cyrilzakka/clinical-trials huggingface dataset:
Foster 100/6 mg NEXThaler Versus Foster 100/6mg Pressurized Metered-dose Inhaler (pMDI) in Patients With Controlled Asthma.

The purpose of this study is to demonstrate the non-inferiority of Foster 100/6mg NEXThaler versus Foster 100/6mg pMDI in terms of pulmonary function in asthmatic patients, as well as the effect of the test treatments in terms of additional lung function parameters and clinical outcome measures. The purpose is also to assess the safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients, Chinese ethnicity aged \>18 years with a clinical diagnosis of asthma for a minimum of 6 months prior to visit 1 confirmed by a chest physician according to International guidelines updated 2016 Global Initiative Asthma (GINA).
* Positive Response to Reversibility Test.
* FEV 1 (Forced Expiratory Volume within the first second) \>80% of the predicted normal value after appropriate washout from bronchodilators.
* Patients on previous regular treatment at a stable dose for at least 3 months prior to visit 1 with either high daily dose of ICS ( Inhaled Corticosteroids) or medium daily dose of ICS

Exclusion Criteria:

* Pregnant or lactating woment
* Intermittent asthma or asthma occurring only duting episodic exposure to an allergen or a chemical sensitizer
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the current Glocal Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines updated 2016
* Current smokers, or ex-smokers
* Severe asthma exacerbation leading to intake of systemic corticosteroids (\> 10 days) within 1 month prior to inclusion or moderate/severe asthma exacerbations
* Patients treated with monoclonal antibodies
* Patients treated with non-potassium sparing diuretics
* Patients treated with monoamine oxidase inhibitors and tricyclic antidepressants
* Patients who are receiving therapy that could interact with steroids
Maintenance Study on the Long Term Safety of XL999

The primary objective of this study is to allow rollover of the two remaining subjects from the other XL999 studies to continue to receive XL999.

The secondary objectives of this study are as follows:

* To evaluate tumor response after long term repeat administration of XL999 in two subjects rolled over from other XL999 studies.
* To characterize the long term safety and tolerability of XL999 after repeat administration in two subjects rolled over from other XL999 studies.
* To characterize the long term effects of XL999 on cardiac function after repeat administration in two subjects rolled over from other XL999 studies.


Eligibility Criteria:
Inclusion Criteria:

* The subject is currently enrolled in Protocols XL999-001 or XL999-204
* The subject has received XL999 for at least one year prior to enrollment
* Per the respective parent XL999 protocol, the subject is eligible to continue to receive XL999 in the absence of progressive disease (PD) or unacceptable drug-related toxicity

Exclusion Criteria:

* Progressive disease
* Any development(s) that would meet the exclusion criteria from the subject's respective XL999 protocol (XL999-001 or XL999-204)
Effectiveness of the Care Coordination, Assessment, and Responsive Engagement Program for Transition-aged Adolescents (t-CARE) With ASD

An analysis of data for adolescents and young adults diagnosed with Autism Spectrum Disorders (ASDs) who are evaluated as part of the Care Coordination, Assessment, and Responsive Engagement for transition-aged adolescents (t-CARE) program which replaced the former Autism Life Care Model (ALCM), which was a clinical program implemented between Fall 2014 and April 2016. The individuals enrolled in the program will be administered a standardized assessment battery during each visit with the care coordinator or study coordinator. The proposed study will analyze data gathered during each of the assessment periods in order to check the efficacy and viability of the protocol.

Current collaboration between individuals, families, and providers through in-person meetings are extremely infrequent, costly, and occur most often when providers are intimately involved as part of a multidisciplinary team in a single setting such as at a school. Often, little information is transmitted between providers and/or school personnel in determining treatment goals and interventions. Furthermore, the transmission of information is often provider to provider or school personnel to provider, which excludes direct patient-input and lessens transparency in decision making. In an effort to improve current care and therefore improve successful adult transitions for adolescents with ASD, t-CARE is designed to mimic multidisciplinary team meetings. These meetings are incredibly impactful as they include direct individual and family involvement through facilitated information-sharing, while also maintaining patient-centered care across multiple providers and complex systems of care.

Eligibility Criteria:
Inclusion Criteria:

1. Between 14 and 19 years of age upon entry into t-CARE
2. A primary diagnosis of Asperger's Syndrome or autism, as indicated by the Social Responsiveness Scale, Second Edition (SRS-2; Constantino \& Gruber, 2012)
3. English as primary language spoken
4. Ability to self-report (i.e. understand and answer assessment questions written at a third grade comprehension level) (self-report questions to be asked by study coordinator)

Exclusion Criteria:

1. A significant language delay
2. Significant psychosis as indicated through a semi-structured interview (Mini-International Neuropsychiatric Interview)
Difference of Gastric Microbiota in the Process of Correa's Model.

