bioihbjkbjnl/mcl2 huggingface dataset:
Predictive Factors for Male Sexual Dysfunction After Traumatic Spinal Cord Injury
Condition: Male Sexual Dysfunction; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational [Patient Registry]

Summary: 
      Objective: To analyze the association between sexual function of men with spinal cord injury
      with possible predictive factors for dysfunction.
    

Detailed description: 
      Method: Observational study (CAAE 41221414.5.0000.5208) conducted with 45 men, mean age 34
      (CI 31.5 to 37.1), with spinal cord injury and active sex life. Sexual function was assessed
      by the International Index of Erectile Function and level and degree of injury were
      determined following the guidelines of the International Standards for Neurological and
      Functional Examination Classification of Spinal Cord Injury. Descriptive statistical
      techniques were applied and multivariate analysis using logistic regression adjusted to
      observe the association between factors, with 0.05 significance level.
    

Intervention name(s): using questionnaires - International Index Erectile Function
Intervention type(s): Other
Intervention description(s): using questionnaires
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study included 45 men, aged between 18 and 60 years with a clinical diagnosis of
        traumatic spinal cord injury, injury time less than six months heterosexual and sexually
        active. The study excluded patients who had erectile dysfunction attributed to endocrine or
        metabolic disease order, those who underwent surgery in the genital area, such as radical
        prostatectomy or penile implant and cognitive impairment.
      
Keywords: Sexuality; Spinal cord injuries; Penile erection; erectile dysfunction; Psychological Sexual Dysfunctions
Shock Wave Therapy On Cervical Pain Following Neck Dissection Surgery
Condition: Pain; Cervical Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Myofascial pain syndrome (MPS) is a musculoskeletal disorder which is characterized by pain,
      muscle spasms and muscle tenderness, as well as a limited range of motion, weakness, and
      rarely, autonomous dysfunction.
    

Detailed description: 
      The occurrences of morbidity of the neck after cancer therapy were considerable and consisted
      of neck pain, loss of sensation, and decreased range of motion. Extracorporeal shock wave
      therapy (ESWT) is one of the treatment options used for patients with myofascial pain
      syndrome through elimination of ischemia and modulation of vasoneuroactive substance (two
      major causes of trigger pathophysiology) and mechanical transduction as a cellular response
      to external stimulation. the aim of this study was to investigate efficacy of extracorporeal
      shock wave therapy (ESWT) on cervical myofascial pain following neck dissection surgery.
    

Intervention name(s): extra-corporeal shock wave therapy; topical none steroidal anti-inflammatory drug
Intervention type(s): Device; Drug
Intervention description(s): Extracorporeal Shock Wave Therapy (ESWT) has been introduced efficiently for more than twenty years as a treatment modality in orthopedic and musculoskeletal disorders. ESWT has mechanical and cellular impacts on tissues regeneration and pain management through cavitation bubbles, acoustic micro streaming, and hyper-vascularity that can directly affect tissue calcifications, and modulate cell activity.; participants received 1% topical diclofenac gel on the tender points 3 times /day for 4 weeks.
Other intervention name(s): shock wave therapy; topical NSAID
Intervention MeSH terms: Anti-Inflammatory Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study in the Treatment of Alcohol Dependence.
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      H8R-MC-HJAQ is a Phase 2, parallel, double-blind, randomized study comparing LY686017 with
      placebo in a 12-week trial that includes Medical Management. This study is an outpatient
      study in which approximately 180 alcohol dependent subjects will be enrolled. Subjects will
      be randomized in a 1:1 fashion to LY686017 or placebo, and will receive once daily dosing for
      twelve weeks.
    


Intervention name(s): LY686017; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 milligrams (mg) daily by oral route for 12 weeks; Daily by oral route for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcoholic
Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks
Condition: Abortion
Study type: Interventional

Summary: 
      Women who are requesting pregnancy termination at 14-16 weeks, who would normally have
      osmotic dilator insertion the day before their procedure, would be asked if they wanted to
      participate. Participants would be randomized to two groups: first, dilator insertion as
      usual, or second, mifepristone taken the day before the procedure.
    


