cyrilzakka/clinical-trials huggingface dataset:
The Use of International GerdQ Questionnaire

There are three main directions for use GerdQ in practice. First of all, GerdQ can be used to diagnose GERD with an accuracy comparable to the accuracy of diagnosis of GERD by the specialist (gastroenterologist). Using GerdQ can evaluate the impact of disease on the patient's life and help in choosing treatment of GERD, as well as direct assessment of treatment efficacy.

In connection with mentioned above, this study is devoted to the estimation of possibility to use GerdQ in routine practice of Russian physicians.

Observational non-interventional study on the use of international GerdQ questionnaire for the diagnosis of gastroesophageal reflux disease in the Russian practice

Eligibility Criteria:
Inclusion Criteria:

* Signing of informed consent to participate in the study
* patients of both sexes, 18 years and older
* planned esophagogastroduodenoscopy

Exclusion Criteria:

* Surgical intervention for upper digestive tract (surgery for gastroesophageal reflux disease, peptic ulcer disease, etc.) In the past
* the presence of contraindications for esophagogastroduodenoscopy or pH-metry
* refusal to sign informed consent
* acceptance of antisecretory drugs (proton pump inhibitors, h2-receptor blockers), antacids and prokinetics for 7 days before enrollment
* Pregnancy
* Confirmed or suspected malignancy
* Impairment of the mental sphere
* Acceptance of nsaids (including acetylsalicylic acid at a dose of 150 mg / day), cytostatics, antibiotics (tetracyclines, lincosamides) at enrollment and during the preceding 30 days
Combined Inspiratory Muscle and 'Whole Muscle' Training in Children With Cystic Fibrosis

To study the effects of an 8-week combined inspiratory muscle training and exercise (resistance+aerobic) program on of a lung volume, inspiratory muscle strength (maximal inspiratory pressure, PImax) and cardiorespiratory fitness (maximal oxygen uptake, VO2peak) (primary outcomes)and dynamic muscle strength, body composition and quality of life (QoL) in children with Cystic Fibrosis (CF) (secondary outcomes).

The investigators hypothesized that the combined training program would significantly benefit most of the aforementioned variables (especially, primary outcomes).

Eligibility Criteria:
Inclusion Criteria:

* boy/girl aged 6-17 years
* living in the Madrid area

Exclusion Criteria:

* severe lung deterioration \[forced expiratory volume (FEV1) \<50% of expected\]
* unstable clinical condition (hospitalization within the previous 3 months)
* Burkholderia cepacia infection
* any disorder (e.g. muscle-skeletal) impairing exercise.
New Pharmacological Treatment for Obstructive Sleep Apnea

This study will determine if mirtazapine, a unique antidepressant that does not disturb sleep, will improve obstructive sleep apnea (OSA). The design is randomized, crossover, double blind, and placebo controlled. On two consecutive nights of one week, the patients receive either 30 mg mirtazapine or placebo at bedtime. The following week, the alternative medication is administered. The patients have known mild to moderate sleep apnea. The endpoints of the study are the apnea + hypopnea index (AHI), sleep quality, and the degree of arterial oxygen desaturation.


Eligibility Criteria:
Inclusion Criteria:

* Known OSA mild to moderate

Exclusion Criteria:

* On antidepressant or antipsychotic medications
Efficacy and Safety of Estracyt® in Metastatic Breast Cancer

This study evaluates efficacy, safety and quality of life in patients affected by metastatic breast cancer RH+/ HER2- and treated by estramustine phosphate.

For patients affected by metastatic breast cancer RH+/HER2-, the conventional treatment is hormonotherapy. But, when patients don't react no recommendations exist.

Estramustine phosphate is currently prescribed for prostate cancer. The estramustine phosphate is an active anti-tumoral agent by oral route, associating a nitrogenous mustard with the estradiol, it settles on membrane receptor and the cytotoxic component acts essentially by dismantling microtubules inhibiting the mitosis.

