cyrilzakka/clinical-trials huggingface dataset:
An Effectiveness Evaluation for Pathway to Healthy Aging (Path-HA) Care on Health Status of Older Adults

The goal of this clinical trial is to provide a scientific evaluation on the effects of a protocol-driven Pathway to Healthy Aging (Path-HA) Program on promoting the health-related quality of life and functional abilities of older adults who are at risk of accelerated aging in the community. Participants will be randomized to one of the two study arms: 1) the intervention group to receive a 14-week Path-HA care intervention; and 2) the control group with no Path-HA care intervention.

This assessor-blind, randomized controlled trial evaluates the effects of the Pathway to Healthy Aging Program, which is based on the WHO ICOPE model, on the promotion of the health-related quality of life (primary outcome) as well as functional abilities (secondary outcomes) as defined by the WHO-ICOPE among community-dwelling older adults with accelerated aging. Six health domains including locomotor function, vitality, psychological function, cognitive function, social functions, and overall health-related quality of life are measured. A total of 1000 participants will be recruited. Outcome evaluation takes place at baseline, upon the completion of the care program, and at 6 months thereafter to allow the detection of long-term program benefits. In-depth individual interviews will be conducted to solicit the participants' experience and perceived benefits of the program.

Eligibility Criteria:
Inclusion Criteria:

* 1) aged 60 or above,
* 2) with at least two risk factors of accelerating aging defined as including reduced physical functioning, malnutrition, depressed mood, loneliness, poor health perception, and presence of geriatric symptoms (e.g. insomnia, pain, etc), based on their health screening results,
* 3) community-dwelling,
* 4) communicable to engage in health education activity.

Exclusion Criteria:

* 1) any who is not at or at only one risk factor of accelerating aging,
* 2) any who has problems in communicating with the research team.
MCCE in Assessing Efficacy of Gastro-oesophageal Varices

This study proposed for the first time the use of MCE to evaluate the efficacy of the treatment of gastroesophageal varices, and compared the examination results with the gold standard to explore whether MCE could replace the electronic gastroscopy as the preferred non-invasive evaluation method for the treatment of gastroesophageal varices.

Gastro-esophageal varices is one of the complications of portal hypertension in cirrhosis. For patients with moderate to severe varicose veins, international guidelines recommend active treatment, including endoscopic therapy such as endoscopic band ligation (EBL) and interventional radiotherapy such as balloon-occluded retrograde transvenous obliteration (B-RTO)Electronic gastroscopy is the gold standard for the diagnosis of varicose veins at higher blood risk (varicose veins requiring retreatment). However, it is relatively invasive and uncomfortable in the examination process, so that patients with gain-and-compensation cirrhosis are often unwilling to accept it, which is not conducive to the standardized follow-up after the treatment of gastro-esophageal varices.Magnetically controlled capsule endoscopy (MCE) is a non-invasive detection method independently developed in China that covers the whole digestive tract (except colon) mucosa. Patients only need to swallow a capsule endoscope to make repeated observation for many times, and the examination process is painless. It is an ideal method for diagnosing varicose veins with high blood risk (varicose veins that need treatment). Therefore, this study proposed for the first time the use of MCE to evaluate the efficacy of the treatment of gastroesophageal varices, and compared the examination results with the gold standard to explore whether MCE could replace the electronic gastroscopy as the preferred non-invasive evaluation method for the treatment of gastroesophageal varices.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old
* Confirmed cirrhosis by clinical or pathological biopsy
* Previous endoscopic treatment of esophageal and gastric varices, including but not limited to sclerotherapy, injection of tissue adhesives, skin entrapment, etc
* Electronic gastroscopy is to be performed
* Voluntary informed consent

Exclusion Criteria:

Absolute contraindications:

* Patients without surgical conditions or refusing any abdominal surgery (once the capsule is stranded, it cannot be removed by surgery)
* There is a pacemaker in the body, except that the pacemaker is a new MRI compatible product
* Electronic devices such as cochlear implants, magnetic metal drug infusion pumps, nerve stimulators and magnetic metal foreign bodies are implanted in the body;
* .Women during pregnancy

Relative contraindication:

* Gastrointestinal obstruction, stenosis, and fistula are known or suspected
* Dysphagia
Falls Prevention for Visually Impaired Older People

This study aims to examine the effectiveness of an intensive five day falls prevention training programme with a home evaluation and a home exercise programme, compared with a home evaluation and exercise programme alone for reducing incidence of falls and fear of falling, and improving confidence in functional ability and objective balance.

