bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Effect of a Strong CYP3A Inhibitor, on Surufatinib in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a 2-period study conducted with 14 healthy male or female subjects.
      Subjects will be administered surufatinib alone in Period 1 and in combination with
      itraconazole in Period 2.
    

Detailed description: 
      This study will be a single center, open label, fixed-sequence crossover, 2-period study
      conducted with 14 healthy male or female subjects. Subjects will be administered surufatinib
      alone in Period 1 and in combination with itraconazole in Period 2. PK samples will be
      collected through out both study periods.Subjects will be confined in the clinic from
      check-in on Day -1 through the end-of study visit on Day 15.
    

Intervention name(s): Surufatinib; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Surufatinib: 200 mg as single dose on Days 1 and 9; Itraconazole: 200 mg BID on Day 5, then 200 mg QD on Days 6 to 14
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of Canola Oil and Coconut Oil on Postprandial Metabolism in Older Adults With Increased Cardiometabolic Risk
Condition: Cardiovascular Diseases; Metabolic Syndrome
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to investigate the postprandial effects of fat content and fatty
      acid composition of mixed meals on parameters associated with cardiometabolic diseases.
      Therefore, older subjects with increased risk of cardiometabolic diseases consume 4 mixed
      meals with 25 or 50 g of either canola or coconut oil. In a postprandial period of 6 hours,
      outcomes associated with cardiometabolic risk (e.g., triglycerides) are analyzed.
    

Detailed description: 
      In a crossover design, 30 older men and women with increased risk of cardiometabolic diseases
      consume 4 mixed meals, enriched with either 25 or 50 g canola or coconut oil. During a
      postprandial period of 6 hours, parameters of lipid metabolism (e.g., plasma triglycerides),
      glucose metabolism (e.g., plasma glucose, serum insulin), as well as markers of inflammation
      (e.g., IL-6), vascular system (e.g., pulse wave velocity) and antioxidant system (e.g.,
      trolox equivalent antioxidative capacity) are analyzed. Furthermore, fatty acid profile,
      neuropsychologic parameters (e.g., appetite) and satiety-associated hormones (e.g., Ghrelin)
      are assessed. Each intervention arm will be separated by a washout period of about 14 days.
    

Intervention name(s): Mixed meals
Intervention type(s): Dietary Supplement
Intervention description(s): Mixed meals enriched with either 25 or 50 g of canola or coconut oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Postprandial metabolic events
Comparison Between Serratus Anterior Plane Block and Erector Spinae Plane Block for Mastectomy
Condition: Breast Cancer Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      In this study, we are comparing two different techniques of plane blocks to control
      postoperative mastectomy pain serratus anterior plane block and erector spinae plane block,
      both are done with ultrasonic guidance We are recording the first time of analgesia request
      postoperatively as a primary outcome
    


Intervention name(s): Plane block
Intervention type(s): Procedure
Intervention description(s): Two different plane blocks to control post-mastectomy pain
Other intervention name(s): Block
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective comparative randomized clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Study on Pharmacokinetics
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of the coadministration of multiple doses
      of BMS-663068 on the systemic exposure of rosuvastatin.
    


Intervention name(s): Rosuvastatin; BMS-663068
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fostemsavir; Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Almond for Physical Performance
Condition: Muscle Soreness; Energy
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      Investigators specific aims are to compare the effects of consuming daily snacks of raw,
      shelled, unsalted almonds (2.0 ounces) versus an isocaloric amount of another commonly
      consumed snack food (pretzels) on energy (vigor) perception and physical activity, exercise
      performance (VO2max and measures of strength), strength and power performance as well as
      muscle soreness recovery after strenuous eccentrically-biased exercise.
    

Detailed description: 
      To accomplish these aims, investigators will examine whether regular consumption of almonds
      versus a common snack food over a period of 8 weeks impacts longer term metabolic,
      physiological and behavioral responses related to energy sensations and exercise
      capacity/performance.
    

Intervention name(s): Almond; Control group
Intervention type(s): Other; Other
Intervention description(s): 2.0 oz of raw, shelled, unsalted almonds; an isocaloric amount of unsalted pretzels
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
The Influence of Perioperative Optimisation to the Hip Arthroplasty Outcomes
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

Summary: 
      Success of the hip arthroplasty depends on the measures that optimize perioperative
      conditions.It is planned to evaluate semi-closed loop system in the hip arthroplasty surgery.
    

Detailed description: 
      Success of the total hip arthroplasty depends on the measures that optimize perioperative
      conditions. They increase the emotional stress of the staff and error probability. It is
      planned to evaluate semi-closed loop infusion system, its adaption for infusion application's
      influence to near and far treatment outcomes done by prospective randomized clinical trial.
      This is done by performing total hip arthroplasty. It's expected to evaluate the semi-closed
      loop system's influence on the doctor's emotional tension during the decision making.
    

