bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Study to Evaluate The Safety and Effectiveness of Performing 0.50 Diopter Astigmatism Correction on the Commercially Available RxSight Light Adjustable Lens (LAL)
Condition: Aphakia; Cataract
MeSH terms: Cataract; Astigmatism; Aphakia
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the safety and effectiveness of performing
      0.50 D cylinder correction on the RxSight Light Adjustable Lens (LAL) in patients who have
      undergone implantation with the FDA approved, commercially available LAL.
    


Intervention name(s): Light Delivery Device (LDD)
Intervention type(s): Device
Intervention description(s): Study eye will undergo Light delivery Device treatments
Intervention model: Single Group Assignment
Intervention model description: All subjects will receive the same treatment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Light Delivery Device; LDD; Intraocular lens; Light Adjustable Lens; LAL
Dexmedetomidine and Neuroprotection in Children Undergoing General Anesthesia
Condition: Dexmedetomidine
Study type: Interventional

Summary: 
      Neuroapoptosis is induced by the administration of anesthetic agents to the young brain.
      Recent studies showed that the a2-adrenoceptor agonist, dexmedetomidine plays a trophic role
      during development and is neuroprotective in several settings of neuronal injury in animals.
      We hypothesized that neuroprotective effect of dexmedetomidine would be associated with
      evidence of brain injury detected by elevation of plasma concentration of glial fibrillary
      acid protein in children undergoing general anesthesia.
    

Detailed description: 
      GFAP measure
    

Intervention name(s): Dexmedetomidine Hydrochloride; control
Intervention type(s): Drug; Other
Intervention description(s): dexmedetomidine 1mcg/kg loading and 0.5mcg/kg/hr continuous infusion during surgery; 0.9% normal saline continuous infusion
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Evaluation of Experimental and Commercial Air-Activated, Adhesive Backed Heat Patches
Condition: Effects of Heat; Tolerability; Adhesiveness; Dermal Irritation
Study type: Interventional

Summary: 
      To assess the safety and tolerability for the extended wear of an experimental air-activated
      self adhesive patch.
    


Intervention name(s): Thermal Adhesive Patch; Marketed Thermal Adhesive Patch; Placebo Patch
Intervention type(s): Device; Device; Device
Other intervention name(s): ThermaCare Heat Wraps
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Indoor Artificial Light at Night and the Relapse Risk of Schizophrenia
Condition: Schizophrenia Relapse; Light Pollution
MeSH terms: Recurrence; Schizophrenia
Study type: Interventional

Summary: 
      A randomized crossover trial of ALAN intervention was conducted in patients with chronic
      schizophrenia in Anhui Mental Health Center from August 15 to September 30, 2022. All
      participants met the diagnostic criteria for schizophrenia in the fifth edition of the
      Diagnostic and Statistical Manual of Mental Disorders (DSM-V). The enrolled patients were in
      the symptom-stable phase and were regularly prescribed antipsychotics (no change in
      medication regimen). The diets of all the participants were uniformly supplied during study.
      Patients with infectious diseases, eye diseases, or gastrointestinal diseases, or who used
      antibiotics at the time of recruitment, were excluded. The wards of the participants were all
      located in the same inpatient building. All included wards had the same size, layout,
      lighting and orientation of doors and windows. In normal conditions, each ward retains a
      small LED lamp (the same layout in all wards) at night as a source of lighting.

      The study was divided into two stages. In the first stage, 10 wards were randomly selected as
      the intervention group (opaque black tape covering part of the light source), and another 10
      wards were selected as the control group (no intervention). After a two-week washout
      interval, the second stage was carried out, with the two groups interchanging interventions.
      At the end of each intervention, participants completed a structured questionnaire scale to
      assess the relapse risk of schizophrenia, and then their fecal samples were collected.
    


Intervention name(s): light cover
Intervention type(s): Other
Intervention description(s): 10 wards were randomly selected as the intervention group (opaque black tape covering part of the light source), and another 10 wards were selected as the control group (no intervention).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Intraoperative Mitomycin C in Lacrimal Sac Mucocele
Condition: Lacrimal Mucocele
MeSH terms: Mucocele
Study type: Interventional

Summary: 
      30 patients had lacrimal sac mucocele and dacryocystorhinostomy was done for them with
      intraoperative mitomycin C was added to decrease postoperative fibrosis and recurrence.
    


