bioihbjkbjnl/mcl2 huggingface dataset:
How Can we Treat Photophobia in Migraine
Condition: Migraine Disorders; Photophobia
MeSH terms: Migraine Disorders; Photophobia
Study type: Interventional

Summary: 
      Photophobia, the aberrantly increased sensitivity to light, is a common symptom in migraine
      patients and light discomfort is frequently found as a trigger for migraine attacks. In
      behavioral studies, planned exposure to light was found to reduce headache in migraineurs
      with photophobia, potentially by increasing habituation to this migraine trigger. Here,
      neurophysiological mechanisms of light exposure versus light deprivation therapy in migraine
      patients are investigated using functional magnetic resonance imaging (fMRI).

      Migraine patients and healthy controls receive light exposure therapy (Flash) and light
      deprivation therapy (Dark) for one hour daily on 7 consecutive days, in a crossover design
      with a wash-out period of three months. Study participants keep a diary including items on
      interictal and ictal photophobia, headache frequency and severity 7 days before, during, and
      7 days after the interventions. One week before and one day after both interventions, fMRI
      using flickering light in a block design is applied. Functional activation is analyzed at
      whole-brain level and habituation of the visual cortex (V1) is modeled with the initial
      amplitude estimate and the corrected habituation slope.
    


Intervention name(s): Light exposure (Flash); Light deprivation (Dark)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Light exposure (Flash) is administered for one hour on 7 consecutive days. During the light exposure, participants are seated 120 cm in front of a white curtain that is illuminated by an LED light source (Dawe stroboscope type 1214B, 5 Hz).; Light deprivation (Dark) is administered for one hour on 7 consecutive days. During the Dark intervention, participants are seated in a room in complete darkness.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants receive light exposure therapy (Flash) and light deprivation therapy (Dark) for one hour daily on 7 consecutive days, in a crossover design with a wash-out period of 3 months. The sequence of the interventions is randomly allocated.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: migraine; photophobia; habituation; headache; functional magnetic resonance imaging
A Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain
Condition: Back Pain Lower Back Chronic
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the efficacy and safety of duloxetine in participants
      with Chronic Low Back Pain (CLBP).
    


Intervention name(s): Duloxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): Cymbalta; LY248686
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Low Back Pain; CLBP
Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
Condition: Narcolepsy; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Shift-Work Sleep Disorder
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders; Parasomnias; Narcolepsy; Sleep Disorders, Circadian Rhythm; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of Armodafinil
      (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12
      months to patients with excessive sleepiness associated with a current diagnosis of
      narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal
      continuous positive airway pressure [nCPAP] therapy), or chronic shift work sleep disorder
      (SWSD).
    


Intervention name(s): CEP-10953 (Armodafinil)
Intervention type(s): Drug
Intervention description(s): Armodafinil (po) 100 to 250 mg/day up to 12 months
Intervention MeSH terms: Modafinil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Excessive Sleepiness; Narcolepsy; Cataplexy; Sleep Attacks; Obstructive Sleep Apnea; Obstructive Sleep Hypopnea; nCPAP; Chronic Shift Work Sleep Disorder; Chronic SWSD; Circadian Rhythm Disorder; Shift Worker; Cepahlon; Cephalon, Inc; Nuvigil
Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The main purpose of the this study is to evaluate the safety and tolerability of Immunose™
      FLU based on Endocine™ and quadrivalent influenza antigen.
    


Intervention name(s): 15 µg HA/strain and 1% Endocine™; 15 µg HA/strain and 2% Endocine™; 15 µg HA/strain; intramuscular comparator; intranasal comparator; Placebo, Saline
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): intranasal administration; intranasal administration; intranasal administration; intramuscular administration; intranasal administration; intranasal administration
Intervention MeSH terms: Endocine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Fetal Growth Pattern in Short Stature Women
Condition: Intrauterine Growth Restriction
MeSH terms: Dwarfism; Fetal Growth Retardation
Study type: Observational

Summary: 
      Women of short stature tend to be classified regarding fetal growth by the same criteria as
      women of normal and tall stature. The objective of the following study is to evaluate fetal
      growth patterns parallel to women's height and try to make conclusions regarding possible
      definitions of subjective Intra-uterine growth restriction.
    

