cyrilzakka/clinical-trials huggingface dataset:
Highlanders With High Altitude Pulmonary Hypertension (HAPH), 6 Minute Walk Distance (6MWD) Assessed at 3200m With and Without Supplemental Oxygen Therapy (SOT)

The investigators aim to study the effect of SOT in highlanders with high altitude pulmonary hypertension (HAPH) who permanently live \>2500m on 6-minute walk distance (6MWD) assessed at 3200m.

Highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA (Tricuspid Regurgitation Pressure Gradient) \>30 mmHg will be recruited for this project. Highlanders permanently living at HA \>2500 m will perform a 6-minute walk distance test near their living altitude in Aksay at 3200 m with and without portable pulsed supplemental oxygen therapy (SOT) via nasal cannula according to a randomized cross-over design.

Eligibility Criteria:
Inclusion Criteria:

* Permanently living \>2500 m
* HAPH diagnosed with a minimum RV/RA of 30 mmHg assessed by echocardiography at an altitude of 3200 m
* Written informed consent

Exclusion Criteria:

* Highlanders who cannot follow the study investigations,
* Patients with moderate to severe concomitant lung disease (FEV1\<70% or forced vital capacity \<70%), severe parenchymal lung disease, heavy smoking \>20 cigarettes/day or \>20 pack-years.
* Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months
* Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)
Pilot Study to Characterize the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of CLn® Skin Care Body Wash

In this pilot study of patients with mycosis fungoides, the most common form of CTCL, we propose to primarily evaluate the impact of daily use of the CLn Body Wash (dilute sodium hypochlorite (0.006% NaOCl)) on the microbiota of CTCL lesions. Should dilute sodium hypochlorite body wash improve the microbiome of MF, reducing the abundance of S. aureus, future, larger studies can more fully evaluate the impact on pruritus, erythema, scaling, disease evolution and its role in CTCL management.


Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18-89 years of age with active mycosis fungoides.
* Patients with concurrent and prior malignancies are allowed as long as any concurrent malignancy does not directly involve the same skin site.

Exclusion Criteria:

* Patients currently or recently (within past 4 weeks) on topical or systemic antibiotics, pregnant persons, or persons with potential of becoming pregnant or are/will be breastfeeding
* Patients that have initiated a new skin-directed therapy over the past month.
Mind-Body Intervention for Older Adults in Long-term Care

Loneliness is a global health issue, particularly affecting the physical and mental health of older adults residing in long term care. The COVID-19 pandemic has further exacerbated isolation in these settings, calling for an urgent attention for finding an effective intervention to alleviate loneliness among long term care residents. Mind-body interventions (MBIs) present as a potentially promising approach aimed at reducing loneliness and mental wellbeing. This study aims to examine the effect of a nurse-led MBI compared to a befriending intervention on loneliness, quality of life, depression and level of mindfulness among older adults in long term care. The primary outcome is loneliness while secondary outcome is quality of life, depression and level of mindfulness.

Loneliness is becoming a global health threat particularly in older population due to natural life events such as illness, death of a spouse and a lack of friends In Hong Kong, it has been reported the 58.1% of the older people experienced a high level of loneliness. Loneliness can have a devastating impact on mental and physical health by increasing the risk of dementia, depression, anxiety, stroke, myocardial infarction and poor quality of sleep.The associated mortality rate can be as high as 26% which is comparable to the harm of prime health dangers like alcohol and cigarette. The problem is particularly pressing for the older adults residing in long term care facilities during the COVID-19 pandemic. Outbreaks occurred in more than 90% of long-term care facility in Hong Kong. Resulting in further isolation in their own facilities or community isolation facilities. Preventing institutionalized older adults from being trapped in loneliness is of key importance. A promotion of intervention that is driven by theoretical framework and suitable for long-term care setting is required.

Mind-body practice has been extensively studied in different population such as chronic pain, heart disease, respiratory disease and community dwelling older adults. However, there is little evidence of wellbeing and loneliness reduction in mind-body practice among long term care older adults. This study will adopt befriending intervention as the control group. As befriending intervention is common in Hong Kong by volunteer visiting.

