cyrilzakka/clinical-trials huggingface dataset:
Combined Effect of CFTR Protein Modulator Drugs and Exercise in Cystic Fibrosis

This study aims to assess the effects of programmed exercise combined with CFTR protein modulator drugs in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis.

The present study is a new clinical trial that extends our previous work intended to assess the effect of programmed exercise with or without electrical stimulation on cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis (ECOMIRIN) registered at ClinicalTrials.gov (Identifier: NCT04153669).

After finishing the study, a subset of the participants was treated with either TEZ/IVA or LUM/IVA per standard of care, as they were considered candidates according to the AEMPS (https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-000833-37/ES). Those patients are expected to complete five months of pharmacological treatment without exercise by June 2020.

Primary Objective To evaluate the effect of an exercise program on physical fitness in cystic fibrosis patients after 5 months of administration of LUM/IVA or TEZ/IVA in comparison to the effect produced by the same exercise program before administration of the drug.

Secondary Objectives Other specific objectives include comparing the beneficial effects of exercise and LUM/IVA or TEZ/IVA on: 1) cardiorespiratory function and muscle strength; 2) the concentration of chlorine in sweat; and 3) quality of life.

Eligibility Criteria:
Inclusion Criteria:

* In order to be included, patients must have participated in the ECOMIRIN clinical trial (ClinicalTrials.gov Identifier: NCT04153669).
* They must have a previous CF diagnosis, defined as: sweat chlorine ≥ 60 mEq/L and/or carry two variants of the CFTR gene characterized as pathogenic.
* Age 6-18 years; eligible to receive treatment with TEZ/IVA or LUM/IVA according to the AEMPS (LUM/IVA for 6-11 year-old children homozygous for the F508del mutation; TEZ/IVA for ≥ 12 year-old children homozygous for the Phe508del mutation, as well as heterozygous for the F508 mutation plus one of the following mutations: P67L, R117C, L206W, R352Q, A455E, D579G, 711 + 3A G, S945L, S977F, R1070W, D1152H, 2789 + 5G A, 3272-26A G, and 3849 + 10kbC T);
* Agreement to collaborate in performing static and dynamic pulmonary function tests.
* Consent of children and/or parents or legal guardians to participate in the study after having read and understood the informed consent form.

Exclusion Criteria:

* CF patients not consenting to participate in the study at any time after reading and understanding the informed consent form will be excluded.
* CF patients who are not eligible to receive treatment with TEZ/IVA or LUM/IVA according to the AEMPS during the course of the study will be excluded.
* Study participants will be excluded if they test positive for any contagious viral infection that may affect the outcomes (e.g. SARS-CoV-2).
Comparison of the Effects of Green Exercise Programs on Metabolic Syndrome Parameters in Elderly Individuals

The aim of this study is to compare the effects of exercise programs that only aerobic exercise and combination aerobic exercise and resistance exercises on the metabolic syndrome parameters in the green exercise concept.

One hundred twenty volunteer participants aged 65 years over will be included in the study. Participants will be randomly divided into three groups as aerobic, aerobic and resistance and control group. While a group will receive only aerobic exercise, the other group group will receive both aerobic and resistance exercises and one of the group will receive no exercise. Exercises will be held in an open and green area. At the beginning of the treatment and at the end of the twelfth week Hemoglobin A1c (HbA1c), Triglyceride, Hdl cholesterol, Ldl cholesterol, total cholesterol and blood glucose will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* people aged over 65 years
* Be fit to participate in exercise program after the first cardiac examination by the physician
* Individuals whose blood lipids, Hg a1c and glucose values were checked within 3 months
* According to the International Physical Activity Assessment Questionnaire, those who are physically inactive
* Having a score above 24 in the Minimental Test

Exclusion Criteria:

* Having neuromuscular disease
* Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.)
* Having an orthopedic disease that interferes with walking
* Having a score below 24 in the Minimental Test
A Study of Anti-PD-L1 Antibody in Neoadjuvant Chemotherapy of Esophageal Squamous Cell Carcinoma.

