bioihbjkbjnl/mcl2 huggingface dataset:
Comparison Study of the ICON™ CPAP Series With and Without SensAwake™
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the
      pressure during wakefulness may improve therapy comfort and potentially adherence without
      compromizing therapy efficacy. SensAwake™ is a unique pressure relief technology developed by
      Fisher & Paykel Healthcare which detects irregularity in the flow signal indicative of the
      transition from sleep to wake. When the transition from sleep to wake is detected the device
      promptly reduces the pressure to help facilitate a return to sleep.

      The purpose of this study is to compare adherence and sleep quality outcomes in patients
      treated by CPAP with and without SensAwake technology.

      It is hypothesised that participants with SensAwake on will have improved adherence and sleep
      quality.
    


Intervention name(s): SensAwake On; SensAwake Off
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Bunionectomy Trial With GRT6005
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the trial is to determine whether the new centrally acting analgesic is
      effective in comparison to placebo and an active comparator (morphine).
    


Intervention name(s): GRT6005; Morphine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): liquid formulation, 200 to 600 µg, single dose, one day; 60 mg; single dosage
Other intervention name(s): Morphine
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: analgesic; bunionectomy; surgery; post operative pain; single Hallux valgus repair
An Open Label, Single Arm, Dose Escalation Phase 1 Trial of PRI-724 in Patients With HCV-induced Cirrhosis
Condition: Hepatitis C Virus-infected Cirrhosis
MeSH terms: Hepatitis C; Hepatitis; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of PRI-724 in
      patients with HCV-induced cirrhosis.
    

Detailed description: 
      This is a single-center, open-label, continuous i.v. administration, dose escalation Phase I
      study in patients with hepatitis C cirrhosis.

      One cycle consisted of one-week continuous i.v. administration of PRI-724 followed by a
      one-week observation period. One cohort was a total of six cycles, a 12-week treatment
      period.

      PRI-724 was administered at a dose of 10 mg/m2/day in Cohort 1, 40 mg/m2/day in Cohort 2, and
      160 mg/m2/day in Cohort 3 in a dose escalation manner. Each cohort was to include 6 subjects.
    

Intervention name(s): PRI-724
Intervention type(s): Drug
Intervention description(s): 10 - 160 mg/m2, 7 days CIV (in the vein) with 7 days rest per one cycle. Number of Cycles: 6.
Other intervention name(s): CBP-beta-catennin inhibitor; OP-724
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C virus, cirrhosis
Single Embryo TrAnsfeR of Euploid Embryo
Condition: Infertility; Aneuploidy
MeSH terms: Infertility; Aneuploidy
Study type: Interventional

Summary: 
      The purpose of the current study is to evaluate the effect of preimplantation genetic
      screening (PGS) by next generation sequencing (NGS) compared to standard morphological
      assessment of embryos on pregnancy rates through a randomized controlled trial (RCT). All
      embryos will be vitrified and a single embryo transfer (SET) will be performed with either
      screened or unscreened embryos depending on randomization.
    


Intervention name(s): Preimplantation Genetic Screening by NGS
Intervention type(s): Other
Intervention description(s): The VeriSeq PGS takes advantage of next-generation sequencing (NGS) technology to provide comprehensive, accurate screening of all 24 chromosomes for selection of euploid embryos.
Other intervention name(s): Veriseq PGS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Preimplantation Genetic Screening; Blastocyst; Vitrification; In vitro fertilization; non-invasive prenatal testing; next generation sequencing
A Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a prospective, single-center, open-label, single-dose, Phase 1 study, to assess the
      effect of mild, moderate, and severe hepatic impairment due to liver cirrhosis on the
      pharmacokinetics of ACT-541468.
    


Intervention name(s): ACT-541468 25 mg; ACT-541468 25 mg (or 10 mg depending on interim results)
Intervention type(s): Drug; Drug
Intervention description(s): Administered as a tablet.; Administered as a tablet.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: prospective, single-center, open-label, single-dose
Masking: None (Open Label)
Primary purpose: Other
Effect of Local Anesthetic Dose on Interscalene Block
Condition: Shoulder Arthroscopy; Interscalene Block
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a decrease in the standard volume of local
      anesthetic used to numb your shoulder area before shoulder arthroscopy will provide adequate
      anesthesia for the procedure and decrease the amount of time until you are ready for
      discharge from the hospital.
    

