cyrilzakka/clinical-trials huggingface dataset:
Evaluating and Monitoring Physical Fatigue While Performing Functional Activities

Fatigue is a critical health parameter in older adults and stroke patients and is associated with negative health outcomes. Current assessment tools predominantly focus on walking related fatigue, neglecting other activities of daily living (ADLs). This study aims to fill this gap by developing a standardized, laboratory-based fatigue protocol that includes a broader range of ADLs, providing a more comprehensive fatigue assessment that's in line with the WHO vision of healthy ageing.

The aim of this study is to evaluate a lab-based fatigue protocol and to unravel the relationship between physiological or movement data and perceived fatigue.

Participants will take part in three separate measurement moments, during which they will execute a performance task that induces fatigue. In addition, relevant sensors will be used to collect meaningful data.


Eligibility Criteria:
Stroke survivors:

Inclusion Criteria:

* \> 18 years old
* ≥ 3 months ago stroke diagnosis
* FAC levels 3-5

Exclusion Criteria:

* Severe problems with speech or memory which prevents the participant to understand or follow instruction
* Co-morbidities that could influence the task execution and collected data

Older adults with sarcopenia:

Inclusion:

* \> 65 years old
* Grip strength: \< 27 kg (man) or \< 16 kg (woman)
* Be mobile independently

Exclusion:

* Severe problems with speech or memory which prevents the participant to understand or follow instruction
* Co-morbidities that could influence the task execution and collected data

Healthy individuals:

Inclusion:

* \> 18 years old
* Healthy physical and medical condition

Exclusion:

* Physical injury or disorder that doesn't allow good physical performance
The Effects of Kegel Pelvic Floor Muscle Exercises on Urinary Retention and Comfort Levels

This study was planned as a randomized controlled trial to investigate the effects of Kegel pelvic floor muscle exercises on urinary retention and comfort levels of patients after lumbar disc herniation surgery.

Postoperative urinary retention is the inability to urinate despite having a full bladder after surgery. It is a relatively common complication of both outpatient and inpatient procedures. Most cases are transient and are managed by temporarily emptying the bladder with bladder catheterization.

Studies in the literature report that transient postoperative urinary retention is common after cervical and lumbar spine surgery procedures. This situation is of great importance in terms of healthcare services, as it can increase both the length of hospital stay and the cost.

Kegel pelvic floor muscle exercises involve the repeated contraction and relaxation of the muscles that form part of the pelvic floor. With these exercises, pelvic floor blood circulation can be increased, pelvic floor muscle tension can be increased, and the contraction of the relaxed bladder can be stimulated indirectly by repeated contraction and relaxation of the pelvic floor muscles, and urine output can be achieved. Therefore, we think that these exercises, which are safe, cost-effective exercises that can be easily applied by healthcare personnel, and patient comfort among nursing practices to improve perioperative results and functional status, will have an effect in preventing urinary retention.

There are no experimental studies in the literature evaluating the effect of Kegel exercises applied after lumbar disc herniation surgery on urinary retention. Therefore, this study was planned to be conducted in patients who will undergo lumbar disc herniation surgery.

This study was planned as a single-center prospective randomized controlled experimental study. After obtaining verbal and written consent from the patients before surgery, the study will be conducted with various data collection forms.

These forms; Patient Information Form, Postoperative Data Collection Form, Numeric Rating Scale (NRS) to determine the pain level of the patients and Visual Analog Scale (VAS) to evaluate the comfort level. Patients will be randomized. Group I will be the Kegel pelvic floor muscle exercise group (n=29), Group II will be the control group (n=29). It is planned to measure the urinary retention and comfort levels of both groups in the postoperative period.

