bioihbjkbjnl/mcl2 huggingface dataset:
PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment
Condition: Renal Disease, End Stage
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to understand how Amisulpride is taken up and distributed around the
      body and how quickly it is eliminated, when given by mouth and into a vein in adults with
      severe kidney disease. In addition it is important to understand how well tolerated
      Amisulpride is in this patient population. Healthy adults will be studied to provide a
      comparison.
    

Detailed description: 
      This will be an open-label, non-randomised, pharmacokinetic study in

        -  6 adult subjects with severe renal impairment and end-stage renal disease (i.e., eGFR <
           30 mL/min/1.73 m2) without dialysis.

        -  6 matched healthy subjects (control group).

      Each subject will be given a single dose of 10 mg IV Amisulpride, followed by a single dose
      of 10 mg oral Amisulpride given 24 hours later.

      Subjects will be admitted to the clinic on Day -1. Dosing will start the following day (Day
      1). Serial blood samples will be taken during Days 1-3 to assess the pharmacokinetics of
      Amisulpride. Subjects will remain in clinic over the duration of the study and will be
      discharged when the final blood sample is drawn on Day 3.

      The tolerability /safety of Amisulpride will be assessed by clinical chemistry and
      haematology assessments, vital signs, electrocardiograms (ECG), physical examination and
      adverse event reporting.
    

Intervention name(s): Amisulpride IV; Amisulpride Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): A single 10mg IV dose of Amisulpride given over 1 minute; A single 10mg dose given as an oral tablet
Intervention MeSH terms: Amisulpride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: One group of subjects with renal impairment will receive 10mg IV Amisulpride followed 24 hours later by a 10mg oral dose.
One group of matched healthy subjects will receive 10mg IV Amisulpride followed 24 hours later by a 10mg oral dose.
Masking: None (Open Label)
Primary purpose: Basic Science
Outcome After Multidisciplinary CO2 Laser Laparoscopic Excision of Deep Infiltrating Colorectal Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      Improved pain, sexuality and quality of life, high fertility and low complication and
      recurrence rates after multidisciplinary CO2 laser laparoscopic excision of deep infiltrating
      colorectal endometriosis.
    

Detailed description: 
      All women (n=56) who had undergone CO2 laser laparoscopic radical excision of deep
      infiltrating endometriosis with active involvement of colorectal surgeon and/or urologist
      were selected retrospectively from the list of all patients (n=more than 2000) operated at
      the Leuven University Fertility Centre (LUFc) between September 1996 and July 2004.

      All 56 multidisciplinary operated patients were asked to complete the Oxford Endometriosis
      Quality of Life questionnaire, a sexual activity questionnaire and visual analogue scales
      (VAS) for dysmenorroe, chronic pelvic pain and deep dyspareunia, to compare their status
      before surgery and at the moment of the evaluation (January 2005).
    

Intervention name(s): multidisciplinary laparoscopy; Questionnaires
Intervention type(s): Procedure; Other
Intervention description(s): Multidisciplinary (with active involvement of the colorectal surgeon/urologist) fertility-sparing CO2 laser laparoscopic radical excision of deep infiltrating endometriosis.; Patients (n=56) were asked to complete questionnaires regarding quality of life (QOL), pain, fertility and sexuality to compare their status before and after surgery, and their medical files were analyzed.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All women (n=56) who had undergone CO2 laser laparoscopic radical excision of deep
        infiltrating endometriosis with active involvement of colorectal surgeon and/or urologist
        were selected retrospectively from the list of all patients (n=more than 2000) operated at
        the Leuven University Fertility Centre (LUFc) between September 1996 and July 2004.
      
Biospecimen description: 
      Endometriosis was proven by histologic examination of excised lesions.
    
Keywords: colorectal endometriosis; deep infiltrating endometriosis; dysmenorroe; dyspareunia; quality of life
Saphenous Nerve Block vs. Femoral Nerve Block for Total Knee Arthroplasty
Condition: Difference Between Femoral Nerve Block and Saphenous Block
Study type: Interventional

Summary: 
      Currently, the regional anesthetic standard of care for total knee replacement surgery is
      combined spinal/epidural to provide long-lasting pain relief with or without a femoral nerve
      block (FNB). The femoral nerve block refers to a technique that your anesthesiologist can use
      to numb the thigh muscle for approximately 18 hours after surgery. While this technique
      offers significant pain relief, it is possible it may cause muscle weakness and increase
      patients' recovery times. Hence there is a need for an alterative anesthetic technique, one
      that may help minimize postoperative pain as effectively as a femoral nerve block, while not
      causing weakness of the thigh muscle.