This study describes a randomised controlled trial designed to compare the effectiveness of a nurse-led MBI versus befriending intervention for LTC residents to reduce loneliness and enhance wellbeing.

Eligibility Criteria:
Inclusion Criteria:

* Long-term care residents aged 60 or above
* Communicable in Cantonese/Chinese
* Mentally competent (Abbreviated Mental Test score \>6)
* Could read, write and understand Chinese language
* Able to provide written consent

Exclusion Criteria:

* Have regular practice of mindfulness once a week or more during the past 6 months
* Have any other contraindication or severe comorbidity that may limit their full participation (e.g. acute psychiatric conditions, severe hearing, vision impairment, or severe medical condition etc).
Impact of a Chewable Plant Sterol Supplement on LDL-C in A Real-World Setting

The purpose of this study is to measure the effectiveness of a twice daily plant sterol supplement, which is in a gummy format and packaged with health insights, in reducing LDL-C cholesterol in a real word setting.

While the safety and benefits of plant sterol supplements have been established and are incorporated into many lipid lowering guidelines, there have been few prior studies of plant sterol chewables in gummy format among real world subjects. In this study, we aim to measure the LDL-C reducing impact of regular plant sterol supplementation in a real world setting.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is an adult ≥18 years of age who continuously used the sponsor's product for at least 10 weeks prior to the Follow-on Lipid Test
2. Baseline Lipid Test conducted within past 2 years
3. If smoker, smoking status or frequency has not changed between two lipid test dates
4. Subject understands the study procedures and signs forms documenting informed consent

Exclusion Criteria:

1. Subject was taking a prescription cholesterol-lowering medication or taking dietary supplements for cholesterol-lowering such as red yeast rice, niacin or omega-3 fatty acid supplements at the time of either lipid test
2. Subject does not read English
Comparison of pCLE and EB in Gastric Lesion Diagnosis

This is a prospective multicenter comparative study, aiming to compare probe-based confocal laser endomicroscopy (pCLE) and endoscopic biopsies in the diagnosis of the whole specific gastric lesion especially for distinguishing low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN) and create an endoscopic image database for the follow-up research.

Traditional endoscopic biopsies can only obtain limited tissues from the whole lesion and is invasive, while probe-based confocal laser endomicroscopy (pCLE) can obtain images at a cellular level of the entire lesion area in real time and non-invasively. There were only single-center and small-sample previous researches for comparing the diagnostic accuracy of CLE and traditional biopsy in the entire gastric lesions, and they did not distinguish gastric low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN). Thus, this study aims to further verify whether pCLE or pCLE combined with biopsy can improve the diagnostic accuracy of the overall lesion and reduce the histological upstaging rate of gastric LGIN after endoscopic submucosal dissection (ESD) by using large sample data and a new pCLE classification method, so as to achieve better guidance of clinical treatment. While verifying the diagnostic efficacy of pCLE, the data of the participants will be collected and collated, and an endoscopic image database will be constructed for the follow-up research.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old and under 75 years old;
* Patients with pathological diagnosis of LGIN, HGIN or early gastric cancer after conventional endoscopy biopsy, whose lesion has clear boundaries under endoscopic observation and is to be admitted for ESD surgery;
* Patients who meet the indications for endoscopic resection of early gastric cancer, or LGIN patients who intend to undergo ESD surgery;
* Patients who are able to provide pathological specimens/sections of previous endoscopic biopsy (in principle, it should be a case of this center).

Exclusion Criteria:

* Patients with advanced gastric cancer or previous gastrectomy;
* Patients with severe cardiopulmonary dysfunction, liver cirrhosis, renal dysfunction, acute gastrointestinal bleeding, esophageal-gastro varices, and coagulation disorders;
* Patients who have a positive result in the fluorescein sodium allergy test;
* Pregnant and lactating women;
* Patients who have psychiatric disorders and are unable to cooperate with endoscopy or sign informed consent.
Assessing the Relationship Between Chronic Pain and Frailty in Older Adults