While previous research shows a clear link between visual impairment and increased risk and incidence of falls, as well as fear of falling, there is little research to investigate the effectiveness of falls prevention programmes for visually impaired populations. At the time of writing there were no studies identified that used this type of intensive training over a period of several days, rather most of the studies that exist have been conducted in community settings.

This study will aim to compare the effectiveness of a comprehensive exercise programme aimed at improving balance, walking technique, postural control and ability to complete functional tasks, with a home exercise programme with either written or audio instructions.

Eligibility Criteria:
Inclusion Criteria:

* Participant is able to mobilise with or without walking aids or hand-hold
* Participant has history of falls
* Any possible medical or pharmaceutical causes of falls have been investigated and excluded
* Participant has a diagnosed visual impairment
* Participant is aged 65 or over
* Participant's falls can not be attributed purely to their visual impairment
* Participant is a member of Blind Veterans UK
* Participant is physically able to take part in group and individual exercise sessions
* Participant is able to understand and follow verbal and/or written instructions

Exclusion Criteria:

* Participant is under 65 years of age
* Participant is medically unwell or has a medical condition for which exercise is contraindicated
* Participant is currently involved in other falls prevention programmes
* Participant is predominantly a wheelchair user
* Participant is unable to understand or follow instruction from staff in English
ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery

In this study, the investigators will detect hepatocellular carcinoma lesions using fluoescence imaging with ITGA6 targeting probes during tumor resection surgery. The aim is to evaluate wether intraoperative fluorescence imaging targeting ITGA6 can help to improve the detction effect of hepatocellular carcinoma, and finally help the accurate surgical resection.

The main purposes of this study include:

1. To raise the detection rate of hepatocellular carcinoma intraoperatively using the novel NIR-II fluorescence molecular imaging and the ITGA6 targeting probe.
2. To validate the safety and effectiveness of the proposed ITGA6 targeting probes for clinical application.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been diagnosed with hepatocellular carcinoma.
2. Planned to receive hepatectomy.
3. Liver function Child-Pugh A.
4. ITGA6 was validated highly expressed preoperatively.
5. Aged 18 to 80, and the expected lifetime is longer than 6 months.
6. Approved to sign the informed consent.

Exclusion Criteria:

1. Allergic to Cy7.
2. Enrolled in other trials in the past 3 months.
3. Another malignant tumor was found.
4. Undesirable function of heart, lung, kidney, or any other organs.
5. Unable to tolerate a hepatectomy.
6. The researchers considered inappropriate to be included.
Does Prehabilitation Improve Exercise Performance and Insulin Resistance After Surgery for Oesophago-gastric Cancer?

The purpose of this study is to evaluate the effect of a multimodal pre-operative prehabilitation programme during neo-adjuvant therapy on cardiopulmonary exercise performance and insulin resistance prior to resection for oesophago-gastric cancer.

The trial objectives are as follows: Primary: To evaluate the effect of a prehabilitation programme during neo-adjuvant therapy on CPX performance prior to resection for oesophago-gastric cancer. Secondary: To investigate the impact of neo-adjuvant chemotherapy on insulin resistance; to determine whether a prehabilitation exercise programme is feasible during neo-adjuvant chemotherapy; to determine whether rehabilitation has a positive impact on quality of life outcomes; to investigate the impact of prehabilitation on clinical outcomes; to assess the effect of prehabilitation on nutritional status; to determine whether prehabilitation affects the stress response to surgery.

This study is a randomised controlled trial where patients will be stratified into 'fit' and 'unfit' groups based upon their anaerobic threshold and then randomised in a 1:1 ratio to receive multimodal prehabilitation or standard care prior to OG cancer surgery, during neo-adjuvant chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients listed for elective oesophagectomy or total gastrectomy for cancer
* Must have capacity to consent
* Age 18-99

Exclusion Criteria:

* Known contraindication for CPX
* Physically unable to perform CPX test or undertake prehabilitation exercise programme
* Pregnant patients or those planning to become pregnant
* Lack of capacity to give informed consent
Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy for Evaluation of Malignant Lymph Nodes - a Pilot Study

Current modalities for lymph node staging in cancer can be limited. Needle-based confocal laser endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the 19-gauge FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time in vivo imaging of lesion tissues at cellular and subcellular levels.This study aimed to evaluate the feasibility of needle-based confocal laser endomicroscopy (nCLE) at the time of endoscopic ultrasound (EUS) and to describe the nCLE features that distinguish between benign and malignant lymph nodes.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing EUS for staging of malignancy or assessment of enlarged lymph nodes

Exclusion Criteria:

* Patients aged \<18 years or \>80 years
* Known allergy to fluorescein dye
* Previous EUS-FNA performed within the past 3 months, and usualcontraindications to EUS-FNA
* Pregnancy or breastfeeding
* Inability to provide informed consent
Couple and Spouse Caregiver in Huntington's Disease

The objectives are to better document the psychosocial status and needs of caregiver of HD patients and understand the dyad functioning, facing the disease at various stages.


