cyrilzakka/clinical-trials huggingface dataset:
Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome

The purpose of this study is to investigate high frequency ultrasound as a future modality for the diagnosis of chronic exertional compartment syndrome (CECS). The results of the ultrasound will help determine if there are any significant radiologic findings or patterns seen in patients with CECS.

The purpose of this study is to investigate high frequency ultrasound as a future modality for the diagnosis of chronic exertional compartment syndrome (CECS). The results of the ultrasound will help determine if there are any significant radiologic findings or patterns seen in patients with CECS. Evaluation of ultrasonographic findings will be dependent on tissue density as measured by hypoechoic versus hyperechoic signal as well as muscle compartment thickness at its largest dimension. A specific aim for this study would be to facilitate future research in order to eliminate the need for painful and invasive diagnostic techniques for CECS.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ages 13 and over
* Patients with any combination of the following symptoms who would otherwise be evaluated for CECS:
* Symptoms of leg pain worsened with activity and relieved by rest
* Pain that is generalized in the anterior or lateral compartments of lower leg
* Numbness or tingling in the distribution of the superficial peroneal nerve
* Sensation of "slap foot" or anterior/lateral compartment weakness
* Able to exercise for CPT testing: Patients will be asked to go through a standardized warm up on a treadmill with increasing speed and incline settings until symptoms are achieved. They will maintain exercise for a minimum of five minutes or to patient tolerance.

Exclusion Criteria:

* Known vascular disease
* Neurogenic or radicular symptoms
Evaluating a Primary-Care Group-based Mindfulness Program

The study evaluates the effectiveness of a group-based mindfulness program conducted in a primary care setting. This study also aims to identify any scale-up and implementation considerations for the program.

A primary care group-based mindfulness program was developed by community physicians and co-op and public health students in Ajax, Ontario. The program was started in January 2018 and is run through the Ajax Harwood Clinic, which is a clinic housing a Family Health Organization (FHO) comprising of 5 physicians and approximately 6,500 patients. The purposes of the program are:

1. To teach mindfulness skills for stress reduction, self-compassion, and dealing with difficult thoughts and emotions,
2. To promote an integrative concept of health, which treats the whole person
3. To promote community building and positive relationships
4. To capitalize on the power of groups to:

   1. Foster peer-to-peer learning and support when it comes to coping with life challenges
   2. Combat isolation
   3. Increase efficiency, quality, and timeliness of care

This study evaluates the 8-week rolling admission mindfulness program, by first doing a retrospective chart review to identify effect sizes and then conducting a before-after study evaluation of the effect of the mindfulness program on key mental health outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Be enrolled in mindfulness-based program through Ajax Harwood Clinic
* Age of 18
* English-speaking ability to participate in program
* Able to provide informed consent

Exclusion Criteria:

* no formal exclusion criteria
Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants

The primary objective of the study was to evaluate the long-term safety and tolerability of filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis.

Participants were enrolled in this open-label long-term follow-up study after they had completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) (NCT01888874) or GLPG0634-CL-204 (DARWIN2) (NCT01894516), and were evaluated for any side effects that might have occured (long-term safety and tolerability) when taking filgotinib. During the course of the study, participants were also examined for long-term effects of filgotinib administration on disease activity (efficacy), participant's disability, fatigue, and quality of life.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants who completed one of the qualifying core studies GLPG0634-CL-203 or GLPG0634-CL-204 and may benefit from filgotinib long-term treatment according to the Investigator's judgment
* Females of childbearing potential and sexually active men must agree to use highly effective method of birth control as specified in the protocol, during the study and for at least 12 weeks after the last dose of filgotinib

Key Exclusion Criteria:

* Participants who prematurely withdrew from one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), for any reason
* Persistent abnormal lab values during one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), according to the Investigator's judgment
* Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis, except for secondary Sjogren's syndrome
* Any condition or circumstances which, in the opinion of the Investigator, may make a participant unlikely or unable to complete the study or comply with study procedures and requirements

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children

The purpose of the present study was to determine whether folic acid supplementation could reduce plasma homocysteine in obese children and to determine the association between dietary folate, serum folate and homocysteine level through the randomized double blinded placebo controlled trial.

