cyrilzakka/clinical-trials huggingface dataset:
Effect of Fluticasone Furoate/Vilanterol on EIA in Adolescents

Exercise induced asthma (EIA) is common in adolescents. (Fluticasone furoate (FF)/Vilanterol (VI)) is a once daily inhaler with bronchodilator effect lasting 24 hours. Our objective was to investigate the short and long-term effects of FF/VI on EIA in adolescents. Adolescent asthmatics were referred for evaluation of EIA. Patients with a positive exercise challenge test, were allocated to a single administration of salbutamol and 22 to FF/VI in a double blind, double dummy method to assess the short-term effect on EIA. Then they received FF/VI for 30-60 days and were reassessed by a repeat exercise test 24-hours after the last dose.

Exercise induced asthma (EIA) is common in adolescents. Relvar® (Fluticasone furoate (FF)/Vilanterol (VI)) is a once daily inhaler with bronchodilator effect lasting 24 hours. Our objective was to investigate the short and long-term effects of FF/VI on EIA in adolescents. Ninety-three adolescent asthmatics aged 12-18 years were referred for evaluation of EIA. 44 patients had a positive exercise challenge test (ECT), 22 (22/44) were allocated to a single administration of salbutamol (400 µg) and 22 to FF/VI (92/22 µg) in a double blind, double dummy method to assess the short-term effect on EIA. Then they received FF/VI for 30-60 days and were reassessed by a repeat ECT 24-hours after the last dose.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent asthmatics aged 12-18 years
* Symptoms of shortness of breath on exercise and asthmatics before entry to military service
* Referral for evaluation of exercise challenge test

Exclusion Criteria:

* Baseline FEV1\<65% before exercise test
* Acute illness
* History of intolerance to beta agonists
* Use of the following medications prior to the study was restricted: inhaled corticosteroids or Montelukast (2 weeks), systemic steroids (2 months) and bronchodilators (24 hours)
ACP for Local Application in Ankle Arthrodesis

To compare the outcomes of patients who undergo three different types of surgeries for ankle fusion and reconstruction.

It is understood that an elevated concentration of platelets in the mix of the arthrodesis construct applied intra-operatively to the bony surface, has osteo-generating and enhanced wound healing properties. With that knowledge there is a clinical need and enthusiasm for the application of concentrated platelets, which release a large quantity of growth factors to encourage recovery in non healing injuries or surgical sites. This study represents an effort to more clearly define the true clinical outcomes with or without biologic enhancement, and fulfills a need for fortifying evidence concerning the efficacy of ACP in live human bone healing-- based on radiographic and CT scans.

Eligibility Criteria:
Inclusion Criteria:

* patients whom present the need for the elective surgery

Exclusion Criteria:

* None
Evaluation Lingual Ring Splint

To evaluate the effectiveness of Lingual Ring Splint For Management of Anterior Disc Displacement With Reduction

To evaluate the effectiveness of Lingual Ring Splint For Management of Anterior Disc Displacement With Reduction.

PICO P- Patient with symptomatic anterior disc displacement with reduction . I- use of Michigan splint C- use of anterior repositioning splint (ARS) . O- Clinical outcome. Pain relief and improvement of mouth opening , lateral excursion and protrusion

Outcome:

* 1ry outcome: Patients' subjective pain experience. Each patient will be asked to rate his or her current and worst pain intensity on numerical rating scale (NRS) of 0-10 with zero being no pain and ten corresponds to the worst pain that the patient ever had.
* 2ry outcome:

  1. Maximum mouth opening (MMO). Assessment of MMO will be performed by measuring the distance in mm between the incisal edges of the upper and lower central incisors using a ruler.
  2. lateral excursion . Assessment of lateral excursion will be performed by measuring the distance in mm between midline of upper and lower jaws
  3. protrusion. The distance in mm from the incisal edge of the maxillary central incisor to the incisor edge of the mandibular incisor will measured in the maximum protruded position.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient from 15 to 50 years old.
* Report of pain in preauricular region, in the last 30 days, worsened by functional activities, such as chewing and talking.
* Presence of disc displacement with reduction, arthralgia and joint clicking that occurred at both middle to late opening and late closing (near maximum cuspation) and pain in the TMJ area aggravated by jaw movement and function.
* positive diagnosis of unilateral or bilateral anterior disc displacement with reduction by means of magnetic resonance imaging (MRI).

