bioihbjkbjnl/mcl2 huggingface dataset:
OCTA Study of Choroidal Vasculature in Open Angle Glaucoma Patients
Condition: Glaucoma Open-Angle Primary
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Observational

Summary: 
      The aim of the present study was to examine and measure SFCT and CCVD using respectively
      EDI-OCT and OCTA in preperimetric and advanced glaucomatous eyes, in order to shed light on
      the vascular pathogenesis of glaucoma disease.
    


Intervention name(s): OCTA
Intervention type(s): Diagnostic Test
Intervention description(s): Choriocapillary vessel density calculated with OCTA
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participans were older than 40 years with diagnosis of open angle glaucoma. They did
        not present any other ophthalmological disease, diabetes, heart diseases and hypertension.
A Study to Assess the Efficacy of Early Physical Therapy Intervention Following a Modified Unilateral Neck Dissection for Treatment of Head and Neck Cancer
Condition: Shoulder Weakness Following Neck Dissection Surgery
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      This study will determine whether patients who receive regular physical therapy immediately
      following a modified neck dissection surgery will report decreased shoulder disability,
      decreased pain, improved or maintained shoulder range of motion and strength, and improved
      quality of life than those who receive only home instruction.
    


Intervention name(s): Physical therapy intervention
Intervention type(s): Other
Intervention description(s): Exercises addressing cervical range of motion, shoulder range of motion and strengthening and scapular stabilization.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Accessory Nerve Palsy, Cranial Nerve XI, shoulder weakness, neck stiffness, head and neck cancer, neck dissection
A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Researchers are trying to learn whether a drug called Lu AG09222 can help prevent migraine
      headaches for people who have not been helped by other treatments that are used to prevent
      migraines.

      People who join this trial have tried 2 to 4 other medications to prevent their migraines,
      but these medications have not helped them.

      When the trial is over, researchers will use this information to find out if the number of
      migraine days decreased more for the participants who got either dose of Lu AG09222 than for
      the participants who got the placebo.
    

Detailed description: 
      Participants will be randomly allocated to one of 3 treatment groups: Lu AG09222 high dose,
      Lu AG09222 low dose, or placebo, in a ratio of 2:1:2.
    

Intervention name(s): Lu AG09222; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lu AG09222 will be administered per schedule specified in the arm.; Placebo matching to Lu AG09222 will be administered per schedule specified in the arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Clinical Trial to Evaluate the Efficacy and Safety of TwiFlow-System for Acute Pulmonary Embolism
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Study type: Interventional

Summary: 
      For a prospective, single-arm clinical study, this study plans to recruit patients with acute
      pulmonary intravascular embolization, use production of transcatheter pulmonary artery bolt
      system which named 'TwiFlow-Thrombectomy Catheter System' developed by the MorningSide
      (NanTong) medical device Co., LTD. on pulmonary artery interventional therapy, for evaluating
      the efficacy and safety of this novel system in the treatment of patients with pulmonary
      intravascular embolization disease.
    

Detailed description: 
      As a prospective, single-arm clinical study, the investigators plan to evaluate the new
      production's efficacy and safety which named 'TwiFlow-Thrombectomy Catheter System'. This
      study will be carried out in Xiamen Cardiovascular Hospital, Xiamen University. A total of 3
      subjects are planned to be enrolled. After screening, all subjects will be treated with
      transcatheter pulmonary artery thrombectomy system, and clinical follow-up will be conducted
      at 48 hours, 14 days and 30 days after surgery.

      Right Ventricular/Left Ventricular decline from baseline to 48 hours after surgery and the
      incidence of major adverse events (MAE) within 48 hours after surgery were used as primary
      endpoints. In instrument performance evaluation, the success rate of surgery, postoperative
      immediate target lesion embolus removal efficiency, pulmonary artery pressure changes before
      and after operation value, values of arterial oxygen partial pressure changes before and
      after operation, death rates related to the equipment in 48 hours after surgery, incident
      rate of bleeding in 48 hours after operation, postoperative clinical deterioration rate in 48
      hours after surgery, postoperative pulmonary vascular injury incidence in 48 hours after
      surgery, the incidence of heart damage injury in 48 hours after surgery, all-cause death rate
      in 30 days after surgery, and symptomatic Pulmonary Embolization recurrence rate in 30 days
      after surgery were secondary endpoints.
    

