cyrilzakka/clinical-trials huggingface dataset:
Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline

The purpose of this study was to support the optimal use of rivastigmine patch in long-term treatment of Alzheimer's Disease in patients demonstrating functional and cognitive decline at the target maintenance dose of rivastigmine patch 10 cm\^2.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients between 50 and 85 years of age with a diagnosis of probable Alzheimers Disease,
* Baseline Mini-Mental State Examination (MMSE) score 10-24 inclusive,
* A primary caregiver willing to accept responsibility for supervising treatment, assessing the patient's condition throughout the study, and for providing input into efficacy assessments.
* For double blind only: Meet the decline criteria of functional (as assessed by the investigator) and cognitive (assessed by a 1 point reduction in Mini-Mental State Examination) score between visits or a 3 point reduction from baseline) decline at weeks 23, 36 or 48.

Exclusion Criteria:

* Presence of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments or put the patient at particular risk,
* Any medical or neurological condition other than Alzheimers Disease that could explain the patient's dementia,
* A diagnosis of probable or possible vascular dementia,
* A current diagnosis of unsuccessfully-treated depression, or any other mental disorder that may interfere with the evaluation of the patient's response to study medication,
* A history or current diagnosis of cerebrovascular disease (e.g. stroke),
* A current diagnosis of severe or unstable cardiovascular disease (e.g. unstable coronary artery disease).

Other protocol-defined inclusion/exclusion criteria may apply.
Measurement of Maximum Diameter of Native Abdominal Aortic Aneurysm by Angio-CT

Screening for an abdominal aortic aneurysm, monitoring its growth and evaluation of its risk of rupture are based on the measure of its maximum diameter. The abdominal aortic aneurysm's treatment to prevent its rupture is recommended from a threshold of 50-55 mm in men and of 45-50 mm in women.

The importance of this measure for patient management justify a specific and homogeneous protocol of measure. However, the diversity of methods of measuring the maximum diameter with scanner and ultrasound was shown.

The impact of various angio-CT based measures of maximum AAA diameter, and the impact of reproducibility limits on the decision to operate have never been investigated.

The aims of the study were :

Analyze the consequences on clinical decisions of this wide choice of methodologies for measurement of abdominal aortic aneurysm maximum diameter when using angio-CT; Identify the method of measurement that yields the best agreement for patient management.

Eligibility Criteria:
Inclusion Criteria:

* patients with abdominal aortic aneurysm

Exclusion Criteria:

* inflammatory aneurysm
* false aneurysm
* aneurysm after open repair or stent graft
Motivation and Barriers for Exercise in Patients With Anxiety or Posttraumatic Stress Disorder

Relevance and Aim: There has been increasing research interest in sport preferences and motivational factors as well as barriers that restrain from engaging in sport activities in people suffering from mental illnesses. Anxiety disorders are one of the leading mental disorders worldwide. Exercise has previously shown anxiolytic effects and is discussed as an adjunctive treatment option in clinical practice. This study aims to depict motivation and barriers in patients with anxiety or posttraumatic stress disorders.

Design and Participants: Observational study of patients diagnosed with anxiety disorder or posttraumatic stress disorder (ICD-10)

Measurements: Structured questionnaire compounded of validated scales for current physical activity, sport motivation, exercise preferences, perceived barriers , self-efficacy, social support for physical activity, motivation,enjoyment, quality of life as well as sociodemographic data.

Duration: The questionnaire will require approximately 20 minutes, the overall duration is 3 months. Personal assistance for completing the questionnaire will be provided if necessary.


Eligibility Criteria:
Inclusion Criteria:

* In- and out-patients with a diagnosed anxiety or posttraumatic stress disorder (F40, F41, F43.1; ICD-10)
* 18 to 65 years

Exclusion Criteria:

* acute psychosis or suicidal behaviour
* cognitive deficits
* problems with German language
A Prospective Open-Label Extension Study of Gaboxadol in Primary Insomnia

To evaluate the safety and tolerability of gaboxadol in primary insomnia

To evaluate long-term safety of gaboxadol in healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of primary insomnia
Accuracy of Anthropometric Equations for Estimating Body Fat in Professional Male Soccer Players Compared With DXA

This study aimed to analyze the accuracy of different anthropometric equations to estimate body fat in professional male soccer players, setting DXA body fat as the reference.

