cyrilzakka/clinical-trials huggingface dataset:
Assessment of Alcon's Ocular Image Quantification System

The purpose of this study was to evaluate ocular responses with different allergen provocation methods.

Subjects demonstrating a successful allergen response to a common allergen received the first study treatment and used as instructed for 5 days, after which they entered the Environmental Exposure Chamber (EEC) for a 3-hour exposure to a known concentration of the allergen. After waiting at least 7 days, subjects received the second study treatment and used as instructed for 5 days, after which a 3-hour Conjunctival Allergen Provocation Test (CAPT) was performed with an escalating concentration of the allergen. Subjects dosed with study treatment approximately 15 minutes prior to each allergen provocation test.

Eligibility Criteria:
Inclusion Criteria:

* History of allergic conjunctivitis;
* Active signs and symptoms of ocular allergies;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* History of dry eye;
* Presence of ocular infection;
* Presence of severe or serious ocular conditions;
* Symptoms of allergic conjunctivitis;
* Use of topical or systemic ocular medications as specified in protocol;
* Ocular surgery or laser surgery within 6 months of study start;
* Unwilling to discontinue contact lens wear 72 hours prior to Visit 1 and during study period;
* Other protocol-defined exclusion criteria may apply.
Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma.

The purpose of this pilot study is to evaluate digitally supported skin self-examination compared to usual care in people treated for localised melanoma.

Patients may be eligible to join this study if they are aged 18 years or above, have been treated for stage 0/I/II melanoma and are attending regular melanoma surveillance follow-ups at the Melanoma Institute Australia (MIA), Royal Prince Alfred Hospital (RPAH) or the Newcastle Skin Check Clinic.

People who are found to be eligible and who consent to participate will be randomised (allocated by chance) to the intervention or usual care in a 1:1 ratio. Usual care group will receive an educational booklet on early melanoma and the usual number of routine clinic visits. In addition to usual care, participants allocated to the intervention group will be required to download a skin checker App to their smartphone and will use a mobile dermatoscope to perform total body skin self-examinations every 2 months for 6 months in total. Email and SMS reminders will also be sent every two months to participants in the intervention group. Participants will be documented on how well they are able to perform a self skin examination, their levels of melanoma-related anxiety, the number of skin lesions biopsied or removed, and the costs of follow-up to the participant and to the healthcare system.

Frequent follow-up of localised melanoma is time and resource intensive, and has not shown improved outcomes. This pilot study will provide evidence on which model is best for follow-up care after treatment for localised melanoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated for stage 0/I/II melanoma and are attending regular melanoma follow-up as indicated by scheduled visit within next 12 months in clinic patient booking system and
* Are able to self-examine;
* Have a suitable study partner (spouse, partner, family member, friend);
* Have a smart phone with access to Wifi / email / SMS text messaging;
* Are able to give informed consent ;
* Have sufficient English language skills to read the materials and complete the questionnaires;

Exclusion Criteria:

* Unable to perform self-examination
* No partner or friend to help with self-examination
* Do not have access to a smart phone with Wifi/email/SMS text messaging
* With a known past or current diagnosis of cognitive impairment
Evaluation of the Feasibility of Camera Measurement of Colorimetric Parameters of the Brain During Neurosurgery Operations: Tissue Oximetry and Endogenous or Induced Fluorescence

The management of many brain pathologies involves obtaining a functional and histological diagnosis and performing neurosurgery when possible. Histological diagnosis makes it possible to differentiate healthy areas from pathological areas. Functional diagnosis allows the identification of brain areas to be spared during neurosurgery in order to avoid any permanent post-operative disability.

The visual analysis of the color and texture of the brain by the trained eye of the neurosurgeon is largely part of his operating practice. It allows it to differentiate between healthy and pathological areas. Likewise, color variations linked to the functional activation of brain areas are sometimes visible to the naked eye. However, this approach is not optimal due to the limits of human vision. It is also very strongly dependent on the experience and expertise acquired by the neurosurgeon. This approach is therefore largely limited in many operating contexts: low visual contrasts, less experienced neurosurgeon.


