the pathologist blinded to device used.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: biopsy quality
Towards Simple and Non-invasive Assessment of Residual Beta-cell Function in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Type 1 diabetes is condition in which progressive autoimmune destruction of insulin-producing
      beta-cells leads to absolute insulin deficiency. At the time of clinical presentation, it is
      estimated that 50-80% of beta-cell function has been lost. Good glycaemic control from
      diagnosis has been shown to preserve beta-cell function. The recent identification of
      immuno-interventions able to reduce autoimmune destruction and preserve beta-cell function
      has lead to an increased urgency to develop such tools.

      With mixed-meal stimulated serum C-peptide being a gold standard, there are currently no
      tests that are suited for use in clinical practice to detect and monitor residual beta cell
      function. There is a therefore a need for a test that is sufficiently sensitive to assess
      beta cell function reserve in Type 1 diabetes for clinical practice purposes, which will be
      simple, reproducible and suitable for use even in the non-observed setting.

      Using mixed meal stimulation of plasma C-peptide (stable by-product in insulin secretion that
      reliably reflects insulin production) response as a reference, we propose to compare mixed
      meal stimulated urinary C-peptide as potential candidate for this application. This is a
      pilot investigation in which a sample of 30 participants will be recruited.

      It is anticipated that the current project will identify a simple method for analysing beta
      cell reserve in Type 1 diabetes. This will then be applied to screening clinic populations of
      recently diagnosed patients with type 1 diabetes. The aim will be to identify subjects who
      may be suitable for early intensified insulin regimes (e.g. insulin pump therapy) and novel
      immuno-intervention strategies designed to preserve residual beta cell function and improve
      long-term outcomes. Currently such immunointervention has been reserved for subjects within 3
      months of diagnosis only, excluding a significant number of subjects who may potentially
      benefit.
    


Intervention name(s): Mixed meal stimulated urinary C peptide for the assessment of residual beta cell function
Intervention type(s): Other
Intervention description(s): Study will be designed to assess stimulated urinary C-peptide in comparison to mixed-meal stimulated plasma C-peptide response in the same individual in 30 number of patients with Type 1 diabetes.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with Type 1 diabetes diagnosed in the last 5 years
      
Keywords: Beta cell reserve, urinary C peptide