cyrilzakka/clinical-trials huggingface dataset:
Post-COVID-19 Condition: Observational Study in Vietnam

The primary objective of this study is to estimate the prevalence of the post-COVID-19 condition in confirmed mild, moderate, and severe COVID-19 adult patients in Hai Phong, Vietnam.

It is a cross-sectional study implemented in Hai Phong (Vietnam) by the Infectious and Tropical Diseases Department of Viet Tiep 2 hospital and the Department of Public Health of the Hai Phong University of Medicine and Pharmacy (HPMU).

The aim is to enroll moderate and severe COVID-19 patients from the 2 following provincial hospitals, Viet Tiep hospital and Kien An hospital, and mild COVID-19 patients from the community level in Hai Phong to assess the burden of post-COVID-19 condition in each patient group (mild, moderate or severe acute COVID-19).

835 participants are aimed to be interviewed through phone calls: 196 participants with mild disease, 289 participants with moderate disease, and 350 participants with severe disease. In case of suspected post-COVID-19 condition, the participant will be proposed to come to Viet Tiep 2 hospital for a study visit i) to confirm the post-COVID-19 condition, ii) to describe symptoms, iii) to evaluate the functional limitations related to the post-COVID-19 condition, and iv) to assess the determinants of the post-COVID-19 condition in patients with mild, moderate, and severe acute COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or more;
* With a history of documented COVID-19 as confirmed by either a positive SARS-CoV-2 RT-PCR or antigenic test, 3-12 months before inclusion;
* Hospitalised in Viet Tiep 2 hospital or Kien An hospital (tertiary care hospitals) with moderate or severe COVID-19 or registered in provincial CDC health system for mild COVID-19;
* Accepting to participate in the study;

Exclusion Criteria:

* Not able to understand or answer a quick phone questionnaire;
* Individuals who refuse or cannot come to Viet Tiep 2 hospital in case of the suspected post-COVID-19 condition.
A Study to Evaluate the Efficacy of a Counselling and Advisory Care for Health (COACH) Program in Dyslipidemic Patients.

This study is a local PCO sponsored, interventional, non-drug study to evaluate the efficacy of a health tele-counselling program in reducing cardiovascular risk in dyslipidemic patients.

Educational / Counseling

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are newly diagnosed with dyslipidemias.
2. Subjects must be lipid drug naive and eligible for statin therapy.

Exclusion Criteria:

1. Subjects who cannot be contacted by telephone or handphone.
2. Subjects with uncontrolled primary hypothyroidism.
ThrombX Retriever for Acute Ischemic Stroke Trial

This trial is designed to assess the safety and effectiveness of the ThrombX Retriever.

This trial is a clinical evaluation is to assess the safety and effectiveness of the ThrombX Retriever in the revascularization of the site of primary occlusion in patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.

Eligibility Criteria:
Inclusion Criteria:

* Acute anterior circulation ischemic stroke
* Pre-stroke Modified Rankin Score ≤ 1
* NIHSS ≥ 6 and \< 25 immediately prior to enrollment
* ASPECT score ≥6 with CT scanning or core infarct volume \<50 mL on magnetic MRI or CT based perfusion imaging
* Occlusion of IC or the middle cerebral artery M1 or M2 division
* Subject can be treated within eight-hours of onset of stroke symptoms

Exclusion Criteria:

* Pregnant or lactating at time of admission
* Known serious sensitivity to radiographic contrast agents
* Known sensitivity to nickel, titanium metals, or their alloys
* Current participation in another investigation drug or device treatment study
* Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency prothrombin time lab results to be available prior to enrollment)
* Renal failure
* Baseline blood glucose of \<50mg/dL (2.78 mmol/L) or \>400mg/dL (22.20 mmol/L)
* Baseline platelet count \< 50,000/uL
* Severe, sustained hypertension
* Presumed septic embolus, suspicion of bacterial endocarditis
* Subject has a contraindication to an angiogram
* Life expectancy \<6 months
* Comorbid disease or condition that would confound assessments
* Known history of arterial tortuosity, preexisting stent, and/or other arterial disease
* Tandem lesions, occlusion requiring angioplasty and/or stent placement or evidence of carotid dissection
* Site of occlusion is heavily calcified
* Imaging or clinical evidence of bilateral strokes or concomitant posterior circulation stroke
* CT or MRI evidence of hemorrhage or evidence of mass effect or intra-cranial tumor
* Imaging evidence suggests subject is not appropriate for mechanical thrombectomy
Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood

The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + rosuvastatin calcium combination therapy with ABT-335 and rosuvastatin calcium monotherapy in subjects with multiple abnormal lipid levels in the blood.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mixed dyslipidemia

Exclusion Criteria:

* Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial.
* Patients who are taking certain medications or unstable dose of specific medications.
* Women who are pregnant or plan on becoming pregnant or women who are lactating.
Retrospective Study on Perioperative Safety and Quality Control Based on Real World Data

Based on the data from the anesthesia record electronic system, patient safety incident (PSI) electronic reporting system and related PSI retrospective cohort in the past 10 years, this project intends to carry out structured and consistent (real world data)RWD processing, and conduct (real world evidence)RWE research related to perioperative safety and quality control in order to characterize the epidemiology of perioperative PSIs, explore the related factors, and construct a prediction model, and on the basis of which to construct a standardized platform for reporting and analysis of perioperative PSIs based on RWD. On this basis, a standardized platform for PSI reporting and analysis was constructed based on RWD.


Eligibility Criteria:
Inclusion Criteria:

* perioperative patients with anesthesia electronic records.
* aged more than 18 years old.

Exclusion Criteria:

* data incomplete
* data missing
Manual Diaphragmatic Release Technique on Exercise Capacity and Sleep Quality

To investigate if there is a significant effect of manual diaphragmatic release technique on exercise capacity, sleep quality, chest expansion, ADL, fatigue and quality of life in older adults with type II diabetes.

Participants, including both genders, will have a history of Diabetes Type II for more than one year. They will be well controlled with HbA1c≤7. Patients will be aged from 55 years and above and had a body mass index less than 30 kg/m². Patients will follow up on the training program and instructions. They will be medically stable.

Eligibility Criteria:
Inclusion Criteria:

* History of Diabetes Type II for more than one year.
* They will be well controlled with HbA1c≤7.
* Patients will be aged from 55 years and above and had a body mass index less than 30 kg/m².
* Patients will follow up on the training program and instructions. They will be medically stable.

Exclusion Criteria:

* Chest diseases.
* Diaphragmatic hernia, clinical evidence of phrenic nerve injury, recent abdominal or thoracic surgery, or history of traumatic lesion possibly affecting diaphragm.
* History of Myocardial infarction and/or cardiothoracic surgery
* Unstable medical status.
* Cognitive disability hindering responding to the questionnaires.
Cash Benefits and Reproductive/Perinatal Health

During the first two years of the COVID-19 pandemic, the City of Chelsea, Massachusetts held a lottery to allocate cash benefits to its residents for ten months. Using data from the Chelsea Eats program, the investigators propose to study the impact of the cash benefit on reproductive and perinatal health.


Eligibility Criteria:
Inclusion Criteria:

* Resident of Chelsea, Massachusetts
* Household income at or below 30% of the U.S. Department of Housing and Urban Development's Area Median Income
* Childbearing age

Exclusion Criteria:

* See inclusion criteria
Aspirin Effectiveness Study

Aspirin is an effective medicine for prevention of heart attacks in patients with coronary artery disease and works by preventing clots from forming. In previous studies aspirin has been found to be ineffective in between 2% and 65% of patients but none of these studies have looked specifically at coronary artery disease patients in Ireland. This study is being done to identify the percentage of patients in Ireland whose aspirin is not working effectively and help identify factors that could be used to target interventions to increase aspirin's effectiveness in Irish patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patients with documented coronary artery disease
* Current treatment with any dose of aspirin daily for a minimum of 3 months
* Able to provide written informed consent based on competent mental status

Exclusion Criteria:

* Myocardial infarction, unstable angina or stroke during the preceding three months
* Platelet count \<125,000/mm
* Known haematological disorders
* Active malignancy on current chemotherapy or a recent diagnosis of cancer
VEGF as a Prognostic Factor for White Matter Damage in Preterm Infants

We hypothesize that misexpression of vascular endothelial growth factor (VEGF) in the Cerebrospinal fluid of preterm infants can be used as a biomarker to predict the risk for developing white matter damage.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants undergoing lumbar puncture.