Eligibility Criteria:
Inclusion Criteria:

* Adult from both sex
* Neurosurgery requiring a functional diagnosis by cortical electrical stimulation OR a histological diagnosis with or without fluorescent agent (5-ALA) for a tumor pathology or epilepsy or an arteriovenous malformation.
* Patient able to sign a non-opposition

Exclusion Criteria:

* Impaired renal function defined by the presence of creatinine clearance less than 30ml/min
* Patient under treatment with beta-blocker
* Contraindication to performing an MRI (pacemaker)
* Contraindication to the use of electrical cortical stimulation
* History of life-threatening allergic reactions or known hypersensitivity to 5-ALA
* Pregnant, breastfeeding woman
* Subject participating in another interventional research including an exclusion period still ongoing at pre-inclusion,...
* Persons deprived of liberty by a judicial or administrative decision
* People receiving psychiatric care
* Persons admitted to a health or social establishment for purposes other than research
* Adults subject to a legal protection measure (guardianship, curatorship)
* Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
CorEvitas Multiple Sclerosis (MS) Registry

This prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for MS in a cohort of patients cared for by neurologists across North America. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.

The objective of the CorEvitas Multiple Sclerosis (MS) Registry is to create a national cohort of patients with MS. Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of MS. This will be done through the standardized collection of validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the prevalence and incidence of comorbidities and adverse events, medication utilization patterns and patient productivity measures.

The design is a prospective, non-interventional, observational registry for patients with MS under the care of a licensed neurologist. Longitudinal follow-up data is collected from both patients and their treating neurologist (also known as "Providers" for a CorEvitas registry study) every 6 months (+/- 30 days) during routine clinical encounters using CorEvitas registry forms. These forms collect data on patient demographics, disease duration, medical history (including all prior and current treatments for MS), smoking status, alcohol use, disease activity and severity, pain, as well as other clinician- and patient-reported outcomes, comorbidities and adverse events, infections, hospitalizations, and other targeted safety outcomes. After the enrollment visit, MS patients and physicians will complete the follow-up questionnaires during regularly scheduled clinical encounters. The goal is to collect data from patients and providers at six month intervals. Adverse events may be volunteered spontaneously by the subject, or be discovered as a result of general questioning by the Investigator. During all CorEvitas related visits with the Investigator, subjects will be questioned regarding the occurrence of adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Has a diagnosis of MS at the time of enrollment.
2. Age 18 years or older at the time of enrollment.
3. Willing to provide Personal Information.
4. Initiating (prescribed or starting) an Eligible Medication for the treatment of MS at the enrollment visit.

Exclusion Criteria:

1) Is participating or planning to participate in a double-blind randomized trial for an MS drug. Note: Concurrent participation in another observational registry or open-label Phase 3b/4 trial is allowed.
The Network Study: Soldiers Connecting for Work and Health

This study will examine the efficacy of an internet-based brief intervention designed to reduce risky behavior in Soldiers as they transition from Active Duty into the civilian workforce as a Veteran. Up to 700 soldiers intending to separate from the Army will be recruited, with the intention of drawing a final sample of 450 participants. Study participants will be randomly assigned to either the intervention or the control group, stratified by age and gender.

The combination of alcohol use and negative emotional states is a particularly toxic combination for suicide risk. The current study examines changes in alcohol/drug use/misuse and depression as soldiers undergo the transition from Active Duty to Veteran and offers a personalized internet-based brief intervention intended to prevent/reduce alcohol misuse and depression in this population.

The study's objectives are to empirically quantify the form of changes that occur with respect to alcohol use and depression over the transition; to identify stable individual risk factors (e.g., personality, military experiences) and dynamic risk factors (e.g., changes in stressors and normative contexts over time) that may be associated with differential temporal patterns of suicide-related behavior (i.e., alcohol use/misuse) and cognition (i.e., depression); and lastly, to determine whether a simple, internet-delivered brief intervention shown can reduce risky behavior in the transitioning Veteran population.

Eligibility Criteria:
Inclusion Criteria:

* Is US solider intending to separate from active duty during the study enrollment period
* Intends to seek civilian employment
* Plans to live in US

Exclusion Criteria:

* Plans to retire and not seek civilian employment
* Plans to live outside of the US
* Is separating or retiring from the National Guard or Reserves
Effects of Video Information on Preoperative Anxiety in Patients With Colorectal Cancer

Patient's anxiety prior to surgery has been linked to more harmful outcome after surgery. The investigators aim to evaluate the effect of video information on preoperative anxiety level in patients with colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age: 20-75
* Elective surgery

Exclusion Criteria:

* History of previous any surgery
* emergency surgery
* dementia
* psychological disease
Study of Oral Venetoclax Tablets in Combination With Intravenous Obinutuzumab Injection to Assess Achievement of Best Response in Adult Participants With Chronic Lymphocytic Leukemia

Chronic Lymphoid Leukemia (CLL) is the most common type of leukemia (cancer of blood cells) in adults affecting men more so than women. The main objective of this study is to assess the how effective venetoclax (Venclexta) in combination with Obinutuzumab is in treating Chronic Lymphocytic Leukemia (CLL). Effectiveness is assessed by achievement of best response.