Intervention name(s): TwiFlow-Thrombectomy Catheter System
Intervention type(s): Device
Intervention description(s): Patients with acute pulmonary embolism and meeting the conditions of this clinical trial will accept the pulmonary embolism removal operation by the novel device named 'TwiFlow-Thrombectomy Catheter System'.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors
Condition: Head and Neck Cancer; Precancerous Condition
MeSH terms: Head and Neck Neoplasms; Precancerous Conditions
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a
      certain kind of light. When the drug is active, tumor cells are killed.

      PURPOSE: This randomized phase I trial is studying the side effects and best dose of
      photodynamic therapy in treating patients with premalignant or early stage head and neck
      tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To evaluate the toxicities associated with aminolevulinic acid-mediated photodynamic
           therapy when administered continuously or in fractionated doses in patients with
           premalignant or early stage head and neck lesions.

      Secondary

        -  To assess the efficacy of this regimen in these patients.

      OUTLINE: This is a dose-escalation study of photodynamic therapy. Patients are randomized to
      1 of 2 treatment arms.

        -  Arm I: Patients receive oral aminolevulinic acid and then undergo continuous
           photodynamic therapy 4-6 hours later.

        -  Arm II: Patients receive aminolevulinic acid as in arm I and then undergo fractionated
           photodynamic therapy 4-6 hours later.

      After completion of study therapy, patients are followed up at 1 month, every 3 months for 2
      years, and then annually thereafter.
    

Intervention name(s): aminolevulinic acid hydrochloride
Intervention type(s): Drug
Intervention description(s): Patients undergo continuous or fractionated photodynamic therapy.
Intervention MeSH terms: Aminolevulinic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: precancerous condition; stage 0 hypopharyngeal cancer; stage 0 laryngeal cancer; stage 0 lip and oral cavity cancer; stage 0 nasopharyngeal cancer; stage 0 oropharyngeal cancer; stage 0 paranasal sinus and nasal cavity cancer
A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens When Compared to Alden Optical HP Sphere Lens
Condition: Contact Lens Wear
Study type: Interventional

Summary: 
      This study is to evaluate the safety and efficacy of Bausch + Lomb custom samfilcon B (test)
      lens compared to the hioxifilcon D, 54% water, Alden Optical HP Sphere (control) lens when
      worn by participants who wear soft contact lens on a daily basis.
    


Intervention name(s): Custom Samfilcon B Contact Lenses; Alden Optical HP Sphere Contact Lens; ReNu MultiPlus Lubricating and Rewetting Drops; Biotrue Multi-Purpose Solution
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Contact lens; Hioxifilcon D, 54% water, Alden Optical HP Sphere lens; For use as needed during the study.; For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study.
Other intervention name(s): Alden Optical® HP Sphere lens; Bausch + Lomb ReNu MultiPlus® Lubricating and Rewetting Drops; Bausch + Lomb Biotrue® MPS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Soft Contact Lens; Soft Contact Lenses
Specific Cognitive Remediation for Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Rationale:

      Cognitive deficits are a core feature in schizophrenia. Conventional treatments
      (antipsychotic medication and psychological treatments) have limited effects so cognitive
      remediation programs were designed to alleviate the problems. Interventions typically involve
      a variety of exercises in a paper and pencil or a computerized format with a growing number
      of specialized computer programs now being developed. However, many of these programs lack
      specificity which does not allow an individual's specific needs to be addressed. More
      targeted interventions might increase the effects of therapy so RECOS - COgnitive REmediation
      for Schizophrenia - was developed to fit this gap.

      Methods: This is a multicenter, randomized, controlled study comparing patients aged 18 to 45
      years suffering from schizophrenia according to DSM-IV-TR. RECOS will be compared to an
      already validated program (CRT).

      220 patients will be randomized as follows :

        -  Arm 1 : RECOS (42 h)

        -  Arm 2 : CRT (42 h) The recruitment is performed by psychiatrists in Lyon, Paris,
           Clermont-de-l'Oise, Niort, Bordeaux, Ville-Evrard and Lausanne.
    


Intervention name(s): cognitive remediation
Intervention type(s): Behavioral
Intervention description(s): RECOS: cognitive remediation for schizophrenia CRT: cognitive remediation therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognitive rehabilitation; schizophrenia
Strength At Home: Veterans' Program (PTSD-Focused Therapy for Anger and Relationship Conflict Among OEF/OIF Veterans)
Condition: Domestic Violence
Study type: Interventional

Summary: 
      This is a research study funded by the Department of Defense to test a therapeutic
      intervention for male combat veterans who engage in intimate partner violence (IPV). The
      investigators hope to decrease the recurrence of relationship aggression and help veterans
      manage anger. The primary aim of the study is to test the intervention.
    

