cyrilzakka/clinical-trials huggingface dataset:
Utilizing Wearable Device to Observe the Clinical Response of COPD Patients Treated With Combined Bronchodilator and Home-based Pulmonary Rehabilitation Program

The effectiveness of combined bronchodilator and exercise training on improving exercise capacity has been reported in COPD. However, little is known about effect of respective treatment in a real-time monitoring. Investigators applied wearable devices in monitoring continuously in COPD patients under treatment of combined dual bronchodilator and exercise training and research on associated inflammatory biomarkers profiles change

The prevalence of chronic obstructive pulmonary disease (COPD) has increased year by year and the estimated mortality rate by 2030 will be in the fourth place. Estimated global prevalence of COPD in the population over age 40 is about 9-10% of the population. In Taiwan, the prevalence is about 16%. COPD is characteristic of irreversible airflow obstruction due to the pathological changes in the small airways, lung parenchyma and pulmonary vessels with chronic inflammation of the specific immune cells, as well as structural changes.

Although studies have suggested that exercise training in patients with COPD benefit the physical activity, but the anti-inflammatory benefits is unknown.Consider individual needs, this study will use the home mobile coach from Dr. Liu domestic development program to further investigate chronic obstructive pulmonary disease patients after receiving this training program,performance and analysis in the clinical laboratory to explore anti-inflammatory and pro-inflammatory between relevance and mechanisms in patients with COPD under real-time wearable devices monitoring

Eligibility Criteria:
Inclusion Criteria:

1. Global Initiative for Chronic Obstructive Lung Disease (GOLD) according to diagnostic criteria of chronic obstructive pulmonary disease (age ≧ 40 years old and ≦ 85 years old), that the use of post-bronchodilator inhalation, pulmonary function test results of the forced expiratory volume first second (FEV1.0) / forced vital capacity (FVC) \<70% 2. COPD patients is not currently accepting any pulmonary rehabilitation program 3. Currently in a stable condition, after researchers explained the purpose of this study, the researchers agreed to participate.

Exclusion Criteria:

1. Asthma, bronchiectasis, tuberculosis, pneumoconiosis, or other pulmonary diseases
2. Associated with neuromuscular function disorders such as hemiplegia or no independent walking function;
3. Severe heart disease, such as acute myocardial infarction, serious or heart failure, etc.
4. Diagnosed with severe mental disorders such as dementia or poor compliance
5. Acute exacerbation or infection in 3 months
Neuron Specific Enolase (NSE) as Outcome Parameter of Cooling Therapy After Survived Sudden Cardiac Death

Sudden cardiac death remains one of the major leading causes of death. Therapeutic hypothermia is a validated standard procedure to avoid or minimize cognitive deficits after cardiac arrest. To assess the efficiency of different cooling methods and further improve these methods, the investigators collected blood samples to measure the neuron specific enolase (NSE) in patients treated with invasive cooling as compared to patients treated with non-invasive cooling.

Consecutive patients with restoration of spontaneous circulation after resuscitation due to sudden cardiac death were randomized to either non-invasive or invasive cooling for at least 24 hours. NSE was collected at designated time points and compared between patients treated with invasive cooling and those treated with non-invasive cooling. Neurological outcome was assessed between groups at hospital discharge and 6 months after discharge.

Eligibility Criteria:
Inclusion Criteria:

* ROSC after sudden cardiac death (SCA) due to VF/VT or PEA/Asystolia
* GCS 3

Exclusion Criteria:

* Non-cardiac sudden death
* Pregnancy
* Unstable circulation with high-dose inotropics
* Life-expectancy reducing concomitant illness
Lithium Cannabis Withdrawal Study

This trial will examine the efficacy of lithium in providing symptomatic relief from the withdrawal discomfort experienced by some dependent users of cannabis on cessation of regular use. Significant withdrawal may be a barrier to achieving abstinence in some clients and can be associated with marked disturbances in mood, sleep, hostility and aggression. Relief from such symptoms may be important in helping some clients achieve a period of abstinence and facilitate subsequent entry into a relapse prevention program.

