bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Pharmacokinetic Study of ER OROS Paliperidone in Pediatric Patients With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to characterize the pharmacokinetics of paliperidone after
      single- and multiple-dose administration of paliperidone ER in children and adolescent
      patients (>= 10 to <= 17 years of age) with schizophrenia, schizoaffective disorder, or
      schizophreniform disorder and to evaluate the safety and tolerability of paliperidone ER in
      this patient population.
    

Detailed description: 
      The current study is designed as a multicenter, open-label, multiple-dose study in children
      and adolescent patients >= 10 to <= 17 years of age with schizophrenia, schizoaffective
      disorder, or schizophreniform disorder. The study includes 3 dosage groups (0.086, 0.129, and
      0.171 mg/kg/day paliperidone ER), which will be studied in a sequential ascending design, so
      that the safety of the drug can be properly evaluated with a lower dosage before proceeding
      to the next higher dosage. The 3 dosages are approximately 6, 9, and 12 mg/day in adults.
      Within each dosage group, patients will be randomly assigned to 1 of 2 pharmacokinetic
      sampling schedules in a 1:1 ratio. For each dosage group, the study consists of a screening
      phase (for a maximum of 21 days); a 2-day, single-dose pharmacokinetic and tolerability
      evaluation phase; a 7-day multiple-dose phase, with evaluation of pharmacokinetics and
      tolerability; and an end-of-study visit. Following the completion of all patients in a given
      dosage group, the sponsor will evaluate the safety and tolerability of the treatment, in
      order to determine whether to proceed to the next higher or lower dosage level. The first
      group will start at 0.086 mg/kg/day. The hypothesis is that paliperidone ER will be well
      tolerated in children and adolescent patients with schizophrenia, schizoaffective disorder,
      or schizophreniform disorder, and will display the expected pharmacokinetic characteristics
      in this population. Paliperidone ER 0.086, 0.129, and 0.171 mg/kg/day, oral administration,
      single dose on Day 1 of study followed by once daily dosing on Days 3 to 9.
    

Intervention name(s): ER OROS paliperidone, paliperidone ER
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective disorder; Schizophreniform disorders; Mood disorders; Antipshychotic drugs; Pediatrics; ER OROS Paliperidone, Paliperidone ER
COMPARISON OF LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR AND LICHTENSTEIN HERNIA REPAIR
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Observational [Patient Registry]

Summary: 
      The superiority of laparoscopic inguinal hernia surgery over open surgery has been shown in
      many high patient-numbered studies with early return to work, less pain and good cosmetic
      results. The aim of this study is to determine the differences between two different methods
      in terms of sexual, sensory, quality of life and urinary results.
    

Detailed description: 
      Between July 2017 and January 2018, 42 sexually active male patients were randomized with
      Laparoscopic Total Extraperitoneal (TEP) method and Lichtenstein (LCH) method and repair of
      inguinal hernia. Patients were evaluated preoperatively, at 1 month and 6 months
      postoperatively, International Sexual Function Index (IFIF), International Prostatic Symptom
      Score, SF-36 Quality of Life Scale, Visual Analog Pain Scale, Beck Depression Scale, Inguinal
      Region Discrimination Test ( DT), DN4 Neuropathic Pain Survey, Uroflowmetry and FSH, LH,
      Total Testosterone levels were evaluated.
    

Intervention name(s): TEP; Lichtenstein repair
Intervention type(s): Procedure; Procedure
Intervention description(s): By making a 2 cm incision under the umbilicus, skin subcutaneous tissues are passed through blunt dissections and the anterior fascia of the rectus muscle is exposed. An anterior rectus sheath with a scalpel is performed with a 15 mm incision. The rectus muscle is laterally lateralized and the balloon trocar or laparoscope itself is advanced from the midline to the symphysis pubis via the posterior rectus sheath. After the peritoneal cavity is dissected, a low pressure pneumoperitone 10 mm Hasson trocar or another 10 mm balloon caged trocar is advanced through the subumblic incision. 9-11 mmHg low pressure pneumoperitoneum is created to prevent the development of subcutaneous emphysema. For proper imaging, the patient should have complete muscle relaxation. The patient is given a position towards the light trandelenburg and non-hernia side.; After the inguinal incision, the skin and subcutaneous camper and scarpa tissues are passed and the external oblique aponeurosis is dissected in the direction of the extension of the fibers and the medial lateral edge of the rectus is dissected to the lateral inguinal ligament, then the spermatic cord is released and suspended.The spermatic cord is separated from the inguinal canal.
In indirect hernias, the hernia sac is dissected from the spermatic cord and rejected into the abdomen by high ligation. In direct hernia, the hernia sac is pushed in and the transverse fascia is sutured with 2-3 separe stitches.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        SEXUAL ACTIVE
      
