cyrilzakka/clinical-trials huggingface dataset:
Trial Comparing 2 Diagnostic Strategies for Preoperative Localization of Parathyroid Adenoma in Primary Hyperparathyroidism:TEMP / CT With Tc99m-sestaMIBI or PET / CT With F18-choline in First Intention

The investigators hypothesize that positron emission tomography with fluorocholline (F18-choline PET) will reduce the proportion of unnecessary invasive surgery decisions and that the higher cost of positron emission tomography versus MIBI scintigraphy (Tc99m-sestaMIBI ) will be offset by lower cost in terms of type. surgery performed wisely and complications.


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years old
* Patient presenting with primary hyperparathyroidism and for whom an excisional surgery is planned
* For women of childbearing age, negative pregnancy test at Baseline
* Biological assessment confirming the diagnosis of primary hyperparathyroidism (high serum PTH and calcium concentrations)
* Affiliation to a social security scheme
* Patient having signed his written consent

Exclusion Criteria:

* Patient deprived of liberty, under tutorship or curatorship
* Hypersensitivity to TECNESCAN SESTAMIBI
* Any associated medical or psychological condition that could compromise the patient's ability to participate in the study
* Pregnant or lactating woman
* History of parathyroid surgery
* Patient with multiple endocrine neoplasia 1 (NEM1)
* Known hypersensitivity to fluorocholine or to any of the excipients (sodium chloride, water for injections)
Lymphatic System Reflux After Lymphatic Operation

This study aimed to determine the impact on outcomes when recipient veins with reflux were used for LVA for the treatment of unilateral lower limb lymphedema.

The use of recipient veins with reflux for lymphaticovenous anastomosis (LVA) is discouraged because of the common belief that it may lead to venous-lymphatic reflux (VLR), a phenomenon in which venous blood is refluxed into the lymphatic lumen after anastomosis, which can lower the long-term patency rate. However, this concept has yet to be validated.

Eligibility Criteria:
Inclusion Criteria:

* This study including patients diagnosed with lymphatic-related diseases at Kaohsiung Chang Gung Memorial Hospital from October 1, 2015, to December 31, 2022.
* Patients who underwent LVA for unilateral lower-limb lymphedema.

Exclusion Criteria:

* Patients under the age of 20.
* Patients lost to follow-up or with incomplete data.
Radiation and Androgen Ablation for Prostate Cancer

A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating prostate cancer.

This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, locally confined adenocarcinoma of the prostate
* Patient must fit D'Amico intermediate risk criteria by clinical stage (T2b-T2c), PSA (prostatic specific antigen) (10-20 ng/mL), and/or Gleason score (Gleason 7).
* The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer.
* Signed study-specific consent form prior to registration

Exclusion Criteria:

* Stage T3-4 disease.
* Gleason 8 or higher score.
* PSA \> 20 ng/ml.
* IPSS (International Prostate Symptom Score) \> 15
* Clinical or Pathological Lymph node involvement (N1).
* Evidence of distant metastases (M1).
* Radical surgery for carcinoma of the prostate.
* Previous Chemotherapy, unless intervention was greater than 5 years from beginning treatment for current prostate cancer.
* Previous pelvic radiation therapy.
* Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years.
* History of inflammatory bowel disease.
* Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.
* Myocardial infarction or cerebrovascular accident within one year from consultation, or other major vascular risk factor which would prevent a patient from receiving appropriate androgen deprivation therapy.11
* Liver function tests (LFTs) greater than twice the upper limit of normal.
Role of Nintendo Wii in Improving Negative Symptoms and Quality of Life in Chronic Schizophrenia

The purpose of this study is to determine whether the use of Nintendo Wii will help improve negative symptoms of Schizophrenia and quality of life of patients with chronic Schizophrenia.

The proposed study seeks to determine whether any benefit in daily functioning and quality of life can be gained from using the Nintendo Wii video game console in chronic mental illness, namely schizophrenia. There is a small research base on the use of the Wii console in elderly nursing home residents as a means of increasing mobility, with attendant benefits in areas such as falls, quality of life, and relief of subsyndromal depression. For individuals with schizophrenia, adjunct exercise therapy has been associated with gains in both psychiatric and physical symptoms. However, people with schizophrenia face physical and functional barriers in initiating and continuing organized activity programs. Thus, the Nintendo Wii Fit Plus interactive fitness video game is being proposed as a novel way of introducing and engaging people with schizophrenia in various forms of physical activity.