Pain is an unpleasant emotional sensation related to one's past experiences, originating from a certain part of the body, due to tissue damage or not. Pain is the most commonly reported symptom in the elderly. Chronic pain is persistent or recurrent pain lasting more than 3 months. It is a maladaptive process or a disease that requires multimodal treatment that causes functional decline, independent of the healing process, accompanied by affective, cognitive and motivational disorders, and deterioration in quality of life. Frailty: It is defined as a clinical condition characterized by weakness, physical disability, functional regression, inadequacy in activities of daily living, and increased dependence, which develops as a result of the decrease in physiological reserves in the body with age. It has been reported that the risk of falls, disability, hospitalization and premature death is higher in the frail elderly. The prevalence of vulnerability in societies varies. Frailty rates ranging from 4 to 59% have been reported in developed and developing countries. In this study, it was aimed to evaluate whether there is a relationship between chronic pain and frailty in individuals aged 65 and over.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic pain who are registered with a family medicine unit

Exclusion Criteria:

* Having an active malignancy,
* having a physical disability,
* being bedridden,
* having a psychotic disorder,
* having a cognitive disorder, and refusing to participate.
Pilot Study of Video and Telephone Primary Care Visits

The inability to access and use smartphones or camera-outfitted internet-connected devices during the COVID-19 pandemic relegates certain patients to receive audio-only telemedicine instead of audio/video-based telemedicine. The investigators are conducting a randomized controlled trial in order to characterize patient and provider attitudes towards these two modalities of care and to test the feasibility of a new model to make tablets for video-based care accessible to those who need that. The investigators hypothesize that patient and provider satisfaction will be higher with video-based telehealth when compared to phone-based telehealth.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for telephone-based visits who are doing so because of a lack of ability to conduct a video visit (i.e. no tablet/laptop; no access to internet) who live in Baltimore City

Exclusion Criteria:

* Patients with significant visual or hearing impairment
* Patients that have legal guardians or who are marked as lacking healthcare decision-making capacity
* Patients that have not selected English as their preferred language
Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes

Background : Type 1 diabetes is associated with an increased risk of fractures. The mechanisms accounting for this bone fragility are not yet fully understood. The lower bone mineral density (BMD) observed in individuals with type 1 diabetes cannot solely explain the higher fracture incidence. Bone microarchitecture defects significantly contribute to bone fragility. Few studies assessed spine fractures in type 1 diabetes.

This cross-sectional multicenter case-control study aims (1) to evaluate the prevalence of asymptomatic vertebral fractures in individuals with type 1 diabetes in comparison to age- and sex-matched healthy controls; (2) to compare individuals with diabetes with vertebral fractures and those without vertebral fracture using clinical, biochemical and radiological parameters.


Eligibility Criteria:
Individuals with type 1 diabetes

Inclusion Criteria:

* Diagnosis of type 1 diabetes for at least 5 years;
* Age 20 years and older.

Exclusion Criteria:

* Pregnancy or breastfeeding;
* Conditions associated with bone disease (significant liver disease, intestinal malabsorption other than celiac disease, organ transplant, active cancer, rheumatoid arthritis, hyperthyroidism, hypothyroidism with abnormal thyroid-stimulating hormone (TSH), hyperparathyroidism, hypoparathyroidism, acromegaly, Cushing syndrome, adrenal insufficiency);
* Any of these medications in the past 6 months : glucocorticoids ≥ 7,5 mg prednisone/day or equivalency ≥ 3 months, aromatase inhibitors, antiandrogens, antiepileptic drugs, anticoagulants, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, thiazolidinediones;
* Past medical history of traumatic vertebral fracture;
* Inability to consent.

Healthy controls

Inclusion Criteria:

* Age 20 years and older.

Exclusion Criteria:

* As above (as individuals with diabetes), and :
* Diagnosis of diabetes or prediabetes;
* Celiac disease;
* Chronic kidney disease (CrCl \< 60 mL/min);
* Any of theses medications in the past 6 months : biphosphonates, teriparatide, denosumab, calcitonin;
* Past medical history of fragility fracture.
Glucomen Day Cascade CGM System 21-Day Wear Study

Assessment of 21-day CGM wear period

This single-site study will include 10 subjects who will wear two CGMs for 21 days. On day 1, 5, 10, 15, and 21 subjects will be in-clinic for 12 hrs of testing with YSI blood glucose measurements taken every 15 minutes.

