bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 3

Summary: 
      Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic
      Phakic and Pseudophakic Presbyopia
    

Detailed description: 
      Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and
      Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia
    

Intervention name(s): BRIMOCHOL™ PF; Carbachol PF; Brimonidine tartrate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single drop in each eye at a visit.; A single drop in each eye at a visit.; A single drop in each eye at a visit.
Other intervention name(s): carbachol/brimonidine tartrate; carbachol monotherapy; brimonidine tartrate monotherapy
Intervention MeSH terms: Brimonidine Tartrate; Carbachol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Morbidity Related to Secondary Hyperparathyroidism After Renal Transplantation
Condition: Secondary Hyperparathyroidism; Disorder Related to Renal Transplantation
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Observational

Summary: 
      The purpose of the study is to evaluate the long term vascular morbidity and mortality in
      kidney transplant recipients based on one year post transplant levels of intact parathyroid
      hormone.
    

Detailed description: 
      Secondary hyperparathyroidism (SHPT) is a well known complication to chronic renal failure.
      With impaired renal function the phosphate excretion from the kidney is reduced. Together
      with low levels of 25- and 1,25-vitamin D3 and hypocalcemia this uremic mineral milieu drives
      the release of parathyroid hormone (PTH) and the development of SHPT. PTH has many functions
      but acts mainly to release calcium from the skeleton, to enhance calcium uptake from the
      intestines (by actions on vitamin D) and to lower serum phosphate by inducing phosphaturia.
      SHPT has been shown to cause vascular morbidity and fractures in the chronic kidney disease
      (CKD) patient. After successful renal transplantation (RT) the mineral disturbances are
      mostly recovered and stabilized at one year post RT, but in recent years it has been shown
      that SHPT persists in the major part of RT-recipients even after long term follow up. This
      has been associated with high risk of fractures and vascular related morbidity in the post
      transplant period. It has also been shown that low levels of iPTH in the post-transplant
      period might be associated with a high risk of fractures. Because of insufficient data on PTH
      levels and associated morbidity there is no specific recommendations of target PTH levels in
      the RT-patient. This indicates that there is need for further observational studies to
      describe the SHPT-associated morbidity in a post transplant cohort based on stabilized levels
      of post transplant iPTH.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All patients who underwent renal transplantation surgery between January 1:st 2003 to
        December 31:st 2005 at Skane University Hospital or Karolinska University Hospital.
      
Keywords: Secondary Hyperparathyroidism; Renal Transplantation; Myocardial Infarction; Fracture; Graft Failure
HIV/STD Safer Sex Skills Groups for Women in Drug Treatment Programs - 1
Condition: Behavior Therapy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to look at a program for women in drug abuse treatment designed
      to reduce Human Immunodeficiency Virus/Sexually Transmitted Disease (HIV/STD) risk behaviors
      and reduce unprotected sexual risk behavior.
    

Detailed description: 
      The proposed trial is intended to test the effectiveness of a proven, manual driven,
      five-session safer sexual skills building group (SSB) intervention (Schilling et al., 1991;
      El Bassel and Schilling, 1992) for female patients in MMTP or in drug-free outpatient
      treatment. The effects of SSB will be compared to a standard group HIV education session
      (HE).

      This study uses a 2-group, randomized, parallel-group design to compare a five-session safer
      sexual skills building group to a single 60-min HIV education session (control condition).
      The control condition is designed to standardize and simulate the usual care at community
      clinics.
    

Intervention name(s): Behavior Therapy
Intervention type(s): Behavioral
Primary purpose: Treatment
Keywords: behavioral intervention
End-range Mobilization on Pressure Pain Threshold
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Pain in knee osteoarthritis (OA) represents increased pain intensity due to peripheral and
      central sensitivity. Pressure pain threshold (PPT) is a widely applied (used) method for
      measuring the magnitude of peripheral and central sensitivity in knee OA. Among several
      manual therapy techniques increasing PPT in knee OA, the effect of end-range mobilization has
      not been evaluated so far. The aim of this study was to investigate the immediate effect of
      end-range mobilization compared to placebo on increase of PPT and some function-related
      measures.
    

