cyrilzakka/clinical-trials huggingface dataset:
Detection of Viable CTCs Using the EPIDROP Technology in Metastatic Prostate Cancer (EPIDROP)

The use of liquid biopsy could be the key for precision medicine. Circulating tumor cells (CTCs) are the most studied circulating biomarkers used to assess the metastatic process and they have shown their clinical validity and utility in cancer patients. However, their detection and capture are still a challenge as they are very rare in the bloodstream. In this clinical trial named "EPIDROP", the investigators will use an innovative device called EPIDROP (for EPIspot in a DROP) in metastatic prostate cancer. EPIDROP is a completely new technology answering to biological and clinical questions by proposing a procedure detecting the functional subset of prostatic CTCs at the single cell level. The investigators will stain cells in the sample for EpCAM, PSMA, CD45 before to encapsulate them one by one in microdroplets and measure the PSA secretion by only the viable CTCs. This study aims to demonstrate the non-inferiority of the EPIDROP compared to the CellSearch system.

Methods :

One hundred patients with a metastatic prostate cancer will be recruited plus 50 healthy donors. Twenty ml of blood will be drawn : 10 ml of blood will be drawn on CellSave tubes (fixed cells) for CTC detection using the FDA-cleared CellSearch system (gold standard) and 10 ml of blood will be drawn on EDTA tubes (viable cells) for the detection of functional CTCs using the EPIDROP. Patients will be followed for 18 months.

Samples from fifty control subjects will be provided by the Etablissement Français du Sang.

Eligibility Criteria:
Inclusion Criteria :

* To be male, over 18 years old
* Metastatic prostate cancer naive to any treatment or metastatic prostate cancer in biological recurrence (PSA increase) and/or clinical recurrence after hormone suppression (mCRPC)

Exclusion Criteria:

* Non-metastatic prostate cancer in biological and/or clinical recurrence after hormone-suppression (nmCRPC)
* Other active or treated cancer less than 5 years old
* Be protected by law (guardianship or curatorship)
* Be deprived of liberty by administrative decision
* Not being affiliated to a social security scheme, or not being a beneficiary of such a plan
* Being in a period of exclusion from another protocol
* Inability to understand and/or respond to questionnaires
* Inability to understand the nature, purpose and methodology of the study
* Refusal to sign informed consent
Transrectal Vacuum Assisted Drainage: A New Method of Treating Anastomotic Leakage After Rectal Resection

Anastomotic leakage is a major and potentially mortal complication with an incidence of 10-13% after resection of the rectum. For patients showing no clinical signs of peritonitis, the traditional method has been a conservative treatment with transrectal rinsing. This treatment is often associated with a very protracted postoperative course with healing times of up to a year or more for the anastomotic leakage.

Treatment with vacuum drainage (VD) is a new method primarily developed for wound therapy.

The objective of this study is to investigate the effects of transrectal vacuum treatment on the healing of anastomotic leakage after rectum resection in a prospective, randomized, controlled multicentre trial in 60 patients found to develop clinically significant anastomotic leakages after elective rectal resection.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically significant\* anastomotic leakage after intended curative rectal resection (LAR) for rectal cancer with primary anastomosis.
* Patients whose operation did not include ileostomy must have surgery to create a stoma within two days after beginning of the vacuum therapy and before randomization. Anastomotic leakage must have been diagnosed within 21 days of the primary operation.
* Patients with and without preoperative radiation therapy may participate.
* Groups will be formed accordingly, because patients who had preoperative radiation therapy heal more slowly.
* Patients with anastomotic leakage (diagnosed by endoscopic or radiology techniques) and clinical signs and symptoms indicating a health impairment (fever, pain, elevated creatinine levels).
* Anastomotic leakage after rectal cancer surgery

Exclusion Criteria:

* Informed consent
* Age \< 18 years
* Acute surgery
* Leakage diagnosed more than 21 days after the primary operation
* Patient does not consent to temporary ileostomy
* Anastomosis technically inaccessible for vacuum-assisted drainage
* Small intestine visible in abscess cavity
* Residual cancer tissue in the pelvic cavity
* Suspicion of fistulation between the abscess cavity and internal genitalia, urinary tract system, or small intestines.
Serum Irisin in Myocardial Infraction and Following Percutaneous Coronary Intevention

The investigators aim to evaluate circulating irisin levels alterations in patients with acute myocardial infraction and in patients with coronary artery disease subjected to percutaneous coronary intervention.

Irisin is a newly discovered myokine induced in exercise. There is evidence that cardiac muscle produces more irisin than skeletal muscle in response to exercise. Furthermore, irisin has been associated with isoproterenol-induced myocardial infarction (MI) in rats while it has been reported to decrease after acute myocardial infarction in humans.

