cyrilzakka/clinical-trials huggingface dataset:
Rehabilitation of Fatigue in Patients with Post-COVID-19 Syndrome

More than half of patients with post-COVID-19 syndrome experience fatigue. Rehabilitation is needed to treat this persistent symptom.

The aim of this study is to conduct a rehabilitation intervention to treat patients with post-COVID-19 syndrome who experience persistent fatigue.

* Background: More than half of patients with post-COVID-19 syndrome experience fatigue. Rehabilitation is needed to treat this persistent symptom.
* Objectives: To conduct a rehabilitation intervention to treat patients with post-COVID-19 syndrome who experience persistent fatigue.
* Methodology: Randomized clinical trial. There will be 3 groups.
* Patients will be recruited from the Virgen de las Nieves University Hospital in Granada.
* The evaluation will be carried out at the University of Granada.
* The rehabilitation will be carried out at the University of Granada and/or patient's home.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of COVID-19
* post-COVID-19 syndrome
* adults ≥ 18 y \< 75 años
* be medically stable
* to be able to walk
* not currently participating in a rehabilitation programme and/or other study.
* fatigue: FSS ≥ 36 puntos
* basic knowledge
* wish to participate in the study and sign the informed consent

Exclusion Criteria:

* patients with severe comorbidities that interfere with the ability to perform the study
* patients with mental, physical or organic problems that under medical criteria may pose a risk to the patient
[68Ga]Ga-HBED-CC-exendin-4 and [68Ga]Ga-NOTA-exendin-4 PET/CT Imaging in the Same Group of Insulinoma Patients

Glucagon-like peptide-1 receptor (GLP-1R)-targeted PET imaging with 68Ga-labeled compounds is able to provide superior sensitivity and specificity to detect insulinoma, like the widely studied \[68Ga\]Ga-NOTA-exendin-4. This pilot study was prospectively designed to evaluate the early dynamic distribution of \[68Ga\]Ga-HBED-CC-exendin-4, a novel radiopharmaceutical targeting GLP-1R, which was compared with \[68Ga\]Ga-NOTA-exendin-4 in the same group of insulinoma patients.

Insulinoma is the most common cause of endogenous hyperinsulinemic hypoglycemia in adult patients without diabetes. The only curative treatment of an insulinoma is its surgical removal. Therefore, exact preoperative localization of the insulinoma is critical to planning the surgical intervention. MR imaging, CT, or endoscopic ultrasound is normally used to localize insulinomas. However, the small size of the tumors (often,1 cm) limits the sensitivity of these methods. In recent years, a new receptor-targeted imaging technique, glucagon-like peptide-1 receptor (GLP-1R) imaging, for detecting insulinoma has been established. GLP-1R is expressed on benign insulinoma cell surfaces with very high incidence (\>90%) and density (8,133 dpm/mg of tissue). No other peptide receptor has been found to exhibit such high expression levels in insulinoma. \[68Ga\]Ga-HBED-CC-exendin-4, a novel radiopharmaceutical targeting GLP-1R, with the urea fragment of a conjugate that employs the HBED-CC chelator for labeling with 68Ga in order to In order to reduce the accumulation of radioactivity in the kidneys. This pilot study was prospectively designed to evaluate the early dynamic distribution of \[68Ga\]Ga-HBED-CC-exendin-4 compared with \[68Ga\]Ga-NOTA-exendin-4 in the same group of Insulinoma patients.

Eligibility Criteria:
Inclusion Criteria:

* confirmed treated or untreated insulinoma patients;
* \[68Ga\]Ga-HBED-CC-exendin-4 and \[68Ga\]Ga-NOTA-exendin-4 PET/CT within two consecutive days;
* signed written consent.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* known allergy against exendin-4;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS)

To determine if supplements of vitamin C, vitamin E, beta-carotene, and B-vitamins (a combination of folic acid, vitamins B6 and B12) reduce risk of major cardiovascular events in high risk women with a prior history of atherosclerotic cardiovascular disease. The trial is a companion to the Women's Health Study (WHS), a primary prevention trial of vitamin E and aspirin in a low risk population of women.