Atherosclerosis is common \& remains a significant clinical problem because of leading to myocardial infarction, stroke and cardiovascular death. Many studies founded hyperhomocysteinemia is an independent risk factor for those cardiovascular diseases which take responsible for about 10% of total cardiovascular disease risk. Reduction of elevated plasma homocysteine may prevent up to 25% of cardiovascular events. One of modifiable cause of hyperhomocysteinemia is prevention of vitamin deficiency, especially folate deficiency.

Obese Thai children are probable risk for folate deficiency due to low dietary folate intake and low serum folate level from unbalanced diet (low vegetables intake \& high fat diet) and high prevalence of thalassemia. Moreover obese children are also at risk of atherosclerosis. However, no data have been reported about effect of folic acid supplementation on homocysteine level in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient age between 9-18 years
* Diagnosed obesity (BMI more than median plus two of standard deviation for age and sex according to WHO reference 2007)

Exclusion Criteria:

* Secondary obesity
* Thalassemia disease
* Renal and hepatic dysfunction
* Drugs: anticonvulsant, estrogen, thiazides, metformin, cholestyramine, methotrexate, fibrates, nicotinic acid
* Previous vitamin supplementation 1 month before study
Radiation Induced Cystitis Treated With Hyperbaric Oxygen - A Randomized Controlled Trial

The primary objective of this study is to assess the relief of symptoms after Hyperbaric Oxygen Therapy (HBOT) in patients with late radiation cystitis by having Expanded Prostate cancer Index Composite (EPIC)symptom estimation scale as primary variable.

Study hypothesis:

* HBOT can reduce or reverse the change or otherwise limit the damage of the bladder function and/or structure, which arose as a result of radiation therapy of cancer in the pelvic region organs.
* The effects of HBOT are associated with relief of symptoms that, at least in part, is related to the reduction of the extent of the radiation damage.
* Vascular density increases, fibrosis prevalence and inflammatory activity are reduced as a sign of an improved function of the mucosa.
* Treatment results of HBOT remains, in whole or in part, during the follow-up (residual effect)

Radiotherapy is commonly used in the management of malignant diseases. Despite a continuous improvement of the technique, with improved efficacy and tolerance, adverse effects are still rather common. The urinary bladder and rectum are the major organs most commonly affected by radiotherapy to the pelvis area.

One of the most significant causes of the symptoms of radio therapy is inflammation and degeneration of blood vessels in the radiated tissue. Hyperbaric oxygen therapy involves administration of oxygen at greater than normal atmospheric pressures. A well-documented effect of HBOT is the stimulation of angiogenesis. HBOT is an established treatment for degeneration of blood vessels in the jaw bone as a result of radiotherapy and several publications have shown good efficacy also when soft tissue is affected.

If the method of treatment with HBOT means a reduction of the radiotherapy side effect it is thus an obvious importance for the individual patient. There is also significant potential savings for the healthcare and society.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Female or male aged 18-80 years
* Intended curative radiation of the pelvic region as a treatment for cancer
* End of radiation therapy more than 6 months ago
* Radiation cystitis with Urological EPIC \< 80
* Radiation cystitis is the most probable cause for the patient's symptoms

Exclusion Criteria:

* Patients with major and ongoing bleedings from the bladder (requiring more than 0.5L blood-transfusion within the last four weeks)
* Refractory incontinence requiring catheter or surgical intervention
* Urine bladder capacity \< 100ml
* Fistula in the urine bladder
* Contraindications for HBOT according to the local centres routines
* Pregnancy
* Mechanical ventilator support
* Unable to follow and understand simple commands
* Not oriented to person, place and time
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder

A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder


Eligibility Criteria:
Inclusion Criteria:

* Ability and acceptance to provide written consent
* Men or women between 18-75 years
* Body Mass Index of ≥ 18 and ≤ 30 kg/m2

Exclusion Criteria:

* History (within the 12 months prior to screening) of psychiatric disorders
* Major surgery, trauma, illness or immobile for 3 or more days within the past month
* Pregnancy or recent pregnancy (within 6 weeks)
* A positive test for drugs of abuse at the screening visit
* Any other sound medical reason as determined by the clinical investigator
Review of the Follow-up of Difficult Airway Guidelines

This questionnaire study aimed to ask the participants selected questions from the recommendations of the main guidelines on airway management. Thus, the compliance rate of anesthesiologists with the guidelines in different difficult airway management situations will be investigated. Secondarily, it was aimed to raise awareness about the recommendations of the guidelines.


Eligibility Criteria:
Inclusion Criteria:

* To be a specialist in Anesthesiology and Reanimation

Exclusion Criteria:

-
Evaluation of Immediate Implant Placement In The Esthetic Zone Using the Bone Shielding Concept Versus Dual Zone Therapy

Immediate implant placement has proven to be a successful treatment procedure that is preferred by patients because of being less traumatic, more time-efficient. Nowadays, the main goal of a successful immediate implant treatment has ceased to be gaining stability and osseointegration, but achieving long-term dimensional stability has become the optimal challenge. Various soft tissue and hard tissue augmentation techniques have been investigated in order to maintain the ridge dimensions following extraction and immediate implant placement.

It has been noted that the different augmentation procedures aid in decreasing the dimensional changes occurring after immediate implant placement in the esthetic zone. Even though immediate implant placement is a predictable procedure, however, labial bone resorption following tooth extraction is inevitable. The available surgical techniques present do not entirely prevent dimensional variations of the peri-implant hard and soft tissues over time. Furthermore, substantial evidence showed that immediate implant placement failed to halt the resorption of the thin buccal bony plate with subsequent gingival recession, particularly in patients with thin gingival phenotype

Eligibility Criteria:
Inclusion Criteria:

* adult (\>18 years) patients having a single non-adjacent hopeless maxillary tooth in the esthetic zone
* type I socket (intact but thin labial plate of bone and intact overlying soft tissues)
* adequate palatal bone
* ≥3 mm apical bone to engage the immediately placed implants
* optimum primary stability (a minimum of 30 Ncm insertion torque) following tooth extraction.

Exclusion Criteria:

* smokers
* pregnant women
* patients with systemic diseases
* periodontal disease, gingival recession
* infected sockets
* periapical pathosis and history of chemotherapy or radiotherapy within the past 2 years.
A Study to Evaluate the Efficacy of Valsartan/Simvastatin Combinations in Patients With Both Essential Hypertension and Hypercholesterolemia

The purpose of this study is to provide data on the dose response of simvastatin in lowering LDL-C when it is co-administered with valsartan in patients with both essential hypertension and hypercholesterolemia. The primary objective of the study will be to show that the combination of valsartan 160mg/simvastatin 40mg has superior efficacy compared to the combination of valsartan 160mg/simvastatin 20mg in percentage change from baseline in LDL-C.


Eligibility Criteria:
Inclusion Criteria:

* Elevated LDL-Cholesterol
* Essential hypertension

Exclusion Criteria:

* Severe Hypertension
* Prior or known muscular or neuromuscular disease of any type
* A history of cardiovascular disease
* Hypertension or hypercholesterolemia due to secondary causes
* Uncontrolled diabetes or insulin treatment
* Evidence of hepatic or renal disease

Other protocol-defined exclusion criteria may apply
Topical Immuonosuppressant Drugs in Spring Catarrh

Spring catarrh is a prevalent type of conjunctival allergic disorder in temperate countries. Topical steroids are the cornerstone management of spring catarrh beside other anti allergic drugs. However, prolonged use of topical steroids especqially in resistant spring catarrh carries risk of ocular side effects as 2nd glaucoma and cataract. We will investigate the safety and efficacy of topical immuonosuppressant in the management of resistant spring catarrh as an alternative to steroid therapy.