As the first study to assess the use of the Nintendo Wii in chronic mental illness, the purpose of this pilot study is to assess the feasibility and the capacity of the Nintendo Wii in improving the health and functioning of people with severe, chronic schizophrenia. Although it is hypothesized that Nintendo Wii use will lead to gains in these domains, the information gained from this study will be used to determine specific areas of benefit and to assess whether any observed differences in outcome measures are sufficient to warrant a full-scale study. Furthermore, this initial study aims to pilot the interview schedule, clarify wording on the questionnaires, ensure that all important areas have been covered by the questionnaires, and determine whether participants are capable of meeting the demands of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Schizophrenia defined by the DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision)
* Males or females aged 18 years of older
* Participate in the Community High Intensity Treatment Team (CHITT) out-patient program
* Certified by their physician to participate in physical activity

Exclusion Criteria:

* History of violence or other risks that may endanger study research assistants during home visits
Effectiveness of Ultrapulse for the Treatment of Androgenic Alopecia Among Malaysian: A Quasi-experimental Study

The goal of this study is to to evaluate the effectiveness of Ultrapulse for the treatment of androgenic alopecia among Malaysian. The main questions it aims to answer are:

* the efficacy of Ultrapulse in treatment of androgenic alopecia among Malaysian
* the safety and adverse effect of Ultrapulse treatment.
* the quality of life of androgenic alopecia among Malaysian.

Ultrapulse is a is a laser beauty device using erbium-doped yttrium aluminium garnet laser (er:YAG). Er:YAG laser is a laser with wavelength of 2940nm which is able to penetrate into the dermis to a depth of 3-4 mm, and energy absorption occurs in the area of the dermal papilla, resulting in an increase in blood circulation of the papilla and activation of metabolism in the hair follicle. It generates multiple micro pores at the epidermal layer that enhances the absorption of the active substances that help to stimulate hair growth developed by Lyzer Co. Ltd in Korea.

Eligibility Criteria:
Inclusion Criteria:

- Patient with androgenic alopecia with severity of Norwood-Hamilton Scale II to VI for male and Ludwig Scale I to III for female

Exclusion Criteria:

* Use of topical or systemic medications affecting hair growth within the 6 months before recruitment
* Previous hair transplantation, underwent scalp reconstruction procedure, hair braiding or scalp tattoo
Effects of a Lower Limb Strength Training Program on a Seated Robotic Device in Patients

The loss of lower limb strength that occurs after an Acquired Brain Injury (ABI) limits the patient's autonomy in participating in activities of daily living, including gait performance. In the sub-acute phase, it is difficult to implement a strengthening program, as weakness prevents exercise being performed with the recommended parameters. This limit can be exceeded by using specific robotic devices, which allow the effort provided to be adapted according to the patient's capacities. In addition, motivation can be improved by the use of feedback or incentive games. The aim of this pilot study is to obtain data on the effect of lower limb strength training with a seated robotic device in subacute ABI patients for a future larger randomised study. In addition, it aims to evaluate the recruitment rate, applicability, resources for implementation and patient tolerance to the training program.


Eligibility Criteria:
Inclusion Criteria:

* Acquired Brain Injury of vascular, traumatic, infectious or tumoral origin in the subacute phase
* Walking ability ≤ Functional Ambulatory Category level 5 (1-6)
* Paresis of the lower limb: strength \<57/100 on the Motricity Index
* Cognitive and memory functions allowing the patient to follow treatment instructions and give informed consent

Exclusion Criteria:

* Significant heart problem
* Venous thrombosis less than 6 months
* Musculoskeletal impairment not compatible with movement
* Degenerative neurological disease
* Oxygen-dependent
* Blood pressure not stabilized
Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women

Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal females ≥35 years with either or both ovaries removed or naturally menopausal with moderate to severe vaginal dryness

Exclusion Criteria:

* Hypersensitivity to estrogen and/or progestin therapy
* Known or suspected premalignant or malignant disease (except successfully treated skin cancers)
* Manifestation of or treatment for significant cardiovascular disease, congestive heart failure, stroke or ischemic attacks
* Insulin-dependent diabetes mellitus
* Increased frequency or severity of headaches while on hormone or estrogen therapy
* Drug or alcohol addiction within last 2 years
* Participation in a clinical trial within 30 days
* Smoking ≥ 15 cigarettes daily
* Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 95 mmHg
Immediate Loading With Provisional Prosthetic Restoration by Means of One Abutment at One Time and Temporary Abutment

This will be a prospective, randomized, controlled, single center clinical trial with

1 year enrollment period, surgical and prosthetic rehabilitation with 1-year post-loading follow-up. A total of 2.0 years of study duration The primary objective is to compare peri-implant hard and soft tissue changes between single implants placed in the posterior mandible and immediately loaded either with definitive (one-time) or provisional abutment.