Detailed description: 
      Traditionally, an interscalene block is done either with nerve stimulator or ultrasound
      guided using 40-60mL of local anesthetic. The study plans to investigate the difference in
      hand grip strength post-operatively in patients who will receive interscalene blocks with
      40mL versus a lower dose (20mL) of local anesthetic. We suspect the lower dose will achieve
      adequate surgical anesthesia while creating less motor block and thus, increase patient
      satisfaction, present fewer complications or adverse affects and decrease time in the
      recovery room.
    

Intervention name(s): Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block; Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block; Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine); Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): Anesthetic volume:
Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL; Anesthetic volume:
Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL
Other intervention name(s): Mepivacaine; Bupivacaine; Mepivacaine; Bupivacaine
Intervention MeSH terms: Bupivacaine; Anesthetics, Local; Mepivacaine; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Interscalene Block
Study to Evaluate CORT125134 in Participants With Cushing's Syndrome
Condition: Cushing's Syndrome
MeSH terms: Cushing Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Cushing's syndrome is a relatively rare disorder caused by prolonged exposure to high levels
      of the glucocorticoid hormone cortisol. Cushing's syndrome may result from elevated
      endogenous or exogenous sources of cortisol. Endogenous Cushing's syndrome resulting from
      cortisol overproduction by the adrenal glands is the subject of this protocol.

      Patients with exogenous Cushing's syndrome, which develops as a side effect of chronic
      administration of high doses of glucocorticoids, were not eligible for enrollment in this
      study.

      The purpose of this study was to evaluate the safety and efficacy of CORT125134 for treatment
      of endogenous Cushing's syndrome. The multicenter study was conducted in the United States
      and in Europe.
    

Detailed description: 
      This was a Phase 2, open-label study with two dose groups, each with a two-step dose
      escalation, designed to evaluate the safety and efficacy of CORT125134 for the treatment of
      endogenous Cushing's syndrome. CORT125134 was administered orally once daily for 16 weeks
      with dose escalations occurring every 4 weeks.

      Pharmacokinetics (PK) profiles were generated at every dose level. A data review committee
      reviewed PK and safety data and recommended the final plan for dose escalation in Group 2.
    

Intervention name(s): CORT125134
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cushing's Syndrome; Cushing's Disease; Cushing's; Hypercortisolemia; Cushingoid; Type 2 Diabetes; Impaired Glucose Intolerance; Hypertension; Adrenal Corticotrophic Hormone (ACTH); Adrenocortical Carcinoma; Primary Pigmented Nodular Adrenal Disease (PPNAD); Moon Facies; Dorsocervical Fat Pad; Adrenal Adenoma; Adrenal Carcinoma; Adrenal Autonomy; Cortisol
A Study to Evaluate the Safety and Tolerability of YM150 in Healthy Caucasian and Japanese Male and Female Subjects, and to Assess the Effect That Gender May Have on Its Actions in the Body
Condition: Pharmacokinetics; Pharmacodynamics; Healthy Subjects; Caucasian; Japanese
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims to investigate the effect of YM150 and to compare gender and ethnic
      differences in healthy Caucasian and Japanese male and female subjects.
    

Detailed description: 
      Each dose group consists of a cohort of 8 Caucasian and 8 Japanese male subjects to be
      randomized such that 6 subjects of each race receive active treatment and 2 subjects of each
      race receive matching placebo. The highest tolerated dose is repeated with a cohort of 8
      Caucasian and 8 Japanese female subjects, unless emerging safety and PK information justifies
      higher dose levels or require additional female dose groups.

      Each subject is administered a single dose YM150 or placebo on Day 1 followed by multiple
      doses of YM150 or placebo once daily on Days 3 to 9.
    

Intervention name(s): YM150; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): darexaban
Intervention MeSH terms: Darexaban
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Pharmacodynamics; Phase 1; YM150; Dose-escalating; Ethnicity; Caucasian; Japanese
Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To evaluate the effects of SAR440340 with or without dupilumab, compared to placebo, on
      reducing the incidence of "loss of asthma control" (LOAC) events.