Detailed description: 
      The purpose of this project is to develop, standardize, and test an intervention for combat
      veterans exposed to trauma who engage in intimate partner aggression (IPA). This
      intervention, formerly labeled PTSD-Focused Cognitive Behavior Therapy for Partner Violence
      (PFCBT), and currently called the Strength at Home, Veteran's Program, incorporates
      components of interventions for IPA and trauma and will target mechanisms implicated in the
      relationship between trauma and IPA. This project addresses a number of the research gaps in
      this area of research including: (a) the development of a novel treatment approach to improve
      functioning and well-being of affected individuals; (b) tertiary prevention (of repeated IPA)
      during re-integration; and (c) examination of the efficacy of a program providing support for
      the families and caregivers of veterans with combat history.
    

Intervention name(s): PTSD-Focused CBT for Partner Violence
Intervention type(s): Behavioral
Intervention description(s): PTSD-Focused CBT (PFCBT) will consist of 12 2-hour weekly sessions,led by two project therapists. In each session, group members will discuss materials and do assignments to practice skills.
Other intervention name(s): Strength at Home; Veterans Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; CBT; Intimate Partner Violence; Treatment
3D Ultrasound in Women With Vacuum or Forceps Deliveries
Condition: Pelvic Floor Injury; Urinary Incontinence; Stool Incontinence
MeSH terms: Urinary Incontinence
Study type: Observational

Summary: 
      The purpose of this study is to investigate of the differences in pelvic floor anatomy and
      function in women who have undergone a vacuum assisted vaginal delivery (VAVD) versus a
      forceps assisted vaginal delivery (FAVD) using three-dimensional ultrasound imaging. Women
      within 1-5 years after first delivery who did not have an internal delivery will be included.
      The total number of subjects is forty. This will include ten primiparous subjects who have
      undergone vacuum delivery, ten who have undergone forceps delivery, ten who had spontaneous
      vaginal delivery and ten who have undergone primary elective cesarean section.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Forty primiparous subjects with a history of a singleton pregnancy who have undergone a
        term vacuum assisted vaginal delivery, forceps assisted vaginal delivery, spontaneous
        vaginal delivery, or elective primary cesarean section or spontaneous vaginal delivery with
        10 subjects in each group.
      
Keywords: Pelvic floor injury; Levator ani muscle
Metabolic Anomolies Associated With the 6 Month Clinical Evolution of Patients Suffering From Motor Conversion Disorder
Condition: Conversion Disorder
MeSH terms: Conversion Disorder; Hysteria; Dissociative Disorders
Study type: Observational

Summary: 
      The main objective of this study is to make a first evaluation of the relationship between
      metabolic abnormalities objectified by Positron emission tomography with
      2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography (PET CT 18 FDH)
      performed at rest at the onset of symptoms in patients with a first episode of motor
      conversion disorder and the persistence of a motor disability at 6 months measured by the
      modified Rankin score (mRS).
    

Detailed description: 
      The secondary objectives of this study are:

      A. To assess whether metabolic abnormalities objectified by PET CT 18 FDH performed at rest
      at the onset of symptoms may be predictive of persistent disability at 6 months as measured
      by the EDSS, the NIHSS and WHO status.

      B. To assess whether metabolic abnormalities objectified by PET CT 18 FDH performed at rest
      at 3 months after diagnosis may be predictive of persistent motor disability at 6 months
      (EDSS, NIHSS, mRS, WHO) C. To search for and characterize any abnormalities of metabolism
      objectified in the initial PET CT 18 FDH predictive of persistent motor disability at 3
      months.

      D. To determine if there are persistent metabolic abnormalities 3 months post-diagnosis
      independently of the clinical course (marker trait).

      E. Define the brain areas whose metabolism is often altered in patients with motor conversion
      disorders.

      F. Establish a collection of biological samples from patients for future research studies of
      prognostic biomarkers of a motor conversion disorder.
    

Intervention name(s): PET CT 18 FDG
Intervention type(s): Device
Intervention description(s): Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography.
This intervention is required for the observational needs of the study.
Intervention MeSH terms: Fluorodeoxyglucose F18
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population consists of patients with paralysis, motor weakness or abnormal
        movements meeting DSM-IV criteria for motor conversion disorder consulting via the
        Emergency or Neurology department of participating centers.
      