The study consisted of evaluating anthropometric measurements and body composition with DXA in professional male soccer player aged 18 years and older. Standardized and certified personnel carried out anthropometric measurements and DXA whole body scan the same day.

Body fat was estimated with several anthropometric equations. These equations were divided into two groups: 1) Derived from non-athletic samples; and 2) Derived from athletic samples.

The body fat estimated from anthropometric equations was compared with DXA, and those with non-significant differences were further analyzed for calculating mean differences and 95% limits of agreement with DXA. This analysis was carried out for all equations.

Eligibility Criteria:
Inclusion Criteria:

* Signed contract with the team

Exclusion Criteria:

* Injured
CKD-828 Primary Hypertension Trial(Dose-selection)

The aim of this trial is to determine the best dose combination of S-Amlodipine and Telmisartan as compared to monotherapy by assessing the blood pressure lowering effects of a once daily regimen of various combinations of S-Amlodipine and Telmisartan, compared to their monotherapy components and placebo, in patients with stage I or II essential hypertension(a mean seated cuff diastolic blood pressure \>=95 and \<=115 mmHg).


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure \>=95 and \<=115 mmHg
* ability to provide written informed consent

Exclusion Criteria:

* severe hypertension defined as: a mean seated cuff diastolic blood pressure \>=116mmHg or a mean seated cuff systolic blood pressure \>=200mmHg
* known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
* has severe heart disease(Heart failure NYHA functional class 3, 4), unstable angina or myocardial infarction, arrhythmia within the past three months
* has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
* Type I Diabets Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) \> 8%
* known severe or malignant retinopathy
* hepatic or renal dysfunction as defined by the following laboratory parameters: AST/ALT \> UNL X 2, serum creatinine \> UNL X 1.5
* acute or chronic inflammatory status need to treatment
* need to additional antihypertensive drugs during the study
* need to concomitant medications known to affect blood pressure during the study
* history of angioedema related to ACE inhibitors or Angiotensin II Receptor Blockers
* known hypersensitivity related to either study drug
* history of drug or alcohol dependency
* any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, currently active gatritis, ulcers of gastrointetinal/rectal bleeding, impaired pancreatic fuction such as pancreatitis,obstructions of the urinary tract or difficulty in voiding)
* cannot swallow investigational products
* administration of other study drugs within 4 weeks prior to randomization
* premenopausal women(last menstration \< 1year) not using adequte contraception, pregnant or breast-feeding
* history of malignancy including leukemia and lymphoma within the past 5 years
* in investigator's judgment
Psycho-social Intervention With Paro Robotic Seal Focused on Patients With Dementia

The overall objective of the study is to evaluate the improvement in patient-perceived quality of life following the use of the Paro robot integrated with traditional intervention in the elderly with dementia.

The primary aim of this study is to evaluate the patient-perceived improvement in terms of quality of life through Quality of Life - Alzheimer's Disease (QoL-AD), following the use of the Paro robot, integrated with traditional intervention carried out within the IRCCS INRCA Alzheimer's Day Center.