Detailed description: 
      Based on a patient registry, women of short stature tend to be classified regarding fetal
      growth by the same criteria as women of normal and tall stature. The objective of the
      following study is to evaluate fetal growth patterns parallel to women's height and try to
      make conclusions regarding possible definitions of subjective Intra-uterine growth
      restriction.

      Informed consent is not required due to the retrospective nature of the study. Patient
      information including medical, obstetric and general background will be collected.
    

Intervention name(s): Analysis of a patient registry
Intervention type(s): Other
Intervention description(s): Analysis of a patient registry.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women of short stature under 1.6 meters.
Male Hormonal Contraceptive Development-ACY-5
Condition: Contraception
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research study is to help in the development of male contraception (birth
      control).
    

Detailed description: 
      The objective is to conduct a male contraceptive trial in which we will evaluate the
      suppressive effects of acyline when administered in combination with Testosterone (T) and the
      progestin depo-medroxyprogesterone acetate (DMPA).

      We will be administering combinations of three drugs: Testosterone (T) by gel, Depot
      Medroxyprogesterone acetate (DMPA) and Acyline to see their effects on sperm production. The
      T/DMPA/Acyline combination will allow us to determine if the more rapid and complete
      gonadotropin suppression mediated by the early addition of a GnRH antagonist will accelerate
      and enhance suppression of spermatogenesis.

      In prior studies with testosterone and DMPA these drug, which are hormones, have been found
      to be safe, and to reversibly suppress sperm counts to zero in about 80% of men. We hope to
      improve this to 100% of men by adding another drug, Acyline.

      Acyline is an GnRH antagonist which blocks the release of LH and FSH from the pituitary. DMPA
      is approved by the FDA for use as a female contraceptive. The endpoint will be suppression of
      spermatogenesis to zero (azoospermia) by the end of the treatment phase.
    

Intervention name(s): Acyline; Testosterone Gel; Depo-Medroxyprogesterone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Acyline 300 mcg/kg SQ every 2 weeks for 12 weeks; Testosterone Gel (10 g daily; DMPA (injected into muscle) Day 0 & month 3
Other intervention name(s): Testim; DMPA
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone; Testosterone; Acyline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Male contraception; testosterone; acyline
Evaluation of Dental Anxiety in Second-Stage Implant Surgery With Er,Cr:YSGG Laser
Condition: Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Implants embedded under the oral mucosa were exposed with scalpel (Group 1) or laser surgery
      (Group 2). Before the operation the patients were asked to fill the State-Trait Anxiety
      Inventory (STAI) and Dental Anxiety Scale (DAS) while resting in the waiting room.
    


Intervention name(s): Scalpel; 2780 nm Er,Cr:YSGG Laser
Intervention type(s): Procedure; Device
Intervention description(s): Exposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with scalpel for placing the healing abutment.; Exposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with erbium laser for placing the healing abutment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dental Anxiety; STAI; Er,Cr:YSGG; oral surgery
Booster Dose (50 µg) of Recombinant Ricin Toxin Vaccine (RVEc™) in Previously Vaccinated Healthy Adults
Condition: Ricin Poisoning
MeSH terms: Poisoning
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of a single 50-μg
      booster dose of RVEc. Subjects will be recruited from the cohort that received three 50-μg
      doses of RVEc in a Phase 1 trial (NCT01317667).
    