Venetoclax is an approved drug developed for the treatment of CLL. Approximately 50 adult participants with previously untreated CLL will be enrolled in approximately 10 to 15 sites in Russian Federation.

Participants will receive oral venetoclax tablets in combination with intravenous (IV) Obinutuzumab as prescribed by the physician prior to enrolling in this study in accordance to the local practice and label.

There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of previously untreated Chronic Lymphocytic Leukemia (CLL).
* Participant for whom the physician has decided to initiate CLL treatment with Venetoclax combo therapy with Obinutuzumab, according to approved local label up to 4 weeks (28 days) after Obinutuzumab treatment initiation.

Exclusion Criteria:

* Contraindications to Venclexta (Venetoclax) as listed on the approved local label in Russian Federation.
* Creatinine Clearance \< 30 milliLitres/minute.
* Richter syndrome or Transformation of CLL to aggressive non-Hodgkin lymphoma.
* Participating in a clinical trial with an investigative drug for CLL.
ZIPS Study - Zip Incision Approximation vs. STAPLE

Study designed to evaluate the Zip Surgical Skin Closure device versus conventional steel staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi later total knee replacement.

This is a randomized, within patient control study aiming to enroll up to 25 subjects requiring bi lateral knee arthroplasty (unicompartmental or toal) at a single study center. Subjects will be followed for up for 6 weeks post surgery to evaluate wound healing and overall satisfaction of closure methods.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty;
* Patients willing to be evaluated at discharge and 6-weeks post op.

Exclusion Criteria:

* Known bleeding disorder not caused by medication
* Known personal or family history of keloid formation or scar hypertrophy
* Known allergy or hypersensitivity to non-latex skin adhesives
* Atrophic skin deemed clinically prone to blistering
* Any skin disorder affecting wound healing
* Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study
Evaluation on the Effects of Two Rehabilitation Treatment and Tape for Functional and Motor Recovery of LBP Patients

The objective of this study is to verify which is the most effective type of rehabilitation treatment (rehabilitation based on core strengthening vs pilates) in patients suffering from low back pain.

The secondary objective is to verify whether the use of Kinesio Tape (KT) associated with rehabilitation treatment can have greater effects in the motor and functional recovery of patients suffering from Low Back Pain than traditional rehabilitation.

Patients will undergo an initial assessment with the Physical Medicine and Rehabilitation Unit Physicians, during which the participants will sign the informed consent. After that a first evaluation will be carried out (T-1) during which the subjects will be asked to perform 10 consecutive sit-to-stand tests and 10 consecutive front bending tests. During the sit-to-stand and front bending tests, the kinematics of the spine will be recorded using two MIMU - XSENS DOT.

The following scales will also be administered:

* Roland and Morris Disability Questionnaire
* Numerical Rating Scales (NRS) 11-point scale to assess the average intensity of pain during the last week
* The Short Form Health Survey 36 (SF-36) questionnaire to assess quality of life
* The Modified Somatic Perception Questionnaire (MSPQ) to assess pain somatization
* The Hospital Anxiety and Depression Scale (HADS) scale to assess anxiety and depression
* The Pain Catastrophizing Scale (PSC) to assess the catastrophization of pain
* The Pain Self-Efficacy Questionnaire (PSEQ) for multidimensional pain assessment
* The Fear Avoidance Beliefs Questionnaire (FABQ) to assess pain avoidance beliefs

Patients will be randomized in 2 groups (Group A and Group B). For both groups there will be 12 treatment sessions, 3 times a week. (4 weeks)

At mid-treatment (after 2 weeks), at the end of treatment (T1), and in follow-ups following 1 month (T2), 3 months (T3), 6 months (T4) and 12 months (T5) the same assessments of the first visit will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Signing of informed consent
* Chronic low back pain defined as non-specific self-reported low back pain that persists daily for at least 3 months or at least half of the days in the last 6 months.

Exclusion Criteria:

* Specific cause of low back pain: disc herniation, spinal stenosis, cauda equina syndrome, infection, fracture, tumor.
* Pregnant women
* Neurological disorders and neurological signs (e.g. CNS disorders, weakness, paresthesia)
* Respiratory disorders
* Previous spinal surgery.
* Pain in the lower limbs or lesions limiting their function
* Taking pain medication
Ankle Instability Treatment in Patients With Chronic Ankle Instability

Ankle joint self mobilization.

The intervention would consist in the administration of self mobilization with movement techniques in patients with chronic ankle instability in addition to an exercise program

Eligibility Criteria:
Inclusion Criteria:

* ankle range of motion limitation respect the contralateral ankle.
* At least two episodes of giving way on the affected ankle.
* Scores of at least 24 in the cumberland ankle instability tool.