Intervention name(s): mifepristone 200 mg; osmotic dilator insertion
Intervention type(s): Drug; Device
Intervention description(s): mifepristone would be given the day before the procedure; osmotic dilators (3-6) would be inserted as usual the day before the procedure
Intervention MeSH terms: Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Length of time for procedure to be completed; Need for additional dilation; Subject satisfaction with procedure
Deep Brain Stimulation and Digestive Symptomatology
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Patients with Parkinson's disease (PD) frequently experience upper gastrointestinal
      disorders. During the disease, weight loss is often noticed. Recently, many studies have
      demonstrated that STN-DBS improved extrapyramidal symptoms. Interestingly, PD patients gain
      weight after STN-DBS, at least in part due to a decrease in resting energy expenditure.

      Purpose: To evaluate benefits of STN-DBS on upper gastrointestinal symptoms and motility.

      Patients et method: PD patients waiting for STN-DBS, will be assessed in a preoperative time
      (2 times at, at least, 3 month intervals, to evaluate the natural history of the disease on
      upper gastrointestinal symptoms and motility) and in a postoperative time, after 6 months of
      chronic STN-DBS. Each assessment will include : 1/ questionnaires about frequency and
      severity of upper gastrointestinal symptoms; 2/ a nutritional assessment (body mass index,
      dietary assessment); 3/ the gastric emptying measurement with the 13C-octanoic acid breath
      test; 4/ the colorectal transit time measurement with radio-opaque markers 5/ an indirect
      calorimetry to estimate resting energy expenditure; 6/ and plasmatic leptin and ghrelin
      concentrations, hormones involved in the homeostatic regulation of appetite.

      Perspectives: This physiopathological study should allow us to understand the mechanisms of
      the effects of STN-DBS on upper gastrointestinal symptoms and weight regulation in PD
      patients.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Parkinson's disease patients with subthalamic nucleus deep brain stimulation
ACTION PAC: Adolescents Committed to Improvement of Nutrition & Physical Activity
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Using a previously created weight management program for adolescents, the intervention will
      be implemented through school-based health centers (SBHC) and will be delivered by SBHC
      providers trained in Motivational Interviewing. Students at intervention school sites will be
      compared to students at control school sites. All students will have baseline, 1 year, and 2
      year follow-up to assess if students in the intervention school sites will have improved risk
      factor profile for metabolic syndrome, improved nutrition and increased physical activity
      when compared with students at control school sites.
    


Intervention name(s): ACTION PAC; Comparison
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Adolescents enrolled in ACTION PAC will meet with SBHC providers. SBHC providers will use Motivational Interviewing to motivate students to adopt strategies for improving nutrition and increasing physical activity. All participants will receive annual BMI results discussion with providers. Overweight/Obese adolescents will meet with providers for 16 sessions over 2 years.; Annual BMI results will not be discussed with participants in comparison schools; however, a letter containing BMI results and obesity prevention recommendations will be sent to parent/guardians.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Adolescent; Overweight; Obesity; Weight loss; Nutrition; Physical Activity; School-based; Primary care; Motivational Interviewing
Monocanalicular Versus Bicanalicular Intubation in the Treatment of Congenital Nasolacrimal Duct Obstruction
Condition: Nasolacrimal Duct Obstruction
MeSH terms: Lacrimal Duct Obstruction
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study was to compare the success rate of monocanalicular intubation versus
      bicanalicular silicone intubation in congenital nasolacrimal duct obstruction in children
      aged between 10 and 36 months.
    

Detailed description: 
      In a prospective, nonrandomized comparative study, the monocanalicular intubations (MCI; n=35
      eyes) through the inferior canaliculus or bicanalicular intubations (BCI; n=35 eyes) were
      performed under general anaeshesia in children between 10 and 36 months of age suffering from
      congenital nasolacrimal duct obstruction (CNLDO). The tubes were removed 3-4 months after the
      tube placement. Thereafter, the children were followed up for 6 months after the removal of
      tubes. The therapeutic success was defined as the fluorescein dye disappearance test grade
      0-1 corresponding with a complete resolution of previous symptoms. The partial success was
      defined as improvement with some residual symptoms.

      The complete and partial improvement was achieved in 31/35(88.57%) in group I with BCI and in
      34/35 (97.14%) in group II with MCI, respectively, and it was not significantly higher
      (p=0,584).

      Complications occurred in both groups. Dislodgement of the tube and premature removal was
      observed in four cases in group I (BCI), the loss of the tube was observed twice in group II
      with MCI.. Canalicular slitting was observed in 5 eyes in the group with BCI. Granuloma
      pyogenicum observed in 2 cases with MCI revealed in a few weeks after the tube removal.
      Corneal erosion in the inferior medial quadrant was observed in 1 eye with MCI and revealed
      in a few days after the local treatment without tube removal.