The investigators aim 1) to investigate circulating irisin levels in patients at the time of acute myocardial infarction and after reprefusion \[primary percutaneous coronary intervention (PCI)\] 2) to compare irisin' s diagnostic and prognostic value and specificity value in myocardial infarction with known markers of cardiac injury such as creatine kinase-MB isoenzyme (CK-MB) and troponin 3) to evaluate irisin as an early necrosis biomarker 4) To evaluate irisin's sensitivity as a biomarker to detect minor myocardial necrosis after elective percutaneous coronary intervention

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute myocardial infraction (MI) or with coronary artery disease without myocardial infraction who need percutaneous coronary intervention

Exclusion Criteria:

* age \< 20 years old
* diseases or medications that could affect cardiac muscle or skeletal muscle metabolism
* musculoskeletal injury of surgery 6 months prior to recruitment
* severe liver or kidney disease (creatinine clearance \< 60ml/min/1.73m2) or liver or kidney transplantation
Correlation of Length of Index Finger to Vertical Dimensions of Occlusion for Edentulous Patients

This study is a randomized clinical trial comparing the conventional method of recording occlusal vertical dimension using Willis gauge from the base of the nose to the base of the chin with the other method using vernier caliper for the length of the index finger to access the satisfaction level of edentulous patients acquiring complete dentures.

This study was to apply the anthropometric methods to correlate the length of fingers to occlusal vertical dimensions and also by using the Willis Method to assess the occlusal vertical dimension for edentulous patients and assess satisfaction by comparing both the methods for patients who are in the process of acquiring complete dentures. Furthermore, conventional methods are applied most commonly for the recording of occlusal vertical dimensions. This study also bridged the knowledge gap among clinicians to adapt to a different methodology for recording the VDO using the anthropometric measurement of fingers which would improve denture satisfaction. Therefore, a total of 71 patients were selected for this study, having lost their OVD due to the complete absence of teeth and having no history of maxillofacial or orthognathic surgery, nor any skeletal deformities or disfigurement of fingers. The measurements were made at the appointment for jaw relations records in which the length of the fingers was measured with a digital Vernier caliper and also the conventional methods were applied for recording the occluding vertical dimensions which included recording the distance from the base of the nose septum (Subnasion - Sn) to the base of the chin (Menton - Me) (Sn-Me). The length of the index finger (2D) was recorded and a correlation was found between Sn-Me and finger length.

Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous patients
* Patients willing to participate in the study
* Male patients without a beard

Exclusion Criteria:

* Partially dentate patients
* Patients having any maxillofacial or myofascial disorders
* Any history of orthognathic or orthodontic surgery
* Deformities or disfigurement of fingers
* Patients with neurological problems in the head and neck
* Any bony defects or visible sharp spicules
* Nose or chin deformity
* TMJ disorders (intracapsular/extracapsular)
* Heavy bulky chin area (double chin)
Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with metformin.

This Phase 3, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of HTD1801 in two phases, a 24-week double-blind phase followed by a 28-week open-label extension. To ensure stabilization of glycemic control, eligible patients will first participate in a 4-week single-blind run-in period where investigators will provide guidance on lifestyle modifications, concomitant medications, and procedures for self-monitoring of blood glucose. Following this period, patient eligibility will be reassessed. Eligible patients will then be randomized 2:1 to receive HTD1801 1000 mg twice daily (BID) or placebo for 24 weeks.

Patients who complete the double-blind treatment phase will enter an open-label extension period where all patients will receive HTD1801 1000 mg BID for 28 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with type 2 diabetes
* Received a stable dose of metformin monotherapy for at least 8 weeks prior to screening
* If used any glucose-lowering drugs other than metformin within the 8 weeks prior to screening such use was ≤7 days and was discontinued at least 4 weeks prior to screening
* Have HbA1c ≥7.5% to ≤11.0% (screening) and HbA1c ≥7.0% to ≤10.5% (pre-randomization)
* Have fasting plasma glucose ≤13.9 mmol/L (screening and pre-randomization)
* Have a body mass index ≥19.0 kg/m\^2 to ≤35.0 kg/m\^2

Exclusion Criteria:

* Have type 1 diabetes
* Have had any acute diabetic complications within 12 months prior to screening
* Have had any Grade 3 hypoglycemic event within 12 months prior to screening
* Have had proliferative retinopathy or macular degeneration, severe diabetic neuropathy, or diabetic foot
* Have been taking any weight loss medication or dietary supplement, have participated in a weight loss program, or have adhered to a special diet within 12 weeks prior to screening
* Have used insulin or an insulin analogue for more than 14 days within 12 months prior to screening
* Have used any hypoglycemic drug other than metformin during the 4-week run-in period prior to randomization
* Have had weight gain or loss ≥5% during the 4-week run-in period prior to randomization
Milk Supplementation and Bone Health in Children

Objectives: to examine the effects of a Yili child formula milk and regular milk on bone health and growth in young children.