Estramustine could be a therapeutic option when currently therapy are exhausted for patients reactive to hormonotherapy previous lines or chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic breast cancer HER2-/RH+
* Progression after hormonotherapy
* Treated by taxanes, anthracyclines, capecitabine and eribulin
* Treated by everolimus
* ECOG ≤ 2
* Hematological Function: neutrophiles ≥ 1,5 x 109 / L, hemoglobin ≥ 9 g / dL, plaques ≥ 100 x 109 / L
* Hepatic function: albumin ≥ 2,5 g / dl, bilirubin serum ≤ 2 x N (superior border of the standard) (unless disease of Gilbert), transaminases ≥ 3 x N
* Renal Function: serum creatinine ≤ 1,5 mg / dL or clearance of the creatinine ≥ 40 mL / min
* Estimated Life expectancy ≥ 3 months

Exclusion Criteria:

* Hypersensitivity known about one of the constituents of the estramustine phosphates
* Preliminary Treatment by estramustine phosphates
* Brain Metastases
* Patients not being under effective contraception
* Minor, pregnant or lactating Patients
* Patients not previously treated by everolimus
* Transaminases \> 3xN
* Other concomitant anticancer treatment less than 1 month before the inclusion
* Digestive function: malabsorption
* History of other cancer in the previous 5 years (other than squamous-cell epithelioma or totally resected in situ carcinoma)
* Active Thrombo-phlebitis
* Risk thromboembolic known,
* Unchecked cardiovascular Pathology
* Grave hepatic Affection
Investigation of the Effects of Proprioceptive Neuromuscular Facilitation Exercises in Patients with Myasthenia Gravis

The goal of this clinical trial is to investigate of the effects of proprioceptive neuromuscular facilitation exercises on fatigue, muscle strength and functional parameters in patient with Myasthenia Gravis. The main questions it aims to answer are:

* Do proprioceptive neuromuscular facilitation exercises reduce fatigue in patients with Myasthenia Gravis?
* Do proprioceptive neuromuscular facilitation exercises increase muscle strength in patients with Myasthenia Gravis?
* Do proprioceptive neuromuscular facilitation exercises improve functional parameters in patients with Myasthenia Gravis?
* How well can patients with Myasthenia Gravis tolerate proprioceptive neuromuscular facilitation exercises? Participants will be divided into 2 groups as control group and exercise group with block randomization method. In this single-blind randomized controlled study, the participants in the control group will be placed on a waiting list without any intervention during the 6-week study period and at the end of the study, the interventions applied to the exercise group will be applied exactly the same. Proprioceptive neuromuscular facilitation exercises will be applied to the exercise group 3 days a week, 1 hour a day for 6 weeks. Individuals will be evaluated at the beginning and at the end of the study.

Researchers will compare exercise and control group to see if there are effects of proprioceptive neuromuscular exercises patients with Myasthenia Gravis.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Being between the ages of 18-65
* It must be confirmed by the Neurologist that the patient has been diagnosed with adult onset and Achr+ generalized Myasthenia Gravis and has been in a stable condition for the last 6 months.
* Being in class II or III according to the American Myasthenia Gravis Foundation Clinical Classification

Exclusion Criteria:

* Having a cognitive problem or having a Mini Mental Test score below 24
* Change in the type and dose of medical treatment within the last 6 months
* Having another cardiorespiratory, metabolic, systemic, rheumatological, orthopaedic and neurological disease (unstable and at a level that prevents participation in the exercise programme) in addition to Myasthenia Gravis
* Having a body mass index below 17 kg/m2 and above 30 kg/m2
* Having participated in any physiotherapy program any intervention study for the last 6 months
* Having undergone pregnancy, birth or surgical operation in the last 6 months.
Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery

The REaCT NSQIP will compare oral antibiotics vs. no antibiotics, which are two standards of care treatments for preoperative preparation of the bowel prior to colorectal surgery

The divergence of clinical practice guidelines, in addition to observation from the large North American retrospective studies, suggest that surgeons and centers have not established a standard of care for the preoperative preparation of the bowel prior to colorectal surgery. Specifically, some centers are employing no preparation, others are administering a mechanical bowel preparation (MBP) and oral antibiotics and still others are using oral antibiotics alone. Recently, the Canadian Society of Colorectal Surgeons was unable to come to a consensus when attempting to update their preoperative guidelines because of the lack of agreement on best practice (personal communication). This is an important yet controversial topic in colorectal surgery and a clinical trial comparing two standard of care therapies will impact current practice in Canada. The REaCT-NSQIP study compares post-operative surgical infectious complications, length of stay, incidence of C. difficile rates, patient quality of life and cost-effectiveness in patients undergoing elective colorectal surgery with either no preparation or oral antibiotics. Data will be collected from the National Surgical Quality Improvement Program (NSQIP) and from patient quality of life questionnaires preoperatively and 30 days postoperatively