      The saphenous nerve, a branch of the femoral nerve, provides sensation to the knee. Thus it
      is hypothesized by "blocking" or anesthetizing the saphenous nerve with local anesthetic
      closer to where it branches off, the area around and below the knee will feel numb. Yet
      unlike the femoral nerve block, the thigh muscle itself will still be able to function.

      For patients undergoing two total knee replacements at one time or bilateral total knee
      replacement, they will be randomly assigned to receive a femoral nerve block on one leg and a
      saphenous block on the other. Pain levels will be measured and thigh muscle strength will be
      tested using a dynamometer before surgery, 6-8 hours following anesthesia administration, and
      on postoperative days 1 and 2.
    


Intervention name(s): Study Technique; Control Technique
Intervention type(s): Procedure; Procedure
Intervention description(s): One leg will receive the saphenous nerve block, at the level of the adductor canal (study technique). The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.; The other leg will receive the femoral nerve block (control technique). The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Bilateral total knee replacement; Femoral Nerve Block; Saphenous Nerve Block
Tackling Depression and Anxiety: A Working Memory Intervention
Condition: Major Depression; Anxiety Disorder
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      Anxiety and depression are both associated with impairments in executive functions, including
      working memory (WM) which is needed to maintain and manipulate goal-relevant information. Due
      to these WM impairments anxious and depressed individuals have difficulties inhibiting and
      shifting from irrelevant (negative) information and updating goal relevant information. This
      study explored whether training WM decreases these impairments and reduces clinical symptoms
      and rumination. Eighty-four individuals diagnosed with major depression and forty-nine
      individuals with an anxiety diagnosis executed WM or control tasks three times a week, during
      four weeks. Before, after training and at a two months follow-up measurement depression and
      anxiety symptoms, WM capacity and rumination behaviour were assessed. Training WM did only
      result in a reduction of anxiety symptoms in the depression group. These findings are
      inconsistent with promising results of individual studies showing training WM result in an
      enlarged WM capacity and a decrease of psychopathological symptoms. However, our results are
      in line with recent meta-analyses and reviews which show that WM training do not lead to
      generalized effects and therefore, doubt the clinical relevance of WM training programs.
    


Intervention name(s): Working memory training; Placebo training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The WM consisted of two tasks; the Number-letter task (Rogers & Monsell, 1995) and an Updating task. The Number-letter task trains the ability to shift between task relevant stimuli. Participants need to shift between four categories. In the Updating task participants receive a set of three words in which they have to compare the two consecutive words on emotional valence (positive or negative) to train their updating skills. Participants executed the training three times a week during four weeks.; Both the WM and the placebo training consisted of two tasks; the Number-letter task (Rogers & Monsell, 1995) and an Updating task. To prevent training WM the placebo training was a simplified version of the Number-letter task in which shifting was not required. In the Updating task the placebo group only had to count the number of positive or negative words. Participants executed the training three times a week during four weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression; Anxiety; Working memory; Rumination; Cognitive training; Executive functioning
Open Label Study to Assess the Absolute Bioavailability of Tasimelteon (HETLIOZ™)
Condition: Non-24-Hour-Sleep-Wake Disorder
MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
Study type: Interventional
Phase: Phase 4

Summary: 
      Hetlioz™ (tasimelteon) is used in the treatment of Non-24-Hour-Sleep-Wake Disorder (Non-24).
      Non-24 is very common in people who are totally blind because light can not reset their body
      clock. This causes the internal sleep-wake cycle to be out of sync with the 24-hour
      day-night. Non-24 is a serious, chronic circadian rhythm disorder in the blind that causes
      nighttime sleep problems and a wide range of daytime difficulties, including an overwhelming
      urge to nap.