      Conclusions: Both MCI and the BCI are effective methods how to treat CNLDO. The advantage of
      the MCI shows the lower incidence of the canalicular slit and easy placement.
    

Intervention name(s): Canalicular intubation
Intervention type(s): Device
Intervention description(s): Intubation through the inferior canaliculus performed under general anaeshesia. The tubes were removed 3-4 months after the tube placement.
Other intervention name(s): silicone tube
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: congenital nasolacrimal duct obstruction; monocanalicular intubation; bicanalicular intubation; complications
A Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a randomised, double-blind, placebo-controlled, multiple ascending dose trial in
      healthy subjects, randomised to ZP7570 or placebo within each cohort
    

Detailed description: 
      Forty subjects are planned to be studied in four cohorts in this multiple ascending dose
      trial. Ten subjects will be allocated to four dose levels. Intermediate dose levels may be
      applied. A sentinel dosing approach (sequential dosing) will be applied. The entire
      observation period comprises 51 days starting with a 96 hours in-house stay after the first
      dose injection, where discharge is planned for Day 5, followed by one outpatient visit. For
      the second and the third injection dose a 36 hours in-house stay is planned. After the fourth
      dose injection there is also a 96 hour in-house stay where discharge is planned for Day 26,
      followed by five outpatient visits and an End of Trial Visit on Day 51. A blinded evaluation
      of each cohort will be performed by a Trial Safety Group to determine whether the trial will
      progress to the next planned dose level based on the stopping rules specified in the
      protocol.
    

Intervention name(s): ZP7570; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each subject will be randomly allocated to multiple doses of ZP7570 at one of four dose levels in each cohort.; Placebo; corresponding volume
Other intervention name(s): Dual GLP-1R/GLP-2R agonist
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, double-blind, placebo-controlled, single ascending dose trial in healthy subjects, randomized to ZP7570 or placebo
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye
Condition: Refractive Errors; Astigmatism
MeSH terms: Astigmatism; Refractive Errors
Study type: Interventional

Summary: 
      Single-center, open-label, prospective study in healthy volunteers desiring refraction for
      correction of visual acuity to compare a handheld device supported by a mobile application
      with the phoropter and autorefractor.
    

Detailed description: 
      Single-center, open-label, prospective study in healthy volunteers desiring refraction for
      correction of visual acuity to compare a handheld device supported by a mobile application
      with the phoropter and autorefractor in male or female subjects 30 to 65 years of age.
    

Intervention name(s): Hand-held device supported by a mobile application; Phoropter; Autorefractor
Intervention type(s): Device; Device; Device
Intervention description(s): Hand-held device supported by a mobile application to obtain refractive error of the eye.; Manual refraction and ETDRS chart; Automated refraction
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: All enrolled subjects will have measurements with the phoropter, autorefractor and handheld device plus mobile app.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: myopia; hyperopia
tDCS for Fatigue in Sjogren's Syndrome
Condition: Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome; Fatigue
Study type: Interventional

Summary: 
      Sjogren's Syndrome (SS) is an autoimune disease of unknown etiology characterized by
      lymphocytic infiltration of the exocrine glands and other organs. patients usually presents
      with xerophthalmia, xerostomia, fatigue and other symptoms. Fatigue has often been reported
      as the biggest problem and the most difficult symptom patients have to deal with. Fatigue
      management in pSS is difficult. However, in other diseases such as Parkinson disease,
      post-polio syndrome and multiple sclerosis the use of Transcranial Direct Current Stimulation
      (tDCS) has recently been studied and has shown effectiveness. The overarching objective of
      this study is to examine the effect of a tDCS protocol in patients with pSS.
    


Intervention name(s): Active Transcranial Direct Current Stimulation; Sham Transcranial Direct Current Stimulation
Intervention type(s): Device; Device
Intervention description(s): Subjects will undergo 5 sessions of tDCS of up to 2mA, at 20 minutes per session, 1x per day. During active stimulation, the current will be active for the full 20 minutes.; Subjects will undergo 5 sessions of tDCS, at 20 minutes per session, 1x per day. For sham tDCS, electrodes will be placed the same way as in the intervention group, for 20 minutes. However, the stimulator will deliver 2mA of current for only 30s. The current will not be active for the rest of the 20 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sjogren's Syndrome; fatigue; tDCS
Microflare Protocol in Poor Responders
Condition: Female Infertility Due to Diminished Ovarian Reserve
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 4

Summary: 
      The effect of use of the microflare down regulation protocol on the outcome of the IVF/ICSI
      cycles in poor responders
    

Detailed description: 
      The microflare as a method of down regulation protocol can be used to prepare the females
      suffering from poor ovarian reserve to undergo IVF/ICSI cycles. In this study we are trying
      to outline its effect on the clinical pregnancy rate as a main primary outcome, and to
      compare its use with the addition of growth hormone to the same protocol.
    