Eligibility Criteria:
Inclusion Criteria:

* Agreeing to participate in the study
* Over 18 years of age
* No communication barrier
* Having undergone lumbar disc herniation surgery under general anesthesia
* Being immobile for the first 8 hours postoperatively
* Not having a urinary catheter inserted during the intraoperative period

Exclusion Criteria:

* Refusal to participate in the study
* Previous urinary disorders/symptoms (such as Benign Prostatic Hyperplasia)
* Spinal trauma, preoperative neurological disorder
* Patients with preoperative catheterization
Amyotrophic Lateral Sclerosis Registry

This study takes amyotrophic lateral sclerosis (ALS) patients as the main research object. Through collecting genetics, imaging and clinical symptoms for Exploratory research, we will construct the gene spectrum of ALS in China, explore unknown pathogenic genes, explore the characteristic image characteristics of ALS, and establish the iPSCs library of ALS, providing resources and basis for the research of pathogenesis and treatment targets of ALS.

This study is a multicenter, prospective registration study that will follow up patients with clinically confirmed and suspected amyotrophic lateral sclerosis for a period of 2 years. A total of 1000 patients will be included to dynamically observe the changes in clinical symptoms and signs, imaging, electrophysiology, biomarkers, biological samples and so on, which will construct a genetic profile of ALS in China, explore the etiology and pathogenesis, and establish an iPSCs library, provide a basis for finding treatment targets.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old ≤ age ≤ 80 years old;
* Patients are diagnosed definite or probable ALS according to the Awaji diagnostic criteria;
* Sign an informed consent form.

Exclusion Criteria:

* Unable to cooperate with research or complete follow-up due to geographical or other reasons.
Replenishing and Maintaining Vitamin D Status in Older Adults in Residential Care Facilities in NI

The vitamin D status of older adults in residential care facilities in Northern Ireland (NI) is currently unknown. An observation study is currently being carried out by Ulster University and the Western Health \& Social Care Trust (WHSCT) to provide data on the prevalence of vitamin-D deficiency among older adults within residential care facilities in NI. It is expected that some 40% of the cohort will be deficient in vitamin D and will require immediate replenishment of vitamin D status. Therefore, as a follow up to the observational study, an intervention study will be conducted, where participants identified as vitamin D deficient (25(OH)D) status \<30nmol/L (cut-off currently used by the WHSCT will be re-contacted and provided with a vitamin D supplement. The aim of this study is to investigate the dose and duration of vitamin D supplementation that is required to replenish and maintain vitamin D status in older adults with vitamin D deficiency within residential care facilities. Participants will be randomly assigned to receive one of two supplementation regimes: 3200IU/day vitamin D3 or 20,000IU/week vitamin D3. Blood samples (no more than 20ml per appointment) will be taken at 4 different time points: week 0, week 2, week 4 and week 8. These two doses are routinely used in clinical practice for remedial supplementation of vitamin D and have been chosen based upon their availability from manufacturers of vitamin D supplements. Also, albeit these doses are currently routinely used to replenish vitamin D status little is known on how effective they are and how soon vitamin D status is optimised. Clinicians can only administer medication for the management of osteoporosis (e.g. bisphosphonates) once vitamin D status is optimised. Therefore, measurements will be taken every two weeks to establish response to the remedial supplementation. This project provides a unique opportunity to monitor the replenishment and maintenance of vitamin D status following remedial supplementation more regularly (at weeks 0,2,4,8) than would be done under standard National Health Service care. This does and duration of vitamin D required to replenish vitamin D deficiency in older adults is currently ambiguous within the literature and clinical care.


Eligibility Criteria:
Inclusion Criteria:

* Currently residing (≥1 month) within residential care facilities in Northern Ireland and who have previously undertaken the observation study (full title: A cross-sectional analysis of vitamin D status and bone health of older adults within residential care facilities in Northern Ireland) and have been identified as vitamin D deficient.