Keywords: Quality of life; Inguinal Hernia; Lichtenstein repair; Sexual Function; Total Extraperitoneal Repair
Prognosis of Hematological Cancer Patient Underwent Mechanical Ventillation
Condition: Hematological Malignancy; Acute Respiratory Failure; Mechanical Ventilation
MeSH terms: Neoplasms; Hematologic Neoplasms; Respiratory Insufficiency
Study type: Observational

Summary: 
      This observational cohort aimed to re-evaluate the outcome of hematologic cancer patients
      admitted to the intensive care unit of Mansoura oncology center through a cohort study as
      regards their need for mechanical ventilation during two years.
    

Detailed description: 
      It has been believed for many years that the scene of cancer patients requiring mechanical
      ventilation is frustrating. The needed life support measures drain much of health resources
      and add a significant burden on the patient's family. Many factors have been responsible for
      the high mortality rates among hematologic cancer patients admitted to intensive care unit.
      Among of these factors, the invasive treatments that are frequently employed in today's
      intensive care unit. These procedures give chance for development of severe infection and
      multiple organ failure which are common events in immune-compromised patients (e.g.
      neutropenia) and in those exposed to chemotherapy. The most common form of organ failure in
      those patients is acute respiratory failure which is a major predictor of mortality in that
      population. The prognosis of such failure may vary depending on its causes and severity, co
      morbidity, associated acute organ failure and characters of the underlying malignancy. After
      the recent advances in the field of intensive care and shedding light on the benefits of the
      noninvasive ventilation in immune-compromised patients, the overall survival rate of cancer
      patients admitted to intensive care unit are improving.
    

Intervention name(s): Mechanical ventilation
Intervention type(s): Procedure
Intervention description(s): requiring mechanical ventilation at admission to ICU for one day or more during the study period
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hematological cancer patients admitted to ICU of oncology center, Mansoura University
      
Keywords: Intensive care unit; Hematological malignancy; Acute respiratory failure; Prognosis; Mechanical ventilation
Gut Hormone Secretion and Macronutrients
Condition: Healthy Volunteers
Study type: Observational

Summary: 
      The role of gut hormone (GLP-1, GIP, PYY...) in glucose homeostasis has been widely
      demonstrated. Furthermore modifications in their pattern of secretion seem to be involved in
      the improvement of glucose control in obese patients after bariatric surgery.

      The purpose of this study is to assess the respective role of carbohydrate, fat and protein
      from a complete meal in gut hormones secretion.
    

Detailed description: 
      The study is designed to asses the role of each individual macronutrient of a compete meal in
      gut hormones secretion in healthy volunteers.

      8 healthy young male subjects will be studied on 5 different occasions. To asses the role of
      each macronutient the subjects will recieve one of the following test meal: a complete
      sandwich, the proteic part of this complete meal, the glucidic part and the lipidic part. The
      fifth test will be a fasting test.

      To assess the entero-insular axis, a 5.5 hours hyperglycaemic clamp will be performed.
    

Intervention name(s): test meal; glucose; fat; protein; control
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Mixed meal containing bread, butter, beef; administration of a glucose meal; administration of a lipid meal; administration of a protein meal; no meal
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy male volunteers
      
Keywords: Gut hormone; hyperglycaemic clamp; glucose turnver
Mothers' Approach to Clinical Research Amongst Their Preterm or Healthy Newborns
Condition: Parents Approval to Research
Study type: Observational

Summary: 
      Parental approval to enroll their sick children in clinical research was studied. However,
      the motivation of parents to enroll healthy children and/or babies was not yet studied. The
      importance of clinical research among the healthy population is of extreme value. The aim of
      this study is to assess the motivation, medical trust and other factors influencing parents'
      decision to enroll their healthy baby in a clinical study.
    

Detailed description: 
      Mothers to either healthy full-term babies post delivery or preterms will be asked to
      anonymously answer a questionnaire. The questionnaire includes demographic data, questions
      regarding their approach to medical issues, factors that influence her to enroll her baby in
      a research trial (different research types, different benefits from the research and fears).
      Finally, the mother will be asked if she will be willing to enroll her baby to on-going
      studies in the department.
    

Observational model: Cohort
Time perspective: Prospective
Keywords: parents; newborn; clinical trials
LEO 124249 Ointment in the Treatment of Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial attempts to investigate the efficacy and safety of LEO 124249 ointment in
      the treatment of alopecia areata and the molecular disease mechanism and biomarkers.
    

