cyrilzakka/clinical-trials huggingface dataset:
Bedrest, Feeding Pattern, and Insulin Sensitivity

In the present study, the investigators will assess the impact of two different feeding patterns (continuous vs intermittent) on insulin sensitivity and muscle mass following bedrest.

In the present study, the investigators will assess the impact of two different feeding patterns on insulin sensitivity and muscle mass following bedrest. Healthy, young males will be fed in a continuous (no breaks in food supply) or intermittent (in boluses throughout the day) manner.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5 and 35
* Recreationally active

Exclusion Criteria:

* Type 2 diabetes
* Performing progressive resistance training in 6 months prior to study
* Back/knee/leg problems
* Hypertension
* Use of certain anticoagulants
* All co morbidities interacting with mobility and muscle metabolism of the lower limbs
* Blood donation in past 3 months
Ketamine and Kidney Injury in Cardiac Surgery

The purpose of this study is to investigate the affects of ketamine use for anesthesia at the beginning of heart surgery on kidneys compared to the use of propofol.


Eligibility Criteria:
Inclusion Criteria:

* Presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota.
* Scheduled to undergo complex cardiac surgery with the use of cardiopulmonary bypass. Complex cardiac surgery will be defined as surgery involving more than one heart valve, redo-sternotomy procedures, or combined valvular and coronary artery bypass graft procedures (aortic repair not excluded if meets other criteria).

Exclusion Criteria:

* Left or right ventricular assist device implantation or explantation.
* Procedures not requiring cardiopulmonary bypass.
* Active infection or sepsis requiring antimicrobial therapy and/or vasopressor therapy (treated endocarditis is not excluded).
* Severe hepatic disease resulting in ascites.
* Pre-operative significant renal dysfunction including a baseline creatinine equal to or greater than 2 mg/dL or requiring dialysis.
* Immunosuppressive medication use (including current IV or oral steroids use, use of anti-rejection medications for transplant within 1 month, or chemotherapy within 6 months).
* Immunodeficiency syndrome including HIV/AIDS, leukemia, and multiple myeloma
Gene Polymorphism Study of Normal Individual Inflammasome Genes

This study is intended to collect blood from healthy individuals to investigate whether variations in immune-related (inflammasome) genes affect how the immune cells found in the blood can help fight infections and prevent diseases.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy with no chronic or acute illnesses, or taking medication which in the opinion of the PI would impact the analyses being conducted.
2. At least 18 years or older.
3. Are capable of reading, understanding and providing written informed consent.

Exclusion Criteria:

1. Non-English speaking.
2. Individuals under 18 years old.
3. Woman who believe they are or may be pregnant. (Based on self reporting. Pregnancy testing will not be conducted for the purposes of this study)
4. Individuals experiencing acute or chronic illnesses which in the opinion of the PI would impact the analyses being conducted.
5. Currently taking prescription or over the counter medication which in the opinion of the PI would impact the analyses being conducted.
6. Individual has donated blood more than twice in the last week or the amount to be drawn will exceed the maximum allowance in the last 8 weeks.
Function and Pain Following Knee Replacement

The goal of this interventional study is to compare pain management techniques (femoral nerve block, intra-articular block, none) in TKA patients. The main questions it aims to answer are:

* Are there differences in postoperative outcomes?
* Does preoperative quadriceps muscle strength predict early functional ability? Participants underwent TKA and assessments. Researchers compared pain management techniques to assess effects on postoperative outcomes and identified the importance of preoperative quadriceps muscle strength as a predictor of early functional ability. Further research is required to refine postoperative pain management strategies.

Total knee arthroplasty (TKA) is a frequently undertaken elective orthopedic intervention for severe knee osteoarthritis, frequently yielding postoperative discomfort and complications. Peripheral nerve blocks, notably femoral nerve blocks, are commonly utilized for analgesia but may transiently impede motor nerve function, weakening the quadriceps muscle. Intra-articular blocks offer a potential alternative to mitigate motor impairment. However, there exists a dearth of information regarding the comparative effectiveness of these methods with respect to short-term functional outcomes in the immediate postoperative phase following TKA.

