cyrilzakka/clinical-trials huggingface dataset:
Candesartan Cilexetil Special Drug Use Surveillance 「Challenge - Quality Control」

The purpose of this study is to gain an understanding of the actual use of candesartan cilexetil (Blopress) in patients with hypertension, and to examine the changes in parameters such as blood pressure.

This special drug use surveillance was planned to gain an understanding of the actual use of candesartan cilexetil in the new anti-hypertensive treatment environment where angiotensin receptor blocker (ARB) combination drugs have become commercially available. The surveillance also investigated the background factors of patients continuing treatment with candesartan cilexetil and patients who switched from candesartan cilexetil to ARB combination drugs, as well as changes in parameters such as blood pressure.

The usual adult dosage of Candesartan cilexetil is 4 to 8 mg, administered orally, once daily. Meanwhile, treatment was to be started at 2 mg once daily in patients with renal impairment and the dose could be increased up to 8 mg as necessary.

Eligibility Criteria:
Inclusion Criteria:

* Hypertensive patients

Exclusion Criteria:

1. Inpatients
2. Patients under dialysis (planned)
3. Patients with a history of coronary artery disease/cerebrovascular disorder within 6 months
4. Patients with ≥ class III of the New York Heart Association (NYHA) classification functional classification of heart failure
5. Patients that have been prescribed with candesartan (this drug/Ecard/Unisia) in the past
6. Patients who are pregnant or may possibly become pregnant
Developing a New, Dynamic, Therapeutic Pacemaker Algorithm for Stabilising Periodic Breathing in Chronic Heart Failure.

To evaluate whether cardiac output manipulation via a cardiac pacemaker can stabilise ventilation.

Many patients with heart failure exhibit a distinctive abnormal cyclical breathing pattern, 'periodic breathing'. This means that patients have a worse prognosis and they have debilitating symptoms including breathlessness, fatigue and disrupted sleep. Many of these patients also have cardiac pacemakers fitted, to improve their heart function. We have discovered a new physiological mechanism linking the heart and lungs, and have shown that by changing the programmed settings of a cardiac pacemakers, we can change a patient's breathing. If we increase the programmed pacing heart rate, we increase the rate of delivery of carbon dioxide to the lungs temporarily, which increases ventilation. When we reduce the programmed pacing heart rate, the converse happens. We aim to demonstrate this phenomenon scientifically, and to use this information to stabilise periodic breathing in heart failure patients using pacemakers. We then plan to continue to investigate whether we can show that sleep quality is improved in heart failure patients with periodic breathing, by our pacing protocol.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cardiac pacemakers implanted on standard clinical grounds, and either normal left ventricular systolic function (as assessed by echocardiogram) or impaired left ventricular systolic function and stable breathing patterns (as assessed by screening in outpatients' clinic).

Exclusion Criteria:

* Patients with atrial fibrillation with a ventricular rate of \>70 bpm will be excluded.
* Patients with implantable cardiac defibrillators with anti-tachycardia therapy set at an unusually low rate (\<120 bpm), because it would limit the ability to vary the heart rate during the experiment.
* Patients with significant respiratory disease (FEV1 \<50% predicted) will be excluded, as will patients with any condition that who have any condition precluding them from lying comfortably on a bed for 90 minutes.
* Patients who have had a recent deterioration in condition i.e. admission in previous six weeks, those in a brittle condition and those who have end-stage renal failure requiring haemodialysis.
Nature-based Therapy Program for Parkinson's Disease (PARC)

The goal of this clinical trial is to learn if a nature-based program has positive effects on the physical and psychosocial health in a group of participants with Parkinson's disease. The main questions it aims to answer are:

Will the program improve:

* The physical outcomes such as mobility, strength and balance?
* The psychosocial health outcomes?

Participants will:

* Be assessed before and after the program;
* Participate in one session per week of the intervention.

The chronic and neurodegenerative disease of Parkinson's (PD) is often characterized by movement and balance disorders, which are accompanied by an increased risk of falls. Falls are one of the most common problems that can lead to subsequent injuries (e.g., femoral head fracture) and associated mortality rates. Falls are frequent, debilitating, and have deleterious effects on self-confidence and the quality of life of individuals with PD. Additionally, according to Parkinson Canada, a high proportion of individuals living with this disease suffer from depression and/or anxiety. Therefore, it is essential to implement intervention programs aimed at improving the physical and functional capacity as well as the well-being of this population to prevent falls and promote sustainable health.

In recent years, an increasing number of studies have demonstrated the benefits of contact with nature on the physical and mental health of individuals. Specific and positive effects on psychological symptoms (e.g., depression) as well as cognition (memory) in adults have also been shown according to this recent evidence. This stimulates our research team to test the effects of a physical intervention in nature on the physical and mental health of individuals suffering from PD. One of the perspectives of this new intervention in nature is also to evaluate its impact on fall risks in this population. The ultimate goal of this project is to contribute to the sustainable health of the population.

