cyrilzakka/clinical-trials huggingface dataset:
Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A

The objective of the study is to determine if habitual or adapted contact lens wearers of Omafilcon A can be confidently refit into Somofilcon A lenses and be successful after one week of daily wear.

The primary outcome variables for this study are:

* Investigator responses to refit questions;
* Lens fit.

This is a prospective, single-site, dispensing, bilateral wear, open label, daily wear switch study, with the test lens (Somofilcon A) being worn for 7 (+5) days.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 17 years of age and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Habitually wears soft spherical contact lenses with a power between +6.00 to -10.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day;
* Habitually wears, or is able to be adequately refit into Proclear 1 Day lenses;
* Demonstrates an acceptable fit with Proclear 1 Day and Clariti 1 Day contact lenses;
* Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with the study lenses or habitual correction;
* Manifest cylindrical spectacle refraction does not exceed -1.00DC in either eye.

Exclusion Criteria:

* Is participating in any concurrent clinical research study;
* Has any known active\* ocular disease and/or infection;
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
* Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
* Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal communication);
* Is aphakic;
* Has undergone refractive error surgery;
* Is an employee of the Centre for Contact Lens Research;
* Has taken part in another clinical or (pharmaceutical) research study within the last 7 days.
Intraoperative Systemic Arterial Hypotension Secondary to Beach Positioning

This study aims at describing the systemic arterial hypotension secondary to intraoperative beach chair positioning. This is a non-interventional prospective study.

The primary endpoint will be the intraoperative systemic arterial pressure measured at the arm.

The secondary endpoints will include postoperative mortality, intensive care admission, post anesthesia care unit length of stay,


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Patient operated in a sitting position at Hopitaux Universitaires de Strasbourg
* Patient willing to participate in the study

Exclusion Criteria:

* Refusal to participate in the study
The Clinical Comparison of Somofilcon A 1 Day and Nelfilcon A Daily Disposable Contact Lenses

This subject-masked, randomized, bilateral crossover study will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis.

This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross-comparison. This will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis.

Subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.

Eligibility Criteria:
Inclusion Criteria:

* They are of legal age (18) and capacity to volunteer.
* They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They agree not to participate in other clinical research for the duration of this study.
* They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)
* They have a maximum of -1.00DC ocular astigmatism in each eye.
* They can be satisfactorily fitted with the study lens types.
* At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
* They currently use soft contact lenses or have done so in the previous six months.
* They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
* They own a wearable pair of spectacles.

Exclusion Criteria:

* They have an ocular disorder which would normally contra-indicate contact lens wear.
* They have a systemic disorder which would normally contra-indicate contact lens wear.
* They are using any topical medication such as eye drops or ointment.
* They have had cataract surgery.
* They have had corneal refractive surgery.
* They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
* They are pregnant or breast-feeding.
* They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
* They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel, or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
* They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
* They currently wear either the clariti 1day or the DAILIES AquaComfort Plus lens.
Analgesic Effect of rTMS in Vasculitic Neuropathy

Vasculitic neuropathy (VN) results from inflammation and destruction of the walls of predominantly small vessels with subsequent ischemic damage of peripheral nerves. VN is painful in vast majority of patients and the pain is intractable with pharmacotherapy in about 40% of cases. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain plasticity and is regarded as one of alternative methods to alleviate pain associated with various kind of neuropathies. The purpose of this study is to compare the effectiveness of analgesic effect of rTMS in vasculitic neuropathy with sham stimulation.

Vasculitic neuropathies (VN) are a group of disorders resulting from inflammation of predominantly small vessels with destruction of their walls and subsequent ischemic damage of peripheral nerves. Neural damage may or may not coexist with the damage of other organs. Examples of conditions associated with VN include diabetes, microscopic polyangiitis, eosinophilic granulomatosis with polyangiitis (Churg-Strauss), granulomatosis with polyangiitis (Wegener's), rheumatoid arthritis, systemic lupus erythematosus and others. VN is painful in about 80% of patients of whom 40% suffer from the pain intractable with pharmacological therapy. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain plasticity. In this method, series of magnetic stimuli are delivered to the cerebral cortex, where they turn to electric current and depolarize repetitively the targeted neurons. If the stimulation is repeated during subsequent days it is capable to modify the activity of targeted cortical area for weeks or even months and by this way to achieve therapeutic effect. rTMS is widely regarded as one of alternative methods to alleviate pain associated with various kind of neuropathies. The purpose of this study is to compare the effectiveness of analgesic effect of rTMS in vasculitic neuropathy with sham stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of vasculitic neuropathy
* Neuropathic pain of constant severity since not less than a month and requiring use of analgesics more than once a week
* Score of 30 milimeter or more on the 100 milimeter visual analog scale of pain intensity at inclusion