Exclusion Criteria:

* Participants will be excluded from the study if by the judgement of the consultant rheumatologist that they have very abnormal bone or vitamin D metabolism due to conditions such as end stage renal failure or bone metastases.
The Impact of Altered Arterioventricular Coupling on Central Cardiovascular Energy Delivery

This study will assess the amount of energy that the heart will deliver to the central circulation and the efficiency of that energy transfer, in patients undergoing a coronary artery bypass graft operation. Measurements will be taken just after induction of anaesthesia and repeated just after the end of the operation. The total energy delivered by the heart will be calculated by multiplying a pressure curve from the artery in the hand with the instantaneous ultrasound recorded cardiac output flow curve. The energy responsible for the acceleration of the blood volume, known as oscillatory power will also be calculated. The energy transfer will be calculated using a mathematical model based upon other ultrasound and blood pressure recorded variables. We would like to see if any alteration in energy delivered is in part due to impairment in energy transfer or alteration of fraction of oscillatory power rather than a change in total energy production. We would also like to study if there are changes in the oscillatory power after cardiac bypass surgery. The patients will be sampled sequentially into the study. We are not aware of any such studies undertaken in humans previously.


Eligibility Criteria:
Inclusion Criteria:

* Elective Coronary Artery Bypass Graft patients
* No contraindications to transoesophageal Echo
* Ejection fraction 40% or over

Exclusion Criteria:

* Lack of consent
* Emergency operation
* Prosthetic aortic valve
SD-OCT Guided Treatment of Fungal Chorioretinitis

Fungal Chorioretinitis is a vision threatening condition.The investigators evaluate the efficacy of SD-OCT role in the treatment

Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination and SD-OCT was done.Procedure included oral fluconazole treatment 1 tablet once for 14 days

Eligibility Criteria:
Inclusion Criteria:

- fungal chorioretinitis

Exclusion Criteria:

* vitritis
* other macular lesion
* macular scar
Effects of Interleukin-1 Receptor Antagonism on Hyperandrogenemia in Women With Polycystic Ovary Syndrome

A prospective, interventional, open-label, single-arm, proof-of-concept study: 18 women with Polycystic Ovary Syndrome (PCOS) will be treated with 100 mg of Anakinra/Kineret® for 4 weeks. 1 week after last injection patients will have a follow-up and a dexamethasone visit after a dexamethasone suppression test. Goal of this study is to investigate the effect of the Interleukin 1( IL-1) receptor antagonist Anakinra/Kineret® on laboratory and clinical features in women with PCOS.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Premenopausal women aged 18 years or older
* Onset of menarche ≥5 years ago
* Diagnosis of PCOS defined by the Rotterdam criteria
* High sensitivity C-reactive protein level ≥1 mg/l
* Follicular phase of menstrual cycle as evident by

  * Serum estradiol level \<200 pmol/l AND
  * Serum progesterone level \<8 ng/ml
* Willingness to use non-hormonal contraceptive measures adequate to prevent becoming pregnant during the study

Exclusion Criteria:

* Intake of any testosterone level modifying drugs in the 8 weeks prior to study inclusion,
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to Anakinra/Kineret,
* Women who are pregnant or breast feeding,
* Female participants who are ovariectomized or hysterectomised or post-menopausal
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons,
* Clinical signs of infection in the week before inclusion or history of a severe infection during the last 2 months,
* Potentially severe immunosuppression or intake of other immunosuppressive drugs
* Severe hematologic disease
* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, active carcinoma),
* History of or suspected tuberculosis and/or hepatitis B/C
Iatrogenic Atrial Septal Defect Study (iASD)

This is an open-label, randomized, controlled trial of iatrogenic atrial septal defect closure with the an atrial septal occluder versus usual care observation in patients post-mitral valve intervention requiring large bore transspetal access.

This study is an open label, prospective, multicenter, non-randomized single-arm study to evaluate the safety and efficacy of the closing iatrogenic atrial septal defects in patients undergoing transcatheter mitral valve procedures using large sheaths.

A maximum of 5 Clinical Sites (referred to as "Sites" in the remainder of this document) in the U.S. Two hundred and ten patients will be enrolled in this study. The patients will randomized 1:2 device: control. The anticipated accrual rate is approximately 20 Subjects per month for a total accrual period of approximately 12-18 months.

Patients may be enrolled into the study provided all inclusion and no exclusion criteria are met as specified in Section 4. Subjects will be evaluated through hospital discharge and return for follow-up visits at 30 days, 6 months, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 at the time of informed consent signature.
2. Capable of complying with Protocol requirements, including follow-up.
3. An Informed Consent Form signed by Subject or legal representative.
4. Patient has had successful reduction of mitral regurgitation to at most moderate regurgitation post-mitral-clip.