There are currently no accepted pharmacotherapies for the management of cannabis withdrawal. A recent study by Cui et al (2001) investigated the effects and mechanism of lithium on cannabinoid withdrawal in rats. The researchers found that lithium administration prevented the development of withdrawal symptoms, and suggested that increased oxytocin secretion resulting from lithium dosing prevented the withdrawal syndrome from occurring. Although caution should be exercised in generalising the results of an animal study, preliminary results of a small pilot study in humans are consistent with the potential utility of lithium in the management of human cannabis withdrawal (Zhang, personal communication). Furthermore, human use of lithium is well established and the addition of a readily available drug such as lithium carbonate would be a useful clinical tool should it prove efficacious in a series of clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of cannabis dependence with at least a three-month history.
* Seeking treatment for primary cannabis problem
* Withdrawal identified as barrier to abstinence

Exclusion Criteria:

* Other drug dependency (excluding nicotine)
* Client is breastfeeding or pregnant.
* Client has contraindicated medical or psychiatric conditions.
* Client currently taking other medications that may interact with lithium.
* Known hypersensitivity / side effects with Lithium.
* Currently receiving Lithium from another source.
* Currently prescribed any antidepressant / mood stabilising / antipsychotic medication.
* Currently receiving opioid pharmacotherapy.
A Study of 2 Doses of MAP0010 in Asthmatic Children

The purpose of this study is to examine the safety of two doses of MAP0010 in asthmatic children, 12 months to 8 years of age, over a 40-week period.


Eligibility Criteria:
Inclusion Criteria:

* Completed 12 weeks of treatment in the MAP0010-CL-P301 study.
* Patient, parent, and guardian (as appropriate) are willing for child to undergo all study procedures and willing to sign the informed consent and assent, as appropriate.

Exclusion Criteria:

* Less than 80% compliance with either study treatment and/or other study procedures (e.g., completion of symptom e-diary) in the MAP0010-CL-P301 Study.
Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease

This study has three objectives about persons with Parkinson's Disease during bicycling:

1. Determine the effect of visual feedback and competition during virtual bicycling on neuromuscular and cardiovascular intensity
2. Determine the effect of visual-feedback and competition during virtual bicycling on the user experience of motivation, enjoyment \& perception of exercise intensity
3. Determine if attention differs during visual feedback compared to competition virtual bicycling

Participants will attend one sessions lasting about 2-3 hours. They will complete movement assessments and questionnaires about physical activity. They will then exercise exercise in three different virtual reality augmented bicycling conditions while wearing a head mounted display (goggles). Each of the three conditions will last approximately 8 minutes and will be followed by questionnaires about the participant's experience.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease following the UK Brain Bank Diagnostic Criteria,
* Hoehn and Yahr stages II-III,
* 45-80 years old,
* Able to ride a stationary upright bicycle,
* Able to sign informed consent.

Exclusion Criteria:

* Have a recent history of severe heart disease, severe lung disease, uncontrolled diabetes, traumatic brain injury or neurological disorder other than Parkinson Disease,
* Are unable to follow directions or sign a consent form,
* Do not have adequate vision or hearing ability to see or hear a television,
* Have unstable medical condition or musculoskeletal disorder such as severe arthritis, recent knee surgery, hip surgery, or any other condition that the investigators determine would impair the ability to ride the bicycle,
* Have any other medical condition that prevents bicycling,
* Have moderate depression (score of 9 or more on GDS screening tool).
Study of the Clinical Efficacy of Autologous SCT in Patients With Critical Limb Ischemia

Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in patients with Critical Limb Ischemia

Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in patients with Critical Limb Ischemia

Eligibility Criteria:
Inclusion Criteria:

* Patients with Critical Limb Ischemia

Exclusion Criteria:

* Patients with other than Critical Limb Ischemia
Assessment of The Efficacy of Intratympanic Platelet Rich Plasma for Treatment of Sensorineural Hearing Loss.

Assessment of the efficacy of Intratympanic platelet rich plasma injection for treatment of idiopathic suden sensorineural hearing loss

Sensorineural hearing loss is the collective term for hearing damage to the cochlea and auditory nerve and is by far the most common type of hearing loss in adults, accounting for over 90% of all cases. Sensorineural hearing loss is a heterogeneous disorder, which can arise due to damage to pathway for sound impulses from the hair cells of inner ear to auditory nerve and less commonly brain.