The overall objective of this project, based on a pilot study, is to assess the effects of an 8-week nature-based intervention program on the physical and mental health of individuals with PD. Various physical measures (mobility, strength, and balance) and mental measures (level of depression, stress) will be studied in this project to better understand the effects of this type of intervention.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with Parkinson's disease (while medicated: ON);
* capable of walking independently;
* presenting mild to moderate disability symptoms according to the Hoehn and Yahr scale (stages 1-3);
* having a frailty score of less than 2/5 (Fried);
* having a cognitive status ≥26 based on the Mini-Mental State Examination (MMSE) questionnaire.

Exclusion Criteria:

* Cancer;
* Red flags (infection, tumor, etc.);
* Severe psychiatric disorders;
* Palliative care;
* Severe systemic syndromes or diseases that may prevent tests and exercises from being performed;
* Stroke - very acute phase (1 week) and this until medial hemodynamic stability.
Long-term Outcome in Late-onset Pompe Disease Treated Beyond 36 Months (STIG-Pompe-Study)

Long-term outcome in late-onset Pompe disease treated beyond 36 months (ATBIG-Pompe-Study), a multicenter, multinational, longitudinal, non-interventional observational study in subjects, at least 8 years old, diagnosed with late-onset Pompe disease retrospectively and prospectively collects data to understand clinical progression in terms of muscle and respiratory function, and clinical symptomology treated with alglucosidase alfa more than 36 months in 100 subjects.

The presentation and course of late-onset Pompe disease is much less foreseeable than the classic infantile form. Some patients experience a rapid worsening in skeletal muscle function leading to loss of ambulation and respiratory failure, while others progress less rapidly. So there is a more inconstant response to treatment in skeletal muscle and lung function in the long-term. Therefore, an unmet clinical need is the collection and analysis of long-term data of rhGAA enzyme replacement therapy (ERT) in late-onset Pompe disease patient aged 8 years and older. The principal goal of our investigator driven study is to gain conclusive insight in long-term outcome data beyond 36 months up to 10 years of ERT treatment. In addition we will collect biological samples from all patients for a future biomarker study including gene modifier search by genome and RNA seq (not part of this proposal). This study may provide clinicians and researchers with a better understanding of late-onset Pompe disease under long-term treatment, to the benefit of all patients affected with late-onset Pompe disease, as well as, individuals and families with related diseases.

Eligibility Criteria:
Inclusion Criteria:

* Late-onset Pompe patients, aged over 8 years.
* The patient is willing and able to provide signed informed consent.
* The patient (and patient's legal guardian if patient is under 18 years of age) must have the ability to comply with the clinical protocol.
* Long-term Myozyme treatment beyond 36 months.
* Known GAA genotype.
* GAA activity (Dried blood spot testing, or other methods).

Exclusion Criteria:

* - The patient is concurrently participating in another clinical study using Myozyme or other treatment.
* The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study.
* The patient has clinically significant organic disease (with the exception of symptoms relating to Pompe disease), including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, precludes participation in the study or potentially decreases survival.
Anesthesia for Awake Fiberoptic Intubation

This is a prospective, comparative, randomized, monocentric, clinical open study, to compare two anesthesia techniques (translaryngeal injection vs. spray as you go) in patients with cervical instability with regard to technical modalities and quality of fiberoptic awake intubation.

In patients with cervical instability anesthesia induction and conventional intubation are associated with the risk of neurological harm. Therefore the method of choice for anesthesia induction is the fiberoptic awake intubation. This method allows to place the ventilation tube without movement of the cervical spinal cord. This procedure is very uncomfortable for the patient and needs the application of topic and/or systemic anesthetics.

With this clinical study we will compare two established techniques for local laryngeal anesthesia with regard to the quality of technical modalities and postoperative outcome.

Eligibility Criteria:
Inclusion Criteria:

* patients with cervical instability undergoing elective decompression of cervical spine

Exclusion Criteria:

* patient refused participation
* contraindications for awake intubation techniques (e.g. nasal bleeding, anatomical disorders)
* patient under alcohol or drugs
* emergency surgery
Terminator 2 Register

All patients with chronic HBeAg negative hepatitis B treated with nucleos(t)ide analogues, who discontinue treatment based in the criteria outlined in the EASL hepatitis B guidelines shall be included in the present study. The aim is to evaluate the clinical outcome (virological relapse, HBsAg decline) and associated virological and immunological parameters.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients with chronic hepatitis B virus infection documented by detectable HBsAg.
2. Age \> 18 years
3. Ongoing antiviral therapy with Entecavir or Tenofovir (TDF)
4. At least 3 years HBV-DNA \< 20 IU/ml (=100 copies/ml)
5. HBeAg negative
6. Willingness to give written informed consent and willingness to participate and to comply with the protocol.