Detailed description: 
      Knee osteoarthritis (OA) is the most common form of arthritis contributing to a major cause
      of disability worldwide. Although many mechanisms may contribute to knee pain severity, the
      patient-reported hyperalgesia can be attributed to peripheral and central sensitivity in knee
      OA. Pressure pain threshold (PPT) measurement is a simple and commonly applied method for
      measuring somatosensory function in musculoskeletal disorders, just as in knee OA. Many
      trials have shown a lower PPT value in knee OA underlining the presence of peripheral and
      central sensitivity compared to healthy controls.

      Manual therapy techniques, as a preferred treatment option, may not only alleviate pain, but
      also increase pain tolerance to locally applied mechanical pressure. Positive results of
      different manual therapy techniques on increase of PPT has been reported in knee OA.
      End-range manual therapy is an option for the decrease of sensitivity in knee OA; however,
      the effect of end-range mobilization has not been evaluated so far in knee OA.
    

Intervention name(s): End-range mobilization; Placebo technique
Intervention type(s): Procedure; Procedure
Intervention description(s): End-range mobilization performed in end-range of the tibiofemoral joints' flexion and extension; Hands-on technique performed in end-range of the tibiofemoral joints' flexion and extension
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Musculoskeletal Manipulations; Osteoarthritis, Knee; Pain Threshold
Interferon Alfa With or Without Isotretinoin in Treating Patients With Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Interferon alfa may interfere with the growth of the cancer cells and slow the
      growth of kidney cancer. Isotretinoin may help kidney cancer cells develop into normal cells.
      It is not yet known whether interferon alfa plus isotretinoin is more effective than
      interferon alfa alone for kidney cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or
      without isotretinoin in treating patients who have metastatic kidney cancer.
    

Detailed description: 
      OBJECTIVES: I. Assess the response rate and response duration of interferon alfa with vs
      without isotretinoin in patients with bidimensionally measurable progressive metastases from
      renal cell cancer. II. Assess the toxic effects of these regimens in this patients
      population. III. Determine the overall survival of this patient population treated with these
      regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      participating center. Patients are randomized to one of two treatment arms. Arm I: Patients
      receive interferon alfa subcutaneously daily. Arm II: Patients receive interferon alfa as in
      arm I plus oral isotretinoin daily. Treatment continues for up to 1 year in the absence of
      disease progression or unacceptable toxicity. Patients are followed until death.

      PROJECTED ACCRUAL: A total of 296 patients will be accrued for this study.
    

Intervention name(s): recombinant interferon alfa; chemotherapy; isotretinoin
Intervention type(s): Biological; Drug; Drug
Intervention MeSH terms: Interferons; Interferon-alpha; Isotretinoin
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage IV renal cell cancer; recurrent renal cell cancer
A Clinical Study to Evaluate CAD-1883 in Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label study designed to evaluate the safety, tolerability and efficacy of
      CAD-1883, a positive allosteric modulator of the SK channel, administered twice daily orally
      to adult patients with ET. Patients with the diagnosis of ET based on the Movement Disorder
      Society (MDS) criteria with a documented severity of tremor based on the
      clinician-administered TETRAS Performance Subscale are eligible to be enrolled in the study.
    

Detailed description: 
      This is an open-label study designed to evaluate the safety, tolerability and efficacy of
      CAD-1883, a positive allosteric modulator (PAM) of the SK channel, administered twice daily
      orally to adult subjects with ET. Positive modulation of the small-conductance
      calcium-activated potassium channels (SK) present in different regions of the brain aims to
      increase the channel sensitivity to calcium resulting in reduction in neuronal firing rate.
      In patients with ET, improving the regularity of firing of action potentials in the
      olivo-cerebellar network can lead to improvement in motor function.

      During the Screening period, each subject will undergo full assessment including medical and
      treatment history for ET, physical examination and other screening assessments. Patients with
      the diagnosis of ET based on the Movement Disorder Society (MDS) criteria with a documented
      severity of tremor based on the clinician-administered TETRAS Performance Subscale are
      eligible to be enrolled in the study. The study consists of treatment groups receiving twice
      daily oral dosing of CAD-1883 for a treatment period of 14 days.

      This study is designed to enable the assessment of safety and tolerability of CAD-1883 in
      patients with ET as well as the determination of early treatment effect on reducing the
      magnitude and severity of tremor while limiting the potential risk associated with a novel
      investigational drug.

      Safety and tolerability will be monitored throughout the study duration including in-clinic
      assessments of adverse events (AEs), serious adverse events (SAEs), vital signs, 12-lead ECG,
      urinalysis, hematology, clinical chemistry, and CAD-1883 plasma concentration level on Days
      1, 7, 14 and 21.

