cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate the Safety and Effect of Food on the Pharmacokinetics of YM178 in Healthy Volunteers

The purpose of the study is to evaluate safety of YM178 and the effect of food intake on the pharmacokinetics of YM178 in healthy adult subjects.

A open-label, randomized, crossover study to assess the effect of food on the pharmacokinetics of single dose of YM178 administered under fasted and fed conditions.

Eligibility Criteria:
Inclusion Criteria:

* A normal or clinically non-significant 12 lead ECG as well as normal or clinically non-significant laboratory test results at the time of Screening
* Body weigh at least 50 kg in male and 45 kg in female and body mass index (BMI) between 18.5 and 26.9 kg/m2
* All women of child bearing potential are required to use adequate contraception consisting of two forms of birth control

Exclusion Criteria:

* Hypersensitivity to YM178 or other beta-3 agonists or any of the constituents of the formulation used
* Liver function test values above the upper limit of normal
* A history or presence of psychiatric illness, serious active or recurrent infection
* A previous history of cancer other than basal cell carcinoma or Stage 1 squamous cell carcinoma that has not been in remission for at least 5 years prior to the study
* Donated or lost ≥ 500 mL blood within 3 months or donated plasma within 2 weeks prior to the study
* Receiving or being anticipated to receive a prescription drug or OTC medications within 14 days prior to the study
* Consuming alcohol, xanthine derivative-containing food/beverages (tea, chocolate), grapefruit juice, grapefruit-containing products or Seville oranges (e.g., bitter marmalade) within 48 hours before the study
* A history of substance abuse, drug addiction, or alcoholism within past 2 years prior to the study
* currently participating in another clinical trial or taking or has been taking an investigational drug at least 60 days
Feasibility of a Video-oculography in Patients With Huntington's Disease VOG-HD Study

The purpose of this study is to know the limits of feasibility of a reliable oculomotor record for patient with Huntington's disease.


Eligibility Criteria:
Inclusion Criteria:

* Corrected visual acuity \>1/10
* Aged over 18 years
* Patient with the mutation that is to say the presence of an abnormal number of trinuclide: CAG\> 38 in the first exon of the huntingtin gene.
* Total Functional Capacity Scale (CFT) ≥ 3

Exclusion Criteria:

* Patients or trustworthy person who have not given their written consent, informed and signed.
* Patients are not affiliated or who are not entitled to Social Security
* Private patients of liberty by administrative or judicial decision, or patients supervision
* Associated disease with neurological repercussions
Efficacy of Peri-neural Platelet Rich Plasma Injection in Treatment of Chemotherapy Induced Peripheral Neuropathy.

This study aims to show the efficacy and safety of ultra-sound guided peri-neural platelet rich injection in treatment of chemotherapy induced peripheral neuropathy.

This study is prospective, randomized, assessor blinded controlled trial. It is aims to study the effect of perineural platelet rich plasma injection in cancer patients with prepheral neuropathy despite of stoppage chemotherapy for 6 months and usage of medical treatment.

Ultrasound-guided PRP injection will be performed after preparation of plasma obtained from the patient by using 10-19 MHz high frequency linear transducer to scan the superficial nerves.

Eligibility Criteria:
Inclusion Criteria:

* cancer patients with peripheral neuropathy confirmed by clinical evaluation and nerve conduction study despite of medical treatment

Exclusion Criteria: patients with:

* Foot ulcers and / or amputation.
* Peripheral vascular disease.
* Uncontrolled diabetes
* Vertebral pathologies.
* Connective tissue diseases.
* Thyriod disorders, significant renal or hepatic dysfunction.
* Platelet dysfunction syndrome, critical thrombocytopenia.
* Septicemia and local infection at the site of the procedure.
* Systemic corticosteriod adminstiration or local injection at the suspected treatment site within the last month.
* Recent fever or illness.
* Hemoglobin level less than 10 g/dl, platelet count less than 105-109/L.
Mechanisms of Refractory Hypertension (High and Low Salt Diet)

The purpose of the study is to test the hypothesis that persistent fluid retention and high sympathetic output contributes to the development of refractory hypertension (HTN). The investigators will determine, in a cross-over assessment of high and low salt diets, if dietary sodium restriction reduces 24-hr ambulatory BP in patients with refractory HTN. Moreover, the investigators will determine if dietary sodium restriction lessens the severity of obstructive sleep apnea (OSA) in patients with refractory HTN.

