bioihbjkbjnl/mcl2 huggingface dataset:
Short-term Metabolic Effects of Ketosteril® Supplemented Low Protein Diet in Pre-dialysis Chronic Kidney Disease (CKD) Patients
Condition: Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency, Chronic; Renal Insufficiency
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Supplementation of ketoanalogues of essential amino acids improves the protein quality of
      protein restricted diets without burdening the kidneys. The ketoanalogues are transaminated
      by aminotransferases to the corresponding amino acids by incorporating nitrogen from amino
      groups derived from endogenous amino acid degradation. Therefore, less nitrogen needs to be
      excreted and the kidney's workload is reduced.

      The purpose of the trial is to investigate the impact of Ketosteril® supplementation on A)
      nutritional safety and tolerance of a low protein diet (LPD) (0.6 g protein/kg bodyweight
      (BW)/day)and B) net protein synthesis in pre-dialysis CKD patients.

      Changes of urea in serum and urine will be assessed under controlled metabolic balance
      conditions in non-dialysed CKD patients consuming a LPD supplemented with Ketosteril® at 1
      tablet/5 kg body weight/day compared to the same, isonitrogenous and isocaloric diet without
      Ketosteril®.

      Changes in protein synthesis and degradation at the defined protein intake with or without
      Ketosteril® supplementation will be investigated - based on nitrogen balance, normalized
      protein catabolic rates as well as blood levels of defined proteins as surrogate markers for
      net protein synthesis and anabolic signaling.
    


Intervention name(s): Ketosteril®
Intervention type(s): Drug
Intervention description(s): Patients will be randomised to receive isonitrogenous and isocaloric LPD providing 0.6 g protein/kg BW/day and an energy intake of 30-35 kcal/kg BW/day with (test group) or without (control group) intake of Ketosteril® (1 tablet/5 kg BW/day). The control group will get additional food protein to balance the nitrogen content of Ketosteril® The mainly vegetarian diet will be maintained for 10 days.
Other intervention name(s): EV product code: PRD1170237
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: CKD; Ketosteril; keto-acids; ketoanalogues; Chronic kidney disease
Cryoballoon Ablation of Pulmonary Veins After Failed RF Ablation in Patients With Paroxysmal AF
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this prospective randomized double-blind study was to compare the efficacy and
      safety of cryoballoon ablation with the RF approach in the treatment of paroxysmal AF after
      failed first radiofrequency ablation.
    


Intervention name(s): cryoballoon ablation; Radiofrequency ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): In Cryo group, 28mm balloon was introduced into the PV ostium with the best possible occlusion of the PV. Every step was controlled by fluoroscopy. Cryoenergy was applied for maximal 6 minutes per application for 2 times, resulting in a circumferential ablation lesion. Before the right superior vein was treated, a quadripolar catheter was placed in the superior vena cava to continuously stimulate the right phrenic nerve during cryoapplication. The application was stopped immediately in the case of diminished diaphragm movements.; n RF group, reisolation of the PV was performed by identifying the breakthrough site. Radiofrequency energy was delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation rate of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Single-dose Novel Selective alpha2c Antagonist Pharmaco-MRI Study in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the present study is to investigate changes in neural activity (BOLD signal), as
      measured using fMRI, in brain areas associated with emotional and working memory during task
      performance after single-dose administration of a novel selective alpha2c adrenoceptor
      antagonist (ORM-12741) in healthy volunteers. Further, it will be explored whether ORM-12741
      affects connectivity between brain areas in rest, as measured using fMRI, and cognitive
      performance in the sample under investigation.
    


Intervention name(s): ORM-12741; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Novel selective alpha2c adrenoceptor antagonist; Identical in appearance to experimental drug, not psycho-active
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: High-dosage (60mg), Low-dosage (10mg), Placebo
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Noradrenalin Agents; Physiological Effects of Drugs; Mood disorders; Behavioral Symptoms
A Study to Understand the Treatment Patterns and Patients and Their Clinical Outcomes Who Are Taking Palbociclib in a Real Life Setting in Israel.
Condition: Metastatic Breast Cancer
Study type: Observational

Summary: 
      The purpose of this study is to understand the treatment patterns, patients and their
      clinical outcomes in a real life setting in Israel. This study was done in adult breast
      cancer patients who have started palbociclib combination treatment as per the national basket
      of health services in January 2018 until August 2020 for all lines of therapy.

      This study had included adult patients who were prescribed with palbociclib for their breast
      cancer which had spread to other parts of the body.

      Patients are followed for around 3.5 years.
    