Study design: cluster randomized controlled trial.

Setting: kindergartens in Hui-ning County of Gansu Province, China (north west).

Participants: \>=246 apparent healthy children aged 4-6 years old.

Interventions:

(I) Yili child formula milk (QQ star formula, SCI-PRO NUTR5+6TM), 195 ml \*2 /day; (II) Yili regular milk (pure milk), 195ml\*2 /day; (III) Controls: about 50g/d grain foods (containing 20-30 g carbohydrates), e.g. bread.

Interventional Duration: 12 months.

Outcome measures: determined at 0, 6 and 12 months post treatments. Primary outcomes: bone density and bone mineral contents at the forearm and heel, bone biomarkers.

Secondary outcomes: (1) anthropometric indices: weight, height, waist circumference, etc.; (2) immune status.

Other measures: dietary intakes, physical activities, general information, medical information, adverse of side effects.

Data Analyses: The one-year changes and percent changes in the primary and secondary outcomes will be compared among the 3 groups.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 4-6 years;
* female and male
* Can be enrolled into kindergarten/school as a normal child.
* Be willing to drinking milk daily.

Exclusion Criteria:

* Milk allergy or intolerance, did not to be used to drinking milk;
* Had the following diseases/conditions confirmed by a hospital: serious diseases of heart, liver, kidney, brain, hematopoietic system, immunity, thyroid or cancer that need to be hospitalization for more than 1 week or take medication(s) for more than 1 month with the past two years.
* having infectious diseases, e.g., tuberculosis, hepatitis, etc.
* Taking vitamin D, calcium tables or nutrient package;
* Consumed more than 3 times (\>600ml) milk each week in the previous month.
* Be not willing to provide informed consent, or have other conditions that were considered to be unsuitable for the study by the investigators.
* Increases of body health were out of the range between 5-8 cm in the last year.
Efficacy Study of Recombinant Interleukin-21 in the Treatment of Ovarian Cancer

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of rIL-21 and Caelyx in cancer patients who have relapsed after, or have persistent disease after, first line therapy. Patients will be treated for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Advanced epithelial Ovarian Cancer (stage IIB-IV)
* Persistent or progressive disease after or relapse within one year of completion of first line therapy
* Measurable or assessable disease
* Eastern Cooperative Oncology Group status less than or equal to 2

Exclusion Criteria:

* History of any other active malignancy
* Signs of CNS metastasis
* More than one prior chemotherapy regimen
* Radiotherapy (bone) less than 4 weeks prior to start of treatment and radiotherapy (visceral) less than 8 weeks
* First line chemotherapy completed at least 1 month prior to start of treatment
Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene of Cutaneous T Cell Lymphoma

Bexarotene is a RXR-selective retinoid, licensed for the treatment of cutaneous T cell lymphoma. The most frequent adverse effect is hypertriglyceridemia but its mechanism is not well known. The purpose of this study is to research a carbohydrate metabolism disorder associated in bexarotene-induced hypertriglyceridemia.

Primary cutaneous lymphomas are the second group of extra nodal lymphomas after gastrointestinal lymphomas. Bexarotene is licensed for the treatment of epidermotropic cutaneous T cell lymphoma .The most common side effect of bexarotene is hypertriglyceridemia (82%) associated with hypercholesterolemia (30 to 40%). Central hypothyroidism is also present in 40-80% of cases. These adverse effects are dose-dependent. The management of hyperlipidemia induced by bexarotene is difficult. The mechanism of lipid disorder induced by bexarotene is not well known. Associated carbohydrate metabolism disorder could be present and play a role in the bexarotene-induced hyperlipidemia.

The main objective is to estimate the frequency of a carbohydrate disorder in patients with hypertriglyceridemia (TG\> 1.5 g / L) induced by bexarotene treatment of cutaneous T cell lymphoma, previously free of diabetes, thyroid dysfunction and dyslipidemia.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged over 18 years
* Diagnosis of epidermotropic CTCL confirmed by histological examination for which consideration will be given treatment with bexarotene due to the advanced stage of lymphoma (stage IIB-IV) or earlier stage if resistance to previous treatment .
* TSH, FT3 and FT4 within normal limits
* AST and ALT ≤ 2 \* upper limit of normal
* Creatinine clearance ≥ 30 mL / min
* Agreement after written information and informed to participate in the study
* Patient accepting the constraints of the study
* Membership of a social security system.