Vernal keratoconjunctivitis (VKC) (spring catarrh) is an allergic disease that affects children and young adults and is one of the most severe forms of atopic ocular disease. Classically, the incidence of VKC peaks in the summer and spring. However, 60% of cases can become chronic with persistent symptoms. VKC is mainly characterized by intense itching, but patients also frequently complain of lacrimation, foreign body sensation and photophobia.

There are three different clinical forms of VKC; the palpebral form, which is characterized by giant papillae in the upper tarsal; the limbal form, with gelatinous nodules composed of eosinophilic infiltrates and degenerated epithelial cells (Horner- Tantra spots) and a mixed form.

The treatment of VKC involves the use of topical Anti-histaminic and Mast Cell Stabilizers, which are usually sufficient to control symptoms in mild cases. However, a high number of patients are refractory to allergy therapy and require treatment with topical steroids. Side effects related to long-term steroid use, such as increased intraocular pressure (IOP), cataract development and increased susceptibility to infections.

Refractory VKC, development of steroid complications or the need for long-term use of Topical steroids are indications to use Topical immune-suppressant drugs as Tacrolimus (TCL) or Cyclosporine A (CsA). Tacrolimus is an immunosuppressant derived from Streptomyces tsukubaensis, is an alternative to steroid therapy for allergic diseases of the ocular surface. Topical Cyclosporine A is a fungal metabolite that reduces ocular inflammation by inhibiting Th2 lymphocyte proliferation and histamine release from mast cells and basophils.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from Vernal Keratoconjunctivitis refractory to conventional treatments (Topical Anti-histaminic agents, Mast-cell stabilizer and steroids) are included.

Exclusion Criteria:

* Contact lens wearer. Patient with one functioning eye. Patients with any other active ocular inflammatory conditions. Patients with hypersentivity reaction to either Cyclosporine A or Tacrolimus. Loss of 2 or more follow up visits.
Evaluation of a Telephone Care Nurse in the Management of Patients With Cancer and Treated by Oral Chemotherapy

The purpose of this study is to assess the effectiveness of a nurse telephone interview in the management of cancer patients treated by oral chemotherapy. This is a multicenter prospective randomized controlled pragmatic interventional trial conducted in collaboration with two oncology care facilities. Eligible population consists of all patients suffering from advanced cancer and treated by oral chemotherapy except hormonotherapy. 184 patients will be enrolled in the study. The experimental group will receive a standard followed by a medical oncologist, hematologist or radiation therapist as part of routine care, and telephone interviews by a nurse every 14 +/- 2 days for 6 months. The control group will receive a standard followed by a medical oncologist, hematologist or radiation therapist as part of routine care.

The effectiveness of the intervention will be evaluated by a toxicity score of the 9 most common side effects of oral cancer (oral mucositis, hand-foot syndrome, diarrhea, nausea, vomiting, pain, asthenia, rash and anorexia) officers from NCI CTCAE v4.0-(Common Toxicity Criteria for Adverse Events) and turned into a single composite criterion (sum of 9 Toxicity grades).