      Efficacy will be evaluated using the clinician-administered TETRAS Performance Subscale as
      well as the use of a wearable sensor in the clinic and at home.
    

Intervention name(s): CAD-1883
Intervention type(s): Drug
Intervention description(s): Treatment groups receiving twice-daily oral dosing of CAD-1883 for a treatment period of 14 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ET; Essential Tremor
The Follow Study of Speech Functions in Preschool Children With Cerebral Palsy: Clinical Measures and Acoustic Analysis
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      The aims of this study:

        1. to investigate the difference in motor speech functions among children with cerebral
           palsy (CP) of different motor severities.

        2. to investigate the longitudinal in motor speech functions at 6 months follow-up phase
           among children with CP of different motor severities.

        3. the correlation between motor severity, personal factors, family factors, language
           ability and motor speech in children with CP.

        4. to identify the variables that can predict motor speech functions in children with CP.
    

Detailed description: 
      Mental impairment, language and speech disorders are the common associated problems in
      children with CP. Previous studies focus on language and motor speech dysfunctions in
      children with CP at school-age child, adolescents and adults. Few literatures identify the
      determinants for predicted the motor speech performance in these children. It is important
      issue to follow-up the language and motor speech functions in children with CP. These data
      will provide clinicians for outcome prediction and goal setting.The aims of this study: (1)
      to investigate the difference in motor speech functions among children with CP of different
      motor severities, and(2) to investigate the longitudinal in motor speech functions at 6
      months follow-up phase among children with CP of different motor severities, and(3) the
      correlation between motor severity, personal factors, family factors, language ability and
      motor speech in children with CP, and(4) to identify the variables that can predict motor
      speech functions in children with CP.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        children with CP having language ability greater than 3 years
      
Keywords: cerebral palsy; language; acoustic; motor speech; follow-up
Mixed Urinary Incontinence Surgical Trial
Condition: Med: Urinary Incontinence (Stress, Urge, Mixed)
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      Surgical management of mixed urinary incontinence
    

Detailed description: 
      Study to evaluate role of anti-incontinent surgery Burch colposuspension Tension free vaginal
      tape Trans obturator tape for the management of mixed urinary incontinence .
    

Intervention name(s): Burch Colposuspension; trans obturator tape; tension free vaginal tape
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Anti-incontinent surgery; Anti-incontinent surgery; Anti-incontinent surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Schroth Exercise Versus Functional Electrical Stimulation in Adolescent With Spinal Deformities
Condition: Idiopathic Spinal Deformities
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      Abnormal spinal curvature can occur as a result of neurologic, orthopedic or idiopathic
      factors. The role of physiotherapy is not only to prevent intrinsic changes that may occur in
      the spine but also be used to correct postural abnormalities. this study will investigate the
      impact of Schroth Exercise compared to Functional Electrical Stimulation in Adolescent With
      Spinal Deformities (scoliosis and or kyphosis).
    


Intervention name(s): Schroth Exercise; Functional Electrical Stimulation (physiotherapy techniques)
Intervention type(s): Other; Other
Intervention description(s): two month (three session per week); two month (three session per week)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Evaluation of Immunological Disorders of T Lymphocytes and Endocrinological Disorders as Pathogen Factors in Patients With Metaplasia of Urinary Bladder
Condition: The Follow-up Duration Was 1-8 Years.; The Main Reasons Behind Visiting the Hospital Were Recurrent Urinary Tract Infection,; Urinary Urgencies, Pollakiuria, Difficulty in Initiating Micturition, Pain in Hypogastrium,; Night Wetting and Day Wetting, Menstruation's Disorders, Urolithiasis, Defects of Urinary; System and Hematuria.
MeSH terms: Urinary Tract Infections; Urolithiasis; Hematuria; Metaplasia; Menstruation Disturbances
Study type: Observational

Summary: 
      Background: Squamous metaplasia refers to the pathological transformation of the urothelium
      leading to non-keratinised stratified squamous metaplasia (N-KSM).

      Objective: To present the investigators experiences in the diagnosis and treatment of N-KSM
      of the urinary bladder in children.
    