      Secondary Objectives:

      To evaluate the effects of SAR440340/REGN3500 and coadministration of SAR440340 and
      dupilumab, compared with placebo, on forced expiratory volume in 1 second (FEV1).

      To evaluate the effects of coadministration of SAR440340 and dupilumab, compared with
      SAR440340 and compared with dupilumab, on FEV1.

      To assess safety and tolerability of SAR440340 alone and in coadministration with dupilumab.
    

Detailed description: 
      The total duration of the study (per participant) was approximately 36 weeks, including 4
      weeks screening, 12 weeks treatment, and 20 weeks post-treatment.
    

Intervention name(s): SAR440340; Dupilumab; Fluticasone or Fluticasone/salmeterol combination; Placebo for SAR440340; Placebo for dupilumab
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: Solution for Injection, Route of administration: SC; Pharmaceutical form: Solution for Injection, Route of administration: SC; Pharmaceutical form: Aerosol, dry powder, Route of administration: Inhaled; Pharmaceutical form: Solution for Injection, Route of administration: SC; Pharmaceutical form: Solution for Injection, Route of administration: SC
Other intervention name(s): REGN3500; SAR231893 (REGN668)
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Acupuncture for Post-Operative Pain Control for Patients Undergoing Gynecological Surgery
Condition: Post-operative Pain; Gynecological Surgery; Acupuncture
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This study investigates the role of acupuncture in controlling post-operative pain in
      patients who have undergone gynecological surgery.
    

Detailed description: 
      The goal of the study is to investigate acupuncture at the time of gynecological surgery as a
      way to decrease post-operative pain which would decrease narcotic intake and hospitalization
      time. To do this, the researchers will recruit non-pregnant patients over the age of 18 who
      are undergoing laparoscopic surgery for a benign gynecological indication. These patients
      will be randomized using a computer generated randomization system to receive either
      acupuncture or sham acupuncture pre-operatively after the induction of anesthesia. The
      acupuncture points used will be points proven in the literature to be associated with
      decreasing general pain, pelvic pain and nausea and vomiting. The needles will be placed by a
      anesthesiologist trained in acupuncture and they will be left in place for 15 minutes while
      the patient is prepped for the surgery. The sham points will be on the hands and feet and
      chosen at random by the gynecologic surgeon who is not trained in acupuncture. For both
      groups, the acupuncture needles will be removed before the first incision of the surgery. All
      patients will be blinded to their group allocation.
    

Intervention name(s): Acupuncture needles
Intervention type(s): Device
Intervention description(s): Acupuncture needles (29 and 30 gauge) used to perform the acupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: surgery; acupuncture; gynecology; pain; narcotics
Long- and Midterm Outcomes of Osteoarticular Infections in Paediatric Patients
Condition: Acute Haematogenous Osteomyelitis; Septic Arthritis
MeSH terms: Infections; Osteomyelitis; Arthritis, Infectious; Arthritis
Study type: Observational

Summary: 
      Multi-centre clinical follow-up study on patients with a history of acute haematogenous
      osteomyelitis and/or septic arthritis. The aim is to describe the frequency of sequelae in
      these former patients with osteoarticular infections. Patients will be invited to participate
      in a single follow-up visit including a standardised interview and a clinical examination.
      The collected data will be analyzed together with data from the patient's hospital stay.
    

Detailed description: 
      Clinical follow-up study on patients with a history of acute haematogenous osteomyelitis
      and/or septic arthritis and were admitted to one of the participating centres between 2005
      and 2014.

      Former patients will be invited to participate in a single-follow-up visit which comprises a
      standardised interview (pain, disabilities in daily life and regarding sports) and a
      standardized clinical examination of the previously affected body part. This includes
      assessment of range of motion in affected and adjacent joints and in case of previously
      affected lower extremity leg axis, gait and body height (percentile).

      The data collected during the follow-up visit will be analyzed in a descriptive manner
      together with data of the patient's hospital stay including baseline data, laboratory works,
      microbiological results and both antibiotic and surgical treatment.
    