Helicobater pylori plays an important role in the development of gastric cancer. Eradication therapy can reducing the morbidity of gastric cancer, but can't totally prevent it especially when atrophy and more serious precancerous lesions already happened. Prior studies found the gastric bacterial difference among gastritis, intestinal metaplasia and gastric cancer. However, they didn't reach an agreement. Correa's model is widely accepted in the development of gastric cancer. The pathological change makes a more suitable environment for bacteria to overgrowth. This study are designed to analyze the gastric microbial difference of non-atrophic gastritis, atrophic gastritis, intestinal metaplasia, intraepithelial neoplasia and gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Patients go through a gastric endoscopy examination with non-atrophic gastritis, atrophic gastris, intestinal metaplasia, intraepithelial neoplasia and gastric cancer.
2. Did not take any antibiotics,PPI,probiotics and chinese herbs in the past one month,and took less than one week in the past three months before the gastroscopy examination.
3. Sign the informed consent.

Exclusion Criteria:

1. Had been taken Helicobacter pylori eradication therapy before.
2. Previous gastrointestinal surgery.
3. During the pregnancy and lactation period.
4. With any serious diseases like liver failure,heart failure,renal failure,malignant tumor,alcoholism or any other disease that may effect the result.
5. With any mental problems.
Whey Protein Intake With and Without Exercise on Visceral Fat: The P+RISE Study

Dietary manipulation is proving to be an effective lifestyle strategy to combat the obesity epidemic. Increased dietary protein is one effective strategy. For example, increased whey protein ingestion with and without exercise training is associated with enhanced weight loss, body composition and subjective hunger in overweight and obese individuals. Our findings suggest that the effects of whey protein ingestion occur independent of a calorie-restricted diet and to a greater extent in individuals following a combined exercise program of resistance exercise, sprint intervals, stretching/yoga/pilates, and aerobic exercise training compared to standard resistance training.

This study was a 16 week whey protein and exercise training intervention in middle aged overweight/obese adults. Subjects were randomized into 3 groups: Whey protein only consumed as 20 grams per serving three times per day (total 60 grams per day) (WP); Whey protein and resistance exercise training (WP-RT); and Whey protein and combined exercise training (P+RISE). All outcomes, including the primary outcome of visceral fat was measured at baseline (week 0) and post-intervention (week 17) in all study subjects.

Eligibility Criteria:
Inclusion Criteria:

* healthy, overweight or obese, inactive

Exclusion Criteria:

* smoker, exercise-trained, recent weight loss, heavy caffeine-consumer
Bioavailability of Proteins From Plant Based Diets

Proteins play an important role as structural and functional components for the human body and prevent stunting. Protein quality has a great importance in meeting the nutritional needs of populations across the world throughout the life course, particularly during pregnancy and early childhood. Dietary protein deficiency is mainly due to protein indigestibility limiting indispensable amino acids (IAAs) bioavailability. In Morocco, as it's the case in many developing countries, diet is mainly based on a large consumption of cereals, fruits, vegetables and pulses, and is generally low in meat, which is the main source of protein and IAA.

The general objective of this study is to evaluate the digestibility of Fava bean proteins and bioavailability of IAA using a dual-tracer method with stable isotopes.

This study aims to develop stable isotope labeled protein of bean cultures that could be used for other local common foods, to quantify dietary indispensable amino acids from beans made available to the body for optimal growth, development and function and to participate in the development of a simple method to assess protein quality in vulnerable populations.

The project is divided in two parts: the first part of harvesting and production of deuterium labeled fava beans. The optimization test done the first year has shown that the best protocol for labelling was a pulse with 25% D2O followed with subsequent labeling with 2.5% D2O during 20 days.

The second part is the intervention stuy that is going to be conducted on 6 healthy volunteers (3 males, 3 females). Each participant will receive a test meal containing 13C labelled spirulina, 2H labelled Fava bean and 13C phenylalanine. The test meal will be divided on 11 subdoses: 3 sub-doses will be administrated at T0 and 1 subdose will be administrated at 1, 2, 3, 4, 5, 6 and 7h. The remaining sub-dose will be kept for measurement of IAA in the test meal. After eating the test meal, blood, urine and breath samples will be collected from each participant at the baseline (T0) and after 5-6, 7h and 8h.