We are proposing a unique phenotype of antihypertensive treatment failure that we refer to as refractory HTN. We have come to feel that while resistant (RHTN) represents a broad phenotype with multiple and overlapping etiologies of treatment resistance, there is a unique subset of patients who never achieve BP control in spite of maximal therapy. In a recently published retrospective analysis of our clinic experience, we found that patients with refractory HTN comprised about 10% of patients referred to us for RHTN.

A large number of intervention studies have verified the benefit of dietary salt restriction to reduce BP. We made such an assessment in a prospective, randomized, cross-over comparison of high- and low salt diets in 12 patients with confirmed RHTN. The average reduction in BP going from high to the low salt diet was 23/10 mmHg in the clinic and 20/10 mmHg during 24-hr ambulatory BP monitoring. These dramatic results demonstrated that patients with RHTN are exquisitely salt-sensitive and highlight the degree of BP reduction that can be accomplished with meaningful salt restriction. However, we are proposing the novel hypothesis that refractory HTN is mechanistically unique from RHTN in that it is not secondary to recalcitrant fluid retention.

Determining an association between dietary salt restriction and severity of obstructive sleep apnea (OSA) would potentially help us to find new therapies guided towards achieving better control of BP in patients with refractory HTN. We will investigate the effect of dietary salt intake on severity of OSA vascular function in patients with refractory HTN by doing vascular studies (pulse wave analysis/velocity, calculating thoracic impedance)).

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects ≥ 19 years of age
* Refractory hypertension defined as office BP \> 140/90 that is uncontrolled with at least 5 different classes of antihypertensive medications
* Self-reported adherence \>80% with prescribed antihypertensive medications

Exclusion Criteria:

* Severe hypertension (office BP \>160/100 mm Hg)
* History of congestive heart failure (ejection fraction of \<40%)
* Chronic kidney disease (creatinine clearance \<60 ml/min)
* History of cardiovascular disease (stroke, TIA, myocardial infarction, or revascularization procedure)
* White coat hypertension defined as office BP \>140/90 mm Hg and ambulatory daytime BP \<135/85 mm Hg
* Pregnant or nursing women
COVID-19 and Mental Health

The overall objective of this study is to assess the enormity of mental health outcomes among healthcare providers (nurses and physicians) exposed to COVID-19 during the time of the pandemic in the United States, specifically targeting those areas most effected.

Healthcare providers (nurses and physicians) on the frontlines of the COVID-19 response are facing a critical situation and are subject to increased psychological distress. Those directly involved in the diagnosis, treatment and care of patients with COVID-19 are at significant risk of developing physical, psychological, and psychosocial distress.

The data examined in this study will further clarify the mental distress experienced by healthcare workers and lead to the development of peer-support and educational initiatives to improve these findings. The central hypothesis of this research is that high levels of mental distress will be associated with caring for patients with COVID-19.

This study will use an observational, cross-sectional on-line survey design. Participants will complete a 15 minute self-administered questionnaire. All data will be de-identified.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare providers (physicians and nurse) working in institutions with known or suspected COVID-19.

Exclusion Criteria:

* Nurses and physicians who are retired, or not currently employed or not working in an environment with known or suspected COVID-19.
Study of Allogeneic Bone Marrow Transplantation Following Cyclophosphamide and Radiotherapy in Patients With Myelodysplastic Syndrome and Acute Leukemia Related to Fanconi's Anemia

OBJECTIVES:

I. Determine the effectiveness of moderate dose cyclophosphamide and radiotherapy in terms of improving survival and reducing the morbidity following allogeneic bone marrow transplantation in patients with myelodysplastic syndrome and acute leukemia related to Fanconi's anemia.