Objectives: This study assesses functional outcomes, pain, quadriceps strength after TKA with femoral nerve block, intra-articular block, and a control group. It identifies predictors of postoperative functional ability.

Methods: 54 patients undergoing TKA were evaluated, measuring pre-op quadriceps strength, and utilizing the Oxford Knee Score for functionality. Post-op, we evaluated mobility using the Timed Up \& Go, Elderly Mobility Scale, and Five Times Sit-to-Stand tests on POD 1 \& 3/4. Pain levels, hospitalization, surgical duration, complications, and falls were also recorded.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, over the age of 18, electively assigned for primary knee replacement surgery.
* ASA score 1-3

Exclusion Criteria:

* Revision surgery
* Patients suffering from chronic pain syndrome or chronic opioid use.
* Patients with previous neurological deficits in the lower extremities.
* A cognitive state that does not allow signing of consent or understanding simple instructions.
Air-charged vs Water-filled Catheters (Bonn)

A comparative study was conducted and the patient underwent a conventional urodynamic study. In order to successfully determine if the Air-Charged (AC) and Water-Perfused (WP) measurements are equivalent, the two sources of intravesical pressure (Pves) and abdominal pressure (Pabd) were collected concurrently at various fill volumes for the bladder.

The objective of this study was to compare the use of water-filled and air-charged catheters in determining equivalency between the two technologies during cystometric assessment.

A total of 25 patients (9M/16F) were recruited. All patients underwent cough and Valsalva manoeuvre pressure tests to measure vesicle pressure (Pves) and abdominal pressure (Pabd). A single dual-lumen catheter (T-DOC 7Fr Air-Charged® catheter) was used to record air and water pressures simultaneously.

The primary outcome was to determine if the maximum pressures during Valsalva manoeuvres, as measured with a single dual-lumen water-perfused and air-charged catheter, are equivalent when the bladder is filled to 200 cc during a urodynamic evaluation.

Exploratory endpoints included the following:

1. To determine if maximum pressures for cough, as measured with a single dual-lumen water-perfused and air-charged catheter, are equivalent when the bladder is filled to 100, 200 and Maximum Bladder Capacity (MBC) cc during a urodynamic evaluation.
2. To determine if maximum pressures for Valsalva manoeuvres, as measured with a single dual-lumen water-perfused and air-charged catheter, are equivalent when the bladder is filled to 100 and MBC cc during a urodynamic evaluation (as well as 200 cc which is the primary objective).
3. To determine if the maximum voiding pressure, as measured with a single dual-lumen water-perfused and air-charged catheter, are equivalent.
4. To determine if the clinical impressions of the urodynamic study are equivalent for the water-perfused and air-charged catheters.
5. To determine if the compliance of the bladder is equivalent when measured by air-charged catheters as compared to water-perfused catheters.

Eligibility Criteria:
Inclusion Criteria:

* Patients normally indicated for urodynamic evaluations

Exclusion Criteria:

* Patients who suffer from bladder infections (not including patients with asymptomatic bacteruria, prophylaxis with an antibiotic is at the discretion of the physician)
* Patients who suffer from strictures in the urethra
* Patients who are pregnant
* Patients who require the use of a suprapubic catheter
A Post-marketing Study to Assess the Safety of Abatacept in Sweden Using the Swedish Rheumatology Quality Register (SRQ) Register

The purpose of this study is to collect real-world data in order to estimate the frequency of overall malignancies, melanoma, basal cell carcinoma, and squamous cell carcinoma in participants with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) enrolled in the SRQ Register in Sweden.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA or PsA
* ≥18 years at index treatment initiation
* Participants starting treatment with:
* abatacept
* non-targeted DMARDs
* targeted DMARD

Exclusion Criteria:

- Not applicable
Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis

Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis

The aim of this project is to develop Leap Motion Sensor-assisted rehabilitation games that can be easily applied in hand rehabilitation in individuals with SSc, motivating, directing to the right exercise, providing therapeutic evaluation and feedback during the game, and comparing the effectiveness of these rehabilitation games with traditional rehabilitation applications.