Exclusion Criteria:

* Individuals with a recent history of trauma in the face and/or neck area.
* Individuals with systemic diseases that can affect TMJ.
* History of TMJ surgery.
* Individuals with dental pain.
* Individuals with myofascial pain, disc displacement with reduction or osteoarthritis.
* Individuals under dental or TMD management.
* Individuals wearing full or partial dentures.
* Individuals with major psychological disorders.
* Nonreducing dislocations of the articular disk in the acute form of TMD
* Consequences of condoyle fractures and/or fracture of another maxillofacial zone.
* In therapy for the same pathologies.
* Articular pathologies of systemic nature (e.g., rheumatoid arthritis, arthrosis, psoriasis arthritis).
* Well-known pathologies of neurologic and/or psychic nature and other forms of migraine.
Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's Disease

Patients who completed the study TVP-1012/232 are eligible to enter the extension study to continue their rasagiline therapy for their Parkinson's disease (PD). During this study the patient's safety, tolerability of rasagiline, and effectiveness of this therapy will be monitored.


Eligibility Criteria:
Inclusion Criteria:

• Patients who completed evaluations of week 52 of the TVP 1012/232 protocol, where continued rasagiline therapy is warranted, in the opinion of the principal investigator

Exclusion Criteria:

• Patients having suffered adverse effects that were probably drug-related in the TVP-1012/232 study
Functional Reserve Estimation of Donor Kidney

The purpose of the study:

* To estimate the role of morphological, clinical, biochemical and imaging studies at stages of kidney transplantation (medical therapy, explantation, preservation, transplantation).
* To improve the ways of preserving optimal functional parameters of renal transplants.

Terminal chronic renal failure (ESRD) as a result of almost any chronic kidney disease develops due to progressive loss of nephrons. This state is characterized by a gradual deterioration of the functional abilities of not only the kidneys, but also the whole body. Currently, ESRD is among the first ten causes of mortality .

Transplantation of donor organs is the only radical treatment for various diseases of the terminal, for patients with a fatal prognosis.

Kidney transplantation has allowed not only save lives, but also to return to normal life, tens of thousands of people. Survival of renal transplant recipients is growing.

Despite the progress made in many clinics worldwide in recent years in the field of transplantation, kidney transplantation, does not settle the problem of reperfusion injury and the associated post-transplant dysfunction with the absence of clear indicators of morphological, clinical, biochemical and instrumental methods to assess functional reserve of organs that remain relevant and meaningful.

Eligibility Criteria:
Inclusion Criteria:

* recipients-patients with end-stage renal disease;
* donor healthy people without absolute contraindications to the kidney transplantation;
* donor and recipients who are both in the genetic and non-genetic related to each other.
* obligatory immunological compatibility by HLA-phenotyping provided that the donor and recipient are not relatives with each other;
* negative result of cross-match between donors and recipients;
* presence of pre-existing lymphotoxic antibodies in a recipient less than 50%;
* absence of standard absolute contraindications in a donor and in a recipient for surgeric intervention.

Age is 18-60 years.

Exclusion Criteria:

* patients with absolute contraindications to surgery: diseases of organs and systems having a threating risk to the life of donor and recipient during and after surgery;
* immunological incompatibility between donor and recipient;
* high level of pre-existing lymphotoxic antibodies in a recipient more than 50%, uncorrected by Therapy;
* donor age is under 18 and over 60 years;
* incapable persons;
* absence of a notarized consent form to kidney transplantation;
* presence of the active phase of viral infection with hepatitis B and C;
* positive results of blood tests for HIV/AIDS, syphilis;
* patients with severe concomitant pathology of kidneys, (or) heart and (or)liver.
L-carnitine and Metformin in Obese PCOS Women.