The Secondary aims are the evaluation of the improvement in cognitive status of the elderly person with dementia, in terms of orientation, attentional-executive, mnestic and visuospatial functions, detected through the Addenbrooke's Cognitive Examination (ACE-R); the assessment of mood improvement in terms of reduction of anxiety and depression, detected through the Rating Anxiety In Dementia (RAID) scale and the Cornell Scale for Depression in Dementia (CSDD); the assessment of the elderly person's acceptance of the technology through Quebec User Evaluation of Satisfaction (QUEST 2.0), semi-structured interview and analysis of physiological activation during interaction, with the Noldus Face Reader system and direct observation by the operator; the analysis of behavioral symptomatology through Neuropsychiatric Inventory (NPI); the assessment of practitioner's acceptance of technology through Technology Acceptance Model (TAM) and the assessment of job quality through semi-structured interview.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild-moderate dementia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM V).
* MMSE between 10 and 24
* Attending the Alzheimer's Day Center since at least 3 months
* Presence of a caregiver

Exclusion Criteria:

* Severe sensory disabilities (visual and auditory)
* Comprehension difficulties
* History of syncopal episodes, epilepsy, and dizziness not controlled pharmacologically
* Severe autonomic system dysfunction
* Severe behavioral syndromes not compensated by medication
Restoring Sinus Rhythm With Cardiac Resynchronization in Patients With Atrial Fibrillation (ReSync AF)

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy may be prescribed.

People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD).

Atrial tachyarrhythmia (AT) is the name for rapid beats in the upper chambers of the heart. People with AT may experience symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of breath, dizziness, fatigue or weakness.

The purpose of this study is to characterize the impact of cardiac resynchronization therapy versus cardiac resynchronization therapy with atrial therapies on the incidence, duration and termination of atrial tachyarrhythmias.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with atrial fibrillation
* Subjects with a heart beat that is too fast and who have been determined by a doctor to require an implantable cardioverter defibrillator (ICD) i.

Exclusion Criteria:

* Subjects with a natural heart rate less than 30bpm
Efficacy and Central Mechanism of Acupuncture for Treating Chronic Subjective Tinnitus Assessed by fNIRS

This randomized controlled pilot trial aims to explore the Efficacy and central mechanism of acupuncture for treating chronic subjective tinnitus using functional near-infrared spectroscopy (fNIRS).

A total of 60 tinnitus patients were randomly assigned to either an acupuncture group or a waiting list group in a 1:1 ratio. Subjects in the acupuncture group will undergo 4-week acupuncture treatment, while subjects in the waiting list group will receive no treatment during the 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Bilateral tinnitus that meets the diagnostic criteria for chronic subjective tinnitus.
2. Male and female, Aged between 18 and 60 years.
3. Participants can cooperate with experimental procedures and sign written inform consent.
4. Not participating in other clinical trials concurrently.

Exclusion Criteria:

1. Participants with objective tinnitus
2. Participants have nervous system diseases or neuropsychiatric diseases that can significantly affect brain blood oxygen metabolism assessed by resting-state functional connectivity.
3. Participants with severe cardiovascular and cerebrovascular diseases, malignant liver and kidney diseases, and other serious diseases.
4. Participants have any contraindications for acupuncture (such as a bleeding tendency)
5. Pregnant or lactating women.
6. Participants have received tinnitus treatment with drugs or other therapies in the last four weeks.
Oral AHR Antagonist in Combination With Nivolumab in Patients With PD-1 Resistant Metastatic or Recurrent Head and Neck Cancer

This is a phase 1b study in adult patients diagnosed with resistant or recurrent head and neck squamous cell carcinoma (HNSCC) designed to assess the safety and tolerability of IK-175 in combination with nivolumab. Disease response, pharmacokinetics (PK), pharmacodynamics, and response biomarkers will also be assessed.

This is an open-label, multicenter, phase 1b dose-expansion study to evaluate the safety, tolerability, preliminary antitumor activity, PK, and pharmacodynamics of 2 dose levels of IK-175, administered PO in combination with nivolumab, in patients with primary PD-1-resistant metastatic or locally incurable, recurrent HNSCC for which standard therapy is no longer effective or is intolerable.