The Women's Antioxidant and Folic Acid Cardiovascular Study tested the effects of vitamin C (500 mg/day), vitamin E (600 IU every other day), and/or beta carotene (50 mg every other day) on the risk of major cardiovascular events (a combined outcome of myocardial infarction, stroke, coronary revascularization, or cardiovascular death) among 8171 female health professionals at increased risk. Participants were 40 years or older with a history of cardiovascular disease or 3 or more cardiovascular risk factors and were followed for an average duration of 9.4 years, from 1995-1996 to 2005. In 1998, 5442 of these participants were further randomized to the B-vitamin intervention (a daily combination pill containing folic acid \[2.5 mg\], vitamin B6 \[50 mg\], vitamin B12 \[1 mg\]) and were followed for 7.3 years, from April 1998 through July 2005.

Eligibility Criteria:
Women, aged 40 and over, at high risk, with a history of cardiovascular disease or three or more coronary heart disease risk factors.
Nab-Paclitaxel in Patients With ER+/HER2- Recurrent Metastatic Breast Cancer

This study is a single-arm, open, multi-center clinical study of nab-paclitaxel as the therapy ER+/HER2- recurrent metastatic breast cancer。


Eligibility Criteria:
Inclusion Criteria:

1. Female, 18 to 70 years old;
2. histologically confirmed recurrent or metastatic breast cancer, ER-positive (\> 10%), HER-2 negative (Definition: immunohistochemical \[IHC\] 0, 1+, or in situ hybridization \[ISH\] negative It is defined as the ratio of HER2 gene copy number to the number of CEP17 signals is less than 2.0, or for single probe detection, the HER2 gene copy number is less than 6);
3. After transfer, ≤2 lines and ≥1 line endocrine therapy, and progress;
4. at least one measurable lesion according to RECIST 1.1 ;
5. ECOG score≤2;
6. Expected survival≥3 months;
7. Bone marrow function: white blood cells≥3×109/L, neutrophils≥1.5×109/L, platelets ≥100×109 / L, hemoglobin≥90g / L;
8. Liver and kidney function: total bilirubin (TBIL) ≤1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are ≤2.5 times the upper limit of normal value; if due to liver metastasis, the above indicators ≤5 times the upper limit of normal value; serum creatinine (Cr) ≤1.5 times the upper limit of normal value;
9. taxane adjuvant chemotherapy for more than 1 year;
10. Women of childbearing age have a negative pregnancy test and must agree to take effective contraceptive measures during the study and within 3 months after the last dose
11. Sign written informed consent before the test.

Exclusion Criteria:

1. Received chemotherapy after transfer;
2. Patients with congestive heart failure with a grade II or above identified by the New York Heart Association (NYHA) score;
3. Uncontrolled brain metastases;
4. Severe systemic infections;
5. Peripheral neuropathy of degree II or above within 4 weeks before enrollment, or patients known to be allergic or intolerant to this drug;
6. Important organ diseases:liver and kidney dysfunction, history of myocardial infarction, unstable heart disease, chronic active hepatitis, etc .;
7. History of other malignant tumors within 5 years (except cured cervical cancer or skin basal cell carcinoma);
8. Received other anti-tumor treatments or other experimental drugs within 1 month before starting treatment;
9. Patients participating in other clinical trials at the same time;
10. Any medical condition in which the investigator considers the patient unsuitable for study
Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Parotidectomy Surgery

The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for parotidectomy and Head \& Neck surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an indication for surgical intervention for a parotidectomy.
* ECOG status ≤ 2.
* Life expectancy \> 3 months.
* Age ≥ 18 years old.
* Able to provide written informed consent and EU Data Protection Directive forms prior to admission to this study.
* Willingness to meet all of the expected requirements of this clinical protocol.