This is a randomized, double-blind, placebo-controlled Ib/Ⅱ clinical study to evaluate the safety and effect of anti-PD-L1 antibody (ZKAB001) in neoadjuvant chemotherapy of esophageal squamous carcinoma in combination with Alb-paclitaxel and cisplatin. The immunotherapy will be given before and after the operation every three weeks.


Eligibility Criteria:
Key inclusion Criteria:

1. Aged 18 to 75 years old of either gender;
2. A histopathological diagnosis of esophageal squamous cell carcinoma with a clinical stage of T2N+M0 or T3-4aN+/-M0 according to the 8th edition of the UICC staging system;
3. ECOG score 0-1;
4. Estimated life expectancy \>3 months;
5. BMI ≥18.5kg/m2 or PG-SGA score A/B;
6. The function of important organs meets the following requirements:

   1. white blood cell count (WBC) ≥ 3.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90g/L;
   2. ALT, AST and AKP ≤ 2.5×ULN;
   3. serum albumin ≥ 30g/L;
   4. total bilirubin ≤ 1.5×ULN;
   5. serum creatinine ≤ 1.0×ULN, creatinine clearance rate ≥60 mL/min;
   6. INR ≤ 1.5, PT≤ 1.5×ULN;
7. Cardiac function: ≤I, pulmonary function: FEV1 \>1.2L, FEV1% \>40%, liver function: Child-Pugh 5-6;
8. Serum HCG negative in premenopausal women ;
9. Ability to understand the study and sign informed consent.

Key exclusion Criteria:

1. Cervical esophageal carcinoma;
2. Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
3. Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of anti-PD-L1 antibody and chemotherapeutic drugs;
4. Active autoimmune diseases;
5. A history of allogeneic stem cell transplantation and organ transplantation;
6. A history of interstitial lung disease or non-infectious pneumonia;
7. Patients who cannot tolerate chemotherapy or surgery due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia;
8. A history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases;
9. Presence of active hepatitis B (HBV DNA ≥ 200 IU/mL or 103 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay);
10. A history of active pulmonary tuberculosis infection within 1 year or a history of active pulmonary tuberculosis infection more than 1 year ago but without formal anti-tuberculosis treatment;
11. A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer;
12. Lymph node metastasis in neck, supraclavicular, abdominal cavity, retroperitoneum and pelvic cavity (except paracardial and left gastric lymph nodes).
Folate and Protection Against Cervical Cancer

This is a randomised double-blind placebo-controlled trial to see whether giving a low dose of the vitamins folic acid and riboflavin is beneficial to women who have very low grade abnormalities of the cervical cells.

The overall aim of the study is to evaluate interactions between intakes of folic acid and riboflavin with a common polymorphism relevant to folate metabolism, in determining the risk of cervical cancer in women who carry high risk human papillomavirus.

We will test the following hypotheses:

Supplements of riboflavin and folic acid will increase the rate of regression of low grade cervical intra epithelial neoplasia (CIN1).

Effects of supplemental folic acid and riboflavin on CIN1 regression are modulated by a common polymorphism in the MTHFRC677T gene.

We will recruit women with biopsy-proven CIN1 and carrying high risk HPV infection, and randomise to a 12month intervention of 1.2mg folic acid and 5mg riboflavin or placebo. The primary outcome will be regression of biopsy-proven CIN1, and secondary outcomes will include measures of DNA stability.

Eligibility Criteria:
Inclusion Criteria:

* biopsy-diagnosed CIN1 infection with oncogenic HPV

Exclusion Criteria:

Any other stage of cervical abnormality pregnant or planning a pregnancy diabetic taking B vitamin supplements taking anti-epileptic treatment taking methotrexate bleeding after intercourse abnormal GI function infection with chlamydia, HIV or other agent
Non-Inferiority Trial Comparing Eurofarma's Experimental Product Saccharomyces Boulardii Versus Floratil® in the Prevention of Antibiotic-Associated Diarrhea

The study's objective is to evaluate the efficacy and safety of two formulations for the prophylactic treatment of diarrhea in subjects using antibiotics.