Eligibility Criteria:
Key Inclusion Criteria:

* Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Subject has a histologically confirmed metastatic or locally incurable, recurrent HNSCC that has progressed within 12 weeks of initiation of PD-1 inhibitor agent, whether it was administered alone or in combination with chemotherapy.
* Tumors must express PD-L1 with a minimum CPS ≥ 1.
* Subjects can be enrolled regardless of their tumor's expression of human papillomavirus (HPV).
* Subjects are required to have received prior treatment with a platinum-based chemotherapy in the recurrent or metastatic disease setting, unless medically contraindicated.
* Subject has at least 1 measurable lesion per RECIST v1.1.

Key Exclusion Criteria:

* Subject has untreated or symptomatic central nervous system (CNS) tumors or brain metastases.
* Subject must have recovered to ≤ Grade 1 from clinically significant AEs related to prior therapy (eg, myelosuppression or renal or hepatic dysfunction.)
* Subject has received prior treatment with an AHR inhibitor.
* Subject has a medical condition that limits oral administration or impairment of gastrointestinal function that is expected to significantly reduce the absorption of IK-175.
* Uncontrolled or life-threatening symptomatic concomitant disease.
* Clinically significant cardiovascular disease as defined in the protocol.
* Subject is on a medication that is a sensitive substrate of CYP2C8, 2C9, 2C19, or 3A4 that cannot be substituted.
* Females who are pregnant or breastfeeding.

Other inclusion/exclusion criteria are listed in the protocol.
Noninvasive Positive Pressure Ventilation in Moderate Acute Respiratory Distress Syndrome

In order to identify the effect of noninvasive positive pressure ventilation (NPPV) on decreasing inflammatory response, improving the pathophysiological manifestation and reducing the morbidity and mortality in the moderate acute respiratory distress syndrome (ARDS) patients, the investigators conduct this clinical trial comparing NPPV with invasive mechanical ventilation in more than twenty ICUs in China.


Eligibility Criteria:
Inclusion Criteria:

1. acute onset
2. a clinical presentation of respiratory distress
3. arterial oxygen tension/inspired oxygen fraction (PaO2/FiO2) between 200 mmHg to 300 mmHg. The arterial oxygen tension will be measured in fifteen minutes after NPPV (CPAP 5 cmH2O) was used to the patients stably
4. presence of bilateral pulmonary infiltrate on chest radiograph
5. no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure( PAWP) \< 18 mmHg

Exclusion Criteria:

1. age \> 70 years or \< 18 years
2. PaCO2 \> 50mmHg
3. Glasgow Coma Scale (GCS)\< 11
4. Upper airway/facial deformity or injury
5. pneumothorax or pneumomediastinum
6. unable to spontaneously clear secretions from their airway
7. respiratory arrest
8. severe ventricular arrhythmia or active myocardial ischemia
9. severe organ dysfunction (including gastrointestinal hemorrhage, disseminated intravascular coagulation, hepatic and renal dysfunction, SOFA score \> 1)
10. severe chronic lung diseases(COPD, Asthma or ILD, et al)
11. end-stage patients who are expected to survive less than six months
12. severe abdominal distension
13. refuse to receive NPPV
14. unable to cooperate with NPPV
Digital Foot Self-Management Program for Older-Diabetes

The aims of this proposed study are to evaluate the effect of a digital foot self-management program on the primary outcome of self-efficacy, and secondary outcomes of self-care behaviors, HbA1c and health promotion satisfaction for older adults with type 2 diabetes.

Literature reveals the needs for diabetic foot self-management intervention programs associated with positive changes in behavior. However, lack of studies focused on measure or improve health outcomes. Promoting effective diabetic foot care strategies in community is more critical than ever during a pandemic such as COVID.

This study are to evaluate the effect of a digital foot self-management program on self-efficacy, self-care behaviors, HbA1c and health promotion satisfaction for older adults with type 2 diabetes.

The contents of the 4-week program include: using a digital platform to providing foot self-management (checking conditions of foot, cleaning, cutting or removing corns and calluses, trimming, clipping nails, foot exercise, dietary related to foot care, foot care logs, etc). A developed digital platform as a self-help foot self-management education resource. The program specifically developed for older adults with diabetes to assist and management their own feet at homes. Week 1 face-to-face training session. Week 2 to week 4 following phone call once per week and LINE messages 3 times per week.by research nurse to encourage and monitor participant's compliance with the program at home by using the digital platform.

