cyrilzakka/clinical-trials huggingface dataset:
PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation

Through the investigators involvement in an international consortium, the investigators had the opportunity to acquire a new type of synthetizer for the radiolabelling of such tracers. The investigators propose in this project to develop on their site, the radiosynthesis of 68Ga-DOTATOC and to evaluate prospectively the diagnosis of neuroendocrine tumors, compared with the current imaging OctreoScan®. The objectives of this project are: - to validate the radiosynthesis of 68Ga-DOTATOC on their site with a new synthetizer - and clinically evaluate, through a prospective preliminary study, the diagnostic accuracy of PET-CT with 68Ga-DOTATOC in comparison with other standard imaging examinations.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Patient who is suspected of endocrine tumors according to symptomatology, biology or imaging or pathological context (multiple endocrine neoplasia type 1)
* initial staging: this includes research multifocal disease or locoregional or metastatic extension if well-differentiated neuroendocrine tumor (grade 1 et/ou 2)
* Search of the primary tumor, especially in the case of the inaugural discovery of metastases
* staging of a known recurrence
* Search occult recurrence or suspicion of recurrence (clinical, laboratory, imaging doubtful)
* Patient who have received in a lower range than 2 months of cervico-thoraco-abdominal-pelvic CT and scintigraphy in OctréoScan®
* Patient who have signed an informed consent
* Patient affiliated or beneficiary of regime of social security of a Member State of the European community

Exclusion Criteria:

* Patient with another evolutive cancer disease and/or treated for less than 5 years
* Pregnant or lactating woman
* Premenopausal woman without effective contraception (estrogen-progestin or intrauterine contraceptive device)
* Patient unable to give their free and informed consent
* Persons placed under judicial protection
Tizanidine and Superficial Cervical Block on Pain After Thyroidectomy

Thyroid surgery is a quite painful procedure performed in a sensitive skin area of the human body. Unless pain is treated adequately thyroid surgery may cause severe postoperative pain and discomfort for the patients.

a2-Agonists are sympatholytic and centrally acting antihypertensive agents. In addition to their hypotensive effect, a2-agonists are also used in anesthetic practice for their sedative and analgesic effects. Tizanidine is a centrally acting a2-agonist with muscle relaxant, sedative and anxiolytic properties. This drug is widely used for the treatment of spasticity and has recently been used to treat musculoskeletal pain conditions.

Ultrasound (US) guidance during regional anesthesia practices has been a revolutionary advancement to improve success and safety of regional anesthesia. Analgesic effect of US guidance superficial cervical plexus block (SCPB) in patients undergoing thyroid surgery has not been reported yet.

The aim of this study was to evaluate the analgesic effect of preemptive oral single dose tizanidine and US guidance SCPB in patients undergoing elective thyroid surgery. The investigators hypothesis that: Tizanidine and US guided SCPB can reduce the pain scores, analgesic consumption, analgesic related side effects.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients undergoing thyroidectomy

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* recurrent goiter
* emergency cases
Tissue-Specific Metabolic Reprogramming in Diabetic Complications

We will perform blood sugar studies to assess changes in metabolic (biochemical processes that occur within us) profiles associated with high blood sugar and diabetes.

Objective: To assess steady state and dynamic metabolite changes in subjects with type 1 diabetes with and without microvascular complications and to understand intrinsic differences from non-diabetics in metabolite levels and flux.

The hypothesis is that diabetic complications arise from tissue-specific metabolic reprogramming resulting in alterations in fuel utilization which lead to dysfunction of the tissue. To test this hypothesis, we will use sensitive and specific mass spectrometer based metabolomic analysis to measure steady state metabolite levels in plasma and urine from controls subjects and subjects with T1DM, without and with diabetic complications during euglycemic and hyperglycemic clamp studies.

Eligibility Criteria:
Group 1: T1DM subjects without complications:

Group 2: T1DM subjects with microalbuminuria . Group 3: T1DM subjects with advanced diabetes complications Group 4: Age-and-sex-matched healthy control subjects .