Intervention name(s): palbociclib
Intervention type(s): Drug
Intervention description(s): As provided in real world practice
Other intervention name(s): Ibrance
Intervention MeSH terms: Palbociclib
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This is a population based retrospective database study that will include patients with
        metastatic, HR+/ HER2- breast cancer and who initiated first or subsequent lines of
        treatment with palbociclib. Data will be available from Maccabi Healthcare Services (MHS)
        database in Israel for patients who received approval for treatment with palbociclib since
        01 January 2018 until 31 August 2020.
      
Keywords: hormone receptor; positive/human epidermal growth factor 2 - negative (HR+/HER2-)
Norepinephrine Infusion Versus Midodrine & Octreotide in Patients With Hepatorenal Syndrome Type 1.
Condition: Renal Impairment in Hepatorenal Syndrome
MeSH terms: Hepatorenal Syndrome; Renal Insufficiency; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aimed to investigate the efficacy of midodrine plus octreotide versus
      norepinephrine and to determine the predictive factors of response in patients with HRS-AKI.
    

Detailed description: 
      Both sexes aged 18 years or older having cirrhosis, ascites, and a diagnosis of HRS-AKI based
      on the 2015 International Club of Ascites (ICA) diagnostic criteria [2] were eligible for
      participation.

      Screening and eligibility criteria were verified upon admission to the ICU. A diagnosis of
      AKI was established through comparing sCr value at time of ICU admission to that recorded in
      the patient's file. Patients who meet all other diagnostic criteria of HRS-AKI provided by
      the previous definition [2] were enrolled in the study. Qualified patients were subjected to
      baseline assessments after informed consent signature. It included vital sign measurements,
      presence of comorbidities, height and weight, Child-Pugh score and Sequential Organ Failure
      Assessment (SOFA) score. Vital signs, Blood urea nitrogen, sCr, serum sodium, serum albumin,
      total bilirubin, and complete blood count with differential were measured at baseline and at
      daily basis throughout the study period. Patients were randomized in a 1:1 ratio to receive
      either continuous infusion of norepinephrine in an initial dose of 0.5mg/h (Maximum 3 mg/h or
      oral midodrine 5mg three times/day (Maximum 12.5mg three times/day) plus octreotide 100μg/6h
      as subcutaneous injection (Maximum 200 μg/6h). Duration of treatment was allowed to extend to
      a maximum of 10 days. Administration of albumin at doses of 20 to 40 gm/day was recommended,
      as clinically indicated, for all patients in both study arms as per current ICA guidelines.
    

Intervention name(s): norepinephrine versus midodrine & octreotide
Intervention type(s): Drug
Intervention description(s): either intravenous infusion (IVi) norepinephrine in a dose of 0.05-0.3ug/Kg/min. to keep mean arterial pressure ≥ 80-100mmHg & continued either until HRS reversal or for maximum 10 days or oral midodrine 5mg three times/day & can be increased every 24h up to 12.5mg three times daily plus octreotide 100ug/ 6h subcutaneous & if needed increased to 200ug/6h.
Intervention MeSH terms: Octreotide; Norepinephrine; Midodrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Influence of Cerebral Blood Flow and PETCO2 on Neuromuscular Function During Passive Heat Stress
Condition: Healthy Males; Neuromuscular Function
MeSH terms: Heat Stress Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Increased core temperature (hyperthermia) has been associated with impaired neuromuscular
      performance; however, the mechanisms associated with these performance decrements and their
      potential synergies remain unclear. While the majority of research suggests that the observed
      fatigue is related to the central nervous system, the influence of changes in cerebral blood
      flow (CBF) and associated changes in cerebral alkalosis (estimated by end-tidal partial
      pressure of carbon dioxide; PETCO2) remains unexamined. In response to hyperthermia, humans
      hyperventilate as means of heat dissipation, resulting in a hypocapnia (reduced PETCO2)
      mediated decrease in CBF and consequently, cerebral alkalosis (increased cerebral pH).
      Previous research suggests that hyperventilation induces changes in neural excitability and
      synaptic transmission; however, it remains unclear if these changes are related to hypocapnia
      mediated decrease in CBF or decreased PETCO2 or both.

      The purpose of the proposed research program is to examine the influence of changes in CBF
      and cerebral alkalosis on neuromuscular function during passive heat stress. The research
      project will consist of 3 separate experimental trials: (a) poikilocapnic hyperthermia
      (increased core temperature; decrease CBF; decrease PETCO2), (b) isocapnic hyperthermia
      (increased core temperature; no change CBF; no change PETCO2) and (c) isocapnic hyperthermia
      + indomethacin (increased core temperature; decrease CBF; no change PETCO2). During each
      manipulation, neuromuscular function will be evaluated and compared to baseline
      (normothermic) conditions using a repeated measures design.

