cyrilzakka/clinical-trials huggingface dataset:
Effect of Oral Nutritional Supplements to Older Patients Discharged with a Rehabilitation Plan

The purpose of the study is to investigate whether an extra intake of energy and protein in the form of nutritional drinks twice a day for 12 weeks can improve muscle strength, muscle mass, quality of life and the implementation of rehabilitation in elderly patients at nutritional risk who are discharged to municipal rehabilitation

The study is a single-blind randomised study where the subjects will be randomly divided into two groups. A group that must consume nutritional drinks in connection with their rehabilitation and a group that must do nothing extra. Based on a statistical power calculation, we will include a total of 124 patients.

In connection with the experiment, different data will be collected three times, in connection with the discharge from the hospital, after 6 weeks via the telephone and after 12 weeks. During a home visit. Here, various questionnaires will have to be answered and data on muscle strength and muscle mass will be collected. Further CRP, vitamin D status and EPA/DHA content in blood will be assessed.

In addition, data is collected from the patient's medical record about e.g. readmissions

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥ 65 years old
* Independent stand function

  * Able to speak and understand Danish
  * At nutritional risk according to NRS-2002
  * (Expected to be) discharged with a new rehabilitation plan
  * Admitted to the medical and orthopaedic departments of Gentofte or Herlev Hospital

Exclusion Criteria:

* Active cancer

  * Renal insufficiency (eGFR \< 27 mL/min/1.73m2)
  * Cognitive impairment (not able to comprehend the purpose of the study/give informed consent)
  * Terminal disease
  * Exclusively receiving texture modified food, enteral or parenteral nutrition
  * Planning to lose weight/go on a special diet
  * Planned transfer to other hospitals/departments
  * Pacemaker/other implanted electrical stimulants (due to Bio-Impedance Analysis (BIA)

    * Taking fish-oil supplements as a medical prescription due to hypertriglyceridemia
    * Taking fish-oil supplements for other reasons and do not wish to stop this during the study period
Peripheral vs. Selective Tumor Marker Venous Sampling in Prostate Cancer

The investigators will compare tumor marker levels, including PSA, in samples taken from a peripheral upper limb vein and the internal iliac veins. These will be collected from patients who are scheduled for prostatectomy as part of their standard of care for prostate cancer. A selective internal iliac vein sampling procedure will be performed in Interventional Radiology. Venous samples will be correlated with prostatectomy specimens. The aim is to predict the side of the prostate containing tumor.


Eligibility Criteria:
Inclusion Criteria:

1. All male patients, age 18 to 99, with biopsy proven prostate adenocarcinoma prior to planned radical prostatectomy.
2. Informed Consent/HIPAA Form discussed and signed by subject.
3. Baseline lab values obtained within 120 days of planned selective venous sampling.

Exclusion Criteria:

1. Skin related problems around the planned venepuncture site (infection, phlebitis, scars)
2. Documented allergy to iodinated contrast or lidocaine.
3. Coagulopathy with an INR of greater than 1.5
4. Thrombocytopenia with platelets less than 25,000 uL
5. Renal insufficiency with a creatinine of 1.5 mg/dL
6. Documented current upper extremity or central venous thrombosis
7. DRE within 4 weeks prior to selective venous sampling
8. Prostate biopsy within 6 weeks prior to selective venous sampling.
9. Patient unable to sign his own consent or does not demonstrate full understanding of the procedure.
10. Patient has known metastatic disease or a known primary cancer other than prostate adenocarcinoma.
11. Patient has already been enrolled in this research study.
12. Life expectancy less than 6 months.
Effect of Multi Vitamin and Mineral Supplementation of Liver Enzymes and Sonography in Patient With NAFLD

The study was performed on 160 participants, to ensure the impact of multi vitamin and mineral to reduce NAFLD

This study was performed on 160 participants, to ensure the impact of multi vitamin and mineral to reduce NAFLD.

Participants were randomly selected to participate in the study. Then divided into the groups (intervention and placebo). Intervention received supplementation for 12 weeks and placebo received same capsule was made for placebo groups.

Eligibility Criteria:
Inclusion Criteria:

* Participants with NAFLD diagnosed

Exclusion Criteria:

* subjects who in the last 6 months received vitamin or mineral supplementation, those with chronic conditions such as diabetes, hypertension, and heart disease, unwillingness to continue the study protocol, lactating women and pregnant women.
Evaluation of Balance and Functionality in Postmenopausal Osteoporosis Using Quadriceps Femoris Muscle Thickness, Beyond Thoracic Hyperkyphosis

To determine the impact of thoracic hyperkyphosis, sarcopenia and quadriceps muscle thickness evaluated by ultrasonography (USG) on balance, fall risk and functional parameters in women with postmenopausal osteoporosis, to assess their interrelationships and to compare the clinical characteristics of sarcopenia and thoracic hyperkyphosis.