Eligibility Criteria:
Inclusion Criteria:

* Having the ability to adapt to exercises
* Not having any diagnosed cardiac or orthopedic disease that may prevent the application of assessment methods

Exclusion Criteria:

* Having a diagnosis of juvenile-onset SSc
* Having a history of neurological disease or trauma that will affect hand functions
* Receiving another treatment, such as intra-articular injection, surgery, that may affect hand rehabilitation in the last 6 months
* Having systemic involvement that may affect the treatment process or activities of daily living
A Study of Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy and Concurrent Chemotherapy

Oral Mucositis associated with adjuvant radiation and concurrent chemotherapy in postoperative Head and Neck setting

This study consisted of 2 phases. The acute oral mucositis (OM) evaluation phase includes the time from randomization to the time of severe OM (WHO Grade 3 or 4) resolution (up to Week 12 or up to Week 15 for participants whose severe OM is not resolved at Week 12). In the acute OM evaluation phase, participants were randomized to receive either a single IV bolus dose of palifermin or placebo at 120 μg/kg, 3 days before the start of radiotherapy, plus 7 once-weekly palifermin or placebo doses at the same dose level during a 7-week radio/chemotherapy course. In the long-term follow up phase, participants are followed until death, withdrawal of consent, or loss to follow-up. The long-term follow up phase is still ongoing.

Eligibility Criteria:
Inclusion Criteria:

* History of newly diagnosed histologically confirmed squamous cell carcinoma (American Joint Committee on Cancer \[AJCC\] Stage II, III, IVA, or IVB) involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx, post surgical resection (R0, R1)
* Scheduled to receive adjuvant concurrent chemoradiation treatment within 12 weeks of surgery
* High-risk subject defined by presence of at least one of the following: R1 resection margins; T3 or T4 tumor stage; 3 or more positive lymph node metastases; \<3 lymph node metastases with extracapsular extension of the disease
* Radiation treatment field to receive planned dose of at least 50Gy to areas of the oral cavity/oropharynx mucosa that can be visualized

Exclusion Criteria:

* Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors
* Metastatic disease (M1) / Stage IV C
* Presence or history of any other primary malignancy
* History of pancreatitis
* Prior radiotherapy to the site of disease
* Prior chemotherapy
* Other investigational procedures
* Thirty days or less since receiving an investigational product or device in another clinical trial. Current enrollment in another clinical trial is not permitted unless the sole purpose of the trial is for long-term follow-up/survival data
Screening Cardiovascular Patients for Aortic Aneurysms

Screening studies for Abdominal Aortic Aneurysms (AAA) in 65 to 79 years aged men, have shown a significant reduction in AAA related mortality. In addition, the cost-effectiveness of screening for AAA in men in the Netherlands has been demonstrated by using a Markov model. Screening might be even more (cost-) effective if targeted on high risk groups, such as patients with a particular cardiovascular disease with a known increased risk of having an AAA.

Project SCAN (Screening CardioVascular patients for Aortic aNeurysms) is a project focused on targeted AAA screening to proactively diagnose patients at high risk of having an aneurysm that eventually may rupture. This pilot project aims to study the value of a screening protocol in daily practice to detect AAA's in high risk patients.

1. Offering PAD and CAD patients a non-invasive abdominal ultrasound after a careful process of shared-decision making
2. Recording data on aneurysm detection on all PAD and CAD patients screened:

   1. General information (age, gender)
   2. Medical history on CardioVascular risk factors (such as smoking history, hypertension, and other cardiovascular medical conditions - only information that is already recorded in the patient's medical history chart)
   3. AAA - Yes/ No (Yes if ≥3 cm AAA)
   4. If ≥3 cm aneurysm, record exact size and outcome in time (surveillance, treatment, no treatment)
   5. If treated, record treatment type (EVAR or Open) and outcome

Eligibility Criteria:
Inclusion Criteria:

* male and female patients
* peripheral arterial disease (ankle brachial index \< 0,90 and/or reduction of \> 0.15 after exercise test) or a carotid stenosis (stenosis ≥ 50%)
* age \> 55 year

Exclusion Criteria:

* Patients unfit for endovascular or open surgery (as judged by vascular surgeon)
* Failure to master the dutch language
Analysis of the Enteric Nervous System Using Colonic Biopsies

The aim of this project is to develop an original biomarker for Parkinson's disease (PD) and other parkinsonian syndromes (multiple system atrophy and progressive supranuclear palsy) based upon the detection of pathological alpha-synuclein species in routine colonoscopic biopsies.


Eligibility Criteria:
Inclusion Criteria:

Patients

* Patients aged 50-80 year old, both genders
* Parkinson's disease patients
* Multiple system atrophy patients
* Progressive supranuclear palsy patients
* Controls: patient at risk of colic cancer for whom a colonoscopy is required
* Patients who signed the informed consent

Controls

* Patients aged 50 to 80 year-old for whom a rectosigmoidoscopy or a colonoscopy is required for colorectal screening
* Patients who signed the informed consent
* Health care beneficiary

Exclusion Criteria:

Patients

* Colonic disorder (except non-complicated diverticular disease)
* Other neurological disorder than parkinsonism
* Patients treated with either platelet antiaggregants, anticoagulants or with a known coagulation disorder
* Patients with a cognitive impairment that preclude them from understanding the informed consent
* Patients placed under legal guardianship

Controls

* Neurodegenerative disorders such as Parkinson's disease, Alzheimer's disease or other dementia, amyotrophic lateral sclerosis...
* Functional bowel disorder such as irritable bowel syndrome
* Patients with a cognitive impairment that preclude them from understanding the informed consent
The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability

There is no ideal sedation technique that can be used during Transesophageal Echocardiography (TEE), and the data concerning the effects of available sedation techniques on Heart Rate Variability (HRV) are limited. In this study the investigators aimed at comparing the effects of sedation through hypnotherapy with medical sedation achieved by midazolam on HRV.

Seventy-six patients with an indication of TEE will be recruited, the age range will be 18-83 years. In Group Topical (T) there are 26 patients who had the procedure under topical pharyngeal anesthesia, in Group Midazolam (D) there are 25 patients who will receive midazolam and in Group H there are 27 patients receiving hypnosis. All patients will have an IV access; throughout the procedure heart rate, rhythm ECG, peripheric O2 saturation will be monitored with a non-invasive monitor, blood pressure measurements were taken every 3 minutes. Rhythm Holter recordings will be obtained from all patients and TEE will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a need of transesophageal echocardiography

Exclusion Criteria:

* Heart failure
* Bad overall condition
* Arrhythmia
A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression

The Investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated iTBS vs an anatomically-guided (Beam F3) accelerated iTBS. The study team will recruit both inpatients and outpatients who had been referred for TMS for the treatment of depression.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 21 years.
2. DSM-5 diagnosis of current Major Depressive Episode.
3. Montgomery-Asberg Depression Rating Scale score of 20 or more.
4. Inadequate response to an adequate trial (4 weeks) of at least one antidepressant medication.
5. Able to give informed consent.

Exclusion Criteria:

1. DSM-5 psychotic disorder
2. Drug or alcohol abuse or dependence (preceding 3 months).
3. Rapid clinical response required, e.g., high suicide risk.
4. Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.
5. Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device.
6. Pregnancy.
7. Unsuitable for MRI.
Electrostimulation of Shoulder Girdle and Quadriceps Muscles in Facioscapulohumeral Muscular Dystrophy Patients

The investigators evaluated clinical tolerance, biological tolerance, feasibility and efficacy of daily electrostimulation training of shoulder girdle and quadriceps muscles in 10 patients with facioscapulohumeral muscular dystrophy, the third most common inherited myopathy.

Autosomal dominant FSHD is characterized by selective pattern of muscle involvement. Weakness and atrophy typically involve facial and shoulder girdle muscles, and progressively anterior forearm and foreleg muscles and pelvic girdle muscles.