Biospecimen description: 
      Blood samples will be taken at baseline, 3 months and 6 months.
Topical Sirolimus in Patients With Basal Cell Nevus Syndrome and in Healthy Participants
Condition: Neoplastic Syndrome; Non-melanomatous Skin Cancer
MeSH terms: Basal Cell Nevus Syndrome; Neoplasms; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Studying samples of blood and tissue from patients with basal cell nevus syndrome
      and from healthy participants in the laboratory may help doctors learn more about changes
      that may occur in DNA and identify biomarkers related to basal cell nevus syndrome.
      Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming
      back. The use of sirolimus may keep basal cell skin cancer from forming in patients with
      basal cell nevus syndrome.

      PURPOSE: This phase I trial is studying topical sirolimus in patients with basal cell nevus
      syndrome and in healthy participants.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare messenger RNA and protein expression patterns in patients with basal cell nevus
           syndrome (BCNS) vs in cultured cells of healthy participants (control) before treatment
           to identify a set of genes that are differentially expressed in BCNS.

        -  Assess the effects of topical sirolimus on gene expression (genes identified in the
           primary objective) in vivo using keratinocytes, fibroblasts, and lymphocytes from
           patients with BCNS and from healthy participants (controls) by targeted expression
           methods.

      OUTLINE: Patients and healthy participants receive topical sirolimus ointment twice daily for
      12 weeks.

      Blood and skin biopsies are obtained at baseline and at week 12 for gene and protein
      expression studies. Alterations in RNA are measured by microarray analysis. Alterations in
      protein expression are measured by 2-dimensional gel electrophoresis and matrix-assisted
      laser desorption ionization time-of-flight mass spectrometry.

      After completion of study therapy, patients and healthy participants are followed at 4 weeks.

      PROJECTED ACCRUAL: A total of 16 patients and healthy participants will be accrued for this
      study.
    

Intervention name(s): sirolimus; comparative genomic hybridization; gene expression analysis; microarray analysis; protein expression analysis; proteomic profiling; laboratory biomarker analysis; mass spectrometry; biopsy
Intervention type(s): Drug; Genetic; Genetic; Genetic; Genetic; Genetic; Other; Other; Procedure
Intervention MeSH terms: Sirolimus
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: basal cell carcinoma of the skin; nevoid basal cell carcinoma syndrome
Association Between TMAO and Diabetes
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Background: The association of trimethylamine-N-oxide (TMAO), a microbiota dependent
      metabolite from dietary choline and carnitine, with type 2 diabetes was inconsistent.

      Objective: The investigators planned to investigate the association between plasma TMAO and
      newly diagnosed type 2 diabetes as well as whether the association could be modified by the
      TMAO-generating enzyme flavin monooxygenase 3 (FMO3) polymorphisms.

      Design: This is an age- and sex-matched case-control study of 2694 participants: 1346 newly
      diagnosed cases of type 2 diabetes and 1348 controls. The patients of newly diagnosed type 2
      diabetes were consecutively recruited from those attending for the first time the outpatient
      clinics of Department of Endocrinology, Tongji Medical College Hospital, Wuhan, China, from
      2012 January to December 2014. Concomitantly, the investigators recruited healthy individuals
      who were frequency-matched by age (±5 years) and sex to patients from an unselected
      population undergoing a routine health check-up in the same hospital. The inclusion criteria
      for controls and newly diagnosed type 2 diabetes were: age ≥ 30 years, body mass index (BMI)
      < 40 kg/m2, no history of a diagnosis of diabetes and no history of receiving pharmacological
      treatment for hyperlipidaemia or hypertension. Patients with clinically significant
      neurological, endocrinological or other systemic diseases, as well as acute illness or
      chronic inflammatory or infective diseases, were excluded from the study. All the
      participants enrolled were of Chinese Han ethnicity. All the participants gave informed
      written consent to the study and did not take any medication known to affect glucose
      tolerance or insulin secretion before participation. The study was approved by the ethics
      committee of the Tongji Medical College. Concentrations of plasma TMAO were measured, and
      FMO3 E158K polymorphism (rs2266782) were genotyped.
    


Intervention name(s): Plasma TMAO concentration
Intervention type(s): Other
Intervention description(s): Plasma TMAO concentration
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All the participants enrolled were of Chinese Han ethnicity. They gave informed written
        consent to the study and did not take any medication known to affect glucose tolerance or
        insulin secretion before participation.
      
Keywords: trimethylamine-N-oxide; type2 Diabetes; enzyme flavin monooxygenase 3 polymorphisms