Exclusion Criteria:

1. HIV infection, persistent HDV-infection, persistent HCV infection
2. History or other evidence of a medical condition associated with chronic liver disease other than HBV associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures).
3. History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
4. Patients with advanced liver fibrosis and liver cirrhosis (fibroscan \>10.0 kPa)
5. Patients with hepatocellular carcinoma
6. History of major organ transplantation or other immunosuppressive conditions
7. History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
8. History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 12 months prior to cessation of antiviral therapy or the expectation that such treatment will be needed at any time during the study

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Implementation Intention for Physical Activity in Multiple Sclerosis

The purpose of this study is to evaluate the effectiveness of an 8-week intervention based on implementation intention (motivation) in patients with multiple sclerosis on objectively measured physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Adult aged between 18 and 65 years
* Multiple sclerosis
* Recruited from CHU Poissy saint germain or Hôpital Raymond-Poincaré
* Informed consent provided during inclusion interview

Exclusion Criteria:

* Already participating in a clinical trial
* Cognitive dysfunctions in understanding simple guidelines
* Treatment reducing fatigue since less than 3 months
* Psychiatric disorders
* Unability to exercise
* Previous cardiovascular diseases
* Regular physical activity practice
Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma

Patients with relapsed or refractory lymphoma often develop resistance to chemotherapy. Chimeric antigen receptor-modified T cell (CART) therapy showed promising effect in B-cell malignancies these years. CD19 and CD22 are proteins expressed on the surface of the lymphoma cells in patients with CD19+CD22+ lymphoma. The CAR enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22. This is a phase 2 trial to study the safety and efficacy of dual specificity CD19 and CD22 CAR-T cell immunotherapy for CD19+CD22+ relapsed and refractory lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Histological detection confirmed CD19/CD22 postive lymphoma;
* Recieved more than 2 lines of chemotherapy;
* Not eligible for hematopoietic stem cell transplantation or relapsed after hematopoietic stem cell transplantation;
* Life expectation for more than 3 months;
* ECOG ≥ 2;
* Adequate organ function: EF≥50%; normal ECG; CCR≥40ml/min; ALT and AST ≤ 3 × upper limitation of normal, T-BIL ≤ 2.0mg/dl; PT and APTT \< 2 × upper limitation of normal; SpO2 \> 92%;
* CBC results: Hb ≥ 80g/L, ANC \> 1 × 10E9/L, Plt ≥ 50 × 10E9/L;
* Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion;
* With measurable disease;
* Written informed consent could be acquired;

Exclusion Criteria:

* Immunosuppressive agents or steroids in recent 1 week before recruitment;
* Uncontrolled infection;
* HIV positive ;
* Active HBV or HCV infection;
* Women in pregnancy and lactation;
* Refuse to conception control during treatment and 1 year after CAR-T infusion;
* Uncured malignancies other than non-Hodgkin lymphoma;
* Have participated similar trial for treating relapse/refractory non-Hodgkin lymphoma;
* Inheritated immune deficiancy;
* Severe heart disease.
Heart EXPAND Continued Access Protocol

The OCS™ Heart System will be used to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria for transplantation in this continued access protocol.

To provide additional data evaluating the safety and effectiveness of the OCS™ Heart System to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation at a range of transplant centers in the U.S. and to permit patients and physicians access to the OCS Heart System while a PMA application is under preparation and review.

Eligibility Criteria:
Inclusion Criteria (DONOR):

At least one of the following:

* Expected total cross-clamp time of ≥ 4 hours
* Expected total cross-clamp time of ≥ 2 hours PLUS one or more of the following risk factors Donor age 45-55 years, inclusive, with no coronary catheterization data; or Donor age ≥ 55 years; or Left ventricular septal or posterior wall thickness of \>12 mm, but ≤ 16 mm; or Reported down time of ≥ 20 min, with stable hemodynamics at time of final assessment; or Left heart ejection fraction (EF) ≥ 40%, but ≤ 50% at time of acceptance of offer; or Donor angiogram with luminal irregularities with no significant CAD (≤ 50%); or History of carbon monoxide poisoning with good cardiac function at time of donor assessment; or Social history of alcoholism with good cardiac function at time of donor assessment; or History of diabetes without significant CAD (≤ 50%) on angiogram.

Exclusion

* CAD with \> 50% stenosis on angiogram, or
* Cardiogenic shock or myocardial infarction, or
* EF consistently \< 40%, or
* Significant valve disease except for competent bicuspid aortic valve.