Hard tissue contour changes will be assessed using standardized two-dimensional intra-oral radiographs and partial small field of view three-dimensional cone beam CT scans. Soft tissue contour changes will be assessed using superimposition of dental digital models. Inflammatory soft tissue reactions will be evaluated by measurement of respective cytokines' levels.A quantitative evaluation of total bacteria amount of the peri-implant samples.

Secondary objectives of this study will be to estimate total bacterial amount (quantitative real-time polymerase chain reaction - qRT-PCR).

Bleeding on probing (BoP), full mouth oral hygiene index, periodontal pocket depth (PPD) and keratinized tissue width will also be evaluated.

Indication: Patients with need of at least two implants (one per side) in the premolar or molar region in the mandible, bilaterally.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 25 years
* In need of a one or two implants.
* Healed site (healed site defined by restored gingiva, free of inflammation and scar tissue , with a keratinized band of 3mm from crest to muco-gingival junction, and sufficient osseous architecture to receive an implant with a minimal diameter of 3.5 mm).
* Mandible second premolar or molar region.
* At least one neighboring tooth to be present.
* Absence of visible active periapical or periodontal inflammation.
* Adequate oral hygiene: PI\< 20%, BoP\< 20%.
* Sufficient occlusal units mesial or distal and antagonizing, including the diastema to be restored: 4 occlusal units.

Exclusion Criteria:

* Medical condition that contraindicates surgery: ASA -score ≥ III
* History of radiotherapy in the head and neck region.
* History of Bisphosphonate medication.
* Medium smokers ≥ 10 cigarettes per day.
* Patients unwilling or incapable of understanding and signing the informed consent.
* Active caries.
* Presence of inflammation expressed by PPD \>4mm and BoP on adjacent teeth.
* Active periapical radiolucency or root canal treatment performed \< 4 months previous to planned implant insertion on a neighboring tooth to future implant.
* Insufficient restorative space.
* Interocclusal plane distance \< 20mm at planed implant position.
The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System

To evaluate the safety and feasibility of the Cordis Neurovascular Self-Expanding Stent System to facilitate endovascular coil embolization of wide neck saccular intracranial aneurysms.

Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel

This is a multi-center, prospective, non-randomized feasibility study including 30 subjects. Subjects will receive a safety follow-up evaluation at 30 days (+ two weeks) and an efficacy follow-up evaluation at 6 months (+ four weeks).

Eligibility Criteria:
Inclusion Criteria:

* Patients with intracranial, wide-neck, saccular aneurysms

Exclusion Criteria:

* Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage
Promoting Seniors' Health With Home Care Aides

This study aims to test whether a safe physical activity program with a built-in motivational enhancement component, performed in a seated position, preserves the function and well-being of older home care clients.

Regular physical activity benefits older adults physically and mentally. However, the availability and the evidence for physical activity programs that are safe and appropriate for home-bound older adults at risk for nursing home admission are limited. The current project aims to examine the effectiveness of a safe physical activity program, led by home care aides who regularly help hard-to-reach older home care clients with housekeeping and routine personal care services in the home. The primary aim is to test whether the safe physical activity program with a built-in motivational enhancement component, performed in a seated position, preserves the function and well-being of home care clients. The secondary aim is to understand for whom the program is efficacious, the extent to which the program can reach the target population, the extent to which participants drop out of the program, the extent to which program participants maintain the behavioral change introduced by the intervention, and what the program's cost-effectiveness is. Building on a pilot project that demonstrated the program's feasibility in a large home care program funded by the state and Medicaid, this randomized controlled trial will inform future expansion of the physical activity program into real-world home care settings.