An observational study was conducted on patients with PMO and/or osteoporotic vertebral fractures according to WHO criteria. One hundred seventeen patients who were 50 years of age or older, with a diagnosis of PMO and/or osteoporotic vertebral fractures according to WHO criteria, who were able to ambulate without any assistive devices were included in the study. Patients with a history of neurological disease which may affect balance and proprioception, visual and vestibular disease, previous major lower extremity surgery or previous vertebra surgery were excluded. The investigators also excluded the patients with advanced heart, liver, or renal failure, stage 4 knee osteoarthritis, psychiatric disorders, and use of any medication affecting the central nervous system.

Age, height, weight, body mass index (BMI), comorbidities, medications, previous surgeries, steroid use, previous fractures and the energy level of these fractures (low or high), fracture location, family history of fractures, alcohol use, smoking, menopausal age and the number of falls in a year were questioned. The FRAX algorithm was used to determine the risk of fracture.

The Cobb angle of thoracic kyphosis was calculated radiographically and QFM thickness was measured from anterior thigh via ultrasonography (USG). The presence of sarcopenia was determined. Balance, fall risk and physical function were evaluated with tandem stance and gait test, Berg balance scale (BBS), Timed up and go test (TUG), hand grip strength, chair stand test (CST).

Eligibility Criteria:
Inclusion Criteria:

* Patient who were 50 years of age or older, had postmenopausal osteoporosis and/or osteoporotic vertebral fractures according to WHO criteria,
* Patient who were able to ambulate without any assistive devices

Exclusion Criteria:

* History of neurological disease which may affect balance and proprioception,
* Visual and vestibular disease
* Previous major lower extremity surgery or previous vertebra surgery
* Advanced heart, liver, or renal failure
* Stage 4 knee osteoarthritis
* Psychiatric disorders
* Use of any medication affecting the central nervous system.
Diet Therapy in Hemodialysis Patients

This study determined the effect of dietary education given to hemodialysis patients on dietary treatment and symptoms.

Diet therapy is a part of the treatment of hemodialysis patients. In order for the treatment to be effective, it is necessary to comply with the diet. Non-compliance with diet treatment affects the symptoms experienced by the patient, resulting in morbidity, low quality of life and mortality. Knowing patients' compliance with diet therapy is important in ensuring symptom control. The aim of this study is to determine the effect of diet therapy on symptom management in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

Being ≥18 years old,

* Agreeing to participate in the research,
* Being literate,
* Being able to communicate verbally,
* Receiving outpatient HD treatment three sessions a week at the same institution,
* No impairment in mental and cognitive functions,
* Has been receiving HD treatment for at least three months (to be defined as a chronic HD program)

Exclusion Criteria:

* Refusal to participate in the research,
* Being on peritoneal dialysis,
* Being diagnosed with a psychiatric disorder diagnosed by a psychiatrist,
* The general condition (hemodynamically) is unstable (heart rate \< 100 mm/Hg or diastolic BP\< 60 mm/Hg),
Musculoskeletal Disorders and the Associated Factors of Healthcare Professionals

The aim is to assess the prevalence of musculoskeletal disorders among Italian health professionals by analysing demographic and psychosocial factors. In addition, the impact of the symptoms detected on the quality of life and physical and mental health was analyzed. All health workers on duty in hospital wards for at least 12 months

The online questionnaire sent to the participants was divided into two sections.

The first section concerned the collection of demographic data of the participants (eg age, gender, level of education, work experience, company to which they belong, department, profession, etc.).

The second section concerned the assessment of the prevalence of musculoskeletal disorders, pain, quality of life and assessment of subjective perception of health and assessment of psychosocial factors in the workplace.

Eligibility Criteria:
Inclusion Criteria:

* health personnel who were active in clinical practice during the study period from January to June 2022.
* All health professionals who signed the informed consent
* Health professionals in service in the wards for at least 12 months from the date of sending the questionnaire.

Exclusion Criteria:

Health workers with unsuitability for handling loads
The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Pancreatic Cancer.

This study aims to investigate the value of 68Ga-grazytracer in predicting the efficacy of immunotherapy for pancreatic cancer.

The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-grazytracer PET/CT after 3 cycles of immunotherapy to evaluate response. The imaging response measurements will be compared with the histopathological or clinical assessment results as gold standard.

Eligibility Criteria:
Inclusion Criteria:

1. Pathological diagnosis of pancreatic cancer requiring combination immunotherapy after evaluation according to clinical guidelines
2. Signed and dated informed consent form
3. Commitment to comply with research procedures and co-operation in the implementation of the full research process 4 .aged 18-75 years old 5 .The patient is in good general condition with an expected survival of \&gt; 6 months

Exclusion Criteria:

1. Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
2. Intestinal perforation, complete intestinal obstruction
3. Pregnant women and women who may be pregnant, women who are breastfeeding.
4. Non-compliant person
A Study to Evaluate the Efficacy and Safety of PPB-R-203-Based Meal Versus TK9-Based Meal in 20 Patients With Diabetes

To evaluate the efficacy of PPB-R-203-Based Meal and TK9-Based Meal on blood glucose control in 20 patients with diabetes for 2 days.

