bioihbjkbjnl/mcl2 huggingface dataset:
Robotic and Manual Cochlear Implantation: An Intra-individual Study of Speech Recognition and Electrode Holder Position (ICRobMan)
Condition: Cochlear Hearing Loss
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural
Study type: Observational

Summary: 
      Cochlear implantation (CI) allows rehabilitation for patients with severe to profound hearing
      impairment. Although the use of a robotic assistant provides technical assistance to the
      surgeon, the assessment of the impact of its use on auditory outcomes remains uncertain, due
      to inter-individual variability of preoperative audiometric thresholds and the various
      possible intrascalar positions of the electrode array. WThe investigators aim to compare the
      hearing results of patients who underwent bilateral cochlear implantation, one side was
      performed with manual insertion and the other side with robot-assisted insertion. The
      electrode array intrascalar positioning and the surgery duration were also studied.

      This retrospective intra-individual study involved 10 patients who underwent bilateral
      cochlear implantation. The unique composition of this cohort enabled the investigators to
      utilize each patient as their own control.
    

Detailed description: 
      Cochlear implantation (CI) allows rehabilitation for patients with severe to profound hearing
      impairment. Although the use of a robotic assistant provides technical assistance to the
      surgeon, the assessment of the impact of its use on auditory outcomes remains uncertain, due
      to inter-individual variability of preoperative audiometric thresholds and the various
      possible intrascalar positions of the electrode array. The investigators aim to compare the
      hearing results of patients who underwent bilateral cochlear implantation, one side was
      performed with manual insertion and the other side with robot-assisted insertion. The
      electrode array intrascalar positioning and the surgery duration were also studied.

      This retrospective intra-individual study involved 10 patients who underwent bilateral
      cochlear implantation. The unique composition of this cohort enabled the investigators to
      utilize each patient as their own control.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This retrospective intra-individual study involved 10 patients who underwent bilateral
        cochlear implantation at a tertiary referral center. Manual cochlear implantations were
        performed between January 2006 and June 2020, while robot-assisted implantations took place
        between September 2020 and May 2022. Sequential implantation was applied to 9 of the
        patients, while 1 patient underwent both manual and robot-assisted cochlear implantations
        in a single procedure.
Impact of SpHb Monitoring on Transfusion
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional

Summary: 
      Continuous and noninvasive hemoglobin (SpHb) monitoring provides clinicians with real-time
      trending of changes or lack of changes in hemoglobin, which has the potential to alter red
      blood cell (RBC) transfusion decision making. The objective of this study was to evaluate the
      impact of SpHb monitoring on RBC transfusions in high blood loss surgery. The investigators
      hypothesize that SpHb will improve blood transfusion practice in the for of change the number
      of blood unit per patient and improve the outcome regards the time to take decision of
      transfusion trigger.
    

Detailed description: 
      Eligible patients scheduled for neurosurgeries were enrolled into either a standard care
      group (Control Group) or an intervention group (SpHb Group). The Control Group received
      typical anesthesia care including estimated blood loss (EBL) assessment and intraoperative
      hemoglobin measurements from the central laboratory (Hb). Blood samples were taken when EBL
      was ≥15% of total blood volume. RBC transfusion was initiated if Hb was ≤10 g/dL and
      continued until the EBL was replaced and Hb >10g/dL was confirmed. The SpHb Group followed
      the same transfusion practice as the Control Group except the anesthesiologist was guided by
      the addition of SpHb monitoring with blood samples still taken pre- and post-transfusion.
      Additionally, the absolute and trend accuracy of SpHb compared to Hb was evaluated. Potential
      cost savings from reduced RBC utilization will be calculated if occured.
    

Intervention name(s): Continuous non-invasive hemoglobin monitoring
Intervention type(s): Device
Intervention description(s): Anesthesiologist is provided with real-time continuous non-invasive hemoglobin monitoring to influence care provided to patient
Other intervention name(s): Masimo Radical-7 with SpHb
Intervention MeSH terms: Chrysarobin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Anemia; Blood transfusion; non invasive hemoglobin monitoring; patient safety
Randomized Trial on Scarpa Fascia Preservation During Hernio-abdominoplasty
Condition: Ventral Hernia
MeSH terms: Hernia, Ventral
Study type: Interventional

Summary: 
      This randomized trial aimed to assess the efficacy of preservation of Scarpa's fascia during
      hernio-abdominoplasty in reducing the volume of postoperative drainage, accelerating time to
      drain removal and recovery, and reducing complication rate.
    