Sensorineural hearing loss is a challenge to physicians, as it progresses with age and causes significant reductions in quality of life and there are no treatments to reverse its effects, other than sound amplification with the use of hearing aids or direct auditory nerve stimulation via cochlear implantation.

Platelet-rich Plasma (PRP) Therapy is a cutting-edge procedure that is revolutionizing the hearing loss and deafness. Intratympanic instillation of Platelet-rich Plasma (PRP) does wonder to the hair cells of inner ear, thus improving the hearing.

Eligibility Criteria:
Inclusion Criteria:

* Patients have sudden idiopathic sensorineural hearing loss

Exclusion Criteria:

1. patients has previous ear surgery.
2. patients has absent cochlea in CT or MRI
3. patients has Cancer,Chronic liver disease, Hemodynamic instability,Hypofibrinogenemia, Platelet dysfunction syndromes, Systemic disorder, sepsis, Low platelet count.
Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)

The purpose of this study is to evaluate the effect of zilebesiran on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of zilebesiran as add-on therapy.


Eligibility Criteria:
Inclusion Criteria:

* Office SBP at Screening as follows:

  1. ≥155 mmHg and ≤180 mmHg for patients with untreated hypertension
  2. ≥145 mmHg and ≤180 mmHg for patients on antihypertensive medications
* 24-hour mean SBP ≥130 mmHg and ≤160 mmHg by ABPM after at least 4 weeks of run-in

Exclusion Criteria:

* Secondary hypertension, orthostatic hypotension
* Elevated potassium \>5 milliequivalents per liter (mEq/L)
* Estimated glomerular filtration rate (eGFR) of \<30 mL/min/1.73m\^2
* Received an investigational agent within the last 30 days
* Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus, or laboratory evidence of diabetes during screening without known diagnosis of diabetes
* History of any cardiovascular event within 6 months prior to randomization
* History of intolerance to SC injection(s)
Outpatient Versus Tele Rehabilitation Among Post-surgical Breast Cancer Survivors

This study is comparing two interventions to identify effective treatment for breast cancer patients.

Tele rehabilitation has gained popularity during Covid 19 pandemic. All the studies carried out at that time was found effective in many countries. Still a literature gap is present in tele rehabilitation in breast cancer patients in Pakistan. Prevalence of breast cancer is high in Pakistan. Now it is the best time to implement tele rehabilitation for breast cancer patients as it will reduce treatment costs and travel expenses. Therefore, the goal of this RCT is to consider tele rehabilitation as part of our treatment plan because if it is found effective for patients than it will be helpful in the field of health and technology.

Eligibility Criteria:
Inclusion Criteria:

* Age 30 to 60 years.
* Breast Cancer Females who underwent mastectomy (Simple total mastectomy).
* Breast Cancer Females without chemotherapy or radiotherapy treatment.
* Accessibility to smart phone.
* Internet access.

Exclusion Criteria:

* Previous history of breast or any other cancer.
* Females with metastatic breast cancer.
* Any Chronic pathology that will result in an increase in symptoms due to physical exercise.
* Any contraindications limiting physical activity.
* Shoulder radiculopathy, or fracture.
Exemestane Versus Anastrozole as First Line Hormone Therapy in Postmenopausal Metastatic Breast Cancer Patients

This is a pivotal phase II, multicenter, open-label trial, designed to compare the efficacy of exemestane versus anastrozole as a first line treatment for advanced breast cancer. One hundred postmenopausal patients, with metastatic, positive hormone receptor breast cancer will be enrolled in this trial.

The primary study endpoint is objective response rate. The study has been designed following Simon's test, with a p1-p0=0.15. p1 is the optimum level of activity of the experimental treatment (exemestane), and p0 is the minimum expected activity. In this study, p1 is 25% (25% of RR) and p0 is 10% (10% of RR). With an alpha error of 0.05 and a beta error of 0.1, Simon test establishes a first step of 21 patients per treatment arm. If at least 2 objective responses are observed in exemestane arm, recruitment will continue until 100 patients have been recruited. After this second recruitment phase, at least 7 objective responses must be observed to confirm the expected exemestane level of activity.