Exclusion Criteria:

* Preterm with IVH or known infection or meningitis.
Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen

To determine the efficacy and safety of telmisartan-based treatment among patients with metabolic syndrome in actual setting in Philippines.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 45 years
* Increased waist circumference (\>88.9cm \[\>35in\] men, \>78.7cm \[\>31in\] for women)
* Elevated triglycerides (\>150mg/dl)
* Low HDL cholesterol (\<40mg/dl in men, \<50mg/dl in women)
* Hypertension (\>130/\>85mmHG)
* Impaired fasting glucose (\>110mg/dl) (8)
* Hypertensive patient assessed to benefit from telmisartan based treatment

Exclusion Criteria:

* Hypersensitivity to telmisartan, hydrochlorothiazide (HCTZ) and its excipients
* \<3 months myocardial infarction (MI), stroke or severe heart failure
Cross-sectional Study of Prevalence Rate of Abdominal Aortic Aneurysm in OSAHS Patients From BTCH

This study explore AAA prevalence in OSAHS patients by ultrasound screening and try to analysis risk factors of AAA in OSAHS patients.

Abdominal aortic aneurysm (AAA) is an extremely high mortality disease, and ultrasound has been recommended for the screening of AAA, which is highly sensitive and specific. Studies have shown that screening for AAA in the population can significantly reduce deaths from ruptured abdominal aortic aneurysms. However, those study mainly focus on cardiovascular disease patients or general population, no previous study target on obstructive sleep apnea hypopnea syndrome (OSAHS) population. Retrospective studies show that the incidence of apnea syndrome in patients with abdominal aortic aneurysm is higher than that in the control group, which suggests that OSAHS may be one of the causes of abdominal aortic aneurysm. At present, there is no relevant research on the screening of AAA in OSAHS population.

The main objective of this study was to screen the prevalence of AAA in OSAHS population by a cross-sectional study.

Eligibility Criteria:
Inclusion Criteria:

* All patients who accept respiratory sleep monitoring in the department of ENT, BTCH, aged over 45 years, from 2018-01-01 to 2019-12-30

Exclusion Criteria:

* 1. Any previous diagnosis of AAA history;
* 2. Received AAA related treatment;
* 3. Past imaging test result suggested increased diameter of the abdominal aorta.
* 4. Poor compliance; refused to follow the requirements set in this study follow-up, and refused to sign informed consent.
AM-101 in the Treatment of Acute Tinnitus 2

The purpose of this research study is to test the safety and effectiveness of the study drug, AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with tinnitus can take part in the study, if their tinnitus started within the last 3 months.

This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of repeated intratymanic AM-101 injections in the treatment of acute peripheral tinnitus (up to 3 months from onset).

Eligibility Criteria:
Inclusion Criteria:

1. Persistent subjective peripheral tinnitus (unilateral or bilateral) following traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma, tympanic membrane trauma) or otitis media with onset no longer than 3 months prior to randomization
2. Age ≥ 18 years and ≤ 75 years (≥ 14 years and ≤ 75 years at selected sites);
3. Negative pregnancy test (woman of childbearing potential);
4. Willing and able to use adequate hearing protection, respectively to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured;
5. Willing and able to protect ear canal and middle ear from water exposure as long as tympanic membrane is not fully closed.