Exclusion Criteria:

* Age \< 18 years old.
* Pregnant or breastfeeding.
* Vulnerable patient populations (homeless patients, patients with drug or alcohol dependence, etc.).
* Concomitant treatments that would affect clotting, post-operative healing, increased chances of infection.
* Previous radiation treatment
* Previous head or neck surgery
Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome

Investigators planed to conduct a randomized, controlled, crossover trial to examine the effects of daily walnuts intake among Korean subjects with metabolic syndrome. Primary objective of this study was to investigate the effects of daily walnut intake on changes of metabolic syndrome indices in Koreans with metabolic syndrome age over 30 years old. This study was consisted of four periods: run-in, first intervention, wash-out, and second intervention phases. As 16 weeks of first intervention period began after the run-in phase, the subjects were randomly assigned into one of two groups: walnut group and control group. Participants in walnut group consumed 45 grams of walnuts on a daily basis and participants in control group were provided iso-caloric white bread for first 16 weeks. After the first intervention and wash-out period (6 weeks), second intervention which is crossover of first intervention was started during the next 16 weeks. Anthropometric measurements and biochemical analyses were done at the beginning and the end of each intervention (0, 16, 22, and 38 weeks of trial). Habitual diet was randomly observed using 3-day diet record once during each phase.

Investigators expected to evaluate 1)effects of walnut ingestion on reverting metabolic syndrome to normal status especially by reducing waist circumference and improving serum levels of triglyceride and high-density lipoprotein, 2)beneficial effects of daily walnut consumption on changes of body composition in the subjects with metabolic syndrome, and 3)regulatory effects of daily walnut intake on inflammatory markers and diabetic markers.


Eligibility Criteria:
Inclusion Criteria: at least three out of five metabolic syndrome components

* waist circumference (WC) \>90 cm for men and \>80 cm for women
* hypertension (DBP ≥85 and \<110 mm Hg)
* hyperglycemia (≥100 mg/dL)
* elevated plasma TG concentrations (≥150 mg/dL)
* decreased plasma HDL-C concentrations (\<40 mg/dL for men and \<50 mg/dL for women)

Exclusion Criteria:

* the presence of morbid obesity (BMI ≥40)
* the use of any medication for the control of blood pressure, glucose, or lipid metabolism
* a medical history of hypocaloric diet consumption within the past year
* gastrointestinal tract disorders
* post-menopausal women
* smokers
The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT

To evaluate the safety and efficacy of low and high doses of lamivudine ( 3TC ) in combination with zidovudine ( AZT ) and zalcitabine ( dideoxycytidine; ddC ) in combination with AZT.

PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.

Patients are randomized to one of three treatment arms: low-dose 3TC plus AZT, high-dose 3TC plus AZT, or ddC plus AZT. Treatment continues for 32 weeks, with possible extension to 52 weeks.

PER 02/27/95 AMENDMENT: Patients may continue therapy on AZT and low-dose 3TC on an open-label basis. Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV positivity.
* CD4 count 100-300 cells/mm3.
* Prior AZT therapy for 24 or more weeks and currently on AZT.

Exclusion Criteria

Patients with the following prior conditions are excluded:

* History of intolerance to AZT.
* History of grade 2 or worse peripheral neuropathy.

Prior Medication:

Excluded:

* Any prior antiretroviral therapy other than AZT.

Required:

* Concomitant AZT therapy.

Required:

* At least 24 weeks of prior AZT.
Addressing Cancer-Related Financial Toxicity in Rural Oncology Care Settings

The financial burden, or financial toxicity (FT), of cancer is a consequential and growing problem, particularly for rural patients. It is important to improve our understanding of how financial navigation (FN) can reduce the material, psychological, and behavioral burden of costs associated with cancer care in both rural and non-rural community settings. The purpose of this study is to conduct a financial navigation program in 5 rural and 4 non-rural oncology practices in North Carolina and evaluate the effects of financial navigation on patient outcomes, including financial toxicity and health-related quality of life.