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnoses of breast cancer.
* Postmenopausal women, defined as:

  * Bilateral surgical oophorectomy or amenorrhoea \>= 5 years;
  * Age \>= 56 years old and amenorrhoea \>= 1 year;
  * Chemotherapy induced amenorrhoea \>= 2 years;
  * Radiotherapy induced amenorrhoea at least 3 months before:
  * Age \< 56 and \< 5 years of amenorrhoea: follicle-stimulating hormone (FSH) levels to confirm postmenopausal status.
* Metastatic breast cancer (stage IV) or non-operable locally advanced breast cancer (stage IIIB).
* Positive estrogen and/or progesterone receptors as \>10% cells or \>10fmol/mg.
* Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
* Patients who have received adjuvant tamoxifen are eligible, if progression has been established at least 24 months since treatment start.
* Neoadjuvant chemotherapy is allowed if progression has been established at least 12 months after end of treatment.
* Patients may have received a first line of chemotherapy for advanced disease, but treatment must have ended at least 4 weeks before enrolment, and all acute toxicities must be resolved. Previous treatment with Herceptin is allowed.
* Normal haematological, hepatic and renal functions.
* Performance status ECOG of 0, 1, 2.
* Life expectancy superior to 3 months.
* Written informed consent.

Exclusion Criteria:

* Previous hormone treatment for metastatic disease.
* Previous treatment with aromatase inhibitors.
* Inflammatory breast cancer, or aggressive metastatic disease, or visceral lesions, or metastasis in the central nervous system (CNS).
* Non-measurable disease.
* Second malignancy except for basal skin carcinoma or cervical in situ carcinoma adequately treated. If other malignancies, patient must have a disease-free period superior to 5 years.
* Treatment with any investigational product in the 4 previous weeks.
* Patients with negative estrogen and progesterone receptor tumours.
Salivary Diagnostic Testing for IVF

This study aims to determine the performance of a salivary hormone competitive immunoassay for monitoring patients during treatment for infertility.

The goal of this study is to determine the performance of a salivary hormone competitive immunoassay for monitoring patient estrogen and progesterone levels during treatment for infertility using controlled ovarian stimulation (COH) and in vitro fertilization (IVF). Specifically, inter- and intra-assay precision, correlation with serum measurements (the gold-standard), and user satisfaction will be determined. Ultimately, the potential applicability and reliability of salivary steroid monitoring in IVF cycles will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing In Vitro Fertilization (IVF) at a participating infertility center
Clear-Road Trial, Investigating the Efficacy of the RoadSaver Stent

The objective of this clinical investigation is to evaluate the clinical outcome (up to 12 months) of treatment by means of stenting with the RoadSaver (Terumo) in subjects at high risk for carotid endarterectomy requiring carotid revascularization due to significant extra-cranial carotid artery stenosis.

It is a Prospective, multi-center, physician-sponsored clinical study.

The objective of this clinical investigation is to evaluate the clinical outcome (up to 12 months) of treatment by means of stenting with the RoadSaver (Terumo) in subjects at high risk for carotid endarterectomy requiring carotid revascularization due to significant extra-cranial carotid artery stenosis.

Eligibility Criteria:
Inclusion Criteria:

High risk for carotid endarterectomy due to anatomical or co-morbid conditions and either:

* has neurological symptoms and ≥ 50% stenosis via angiography, or
* is asymptomatic and has ≥ 80% stenosis via angiography.

  1. Target lesion located in the distal common carotid artery (CCA), internal carotid artery (ICA), or carotid bifurcation.
  2. Arterial segment to be stented has a diameter between 4mm and 9mm
  3. Age ≥ 18 years.
  4. Life expectancy \> 12 months from the date of the index procedure.
  5. Provides a signed, IRB (Institutional Review Board) / IEC (Institutional Ethical Committee) approved informed consent form prior to participation.
  6. Willing and able to comply with follow-up requirements.