Exclusion Criteria:

* Pregnant or lactating woman
* Women of childbearing potential without effective contraception
* Insufficient thyroid or hyperthyroidism
* Diabetes known or detected
* Hyperlipidemia known or detected
* Hepatic insufficiency
* Difficulties to understand
* Persons covered by a plan of legal protection (protection of justice, guardianship, curator) or unable to issue a consent
Influence of Artificial Tears on Keratometry and Biometry Measurements With Different Devices

The goal of this clinical trial is to learn about the influence of artificial tears on measurements of healthy eyes with three different devices. The main questions it aims to answer are:

* Do artificial tears alter the measurements of the corneal surface
* Is there a difference between the devices used in this study

This is relevant because high quality measurements improve the postoperative outcome after cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Healthy eyes

Exclusion Criteria:

* Any prior intraocular surgery or trauma
* Any corneal pathology (ABMD, Fuch's, etc.)
* Active ocular pathology (e.g., amblyopia, ARMD)
* Contact lens wear within 2 weeks of study
* Any corneal relaxing incisions or astigmatic keratotomy
Influence of Multidisciplinary Breast Tumor Board on Physician Decision

In our study, the treatment plan for the case prior to the breast tumor counseling will be asked to physician and the treatment protocol observed by the primary physician will be observed after the decision of the tumor council.


Eligibility Criteria:
Inclusion Criteria:

Patients having primary breast cancer

Exclusion Criteria:

Patients having recurrent breast cancer -
Endomicroscopy, IBS and Food Intolerance

Background:

The immediate endoscopic identification and diagnosis of intraepithelial structures and immediate and delayed reactions to allergens in the mucosal surface of the gut are unmet goals in the diagnosis and management of subjects with food intolerances, who are negative to all available tests. Endomicroscopy may be helpful to further visualize and characterize unmasked small bowel reactions to foods, which has not been described before.

Confocal laser endomicroscopy provides confocal microscopic imaging simultaneously to the macroscopic view ,which enables the examiner to see immediate reactions after exposure and it further allows capturing of fluid excreted by the gut for further analysis to understand the pathology behind this reaction further.

N=50 patients with unexplained bloating and diarrhoea with suspicion of food intolerance and negative testing with routine methods. Patients with Lactose intolerance n=10 patients to compare results. Patients with Fructose intolerance n=10 patients to compare results. Volunteers with Barrett's esophagus who need evaluation for possible dysplasia in the Barrett's mucosa with confocal endomicrosopy but no symptoms of bloating and abdominal pain (n=10) to serve as healthy controls for allergy testing.

Methods:

The primary objective is to investigate whether endomicroscopy will allow the detection of an allergic reaction of the gut after exposure of the 5 major allergens in the following way:

After standard gastroscopy with the endomicroscope including evaluation of the surface of the upper gastrointestinal tract, i.v. injection of Fluorescein, then initial visualisation of the duodenal surface including count of initial lymphocytes/mononuclear cells in the lamina propria: Allergen 1 (milk), allergen 2 (wheat), allergen 3 (soya),allergen 4 (apple), allergen 5 (yeast).

The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in the lamina propria of the duodenum, representing an acute reaction to one of the allergens sprayed to its surface through the endoscope channel.

The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in the lamina propria of the duodenum, representing an acute reaction to one of the allergens sprayed to its surface through the endoscope channel.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* ongoing abdominal symptoms such as bloating and abdominal pain
* negative routine testing for food intolerance (or known lactose/fructose intolerance)
* written informed consent

Exclusion Criteria:

* no consent
* known reason for the abdominal pain and bloating other than lactose/fructose intolerance
* M. Whipple
* known infectious gastrointestinal disease
* stricture in the upper gastrointestinal tract
* age \>18years
* impaired renal function (Creatinine \>1.2 mg/dL)
* pregnancy or breast feeding
* inability to obtain informed consent
* active GI Bleeding
* known allergy to Methylene blue or Fluorescein
* participation in other clinical trials within the last 4 weeks
Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum

Bioequivalence between oral nicotine replacement products and Nicorette® gum.

This study compares a new oral Nicotine Replacement Therapy (NRT) product containing 2 and 4 mg nicotine with Nicorette® gum 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 10 hours after start of administration. Single doses of each treatment are given once in the morning during four separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 88 healthy smokers between 18-50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Eligibility Criteria:
Inclusion Criteria:

* Healthy smokers, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
Pilot Study of Connected Diabetes Technology

To test the hypothesis that remote sharing of health data - including measured blood glucose values as well as patient-reported carbohydrate counts and insulin doses - with the UC Davis Pediatric Diabetes team via connected health applications is feasible for pediatric patients with newly diagnosed type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with T1D in the past 6 weeks
* Daily access to the internet via a wireless connection

Exclusion Criteria:

* Does not plan to attend the UC Davis Pediatric Endocrinology clinic for future diabetes care
* Primary caregiver does not speak English