Inclusion Criteria:

General entry criteria:

Must have type 1 diabetes \> 5 years duration. 18 years of age or older

Subjects in the microalbuminuria group will have a history of urinary microalbumin to creatinine ration between 30-300 m/g confirmed on repeat testing while the non-albuminuric group will have a value of less than 30 mg/g.

Subjects in advanced complications group will have confirmed Retinopathy, Peripheral and/or Autonomic Neuropathy and nephropathy.

Non diabetic individuals will be matched for age and gender and will have normal glucose tolerance, normal lipid metabolism, and normal blood pressure.

Exclusion Criteria:

Age less than 18 . Women of child-bearing potential who may be pregnant or lactating History of pancreas, kidney or liver transplant History of drug or alcohol use. History of cancer other than basal cell carcinoma or squamous cell skin cancer. Presence of a condition that in the opinion of the investigator would make it unlikely for the subject to complete the study.

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Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder

The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.


Eligibility Criteria:
Inclusion Criteria:

* Patient is able to provide written assent and the parents or legal guardian of the patient are/is able to provide written informed consent before beginning any study related procedures
* Patient previously enrolled in either double-blind Study D1441C00149 or D1441C00112
* Patient has documented clinical diagnosis of schizophrenia or bipolar I disorder
* Patient's parent or legal guardian will be able to accompany the patient to each scheduled study visit

Exclusion Criteria:

* Patients (female) must not be pregnant or lactating
* Patients with a known intolerance or lack of response to previous treatment with quetiapine
* Patients who have previously participated in this study
Analysis of Biliary Microbiota in Hepatobiliopancreatic Diseases Compared to Healthy People [MICROBILIO]

The performance of the microbiota is observed in all clinical and pathological stages of carcinogenesis, since its development, diagnosis and treatment, including prognosis and survival. However, it was found that there is a scarcity of studies on biliary microbiota and its relationship with hepatobiliopancreatic diseases. Therefore, further investigation is necessary, since reaching the biliary microbiota may suggest ways for studies of biomarkers, diagnoses, tests and therapies in hepatobiliopancreatic diseases. For this, bile samples will be collected in cases and controls patients to characterize the microbiota and its variations according to the disease.


Eligibility Criteria:
Inclusion Criteria:

Endoscopic retrograde cholangiopancreatography (ERCP) candidates (case group)

* Patients over 18 years old complete
* Patients previously scheduled for ERCP
* Cannulation of the bile duct, via the transpapillary route, with the aid of a papillotome with an end kept sterile until contact with the papilla

Liver transplant living-donor (control group)

* Patients over 18 years old up to 55 years
* Previously selected patients with scheduled surgery
* BMI: 18 kg / m² to 28 kg / m²
* Blood typing identical to the recipient
* Absence of significant medical, psychiatric problems or previous abdominal surgery
* Normal laboratory tests: liver function tests, blood count, coagulogram, pregnancy test and serology for hepatitis B, C and HIV
* Normal imaging exams: CT of the abdomen and pelvis with liver volume (remaining volume - 30-40% of the total liver volume), MRI with cholangioresonance

Exclusion Criteria:

* ERCP candidates (case group)

  * Use of antibiotics during ERCP or in the last 2 months prior to the procedure
  * Emergency ERCP
  * Pregnancy
  * Uncorrected coagulopathy

Liver transplant living-donor (control group)

* Use of antibiotics in the last 2 months prior to the procedure
* Pregnancy
* Uncorrected coagulopathy
Characterization of Fecal Microbiome Changes After Administration of PRIM-DJ2727 in Parkinson's Disease Patients

The purpose of this study is to characterize the intestinal flora in subjects with Parkinson's Disease (PD) and to determine safety and trends in improvements in diversity of colonic microbiome following fecal microbiota transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis PD with a Hoehn and Yahr stage of \< 3 in the "Off medicine" state
* Sexually active male and female subjects of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period
* Female subjects of child-bearing potential must have a negative pregnancy test in the 72 hours before the procedure
* Subject willing to sign an informed consent form
* Subject deemed likely to survive for ≥ 1 year after enrolment
* Subject's attending physician will refer and provide non-transplant care for the subject
* Subjects must demonstrate adherence to and the ability to maintain a Parkinson's therapy medical regimen that is stable for 90 days before enrolment and participation in the study.