PROTOCOL OUTLINE:

Patients receive cyclophosphamide IV over 1-2 hours on day -6 through -3 and total body radiotherapy on day -1. Patients undergo allogeneic bone marrow transplantation on day 0.

Eligibility Criteria:
* Diagnosis of Fanconi's anemia with the family history and typical phenotype including: Short stature Hypoplastic radii Skin pigmentation Renal anomalies Chromosomal fragility
* Evidence of Fanconi's myelodysplastic syndrome Bone marrow dysplasia of all 3 marrow cell lines AND Clonal cytogenetic abnormalities demonstrable in marrow cells
* First complete remission following therapy for Fanconi's acute leukemia allowed
* Must have related histocompatible donor No evidence of excessive in vitro chromosome fragility typical of Fanconi's anemia Normal CBC and bone marrow
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure

Hypertension is the leading modifiable risk factor for cardiovascular disease and is implicated in half of all strokes and myocardial infarctions. One-third of adults in Scotland have hypertension yet only one-quarter of these have their blood pressure (BP) controlled to target (\<140/90 mmHg). Reasons for the low rate of control are varied but include individuals lack of confidence, knowledge and understanding of the condition and treatment strategy, non-adherence to medication and infrequent BP monitoring. These issues have been compounded by the ongoing COVID-19 pandemic which has brought changes in routine BP screening, access to medical care and chronic disease management in primary and secondary care, shielding of the highest risk groups and a change in health and research focus. Shared decision making and issues around health literacy were highlighted by the Scottish Government Cross Party Group on Heart Disease and Stroke: High Blood Pressure Task Force in 2019. Empowering patients to have a better understanding of their condition and becoming actively involved in the monitoring and management of hypertension may lead to improved patient satisfaction, improved BP control and health outcomes and reduction in the use of primary/secondary care hypertension clinics.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Current attendance at the GBPC

Exclusion Criteria:

* Inability to give informed consent
* Non-English speakers
* No internet access
* Clinic or ambulatory blood pressure ≥180/120 mmHg
* Arm circumference \>42cm
* Inability to perform HBPM
* Inability to use Kvatchii portal
* Pregnancy
* Persistent atrial fibrillation
* Acute cardiovascular event requiring hospitalisation in the previous 3 months
* CKD stage ≥4 or renal dialysis
* Severe or terminal illness limiting study participation
Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

The aim of this study is to determine the efficacy and safety of PEG 3350 (polyethylene glycol 3350) for short-term treatment of chronic constipation in adults.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females aged ≥ 18 years.
2. Body Mass Index (BMI) ≥ 18.5
3. Organic bowel disease will be ruled out by Fecal Immunochemical Test (FIT) and/or colonoscopy.
4. Must have ≤ 2 bowel movements during a 7-day qualification period.
5. In otherwise good health as judged by a physical examination and laboratory testing.
6. Not taking medications known to affect bowel function in one week before study.
7. Willing to participate in the study by signing the informed consent.

Exclusion Criteria:

1. Hypersensitive to the study medication.
2. obstructive ileus.
3. Irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD)
Evaluation of Effects of Estetrol on Testosterone Suppression and Quality of Life in Prostate Cancer Patients Treated With an LHRH Agonist.

This is a phase IIa, double-blind, randomised, placebo-controlled, multi-center study to evaluate the effects of estetrol on testosterone suppression and quality of life in prostate cancer patients treated with an LHRH agonist. Patients will be treated with estetrol or placebo for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Male patients with prostate cancer, qualifying for treatment with a LHRH agonist;
* Age ≥ 18 years;
* Body mass index (BMI) between ≥ 18.0 and ≤ 35.0 kg/m2 (inclusive);
* Reasonable physical and mental health as judged by the Investigator determined by physical examination, clinical laboratory assessments and vital signs;
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1;
* Life expectancy of at least 2 years.