This study is designed to evaluate the implementation and effectiveness of a financial navigation intervention within 5 rural and 4 non-rural oncology settings in North Carolina. Financial navigators from each of the 9 sites will recruit and enroll 255 patients total across all sites into a financial navigation program. The financial navigation intervention consists of screening patients using the COST measure for financial toxicity. If the patient scores 23 or lower, they are considered to have moderate to severe financial toxicity and will be enrolled in the study. Patients will then complete a series of baseline questionnaires to measure their health related quality of life and then they will meet with a financial navigator for a comprehensive intake process to determine potential financial assistance resources the patient may be eligible for and continued visits with the financial navigator until all financial assistance resources have been explored and patients have received benefits or referrals to financial assistance programs. At the end of the intervention, the patients will complete the COST measure again, and repeat baseline surveys to measure health-related quality of life and the patient's acceptability and responsiveness of the financial navigation intervention. Patient participation depends on the depth of patient need but ranges from 2 visits to 6 visits with the financial navigator over approximately 4 months but possibly longer depending on the complexity of the patient's financial need.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age and older
* Patients with any type of cancer diagnosed within 5 years and/or living with advanced disease
* Patients who score 22 or lower on the COST measure indicating high FT
* Patients must be able to read and speak English

Exclusion Criteria:

* Participants without a cancer diagnosis
* Patients diagnosed more than 5 years ago without advanced disease
* Patients or caregivers under the age of 18
* Patients who do not sign the consent form
* Patients who do not complete the baseline COST survey
* Patients who cannot read and speak English
Association of Brain Derived Neurotrophic Factor (BDNF) rs6265 Gene Polymorphism With Susceptibility to Epilepsy

Epilepsy is a common neurological condition that affects people of all ages.Recent studies found that epilepsy is associated with several chromosomal regions, where mutations in these regions cause neurological dysfunction.

BDNF which is the most ample neurotropic factor in the CNS, has survival and growth promoting roles in a variety of neurons. It has been shown to promote excitatory (glutamatergic) synapses while weakening inhibitory (GABAergic) ones.

A nonsynonymous G to A single-nucleotide polymorphism (SNP) exists at position 196 of exon 2 (rs6265), which results in valine (val) to methionine (met) substitution. This polymorphism affects intracellular packaging of pro-BDNF, its axonal transport and in turn, activity-dependent secretion of BDNF at the synapse.

Epilepsy was defined as the separate occurrence of two or more unprovoked seizures, manifested by involuntary motor, sensory, or autonomic, alone or in combination, and not diagnosed as neonatal or febrile seizures. Despite extensive studies, the molecular causes of the disease are not yet discovered completely. A functional imbalance between excitatory (transmitted by glutamate) and inhibitory signals (transmitted by γ-amino butyric acid or GABA) in neural cells has been regarded as a putative contributing factor in epilepsy.

The brain-derived neurotropic factor (BDNF) encodes a small dimeric protein which is the most ample neurotropic factor in the CNS.It has been shown to promote excitatory (glutamatergic) synapses while weakening inhibitory (GABAergic) ones.Any interference with the BDNF signaling pathway may negatively affect downstream neuronal functions and cause neuronal diseases.

A nonsynonymous G to A single-nucleotide polymorphism (SNP) exists at position 196 of exon 2 (rs6265), which results in valine (val) to methionine (met) substitution at codon 66 (val66met), changing the 5' proregion of the human BDNF protein. This polymorphism affects intracellular packaging of pro-BDNF, its axonal transport and in turn, activity-dependent secretion of BDNF at the synapse

Eligibility Criteria:
Inclusion Criteria:

• Epileptic patients aged more than 1 year and less than 15 year who recently had seizures over a period of one year

Exclusion Criteria:

* Patients \> 15 years old or less than 1 year.
* Patients that have epilepsy as a result of head injuries, brain tumors , exposure to low oxygen during birth or infections such as meningitis or encephalitis .
* Patients that have no sufficient medical records or unreliable seizure frequency,
* patients with developmental disorders such as Autism and Neurofibromatosis
Study of Alloknesia in Atopic Dermatitis

Alloknesia is defined as pruritus (= itching) triggered by light mechanical stimuli, which are responsible for the perception of light touch under physiological conditions, but which are perceived as pruritic under pathological conditions. Alloknesia occurs mainly in the context of chronic pruritus. Consequently, patients suffering from chronic pruritus frequently perceive light touch sensations as pruritic, which can be particularly unpleasant and alter human interactions and quality of life on a daily basis. However, the epidemiology and burden of alloknesia have never been studied, whatever the cause of chronic pruritus.