Eligibility Criteria:
Inclusion Criteria:

1. ICF signature;
2. The subject must agree to follow the instructions and to perform study procedures and visits;
3. Male and female subjects between 18 and 65 years old;
4. Subjects who have scheduled a treatment or started the use of antibiotics over 24 hours ago:

Exclusion Criteria:

1. Generalized infection or bacteremia;
2. Chronic gastrointestinal diseases (e.g., Crohn's Disease and Irritable Bowel Syndrome);
3. Documented chronic diarrhea;
4. Acute diarrhea episode within 24 hours prior to the start of antibiotic use. Use of tube feeding (nasogastric and nasoenteral);
5. Immunodeficiency (radiotherapy or chemotherapy);
6. Use of food with probiotic properties in the last 10 days;
Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage

The purpose of our study is to determine how well Triple-H works and how safe it is. The investigators are hoping to determine the effects of starting the therapy early and to explore if hypervolemia and/or hypertension are beneficial, and what the optimal target ranges are.

Efficacy of Triple-H therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age more than or equal to 18 years
2. Aneurysmal SAH of any clinical grade
3. Head computed tomography demonstrating SAH
4. Cerebral angiography revealing the presence of cerebral aneurysm(s) in a location that explains the SAH
5. Treatment of aneurysm with clipping or coiling must be carried out prior to randomization and within 72 hours of bleeding
6. Signed consent by study participant or applicable legal representative within 72 hours after SAH

Exclusion Criteria:

1. History of traumatic SAH
2. Non-aneurysmal SAH as indicated by no demonstrable aneurysm by cerebral angiography
3. Presence of an unsecured intracranial aneurysm(s) at risk of rupture that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
4. Delayed referral with clipping/coiling greater than 72 hours after the initial bleeding
5. Time of symptom onset cannot be reliably determined
6. Intracranial hypertension (ICP \>25 mm Hg) at the time of screening
7. History within the past six months and/or physical findings on admission of decompensated congestive heart failure (NYHA functional class III or IV, or objective class C or D)
8. Acute, evolving or recent myocardial infarction
9. Cardiac arrhythmia or second and third degree atrio-ventricular block causing hemodynamic instability
10. Chronic renal failure requiring dialysis
11. Suspected or confirmed pregnancy
12. Non English speaking
13. A condition that would preclude the performance of the neurobehavioral test battery due to a prior diagnosis of Alzheimer's disease, stroke, degenerative condition, cerebral tumor, or mental retardation
14. Severe terminal disease with life expectancy less than 6 months
15. Refusal of consent
Study of Biomarkers in Gynecological Cancers

In recent years, there has been a significant improvement in understanding the biology of cancer and this information has been used to improve cancer care and patient outcome.

Research has shown that changes in some genes and/or proteins may be important indicators for certain cancers and response to treatments. Genes are molecules made up of ribonucleic acid (RNA) and deoxyribonucleic acid (DNA). DNA contain instructions for the development and functioning of the cells in the body and are passed down from parent to child. RNA is involved with producing proteins in the body. Further research is needed to better understand the changes found in cancer cells and how to target them to stop or reduce cancer growth.

A drug that may be able to block certain specific cancer cell changes is called "targeted therapy". Different people with the same type of cancer receiving the same drug could have different responses to it. For example, one person may experience a reduction of their tumor while another person's cancer may worsen. The reason for this is still not well understood and could lie in gene changes.

Understanding these changes may allow researchers to predict how treatments may work in guiding decisions around choice of drugs.

The purpose of the study is to learn more about gene changes or protein expression (levels) of tumors to better understand the behavior of gynecological diseases and, if possible, better address participants' cancer care now or in the future.


Eligibility Criteria:
Pre-Screening Eligibility:

Inclusion Criteria:

* Patients with probable diagnoses of gynecological malignancy (ovarian, tubal, primary peritoneal, uterine, cervical, vulvar and rare gynecological cancers) and confirmed to be undergoing upfront debulking surgery/radiation
* Patient must be ≥16 years of age at the time of consent.
* Ability to understand and provide written informed consent.
* ECOG Performance Status ≤ 2.
* Patient must consent to provide tissue sample from surgery and blood samples
* Life expectancy ≥3 months.