L-carnitine and plus metformin in clomiphene-resistant obese PCOS women, reproductive and metabolic effect: a randomized clinical trial

the trial aims to compare L-carnitine and plus metformin in clomiphene-resistant obese PCOS women with placebo to state the reproductive and metabolic effects in form of pregnancy and insulin resistance parameters and lipid metabolism.

Eligibility Criteria:
Inclusion Criteria:

* pco
* obese
* ifertile

Exclusion Criteria:

* no medical disorders
* no hormonal treatment in the previous 3 months
Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes

The aim of this clinical trial is to compare the horizontal bone gain when grafting a bone substitute with non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group) in resorbed ridges requiring Guided Bone Regeneration (GBR) to facilitate implant placement at 6 months.

The aim of this clinical trial is to compare the horizontal bone gain when grafting a mixture of xenograft and allograft (50/50) with non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group) in resorbed ridges requiring Guided Bone Regeneration (GBR) to facilitate implant placement at 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women over 18 years old or older
2. Patients requiring Guided Bone Regeneration due to insufficient ridge width(≤5mm) to place dental implants, with sufficient vertical ridge height (≥9mm) from vital anatomical structures (the inferior alveolar nerve in the Mandible, or the sinus in the Maxilla)
3. One or more teeth missing in posterior zone (Premolars, and Molars)
4. Absence of active Periodontal disease
5. Good level of oral hygiene (Plaque index \<25%)
6. Absence of systemic diseases that could influence the outcome of the therapy (Uncontrolled diabetes, osteoporosis, bisphosphonate medications)
7. Non smokers or light smokers (\<10 cigarettes per day)
8. Informed consent signed

Exclusion Criteria:

1. Patients with sufficient ridge width (\>5 mm) and height (≥9mm) from vital anatomical structure) requiring no GBR to place dental implants
2. Patients with severe horizontal and vertical defects requiring other surgical techniques.
3. Long-term non-steroidal anti-inflammatory drug therapy (3months).
4. Lactating females or currently pregnant women.
5. Severe cognitive or psychiatric disorders.
6. Unwillingness to return for follow-up examination.
Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage

The papers propose a new method to prevent postoperative cerebrospinal fluid leakage. Doctors use the absorbable polyglycolic acid (PGA) and fibrin glue to repair in surgery, prevent cerebrospinal fluid leakage and reduce the necessity of postoperative lumbar drainage after surgery. This study will analyze the changes in cerebrospinal fluid leakage in patients with pituitary tumors and skull base tumors after surgery, and further understand the effectiveness of Neoveil , as the basis for the development of new treatments.

Neoveil, the main component, is polyglycolic acid (PGA), which is a kind of absorbable material, and is made into a soft and tension non-woven material by special processing with good tissue compatibility and degradability. In the human body, its strength will gradually decrease due to hydrolysis, and will eventually be absorbed and metabolized. In the process of absorption, at first its strength is reduced, then the mass will gradually decrease, and it will be completely absorbed after about 15 weeks. At present, the United States, Europe, Australia, China and South Korea have been marketed, it is applied to the spine , pituitary tumors , skull base tumors and aneurysm surgery,etc. inthe related field of Neurosurgery in foreign countries. It can prevent the leakage of cerebrospinal fluid, and reduce the postoperative hospital stay and the probability of complications after surgery. There is a license from the TFDA. In clinical, it can be used in the sutures of parts or fragile organs that do not need to be healed for a long time, such as the lung, liver, and digestive tract, by suture (thick slice and tube type) or adhesion (Sheet) In the tissue, it can strengthen the compressive ability of the local tissue, prevent the suture thread from splitting the suture tissue, prevent the lung tissue from leaking, reduce the blood and fluid leakage from the surgical site, and reduce the postoperative hospital stay and after the operation The complication rate .