Eligibility Criteria:
Inclusion Criteria:

* aged over 18 years
* treated in medical oncology, hematology or radiotherapy
* to receive any oral chemotherapy for any cancer except hormone therapy according to decision of the Meeting of Consultation Multidisciplinary

Exclusion Criteria:

* Refusal of participation, protected adult patient under guardianship.
* Patient currently treated with oral chemotherapy
* Patient already included in another clinical research protocol including telephone follow-up
* Patient followed by a Nurse navigators or participating in a therapeutic education program
* Patient concomitantly treated with an injectable chemotherapy regimen or radiotherapy unless irradiation palliative analgesic.
* Patient in inability to understand how the study or inability to follow a telephone conversation.
* Patient with documented history of cognitive or psychiatric disorders.
* Patient residing outside the Rhône Alpes area
* Patient doesn't understand French
* Patient with no phone means
Osimertinib in Subjects With Advanced Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive

This is a retrospective, multicenter and observational study of Osimertinib monotherapy treatment in Subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) EGFR-T790M mutation-positive who have received the treatment within the Special Use Medication Program (SUMP) in Spain.

The study is based on the collection of data about the patients treated with Osimertinib within the Special Use medication Program. the patienes participating in this non-interventional study will not receive treatment in relation to the study.

Approximately a total of 270 patients will be included in this project from several Spanish sites. Around 52 hospitals will participate in the study. the observation period is from August 2016 to December 2018 and will include patients who started the treatment with Osimertininb from August 2016 to April 2018.

The primary objective is to estimate the progression free survival of the Osimertinib treatment.

Eligibility Criteria:
Inclusion Criteria:

* Squamous or Non-Squamous, non-small cell lung cancer (NSCLC), Stage IIIb/IV (histologically or cytologically confirmed), EGFRm/T790M, who received osimertinib treatment within the Spanish special use medication program of Osimertinib (SUMP).
* Alive patients must have signed, dated and IRB/EC-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.

Exclusion Criteria:

* Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form.
* Patients who were accepted in the SUMP, but did not receive treatment.
Efficacy and Safety of Snail Slime and Natural Extracts for Healing in Diabetic Foot Ulcers

The primary objective is to evaluate the efficacy and safety of the use of a formulation of snail slime and natural extracts, for the curative treatment of ulcer wonds in diabetic foot.

The secondary objetives:

1. To evaluate the efficacy of the use of a formulation of snail slime Helix aspersa Müller and natural extracts (MU001) for the curative treatment of ulcer wonds in diabetic foot with respect to the standard of care, by means the application of patchs that containing the formulation in a treatment period of until 60 days.
2. To determine the safety of the use of a formulation of snail slime Helix aspersa Müller and natural extracts (MU001) in diabetic individuals in a treatment period of until 60 days.

Clinical Study of phase I-II, controlled, simple blind (in relation with biostatistical analysis), randomized, of formulation that containing snail slime Helix aspersa Müller (Cryptophalus aspersus), natural calendula extract, propolis and excipients (MU001).

The formulation in study MU001 wil be added to the standard of care for healing in diabetic foot indicated. The period of recruitment estimated will be 4 month and the follow-up of the patients will be of until 60 days.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes type 2
* Unilateral ulcers
* Grade 1 or grade 2 Wagner ulcers.
* Without infection (except onychomycosis)
* Network family, hygiene, adherence and compliance appropiated

Exclusion Criteria:

* Bilateral ulcers
* Medical conditions with high risk (cancer, allergies)
* Consum of abuse drugs
Clinical Evaluation of QFlu Combo Test

Currently effective antivials for influenza treatment are two influenza viral neuraminidase inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza). Resistance to these drugs is reflected by reduced susceptibility of viral neuraminidase to these drugs. The hypothesis is that the signal ratio of two reagents (with or without a single concentration of the drug) correlates the IC50 value, an accurate measurement of drug resistance but impractical for clinical use.

The study design is to collect samples from participants. A portion of the sample is used for drug resistance detection using the test (QFlu Combo Test) under investigation. The remaining portion of the sample is used for culture. The culture positive samples are used for determination of IC50 values, which is used as a gold standard for defining whether a virus isolate is resistant to a drug or not. The sensitivity and specificity of the QFlu test will be calculated by comparing to the gold standard test.

Eligibility Criteria:
Inclusion Criteria:

* Those who exhibit flu-like symptom(s) during a flu season and who (or whose guardians) are willing to participate in the study.