Exclusion Criteria:

1. Remaining mitral regurgitation of ≥ moderate-severe
2. Subject unable or unwilling to provide informed consent
3. Concomitant severe aortic valve disease
4. Dialysis
5. Pregnancy or intent to become pregnant
6. Life expectancy \< 1 year
7. Active bleeding
8. Inability to follow up with 6-month timepoint due logistical concerns
Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes (OCT-DES)

The aim of this study is a comparative evaluation of re-endothelailisation of the Integrity Resolute zotarolimus eluting stent (Medtronic) and of the Promus Element erolimus eluting stent (Boston Scientific), in patients with diabetes.

We plan to compare endothelial coverage and neointimal proliferation using OCT and compare this data to published results from conventional stents.


Eligibility Criteria:
Inclusion Criteria:

* Known to have diabetes
* Scheduled for percutaneous coronary intervention (PCI) with a stenosis suitable for DES implantation and OCT imaging
* Reference vessel diameter over 2.5mm by operator assessment.
* Able to understand and sign the written Informed Consent Form.
* Able and willing to follow the Protocol requirements.

Exclusion Criteria:

* Inability to consent
* Cardiogenic shock
* Planned use of a bare metal stent
* LMS coronary artery disease
* Congestive cardiac failure or low ejection fraction (LVEF \<35%)
* Lesions unsuitable for OCT
* Total length of stented lesion greater than 55mm (total combination of stent lengths)
* Age less than 18 years or age greater than 80 years
* Planned surgical procedure ≤ 12 months post PCI procedure
* Patient demonstrates evidence of thrombocytopenia (platelet count \< 100,000/mm3)
* Patients with contraindications to ASA, clopidogrel, or prasogrel
* Patient is currently on warfarin, or possibility of treatment with warfarin during the following 12 months post index procedure
* Allergy to contrast
* Patients enrolled in another active clinical trial.
* Potential for non-compliance towards the requirements in the study protocol.
* Serious known concomitant disease with a life expectancy of less than one year
* Follow-up impossible (no fixed abode, etc)
* Patients with renal impairment (Creatinine \>200mmol/L)
* Subjects of childbearing potential
Studying Melatonin and Recovery in Teens

The goal of this feasibility clinical trial is to learn if melatonin can help teens having major musculoskeletal surgery by promoting healthy sleep. Melatonin is available as a dietary supplement that may be effective in promoting longer, higher quality sleep. This study will assess the feasibility and acceptability of melatonin for teens undergoing major musculoskeletal surgery, as well as determine optimal measured outcomes (sleep, pain, health-related quality of life) at short- and long-term follow-up.

The investigators will enroll a total of 45 adolescents ages 12-18 years old who are scheduled to undergo major musculoskeletal surgery and one of their caregivers who meet inclusion and exclusion criteria. Participants will be asked to:

1. Take melatonin or a placebo before and after surgery. All participants will receive sleep hygiene instructions.
2. Wear a watch-like actigraphy device before and after surgery
3. Complete 1-minute check-in surveys twice each day, for about 5 weeks total before and after surgery
4. Complete 10-20-minute online surveys 3 times over 4 months.

Researchers will compare participants randomized to the placebo arm and melatonin arm to see if the trial design and outcomes are both feasible and acceptable to patients and their families.

The main aims are:

Aim 1. To assess the feasibility and acceptability of melatonin for youth undergoing musculoskeletal surgery Aim 2. To determine optimal primary and secondary outcomes (sleep, pain, health-related quality of life) at short-term (during the initial 21 days) and at final follow-up (3 months after surgery). The investigators will examine completion rates, the extent and pattern of missing data, and gather data to provide effect estimates, variances, and 95% confidence intervals.

