bioihbjkbjnl/mcl2 huggingface dataset:
A SU011248 Expanded Access Protocol for Systemic Therapy of Patients With Metastatic Renal Cell Carcinoma Who Are Ineligible for Participation in Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248
Condition: Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional

Summary: 
      A SU011248 expanded access protocol for systemic therapy of patients with metastatic Renal
      Cell Carcinoma who are ineligible for participation in other SU011248 protocols but may
      derive benefit from treatment with SU011248
    


Intervention name(s): SU011248
Intervention type(s): Drug
Intervention description(s): SU011248 Expanded Access Protocol for Systemic Therapy
Intervention MeSH terms: Sunitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Anthropometric Measures and Severity of Gastroesophageal Reflux Disease
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Observational [Patient Registry]

Summary: 
      evaluate the impact of different anthropometric measures on clinical and endoscopic severity
      of GERD and its relation to serum leptin.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This prospective, case-controlled study included 60 Egyptian patients who attended Ain
        Shams University Hospitals and Theodor Bilharz Research Institute; Cairo, Egypt
      
Keywords: Gastroesophageal Reflux Disease; Anthropometric Measures; Leptin
Glucose Metabolism in Subjects With Aldosterone-Producing Adenomas
Condition: Primary Aldosteronism
MeSH terms: Adenoma; Hyperaldosteronism
Study type: Observational

Summary: 
      This observational study tests the hypothesis that endogenous aldosterone impairs insulin
      secretion and insulin sensitivity in subjects with primary aldosteronism.
    

Detailed description: 
      The week of each study period, subjects will be provided a standard 160mmol/d sodium diet for
      6-8 days to control for inter-individual sodium intake.

      In period 1, subjects will report after 5 days of controlled sodium diet for a hyperglycemic
      clamp study (to measure insulin secretion). Subjects will continue the study diet, and then
      return for a hyperinsulinemic-euglycemic clamp study (to measure insulin sensitivity).

      After completion of period 1 assessment, subjects will undergo adrenalectomy by our endocrine
      surgeons or initiate medical treatment, according to routine clinical care.

      In period 2, the investigators will repeat the studies in the same manner as period 1, 3 to
      12 months after adrenalectomy or initiation of medical treatment.
    

Intervention name(s): Adrenalectomy; mineralocorticoid receptor antagonist
Intervention type(s): Other; Drug
Intervention description(s): Adrenalectomy for treatment of primary aldosteronism, according to standard of care; Subjects will be treated with a mineralocorticoid receptor antagonist according to standard of care
Other intervention name(s): spironolactone; eplerenone
Intervention MeSH terms: Eplerenone; Spironolactone; Mineralocorticoid Receptor Antagonists; Mineralocorticoids
Preoperative Pain Control in Liver Surgery Patients
Condition: Pain, Postoperative; Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Pain, Postoperative
Study type: Interventional

Summary: 
      Pregabalin 150mg or placebo are administered 1 hour preoperatively in patients undergoing
      partial hepatectomy. Postoperatively, patients receive morphine as rescue analgesic. Morphine
      consumption in the first 48 hours is documented. Postoperative pain is measured by the visual
      analogue scale (VAS) score.
    

Detailed description: 
      Methods: In this Randomized Controlled Trial, patients undergoing partial hepatectomy will be
      administered a single pre-operative dose of Pregabalin or a placebo. Primary endpoints are as
      follows:

        -  Post-operative analgesic requirements

        -  Post-operative VAS scale (rated 0-10)

        -  Complications

        -  Post-operative antiemetic requirement

        -  Length of stay
    

Intervention name(s): Pregabalin; Placebo (for Pregabalin)
Intervention type(s): Drug; Drug
Intervention description(s): One 150 mg oral dose of Pregabalin given before surgery; One oral dose of placebo given before surgery
Other intervention name(s): Lyrica; Sugar pill manufactured to mimic Pregabalin 150 mg tablet
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hepatocellular carcinoma; Hepatectomy; randomized controlled trials(RCTs); Postoperative Pain
Cystic Fibrosis Treatment Adherence Cayston Proof-of-Concept Pilot Study
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains
      discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic
      saline. Programs to enhance adherence, including comprehensive behavioral interventions with
      adolescents, have met with mixed success. Advances in therapy, treatment delivery systems,
      and data capture technology offer the potential for enhancing adherence by providing
      immediate and more frequent feedback to the patient regarding his or her fidelity to the
      prescribed treatment regimen. We propose to conduct a proof-of-concept study to evaluate a
      systematic approach to linking treatment and feedback components to enhance adherence.
    