Exclusion Criteria:

* Current or prior (during the last 12 months) hormonal therapy, immunotherapy or chemotherapy for prostate cancer. Allowed are 14 days concomitant treatment with an anti-androgen to prevent the flare-up, radiotherapy and low dose radiation to prevent gynecomastia;
* History of deep vein thrombosis, pulmonary embolism, or cerebrovascular accident. However, patients with such history using anticoagulants for ≥ 6 months are eligible for the study provided anticoagulant treatment is continued throughout the whole study;
* History of myocardial infarction or a coronary vascular procedure (e.g. percutaneous coronary intervention, coronary artery bypass graft). However, patients with such history using anticoagulants for ≥ 6 months are eligible for the study provided anticoagulant treatment is continued throughout the whole study;
* Patients who have unstable angina or clinical congestive heart failure;
* A defect in the blood coagulation system, assessed at screening: deficiencies in AT-III, protein C and protein S and elevated factor VIII;
* Mutation in coagulation factor II and/or positive for factor V Leiden, assessed at screening;
* Diabetes mellitus with poor glycaemic control in the past 6 months (haemoglobin A1c (HbA1c) above 7.5%);
* Known primary hyperlipidaemias (Fredrickson);
* Disturbance of liver function: cholestatic jaundice, a history of jaundice due to previous estrogen use, Rotor syndrome and Dubin-Johnson syndrome;
* Known porphyria;
* Uncontrolled hypertension, i.e. systolic blood pressure 160 mmHg and/or diastolic blood pressure 100 mmHg in the last 6 months with or without medication.
Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia

the aim of this study is to evaluate the effect of Spirulina compared to Amlodipine on cardiac iron overload and cardiac functions in multi-transfused children with beta thalassemia major

the aim of this study is to evaluate the effect of Spirulina compared to Amlodipine on cardiac iron overload using magnetic resonance imaging and cardiac functions in multi-transfused children with beta thalassemia major

Eligibility Criteria:
Inclusion Criteria:

* patients on regular blood transfusions.
* iron overload with no perspective of changing the chelation therapy in the following three months

Exclusion Criteria:

* formal contraindication to magnetic resonance examinations
* implantable cardiac device
* advanced cardiomyopathy or conduction block
* other types of hemolytic anemias
Effects of Dexmedetomidine on Postoperative Cognitive Dysfunction During One-lung Ventilation in Elder Patients

This study is to explore the effects of dexmedetomidine on postoperative cognitive dysfunction during one-lung ventilation in elder patients.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Ongoing one-lung ventilation surgery.
* American Society of Anesthesiologists class I to III.
* Aged between 55 and 75 years old.
* Body Mass Index between 18 and 25 kg/m2.

Exclusion Criteria:

* Systolic blood pressure more than 180 mmHg or lower than 90 mmHg,diastolic blood pressure more than 110 mmHg or lower than 60 mmHg.
* Serious heart,liver,kidney, pulmonary, and endocrine disease or serious infection.
* Suspected or confirmed difficult airway.
* History of abnormal anesthesia.
* Suspected of malignant hyperthermia.
* Use of sedative and antidepressant drug or serious alcoholism
* Mini-mental State Examination less than 17.
* Highest academic degree below grade 6 in primary schools
* Patients inability to exchange with serious visual and hearing impairment or mental disability.
* History of shock.
* Carotid artery stenosis and central nervous system disease such as stroke, epilepsy.
* Allergic to investigational products or with other contraindication.
* Participated in other study within 30 days .
Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas

The primary objective of the protocol is to estimate the complete response rate of three courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma

Phase II study of the efficacy and toxicity of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma.

The study intervention is an administration of 3 courses of the abovementioned drugs, witch doses are detailed below. Remission is assessed and the investigator is free to proceed with any kind of consolidation , he decides best for the patient( high dose or standard chemotherapy).

The addition of Rituximab the the NIMP protocol is warranted on the basis of previous publications wtich have shown a significant advantage in addition to chemotherapy in complete remission rate and in overall survival.