The MiniMed Medtronic CGMS (continuous glucose monitoring system), the first model approved by FDA, was used for subcutaneous glucose monitoring. The CGMS continually measures the glucose concentration of the interstitial fluid every 10 seconds and then stores an average glucose value for each 5 minutes period, for a total of up to 288 measurements each day.

Eligibility Criteria:
Inclusion Criteria:

1. Diabetes mellitus patient.
2. Aged between 20 to 65 years old.
3. Informed consent form signed.

Exclusion Criteria:

1. A recent history of drug or alcohol abuse.
2. Sensitivity to analogous product.
3. Serious cardiovascular disorders.
4. Participation in another clinical investigation study.
5. Ongoing influenza, autoimmune disease and other metabolic diseases.
6. Pregnant or lactating women.
7. Individuals are judged by the investigators or co-investigator to be undesirable as subjects.
Rapid Diagnosis and Prognosis Recognition of Imaging and Biomarkers in Mild to Moderate Traumatic Brain Injury

The investigators will carry out multi-center and large sample research based on the Chinese population, screen the optimal diagnostic and prognosis recognition biomarkers and analyze the diagnostic critical cutoff values in patients with mild to moderate traumatic brain injury, so as to provide a substantial basis for clinical diagnosis and prognosis recognition.

Traumatic brain injury (TBI) is a complex disorder that comprises a spectrum of intracranial pathologies, many of which present diagnostic challenges. Detection of intracranial injuries after TBI relies on head CT, which is overused and resource intensive. Prior studies have shown the potential for blood-based brain injury biomarkers to predict the absence of intracranial injury after TBI and aid in reducing unnecessary head CT use. Furthermore, plasma biomarker concentrations in the acute phase after TBI identified patients with a suspected TBI and normal head CT who had detectable pathology on MRI. However, most of the current studies are based on the European and American population, and whether the research results are applicable to the Chinese population remains to be studied. Therefore, the investigators will carry out multi-center and large sample research based on the Chinese population, screen the optimal diagnostic and prognosis recognition biomarkers and analyze the diagnostic critical cutoff values, so as to provide a substantial basis for clinical diagnosis and prognosis recognition.

Eligibility Criteria:
Inclusion Criteria:

* age 18-75 years at time of recruitment.
* Glasgow Coma Scale (GCS) score of 9-15 at the time of informed consent.
* non-penetrating TBI resulting from an external force.
* diagnosed within 1 week after onset of TBI.
* provision of informed written consent.

Exclusion Criteria:

* acute suspected stroke, neurosurgery, stroke or TIA within the last 30 days.
* neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors.
* a history of a previous brain injury, or a history of concurrent substance or alcohol abuse;
* the manifestation of TBI caused by medications, alcohol, drugs for other injuries (such as systemic injuries, facial injuries, or intubation).
* pregnancy or breastfeeding.
* Patients with contraindications to MRI scanning (such as patients with metal implants in their bodies, cardiac pacemakers, dentures, etc.)
* participation in a clinical research study with potential to affect the results of this study
Telemonitoring of CPAP Therapy in Apoplexy Patients With OSA

Apoplexy patients with OSA are often not receiving a CPAP therapy due to generally poor acceptance and adherence. There is a great potential to significantly improve the treatment and care of these patients in a time economic way by telemonitoring the therapy in home environment.

This study is planned to prove that telephone consultancy and motivation in times of recorded decreasing CPAP therapy usage can improve adherence, neurological function and quality of life.

Eligible patients with confirmed OSA from neurological rehab department of Helios Clinic Hagen Ambrock are asked to join the study. They will be randomly assigned to one of two arms \[CPAP with Telemonitoring (MTM) or without Telemonitoring (OTM)\] for 6 months of home treatment after hospital discharge. The MTM arm will receive supporting phone calls when the monitored usage time decreases.

Eligibility Criteria:
Inclusion Criteria:

* s/p ACM (Arteria Cerebri Media Insult)
* Diagnosed OSA AHI \>15/h
* Barthel Index item 8 \> 5 points (or home assistance)
* Life expectancy \>6 month
* Capable of giving consent

Exclusion Criteria:

* Already existing ventilatory support (CPAP, NIV etc)
* Central AI \>50% baseline
* Central AI \>5/h under CPAP therapy
* Drug abuse
* Pregnant or nursing women
* Participation in another clinical trial last 4 weeks
Expanding Fertility Care to Poor and Low Resourced Settings Study

The investigators currently lack an understanding of barriers to completing the male factor infertility evaluation. Furthermore, as the investigators continue to expand access to fertility treatment particularly within low-resourced settings, it is important that all aspects of infertility within a couple are equally explored. The COVID-19 pandemic has disproportionately affected low-income communities and communities of color at greater rates in terms of not only disease morbidity/mortality but how medical systems are accessed and care is delivered.