Detailed description: 
      Study Design: This will be a single group intervention involving a 28-day baseline (Phase 1),
      a 28-day treatment period with enhanced adherence feedback. Subjects will be treated with
      Cayston via a blue tooth enabled nebulizer.
    

Intervention name(s): Adherence dashboard motivational interviewing
Intervention type(s): Behavioral
Intervention description(s): These data will be aggregated and displayed graphically in weekly intervals. Adherence will be displayed as percentage and timing percentage within a set criterion of prescribed inter-dose interval. Drug holidays, operationally defined as missing two or more consecutive doses will be displayed along with average length. Patient self-reported adherence information, collected via handheld (i.e, smart phone, tablet, laptop) application will be displayed as percentage and timing percentage on the dashboard. Review of dashboard weekly with investigator for motivational interviewing
Other intervention name(s): PARI; Altera; Cayston
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with cystic fibrosis over age 8 with difficulties with adherence to aerosolized
        Caysotn
      
Keywords: adherence; cystic fibrosis; adolescents; adults
Pain Relief by Intra-Peritoneal Nebulization of Ropivacaine Under Remifentanil Anesthesia for Gynecological Laparoscopy
Condition: Gynecological Laparoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      In our prospective, randomized, placebo controlled and double-blinded study we will study the
      efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecologic
      laparoscopic surgery. This is a second steady with protocol of general anesthesia used of
      Remifentanil.
    

Detailed description: 
      Outcome Measures :

        -  VAS score

        -  Use of analgesics during operation and postoperative period
    

Intervention name(s): 10 mLRopivacaine 1%; Water for injection; 10 mL Ropivacaine 1%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intraperitoneal nebulization of 10 mL Ropivacaine 1%; Intraperitoneal nebulization of 10 mL water for injection; Intraperitoneal nebulization of 10 mL Ropivacaine 1%
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Phase 0 Study of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa to
      identify biomarkers of disease activity and clinical response.
    

Detailed description: 
      Phase 0, Open Label study of Brodalumab in patients with moderate to severe Hidradenitis
      Suppurativa. Consisting of n=10 patients receiving 210mg subcutaneously every 2 weeks for 24
      weeks. Patients will be followed for a period of 36 weeks (12 weeks after last dose of
      Brodalumab) to assess for safety.
    

Intervention name(s): Brodalumab
Intervention type(s): Drug
Intervention description(s): interleukin 17 receptor A antagonist
Other intervention name(s): Siliq
Intervention MeSH terms: Brodalumab
Intervention model: Single Group Assignment
Intervention model description: Open Label Single Arm Study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hidradenitis Suppurativa; Acne Inversa; Brodalumab
Bioequivalence of IMP 08P1902F0 Relative to Contramal® (100 mg/mL Oral Solution)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to demonstrate the bioequivalence between the formulation of 5 mg/mL Tramadol
      Hydrochloride Oral Solution (08P1902F0) Relative to the reference product Contramal® (100
      mg/mL Oral Solution).
    


Intervention name(s): Tramadol Hydrochloride 5 MG/ML Oral Solution; Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r))
Intervention type(s): Drug; Drug
Intervention description(s): 50mg (10mL) single dose; 50mg (20 drops) single dose
Intervention MeSH terms: Tramadol; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Open-label, randomized, single dose, two-sequence, two-period crossover study
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Mantra on Hypertensive Patients
Condition: High Blood Pressure
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Mantras are specialized energized sound or words, which are defined most important sound
      therapy in Vedic healing. Present study was undertaken to evaluate the immediate effect of
      specialized Mantra chant on cardiovascular parameters in high blood pressure patients.
    


Intervention name(s): Mantra Chikitsa
Intervention type(s): Other
Intervention description(s): Specific Mantra were given to chants for 15 mins and resting in the impact of chants for following 15 mins.
Other intervention name(s): Mantra therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Patient Education Manual on Patients With Knee Osteoarthritis.
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This RCT was conducted to see effects of patient education manual on pain, ROM and functional
      performance in patient of knee osteoarthritis. In this study the investigators were provide
      an educational manual as a home plan in which the investigators educate and guide patients
      about proper posture, life style modification, precautions and safety measures and home
      exercise in patient with knee osteoarthritis
    

Detailed description: 
      This RCT was conducted to see effects of patient education manual on pain, ROM and functional
      performance in patient of knee osteoarthritis. In this study the investigators provide an
      educational manual as a home plan in which they educate and guide patients about proper
      posture, life style modification, precautions and safety measures and home exercise in
      patient with knee osteoarthritis.