Intervention name(s): Canaliculo- Dacryocystorhinostomy
Intervention type(s): Procedure
Intervention description(s): Bypass lacrimal passage obstruction by opening a shunt between the lacrimal sac and the nasal mucosa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Placebo-Controlled Study of Clonidine for Fecal Incontinence.
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional
Phase: Phase 2

Summary: 
      Fecal incontinence is the involuntary leakage of stool from the anus. Doctors at Mayo Clinic
      are doing a research study to assess the effects of a medication, clonidine, on fecal
      incontinence and rectal functions in women. Clonidine has been approved by the Food and Drug
      Administration (FDA) for treating high blood pressure, but not for treating incontinence and
      rectal functions. The hypothesis of this study is clonidine will improve fecal incontinence,
      increase rectal capacity and reduce rectal sensation to a greater extent than placebo in
      women.
    

Detailed description: 
      Available therapeutic options for idiopathic fecal incontinence (FI) are limited and
      unsatisfactory. In addition to weak anal sphincters, our data suggest that reduced rectal
      capacity may contribute to rectal hypersensitivity and the symptom of rectal urgency in FI.
      During a 4 week study, oral clonidine restored rectal capacity and improved fecal continence
      in women with urge-predominant FI. Clonidine improves fecal continence and stool consistency
      in diarrhea-predominant irritable bowel syndrome (IBS). Therefore, we now propose a
      placebo-controlled study of clonidine for FI. Our aims are to (i) compare the effects of
      clonidine and placebo, to be given for 4 weeks, on symptoms, anal pressures, rectal
      compliance and sensation in women with FI. Forty four women (18-75 y) with urge predominant
      "idiopathic" FI and ≥ 4 episodes of FI during a 4 week screening period will be recruited to
      this study. Thereafter, patients will be treated with clonidine or placebo for 4 weeks. Bowel
      symptoms will be recorded in a diary. Anal sphincter pressures, rectal compliance and
      sensation will be evaluated before and during treatment with clonidine.
    

Intervention name(s): Clonidine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.; Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
Other intervention name(s): Kapvay; Nexiclon; Catapres
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fecal incontinence; stool leakage; incontinence; FI; Urge predominant fecal incontinence
Hormonal and Bone Turnover Marker Response to an Acute Bout of Resistance or Plyometric Exercise
Condition: Osteoporosis; Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Observational

Summary: 
      We are interested in determining if there exist a short-term response in the serum markers
      and hormones that participate in the regulation of bone tissue formation and breakdown to a
      single, high-intensity exercise session of weight lifting (resistance exercise) or jumping
      (plyometrics). We are also interested in determining if the bone marker response to exercise
      is altered by changing the negative energy state caused by the exercise treatment, when
      subjects are given a moderate calorie meal.
    

Detailed description: 
      Bone tissue responds to impact and strain forces, like high-intensity exercise, by
      upregulating the bone remolding process, resulting in the deposition of calcium phosphate
      minerals into the collagen matrix of bone. Bone remodeling is a continually active process
      that involves both activation cells regulating bone formation (osteoblasts) and resorption
      (osteoclasts). Alterations in the balance between formation and resorption are critical for
      changes in bone density and mineral content to occur, which is regulated by several hormones
      including vitamin D and growth hormone, the sex hormones estrogen and testosterone, and
      parathyroid hormone. Importantly, it remains unclear how single bouts of physical activity
      contribute to the overall changes in remodeling and whether those acute alterations can be
      detected in the hours after exercise. Additionally, research studies examining the effects of
      exercise on bone remodeling often draw blood samples after 24 hours of physical inactivity,
      potentially diminishing the magnitude of the exercise response. Therefore, we plan to
      evaluate the acute effects of plyometrics and resistance exercise on changes in serum
      hormones and markers of bone turnover in non-sedentary, healthy males, with or without a
      moderate calorie supplement.
    

Intervention name(s): plyometric exercise; resistance exercise; No exercise
Intervention type(s): Other; Other; Other
Intervention description(s): single bout of plyometric exercise; single bout of resistance exercise; Will not do any exercise
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Male participants apparently healthy and non-sedentary free of disease that affects bone
        and not have used or currently use any medication that affects bone.
      