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

1. Fluctuating tinnitus;
2. Intermittent tinnitus;
3. Tinnitus resulting from traumatic head or neck injury;
4. Presence of chronic tinnitus;
5. Meniere's Disease, history of endolymphatic hydrops, or history of fluctuating hearing loss;
6. History of repeated idiopathic sudden sensorineural hearing loss or history of acoustic neuroma;
7. Ongoing acute or chronic otitis media or otitis externa;
8. Other treatment of tinnitus for the study duration;
9. Known hypersensitivity, allergy or intolerance to the study medication or any history of severe, abnormal drug reaction;
10. Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
11. Women of childbearing potential who are unwilling or unable to practice contraception, such as hormonal contraceptives, double barrier, sexual abstinence or intercourse with a partner who has been vasectomised for at least three months;
12. Concurrent participation in another clinical study or participation in another clinical study within 30 days prior to randomization.

Other protocol-defined exclusion criteria may apply.
Automated, Assistive, Non-Contact Sleep Quality Monitor for Individuals With Alzheimer's Disease

This study seeks to evaluate the utility and efficacy of the Non-Contact Sleep Quality Monitor System when used to monitor the sleep quality of individuals living in long-term care (LTC) with either Alzheimer's Disease (AD) or Alzheimer's Disease Related Dementia (ADRD). This before-after comparison trial will be conducted in several LTC facilities to evaluate the effect access to System Sleep Quality Data has on documentation of sleep disorders or treatments and sleep quality change over time for AD/ADRD participants in the intervention group as compared to the control group.

All subjects will undergo sleep quality monitoring for 4-weeks. At the end of the first 2-weeks, research staff and LTC facility staff and medical providers will receive access to sleep monitoring data. We hypothesize that when real-time System Sleep Data is shared with LTC staff or healthcare providers, that sleep disturbances will be more readily detected, leading to timelier, better tailored treatment interventions for sleep disturbances, thereby improving sleep quality and decreasing daytime physical inactivity.

The purpose of this study is to evaluate the utility of a Non-Contact Sleep Quality Monitor System and determine the effect that sharing System Sleep Data with long-term care (LTC) staff and healthcare providers has on documentation and treatment of sleep disorders and change in AD/ADRD participant sleep quality. System Sleep Data will be collected for a total of 4-weeks. During the Intervention condition System Sleep Data will be shared for 2-weeks, while in the initial Control condition no System Sleep Data will be shared for 2-weeks. Healthcare providers can prescribe a non-pharmacologic sleep protocol and/or if they so choose, pharmacotherapy to manage sleep disturbances for subjects in either the Intervention or Control condition, in accordance with standard medical practice. The investigators hypothesize that when real-time System Sleep Data is shared with LTC staff or healthcare providers, that sleep disturbances will be more readily detected, leading to timelier, better tailored treatment interventions for sleep disturbances, thereby improving sleep quality and decreasing daytime physical inactivity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Alzheimer's Disease (AD) or Alzheimer's Disease Related Dementias (ADRD)
* Residents of long-term care (LTC) facility study site location for a minimum of 30 days.
* Willingness to consent to study or when a potential participant lacks decision making capacity (determined by LTC facility clinical provider) willingness of a Legally Authorized Representative (LAR) to consent to study participation on potential participant's behalf.

Exclusion Criteria:

* Currently on hospice
Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections

The purpose of this study is to evaluate the pharmacokinetics of a single dose of intravenous or oral omadacycline in children and adolescents with suspected or confirmed bacterial infections.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, age 8 to \< 18 (inclusive) who have written and signed parental/legal authorized representative (LAR) informed consent and pediatric assent.
* Currently hospitalized with a suspected or confirmed bacterial infection and receiving or planned to receive systemic antibiotic therapy other than omadacycline.
* Weight within the 5th and 95th percentile for age and sex.
* Subjects must not be pregnant or nursing at the time of enrollment, and must agree to use a highly effective birth control method during the study

Exclusion Criteria:

* Evidence of a medical condition that may pose a safety risk or impair study participation.
* Confirmed or suspected SARS-CoV-2 infection.
* Has a history of hypersensitivity or allergic reaction to any tetracycline antibiotic.
* Has received an investigational drug within the past 30 days.
Phase III Clinical Study to Evaluate the Efficacy and Safety of the Combination of Lercanidipine/Valsartan in Hypertensive Patients