Eligibility Criteria:
Inclusion Criteria:

Patients/youth:

* Age 12-18 years
* Participants undergoing elective major musculoskeletal surgery for eligible conditions
* California state resident
* Regular access to internet and smartphone
* Can read and understand English

Parents/caregivers

* Biological parent or legal guardian of youth
* Can read and understand English

Exclusion Criteria:

Patients/youth

* Prescription medication for premorbid insomnia
* Cognitive impairment or developmental delay
* Does not agree to a 1-week washout if taking over the counter supplements or other sleep aids prior to the start of the study medication
* High risk for sleep related breathing disorder
* Chronic medical condition that is severe/systemic or requires regular treatment regimen
* Psychiatric admission in prior 30 days
* Patients that underwent major surgery in the last 3 months, or those that have not fully recovered from a prior surgery
* BMI ≥ 99th percentile
* Enrollment in another therapeutic study
* Any serious underlying medical or psychiatric condition, that, in the opinion of the investigator, would contraindicate the patient\&#39;s participation in the study
Formulated PSTA Injection Versus PATA Alone in the Management of Macular Edema Secondary to Non-ischemic Retinal Vein Occlusions

The aim of this study is to compare formulated Posterior Subtenon Triamcinolone acetonide (PSTA) injection versus Posterior Subtenon Triamcinolone acetonide alone in the management of macular edema secondary to non-ischemic retinal vein occlusions, either central or branch.


Eligibility Criteria:
Inclusion Criteria:

* Diminution vision due to macular edema secondary to non-ischemic retinal vein occlusions, either central or branch, as evidenced by clinical and angiographic evaluation
* CMT ≥ 250 µ.
* Willing to participate in the study

Exclusion Criteria:

* Unwilling to participate in the study.
* Ischemic RVO
* Prior laser treatment
* Glaucoma/Ocular Hypertension
* Cataract which lead to difficulty in the evaluation of macula
* Vitreous hemorrhage
* Macular ischemia
* Iris neovascularisation
* patients with intravitreal injection of anti VEGFs, steroid, or any intraocular surgery 3 months prior to the inclusion.
Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study

This is a prospective, single-center clinical trial. One hundred and fifty patients affected by adnexal and uterine diseases will be recruited to undergo treatment with robotic assisted laparoscopic procedures using the innovative TELELAP ALF-X Endoscopic Robotic Surgical System with the primary objective of assessing the feasibility, efficacy and safety of this approach.

The study proposed comprises a prospective, single-center clinical trial (Catholic University of the Sacred Heart of Rome, A. Gemelli University Polyclinic).

One hundred and fifty patients affected by adnexal and uterine diseases will be recruited to undergo treatment with robotic assisted laparoscopic procedures using the innovative TELELAP ALF-X Endoscopic Robotic Surgical System with the primary objective of assessing the feasibility, efficacy and safety of this approach.

Post-operative pain will be reported by the patients through a Visual Analog Scale (VAS). It will be assessed at 2, 4 and 12 and 24 hours after the procedure.

At the end of patient recruitment, surgical procedure times, the technical limits encountered, estimated blood loss, intra- and post-operative complications and the percentage of conversions from the standard laparoscopic approach to multiple access and/or to a laparotomic approach will be analyzed in order to arrive at the feasibility and efficacy of robotic assisted treatment.

Eligibility Criteria:
Patient Inclusion Criteria:

* Age ≥ 18 years old
* Sign the informed consent form
* BMI ≤ 40
* A.S.A. Class \< III or IV

Disease Inclusion Criteria:

* Ovarian cyst (enucleation/oophorectomy)
* Prophylactic bilateral oophorectomy
* Ectopic pregnancy (salpingotomy/salpingectomy)
* Tubal inflammatory disease (salpingotomy/salpingectomy)
* Infertility and sterility (treatment of endometriosis, chromo-salpingography, etc.)
* Benign uterine disease (Fibromatosis, Adenomyosis)
* Endometrial hyperplasia
* Stage Ia G1-2 Endometrial tumors
* Precancerous lesions of the uterine cervix
* Stage Ia uterine cervical tumors
* Pelvic endometriosis

Patient Exclusion Criteria:

* Pregnancy
* Liver disease
* Coagulation disorders
* Patient internal or anatomical criteria that preclude a laparoscopic approach