Eligibility Criteria:
A. Inclusion criteria

1. Patients with primary or recurrent pituitary tumors require endoscopic nasal surgery.

B. Exclusion criteria

1. Patients with pituitary gland tumors who do not receive surgical treatment.
2. Patients with other brain tumors.
3. Patients allergic to polyglycolic acid (PGA).
4. Patients who have had previous radiation therapy or chemotherapy.
Intervening on Opioid Use and Loneliness

This study aims to enroll 300 participants who will be assigned to one of three 3 groups. Each group will receive an intervention lasting 6, weekly sessions of 40-60 minutes. Eligibility include having an opioid use disorder and reporting loneliness or feeling alone or disconnected.

Individuals (n = 300) with an opioid use disorder reporting loneliness will be randomized to either (1) therapist-delivered cognitive-behavioral therapy for perceived social isolation, (2) therapist-delivered Health Education, or (3) self-guided Health Education. Loneliness, opioid and other substance use, the amount of social interactions, social support, and mental and physical health factors prior to starting the treatment, after completing the treatment, and 1, 3, and 6 months following the treatment will be assessed to see how well they work compared to each other.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18+
* understand English -have internet access-
* screen positive for an opioid use disorder
* screen positive for elevated loneliness

Exclusion Criteria:

* does not understand consent
* does not have consistent access to a phone and internet
Topical Imiquimod in Treating Patients With Recurrent Paget's Disease of the Vulva

RATIONALE: Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Applying topical imiquimod to the vulva may be an effective treatment for recurrent Paget's disease.

PURPOSE: This clinical trial is studying how well topical imiquimod works in treating patients with recurrent Paget's disease of the vulva.

OBJECTIVES:

* To assess the clinical and histologic effects of topical imiquimod therapy on recurrent extramammary Paget's disease.

OUTLINE: This is a pilot, prospective, multicenter study.

Patients apply topical imiquimod cream to a target vulvar lesion 3 times weekly. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity. If the lesion is still present after completion of 12 weeks of imiquimod therapy, the patient undergoes surgical excision of the target lesion (and any other progressive lesions suspicious for evolving adenocarcinoma) at week 16.

Patients undergo punch biopsy and photographic assessment of a target vulvar lesion at baseline and again at 12 weeks.

After completion of imiquimod therapy or after surgical excision, patients are followed at 6 weeks and then every 3 months for at least 2 years.

Eligibility Criteria:
Inclusion Criteria:

All patients presenting to the Gynecology outpatient service at a participating institution who meet eligibility requirements may be included in this clinical trial. The eligibility requirements are as follows:

* Age ≥18.
* Ability to give informed consent.
* Patients must have biopsy proven recurrent extramammary Paget's disease confirmed at the participating site.

Exclusion Criteria:

* Patients with known hypersensitivity to imiquimod.
* Pregnant and nursing women are not eligible
* Patients with underlying adenocarcinoma on biopsy of lesion confirmed at the participating site.
A Randomized, Double-Blind, Multicenter Study to Evaluate the Acid-inhibitory and Dose-response Efficacy of TAK-438 (20 mg, 40 mg) in Patients With Proton Pump Inhibitor (PPI) - Resistant Erosive Esophagitis

The purpose of this study is to evaluate the acid-inhibitory and dose-response efficacy of TAK-438 (20 mg, 40 mg) in patients with PPI-resistant erosive esophagitis.


Eligibility Criteria:
Inclusion Criteria:

1. The participant has been treated with standard-dose or higher-than-standard-dose PPI until immediately before the start of the Observation Phase.
2. Outpatient (in principle)
3. At the endoscopy scheduled for the Observation Phase (Visit 2), the participant must have endoscopically confirmed reflux esophagitis of Grade A to D, as defined by the LA classification grading system, which remains insufficiently controlled with standard-dose or higher-than-standard-dose PPI therapy.
4. The participant showed good compliance to the study medication in the Observation Phase (compliance rate 80% or more).