Atopic dermatitis is one of the main diseases causing chronic itching, and patients frequently complain of alloknesia.

In this study, we aim to investigate the frequency of alloknesia in patients with atopic dermatitis and to measure the consequences of alloknesia in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* No opposition from the patient
* Diagnosis of atopic dermatitis more than 6 months old

Exclusion Criteria:

* Patients who are physically or mentally unable to complete the questionnaires.
* Patients on systemic treatment for 1 month or more
* Refusal to participate
* Patients under legal protection (guardianship, curatorship)
* Patients under court protection
Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Adhesive Capsulitis : A Pilot Study

This is a 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for adhesive capsulitis.

Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (25:25) for pharmacopuncture therapy and physical therapy group. Participants of each group will receive twice a week for total 6 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions.

Eligibility Criteria:
Inclusion Criteria:

* Limitation of the shoulder movement (active or passive)
* Numeric Rating Scale (NRS) of neck pain is more than 5
* Symptoms of adhesive capsulitis for more than 1 month
* Discrimination findings which can explain clinical symptoms on shoulder MRI or CT
* 19-69 years old
* participants who agreed and wrote informed consents

Exclusion Criteria:

* Case of being diagnosed with a specific serious disease that may cause shoulder pain(Fracture, Dislocation, etc.)
* Cause of pain due to soft tissue disease, not the spine(Cancer, fibromyalgia, RA, goat, or etc.) Other chronic diseases(stroke, MI, kidney disease, diabetic neuropathy, dimentia, epilepsy, or etc.) that may interfere with the interpretation of therapeutic effects or outcomes
* Participants taking steroid, immunosuppressant, psychotropic medication, or taking other drugs that may affect outcomes
* Inappropriate or unsafe pharmacopuncture therapy; hemorrhagic disease, taking anticoagulant drug, or severe diabetes patients who are likely to be infected
* Participants who took NSAIDs or pharmacopuncture, acupuncture, physical therapy within 1 week
* Pregnant, planning to get pregnant or lactating women
* Participants who had undergone shoulder surgery within 3 months
* Participants who had participated in other clinical trial within 1 month, had participated in other study within 6 months from the date of selection, or have plan for participation in other trial during follow up period of this trial
* Participants who can not write informed consent
* Participants who is difficult to participate in the trial according to investigator's decision
Assessments of Dietary Restrictions in Young and Elderly Obese Men : Metabolism Obesity Nutrition Age

The prevalence of obesity is growing in elderly with heavy consequences in term of medical complications and mortality, so that this is nowadays an important public health issue.

The major therapeutic solution is dietary restrictions, but and the advantages and the metabolic consequences are not well known in elderly. The MONA study main aim is to assess the metabolic changes in this population, after dietary restrictions, compared to young people.

Primary endpoint : Study the metabolic adaptations of the subcutaneous adipose tissue after a diet in elderly obese men compared to young obese men.

Secondary endpoints : Study the metabolic adaptations of skeletal muscle, the genetic adaptations of subcutaneous adipose tissue and skeletal muscle, the inflammatory and fibrosis modifications of subcutaneous adipose tissue, the insulinosensibility modifications, the modifications on the physical composition, modifications of the energy expenditure in resting state and the oxidation of the substrata, study the lipoproteins metabolism and identify new biomarkers. All those endpoints are studied comparing elderly obese subjects versus young obese subjects.

Eligibility Criteria:
Inclusion Criteria:

* 30 \< years old \< 40 OR 60 \< years old \< 70
* obesity : 30 \< BMI \< 40
* stable blood pressure (diastolic \<90mmHg, systolic \< 140mmHg)
* glycemia \< 1,26g/L, LDL cholest \<1,9-1,6g/L, Triglycerides \<2,5g/L
* risk factors concerning high blood pressure, diabetes and dyslipidemia under control

Exclusion Criteria:

* Insulin dependent diabetes, non-insulin dependent diabetes
* high blood pressure
* dyslipidemia
* history of cardiovascular diseases or bariatric surgery
* undernutrition
* HbA1C \>7%
* non authorized treatments : Glucagon-like peptide-1 agonists,
* incapacity to do physical activity