Intervention name(s): 50-μg booster dose RVEc
Intervention type(s): Biological
Intervention description(s): Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination.
Other intervention name(s): Ricin Vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pretreatment Group Consultation for Patients With Colorectal Cancer
Condition: Colorectal Neoplasm
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      An explorative study of the patients' experience of participating at a group consultation,
      together with other patients with newly diagnosed colon or rectal cancer
    

Detailed description: 
      The group consultation is planned to be on the Friday of the same week as the patient
      recieved a suggested treatment plan i.e. after MDT, at a personal consultation with his/her
      colorectal surgeon. During the group consultation the steps necessary for the patient to take
      responsability for in connection with the operation. Ample time for questions, clarifications
      and discussions. Appropriate clinical trials are presented
    

Intervention name(s): Pretreatment group consultation
Intervention type(s): Other
Intervention description(s): A consultation in group with several patients and one surgeon
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with colon or rectal cancer at the Sahlgrenska University Hospital/Östra planned
        for surgical treatment
Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty
Condition: Hip Replacement Arthroplasty
Study type: Interventional
Phase: Phase 4

Summary: 
      Currently the most use solution to volemic reposition in hip replacement arthroplasty is the
      crystalloid solution. This trial intends to compare two different volemic replacements: HES
      and Ringer's lactate. This research has been analyzing hemodynamic parameters and the
      coagulation status before and after the pre-expansion with the solutions above mentioned.
    

Detailed description: 
      This trial is randomized an blind to the physician who is analyzing the results.It has been
      select adults; both sex; ASA I and II. These patients must be submitted to hip arthroplasty
      replacement. The anesthesia technique is single shot spinal anesthesia. Primary endpoint:
      assessment alternative; technique replacement volemic with HES 130/04. Secondary endpoint:
      haemostatic abnormalities; blood loss; transfusion blood.
    

Intervention name(s): Hydroxyethyl Starch; Ringer's lactate
Intervention type(s): Drug; Drug
Intervention description(s): Dosage: 30ml/kg; frequency: one time; duration: 60min; Dosage: 30ml/kg; frequency: one time; duration: 60min.After 10ml-kg-h both groups
Other intervention name(s): Voluven
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hip Replacement Arthroplasty; Hydroxyethyl Starch; Hemodilution; Hetastarch; Colloids
Fascial Manipulation in Patients With Hip Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The study will test the efficacy of the treatment of soft tissues for osteoarthritis patients
      that are waiting for total hip arthroplasty. The fascial manipulation provides a deep
      pressure of specific points of the muscle fascia. The aims of this treatment are the improve
      of pain before the surgery and the improve of functional performance after the surgery.
    


Intervention name(s): fascial manipulation; standard treatment
Intervention type(s): Other; Other
Intervention description(s): Recruited patients in study's group will be treated with the standard treatment and fascial manipulation.
Specific points of fascial tissue will be treated with a deep friction to improve elasticity.
The number of point treated will be refered to a specific evaluation for each patient.
Fascial manipulation provide 3 session treatment (one treatment for week).; Before surgery, standard physiotherapy treatment provides an education session about the rehabilitation program tha is going to be execute after surgery.
After surgery 2 daily physiotherapy treatment are implemented: bed exercise as active and passive flex-extension of lower limb, movements for postural change to reach sitting and standing position, walking training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
PENG Block for Total Hip Arthroplasty
Condition: Hip Osteoarthritis; Hip Arthropathy; Hip Disease; Hip Pain Chronic
MeSH terms: Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized, double-blinded, placebo-controlled trial seeks to evaluate the efficacy of
      the pericapsular nerve group block on postoperative rehabilitation.
    

Detailed description: 
      The pericapsular nerve group, or PENG block, has been recently described and shows promise in
      providing analgesia to the hip joint. However, the effect of this block on postoperative
      rehabilitation is uncertain. This study compares a preoperative PENG block to a placebo
      before total hip arthroplasty under spinal anesthesia. The primary outcome measure is
      verticalization, walking distance, ability to go out of bed, active lifting of the limb,
      range of motion in the hip joint, bending range of motion, and abduction range of motion. The
      secondary measure is postoperative pain assessment during rehabilitation.
    

Intervention name(s): Ropivacaine 0.5% Injectable Solution; 0,9% normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 20 mL 0.5% ropivacaine will be injected for the PENG block; 20 mL 0.9% normal saline will be injected for the PENG block
Other intervention name(s): Ropimol; placebo
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blind, placebo-controlled
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: periarticular nerve group block; total hip arthroplasty; pain management; multimodal analgesia; regional anesthesia
A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up
      to 90 micrograms per kilogram per hour (μg/kg/h) for 60 hours reduces depressive symptoms in
      participants with severe postpartum depression (PPD) compared to placebo injection as
      assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total
      score.
    