Eligibility Criteria:
Inclusion Criteria:

* • Diagnosis of type 1 or type 2 (on insulin therapy) diabetes mellitus for at least 6 months

  * 18 years of age or older
  * Currently self-monitoring capillary blood glucose (on average at least three times per day or more) or on a CGM for at least three months
  * Be willing to have blood glucose levels manipulated into high and low glucose levels during in clinic days if deemed appropriate per the protocol based on insulin use.
  * Willing to follow all study procedures, including attending all clinic visits during which a venous line will be inserted for blood sampling, wearing CGM sensors for entire study, performing fingertip glucose tests for self-monitoring and calibration, and keeping a diary of activities.
  * Be willing to wear two investigational CGM devices.
  * Sign informed consent form

Exclusion Criteria:

* • Known allergy to medical grade adhesives

  * Magnetic Resonance Imaging (MRI) scheduled during CGM sensor wear period
  * Persons with type 2 diabetes using diet and exercise only for diabetes management
  * Used an investigational drug within 30 days prior to study entry
  * Hematocrit \< 32% (obtained during screening)
  * Inadequate veins (in the opinion of the investigator) or known contraindication to placement of a dedicated peripheral line for venous blood withdrawal
  * Symptomatic coronary artery disease with a history of angina, or history of a myocardial infarction or coronary intervention (e.g., percutaneous transluminal coronary angioplasty \[PTCA\], stent placement), or coronary artery bypass graft (CABG) within the past six months
  * Diagnosis of the following diabetic autonomic neuropathies: orthostatic hypotension, heart rate anomalies, gastroparesis
  * Cerebrovascular incident within the past six months
  * History or presence of eczema, psoriasis, atopic or contact dermatitis
  * Pregnancy at the start of the study.
  * Current use or within one-week exposure to topical medications at the proposed insertion sites
  * Seizure disorder (epilepsy)
  * Malignancy within the past five years, except basal cell or squamous cell skin cancers
  * Major surgical operation within 30 days prior to screening
  * Other medical conditions that would pose safety concerns, interfere with study conduct or seriously compromise study integrity (reason for exclusion will be clearly documented by investigator or designee)
Clinical Evaluation of the One-Piece Tecnis Multifocal Intraocular Lens (IOL)

The purpose of this study is to evaluate near vision of the One-Piece Tecnis Multifocal lens (ZMB00) vs. the One-piece Tecnis monofocal lens (ZCB00)and additionally evaluate general postoperative outcomes of the One-Piece Tecnis Multifocal lens.


Eligibility Criteria:
Inclusion Criteria:

* bilateral cataracts and otherwise healthy eyes
* visual potential of Decimal 0.8 in each eye

Exclusion Criteria:

* any medications affecting vision
* any chronic disease/illness that would affect risk to subject or outcomes of the study
* any ocular pathology/abnormalities that may affect visual outcomes or confound study results
* desire for monovision
PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film.

PREG2 is a randomized controlled trial that aims to evaluate efficacy in preventing intrauterine adhesion recurrence after hysteroscopic adhesiolysis of a novel intrauterine barrier film named Womed Leaf

PREG2 is a prospective, multi-center, randomized, controlled, two arm clinical study. The objective is to evaluate the efficacy of Womed Leaf in preventing intrauterine adhesion recurrence after adhesiolysis compared to adhesiolysis alone.

The study will be performed on women with moderate or severe adhesions (AFS score \>=5) scheduled for adhesiolysis. Indeed, the risk of intrauterine adhesion is very high (up to 60%) in this population of patients.

A follow-up diagnostic hysteroscopy will be performed 6-8 weeks after the adhesiolysis procedure to determine the presence and severity of IUAs according to the American Fertility Society and European Society of Gynecologic Endoscopy classification systems of adhesions. Fertility-related outcome will include live pregnancy at 1 year, 2 years and 3 years and will be reported as secondary endpoints. 154 women are planned to be included in the PREG2 study.