This pilot study was designed to help providers identify barriers to completing the basic infertility work-up in a low resource setting with a focus on accessibility and feasibility of semen analysis testing. As a pilot study, a total of 60 male partners of patients who are seeking infertility treatment at the Zuckerberg San Francisco General Hospital Gynecology clinic will be recruited. Participants will be randomized to completing a semen analysis by either the standard in-clinic test or an at-home sperm testing kit. The investigators hypothesis is that there will be an increase in participants completing their semen analysis when using the at-home sperm testing kit as opposed to having to come to the lab.

Specific Aims:

1. To identify barriers to completing a semen analysis.
2. To compare barriers unique to completing an in-clinic versus at-home testing.
3. To compare satisfaction scores with in-clinic versus at-home testing.
4. To compare the time to complete the semen analysis with in-clinic versus at-home testing.
5. To compare the time to initiating treatment after completing in-clinic versus at-home testing.

Patients seen at Zuckerberg San Francisco General who are currently undergoing an infertility evaluation as a part of the basic infertility assessment will be contacted. Consented participants will be randomized to complete an at home vs. lab semen analysis. After the semen analysis is completed, participants will be sent a comprehensive questionnaire regarding their experience, level of satisfaction, and barriers with completion of the recent semen analysis. Participants will be given 3 months to complete the semen analysis. If not completed in this timeframe, participants will be sent a different comprehensive questionnaire regarding their barriers with completion of the semen analysis. Additional clinical questions include time from semen analysis order to completion as well as time from semen analysis completion to start of treatment plan.

Eligibility Criteria:
Inclusion Criteria:

* All English or Spanish speaking male partners of female patients undergoing an infertility work-up evaluation at Zuckerberg San Francisco General Hospital and recommended to undergo a semen analysis as a part of this workup.

Exclusion Criteria:

* If they do not speak English or Spanish they will be excluded
* If they are under the age of 18 y.o
* If they are not recommended to undergo a semen analysis as a part of the infertility evaluation
* If they are unable to produce a semen sample.
ACURATE Neo2™ Post Market Clinical Follow Up Study

The ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic stenosis.

ACURATE neo2 PMCF is a prospective, open-label, single-arm, multicenter, observational post-market surveillance study. All subjects deemed treatable with the ACURATE neo2 valve will be approached to participate in the study.

A subject who provides an Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC) and signed by the subject or the subject's legally authorized representative is considered enrolled once an attempt is made to insert the commercially available ACURATE neo2 Transfemoral Delivery System. Approximately 200 subjects will be enrolled.

Follow-up will occur at pre-discharge, 30 days, 1 year, and then annually from 2 through 5 years post index procedure per standard of care. Visits are in-person through 1 year and in-person (preferred) or via telephone interview in years 2 through 5. All subjects will undergo 4D computed tomography (CT) imaging at 30 days and 1 year.

ACURATE neo2 PMCF Study Design Overview Abbreviations: CT=computed tomography; ICF=Informed Consent Form

Eligibility Criteria:
Inclusion Criteria:

There are no specific inclusion criteria set for this post-market surveillance study. A subject must sign an IEC-approved ICF and the ACURATE neo2 Transfemoral Aortic Valve System should be used according to the commercial IFU.

Exclusion Criteria:

EC1. Subject has a previous bioprosthesis in the aortic position.

EC2. Subject has eGFR \<30 mL/min (chronic kidney disease stage IV or stage V).

EC3. Subject has atrial fibrillation that cannot be rate controlled to ventricular response rate \< 60 bpm.

EC4. Subject is expected to undergo chronic anticoagulation therapy after the TAVI procedure

Note : Subjects treated with short-term anticoagulation post-procedure can be included; in these subjects the 30-day imaging will be performed 30 days after discontinuation of anticoagulation.
A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease

A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease study is being conducted at the University of California San Francisco and 30 other sites around the United States who are part of the CCFA Clinical Alliance. The aim of this study is to determine the effect of medication use and disease activity on the outcome of pregnancy among women with IBD up to 18 years from birth.

All pregnant women with IBD diagnosis who are taking biologics medicines and immunosuppressants will be entered in the study.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with confirmed IBD diagnoses who are pregnant and taking immunosuppressants and/or biologic therapy

Exclusion Criteria:

* Pregnant female patients younger than 18 years of age
* Confirmed multiple gestation