Exclusion Criteria:

* Greater than 20 grams of ethanol intake daily
* Unstable Parkinson's disease
* Other immune disorder or clinical immunosuppression
* Probiotic used during study period
* Severe underlying disease such that the subject is not expected to survive for one or more years or unstable medical condition requiring frequent change in treatments
* Current or recent within one month receipt of an antibiotic with expected activity against enteric bacteria
* Prior Deep Brain Stimulation, or surgical intervention for PD , intravenous glutathione therapy or stem cell therapy
* HIV or Hepatitis B / C positive
The Oral Iron on the Prevention of Iron Deficiency Anemia in Obese Pregnant

Anemia is known as a condition in which the hemoglobin level is lower than normal. Anemia is one of the most common complications during pregnancy. Anemia in pregnancy is defined as a hemoglobin level \< 110 g/L . Anemia is an important risk factor in pregnancy which leads to both maternal and fetal morbidity and mortality.

The pregnant woman needs more iron during pregnancy, so iron deficiency anemia is very common during pregnancy. In Egypt; iron deficiency anemia affects about one in every two pregnant women, especially in rural areas. Pregnant women require about 27 mg/day elemental iron to cover their increased need. The pregnant women should start taking a daily supplement of 30mg of elemental iron as a preventive measure against iron deficiency anemia especially in poor countries.

Obesity is defined as having an excessive amount of body fat. The body mass index, a measurement based on height and weight, determines the obese if the figure more than 30 kg/m2. There is an increased rate of overweight and obesity among pregnant women. According to the World Health Organization, 46% of adult females in Egypt are obese.

Many researches in the literature revealed a strong relationship between high BMI in pregnancy and iron deficiency anemia. Hepcidin is an iron regulating hormone in the body. Increases in iron levels in the plasma stimulate the production of hepcidin, which blocks iron absorption from the diet, so; hepcidin production is suppressed in the case of iron deficiency.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant woman in a singleton pregnancy (12-14 weeks).
2. BMI (30- 40 kg/m2).
3. Normal hemoglobin level (\>11 g/dL).
4. Normal hematocrit (Hct 31-41%).
5. Normal ferritin level (6-130 ng/mL).
6. Women willingness to participate in the study.
7. Women living in the nearby area to make follow-up visits possible.

Exclusion Criteria:

1. Multiple gestations.
2. Women received a recent blood transfusion.
3. Women with threatened miscarriage.
4. Women are known to have pathological blood loss.
5. Intolerant to oral iron form.
6. History of the hematologic disorder.
7. Women used iron in the past 3 months.
8. Women with chronic diseases (hypertension, diabetes, renal diseases, thyroid disease......).
Investigation of the Bioavailability of Marine Based Collagen Peptides in Healthy Subjects

The aim of this study is to evaluate the relative bioavailability of Peptan® Type I collagen peptides from different marine origin (different fish sources, production process and molecular weight) in healthy human subjects.

The aim of this study is to evaluate the relative bioavailability of different Peptan® Type I collagen peptides in healthy human subjects. The pharmacokinetic parameters AUC0-6h, Cmax and Tmax will be determined from the concentration-time curves of characteristic collagen markers (e.g. hydroxyproline, proline, glycine, di- and tripeptides together with further amino acids) after oral single dose administration.