Exclusion Criteria:

* recent fractures of the involved limb.
* Vestibular or balance dysfunction.
* Acute ankle sprain.
Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis

In allergic rhinitis patients with severe symptoms, control of severe allergic reactions is limited with saline nasal irrigation. Therefore, there have been several attempts to use saline nasal irrigation in combination with other treatments to treat allergic rhinitis. This study tries to explore the effect of nasal irrigation with Chinese herbal medicines on allergic rhinitis.

In this study, patients with allergic rhinitis over 20 years old were collected from the clinics of Otolaryngology and Traditional Chinese Medicine clinics. The subjects were randomly divided into two groups. They used the devices of NeiMed sinus rinse to irrigate the nose with 240 cc of Chinese herbal medicine solution or placebo each morning and evening for 2 months. Subjects in both groups filled questionnaires, and received acoustic rhinometry, rhinomanometry, and eustachian tube function tests before and after nasal irrigation. This study tries to explore the effect of nasal irrigation with Chinese herbal medicines on allergic rhinitis.

Eligibility Criteria:
Inclusion Criteria:

* Allergic rhinitis patients diagnosed based on the history and allergen test

Exclusion Criteria:

* Those younger than 20 years old, Immunocompromised patients Pregnant women or breastfeeding women Those with a history of allergy to traditional Chinese medicine Those with liver and kidney insufficiency Those who cannot cooperate with nasal irrigation
Static Balance Disorders in Patients After Surgical Treatment of Hip Acetabular Fractures

The mechanism of maintaining balance is a complex phenomenon, involving numerous systems of human body. High-energy trauma resulting in acetabular fracture damages some of the elements composing this delicate mechanism, potentially increasing the risk of falls in patients. There have not been any studies so far on balance levels in patients after surgical treatment of acetabular fractures.

Questions/purposes

1. Do balance disorders occur in patients after ORIF of acetabular fractures?
2. Do surgical approach and fracture pattern influence balance level of patients?
3. Should therapy programs include certain stabilometric parameters adequate especially for this type of injury?

Methods Between 2014-2017, investigators evaluated 110 subjects: 55 patients after surgical treatment of acetabular fracture - the study population (mean age 43.6 ± 14.8 years) and 55 healthy subjects - the clinical control group (mean age 43.8 ± 14.9 years).

To ensure reliability of results, controls were individually matched to appropriate study population patients, in terms age, sex, body height and mass.

The study was conducted in Public Hospital and the protocol was approved by the Commission of Ethics (SKE 01-21/2014).

Investigators measured static balance in double leg stance (eyes open/eyes closed) for 30s on CQStab2P, a double module stabilometric platform.

The pain component of the Harris Hip score and the quality of fracture reduction (according to Matta's criteria) in digitized anteroposterior and two oblique view radiographs were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* written consent to participate in the study,
* full legal age,
* surgically treated hip acetabular fracture,
* time after the surgery between 3 and 84 months,
* full cognitive abilities, -full medical documentation, - the ability to fully load the operated limb (doctor's consent).

Exclusion Criteria:

* craniocerebral injuries,
* visual system disorders,
* neurological disorders,
* ear and sinuses infections,
* spinal pain
* injuries to the lower extremities,
* chronic illnesses (cancer, Parkinson's disease, epilepsy, diabetes, neuro-muscular disorders, uncontrolled coronary heart disease),
* taking psychoactive substances,
* lower limb thrombosis
Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis

The investigators will determine the prevalence of gastroesophageal reflux disease (GERD) in Eosinophilic Esophagitis (EoE) and importantly determine the predictors of response to Proton Pump Inhibitor (PPI) therapy in EoE. Moreover, the investigators will determine the effect of GERD on the location of esophageal eosinophilia.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age \< 80 years of age
* 14 eosinophils / hpf on biopsies from esophagus

  * Abnormal validated Mayo dysphagia questionnaire (MDQ-30) (question 2"yes", question 4 \> "moderate" and question 7 \> "once a week")
  * Clinically performed EGD with \> 14 eosinophils/hpf completed within last 3 months

Exclusion Criteria:

* Other cause of dysphagia identified at endoscopy (e.g. stricture, web, infection, ring, achalasia, esophageal neoplasm)
* Dilatation of esophagus at time of index endoscopy
* Treatment with topical steroid within 3 months of index endoscopy
* Treatment with PPI in last 30 days prior to index EGD

Patient population - adults with EoE recruited from Mayo Clinic Rochester, MN patient population