Intervention name(s): Growth hormone (Norditropin, Novo nordisk)
Intervention type(s): Drug
Intervention description(s): Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.
Other intervention name(s): Norditropin, Novo nordisk
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Poor responders; Poor ovarian response; IVF/ICSI; Microflare protocol; Growth hormone; Oral contraceptive pills
Leukotriene Antagonism in Recruitment of CD49d Expressing Neutrophils in Atopic Subjects
Condition: Nasal Allergy
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this study is to see if the recruitment of a certain cell type (the alpha 4
      integrin (CD49d) expressing neutrophil) during a nasal allergen challenge can be inhibited by
      pretreatment with an FDA approved leukotriene antagonist (montelukast).
    

Detailed description: 
      Subjects will be consented, undergo skin testing, medical history questionnaires, and
      randomized to either placebo or montelukast (10 mg). In one week, subjects return, undergo a
      blood draw, medical history questionnaires, nasal lavage, and nasal allergen challenge
      (followed by lavage in 6 hours). Subjects will then cross-over to the other study drug. One
      week later subjects will undergo a blood draw, medical history questionnaires, lavage,
      allergen challenge, and repeat lavage (after 6 hours).
    

Intervention name(s): Nasal lavage; Nasal allergen challenge; Epicutaneous skin testing; Peripheral blood; Montelukast 10Mg Tablet; Placebo Oral Tablet
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Drug; Drug
Intervention description(s): determine frequency of CD49d expressing neutrophils in the nasal lavage by flow cytometry; A small amount of allergen extract will be applied to one naris.; Skin testing (prick) to determine allergies.; Peripheral blood draw; one pill orally, daily, for 1 week; one pill orally, daily, for 1 week
Other intervention name(s): montelukast; placebo
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: allergen; neutrophils; allergy
Safety and Tolerability Study of rAvPAL-PEG to Treat Phenylketonuria
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of injections of
      rAvPAL-PEG in subjects with PKU.
    

Detailed description: 
      This is a Phase 1, open-label, single-dose study in approximately 35 subjects with PKU who
      are 16 to 50 years old. Seven cohorts are planned, each consisting of 5 subjects; the cohorts
      as planned are 0.001, 0.003, 0.01, 0.03, 0.1, 0.3, and 1.0 mg/kg. Increasing doses of
      rAvPAL-PEG will be assessed sequentially until the final dose is evaluated or any of the
      stopping criteria are reached. Subjects will each receive a single dose and then will be
      followed for a total of 42 days (6 weeks) with visits to the clinical research unit (CRU) as
      specified in the Schedule of Events Toxicity will be measured according to the National
      Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, v 3).
    

Intervention name(s): rAvPAL-PEG
Intervention type(s): Drug
Intervention description(s): rAvPAL-PEG will be administered as a single, SC injection at dose levels of 0.001, 0.003, 0.01, 0.03, 0.1, 0.3, and 1.0 mg/kg. The duration of treatment is a single dose of study drug with 42 days (6 weeks) of follow-up.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Different Dietary Regimens on Tolerance Acquisition in Children With Cow's Milk Allergy
Condition: Cow's Milk Allergy
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Study type: Observational

Summary: 
      Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively
      evaluated. Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of
      the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded. A
      food challenge was performed 6 and 12 months after the diagnosis to assess clinical tolerance
      acquisition. Main demographic and clinical characteristics were collected for each patient.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        We prospectively evaluated otherwise healthy infants (1-12 months of age at the diagnosis)
        visit one the Pediatric Gastroenterology and Allergology Centre because of the necessity of
        a diagnostic oral food challenge for cow's milk proteins. Children were in stable clinical
        condition without signs of CMA already on exclusion diet with an hypoallergenic formula for
        a period of 7-15 days as presented by the general paediatrician, immediately the symptoms
        appear and before being attended at the Center for diagnosis of CMA.
      
Keywords: cow's milk allergy; formulas; probiotics