Eligibility Criteria:
Inclusion Criteria:

* Women with moderate or severe intrauterine adhesions according to the AFS classification, i.e AFS score \>=5, confirmed by hysteroscopy right before adhesiolysis
* Scheduled for hysteroscopic adhesiolysis
* Age above or equal to 18
* Subjects who are willing to provide a written informed consent.
* Subjects who can comply with the study follow-up (second look hysteroscopy) and other study requirements
* Subjects who agree to refrain from intercourse or use a reliable form of barrier contraception to prevent unintended pregnancy until the follow-up hysteroscopy.
* Subjects who agree to avoid all intrauterine devices (IUDs) until the follow-up hysteroscopy.

Exclusion Criteria:

Pre-operative criteria

* Post menopause
* Pregnant (confirmed by a positive pregnancy test) or lactating
* Abnormal uterine cavity according to ESHRE classification I to V such as unicornis, bicornis, septate, duplex
* Known or suspected endometrial hyperplasia
* History of cervical or endometrial cancer
* Active pelvic infection or history of pelvic peritonitis
* History of endometrial ablation
* Known contraindication or hypersensitivity to Womed Leaf component
* Current participation in another clinical investigation that has not yet received the primary endpoint.
* Any other condition that makes participation in the study contrary to the patient's best interests.

Intra-operative criteria, post adhesiolysis:

* Perforation during adhesiolysis
* Uterine depth \< 5cm or \> 10cm
Lyon Registry of Stroke Treated by Thrombolysis or Thrombectomy

This observational study as an objective of characterizing the population of patients treated within the neurovascular unit of the Pierre Wertheimer hospital (Hospices Civils de Lyon) in order to determine their phenotype (age, sex, risk factors, etc.) and its evolution over time. It also aims to assess the management of ischemic stroke (IS) in the neurovascular unit of Pierre Wertheimer Hospital. We will assess in particular the pre-hospital and hospital care times, the type of medical care (thrombolysis and / or thrombectomy) as well as the efficiency of this care (effective recanalization, outcome of patient, etc.).

All patient who has had an IS with an indication of thrombolysis and / or thrombectomy, hospitalized in the neurovascular unit of Pierre Wertheimer Hospital (HCL) since January 2013 and until December 2030 will be contacted for this study

Eligibility Criteria:
Inclusion Criteria:

* - Patients over 18 years old,
* Hospitalization in the neurovascular unit of the Pierre Wertheimer Neurological Hospital (Hospices Civils de Lyon),
* Ischemic stroke treated by thrombolysis and / or mechanical thrombectomy.

Exclusion Criteria:

* - Opposition to this research.
Coronary Arteriogenetic Heparinized Exercise

This study evaluates the addition of heparin to a 2-week cycle of physical rehabilitation in the treatment of refractory angina. Half of the patients will undergo heparin-primed physical rehabilitation, while the other half will undergo only physical rehabilitation.

Our approach is based on the combination of pharmacological stimuli (with heparin) on top of a 2-week cycle of physical rehabilitation. The rationale for this chemical-physical cocktail stems from the fact that increase in shear stress (achieved with exercise), or heparin (when used alone) have no significant effect on coronary arteriogenesis. Nevertheless, when the two stimuli are coupled coronary arteriogenesis is consistently present, and clinically significant.

The basic principle of heparin treatment is to potentiates angiogenic growth factors, which are over expressed by increased shear stress at the site of pre-existing collateral vessels as a result of exercise or pacing. Although the precise mechanisms by which heparin potentiates arteriogenesis remain to be completely elucidated, heparin administration combined with exercise has great potential in treating patients with effort angina who are not indicated for conventional revascularization therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with documented coronary artery disease not amenable of future treatment and belonging to "no-option" category with symptoms consistent with angina pectoris

Exclusion Criteria:

* Patients with unstable angina, recent myocardial infarction, uncontrolled hypertension, hemodynamically valvular heart disease, bronchial asthma, and neurologic and/or orthopedic illnesses that limit exercise capacity .
* Patients receiving vitamin K antagonist.
* Patients actively involved in programmes of cardiac rehabilitation or exercise training.