      It is hypothesized that changes in PETCO2 and therefore, changes in cerebral alkalosis will
      contribute to neuromuscular fatigue independent of changes in CBF or increases in core
      temperature.
    


Intervention name(s): Indomethacin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Indomethacin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya.
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Observational

Summary: 
      In this study we wish to test the hypothesis that continuous Gilenya treatment alters immune
      homeostasis in favor of an anti-inflammatory type II monocyte and macrophage (M2) phenotype
      in the circulation of patients with relapsing-remitting Multiple Sclerosis (MS). In this
      study we will determine the change in ratio of M2 (type II, alternatively activated) versus
      M1 (type I, classically activated) monocytes and macrophages in a cohort of patients that
      have received continuous Gilenya treatment for 0, 1, 3, 6 or 12 months. We will also assess
      changes in cell surface expression of the M1 marker CCR7 and the M2 markers CD206 or CD301 by
      monocytes and macrophages using FACS analysis of whole blood, and assess the tyrosine
      phosphorylation of the signal transducer and activator of transcription STAT-1 (pTyr-STAT1),
      which is critical for the activation of M1 myeloid cells. We will assess correlates with
      changes in M1 and M2 cytokine expression assessing possible mechanisms of action of Gilenya
      on myeloid lineage cells.
    


Intervention name(s): Gilenya
Intervention type(s): Drug
Intervention MeSH terms: Fingolimod Hydrochloride
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be selected from those seen by physicians at the USC Multiple Sclerosis
        Comprehensive Care Center.
A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV)
Condition: Pemphigus Vulgaris
MeSH terms: Pemphigus
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase III, randomized, double-blind, double-dummy, active-comparator, parallel-arm,
      multicenter study to evaluate the efficacy and safety of rituximab compared with MMF in
      participants with moderate-to-severely active PV requiring 60-120 milligrams per day (mg/day)
      oral prednisone or equivalent. Participants must have a confirmed diagnosis of PV within the
      previous 24 months (by skin or mucosal biopsy and immunohistochemistry) and evidence of
      active disease at screening.

      Approximately 135 participants will be enrolled at up to 60 centers worldwide. Participants
      will be randomized in a 1:1 ratio to receive either rituximab plus MMF placebo or rituximab
      placebo plus MMF. Randomization will be stratified by duration of illness.

      The study will consist of three periods: a screening period of up to 28 days, a 52-week
      double-blind treatment period, and a 48-week safety follow up period that begins at the time
      of study treatment completion or discontinuation.
    


Intervention name(s): Mycophenolate Mofetil Placebo; Mycophenolate Mofetil; Rituximab; Rituximab Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): MMF matching placebo will be administered orally Q12H.; MMF will be administered at a starting dose of 500 milligrams (mg) Q12H and the dose will be titrated to achieve a goal of 1 gram (gm) Q12H.; Rituximab will be administered at a dose of 1000 mg via IV infusion.; Rituximab matching placebo will be administered via IV infusion.
Other intervention name(s): MMF, CellCept; MabThera/Rituxan; MabThera/Rituxan
Intervention MeSH terms: Mycophenolic Acid; Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Volumetric Study of the Buttocks After Flap Augmentation in Buttocks Lifting
Condition: Weight Loss
MeSH terms: Weight Loss
Study type: Observational

Summary: 
      The development of bariatric surgery, its effectiveness and the reduction of complications
      are at the origin of massive weight loss, the corollary of which has been a clear increase in
      the demands of treatment of sequelae of weight loss.
    


Intervention name(s): gluteal augmentation with flap in circumferential body lift
Intervention type(s): Procedure
Intervention description(s): classic circumferential bodylift surgery, using two differents well-known flaps for gluteal augmentation
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients after massiv weight loss who come in toulouse or montpellier hospital to take care
        of slimming effects
      
Keywords: plastic and reconstructive surgery; gluteal ptosis; platipygia
Minnesota Healthy Brain Initiative
Condition: Cognitive Ability, General
Study type: Observational [Patient Registry]

Summary: 
      Minnesota Healthy Brain Initiative will be an ongoing project that aims to increase awareness
      regarding brain health and its maintenance as well as increasing awareness of the impact of
      alcohol on brain function. In the immediate future, we hope to obtain data from a non-injured
      normative, diverse population represented by the state fair patrons.
    