Eligibility Criteria:
HOME CARE CLIENTS

Inclusion Criteria:

* English or Spanish-speaking older adults aged 60+
* Receiving Illinois Department on Aging Community Care Program In-Home service from the collaborating home care agency
* Able to sit in a chair independently for \>=15 minutes (it is fine if the person needs help with transferring to a chair)
* Cognitive status sufficient to follow directions and respond to survey questions as determined by the Six-Item Screener (Callahan, et al., 2002) (the instrument used in the phone screening) and the Modified Mini-Mental State (3MS) Examination (the instrument used in the in-home screening)
* Willing to be assigned to either intervention program
* Willing to have the research team notify the primary care physician of the client's study participation

Exclusion Criteria:

* Having a legal guardian appointed
* Bedridden or unable to sit in a chair independently
* Receiving hospice care or having a terminal diagnosis
* Self-reported inability to read large print books

HOME CARE AIDES

Inclusion Criteria:

* English or Spanish-speaking home care aide caring for an older home care client eligible for the study
* Age 18 and older
* Willing to implement the intervention program routine with their eligible client(s) for the full 4 months
* Willing to be randomly assigned to either intervention program
* Intend to be a home care aide for the next 12 months

Exclusion Criteria

• Not having a home care client who participates in the study
BNP Evaluation Before Surgery Study: an Observational Study of Natriuretic Peptide Levels Prior to Surgery.

A prospective, multi-centre, observational study of preoperative natriuretic peptide testing for patients undergoing non-cardiac surgery conducted over four weeks.

Identification of high-risk surgical patients requires risk stratification. Current clinical risk stratification tools, e.g. Revised Cardiac Risk Index (RCRI), only have a moderate ability to identify these patients. International guidelines, like Canadian Cardiovascular Society on perioperative cardiovascular risk assessment, advocate that all patients 45 yrs and older or patients \>18y rs who have significant cardiovascular disease and who are coming for intermediate to high-risk surgery, should get natriuretic peptide (NP) testing. This is because raised preoperative B-type natriuretic peptides have a strong association with postoperative cardiac complications according to observational studies and meta-analyses.

However, in these patients with significant cardiovascular disease coming for intermediate to high-risk surgery it is unknown how many patients will actually have raised B-type natriuretic peptides. That is, which group of patients have an even higher risk in this already high-risk group. Natriuretic peptide (NP) testing is also expensive.

Further identification of patients that need NP testing will reduce costs and focus efforts on those patients who really need it.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 45 years of age.
2. Undergoing intermediate or major non-cardiac surgery requiring an overnight stay in hospital.
3. With at least one of the following criteria:

   1. History of ischaemic heart disease or peripheral vascular disease (coronary equivalent)
   2. History of stroke or transient ischaemic attack
   3. History of congestive cardiac failure
   4. Diabetes currently on an oral hypoglycaemic agent or insulin
   5. Serum creatinine \>175 µmol/L (\>2.0mg/dl)

Exclusion Criteria:

1. Patient refusal to participate.
2. Patients presenting for cardiac and obstetric or emergency surgery.
Exploring the Long-term Cardiovascular Effects of Vaping

Smoking is the "leading, preventable death-cause worldwide", being responsible for almost 700,000 deaths in the E.U. annually. Therefore, implementing successful, long-term smoking cessation strategies is a long-term priority for the NHS.

Recent evidence suggests that e-cigarettes (i.e., vaping) are a successful cessation tool, with around 3.6 million users in the UK. There are concerns about long-term vaping, particularly in relation to their cardiovascular effects, as there are no relevant, longitudinal studies.

Therefore, we propose a 38-month, four-group longitudinal study exploring the cardiovascular physiological effects of the use of e-cigarettes over a two-year period, informing policy makers and e-cigarette users (vapers). Our study was developed with the support of vapers.

The main research question is whether there are any differences in cardiovascular physiology between vapers, who are ex-smokers (Group A), vapers with no previous smoking experience (Group B), dual users (i.e., those who vape and smoke (Group C) and ex-smokers who don't vape (Group D).

Two-hundred participants from Sheffield and Leeds will be invited on five occasions (baseline, as well as 6-,12-,18- and 24-months post-baseline).

We will assess macrovascular and lung function, cardiovascular disease risk (through questionnaires and blood biomarkers), vaping and smoking dependence, smoking and and vaping history among others.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria: Age ≥18 years of either gender. Specific group inclusion criteria include:

Group A: Ex-smokers with previous smoking history of at least two years, who vape for at least one year, at least 50 puffs a day.

Group B: Current vapers who have been vaping daily (minimum 50 puffs/day) for at least one year, with no previous smoking history, Group C: Current vapers (50 puffs/day), who smoke at least 20 cigarettes per week. Group D: Ex-smokers, who have stopped smoking for a period greater than one year and who currently do not vape.

Exclusion Criteria:

* Non-ambulant people and people with a recent (e.g., within 6 months) CVD event (e.g. stroke, myocardial infarction) or cardiac surgery,
* pregnancy,
* people who require major surgery (which will prevent them of taking part in the study),
* people who are unable or unwilling to give informed consent.