Exclusion Criteria:

1. Contra-indication to percutaneous transluminal angioplasty (PTA).
2. Sever vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system.
3. Lesions in the ostium of the common carotid artery.
4. Occlusion of the target vessel.
5. Evidence of intraluminal thrombus.
6. Known sensitivity to nickel-titanium.
7. Known allergy to heparin, aspirin or other anticoagulant/antiplatelet therapies, or is unable or unwilling to tolerate such therapies.
8. Uncorrectable bleeding disorders, or will refuse block transfusion.
9. History of prior life-threatening contrast media reaction.
10. Previous stent placement in the target vessel.
11. Evolving stroke or intracranial haemorrhage.
12. Previous intracranial haemorrhage or brain surgery within the past 12 months.
13. Clinical condition that makes endovascular therapy impossible or hazardous.
Low-temperature Radiofrequency Coblation Micro-tenotomy for the Treatment of Achilles Tendinopathy

This is a prospective randomized, double-blinded, placebo-controlled superiority trial with two parallel groups and a 1:1 allocation ratio to investigate the effectiveness of radiofrequency coblation micro-tenotomy for patients with Achilles tendinopathy. All participants will be randomized into two groups: the intervention group (n=24; radiofrequency coblation micro-tenotomy + endoscopic Achilles debridement) and the control group (n=24; endoscopic Achilles debridement only). Adults (age \>18) with clinically diagnosed midportion Achilles tendinopathy will be recruited and scheduled for ultrasound screening. All participants will undergo a 12-week eccentric exercise program taught by a registered physiotherapist / athletic trainer. Undergo Endoscopic Achilles debridement and Radiofrequency coblation micro-tenotomy intervention. Criteria for discontinuing or modifying allocated interventions, Strategies to improve adherence to interventions, Relevant concomitant care permitted or prohibited during the trial and Provisions for post-trial care. Outocme measure will use VISA-A, pain scores, ultrasound measurement of thickness and vascularity, calf muscle strength, and ankle range of motion.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion is ultrasound-confirmed Achilles tendinopathy. Adults (age \>18) with clinically diagnosed midportion Achilles tendinopathy will be recruited and scheduled for ultrasound screening. Ultrasonography diagnostic criteria include a thickened Achilles tendon and a Colour Doppler of at least 1 out of 3 in the Öhberg score 2-6 cm proximal to the Achilles tendon insertion. Victorian Institute of Sports Assessment -Achilles (VISA-A) scores below 60 points.

Exclusion Criteria:

* Patients will be excluded if they had a history of major injury or surgery on the affected lower limb in the past year and have mental/physical limitations hindering the participant's ability to complete assessments (ankle arthritis, neuromuscular disorders, etc.), including severe cognitive impairment and psychiatric disorders.
Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)

The purpose of this research study is to (1) provide access to fenfluramine for patients with intractable epilepsy associated with Dravet syndrome, and (2) evaluate the safety of fenfluramine.

The purpose of this research study is to (1) provide access to fenfluramine for patients with intractable epilepsy associated with Dravet syndrome, and (2) evaluate the safety of fenfluramine.

Eligibility Criteria:
Inclusion Criteria:

* Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures.
INTER-Regional COHORTE of Long Term Pancreatic Cancer Survivors

The study is particularly innovative as it will accurately analyze the microscopic characteristics of the stroma, tumor budding and mucin expression in adenocarcinomas of the pancreas, using a comparative approach of long-survivor/short-survival patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age at diagnosis
* Primary pancreatic cancer patients operated on in one of the 4 centres between 2001 and 2016
* Histopathological diagnosis of excreto-pancreatic adenocarcinoma of the pancreas, ductal adenocarcinoma or classical adenocarcinoma
* Tissue blocks (FFPE) available (tumour/healthy tissue)
* Affiliated to a social security scheme

Exclusion Criteria:

* Absence of Primary Cancer Tissue Blocks (PCTBs)
* Paraffin block fixed in Bouin or AFA
* Patient Refusal
* Pancreatic cancer not corresponding to a conventional excretopancreatic adenocarcinoma such as: carcinoma on intraductal papillary mucinous neoplasm, endocrine tumor/carcinoma, acinar cell carcinoma, ...).
* Patient died due to post-surgical complications (death within 30 days post-surgery).
* Surgical resection of macroscopic R2 type.