Detailed description: 
      We hypothesize that a non-invasive 30-minute test, requiring a subject to complete
      questionnaires and watch images on a TV screen, will yield information relevant to both
      diagnosis and prognosis of neurological state. To clarify, these tests will not produce
      information that would involve a diagnostic finding for the participants. We will measure eye
      movements under a range of visual conditions, including saccades, fixations, smooth pursuit,
      scan paths and optico-kinetic nystagmus

      After receiving proper introduction and signing the proper consent forms, the subject will
      receive instructions to carry out cognitive assessments and answer verbal questionnaires. The
      subject will also undergo eye tracking. In order to validate the data collected by our
      eye-trackers, we may ask the subject to complete a non-invasive vision assessment and a
      breathalyzer assessment. Due to the nature of the breathalyzer assessment, we have decided
      not to administer the breathalyzer assessment to subjects who are under the age of 21 and/or
      pregnant. We also refuse to disclose the results of the breathalyzer assessment to the
      subject since the data will be collected only for research purposes. Subjects' eye movements
      will be tracked binocularly at a fixed distance from a computer monitor over a brief time
      period. The visual stimuli will be video clips appropriate for a general or pediatric
      audience. If at any point the subject becomes uncomfortable, the procedure will be aborted
      and can be resumed at a later time.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Since we hope to gather a normative distribution, all subjects interested in participating
        in the study will be considered.
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pozelimab in Combination With Cemdisiran in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of ascending
      doses of subcutaneous (SC) pozelimab and SC cemdisiran when administered on the same day or
      sequentially 28 days apart.

      The secondary objectives of the study are:

        -  To assess the concentration-time profiles of total pozelimab, total complement component
           5 (C5), cemdisiran, and cemdisiran metabolite(s) following single ascending doses of SC
           pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days
           apart

        -  To assess the pharmacodynamic (PD) profile of ascending doses of SC pozelimab and SC
           cemdisiran, as well as when administered on the same day or sequentially 28 days apart

        -  To assess the immunogenicity of pozelimab and cemdisiran
    


Intervention name(s): Pozelimab; Cemdisiran
Intervention type(s): Drug; Drug
Intervention description(s): Single dose administered subcutaneously; Single dose administered SC
Other intervention name(s): REGN3918; ALN-CC5
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clomiphene Citrate for Treatment of Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the impact of clomiphene citrate on serum insulin like growth factor 1 and
      testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy
      and/or medical treatments (somatostatin analogues, dopamine agonists and/or growth hormone
      receptor antagonist)
    

Detailed description: 
      Acromegaly, a disease caused by a growth hormone secreting pituitary adenoma, results in
      reduced life span. Despite the many modalities available to treat this disease,as surgery,
      medical treatment and radiotherapy, uncontrolled disease persists in a significant portion of
      patients

      Oral estrogens, alone or in combination with somatostatin receptor analogues, have been shown
      to control acromegaly in women. Selective estrogen receptor modulators (SERMs) resulted in
      similar effects in both genders. Clomiphene citrate, a SERM that increases luteinizing
      hormone and follicle stimulating hormone secretion, improves hypogonadism and fertility
      outcomes.

      The aim of this study is to assess the impact of clomiphene citrate on serum insulin like
      growth factor 1 and testosterone levels in male acromegalic patients not controlled by
      surgery, radiotherapy and/or medical treatment.

      In this prospective, open label, single center trial, sixteen male patients were studied.
      Clomiphene citrate (50 mg/day) was added to previous medical treatment for 3 months and
      hormonal assessment was performed prior to and during the intervention. Hormones included:
      growth hormone, insulin like growth factor, total testosterone, follicle stimulating hormone,
      luteinizing hormone and prostate-specific antigen.
    

Intervention name(s): Clomiphene Citrate
Intervention type(s): Drug
Intervention description(s): Clomiphene citrate, 50 mg, orally for three months
Other intervention name(s): Clomid; Serophene; Indux
Intervention MeSH terms: Clomiphene; Enclomiphene; Zuclomiphene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acromegaly; SERM; Clomiphene
Delaying the Superficial Inferior Epigastric Artery (SIEA) Flap and Determining the Change in SIEA Diameter and Blood Flow
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether delaying the superficial inferior
      epigastric artery (SIEA) flap results in widening of diameter and enhancing of blood flow of
      its donor artery.
    


Intervention name(s): Delay procedure of SIEA flap.
Intervention type(s): Procedure
Intervention description(s): Ligating the deep inferior epigastric artery ipsilaterally to the planned raising of the SIEA flap 2 weeks prior to the reconstructive procedure.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Superficial inferior epigastric artery flap, delay phenomenon