      Tasimelteon will be given in two ways; orally (by mouth) as a 20 mg capsule and intravenously
      (I.V.) by infusion through a catheter (not an injection) into a vein. The oral administration
      is approved by the FDA. The I.V. administration is considered investigational as it has not
      been approved by the FDA. This will be the first time tasimelteon will be given to humans by
      intravenous (I.V.) injection.

      The purposes of this research study are to:

        -  assess how quickly a single 20 mg oral dose of tasimelteon is absorbed into the body;

        -  evaluate the single-dose pharmacokinetics of tasimelteon after a single 20 mg oral dose
           and after a single 2 mg I.V. dose;

        -  evaluate the single-dose pharmacokinetics of tasimelteon metabolites after a single 20
           mg oral dose and after a single 2 mg I.V. dose;

        -  evaluate the safety and tolerability of a single 20 mg oral dose of tasimelteon; and

        -  evaluate the safety and tolerability of a single 2 mg I.V. dose of tasimelteon.

      Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and
      eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood
      samples will be taken throughout the study for PK analysis.
    


Intervention name(s): tasimelteon 20 mg capsule; tasimelteon 2 mg I.V.
Intervention type(s): Drug; Drug
Other intervention name(s): Hetlioz™ 20 mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Non-24; absolute bioavailability; tasimelteon; Hetlioz™
Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or
      severe renal impairment, who do not require hemodialysis, compared to healthy controls.
    


Intervention name(s): CP-690,550; CP-690,550; CP-690,550; CP-690,550
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 mg (2 x 5 mg tablets), single dose; 10 mg (2 x 5 mg tablets), single dose; 10 mg (2 x 5 mg tablets), single dose; 10 mg (2 x 5 mg tablets), single dose
Intervention MeSH terms: Tofacitinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: CP-690; 550; pharmacokinetics; renal impairment
Hop Compounds and Immune System
Condition: Inflammatory Response
Study type: Interventional

Summary: 
      The aim of the present study is to determine the effect of Xanthohumol and Iso-alpha-acids
      from hops on the immune response of healthy participants.
    

Detailed description: 
      In this placebo-controlled crossover study a study drink enriched with either a placebo,
      Xanthohumol, Iso-alpha Acids or a combination of latter is given to the participants. A
      washout phase before intervention and between each intervention is introduced. On day one of
      each intervention blood is drawn in fasted state from each participant. Subsequently the
      study drink combined with a standardized breakfast is given to the participants following a
      second blood drawing one hour after the consumption of the study drink. On the last day of
      each intervention blood is taken from study participants in the same manner as on day one. To
      assess the effect of Xanthohumol and Iso-alpha acids or a combination of both, clinical
      chemical parameters e.g. ALT, AST, γ-GT, blood lipids (triglycerides, total cholesterol, HDL,
      LDL), blood glucose, uric acid and CRP are determined. Furthermore, PBMC's isolated from
      blood samples of each time point were stimulated for either 24 or 48 h. Protein levels and
      mRNA expression of markers of inflammation is measured in PBMC's and supernatant of
      stimulated cells.
    

Intervention name(s): Dietary Intervention 1: Placebo; Dietary Intervention 2: Xanthohumol and Iso-alpha acids
Intervention type(s): Other; Other
Intervention description(s): Participants receive a study drink supplemented with a placebo for 5 days; Participants receive a study drink supplemented with xanthohumol, Iso-alpha acids or a combination of both for 5 days
Intervention MeSH terms: Xanthohumol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effect of Education Based on The Health Belief Model on Healthy Lifestyle Behaviors in Individuals With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This research will be carried out with a randomized controlled experimental design to examine
      the effect of education based on the Health Belief Model for individuals with Type 2 Diabetes
      on their health beliefs, self-efficacy and healthy lifestyle behaviors.

      During the research, the relevant polyclinic will be visited regularly. The patients who are
      followed up in the outpatient clinic for type 2 diabetes will be evaluated in terms of
      sampling eligibility criteria and their willingness to participate in the research will be
      questioned. The patients to be included in the study will be randomly assigned to
      intervention and control groups using the random sampling method. In determining the sample
      size, two groups, intervention and control, were compared using the "G*Power v3.1.9.4"
      program. Effect size (d) = 0.80, type I margin of error (α) = 0.05, minimum sample volume to
      provide test power (1-β) = 0.90, total 68 (experimental group 34, control group 34) is sick.
      However, it is planned to recruit 20% more patients (41 experiment, 41 control) in order to
      increase the power and reliability of the research, and there may be losses in the research
      process.