Biospecimen description: 
      serum plasma
Zero Fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for Right Atrial Arrhythmias
Condition: Atrial Arrhythmia; Atrial Premature Complexes; Atrial Tachycardia
MeSH terms: Arrhythmias, Cardiac; Tachycardia; Atrial Premature Complexes
Study type: Interventional

Summary: 
      This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopic
      approach with conventional fluoroscopic approach as performing catheter ablation of right
      atrial arrhythmias.
    

Detailed description: 
      Catheter ablation is a well-established treatment to treat patients with a wide range of
      heart rhythm disturbances.

      Fluoroscopy is the imaging modality routinely used for cardiac device implantation and
      electrophysiological procedures. Due to the rising concern regarding the harmful effects of
      radiation exposure to both the patients and operation staffs, novel three-dimensional mapping
      systems such as Ensite NavX have been developed and implemented in electrophysiological
      procedure for the navigation of catheters inside the heart chambers.

      Ensite NavX is a promising system to guide catheters inside the cardiac chambers and vessels
      without the use of fluoroscopy.

      This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopic
      approach with conventional fluoroscopic approach as performing catheter ablation of right
      atrial arrhythmias.
    

Intervention name(s): Zero-fluoroscopy ablation; Conventional fluoroscopy ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): Catheter ablation will be performed under the guidance of one kind of three-dimensional navigation system and without fluoroscopic guidance.; Catheter ablation will be performed using fluoroscopy plus one kind of three-dimensional navigation system.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Fluoroscopy; Ablation; Three dimensional; Atrial arrhythmia; Radiation
Study to Evaluate the Pharmacokinetics and Safety of INX-08189 Administered With VictrelisTM in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to evaluate the potential for a pharmacokinetic drug-drug interaction
      between INX-08189 and Victrelis, a Direct Acting Antiviral (DAA).
    

Detailed description: 
      This is a single-center, randomized, placebo-controlled study in thirty-two 18 to 55 year
      old, male and female, healthy adult volunteers.

      Primary Objectives:

      Pharmacokinetic

        -  To characterize the pharmacokinetic (PK) profile of INX-08189 and INX-08032 when
           INX-08189 is dosed alone as compared to when dosed in combination with Victrelis

        -  To characterize the PK profile of Victrelis when dosed alone as compared to when dosed
           in combination with INX-08189

      Safety

      - To evaluate the safety of INX-08189 and Victrelis when dosed alone and when dosed in
      combination
    

Intervention name(s): INX-08189 50 mg QD X 5 days; INX-08189 / Victrelis 800 mg TID X three days; Victrelis 800 mg TID x 3 days; Victrelis 800 mg TID with INX-08189 50 mg QD; Placebo with Victrelis 800 mg; Cohort 2: Victrelis 800 mg with Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Cohort 1: Subjects will begin administration of INX-08189 50 mg QD on Study Day 0. Dosing will occur each morning for 5 days after a fast of at least 8 hours prior to each dose on Study Days 0 through 4. INX-08189 will be administered with water, and subjects will remain fasting for 2 hours following each dose.; Cohort 1: INX-08189 50 mg QD will be administered concurrently with Victrelis 800 mg TID for 3 additional days (Study Days 5 through 7); In Cohort 2, subjects will begin administration of Victrelis 800 mg TID on the morning of Study Day 0. Victrelis will be administered with water and food with doses at least 7 hours apart. Victrelis 800 mg TID will be administered for a total of 3 days (Study Days 0 through 2).; Victrelis 800 mg TID will be administered concurrently with INX-08189 50 mg QD for 5 additional days (Study Days 3 through 7).; During combination dosing with INX-08189 and Victrelis, each morning dose will start with INX-08189 or placebo after at least an 8 hour fast, followed by a 2 hour fast with the first Victrelis dose of the day then administered with food.; During combination dosing with INX-08189 and Victrelis, each morning dose will start with INX-08189 or placebo after at least an 8 hour fast, followed by a 2 hour fast with the first Victrelis dose of the day then administered with food.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: PK; pharmacokinetics; INX08189; Victrelis; Inhibitex
Rotigotine Effect on All-day Functioning and Quality of Life in Subjects With Moderate to Severe Restless Legs Syndrome (RLS)
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to show that Rotigotine improves Restless Legs Syndrome (RLS)
      symptoms in subjects with moderate to severe RLS during both day and evening.
    