This study aims to compare and assess the efficacy and the safety of the combination agent of Lercanidipine and Valsartan and monotherapy of Lercanidipine alone in patients with essential hypertension


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 20 to ≤75 years old
* Patient with essential hypertension

Exclusion Criteria:

* When the BP level measured at screening was sitDBP\>120 mmHg or sitSBP \>180 mmHg
* Patient with difference in repeatedly measured blood pressures from the selected arm at screening was sitSBP≥ 20mmHg or sitDBP ≥ 10mmHg
Effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Child Malnutrition

The overall objective of this project is to assess the effectiveness and cost-effectiveness of RUF (ready-to-Use Food, Plumpy Doz(r)) to prevent moderate acute malnutrition in children aged 6-36 months if embedded in a program of conditional household food assistance.


Eligibility Criteria:
Inclusion Criteria:

* WH≥80% of median of NCHS reference without bilateral pitting oedema;
* Age ≥ 6 months and ≤36 months;
* Member of a household with a dependency ratio \>4;
* Not planning to leave the study zone for the coming 5 months;

Exclusion Criteria:

* Not showing appetite;
* Age \< 6 months or age \> 36 months
* Weight-for-Height Z-score \<-2 and/or the presence of bilateral pitting oedema in children 6-36 months;
* Member of a household with a dependency ration ≤ 4;
* Clinical complications
* Presence of chronic illness, cardiac disease, congenital abnormalities, cancer;
* Being allergic to one of the ingredients of the RUF.
New Horizons for the Treatment of Cardiomyopathy in Children

Collecting mono nuclear cells from the patient's blood after a course of granulocyte stimulation then injecting them into the weak heart muscle measuring the heart function at the beginning and after 2.4.6 months to assess the improvement due to this procedure, by comparing these patients to patients with the same condition treated the classic way.

Dilated cardiomyopathy in children has high morbidity and mortality, current treatment doesn't improve the prognosis and the only cure available is heart transplantation which is limited, has long waiting list (if available), high cost, and has many side effects, leading to the need of novel effective, less costly therapeutic alternatives.

Stem cell therapy has proven to improve the cardiac function, reverse the pathologic histological changes, decrease the morbidity and mortality, offering a possible replacement to heart transplantation, different reports proved the safety and efficacy of this therapy using different types of cells and different routs of application in cardiomyopathy and acute myocardial infarction in children and adults, and in congenital heart disease, but the published cases of this therapy conducted on children with dilated cardiomyopathy are scanty .

Eligibility Criteria:
Inclusion Criteria:

* Dilated cardiomyopathy diagnosed and treated at least 6 mo. Ago
* LVEF less than 40%
* Use of I.V inotropes

Exclusion Criteria:

* Acute infection
* Severe organ failure (other than the heart)
Outcome of Extremely Preterm Infants Who Received Systemic Postnatal Corticosteroid for Bronchopulmonary Dysplasia

Bronchopulmonary dysplasia is a complication of prematurity. Postnatal corticosteroid is used to treat the inflammatory part of this pathology, in particular to wean premature infants from the ventilator at the end of the first month of life. However, this therapy remains controversial because it may induce suboptimal neurocognitive development. Parents of infants who receive postnatal corticosteroid should be provided with information about the risks. The objective of our work was to evaluate the respiratory, neurodevelopmental and growth outcomes at 24 months corrected age of extremely preterm infants who received postnatal corticosteroid.


Eligibility Criteria:
Inclusion Criteria:

* Extremely preterm infants less than 29 weeks' gestation
* Infants hospitalized for at least the first 30 days of life in the neonatology department of the Croix-Rousse Hospital in Lyon
* Infants born between January 1, 2013 and December 31, 2016

Exclusion Criteria:

* Infants with a congenital heart, lung or brain malformation
* Infants with a neuromuscular disease
* Infants with a genetic disorder
* Infants who died before the age of 24 months corrected age
* Infants lost to follow-up or with incomplete data at 24 months corrected age