Detailed description: 
      Design, setting, and participants: In this study, the investigators present their experiences
      in the diagnosis and treatment of N-KSM of the urinary bladder in children aged from 5 to 17
      years. From 2005 to 2013, metaplasia was diagnosed in 119 patients - 116 girls and 3 boys.
      The reasons behind visiting the hospital were non-specific intense pain in the abdomen,
      recurrent urinary tract infections, and urination disorders. The most common symptoms of
      urinary bladder dysfunction were pollakiuria and difficulties in initiating micturition and
      retention of urine (reduced detrusor muscle activity).

      Outcome measurements and statistical analysis: In 20 patients (16.8%), metaplasia was
      incidentally diagnosed during cystoscopy performed for other causes. Only the children whose
      bladders showed metaplastic changes on cystoscopy were subjected to a bladder biopsy for
      collecting specimens for further histopathological examination.
    

Intervention name(s): Second-generation cephalosporin, nitrofurantoin, 1% aminoglycoside solution; cephalosporin with chemotherapeutics
Intervention type(s): Drug; Drug
Intervention description(s): Second-generation cephalosporin was prescribed for 10 days, and then treatment crossover with chemotherapeutics in therapeutic dose (change in every week) during 3 months
Intervention MeSH terms: Nitrofurantoin; Cephalosporins
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        In all, 119 children (116 girls and 3 boys), aged between 5 and 17 years (mean age, 13.7
        years), who were treated in the Pediatric Surgery Department during the period of 2005-2013
        were included in this study
      
Keywords: metaplasia, dysfunction, urinary bladder, children
Reactions to Warnings on Hookah Ads
Condition: Reactions to Warnings; Hookah Smoking
Study type: Interventional

Summary: 
      The purpose of this study is to help us better understand what kinds of waterpipe tobacco
      advertisements appeal to young adults as well as to help evaluate and create health warnings
      that can be placed on waterpipe tobacco advertisements to inform young adults of the risks
      associated with smoking hookah tobacco.
    


Intervention name(s): Control; Text Only; Text + Graphic
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will view 24 ads with and without health warnings. Additionally, 16 control non-tobacco ads matched for graphical content, presence of text, people, and other factors will be randomly distributed among these ads.; Participants will view at random 24 ads twice, each ad will have a different health warning chosen at random with the caveat that each health warning will be seen 3 times. The 16 control ads will have text disclaimers to control for physical features of the ads.; This arm is identical to the text only intervention except a graphic will be added to the health warning. Thus, each ad will be seen twice; the text + graphic warnings will be seen three times. The 16 control ads will have text disclaimers and logos or other images to control for physical features of ads.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Hookah; Shisha; Tobacco; Narghile
Safety and Tolerability of MK0773 in Healthy Older Men (0773-004)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of
      MK0773 in healthy older men.
    


Intervention name(s): MK0773; Comparator: testosterone enanthate; Comparator: placebo oral tablet; Comparator: placebo injection
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Three 25mg oral tablets MK0773 bid, for 12 weeks; intramuscular injection 200mg testosterone enanthate q14d, for 12 weeks; placebo oral tablet bid, for 12 weeks; placebo intramuscular injection q14d, for 12 weeks
Other intervention name(s): Delatestryl
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy Adults
Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the bioequivalence between Amlodipine besylate/Atorvastatin calcium
      Tablets 10mg/80mg of Dr. Reddy's Laboratories Limited, India and CADUET® (amlodipine besylate
      and atorvastatin calcium) tablets 10mg/80mg of Pfizer Ireland Pharmaceuticals Dublin, Ireland
      in Healthy Male and Female Volunteers under Fasting conditions.
    

Detailed description: 
      Open label, randomized, two-treatment, two-period, two-sequence, crossover, single dose, oral
      bioequivalence study of Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg under
      Fasting conditions.
    

Intervention name(s): Amlodipine besylate/Atorvastatin calcium
Intervention type(s): Drug
Intervention description(s): Amlodipine besylate/Atorvastatin calcium 10/80 mg
Other intervention name(s): Caduet
Intervention MeSH terms: Amlodipine; Atorvastatin; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Topical Aprepitant in Prurigo Patients
Condition: Pruritus
MeSH terms: Pruritus; Prurigo
Study type: Interventional
Phase: Phase 2

Summary: 
      Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically
      Applied Aprepitant in Patients With Prurigo
    


Intervention name(s): Aprepitant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Aprepitant gel (10 mg/g); gel without active component
Other intervention name(s): Aprepitant gel; aprepitant gel vehicle
Intervention MeSH terms: Aprepitant; Fosaprepitant
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pruritus