In this study, it is hypothesized that it is the oral antibiotics, and not the MBP, that is responsible for the reduction in postoperative infectious surgical complications (deep or superficial surgical site infection (SSI)) in patients undergoing elective colorectal resections. This improvement in postoperative infectious complications is not anticipated to result in a clinically significant increase in postoperative C. difficile infections or antibiotic resistant hospital-acquired infections.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective, non-emergency colon, resection surgery or abdominal perineal resection and no other requirements exists for a mechanical bowel preparation (as determined by the operating surgeon)
* 18 years of age or older
* Able to provide oral consent

Exclusion Criteria:

* Contraindication to the oral antibiotics, including allergies or adverse reactions to either metronidazole or neomycin
* Undergoing a rectal resection with a planned anastomosis (these patients will all receive MBP)
* Emergency surgery where no opportunity to administer preoperative oral antibiotics exists
* Requirement for a MBP (i.e. rectal resection with pelvic anastomosis, intraoperative colonoscopy, or at the discretion of the treating surgeon
CEQUA for Sjogren's Syndrome Dry Eye

The primary objective of this study is to show that CEQUA (cyclosporine 0.09% ophthalmic solution) improves symptoms of dry eye disease in a population of patients with Sjogren's Syndrome diagnosis.

After being informed about the study and potential risks, all participants giving informed consent will have an eye exam and will be asked about their medical history to determine eligibility for the study. Eligible participants will continue to the second visit the same day or up to 10 days later. During the second visit participants will answer questionnaires about their eyes and have their vision, eyes, and tears examined. All participants will be given CEQUA to use over the duration of the study. The same procedures will be repeated every four weeks for 3 months total.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Sjogren's Syndrome.
* Self-reported complaints of ocular dryness for a period of at least 3 months
* Best-corrected distance visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

* Use of cyclosporine within the last 3 months.
* Use of ocular steroid within the 3 months.
* Previous history of treatment failure with cyclosporine.
* Known hypersensitivity or contraindication to the study medication or any of its ingredients.
* Use of any systemic or topical ocular medication that is known to cause or exacerbate dry eye.
* Any active ocular infection.
* Severe or serious ocular condition in either eye or any other unstable medical condition that may preclude study treatment or follow-up.
* History or presence of chronic generalized systemic disease that might increase the risk to the subject or confound the results of the study.
* Currently pregnant or lactating.
OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

The primary objectives of this study are to assess the safety and efficacy of MS1819-SD vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).

This is a Phase 2, open-label, multi-center, 2x2 crossover study assessing the safety and efficacy of MS1819-SD (spray dried) vs porcine PERT given at the same dose that was being administered during the pre-study period.

MS1819-SD will be assessed in a 2x2 crossover including at least 30 patients completing both periods.

Eligibility Criteria:
Inclusion Criteria:

1. Cystic fibrosis, based on 2 clinical features consistent with CF, plus initial diagnostic sweat chloride ≥ 60 mmol/L
2. Under stable dose of porcine PERT
3. A fair or better nutritional status
4. Fecal elastase \<100 µg/g
5. Standard-of-care medications including Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulators are allowed

Exclusion Criteria:

1. History or diagnosis of fibrosing colonopathy
2. Any chronic diarrheal illness unrelated to pancreatic insufficiency
3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥5 ×upper limit of normal (ULN), or total bilirubin level ≥1.5 ×ULN at the Screening visit
4. Feeding via an enteral tube during 6 months before screening
5. Forced expiratory volume ≤30% at the Screening visit
Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)

This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy, and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a functional, well-differentiated NET, with carcinoid symptoms.

This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy, and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a functional, well-differentiated NET, with carcinoid symptoms, treated for at least 2 months with Sandostatin LAR at doses of 10 mg, 20 mg, or 30 mg before the start of the Sandostatin LAR Last Dose Assessment Phase (Day -28).

Eligibility Criteria:
Inclusion Criteria:

Acromegaly:

* Male or female patients ≥18 years of age
* Acromegaly currently treated with Sandostatin LAR

NET:

* Male or female patients ≥18 years of age
* Functional, well-differentiated (Grade 1 or Grade 2) NET with symptoms of carcinoid syndrome (number of bowel movements and/or flushing)
* Currently treated with Sandostatin LAR for symptom control

Exclusion Criteria:

Acromegaly:

* Inadequate bone marrow function
* Abnormal coagulation or chronic treatment with warfarin or coumarin derivates
* Impaired liver, cardiac and/or renal function
* Known gallbladder, bile duct disease or pancreatitis
* Diabetes with poorly controlled blood glucose levels despite adequate therapy
* Hypothyroidisms not adequately treated

NET:

* Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, pancreatic islet cell carcinoma, insulinoma, glucagonoma, gastrinoma, goblet cell carcinoid, typical and atypical lung carcinoids, large cell neuroendocrine carcinoma and small cell carcinoma
* Carcinoid syndrome refractory to treatment with conventional doses of somatostatin analogues (SSAs)
* Inadequate bone marrow function
* Abnormal coagulation or chronic treatment with warfarin or coumarin derivates
* Impaired liver, cardiac and/or renal function
* Known gallbladder, bile duct disease or pancreatitis
* Short-bowel syndrome
* Diabetics with poorly controlled blood glucose levels despite adequate therapy
* Hypothyroidism, not adequately treated
Azithromycin for Critical Asthma - Pediatrics

The CR-AZI Study will assess the immunomodulatory effects of Azithromycin for pediatric Critical Asthma.

Azithromycin (AZI), a macrolide antibiotic, has been applied for adult and pediatric respiratory pathology to alter immune system response.1 For pediatric critical asthma (CA), a term used to describe a critically ill child hospitalized with an asthma exacerbation requiring an intensive care unit (PICU) hospitalization, the investigator's prior research has revealed 1 in 10 will receive AZI.2 Yet, the application of AZI in this setting is poorly studied nor is clear if, and to what degree AZI alters the immune response in conjunction with systemic corticosteroids traditionally applied in CA.

In this proposal, the investigators aim to characterize a respiratory epithelial inflammatory biomarker, periostin, among children with CA with and without exposure to AZI. The investigators hypothesize children receiving AZI will have lower periostin levels. As a secondary analysis, the investigators will describe the rates of adverse events related to AZI (previously not done) and explore differences in clinical and physiologic CA efficacy markers.

Eligibility Criteria:
Inclusion criteria

* Age 3-17 years
* Admission to the PICU
* Primary diagnosis of critical asthma
* Prescription for continuous inhaled beta-agonist therapy and/or intravenous (IV) beta-agonist therapy
* Prescription for intravenous systemic corticosteroids

Exclusion criteria

* Critical Congenital Heart Disease Unrepaired
* Tracheostomy Dependence at Admission
* Ongoing Exposure to Azithromycin or Macrolide Antibiotics for any indication
* Past Medical History of Prolonged QT Syndrome or Arrhythmias
* Concomitant respiratory pathology including Acute Chest Syndrome, Interstitial Lung Disease, Cystic Fibrosis, and pulmonary hypertension
Patient Automated Text Hovering for IBD

This is a 2-arm randomized trial aimed at leveraging behavioral science principles to improve patient engagement between office visits among patients with inflammatory bowel disease (IBD).

Crohn's Disease (CD) and Ulcerative Colitis (UC), collectively known as inflammatory bowel disease (IBD), are common chronic gastrointestinal diseases with significant morbidity and decreased quality of life. Care for patients with IBD has been transformed by biologic therapies which dramatically improve inflammation and clinical outcomes. As they are delivered through infusion or injection with long intervals between doses, it can be challenging for patients to maintain adherence due to systems issues such as prior authorization and site of service limitations, in addition to traditional reasons for non-adherence such as inertia and present-time bias. Despite evidence that high adherence is needed for effectiveness, estimates are as low as 66%.

Preliminary observations and interviews show that an important gap for providers is lack of knowledge of how their patients are doing between visits. Specifically, patients may not adhere to necessary therapy, and physicians are unaware of changes in course of the disease. A large cross-sectional study has shown that patient-reported outcomes are associated with control of the disease, but serially monitoring these measures has not been tested prospectively. A prior study found that assessing symptoms weekly is highly correlated with information collected with a more cumbersome daily diary. This may provide additional data to clinicians to better manage symptoms and therapy.

Text messaging is an attractive tool to engage with patients due to the high prevalence of cell phones. The investigators will develop and test a new IBD hovering program that improves the care of patients between office visits. The investigators will enroll patients prescribed biologic therapy and provide text message reminders about scheduled infusions or injections that incorporate behavioral science principles such as anticipated regret, precommitment, and reciprocity. The investigators will also have the patient identify a friend or family member to serve as a support partner to encourage adherence and provide assistance as needed. The platform will communicate with patients weekly to ask about the course of their symptoms, send messaging to the feedback partner, and send alerts to physicians as needed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Crohn's Disease or Ulcerative Colitis
* Has had at least 2 visits with Penn Gastroenterology in the past 2 years
* Currently prescribed a biologic therapy (infliximab, adalimumab, ustekinumab, certolizumab, golimumab, or vedolizumab). Of note, this study is not limited to new initiators of these medications.

Exclusion Criteria:

* Patients will be excluded if they do not have a phone with text messaging.