Eligibility Criteria:
Inclusion Criteria:

For patient :

* HD, CAG \> 36, motor UHDRS \> 5
* Being able to communicate with the investigator

For both spouses :

* Living together since at least 5 years
* 30 to 60 years old

Exclusion Criteria:

For patient :

- Other chronic neurologic disorder

For both spouses :

* Psychiatric disease
* Unable to participate, incl read, understand and sign the informed consent
Evaluation of MN-166 (ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients with ALS

A Phase 2b/3 multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and tolerability of MN-166 given to ALS participants for 12 months followed by a 6-month open-label extension phase.

This is a Phase 2b/3 multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and tolerability of MN-166 followed by an open-label extension phase compared to matching placebo in subjects diagnosed with ALS.

The study will consist of a screening phase (up to 30 days) followed by a double-blind phase (12 months). Following the screening phase, subjects who continue to meet entry criteria will be randomly assigned to one of two treatment groups: MN-166 or matching placebo in a 1:1 ratio. Upon completion of the double-blind phase, subjects will be given the option to continue to the Open-label Extension Phase for a period of six months.

Eligibility Criteria:
Major Inclusion Criteria:

* Male or female subjects age 18 - 80 years, inclusive;
* Diagnosis of familial or sporadic ALS as defined by the El Escorial-Revised (2000) research diagnostic criteria for ALS \[clinically definite, clinically probable, probable-laboratory-supported\];
* ALS onset of ≤18 months from first clinical signs of weakness prior to screening;
* If currently using riluzole, subject must be on a stable dose for at least 30 days prior to initiation of study drug;
* If currently using edaravone, subject should have completed at least 14 days of their initial treatment cycle prior to initiation of study drug;
* Last documented pulmonary function test result (i.e., slow vital capacity or forced vital capacity) must be greater than or equal to 70% predicted;
* Able to swallow study medication capsules;
* No known allergies to the study drug or its excipients;
* Received pneumococcal vaccine within 6 years prior to starting clinical trial.

Major Exclusion Criteria:

* Confirmed hepatic insufficiency or abnormal liver function (AST and/or ALT \>3 times upper limit of normal);
* Currently diagnosed with a clinically significant psychiatric disorder or dementia that would preclude evaluation of symptoms;
* Currently use or treated with parenteral (intramuscular or intravenous) high dose (\>25 mg/week) Vitamin B12 within 30 days prior to study drug administration;
* Poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator;
* Currently participating, or has participated in a study with an investigational or marketed compound or device within 30 days or 5 half-lives, whichever is shorter, prior to signing the informed consent;
* Use of tracheostomy or \>22/24-hour ventilatory support.
3D Echo Evaluation of the Ventricles in Sclero Associated Severe PAH

The aim of the study is to document the left and right ventricular function in patients with sclerodermia associated pulmonal arterial hypertension via 3D echocardiography. The results of this study should help to generate hypothesis for further future studies.

The primary hypothesis is that the increased use of modern image guided methods could provide essential aspects for the follow up.

The 3D echocardiography could provide early and detailed information about the changes in the left and right ventricle.

The prediction of sclerodermia associated pulmonary arterial hypertension (PAH) is rather adverse, so it makes sense to evaluate relevant changes of the left-ventricular longitudinal strain soon to adapt the PAH specific therapy accordingly.

Eligibility Criteria:
Inclusion Criteria:

* age \>17
* pulmonary arterial hypertension (PAH) associated with WHO group 1 who start a parenteral prostanoid-therapy
* written informed consent
* prostanoid naive
* no change of the PAH specific therapy within 3 weeks of the recruitment to the study

Exclusion Criteria:

* pregnancy and lactation period
* Women of child bearing potential who do not use an effective and secure method for birth control
* severe chronic kidney insufficiency (glomerular filtration rate \<30), which will remain for more than 3 months
* liver-insufficiency Child C
* life expectancy shorter than the course of the study (for example because of malignant disease
Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders Older Than 40 Years at Altitude.

Randomized, placebo controlled trial evaluating efficacy of acetazolamide on right heart function at rest in lowlanders older than 40 years travelling from 760 m to 3'100 m.