Eligibility Criteria:
Inclusion Criteria:

Healthy, non-pregnant adults 18-65 years of age

Not taking any medication, including NSAIDs Not taking antibiotics within 4 weeks of study BMI within 18-35 range Stable weight

Exclusion Criteria:

Children and elderly (over 65)

Pregnancy Diagnosed with non-communicable or communicable disease Being under restrictive diet Antibiotics within 4 weeks of study Medications within 4 weeks of study
Cricopharyngeal Dysfunction in Adults

The objective of the study, after reviewing the recent literature, is to corroborate the thesis of the authors considering the injection of botulinum toxin as a gesture that is both diagnostic and therapeutic in the disorders of the Upper Esophageal Sphincter and reinforce the results already published with a larger series of patients.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman whose age older than 18 years
* Dysphagia with solids and / or liquids
* Dysfunction of primary or secondary Upper Esophageal Sphincter with indirect video-fibroscopy and / or video-fluoroscopy and / or high resolution pharyngo-oesophageal manometry
* Subject having at least one injection of botulinum toxin A in the crico-pharyngeal muscle for Upper Esophageal Sphincter dysfunction in the ENT department and cervico-facial surgery of Hautepierre.
* Subject who has consented to the use of his data from his medical file for the purpose of this research

Exclusion Criteria:

* Myotomy in the first place
* Refusal of the subject to participate in the study
* Subject under the protection of justice
* Subject under guardianship or curatorship
Study of Taxotere, Cisplatin, 5-Fluorouracil, and Leucovorin for Squamous Cell Carcinoma of the Head and Neck

The purpose of this study is to determine the safety and maximum tolerated dose of the combination taxotere, cisplatin, 5-fluorouracil and leucovorin. We will also preliminarily assess whether the combination is effective in treating squamous cell carcinoma of the head and neck.

* Patients will be premedicated at home with dexamethasone and leucovorin.
* On the first day of treatment, the patient will receive taxotere intravenously for one hour. Approximately one hour after the taxotere is completed, the patient will receive a 4 hour infusion of cisplatin and begin a four day continuous infusion of 5-fluorouracil and leucovorin. The infusion of 5-fluorouracil and leucovorin will be completed at home with the use of an infusion pump. This process will be repeated every 21-35 days (1 cycle) depending upon how quickly the patient recovers from the chemotherapy.
* During each cycle blood tests will be performed weekly. During the first cycle a physical exam will be performed weekly and then halfway through each subsequent cycle and immediately prior to the start of each subsequent cycle.
* At the end of each cycle the impact of the chemotherapy will be assessed. If after 2 cycles the cancer has not responded the treatment will end. If significant reduction in the size of the tumor is observed, a third and final cycle will be done.
* After the last cycle of chemotherapy is done, radiation therapy will be performed twice daily for 6-7 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Histologic documentation of squamous cell carcinoma of head and neck
* Patients will previously untreated stage III or IV squamous cell carcinoma.
* Patients with locally recurrent disease after surgery.
* Life expectancy of longer than 3 months.
* Kidney function: 1.5 or a 24 hour creatinine clearance of \> 30ml/min
* Liver function: SGOT \< 1.5 X upper normal limit and alkaline phosphatase of \< 2.5 X upper normal limit.
* WBC greater than or equal to 4,000/mm
* Platelet count greater than or equal to 100,000/mm
* Hemoglobin greater than or equal to 10gm/dl
* Patients of child-bearing age must use effective methods of contraception.

Exclusion Criteria:

* Patients treated with previous chemotherapy or radiotherapy for head and neck cancer.
* Patients with concurrent malignancy of any site except limited basal cell carcinoma, squamous carcinoma of the skin or carcinoma in situ of the cervix.
* Pregnant or breast-feeding women
e-Health Psychosocial Stress and Symptom Management (ePSMI) for Pancreatic Cancer Patients

The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress.


Eligibility Criteria:
Inclusion Criteria:

1. Greater than 18 years of age.
2. Spanish or English speaker with ability to read one of these languages.
3. Diagnosis of pancreatic cancer.
4. Patients diagnosed with pancreatic neuroendocrine tumor (PNET).

Exclusion Criteria:

1. Patients unable to read Spanish or English, as participants will not be unable to complete surveys.
2. Have a history of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient treatment in the past 12 months).
3. Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
Long Term Use of the Provox Vega 22.5

The purpose of this study was to investigate the long-term feasibility of the new Provox Vega 22.5 voice prosthesis (outer diameter of 22.5 French) and its insertion system (SmartInserter) in laryngectomized patients who currently use a Provox2 voice prothesis.