      The investigators will divide the patients in two groups. One group was treated with the
      patient education manual and routine physical therapy and the other group was treated with
      routine physical therapy alone. After baseline assessment patient was assessed at 2nd, 4th
      and 6th week and then do final assessment to analyse our results on SPSS, either patient
      education manual is helpful in minimising there pain functional limitation and increasing
      their Range Of Motion. Visual analogue scale, goniometry and WOMEC was used to measure
      outcome regarding pain, Range of motion and functional performance in patients with knee
      osteoarthritis. This study was help full in the management, to improve function and to
      decrease status of disability in future in patients with knee osteoarthritis.
    

Intervention name(s): Traditional physical therapy; patient education manual +traditional physical therapy
Intervention type(s): Other; Other
Intervention description(s): Traditional physical therapy Ultrasound posteriorly 6 mints 4 days/week hydrocollateral pack anteriorly 10 mints 4 days/week Quadriceps isometrics 10 repetitions×1 set, 4 days/week and Hamstring muscle strechings 10 repetitions×1 set, 4 days/; Patient educational Manual
+ Traditional physical therapy Ultrasound posteriorly 6 mints 4 days/week hydrocollateral pack anteriorly 10 mints 4 days/week Quadriceps isometrics 10 repetitions×1 set, 4 days/week and Hamstring muscle strechings 10 repetitions×1 set, 4 days/
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Patient education manual; Knee O.A; Pain; ROM
The Evaluation of the Effect of Microfluidic Sperm Sorting Chip 'Labs-on-a-chip' on IVF Success in Male Factor
Condition: Male Infertility; Infertility, Male
MeSH terms: Infertility; Infertility, Male
Study type: Interventional

Summary: 
      Microfluidic chips are one of the methods of sperm separation to eliminate DNA fragmentation
      in sperm. It is thought that the separation of sperm by centrifugation in the classical
      gradient density (Percoll) method used in sperm separation in IVF (in vitro fertilization)
      laboratories leads to the increase of reactive oxygen radicals in sperm and this leads to
      sperm DNA fragmentation. Studies comparing Percoll and microfluidic chip method in terms of
      sperm, embryo quality and pregnancy rates are limited. In this context, it is aimed to
      investigate the effect of Percoll or Microfluidic Chip Technology on the quality of sperms
      and embryos obtained with these sperms and their pregnancy rates prospectively.
    

Detailed description: 
      The increase in male infertility rate due to environmental and physiological conditions leads
      to an increase in the use of assisted reproductive techniques. Isolation of living and
      morphologically normal live sperm is an integrated procedure in commonly used IVF /
      ICSI(intracytoplasmic sperm injection) / IUI(intrauterine insemination) procedures. Although
      current IVF / ICSI procedures result in a successful pregnancy of around 50%, the process can
      be greatly compromised if the selected sperm is abnormal. Microfluidic chips are one of the
      recommended sperm separation methods to eliminate DNA fragmentation in sperm. It is thought
      that the separation of the sperm by centrifugation in the classical gradient density
      (Percoll) method which is used in the separation of sperm in the IVF Laboratories, causes the
      increase of reactive oxygen radicals in sperm and this leads to sperm DNA fragmentation.
      Studies comparing Percoll and microfluidic chip method in terms of sperm, embryo quality and
      pregnancy rates are limited. In this context, it is aimed to investigate the effect of
      Percoll or Microfluidic Chip Technology on the quality of sperms and embryos obtained with
      these sperms and their pregnancy rates prospectively.
    

Intervention name(s): MicroFluidic Sperm Sorting Chips; Gradient-Density Centrifugation
Intervention type(s): Other; Other
Intervention description(s): sperm selection of IVF treatment; sperm selection of IVF treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: microfluid chip; gradient-density; IVF; male factor
Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections
Condition: Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Observational

Summary: 
      The objective of this study was to obtain data on the safety, tolerability and compliance
      with Zithromax in children with bacterial infections of the upper and lower respiratory
      tract.
    

Detailed description: 
      Patients were recruited from the outpatient departments of the participating
      sites/hospitals/clinics.
    