Exclusion Criteria:

* Patients must be treatment naïve (no previous treatment of Neoadjuvant chemotherapy nor radiation for newly diagnosed disease)

Eligibility for Patients with Gynecological Diagnosis

Inclusion Criteria:

* Patients with histological confirmation of gynecological malignancy (except ovarian cancer with high grade serous histology, tubal, primary peritoneal, uterine, cervical, vulvar and vaginal cancer and rare gynecological cancers).
* Patient must be ≥16 years of age at the time of consent.
* Ability to understand and provide written informed consent.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
* Patient must consent to providing archival tissue and/or to undergo tumour biopsy and/or to provide blood or fluid collection samples. Patients will also be asked to provide a blood sample for germline mutation analysis.
* Life expectancy ≥3 months.
* No limits of previous lines of treatment.

Exclusion Criteria:

* Any contraindication to tumour biopsy or blood collection
* Patient with diagnosis of High grade serous Ovarian Cancer are excluded
A Study Evaluating the Efficacy and Safety of Sunitinib With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer (SABRE-R)

This is a Phase II, multicenter, randomized, blinded, placebo-controlled study designed to evaluate the safety and efficacy of combining bevacizumab with sunitinib relative to placebo with sunitinib in patients with metastatic RCC who have not received prior systemic therapy for metastatic disease. The study will enroll approximately 100 patients at approximately 20 centers in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Histologically confirmed metastatic RCC
* Measurable disease, as defined by RECIST
* Age ≥ 18 years
* ECOG performance status of 0 or 1
* Prior nephrectomy
* Ability and capacity to comply with study and follow-up procedures

Exclusion Criteria:

* RCC with predominantly sarcomatoid features
* Prior systemic or adjuvant therapy for RCC
* Radiotherapy for RCC within 28 days prior to Day 1
* Prior treatment with bevacizumab, sunitinib, sorafenib, axitinib, thalidomide, or other similar agents
* Current need for dialysis
* Life expectancy of \< 12 weeks
* Current, recent, or planned participation in an experimental drug study
* Inadequate organ function
* Active infection or fever \> 38.5°C within 3 days of starting treatment
* History of other malignancies within 5 years prior to Day 1
* Any other medical conditions (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a patient's ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results
* Inadequately controlled hypertension
* Prior history of hypertensive crisis or hypertensive encephalopathy
* New York Heart Association (NYHA) Class II or greater CHF
* History of myocardial infarction or unstable angina within 6 months prior to Day 1
* History of stroke or transient ischemic attack within 6 months prior to Day 1
* Known CNS disease except for treated brain metastasis
* Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within 6 months prior to Day 1
* History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
* Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
* Major surgical procedure or anticipation of need for major surgical procedure during the course of the study
* Serious, non-healing wound; active ulcer; or untreated bone fracture
* Known hypersensitivity to any component of bevacizumab
* Pregnancy (positive pregnancy test) or lactation
* Current, ongoing treatment with full-dose warfarin
Use of Levemir® Improves Metabolic and Clinical Status in Cystic Fibrosis-related Diabetes (CFRD)

This is a study to find out if Levemir® (a long acting or basal insulin) is safe and effective in treating cystic fibrosis related diabetes (CFRD).

Cystic fibrosis (CF) related diabetes (CFRD) and glucose intolerance affects more than 50%-75% of teens and adults with CF. The 1998 North American CF Foundation on CFRD categorized the disease differently than other types of diabetes: CFRD with fasting hyperglycemia (FH), CFRD without FH and transient CFRD. The outcome of this consensus conference was the use of insulin as the only recommended treatment of CFRD. Although the conference report mandated treatment for CFRD with FH, treatment was not mandated for the other types of CFRD, the choice to treat was left to the clinician's discretion. However, insulin was the only recommended therapy for all types of CFRD. Although some clinicians have used basal bolus regimens as the insulin management, many still use NPH. Given the need for CF patients to eat many frequent meals and snacks to maintain their weight, use of NPH insulin rarely renders good glycemic control. A basal bolus regimen is much more physiologic and would allow good glycemic control even with frequent meals and snacks. To date, there are no studies documenting safety and efficacy of true basal insulin, or a basal bolus regimen. Furthermore, protein catabolism and excessive muscle loss has been well documented in CF patients, both in those with and those without, glucose intolerance. Studies by our group and others have documented that a major reason for the catabolism is resistance to insulin's anti-catabolic effects on protein turnover. Thus, there is potential clinical benefit of improving muscle mass and general health by insulin treatment even for CF patients who do not have fasting hyperglycemia. A non-peaking basal insulin would be the only reasonable choice, yet studies are lacking. Our overall goal is to study the safety and efficacy of LevemirTM for the improvement of glycemic control of patients with CFRD. As a second goal, we will explore the ability of this basal insulin to improve protein catabolism and muscle mass. The study will be conducted as a six month trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with CFRD by oral glucose tolerance test (OGTT) who are medically stable. Medical stability will be defined as:

  * No hospital admission for six weeks or more before the study
  * No oral or intravenous antibiotics for at least six weeks preceding the study (subjects will be allowed to use low doses of inhaled corticosteroids).

Exclusion Criteria:

* Use of oral or intravenous corticosteroid medications within six weeks of the study.
* Evidence of clinically significant liver disease.
* Colonization with Burkholderia cepacia.
* Colonization with Aspergillus.
* Pregnancy.
* Medically unstable (stability defined above).
Confocal Laser Micro-endoscopy in Chronic Obstructive Pulmonary Disease (COPD) and Lung Transplant Recipients

Aspects of confocal laser micro-endoscopy (CLME) and morphometry in chronic obstructive pulmonary disease (COPD) and lung transplant recipients is described and will be correlated with clinical findings in order to described small airway remodelling in these patients.

In early phases of COPD, changes in small airway characteristics may develop. Elastin decay and matrix remodelling could be responsible for these changes. Using CLME changes of in the bronchiolar wall and alveolar ducts can be visualized, described and measured.

In lung transplant recipients, CMLE will be performed to distinguish characteristics of distal airways in stabile patient in contrast to patients with bronchiolitis obliterans syndrome.

In both groups data will be correlated with CT findings, pulmonary function tests and anatomopathological results.

Eligibility Criteria:
Inclusion Criteria:

* referral for bronchoscopic investigation/sampling
* informed consent signed
* recent spirometric data

Exclusion Criteria:

* sedated and/or ventilated patients
* patients on ICU
* patients under oral anticoagulation
* co-existing lung disease
* acute infectious pulmonary disease
Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects

The purpose of this study was to determine the pharmacokinetic (PK) and safety profile of single and multiple doses of rufinamide. The effects of food and sex on the PK properties of rufinamide in these Chinese volunteers were also evaluated.

This single- and multiple-dose, randomized, open-label study was conducted in healthy Chinese subjects. In the single-dose study, volunteers were randomly assigned to 4 dose groups and received a single dose of 200, 400, 800, 1200 mg rufinamide tablets under fasted condition. An additional food effect study was performed in the 200-mg dose group by assessing changes in PK parameters after high-fat diet. In the multiple-dose study, 10 subjects were administered 200-mg rufinamide formulation twice daily for 6 consecutive days. LC-MS/MS method was applied to determine plasma concentration of rufinamide. Tolerability was assessed based on investigator inquiries, spontaneous reports, and clinical evaluations such as standard laboratory tests, vital signs, physical examinations and 12-lead electrocardiography.

Eligibility Criteria:
Inclusion Criteria:

* body mass index between19 and 24 kg/m2
* negative for HIV and hepatitis B
* had no clinicallyimportant findings on health tests
* thorax radiography and ECG with no abnormalities
* normal blood pressure values
* heart rate

Exclusion Criteria:

* any drug treatment within 2 weeks before starting the study
* participation in another clinical study within the previous 3 months
* alcoholism and smoking
* pregnancy
* breast-feeding
* hypocalcemia
* blood donation or participation in other clinical trials within 3 months before enrollment in the study
* sitting blood pressure \<80/50 mm Hg or \>140/100 mm Hg
* A ventricular rate \<60 beats/min or \>100 beats/min at rest