Intervention name(s): no intervention, only clinical examination
Intervention type(s): Other
Intervention description(s): standardised interview and clinical examination
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Former patients admitted to one of the participating centres for an acute osteoarticular
        infection.
      
Keywords: Acute Haematogenous Osteomyelitis; Septic Arthritis; Outcome; Osteoarticular Infections; Follow-up
Study of Cingal® for Symptomatic Relief of Osteoarthritis of Hip Joint
Condition: Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 3

Summary: 
      This Trial will obtain clinical data to support an expanded indication for a single injection
      of Cingal® used for the symptomatic relief of osteoarthritis in the hip joint.
    

Detailed description: 
      CINGAL® is a chemically cross-linked sodium hyaluronate combined with Triamcinolone
      Hexacetonide supplied as a 4-mL unit dose in a 5-mL glass syringe. Cingal will be injected
      into the intraarticular (IA) space of the index hip using an 18-21-gauge needle. It is used
      for the symptomatic relief of osteoarthritis in the hip joint.
    

Intervention name(s): Cingal
Intervention type(s): Device
Intervention description(s): CINGAL® is a chemically cross-linked sodium hyaluronate combined with Triamcinolone Hexacetonide supplied as a 4-mL unit dose in a 5-mL glass syringe.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sodium Hyaluronate; Triamcinolone Hexacetonide
Green Tea Extract for Endometriosis Treatment
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of green tea in
      endometriosis.
    

Detailed description: 
      Women with endometrioma will be randomised into either the experimental group or the placebo
      comparator group in a 1:1 ratio. The subjects will be given SUNPHENON EGCg or placebo for 3
      months prior to their planned surgery.
    

Intervention name(s): SUNPHENON EGCg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SUNPHENON EGCg Oral, 400mg, twice per day; Placebo
Other intervention name(s): green tea extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery
Condition: Breast Cancer; Mastectomy; Perfusion; Complications; Hemostasis
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Low thermal dissection devices have been introduced as a tool to improve surgical outcomes.
      PlasmaBlade, a low thermal dissection device, has shown to be associated with effective
      cutting, and significantly lower temperature than traditional electrosurgical dissection
      device. Thus, low thermal devices would improve flap perfusion by decreasing the thermal
      injury resulted by the dissection. Looking into the use of low thermal devices in cases of
      mastectomy and immediate breast reconstruction has not been documented. The aim of this study
      is to determine if there are clinical flap perfusion, surgical site drainage, and pain scores
      differences between mastectomy flaps created using low thermal dissection device and those
      done with the standard care of Bovie cautery in order to warrant a formal study.
    

Detailed description: 
      This is a single-blinded, randomized, controlled clinical trial comparing postoperative flap
      perfusion and surgical site drainage between patients randomized to breast flap creation by
      PlasmaBlade (low thermal dissection intervention) on one breast and by a Bovie cautery
      (Control) for the contralateral breast flap. Candidates will have elected to undergo
      bilateral post-mastectomy immediate breast reconstruction (IBR). Participants meeting
      inclusion criteria will be enrolled and baseline data collection completed prior to
      randomization and surgery.

      Patients and the plastic surgeon will be blinded in regards to intervention randomization.
      Only the oncology surgeon has knowledge of which device used for each breast flap. However,
      after the plastic surgeon makes the assessment of the flap, he/she will be unblinded in order
      to complete the reconstruction procedure using the same dissection device on the same side it
      was used for in the mastectomy procedure. Patient-specific surgical details will be recorded
      intraoperatively. Following the surgery, post-operative flap perfusion will be recorded using
      SPY imaging system. Surgical site drainage will be measured until drainage removal.
      Post-operative pain (Visual Analog Scale for Pain) and the occurrence of adverse events will
      be recorded up until discharge and 30-days postoperative follow up visit.
    

Intervention name(s): PlasmaBlade 3.0S
Intervention type(s): Device
Intervention description(s): PlasmaBlade (Medtronic) is approved by United States Food and Drug Administration (FDA) as a low thermal dissection device that has shown to be associated with effective cutting, and significantly lower temperature than traditional electrosurgical dissection devices.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Device Feasibility
Keywords: Breast cancer; Mastectomy; Perfusion; Hemostasis