Navelbine has shown an interesting activity in lymphoma relapse. Mitoxantrone has a good toxicity profile for patients who have prevously received anthracyclines, and there is not so much cross resistance between the two drugs.

Ifosfamide is commonly used in the treatment of relapsed and refractory lymphoma, because of its low hematologic toxicity profile and good antitumor activity.

Eligibility Criteria:
Inclusion Criteria:

* Both genders, between 18 and 75 years old
* CD 20+ large cell lymphoma
* In first relapse
* No previous autologous stem cell transplantation or relapsing more than 12 months after an autologous stem cell transplantation
* Ann Arbor stage I, II, III ou IV
* ECOG 0,1 or 2
* Signed informed consent

Exclusion Criteria:

* age: before 18 and more than 75 years old
* other type of lymphoma
* Informed consent not signed
Next Generation Sequencing-based "Oncochip" for Therapeutic Decision in Metastatic Breast Cancer. Study SHARP

The present trial clinical proposes to randomize patients with cancer metastatic disease of the breast progressing on standard therapy to receive a treatment selected from 4 "targeted" drugs (a MEK kinase inhibitor, an mTOR kinase inhibitor, an of the enzyme involved in DNA repair PARP and an androgen receptor inhibitor) on the basis of possible presence of mutations in a panel of 61 genes analyzed on metastatic tissue from biopsy, or receive standard chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients (women or men) with histologically confirmed metastatic breast cancer
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Written informed consent obtained prior to enrollment
* Age ≥ 18 years
* Blood and tumor tissue sample available for research
* Measurable disease
* Other site accessible for biopsy, except bone lesions if this is the only accessible site, or biopsy obtained within the previous 6 months
* Medical history, blood parameters and clinical conditions do not indicate major dysfunctions of organ

To treatment:

- Maintenance of screening inclusion criteria

Exclusion Criteria:

* Presence of visceral crisis, defined according to ABC3/ESMO guidelines
* Patients with local recurrence that can be treated with surgery and/or radiotherapy alone
* Patients who have previously received palliative radiotherapy on the only site accessible to biopsy
* Patients with metastatic disease limited to bone
* Patients with metastatic disease limited to the brain, unless planned a surgical excision, in which case tissue can be collected for screening
* Severe hematopoietic, renal and/or hepatic insufficiency
* Known contraindication to biopsy
* Neoplastic pathology of different histology in the previous 5 years, except carcinoma in situ of cervical basal or squamous cell carcinoma of the skin, if adequately treated
AdaptResponse Clinical Trial

The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).


Eligibility Criteria:
Inclusion Criteria:

* Subject is willing to sign and date the study Patient Informed Consent Form.
* Subject is indicated for a CRT device according to local guidelines.
* Sinus Rhythm at time of enrollment
* Complete Left Bundle Branch Block (LBBB) as documented on an ECG (within 30 days prior to enrollment). Strauss Criteria used for LBBB.
* Intrinsic, normal AV conduction as documented on an ECG by a PR interval less than or equal to 200ms (within 30 days prior to enrollment).
* Left ventricular ejection fraction less than or equal to 35% (documented within 180 days prior to enrollment).
* NYHA class II, III or IV (documented within 30 days prior to enrollment) despite optimal medical therapy. Optimal medical therapy is defined as maximal tolerated dose of Beta-blockers and a therapeutic dose of ACE-I, ARB or Aldosterone Antagonist.

Exclusion Criteria:

* Subject is less than 18 years of age (or has not reached minimum age per local law).
* Subject is not expected to remain available for at least 2 years of follow-up visits.
* Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted
* Subject is, or previously has been, receiving cardiac resynchronization therapy.
* Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
* Subject has unstable angina, or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 30 days prior to enrollment.
* Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study.
* Subject is post heart transplant (subjects on the heart transplant list for the first time are not excluded).
* Subject has a limited life expectancy due to non-cardiac causes that would not allow completion of the study.
* Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to device implant).
* Subject meets any exclusion criteria required by local law.