Intervention name(s): Semi-closed loop infusion system tactic.; Routine infusion therapy tactic
Intervention type(s): Procedure; Procedure
Intervention description(s): Semi -closed loop infusion system tactic.Use volume loading test twice (before surgery and 12hrs postoperatively). Computer provides advisory hypotension treatment algorithm. Computer provides advisory anemia treatment algorithm. Programmed iv fluid and blood infusions system ,,Belmont Rapid Infuser" and programmable syringe pump for adrenaline infusion.; Routine re-hydration bolus before surgery. Routine treatment of hypotension. Routine treatment of anemia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Prognostic Value of Progesterone for In Vitro Fertilization (IVF) Outcome
Condition: Subfertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      This observational study attempts to investigate the potential role of serum progesterone
      levels on the day of hCG administration (thus, the end of the follicular phase) on the
      probability of pregnancy, in patients undergoing IVF with the use of GnRH antagonists and
      recombinant gonadotrophins.

      There has been evidence, that increased serum levels of progesterone are associated with a
      decreased probability of pregnancy after IVF.

      This study will attempt to explore the role of progesterone on the outcome of IVF, by closely
      monitoring its levels during the late follicular phase.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women undergoing ovarian stimulation with the use of rFSH and GnRH antagonists for in-vitro
        fertilization.
      
Biospecimen description: 
      6ml of serum will be frozen and stored for later analysis
Study on the Efficacy of LAS41005 in the Treatment of Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the efficacy of LAS41005 in comparison to placebo
      and to LAS106521 in actinic keratosis (AK).
    

Detailed description: 
      To investigate as primary objective:

        -  Superiority to placebo and non-inferiority to LAS106521 measured by histological
           clearance of one predefined target lesion;

      To investigate as secondary objective:

        -  Superiority to LAS106521

        -  Improvement of treated lesions (lesion response)

        -  Assessment of tolerability and safety by physicians global assessment score (PGA, PGT)

        -  Patient's assessment of tolerability and efficacy and patient's compliance
    

Intervention name(s): Placebo Gel; LAS41005; LAS106521
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Topical; Topical; Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Actinic Keratosis; AK; NMSC; Combination
A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 1 of 2)
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient,
      early-intervention evaluation of subjects who have migraine with or without aura and who
      discontinued use of short acting triptan(s) within the past year due to non-response or
      intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each
      attack; one attack will be treated with one tablet of the Combination Product (sumatriptan
      succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover
      design). [Study 1 of 2]
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient,
      early-intervention evaluation of subjects who have migraine with or without aura and who
      discontinued use of short acting triptan(s) within the past year due to non-response or
      intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each
      attack; one attack will be treated with one tablet of the Combination Product (sumatriptan
      succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover
      design); however, the order of these treatments will be randomized. A minimum 1-week washout
      period is required between study medication treatment of the first and second migraine
      attacks.

      Each subject will have two visits: (1) a Screening visit at study entry and (2) a Final visit
      4-10 days after the second (or last) attack. A telephone contact will also be required 1-3
      days after the first attack, and then once per month until the Final visit.

      The primary study objective is to assess efficacy as measured by sustained pain-free (SPF)
      relief of Combination Product compared to placebo in treating migraine subjects who have
      previously discontinued treatment with short acting triptans (rizatriptan, sumatriptan,
      almotriptan, zolmitriptan, and eletriptan).
    

Intervention name(s): Combination Product (sumatriptan succinate / naproxen sodium); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Bilayer tablet containing 85mg sumatriptan (as 119mg sumatriptan succinate; fast disintegrating/rapid release formulation) active ingredient in one layer, and 500mg naproxen sodium active ingredient in the second layer.; Matching placebo tablet.
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Combination Product; naproxen sodium; sumatriptan succinate; short acting triptan; migraine, acute; Poor response
The CArdiovasCulAr Diabetes & Ethanol (CASCADE) Trial
Condition: Diabetes; Prediabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      Moderate alcohol may be beneficial for diabetics
    


Intervention name(s): alcohol
Intervention type(s): Dietary Supplement
Intervention description(s): 150 cc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: alcohol diabetes CVD
Probiotic in Treatment of Adult Patients With Drug-resistant Epilepsy
Condition: Epilepsy; Treatment
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a randomized, double-blind parallel group placebo-controlled clinical trial
      with the aim of investigating the effect of probiotic versus placebo on drug-resistant adult
      patients with epilepsy.
    


Intervention name(s): Probiotic
Intervention type(s): Drug
Intervention description(s): Each probiotic capsule contained combination of lactobacillus and Bifidobacterium species.
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
SD, IL-13 Production Rate in IPF
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate how QAX576 affects levels of interleukin 13
      (IL-13) in patients with idiopathic pulmonary fibrosis (IPF).
    


Intervention name(s): QAX576
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Idiopathic Pulmonary Fibrosis
Transdiagnostic Sleep and Anxiety Treatment
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Background: Anxiety and insomnia disorders are two of the most common and costly mental
      health conditions. These disorders are frequently comorbid, but current treatment approaches
      do not target both. To streamline treatment for these commonly comorbid conditions, a novel,
      computerized intervention was developed targeting a transdiagnostic factor, safety aids,
      which are cognitive or behavioral strategies individuals use to cope with distress associated
      with anxiety or insomnia, that paradoxically exacerbate symptoms. A randomized controlled
      trial was conducted to determine the acceptability and efficacy of this newly developed
      intervention. Method: Young adults (N = 61) with elevated anxiety and insomnia symptoms were
      randomized to receive the anxiety-insomnia intervention or a computerized control condition
      focused on general physical health behaviors. After the intervention, participants were
      followed up at one week and one month and completed self-report measures.
    