Intervention name(s): Rotigotine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg /24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance); Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours.
7 weeks (titration plus maintenance)
Other intervention name(s): Neupro®
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rotigotine; Restless Legs Syndrome; Neupro®
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-393 in Healthy Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, randomized, fed, single dose, crossover study to evaluate the
      pharmacokinetics, safety and tolerability of CKD-393 in healthy subjects
    

Detailed description: 
      To healthy subjects of twenty-four (24), following treatments are administered dosing in each
      period and wash-out period is a minimum of 7 days.

      Reference drug: 1) CKD-501 0.5mg 2) D759 3) D150 Test drug: 1) CKD-393 0.5/100/1000mg
      formulation Ⅰ Tab. 2) CKD-393 0.5/100/1000mg formulation Ⅱ Tab.

      Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics
      and safety are assessed.
    

Intervention name(s): CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T; CKD-393 0.5/100/1000mg formulation 1 Tab. 1T; CKD-393 0.5/100/1000mg formulation 2 Tab. 1T
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single oral administration under fed condition; single oral administration under fed condition; single oral administration under fed condition
Other intervention name(s): Treatment A; Treatment B; Treatment C
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Influence of Degree of Head Elevation on Insertion Success for ProSeal Laryngeal Mask Airway Insertion
Condition: Anesthesia
Study type: Interventional

Summary: 
      Background - The purpose of the present study is to evaluate the success and pharyngeal
      trauma when 3 or 6 cm height of pillow is used for the ProSealTM laryngeal mask airway
      insertion

      Methods

      - This prospective randomized, controlled study included 80 adult patients . In the 3 cm
      (n=40) or 6 cm group (n=40), the PLMA was inserted while the head is placed on the 3 cm or 6
      cm height of pillow. The success rate at first and second attempt, insertion time, blood
      staining on cuff, sore throat and hoarseness were assessed.
    

Detailed description: 
      Background: The "sniffing position" (i.e., the neck flexed and head extended by means of a
      pillow) eases tracheal intubation because the three axes, namely, the axis of the mouth, the
      pharyngeal axis and the laryngeal axis, are put in almost a straight line. The benefit of the
      sniffing position that align three axis could possibly be applicable when the ProSeal LMA is
      inserted. For the endotracheal intubation, it has been recommended to elevate the patient's
      head 8 to 10 cm with pads under the occiput (shoulder remaining on the table) and extend the
      head at the atlanto-occipital joint to align the oral, pharyngeal, and laryngeal axes such
      that the passage and line of vision from the lips to the glottic opening are most nearly a
      straight line.

      There have been several clinical studies about the effect of head and neck position including
      neutral, flexion or extension on the ease of LMA insertion.

      However, it has not been much recommended or investigated about the influence of head
      elevation on the insertion success of PLMA until now. The purpose of the present study is to
      evaluate the success and pharyngeal trauma when 3 or 6 cm height of pillow is used for the
      ProSeal laryngeal mask airway insertion in adult patients.
    

Intervention name(s): Insertion of ProSeal laryngeal mask airway
Intervention type(s): Device
Intervention description(s): The patient's head was placed on the 3 cm or 6 cm height of a pillow in supine and PLMA was inserted using a standard method in the sniffing position.
The success rate at first and second attempt, insertion time, Seal pressure, hemodynamic variables, complications(blood staining on cuff, sore throat and hoarseness) were assessed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: ProSeal laryngeal mask airway; Insertion success; complication
Frequency of ICAM-1 Polymorphisms in Obese Subjects
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The genetic contribution to the development of obesity is now well recognized. However
      obesity is a polygenic disease and thus many genes are likely to be involved. This study aims
      to investigate the possible association between specific variants of the gene coding for the
      Intercellular Adhesion Molecule-1 (ICAM-1)and the development of severe obesity in an Italian
      population
    

Detailed description: 
      Severely obese subjects referred to our institution will be evaluated. For the aim of the
      study, a venous blood sample will be obtained from these subjects and from a group of normal
      weight volunteers. Genomic DNA will be extracted from the blood samples and analysed by
      standard molecular biology techniques.The allelic and genotype frequencies of the two ICAM-1
      variants will be calculated in the obese and control groups. The statistical significance of
      possible differences will be determined
    

Observational model: Defined Population
Time perspective: Prospective
Keywords: ICAM-1; Obesity; Gene variants