Detailed description: 
      The objectives of this clinical trial are to compare the efficacy of twice-daily topical LEO
      124249 30 mg/g ointment with LEO 124249 ointment vehicle for 12 weeks in the treatment of
      hair loss in subjects with alopecia areata, to evaluate the safety of this treatment, to
      evaluate hair regrowth, to determine subject quality of life, and to explore disease
      mechanism and its biomarkers.
    

Intervention name(s): LEO 124249; Vehicle
Intervention type(s): Drug; Other
Other intervention name(s): LEO 124249 Ointment; LEO 124249 Vehicle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Remediation of Cognitive Dysfunction in Euthymic Bipolar Disorder Patients Using Transcranial Direct Current Stimulation (tDCS)
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to investigate the potential for Transcranial Direct Current Stimulation
      (tDCS) to enhance cognitive functioning in euthymic bipolar patients through comparing the
      effect of active or sham tDCS (placebo control) during the performance of two cognitive
      tasks. The investigators hypothesize that task performance will be improved with active
      relative to sham tDCS.
    


Intervention name(s): Transcranial direct current stimulation (Eldith DC Stimulator)
Intervention type(s): Device
Intervention description(s): Eldith DC Stimulator (NeuroConn GmbH, Germany)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Elderly Patients With Advanced Stages Hodgkin's Lymphoma
Condition: Hodgkin's Disease
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objectives of this study are to assess the feasibility and efficacy of a combination
      chemotherapy (PVAG) in elderly patients with advanced stages Hodgkin's lymphoma.
    

Detailed description: 
      Gemcitabine shows promising activity in patients with relapsed lymphoma either administered
      as single agent or in combination with other cytotoxic agents. No trial to date evaluated its
      role in patients with primary Hodgkin's lymphoma. We therefore developed a three-weekly
      regimen based on the standard ABVD regimen.
    

Intervention name(s): Prednisone; Vinblastine; Doxorubicin (Adriamycin); Gemcitabine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Prednisone; Gemcitabine; Doxorubicin; Liposomal doxorubicin; Vinblastine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lymphoma; Gemcitabine; Advanced stages Hodgkin's lymphoma; Elderly
Single Dose Study of ALZ-801 Prototype Tablets
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, single-center, open-label, non-randomized, sequential single dose 4-period study in
      12 healthy subjects to assess the pharmacokinetics of ALZ-801, tramiprosate and the primary
      metabolite of tramiprosate, NRM5074, from prototype drug product formulations of ALZ-801, and
      to assess effect of food on the bioavailability of ALZ-801 and tramiprosate of the prototype
      tablet formulation.
    

Detailed description: 
      This is a single-center, open-label, non-randomized, sequential, single-dose, 4-period study
      in 12 healthy adult subjects. Subjects are to receive a single oral dose of ALZ-801 in each
      of the 4 study periods (Regimens A, B, C and D) in a non-randomized, sequential manner,
      separated by a minimum washout period of 7 days. The washout period is expected to last
      approximately 14 days to permit interim decisions to take place and to allow for the
      selection of the formulation of the subsequent regimen. Periods of interim analysis will take
      place following dosing with prototype formulations Regimens A, B, and C, during which the PK
      and safety data are reviewed to determine the dose to be administered in the subsequent
      treatment period. Interim decisions aim to identify a prototype ALZ-801 immediate release
      tablet formulation that provides a similar tramiprosate AUC and Cmax to that of historical
      values after administration of a 100 mg loose-filled tramiprosate capsule in the fasted
      state.

      Optimization of the required tramiprosate exposure will be made by adjusting the dose of
      ALZ-801 in the prototype tablets using a formulation design space with a target dose range,
      per tablet, of 171 to 514 mg ALZ-801 (equivalent to 100 mg to 300 mg tramiprosate). Dose
      selection will be made after a complete review of all data collected from the previous dose
      group. For dose selection to occur, data is required to be available from a minimum of 8
      evaluable subjects with complete safety assessments up to 24 h post-dose, and required safety
      and PK data (AEs, plasma concentrations of ALZ-801, tramiprosate and NRM5074, and Tmax, Cmax
      and AUC estimates for ALZ-801 and tramiprosate).
    

Intervention name(s): ALZ-801 170 mg Fasting; ALZ-801 205 mg Fasting; ALZ-801 205 mg After Food; ALZ-801 342 mg Fasting
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Subjects were to receive a single oral dose of ALZ-801 in each of the 4 study periods (Regimens A, B, C and D) in a non-randomized, sequential manner, separated by a minimum washout period of 7 days.
Masking: None (Open Label)
Primary purpose: Treatment
Non-inferiority Trial of Dapaconazole Versus Ketoconazole
Condition: Tinea Pedis
MeSH terms: Tinea; Tinea Pedis
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to demonstrate that dapaconazole cream 2% (experimental
      drug) is non-inferior to ketoconazole cream 2% (Nizoral® - active comparator) for the
      treatment of dermatological lesions of Tinea pedis, when applied to the skin (topically) once
      daily during 28 days. Additionally, the safety and tolerability aspects will be evaluated in
      a descriptive way, through the observation of the incidence of adverse events.
    