A total of 100 older adults with type 2 diabetes will be recruited from the 5 community clinics in southern Taiwan.A computerised random number generated by an independent statistician will be used to allocate each potential participant to the control or intervention group in a one-to-one ratio. All participants will be blinded to group allocation. Participants in control group will receive routine care provided in diabetes clinic, including routine check-ups and foot care education. While participants in the intervention group received the digital foot self-management program in addition to the routine care. Data will be collected at baseline and 4 weeks from baseline for self-efficacy, self-care behaviors,health promotion satisfaction and 12 weeks from baseline for HbA1c. The digital program will be delivered by trained registered nurse. A research assistant will be blinded to study protocol, who are employed to undertake data collection.

Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with type 2 diabetes.
* ≧65 years.
* Possess and able to use a smart device (e.g. Samsung Galaxy, iPhone, iPad, tabletop)
* Are able to speak and comprehend Chinese

Exclusion Criteria:

* Unable to perform physical activities.
* Cognitive impairments.
* Unable to read and speak Chinese
Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis

NutriPEPA2 is a randomized, single-blind, prospective, multicenter trial, in two parallel arms to confirm that the adsorbent PEPA membrane may decrease mortality related to inflammation and malnutrition encountered in HD or HDF-treated stage 5 renal failure compared to a non-adsorbent synthetic membrane.

The objective of NutriPEPA2 study is to demonstrate that the use of an adsorbent membrane (PEPA-Poly Ester Poly Arylate synthetic co-polymer membrane) decreases undernutrition (often associated with inflammation) and consequently morbidity, comparing one year mortality in patients with Chronic Kidney Disease (CKD), with severe Protein-Energy Wasting (PEW), treated with dialysis using a non-adsorbent synthetic membrane (Polysulfone or Polyethersulfone) versus an adsorbent membrane (PEPA).

Eligibility Criteria:
Inclusion Criteria:

* Patient with Chronic Renal Insufficiency Stage 5, treated by fistula or permanent catheters,
* Medium albumin (on 3 recent assays) of less than 35 g / l (this assay being carried out by a non-electrophoretic technique),
* PINI score greater than or equal to 1,
* Beginning of the treatment of extra-renal purification by hemodialysis for at least 3 months on a non-adsorbing synthetic membrane (of the Polysulfone, Polyethersulfone, PolyArylethersulfone type) of surface at least equal to that of the PEPA dialyser

Exclusion Criteria:

* Patients allergic to PEPA,
* Patients with insufficient vascular access,
* Patients with digestive syndromes: Hepatopathy, gastrointestinal amyloidosis, chronic diarrhea, myeloma and dysglobulinaemia, neoplasia and hematopathy, a serious illness that is life-threatening in the short term,
Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping)

An extension of the PREMOD2 trial, the PREMOD2 Follow-Up trial will evaluate the neurodevelopmental outcomes at 22-26 months corrected age of preterm children who received UCM or DCC. This prospective multi-national randomized controlled trial (RCT) is a two-arm parallel non-inferiority design of two alternative approaches of treatment.

The PREMOD2 Follow-up trial will examine the difference in early childhood neurodevelopmental outcomes of subjects enrolled in the PREMOD2 umbilical cord milking (UCM) vs. delayed cord clamping (DCC) trial, using standardized neurologic and developmental assessments at 22-26 months corrected age (CA). The corrected age may be extended out to 42 months CA due to Covid-19 pandemic for undetermined period of time.

Eligibility Criteria:
Inclusion Criteria:

* Children enrolled in the PREMOD2 non-inferiority trial at birth who survive to 2 years corrected age.

Exclusion Criteria:

* Children enrolled in the PREMOD2 non-inferiority trial at birth who did not survive or are lost to follow-up.