Intervention name(s): Azithromycin
Intervention type(s): Drug
Intervention description(s): Zithromax was dispensed according to the Summary of Product Characteristics (SPC) as either a tablet or suspension. Zithromax was administered as a total dose of 30 mg/kg which was given as single daily doses of 10 mg/kg for 3 days, or as a 5 day dose starting with 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5.
Other intervention name(s): Zithromax
Intervention MeSH terms: Azithromycin
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ZITHROMAX® administration will be considered in children / adolescents from the first year
        of life up to 14 years old with the following diagnoses: Acute otitis media, Sinusitis,
        Pharyngitis/tonsillitis, Pneumonia, Bronchitis.
      
Keywords: Compliance and Safety Study in Children with Upper and Lower Respiratory Tract Infections
Single Ascending Doses Study of Anti- Interleukin-7 Receptor α Monoclonal Antibody (GSK2618960) in Healthy Volunteers
Condition: Autoimmune Diseases
MeSH terms: Autoimmune Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2618960 is a humanized Immunoglobulin G 1 ( IgG1) monoclonal antibody (mAb) that binds to
      the alpha component (CD127) of the heterodimeric Interleukin-7 receptor (IL-7R). It is being
      developed for the treatment of autoimmune indications. This study is intended to further
      explore the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and
      immunogenicity of single ascending doses GSK2618960 in healthy volunteers beyond those
      already evaluated in I7R116702 (First Time In Human study). The study is anticipated to enrol
      18 subjects in total, with 9 subjects in each of the two cohorts.
    


Intervention name(s): GSK2618960; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK2618960 will be provided as 100 mg/mL solution for injection to be administered as single dose IV infusion that has to be diluted at the study site with placebo; It is Sodium Chloride Intravenous Infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Interleukin-7 Receptor α; monoclonal antibody
The Impact of Physical (In)Activity on Sleep Quality
Condition: Sleep
Study type: Interventional

Summary: 
      The proposed research will examine the role of physical activity (PA) on altering sleep
      quality (SQ) while systematically examining novel mechanisms that may drive changes in SQ.
      Specifically, the study will examine how a 2 week reduction in PA alters sleep quality in
      young, healthy individuals. Additionally, during this reduction in PA, the study will examine
      changes in inflammation, oxidative stress, and sympathetic activity to identify potential
      mechanisms for alterations in sleep quality.
    

Detailed description: 
      Sleep, which makes up approximately one third of an individual's life, plays a vital role in
      normal bodily functioning by regulating metabolic and endocrine function. Disturbed sleep,
      defined as any alteration to normal sleep patterns, is highly prevalent, affecting 35% and
      41% of the general population in the United States and has been linked to poor cardiovascular
      health, diabetes, obesity, dyslipidemia, and hypertension. Young adults are a population at
      high risk for disturbed sleep-related health outcomes due to negative lifestyle behaviors
      such as alcohol consumption, drug use, study patterns, and excessive screen time that remain
      with advancing age. Due to the importance of improving or maintaining health outcomes through
      adequate sleep quality (SQ), the proposed research will examine the role of physical activity
      (PA) on altering SQ while systematically examining novel mechanisms that may drive changes in
      SQ. Specifically, this study will examine how alterations (increases and decreases) in PA
      impact SQ and how these alterations modify inflammation, oxidative stress, and sympathetic
      stimulation in young adults.
    

Intervention name(s): Reduced Physical Activity
Intervention type(s): Behavioral
Intervention description(s): Preliminary Phase (Baseline to Day 7): Subjects will begin wearing an accelerometer for 7 days to track physical activity and sleep patterns.
Experimental Phase 1 (Day 7 to Day 21): Participants will be required to reduce their step count by 5,000 steps per day and engage in no moderate-vigorous physical activity during this timeframe. Every 7 days subjects undergo the blood draw, vascular health measures and questionnaire assessments.
Experimental Phase 2 (Day 21 to 28): During the week of assessment, subjects will be asked to return to their normal physical activity patterns.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of the Absorption, Distribution, Metabolism and Excretion of LY3039478 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This type of study is called a radiolabeled study. For this study, LY3039478 (study drug) has
      been specially prepared to contain radiolabeled carbon [¹⁴C]. [¹⁴C] is a naturally occurring
      radioactive form of the element carbon. This study will help determine how the drug appears
      in the blood, urine, and stool after it is administered by mouth to healthy people.
      Information about any side effects that may occur will also be collected. This study will
      last about 10 weeks for each participant.
    


Intervention name(s): LY3039478
Intervention type(s): Drug
Intervention description(s): Administered orally
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science