Nowadays, many laryngectomized patients use a voice prosthesis to speak. The Provox2 is an indwelling voice prosthesis that has been on the market since 1997. Recently a new Provox voice prosthesis has been developed, the Provox Vega. This prosthesis is available in 3 different outer diameters. In this study the device with an outer diameter of 22.5 French is tested. The Provox Vega 22.5 is the successor of the Provox2 voice prosthesis. Both prostheses have an outer diameter of 22.5 French.

Outcomes were recorded by means of patient questionnaires and device life.

It is expected that some patients will like the new device (Provox Vega 22.5) better than the old one (Provox2) because the airflow resistance for speaking of the new prosthesis is lower when measured in a laboratory.

Eligibility Criteria:
Inclusion Criteria:

* total laryngectomy
* Provox2 user
* at least two previous replacements

Exclusion Criteria:

* patients' refusal
* fistula problems
* Provox ActiValve users
Pain Reduction With Topical Bromfenac Versus Artificial Tear After Intravitreal Injection.

The purpose of this prospective interventional study is to compare post-intravitreal injection pain between eyes receiving topical bromfenac versus artificial tears as an analgesic after intravitreal injection.

This proposed study is a double-masked randomized trial of adult patients receiving bilateral intravitreal injections. Patient data from March 2021 to June 2022 will be collected. Patient pain perception, quantified using the Wong-Baker FACES and the short-form McGill Pain Questionnaire, will be utilized to compare post-intravitreal injection pain between eyes receiving pre-injection bromfenac 0.09% ophthalmic solution versus artificial tears.

Eligibility Criteria:
Inclusion criteria are:

* Current patient of the Wills Eye Hospital Retina Service including all Mid Atlantic Retina offices
* Clinical indication of bilateral intravitreal anti-vascular endothelial growth factor (VEGF) injection as determined by the treating retina specialist for diseases such as age-related macular degeneration, choroidal neovascularization, diabetic macular edema, diabetic retinopathy, macular edema. proliferative retinopathy, or macular edema associated with retina vein occlusion.
* Age greater than 18
* Patient's that have had at least three prior injections in each eye

Exclusion criteria are:

* Prior ocular surgery (non-cataract)
* Herpetic eye disease
* Uncontrolled uveitis
* Active conjunctivitis, keratitis or keratopathy
* Current unilateral use of prescription eye drops.
* Allergy to NSAID
Safety and Maintenance Study of Entocort for Children With Crohn's Disease

A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.

A Multicenter, Open label, Non-comparative Study to Evaluate the Safety of Entocort EC as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Eligibility Criteria:
Inclusion Criteria:

* All male and female subjects must be aged 5 to 17, inclusive, and must not have reached their 18th birthday by the estimated final office visit.
* All subjects must weight \>= 15 kg at the time of enrollment.
* Subjects must have been diagnosed and treated for active Crohn's disease of the ileum and/or ascending colon confirmed by endoscopic and/or radiographic evidence, and/or evidence of mucosal erosions and/or histology and have a PCDAI \<= 10

Exclusion Criteria:

* Subjects who have had any previous intestinal resection proximal to and including the ascending colon.
* Subjects with evidence of active Crohn's disease (PCDAI \> 10) and/or stricturing, prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications.
* Subjects with morning cortisol level \<150 nmol/l (5.4 ug/dl) or DHEA-S below normal range for age and gender (NOTE: Subjects from the induction protocol with abnormal morning cortisol/DHEA-S levels at Visit 4, who otherwise meet the eligibility criteria, may be enrolled if the investigator decides that Entocort 6 mg is an appropriate therapy option.
Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery

A good efficacy as well as good rotary stability is expected with the ocular implant.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient must be available for 6 months follow-up
* The patient it aged at least 18 years
* Patient requires surgery for cataracts with removal of the opacified natural lens and replacement with the SISA implant, according to standard procedure
* The surgery is elective
* The patient has clear and non-pathological corneas
* The patient needs an implant strength (LIO) between +10D and +30D
* Corneal astigmatism less than or equal to 1.50D in the eye to be operated (or cataract eye

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The patient is under safeguard of justice or state guardianship
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is pregnant or breastfeeding
* The patient has other ocular comorbidities with poor visual acuity prognosis postoperatively
* Previous ocular trauma or surgery
* Dilation of the pupil \<7mm with mydriatic drugs
* Implantation with a rhexis that does not cover the optic of the implant by more than 1 cadranel