Detailed description: 
      This is a non-inferiority, phase 3, multicenter, double-blind, randomized (allocation of
      treatment), balanced, controlled (active comparator) trial, with two parallel groups in a 1:1
      proportion.

      Randomization will depend on inclusion/exclusion criteria, taking into account the
      confirmation of diagnosis by the direct mycological test performed during the screening
      phase. However, cases whose diagnosis is not additionally confirmed by positive fungal
      culture (sampled during the screening phase) will be excluded from the efficacy analysis.

      Participants will show up to the clinic, for treatment, during 42 consecutive days, when one
      of the investigational products (according to the randomization) will be applied by a blind
      member of the study staff. A non-blind member of the study staff will weigh the corresponding
      investigational product and pass on to the blind member only a spatula with the weighed
      product, in order to maintain the blinded aspect of the trial.

      For exploratory purposes, clinical and mycological evaluations will also be performed after 7
      and after 14 days of treatment.

      Safety analysis will be performed considering all the randomized patients to which at least
      one dose of the investigational products has been applied, regardless of the result of the
      fungal culture.

      Conclusion of non-inferiority will be based on the per protocol set. It will be deemed as per
      protocol those participants who do not miss more than 20% of the applications and, also, no
      more than four consecutive application days.
    

Intervention name(s): Dapaconazole; Ketoconazole
Intervention type(s): Drug; Drug
Intervention description(s): Application of 1 to 3 grams, depending on the lesion extension, per affected foot.; Application of 1 to 3 grams, depending on the lesion extension, per affected foot.
Other intervention name(s): Zilt; Nizoral®
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mycoses; Dermatomycoses; Antifugal Agents; Dapaconazole
Pharmacodynamic Comparison of Truncal Blocks in Patients With or Without Metabolic Disease (Kidney Failure, Diabetes)
Condition: Renal Insufficiency; Diabetes
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Metabolic Diseases
Study type: Observational

Summary: 
      The primary objective is to demonstrate a longer period of neurologic recovery from a sensory
      block assessed in each test group versus the group without metabolic disease.
    


Intervention name(s): Truncal block
Intervention type(s): Procedure
Intervention description(s): Patients will have a truncal block during hand or wrist surgery.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Three patient populations schelduled for surgery on the hand or wrist. The three groups
        include (1) patients with no metabolic or neurologic disease history, (2) patients with
        renal insufficiency but not diabetes and (3) patients with diabetes but not renal
        insufficiency.
A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients
Condition: Osteonecrosis; Osteoarthritis
MeSH terms: Osteonecrosis; Seizures
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators determined whether

        1. new short, metaphyseal-fitting cementless anatomical femoral stem provides major
           functional improvements

        2. radiographically secure implant fixation is achieved with this new stem

        3. the bone content is preserved at the baseline level or above at the final follow-up

        4. these procedures are associated with early failure and complications.
    

Detailed description: 
      To attempt reduction of stress shielding and thigh pain as well as to improve survivorship, a
      new short, metaphyseal-fitting cementless anatomical femoral stem was developed. The question
      arises as to whether it is possible to obtain rigid fixation of the stem without diaphyseal
      fixation in the young as well as in the elderly patients. The purpose of this study was to
      determine the clinical and radiographic results of the new short, metaphyseal-fitting
      cementless anatomical femoral stem in the young as well as in the elderly patients.
    

Intervention name(s): Total Hip Arthroplasty
Intervention type(s): Device
Intervention description(s): Total Hip Arthroplasty
Other intervention name(s): Proxima
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: short, metaphyseal-fitting femoral stem; cementless anatomical femoral stem; young patient; elderly patient
Protective Effects of EPI-743 on Noise-Induced Hearing Loss
Condition: Noise-induced Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Noise-Induced
Study type: Interventional
Phase: Phase 2

Summary: 
      If effective, administration of EPI-743 should have protective effects against temporary
      noise-induced hearing loss.
    


Intervention name(s): EPI-743; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): EPI-743 (2 capsules 200 mg each) taken at a dose of 400 mg P.O. TID for 9 days with noise exposure for 4 hours on Day 8.; 2 Placebo capsules P.O. TID for 9 days with noise exposure for 4 hours on Day 8.
Other intervention name(s): VincerinoneTM; EPI743; Matching placebo
Intervention MeSH terms: Ubiquinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: hearing; noise; oxidative stress