Eligibility Criteria (RECIPIENT)

* Registered primary heart transplant candidate
* Age \>18 years old
* Written informed consent. Exclusion
* Prior solid organ or bone marrow transplant
* Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal insufficiency requiring dialysis
* Multi-organ transplant.
Rapid dEvice Testing pROtocol for Parkinson's Disease

This is an 8 week observational study to evaluate the feasibility of using remote monitoring technologies in future studies of PD. The study will 2 clinical evaluations (one initial, one final), and an 8-week monitoring period including 4 virtual visits where participants will use a combination of digital devices (Emerald touchless sensor system with associated ankle accelerometer, iPhone, Apple Watch, iPad, Fitbit Aria, FitBit Versa, Withings Blood Pressure Monitor Connect, and/or Withings Sleep Mat) during their daily lives.


Eligibility Criteria:
Inclusion Criteria:

Participants with PD

* At least 30 years of age
* Clinical diagnosis of PD by a neurologist or other movement disorder specialist as reported by the participant, with current motor symptoms
* Able to ambulate independently (assistance of minor walking aids such as a cane is permitted, but depending on a walker for ambulation is not)
* Have a BMI of 33 or below calculated by participant reported height and weight at the time of screening
* Have a care partner who meets the study's inclusion criteria
* Able to read, understand, and provide written informed consent in English
* Able, either alone or with a care partner, to operate digital devices
* Have reliable wifi in their home and the ability to connect new devices to their home wifi

Care partners

* At least 18 years of age
* Able to read, understand, and provide written informed consent in English
* Able to operate digital devices
* Care partner for the participant with PD enrolled in the study
* Lives with the participant with PD enrolled in the study
* Able to ambulate independently (assistance of minor walking aids such as a cane is permitted, but depending on a walker for ambulation is not)
* Willing to exclude pet from the participant's bedroom at night for the duration of the study

Exclusion Criteria:

Participants with PD

* Any non-PD forms of Parkinsonism
* Active psychiatric disorders that affect the ability to complete study tasks
* Any other medical condition that is the primary cause of the present movement disorder
* Cognitive dysfunction (score \> 7 on the Six-Item Cognitive Impairment Test)
* Considered by the investigator to be an unsuitable participant
* Live in a household with more than three people
* Unwilling to exclude pet from their bedroom at night for the duration of the study

Care partners

* Cognitive dysfunction (score \> 7 on the Six-Item Cognitive Impairment Test)
* Considered by the investigator to be an unsuitable participant
Fall Risk Assessment in People With Diabetic Neuropathy

Fall risk is increased in people with diabetic peripheral neuropathy (DPN) and yet, minimal research has been conducted to identify appropriate fall risk assessment tools and improve our understanding of falls in these individuals. Purpose: The primary purpose of this study is to establish a foundation of knowledge needed to address falls in people with DPN. This will be accomplished through 1) comparing the validity of 4 fall risk assessment tools, 2) identifying risk factors for falls and 3) determining how quality of life is influenced by factors related to falls in people with DPN.

All subjects participate in testing that involves questionnaires, cognitive testing, fall risk assessment, and other testing related to physical parameters including body mass index, glycosylated hemoglobin, lower extremity nerve conduction study, and ankle range of motion, proprioception and strength. After testing, subjects are interviewed to determine fall status (faller or non-faller). A "faller" is defined as someone that has fallen at least 2 times in the past year. Data Analysis: The validity of the fall risk assessment tools will be compared using sensitivity and specificity analyses. Variables related to ankle function, neuropathy, glycemic control and general activity will be analyzed for association with recent fall history through multivariable logistic regression. Variables related to falls, neuropathy and activity level will be analyzed for association with health-related quality of life through multivariable linear regression.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with diabetic peripheral neuropathy

Exclusion Criteria:

* major medical depression
* non-diabetes related musculoskeletal problems that limit ambulation
* open wounds on the weight bearing surfaces of the feet
* requires another person's assistance to walk
* uncorrected visual deficits that influence gait and/or balance
* history of stroke or other CNS pathology that impairs gait and/or balance
* diagnosed untreated vestibular disorder that results in gait and/or balance disturbances
DMT210 Topical Gel in the Treatment of Acne Rosacea

The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of participants will receive DMT210 Gel while the other half will receive vehicle control.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or non-pregnant female at least 18 years of age.
* Clinical diagnosis of moderate to severe facial rosacea as determined by Investigator's Global Assessment (IGA) at Randomization
* Patient has at least ten inflammatory lesions of rosacea on the face at Randomization
* Patient is willing to apply the Investigational Product as directed
* Patient is willing and able to comply with the protocol

Exclusion Criteria:

* Patient is pregnant or planning to become pregnant
* Patient is taking a topical therapy which may affect the patient's rosacea