Exclusion Criteria:

* Severe depression
* Personality disorders and other psychiatric conditions, which could disturb the participation in the study
* Cognitive deficits, which could disturb the participation in the study
* Contraindications for rTMS as listed by the Guidelines of the International Federation of Clinical Neurophysiology (Rossi et al. 2009) i.e. seizure in the past, epilepsy, presence of magnetic material in the reach of magnetic field, pregnancy, likelihood to get pregnant, intracranial electrodes, cardiac pacemaker or intracardiac lines, frequent syncopes
Feasibility of Using Telepractice to Provide Modified Interaction Guidance.

The purpose of this study is to determine the feasibility of using telepractice to provide Modified Interaction Guidance (MIG) to caregivers and their child with autism. MIG as an intervention to improve attachment for children with autism and their primary caregiver.

The process objectives target focus on1) recruitment, 2) retention, 3) engagement with tools, 4) time demand on dyads, and 5) eligibility criteria.

The resource assessment objectives include: 1) equipment and internet accessibility 2) communication methods, and 3) timelines.

The management assessment objectives address: 1) ethical standards, 2) researcher qualifications and 3) data storage and collection.

Finally, when looking at the scientific assessment, the objectives relate to: 1) Is use of a concurrent multiple baseline single-subject design feasible with this population? 2)capturing dyad needs, 3) burden levels, and 4) safety protocols.

This study will evaluate the above listed dimensions of feasibility using a embedded mixed methods approach that incorporates both a single-subject design and qualitative data gathered throughout the research process and post intervention individual interviews.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of autism spectrum disorder
2. Child between the ages of 24-60 months
3. First born child
4. No physical or medical conditions that affect the child's ability to participate in the activities that are part of the intervention process
5. Ability to follow simple verbal directions in English
6. No current plan to initiate any treatment alternatives during the study period
7. Willingness to participate in a -week intervention with a frequency of once a week
8. Adults are primary caregiver
9. Under age of 35
10. Speak English
11. Minimum grade 5 schooling
12. Access to a computer and broadband wired or wireless (3G or 4G/LTE) internet connection?

Exclusion Criteria:

* Participants (both child and adult) will be excluded from the present study if they were deemed low functioning
* child is not the first-born child
* child already receiving ABA treatment
* parents have a history of mental illness
Predictors of Response to Tofacitinib Treatment in Rheumatoid Arthritis Patients

This is a 24-month, prospective, non-interventional, multi-center study with primary aim to identify baseline characteristics of patients that predict response at 6 months of treatment. The study also aims to describe the treatment patterns of RA patients prescribed tofacitinib in a real-world setting and assess the effect of treatment on patient quality of life and physical function. Finally the study will assess the use of healthcare resources and costs in patients with RA treated with tofacitinib in Greece.

The planned recruitment period is 12 months. The planned observation period of each patient is 12 months. In this time period up to 4 visits will be documented.

The study will be reviewed and approved by the Central Regulatory Committee for NIS and IRB Board of each participating site


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects with moderately to severely active rheumatoid arthritis who start treatment with tofacitinib in usual clinical practice conditions in compliance with the label

  1. Patients aged ≥ 18 years
  2. Confirmed Diagnosis of Rheumatoid Arthritis by rheumatologist
  3. Patients with moderate to severe RA diagnosed according to local practice who have already been started on treatment with tofacitinib, for at most seven working days .
  4. Patients eligible for tofacitinib treatment according to current approved Summary of Product Characteristics (SmPC).
  5. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Patients meeting any of the following criteria will not be included in the study:

  1. Exclusion Criteria according to the Xeljanz® SmPC.
  2. Contraindications to Xeljanz® according to SmPC.
  3. Hypersensitivity to the active substance (tofacitinib) or to any of the excipients.
  4. Active tuberculosis (TB), serious infections, such as sepsis, or opportunistic infections.
  5. Receipt of any investigational drug within 3 months before study inclusion as well as currently not participating in an interventional clinical trial.
  6. Subjects who have received any previous treatment with tofacitinib or other JAK inhibitors.
  7. Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
Thoracic Paravertebral Blocks in Open Nephrectomy

60 patients ASA I-III, undergoing open nephrectomy will be randomly assigned into one of two groups, namely group A (n=30), where a thoracic paravertebral block will be performed preoperatively and a paravertebral catheter for continuous and patient controlled bolus local anesthetic (ropivacaine) doses will be inserted and group B (n=30) where morphine IV will be administered at the beginning and the end of operation and postoperatively through patient controlled IV doses. NRS scores in static and dynamic conditions, complications, patient satisfaction, oxidative stress (through lactic acid, superoxide dismutase, malondialdehyde) and NGAL pre- and postoperatively, will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Physical status according to American Society of Anesthesiologists (ASA) I-III
* Patients scheduled for open nephrectomy

Exclusion Criteria:

* Previous operation on same kidney
* Contraindication of paravertebral block or any of the agents used in the protocol
* BMI above 32
* Any concurrent malignancy not cured
* Serious psychiatric, mental and cognitive disorders
* Block failure
* Chronic pain
* Severe kidney disfunction
Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients

The purpose of this study is to evaluate whether transcranial direct current stimulation of the cerebral swallow motor cortex in addition to standard care can enhance recovery of swallow function in acute dysphagic stroke patients compared to sham treatment plus standard care.


Eligibility Criteria:
Inclusion Criteria:

- dysphagia due to acute stroke

Exclusion Criteria:

* preexisting dysphagia
* comorbidities that can possibly cause dysphagia
* psychiatric comorbidities
* pacemaker or other implanted electronic devices
* inability to give informed consent
"Effects of Kinesio Taping in Adjunct to Traditional Physical Therapy on Pain, Range of Motion and Gait Parameters in Patients With Plantar Fasciitis : a Randomized Controlled Trail"

THIS STUDY IS A RANDOMIZED CONTROL TRIAL AND THE PURPOSE OF THIS STUDY IS TO DETERMINE THE EFFECTS OF KINESIO TAPING ON GAIT PARAMETERS IN PATIENTS WITH PLANTAR FASCITIS

The purpose of this study is to determine the difference between efffects of KInesio taping combined with traditional physical versus physical therapy alone.

The individual of Age 20-40 years among both genders and are diagnosed cases of plantar fasciitis Pain levels will be assessed using the Numeric Pain Rating Scale (NPRS). ROM will be assessed through goniometry. Gait parameters will be assessed through 30 meter walk test. Participants of interest would be approached and explained about the research. Informed written consent will be taken. It is a single-blinded study and randomization will be done through coin toss method. Both groups will receive conventional intervention. Additionally, Group B will receive kinesio taping treatment. Baseline and post intervention scores would be recorded for both groups.

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Age 20-40 years
* Diagnosed Cases of plantar fasciitis as per diagnosis criteria established by APTA

As described by American Physical Therapy Association:

Plantar medial heel pain: most noticeable with initial steps after a period of inactivity but also worse following prolonged weight bearing

* Heel pain precipitated by a recent increase in weight-bearing activity
* Pain with palpation of the proximal insertion of the plantar fascia
* Positive windlass test
* Negative tarsal tunnel tests
* Limited active and passive talocrural joint dorsiflexion range of motion
* Abnormal Foot Posture Index score

Exclusion criteria:

* Recent steroid injections
* History of ankle or foot surgery
* Arthritis history
* Radiculopathy
* Diabetic foot
Clinical Trial to Assess the Efficacy and Safety of Tacrolimus Ointment Treatment of Atopic Dermatitis in Adult Patients

Objective: Assess efficacy and safety of tacrolimus ointment when used in adults with moderate or severe atopic dermatitis. The ointment was applied on the affected skin twice daily for 3 weeks and then once daily until all lesions were cleared

The study was a one arm non-comparative study. The only study medication was Tacrolimus ointment 0.1% (Protopic ® 0.1%).