Intervention name(s): Placebo; SAGE-547 60 μg/kg/h; SAGE-547 90 μg/kg/h
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous infusion of matching placebo for either SAGE-547 60 μg/kg/h or 90 μg/kg/h.; Intravenous infusion of SAGE-547.; Intravenous infusion of SAGE-547.
Intervention MeSH terms: Pregnanolone; Brexanolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Severe Postpartum Depression; SAGE-547
Anesthesia in PROstate Biopsy Pain Obstruction Study
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This is a multicentre randomized controlled trial in comparison of the perineal nerve block
      approach between the periprostatic block in the pain control in men undergo a transperineal
      prostate biopsy.
    

Detailed description: 
      This trial is a prospective, multicentre, randomized controlled study in which all men plan
      to undergo a transperineal prostate biopsy. This study aims to determine whether the perineal
      nerve block approach is better than the periprostatic block in the pain control in men
      undergo a transperineal prostate biopsy.
    

Intervention name(s): perineal nerve block; periprostatic block
Intervention type(s): Behavioral; Behavioral
Intervention description(s): An anesthesia method to block perineal nerve; An anesthesia method to block periprostate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prostate Cancer; transperineal prostate biopsy; perineal nerve block; periprostatic block; anesthesia
Study to Evaluate Safety, Tolerability, and Effect of AL208 on Mild Cognitive Impairment Following Coronary Artery Bypass Graft Surgery
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to compare mild cognitive impairment in the AL-208 group with the
      placebo group at 14 + - 3 days after CABG surgery
    


Intervention name(s): AL-208; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 dose of 300 mg; 1 dose of placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MCI following CABG surgery
The EASE Study - Human Factor and Usability Testing of a Binocular OCT System
Condition: Glaucoma; Retinal Disease; Strabismus; Healthy Volunteers
MeSH terms: Strabismus; Retinal Diseases
Study type: Observational

Summary: 
      Ophthalmology is among the most technology driven of all medical specialties, with advanced
      medical imaging devices - and specialised computer software - increasingly adopted for
      routine clinical use. While many such devices are capable of completing specific tasks, lack
      of "usability" prevents their widespread adoption (i.e., such devices are not easy to learn
      and remember, or are not efficient or subjectively pleasing to use). Moreover, devices that
      are difficult to use expose patients to clinical risk as a result of human error during
      usage.

      With the introduction of a new medical technology, it is essential, therefore, to have a deep
      understanding of patients, what they need, what they value, their abilities, and also their
      limitations.

      Human factor and usability testing, also known as "human factor engineering", deals with the
      formal study of people's interaction with their environment (in this case, the binocular
      optical coherence tomography (OCT) device). Structured, patient-centred, usability testing is
      essential to the design, clinical validation, regulatory approval, and widespread
      implementation, of all new medical devices. This is particularly the case for a putative
      binocular OCT system - a device intended for automated use in visually impaired, often
      elderly, populations. Although the binocular OCT is already at an advanced stage of hardware
      development, the EASE study will facilitate an iterative process of operating software and
      workflow modifications to optimize the device for use in these populations.
    


Intervention name(s): Binocular OCT prototype
Intervention type(s): Device
Intervention description(s): Testing will begin using a prototype binocular OCT system. Subjects will undergo the full suite of diagnostic assessments offered by the system at that time (i.e., visual acuity, ophthalmic history, pupillometry, ocular motility, perimetry, anterior segment and posterior segment OCT imaging).
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants with chronic eye disease (retinal disease, glaucoma, and strabismus) will be
        recruited from appropriate eye clinics at Moorfields Eye Hospital and from a patient
        advisory group established for this purpose.
      
Keywords: optical coherence tomography; optical imaging; retinal imaging