The following objectives will be evaluated by comparison of pharmacokinetic parameters between the products:

* The impact of different production processes
* The impact of size of collagen peptides
* The impact of different fish sources

Eligibility Criteria:
Inclusion Criteria:

* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
* Age: 18 - 50 years
* Healthy men and women
* BMI: 19 - 28 kg/m2
* Non-smoker

Exclusion Criteria:

* Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases, heavy depression, diabetes, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.)
* A significant CVD event within last 3 mo. incl. myocardial infarction, stroke, congestive heart failure
* Significant changes in lifestyle or medication (within last 3 mo.) or surgical intervention or surgical procedure such as bariatric surgery
* For this study clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
* Blood donation within 1 month prior to study start or during study
* "Extreme dietary regimes": vegan lifestyle, weight loss diet with \<1200 kcal/day for women and \<1800 kcal for men
* Intake of anticoagulants like Heparin, Marcumar etc.
* Regular intake of drugs or supplements possibly interfering with this study within 2 weeks prior to study start or during study
* History of hypersensitivity to fish
Observational Study With Metronomic Oral Vinorelbine in Elderly Patients With Locally Advanced / Metastatic Non-small-cell Lung Cancer (NSCLC)

Vinorelbine is the first line reference drug in the elderly patient with locally advanced / metastatic non-small-cell lung cancer (NSCLC). The introduction of the oral formulation of vinorelbine has determined a further impulse to its use in 1st line and above all to its use as "metronomic" therapy. Metronomic chemotherapy offers the advantage of increasing the overall dosage of the drug administered, but reducing the side effects or making them more easily manageable; it is practically a question of administering fractionated doses of the drug continuously for long periods (generally up to the progression of unacceptable disease or toxicity). This study collects data on the efficacy and tolerability of oral metronomic vinorelbine in elderly patients with NSCLC, performed as per normal clinical practice.

Vinorelbine is the first line reference drug in the elderly patient with locally advanced / metastatic non-small-cell lung cancer (NSCLC). The introduction of the oral formulation of vinorelbine has determined a further impulse to its use in 1st line and above all to its use as "metronomic" therapy. Metronomic chemotherapy offers the advantage of increasing the overall dosage of the drug administered, but reducing the side effects or making them more easily manageable; it is practically a question of administering fractionated doses of the drug continuously for long periods (generally up to the progression of unacceptable disease or toxicity). This study collects data on the efficacy and tolerability of oral metronomic vinorelbine in elderly patients with NSCLC, performed as per normal clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of histologically documented NSCLC (adenocarcinoma and squamous carcinoma), stage IIIB (not eligible for surgery or chemo-radiotherapy) and stage IV according to the 8th edition of TNM
* "Wild type" for EGFR, ALK and PDL-1
* Age ≥ 70 years
* PS 0 - 2
* Adequate medullary reserve (neutrophils\> 1500; PLT\> 100,000 mm3); hepatic / renal function preserved
* Written informed consent

Exclusion Criteria:

* Gastrointestinal disorders that contraindicate the intake of the capsules (type ulcerative colitis or Chron's disease).
* Performance Status ECOG ≥ 3
Ultrasound Guidance for Interscalene Brachial Plexus Block

This study has been designed to assess the possible advantages of using ultrasound imaging to block the brachial plexus (i.e., nerves of the upper limb) in patients undergoing shoulder surgery.

The ultrasound technique will be compared with the current gold standard, electrical nerve stimulation.

The aim of this study is to define which technique is better in terms of time to onset of anesthesia.

The study will compare real-time ultrasound (US) guidance and electrical nerve stimulation (ENS) in terms of onset time for interscalene brachial plexus anesthesia.

The main hypothesis is that direct visualization of neural structures under US guidance will grant better local anesthetic (LA) disposition around the roots of the plexus, thus improving onset times.

Perineural catheters will be used to maintain regional analgesia for 48 hours after surgery. We hypothesize that US guidance may also help physicians place perineural catheters more precisely, thus improving analgesia in the following hours to days.

Finally, we will investigate for possible differences in minor adverse events such as vascular puncture, pain during the anesthetic procedure.

Eligibility Criteria:
Inclusion Criteria:

* ASA Physical Status Class I-III
* Elective surgery of the shoulder
* Informed consent to regional anesthesia

Exclusion Criteria:

* Inability to effectively communicate
* Chronic opioid use
* Absence of informed consent to participation to the study
* Ipsilateral upper limb neurological deficits
* Known allergy to study medications
* Contraindications to continuous block placement
Observational, Retrospective, Multicenter, Nonprofit Study on the Prevalence of Renal Involvement in Pediatric Patients With Tuberous Sclerosis

Observational, retrospective, multicenter, nonprofit study on the prevalence of renal involvement in pediatric patients with tuberous sclerosis.