Eligibility Criteria:
Inclusion Criteria:

* Male or female, any ethnic group, age ≥16
* Moderate to severe atopic dermatitis
* Has given informed consent

Exclusion Criteria:

* Erythroderma
* Pregnant or breast-feeding
* Skin infection on the affected area
RCT Comparing Non-operative vs Operative Treatment of Suprasyndesmotic Ankle Fractures.

Weight-bearing radiographs will be used to evaluate the stability of suprasyndesmotic ankle fractures. Patients with stable fractures will be randomised to operative or non-operative treatment.

Suprasyndesmotic fractures (Weber type C) are historically treated operatively because of the assumption that the distal tibiofibular syndesmosis is ruptured, leading to joint instability (Lauge-Hansen 1950, Boden 1989).

However, the medial deltoid ligament may function as the main stabiliser of the ankle joint by preventing external rotation of the talus and therefore maintains the dynamic congruity (Michelson 2007). Due to the stabilising effect of the deltoid ligament, an increasing number of transsyndesmotic fractures (Weber type B) are treated non-operatively with excellent results and without the burden of complications that accompany surgery (Gougoulias 2017, Mittal 2017, Bauer 1985).

The aims of the present study are to test the stability of suprasyndesmotic ankle fractures on weight-bearing radiographs and to evaluate the effect of non-operative versus operative treatment of stable suprasyndesmotic fractures.

The patients will have a weight-bearing (at least 50% of body weight) standing radiograph for the evaluation of the stability of the fracture. Patients with a congruent ankle mortise (i.e., stable fracture) on weight-bearing radiographs will be randomised to either operative (ORIF, reference treatment) or non-operative treatment (cast). Patients in both groups are allowed full weight-bearing.

Patients with an incongruent ankle mortise (i.e., unstable fracture) will be treated operatively according to current clinical practice and included in a parallel observational cohort study. Patients who are unwilling to participate in the intervention study are also invited to participate in the observational cohort study.

Eligibility Criteria:
Inclusion Criteria:

* patients who present with a closed, isolated fibular fracture classified as suprasyndesmotic (Weber C) with a medial clear space of less than 7 mm in mortise view on primary radiographs.
* presentation less than 14 days after the injury.

Exclusion Criteria:

* previous fractures or ligamentous injury to the injured ankle.
* pathological fracture.
* diabetic neuropathy or other neuropathies.
* drug abuse.
* inability to consent and/or comply.
* inability to understand Norwegian language.
* inability to walk unaided prior to the fracture.
* patients with a concomitant tibial fracture requiring surgical treatment are excluded, but patients with undisplaced concomitant tibial fractures can be included.
* patients from outside the catchment area of the recruiting hospitals. However, they can be included if they are willing to undergo follow-up visits at one of the recruiting hospitals.
Effect of Phaseolus Vulgaris L. Dry Extract on the Modulation of Weight and Metabolic Parameters

Evaluation of the efficacy of Phaseolus vulgaris L. dry extract on weight modulation.

Monocentric, prospective, randomized, single-blind clinical trial to evaluate the effects of Phaseolus vulgaris L. dry extract (test) on weight reduction and on metabolic parameters after 12 weeks of supplementation. The efficacy on weight reduction will be evaluated in comparison with the placebo group (control).

Eligibility Criteria:
Inclusion Criteria:

* Male subjects aged between 18 and 60 years
* BMI between 25 and 35 kg/m2
* Habitual consumption of three main meals a day
* Stable body weight during the 3 months prior to enrollment
* Commitment to adhere to the diet and avoid the use of other weight loss products during the study
* Commitment not to change lifestyle significantly for the entire duration of the study.
* Signing of informed consent

Exclusion Criteria:

* Hypergonadotropic hypogonadism and hypogonadotropic hypogonadism
* Diabetes mellitus
* Smoking \> 10 cigarettes/day
* Alcohol \> 2 alcohol units/day (equal to 24 g of ethanol)
* History of eating disorders during the 12 months prior to enrollment
* Use of any drug or product to treat obesity (e.g. meal replacements)
* Presence of acute or chronic gastrointestinal diseases
* Active use of drugs that could influence the functions: gastrointestinal (e.g. laxatives, etc.), insulin (insulin sensitizers, etc.) and/or testicular (hormones, substances that influece testosterone production
* Known sensitivity to the ingredients of the preparation
* Any other clinical condition judged by the investigator to be incompatible with participation in the trial