Intervention name(s): Scarpa's preserving hernio-abdominoplasty; Classical hernio-abdominoplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): Scarpa's fascia is preserved during hernio-abdominoplasty; Scarpa's fascia is removed during hernio-abdominoplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
CYP2B6 Polymorphisms in Methadone Disposition
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This research study will determine if genetic variation in CYP2B6 affects how the body
      metabolizes methadone.
    

Detailed description: 
      This investigation determined the influence of CYP2B6 genetic variation, specifically
      CYP2B6*6 polymorphism, on clinical methadone plasma concentrations, clearance, and
      metabolism. The hypothesis was that CYP2B6*6 heterozygotes or homozygotes would have reduced
      metabolism and clearance. A secondary objective was to evaluate other less common genotypic
      variants, when encountered. Healthy volunteers in genotype cohorts CYP2B6*1/*1, CYP2B6*1/*6 ,
      and CYP2B6*6/*6, and also CYP2B6*4 and CYP2B6*5 carriers, received single doses of IV and
      oral methadone. Plasma and urine methadone and metabolite concentrations were determined by
      tandem mass spectrometry. The primary outcome measure was methadone metabolism, measured as
      plasma metabolite/patent area under the concentration-time curve ratio and metabolite
      formation clearance.
    

Intervention name(s): IV racemic methadone HCl; Oral racemic methadone HCl
Intervention type(s): Drug; Drug
Intervention description(s): IV racemic Methadone HC1 6 mg; oral d5-methadone HCl 11 mg
Intervention MeSH terms: Methadone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: methadone polymorphisms
Improving Quality of Life in Heart Failure
Condition: Heart Failure; Quality of Life
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      This research study has been designed to test the efficacy of telephone-delivered
      Problem-Solving Treatment (PST) for improving the quality of life (QoL) in outpatients with
      stable heart failure (HF).
    

Detailed description: 
      Heart failure (HF) is the end stage of all cardiovascular diseases, and it imposes a huge
      burden in the United States in terms of morbidity, mortality, and economic cost. Although
      disease management programs have been developed to curb these costs and address the
      complexities of HF management, evaluations of these programs have yielded equivocal results.

      With this study the Investigators plan to: (1) to determine the feasibility of telephone
      delivered PST for outpatients with HF and reduced QoL by obtaining estimates of yield,
      retention, patient acceptance, and patient satisfaction; (2) to determine whether
      telephone-delivered PST is associated with greater improvements in QoL than
      telephone-delivered Time Management over 8 weeks; and (3) to determine whether
      telephone-delivered PST is associated with greater reductions in depressive symptoms and/or
      greater improvements in self-efficacy or objectively assessed daily physical activity than
      telephone-delivered Time Management over 8 weeks.
    

Intervention name(s): Problem-Solving Treatment; Time Management
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Tadalafil for the Treatment of Diabetic Patients With Symptoms of Upset Stomach and Delayed Stomach Emptying
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purposes of this study are to determine whether an experimental drug known as tadalafil
      can reduce symptoms of dyspepsia (fullness after eating, inability to finish a regular meal,
      bloating, discomfort or pain in the upper abdomen, belching after meals, nausea, vomiting) in
      diabetic patients, and/or reduce the amount of time the stomach takes to empty the contents
      of a standard meal. The safety of tadalafil given once daily for 8 weeks in this population
      will also be studied.
    