Tuberous sclerosis (TSC) is an autosomal dominant transmission neurocutaneous syndrome caused by mutations in the TSC1 (9q34) and TSC2 (16p13.3) genes. Renal involvement in tuberous sclerosis is frequent and consists of the presence of angiomyolipomas, cysts, increased risk of renal carcinoma (predominantly clear cell renal cell carcinoma), and proteinuria in the absence of angiomyolipomas or cysts, which may evolve into chronic kidney disease. Renal involvement in tuberous sclerosis is often asymptomatic, and in most cases the finding of angiomyolipomas, cysts, or changes in renal function is an occasional finding on examinations performed during follow-up. Angiomyolipomas are the most frequent form of renal involvement in tuberous sclerosis and, when symptomatic, cause potentially fatal hemorrhages (intratumoral or retroperitoneal), anemia, hypertension, hematuria, and renal failure due to subversion of the renal parenchyma.

The renal picture of TSC (hemorrhage, end-stage renal disease, and metastasis to renal carcinoma) is the second leading cause of death in pediatric TSC patients, after neurological, and the first in the adult population. Data regarding renal involvement in the pediatric population with TSC are scarce in the literature.

This study aims to assess the prevalence of renal involvement in pediatric TSC patients. More in detail, the primary aim is to assess the prevalence of angiomyolipomas and renal cysts in pediatric TSC patients. The secondary aims are to evaluate the correlation between genetic alteration and the presence of angiomyolipomas and renal cysts in TSC patients; to evaluate the renal outcome in terms of renal function and blood pressure in pediatric TSC patients with renal involvement; to evaluate the volume change of angiomyolipomas in pediatric patients with TSC on Everolimus therapy prescribed for neurological complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex under the age of 17 years at the time of last observation (06/30/2021);
* Patients clinically evaluated in an outpatient or inpatient setting during 01/01/2018- 30/06/2021 with a diagnosis of TSC;
* Informed consent signed by parent or legal guardian.

Exclusion Criteria:

* Patients older than 18 years of age;
* Patients with other phacomatoses.
Examining the Relationship Between Pain, Upper Extremity Functionality and Depression in Individuals With Chronic Shoulder Pain

The aim of the study is to examine the relationship between pain, upper extremity functionality and depression in individuals with chronic shoulder pain.


Eligibility Criteria:
Inclusion Criteria:

* Have been suffering from shoulder pain for more than three months

Exclusion Criteria:

* People who have had shoulder surgery
Pilate Mat Exercise Versus Muscle Energy Technique on Chronic Non Specific Low Back Pain

to investigate the effect of pilat mat exercise versus MET on chronic non specific LBP:Randomized controlled trial

Low back pain (LBP) affects almost everyone at least once per life. Hence,it has been considered one of the most common musculoskeletal problems.The Pilates Method starts by strengthening the core, which is achieved by coordinating breathing with movement. Muscle energy technique is an associate degree of osteopathic manipulation methodology. The muscles of patients were used, on request, to type a singular controlled position, in a very specific direction, and against a distinctly executed therapist-applied counterforce.pilate mat exercise and muscle energy technique play a major role in treatment of patients with chronic non specific LBP so this trial will be conducted to investigate the effect of pilat mat exercise versus MET on chronic non specific LBP:

Eligibility Criteria:
Inclusion Criteria:

* Seventyeight Subjects will be selected from both genders, with age above 18 years.
* Normal body mass index (BMI) will be included.
* Participants diagnosed with chronic nonspecific LBP.

Exclusion Criteria:

* The participants will be excluded if they had one of the following criteria:
* Patient with previous back surgery, lumbar disc herniation, spinal deformities.
* Neuromusculoskeletal problems as hip arthrodesis or arthroplasty and spondylolisthesis.
* History of Cardiovascular disease, diabetes mellitus and rheumatoid arthritis
* Pregnant women and Osteoprosis.
* Leg length discrepancy.