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of preventive acetazolamide intake on right heart function at rest in lowlanders older than 40 years travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3'100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3'100 m.

An interim analysis will be carried out when 200 participants will have completed the study and/or after the first year. The Peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women, age 40-75 yrs, without any disease and need of medication.
* Born, raised and currently living at low altitude (\<800m).
* Written informed consent.
* Kyrgyz ethnicity

Exclusion Criteria:

* Any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure.
* Any condition that may interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day or \>20 pack-years with active smoking during the last 10 years), regular use of alcohol.
* Allergy to acetazolamide and other sulfonamides.
Retrospective Database Studies

Data collection and comparison of relationships between patient demographics, stimulation protocols and outcomes, retrieval and transfer outcomes, number and quality of oocytes and embryos retrieved and transferred, pregnancy rates and pregnancy outcomes.

No patient treatment is associated with the study.

Eligibility Criteria:
Inclusion Criteria:

none

Exclusion Criteria:

none
Femoral Neuropathy After Anterior Cruciate Ligament Reconstruction: Femoral Nerve Block vs Patient-controlled Analgesia (PCA)

Femoral neuropathy after anterior cruciate ligament reconstruction with femoral nerve block may be as high as 24% at 6 postoperative weeks when evaluated prospectively and systematically through a clinical neurological and an electroneuromyography (ENMG). It is still unclear whether this neuropathy is the result of the surgery, especially the Tourniquet, or the block nerve. The goal of this study is to define the etiology of this postoperative neuropathy.

Anterior cruciate ligament reconstruction is associated with moderate to severe postoperative pain. Among different analgesic strategies, continuous femoral nerve block is reported as an efficient method, reducing opioid consumption and allowing rapid rehabilitation; however, patients may develop a transient neuropathy after surgery, which could have a significant impact on active patients, particularly on athletes who need immediate rehabilitation and who will put their knee to greater use during the postoperative period. This study is designed to compare the incidence of femoral neuropathy in two groups of patients: one with a femoral nerve block, and one with a PCA of morphine (self-iv administration of morphine). All patients will have a clinical neurological exam with a preoperative ENMG in order to rule out a pre-existing neuropathy. Another clinical neurological exam with ENMG will be performed between 4 and 6 weeks and, if pathological, repeated at 6 months, 9 months and 12 months. The operation will be done under general anesthesia for all patients.

Eligibility Criteria:
Inclusion Criteria:

* patients planned for anterior cruciate ligament reconstruction
* ASA 1 and 2
* age 16 years and more

Exclusion Criteria:

* peripheral neuropathy
* pre-existing femoral neuropathy
* diabetes mellitus
* alcoholism
* drug addiction
* cancer with chemotherapy
* chronic pain state
Intralesional Injection of STS in Treatment of Calcinosis

The specific objective of this study is to perform a small, open-label study to assess the safety and efficacy of intralesional, subcutaneous injection of STS on calcinosis symptoms and lesion size in systemic sclerosis (SSc), mixed connective tissue disease (MCTD) and dermatomyositis (DM) patients. Injection will be guided by ultrasound, lesion size assessed by ultrasound, and symptom burden by patient-reported outcome measures.

Calcinosis is a condition in which calcium builds up in the skin and tissue under the skin. It develops in ∼30% of adult dermatomyositis,18%-49% of systemic sclerosis patients, 25-40% of patients with limited systemic sclerosis. There is no standard treatment recommended by physicians currently. Many treatments have been tested, all with limited benefits and without good evidence that any are effective. They are, based only on single cases or small numbers of patients in studies called "case series." But in some cases, these agents may be effective.

There are several case series that have shown the effectiveness of injecting a chemical compound called sodium thiosulfate (or "STS") into calcinosis lesions. There was some improvement in terms of pain control, and a decrease in size and resolution of the calcinosis. The aim of our study is to test intralesional sodium thiosulfate (STS) injection for symptoms relief of calcinosis. STS has been approved by the U.S. Food and Drug Administration for certain conditions related to childhood cancers. It has not been approved by the FDA to treat calcinosis. The specific aims of this study are to assess change in calcinosis size and quality-of-life measures.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of systemic sclerosis, mixed connective tissue disease or inﬂammatory myopathy
* Must be over 18 years of age
* Participants must be competent to give informed consent
* Participants must have radiographic evidence (xray or ultrasound) of calcinosis.
* Participants must need symptomatic relief

Exclusion Criteria:

• Pregnant women will be excluded