Exclusion Criteria:

1. Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included.
2. Participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis \[excluding Schatzki's ring\], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy)
3. Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating) at the start of the Observation Phase (Visit 1) or at endoscopy during the Observation Phase (Visit 2) . However, participants with gastric or duodenal erosions are allowed to be included.
4. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders.
Impact of Three Different Gonadotrophin Regimes on Egg Donation Program

Exploratory study assessing the effect of three gonadotrophin protocols on Controlled Ovarian Stimulation (COS) parameters and IVF outcome in oocyte donors undergoing GnRH analogue (long protocol). 1,028 donors were randomized in three groups: Group I (n= 346) only r-FSH, Group II (n= 333) only HP-hMG and Group III (n= 349) r-FSH plus HP-hMG. IVF outcome of 1,059 oocyte recipients was compared.


Eligibility Criteria:
Inclusion Criteria:

* healthy women 18-34 years of age
* regular menstrual cycles
* no family history of hereditary or chromosomal diseases
* normal karyotype
* BMI 18-29 Kg/m2
* negative screening for sexually transmitted diseases

Exclusion Criteria:

* women with PCOS were not included in this study
Novel MRI Biomarkers for Monitoring Disease Progression in ALS

Routine MRI is normal in motor neuron diseases such as ALS. However, advanced MRI techniques can provide an objective measure of degeneration (a "biomarker") by examining brain structure, wiring, chemistry, and function. We will develop and evaluate novel MRI techniques that could improve our understanding of ALS and provide a means to diagnose it sooner and monitor its progression. Importantly, we expect these techniques to improve how new drugs are tested, which may lead to the more rapid discovery of a treatment for ALS.

Each participant will have 3 MRI scans over a period of 8 months, along with neurological and cognitive evaluations. Study visits will take 2 - 3 hours. MRI is a safe technique that does not involve radiation.

Current clinical measures of disease burden have suboptimal sensitivity to disease progression in ALS. A biomarker would play an essential role in the evaluation of novel therapeutics, leading to the realization of effective treatments faster. Magnetic resonance imaging (MRI) holds promise as a non-invasive source of biomarkers in ALS. In this study data is collected from a national imaging platform (the Canadian ALS Neuroimaging Consortium \[CALSNIC\]) using standardized MRI and clinical protocols.

CALSNIC was founded with the objective to validate MRI biomarkers on a standardized multi-centre platform. CALSNIC is a multidisciplinary group of scientists at 7 centres across Canada. The first CALSNIC study entitled "MRI Biomarkers in ALS" (CALSNIC-1) is ongoing and slated to finish recruitment in 2017.

This study ("Novel MRI Biomarkers for Monitoring Disease Progression in ALS", CALSNIC-2) is a new project that will evaluate novel MRI biomarkers using advanced imaging acquisition and processing methods. The specific aims of CALSNIC-2 are 1) to establish a standardized MRI and clinical protocol across the 7 centres, and 2) to validate MRI measures with clinical measures of disease burden and progression.

It is anticipated that the project will lead to the discovery of MR-based biomarkers of cerebral degeneration that can be applied across different centres and hence, can assist with drug development. Secondly, this project will expand CALSNIC to include more centres and provide opportunities for collaborative and multidisciplinary translational research on a national scale.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a suspected or confirmed diagnosis as described in Study Populations
* For those with a diagnosis of ALS, patients will be considered with an El Escorial classification of suspected, possible, probable, probable lab-supported, and definite ALS.
* Patients 18 years of age or older
* Healthy controls over the age of 40.
* Be able to lie in an MRI machine for approximately 60 minutes

Exclusion Criteria:

* Subjects with psychiatric/CNS illnesses such as Major Depressive Disorder, Schizophrenia, and Bipolar disorder.
* Subjects with significant head injury or other neurological disease (stroke, brain tumour).
* Subjects ineligible for MRI investigation due to a pacemaker or other metallic foreign body.