The physiopatholgical mechanism of this disease, due to a deletion of repeated units named D4Z4 located on 4q35, is still controversial. Up to date, no curative therapy is available for these patients. We proposed in the present study to test feasibility, clinical and biological tolerance and efficacy of shoulder muscle training by electrostimulation in a group of FSHD patients. 10 patients displaying classical FSHD phenotype participate to this study consisting in daily session of shoulder girdle and quadriceps muscles electrostimulation of 23 minutes for a period of 5 months.

We evaluated: clinical tolerance by daily pain and fatigue analogic scales, biological tolerance by measuring CK; feasibility: by measuring the monthly score of participation to sessions; the efficacy by manual muscle testing, quantitative muscle assessment, fatigue severity scale.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years old patient
* FSHD diagnosis confirmed by molecular biology
* FSHD clinical phenotype including shoulder girdle and quadriceps involvement
* Patient with Vignos scale ≤ 5 (patient able to walk)
* Patient with health insurance
* Patient that could be followed for at least 6 months

Exclusion Criteria:

* Patient with monolateral or bilateral scapular omopexia
* Patient that has already had electrostimulation training
* Patients with CK values \> 5 time normal values
* Patient that has not signed informed consent
* Patient with cancer, collagenopathies or others joint diseases
* Pregnancy and breast-feeding
* Patient on guardianship or trusteeship.
* Patient actively participating to other biomedical researches or whose exclusion period is not ended
* Patient with a formal contraindication to the protocol detected by inclusion examinations
Evaluation of the Effects of Different Positions Given During Antenatal Electro-Fetal Monitoring

The objective of this study was to assess the effects of different maternal positions during electronic fetal monitoring (EFM) on maternal and fetal health outcomes. The study was conducted between December 2021 and January 2023 in a maternity hospital in Istanbul, employing a randomized controlled trial design. A total of 240 pregnant women were randomized into three groups: 60 participants were assigned to the right-side lying position (intervention 1), 60 to the semi-sitting position (intervention 2), and 120 to the left-side lying.

Maternal systolic blood pressure, body temperature, and pulse rate were measured before, during, and after the EFM procedure. Research data were collected through the Information Form and the General Comfort Scale-Short Form.

IIntroduction: Electronic fetal monitoring (EFM) is widely utilized for pregnancy and labor management due to its non-invasive nature, ease of use, and accessibility. However, the accuracy of EFM outcomes may be influenced by various factors, including the maternal position during monitoring, maternal comfort, and maternal blood pressure. This study aimed to explore how different positions during EFM influence both maternal.

Objective: The primary objective of this study was to examine the effects of three different maternal positions during EFM-right-side lying, semi-sitting, and left-side lying-on maternal and fetal health parameters. These parameters included systolic blood pressure, body temperature, pulse rate, and maternal comfort.

Methods:

A randomized controlled trial was conducted in a pregnancy follow-up outpatient clinic at a maternity hospital in Istanbul from December 2021 to January 2023. The study included 240 pregnant women, who were randomly assigned to one of three groups:

* Intervention 1 (right-side lying position) - 60 participants
* Intervention 2 (semi-sitting position) - 60 participants
* Control group (left-side lying position) - 120 participants Maternal physiological data were collected at three time points: pre-EFM, during EFM, and post-EFM. The General Comfort Scale-Short Form was used to assess maternal comfort. Statistical analyses were conducted to identify significant differences between groups and over time.

Eligibility Criteria:
Inclusion Criteria:

* Being over the age of 18,
* Being 35 years of age and under,
* Being a single fetus in the late 3rd trimester (34th-40th gestational week),
* Fetal biometric measurements between 34-40 weeks of gestation,
* No maternal and fetal risk affecting pregnancy,
* It was determined that the vital signs were within normal values before the application, not being hungry during the application (at the latest 2 hours of fasting time will be checked), and accepting the recommended application position.

Exclusion Criteria:

- The pregnant woman does not accept the recommended application position.