Intervention name(s): FSET Anxiety and Sleep Treatment; Control
Intervention type(s): Other; Other
Intervention description(s): Computerized anxiety and insomnia intervention.; Physical health control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Femoral Neuropathy After Anterior Cruciate Ligament Reconstruction: Femoral Nerve Block vs Patient-controlled Analgesia (PCA)
Condition: Femoral Neuropathy
MeSH terms: Femoral Neuropathy
Study type: Interventional

Summary: 
      Femoral neuropathy after anterior cruciate ligament reconstruction with femoral nerve block
      may be as high as 24% at 6 postoperative weeks when evaluated prospectively and
      systematically through a clinical neurological and an electroneuromyography (ENMG). It is
      still unclear whether this neuropathy is the result of the surgery, especially the
      Tourniquet, or the block nerve. The goal of this study is to define the etiology of this
      postoperative neuropathy.
    

Detailed description: 
      Anterior cruciate ligament reconstruction is associated with moderate to severe postoperative
      pain. Among different analgesic strategies, continuous femoral nerve block is reported as an
      efficient method, reducing opioid consumption and allowing rapid rehabilitation; however,
      patients may develop a transient neuropathy after surgery, which could have a significant
      impact on active patients, particularly on athletes who need immediate rehabilitation and who
      will put their knee to greater use during the postoperative period. This study is designed to
      compare the incidence of femoral neuropathy in two groups of patients: one with a femoral
      nerve block, and one with a PCA of morphine (self-iv administration of morphine). All
      patients will have a clinical neurological exam with a preoperative ENMG in order to rule out
      a pre-existing neuropathy. Another clinical neurological exam with ENMG will be performed
      between 4 and 6 weeks and, if pathological, repeated at 6 months, 9 months and 12 months. The
      operation will be done under general anesthesia for all patients.
    

Intervention name(s): Femoral nerve block; PCA morphine
Intervention type(s): Procedure; Procedure
Intervention description(s): The femoral nerve block will be performed with ultrasound 30 minutes before the intervention; Postoperative analgesia with self-administration iv morphine
Other intervention name(s): ANY; ANY
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Electrophysiological study; Nerve block; Analgesia, Patient-Controlled; Anterior cruciate ligament
IVM Versus IVF: Differences in Patients' Emotional Adjustment and Quality of Life
Condition: Infertility, Female; Polycystic Ovary Syndrome; Psychological Stress; Quality of Life
MeSH terms: Polycystic Ovary Syndrome; Infertility; Infertility, Female; Stress, Psychological
Study type: Observational [Patient Registry]

Summary: 
      Patients who undergo in vitro fertilization with or without intracytoplasmic sperm injection
      (IVF / ICSI) often experience an impact on their quality of life and emotional maladjustment
      to treatment and outcome. Multiple contributors to this negative impact have been identified,
      including interference with professional activities, expenses related to fertility treatment
      and hormonal side effects. In-vitro maturation (IVM) of human oocytes obtained from minimally
      stimulated or unstimulated ovaries offers a more "patient friendly" treatment option than the
      conventional ovarian stimulation protocols for Assisted Reproductive Technology (ART)
      treatment. Historically, IVM has been offered to women with increased ovarian response
      (so-called "high responders"), typically women with polycystic ovaries (PCO/PCOS), who are at
      increased risk for ovarian hyperstimulation syndrome (OHSS) if conventional ART protocols are
      used. IVM treatment programs are characterised by a minimal administration of fertility
      hormones, are less disruptive to patients' daily life through a reduced need for hormonal and
      ultrasound monitoring, avoid a range of minor and major complications because of the reduced
      hormonal burden of this procedure, and aim to reduce the total cost for of infertility
      treatment.

      To facilitate the application of IVM as a treatment that can potentially improve the overall
      patient experience, a study comparing the psychological impact of a conventional ovarian
      stimulation protocol versus an IVM protocol will be conducted; furthermore, a study
      investigating the differences in quality of life between the two subgroups will also be
      performed.

      Socio-demographic data, medical characteristics and the following questionnaires will be
      collected: Specific questions for patients with fertility problems (FertiQol); Hospital
      Anxiety and Depression Scale (HAD) and an instrument to measure side effects designed by the
      research group. The study group (IVF patients and IVM patients) will be evaluated at three
      predefined time points: at intake, after oocyte collection and when the outcome after the
      first embryo transfer is known.

      Descriptive analysis, intergroup comparisons and explanatory/predictive model of the
      dependent variables (quality of life, emotional adjustment) will be performed.
    


Intervention name(s): Questionnaires
Intervention type(s): Other
Intervention description(s): FertiQoL and HADS (Hospital Anxiety and Depression Scale) questionnaires
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Female infertility patients between 18 and 36 years.