Intervention name(s): tadalafil; tadalafil; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5 mg tadalafil tablet taken by mouth once a day for 8 weeks; 20 mg tadalafil tablet taken by mouth once a day for 8 weeks; Placebo tablet taken by mouth once a day for 8 weeks
Other intervention name(s): LY450190; Cialis; IC351; LY450190; Cialis; IC351
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Randomized Comparison of Ultrasound Versus Radiofrequency Denervation in Patients With Therapy Resistant Hypertension
Condition: Therapy Resistant Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Prospective, randomized trial to assess the effectiveness of different renal sympathetic
      denervation methods (radiofrequency main vs. branches + main vs. ultrasound based) in a
      cohort of patients with therapy refractory arterial hypertension and large renal arteries
    

Detailed description: 
      The aim of this trial is a prospective, randomized comparison of three different techniques
      for catheter based renal sympathetic denervation. Patients with larger (>5.5 mm) renal
      arteries are randomized to a treatment with a radiofrequency based catheter of the main renal
      artery, the main renal artery, its side-branches and accessories or an ultrasound-based
      denervation of the main renal artery only. The primary endpoint is the change in daytime
      blood pressure acquired in ambulatory blood pressure measurement at 3 months.
    

Intervention name(s): Radiofrequency denervation of the main renal arteries; Radiofrequency denervation of renal arteries and branches; Ultrasound denervation of the main renal arteries
Intervention type(s): Device; Device; Device
Intervention description(s): Catheter based renal sympathetic denervation of the main renal arteries using the Spyral™ Catheter (Medtronic, MN, USA); Catheter based renal sympathetic denervation of the main renal arteries and its branches using the Spyral™ Catheter (Medtronic, MN, USA); Catheter based renal sympathetic denervation of the main renal arteries using the Paradise™ Catheter (ReCor Medical, CA, USA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070)
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, non-randomized study was designed to compare pharmacokinetics of a single 50
      milligram (mg) dose of MK-0822 in participants with and without moderate hepatic
      insufficiency (abnormal liver function) in order to determine to what degree hepatic
      dysfunction may impact therapeutic blood levels of MK-0822. The primary hypothesis is that
      plasma AUC0-∞ of odanacatib in participants with moderate hepatic insufficiency is similar to
      that in matched healthy participants following a single 50 mg oral dose.
    


Intervention name(s): MK-0822
Intervention type(s): Drug
Intervention description(s): A single oral dose (50 mg tablet) of MK 0822 will be administered on Day 1 after an overnight fast.
Other intervention name(s): odanacatib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effectiveness of Massage in Treating Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of massage based on the tensegrity
      rule and classical abdominal massage in persons with constipation.
    

Detailed description: 
      Constipation can be defined as "an embarrassing ailment of the 21st century". It affects
      about 20-25% of the population, women as well as men, but occurs more frequently in women
      (female:male ratio of 2.2:1). Persons of different age suffer from it. Constipation is a
      bothersome ailment which negatively affects the general physical and mental state, lowers
      physical and mental fitness, significantly hinders professional work, and decreases life
      comfort As the factors which contribute to the occurrence of constipation are very diverse
      and complex, the treatment is a long-term and slow process. There are numerous conservative
      treatment methods for constipation, such as physical treatments, reflexotherapy, biofeedback,
      pharmacotherapy, and modification of lifestyle. There is also a possibility of applying
      classical massage in persons with constipation. However, observations of the authors suggest
      it is not a therapy commonly applied.
    

Intervention name(s): massage based on the tensegrity rule; massage - classical abdominal
Intervention type(s): Other; Other
Intervention description(s): The massage consist of brushing the skin, stroking of the lower abdominal integuments. Elastic deformation of the thoracolumbar fascia. Then the abdominal integuments were elastically deformed by kneading to normalize the rest tension of the muscles of the abdominal integuments as well as, indirectly, the myofascial apparatus of the pelvic floor and in this way improve venous blood and lymph outflow from the large intestine and the sigmoid colon area. The next treatment stage - performing circular movements within the limits of the skin's mobility at 1/3 of the medial part of the thigh. By stroking movements in the direction of the armpit in accordance with the run of the thoracoepigastric and costalaxillary veins. Then the intercostal muscles were deformed.; The classical abdominal massage consisted of circular movements performed on the abdominal integuments by superficial and deep stroking techniques according to the colonic route (clockwise)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: constipation; massage; tensegrity
A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to measure the amount of atorvastatin and ETC-1002 in
      the blood, to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol)
      and other markers of health and disease in blood and urine, and to see how ETC-1002 is
      tolerated in the body compared to placebo when added to stable atorvastatin 80 mg background
      therapy in statin-treated patients.
    