      In the collection of research data; Introductory Characteristics Information Form, Diabetes
      Health Belief Model Scale, Diabetes Self-Efficacy Scale and Healthy Lifestyle Behaviors
      Scale-II will be applied.
    


Intervention name(s): Education based on the health belief model
Intervention type(s): Behavioral
Intervention description(s): After the intervention, it is expected that the scores of the patients on the healthy lifestyle behaviors scale will increase.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Self Efficacy; Healthy Lifestyle; Health Belief Model
Long-term Bilateral Theta Burst Stimulation for the Treatment of Major Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Repetitive transcranial magnetic stimulation has been shown to be moderately effective in the
      treatment of major depression. Theta burst stimulation (TBS) is a new form of rTMS that may
      exert larger effects.

      This sham-controlled study examines the effectivity of daily bilateral TBS to the
      dorsolateral frontal cortex over 6 weeks in 2x16 patients with major depression add on to the
      local standard of a combined pharmacological/psychotherapeutical treatment.
    


Intervention name(s): Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)
Intervention type(s): Device
Intervention description(s): intermittent TBS (iTBS) to the left DLPFC (600 stimuli, 80% resting motor threshold) continuous TBS (cTBS) to the right DLPFC (600 stimuli, 80% resting motor threshold)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial Magnetic Stimulation; Depression; Theta Burst Stimulation
Multi-center Clinical Study on Neonatal Hyperbilirubinemia
Condition: Quality Improvement; Hyperbilirubinemia, Neonatal
MeSH terms: Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
Study type: Interventional

Summary: 
      Eight hospitals in China will participate in the study, which aims to decrease the incidence
      of severe hyperbilirubinemia.
    

Detailed description: 
      Through a prospective cohort study of healthy term and near-term infants, the study tries to
      truly reflect the epidemiology, intervention status, and outcomes of neonatal
      hyperbilirubinemia and the cost. Hopefully, by improving the quality of management of
      neonatal jaundice,we can explore and obtain a healthy term and near-term jaundice management
      model suitable for China's national condition, which can eventually reduce the incidence rate
      of neonatal severe hyperbilirubinemia and bilirubin encephalopathy.
    

Intervention name(s): Quality improvement of management of neonatal jaundice
Intervention type(s): Behavioral
Intervention description(s): During the Intervention phase and Sustainability phase ,The hospitals will receive training of multiple evidence based quality improvement methods.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Quality improvement; Hyperbilirubinemia; screening; follow-up
A Study to Assess the Clinical Effects of Navarixin in Participants With Psoriasis (MK-7123-009)
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was conducted: 1) to assess the clinical effect of Navarixin on the Psoriasis
      Activity and Severity Index (PASI), 2) to determine the effects of Navarixin on the
      Physician's Global Assessment (PGA), 3) to evaluate the safety and tolerability of Navarixin,
      and 4) to determine the multiple-dose pharmacokinetics of Navarixin.
    


Intervention name(s): Navarixin 10 mg; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Navarixin capsules orally, once daily for 28 days.; Matching placebo capsules to Navarixin orally, once daily for 28 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast
Condition: Breast Cancer
MeSH terms: Phyllodes Tumor
Study type: Interventional

Summary: 
      PURPOSE: This phase II trial studied how well radiation therapy works after surgery in
      treating women with phyllodes tumor of the breast.

      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy
      following surgery may be effective in treating patients with phyllodes tumor of the breast.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the local recurrence rate in women with phyllodes tumors of the breast
           previously treated with local excision with negative margins and are now treated with
           adjuvant radiotherapy.

        -  Determine the survival rate in patients treated with this regimen.

      METHODS: Within 12 weeks after prior local excision or breast reexcision, patients underwent
      adjuvant radiotherapy 5 days a week for a total of 28 treatments. Patients were then followed
      every 6 months for 10 years.
    

Intervention name(s): Adjuvant Radiotherapy
Intervention type(s): Radiation
Intervention description(s): Adjuvant radiation therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent breast cancer; phyllodes tumor