Intervention name(s): ETC-1002; Atorvastatin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Blinded ETC-1002 180 mg tablet once daily for 4 weeks (Weeks 1 to 4); Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4); Blinded ETC-1002-matched placebo tablet once daily for 4 weeks (Weeks 1 to 4)
Other intervention name(s): bempedoic acid
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: LDL-cholesterol; Hypercholesterolemia; ETC-1002; Adenosine triphosphate citrate lyase; Atorvastatin
Are There Differences Between Carriers of Haemophilia A and B?
Condition: Hemophilia
MeSH terms: Hemophilia A
Study type: Observational

Summary: 
      This study aims to develop a systematic genetic screening strategy for (potential) female
      carriers of haemophilia by identifying as many female carriers as possible within the
      families of haemophilia patients regularly followed at Cliniques universitaires Saint-Luc
      (CUSL) and to search for differences between female carriers of haemophilia A (HA) and B
      (HB).
    

Detailed description: 
      In order to complete our local registry of female carriers, the family trees of haemophilia
      patients will be systematically updated during their follow-up consultations at the
      haemophilia centre. Female carriers not yet known in our centre, identified by the updating
      of pedigrees, will be invited to present themselves in the haematology consultation and to
      participate in the study by means of an invitation and information letter which will be
      given/sent to them by the index haemophilia patient. Female carriers already known for whom
      missing data and/or the indication of regular follow-up have been identified during the file
      review will also be invited to attend a consultation within the framework of the study.

      At these consultations, (potential) carriers will be given information about haemophilia, the
      mode of genetic transmission and the implications of carrier status on patients' lives
      (bleeding prevention, reproductive choices, current haemophilia treatments and future
      prospects). We will then determine the bleeding phenotype of each patient by taking a
      comprehensive bleeding history. With the consent of the participants concerned, the familial
      genetic variant responsible for haemophilia will be sought in them in order to definitively
      establish their carrier status. The basal level of coagulation factors VIII (HA)/IX (HB) will
      also be determined. If a deficiency is found, haemostatic treatment adapted to the patient's
      situation will be initiated and clinical follow-up outside the study recommended.

      After completion of the data collection, the data will be analyzed and compared between HA
      and HB carriers in order to identify possible differences between these two populations.
    

Intervention name(s): Genetic assessment (hemophilia testing)
Intervention type(s): Other
Intervention description(s): Determination of carrier ship of hemophilia with molecular tests
Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1. Carriers of HA/HB already known and registered at the HTC (i.e. with an EMR).

          2. Carriers identified by pedigree review, invited/informed by family related haemophilia
             patients registered in the HTC, accepting to participate after informed consent.
      
Biospecimen description: 
      Genetic testing for hemophilia
    
Keywords: hemophilia A; hemophilia B; genetic testing; carriers
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders
Condition: Paralysis, Hyperkalemic Periodic; Hypokalemic Periodic Paralysis; Paramyotonia Congenita
MeSH terms: Myotonic Disorders; Hypokalemic Periodic Paralysis; Paralysis, Hyperkalemic Periodic; Paralysis
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES:

      I. Assess the efficacy of dichlorphenamide in the treatment of episodic weakness attacks in
      patients with hyperkalemic periodic paralysis, paramyotonia congenita with periodic
      paralysis, and hypokalemic periodic paralysis.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by
      participating institution and diagnosis.

      The weekly attack rate is determined during an 8-week assessment prior to therapy initiation
      and at crossover.

      Patients are randomly assigned to oral dichlorphenamide (DCP) or placebo for 9 weeks and then
      cross to the alternate treatment. Patients on DCP at baseline continue on the same dose;
      those on acetazolamide (ACZ) at baseline receive a DCP dose equivalent to one fifth of the
      ACZ dose.
    

Intervention name(s): dichlorphenamide
Intervention type(s): Drug
Intervention MeSH terms: Dichlorphenamide
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: neurologic and psychiatric disorders; periodic paralysis; rare disease