cyrilzakka/clinical-trials huggingface dataset:
Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis]

The primary objective of this study is to investigate whether bicalutamide given in combination with anastrozole once daily for 12 months is effective in treating testotoxicosis in boys. Testotoxicosis is a condition that causes early puberty in boys including growth in height, and development of muscles and sexual organs .


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent of parent/legal guardian and subject assent (as needed by local requirements)
* Male aged 2 years and over
* Diagnosis of testotoxicosis based on the following:
* Clinical features of Progressive sexual precocity documented by Tanner staging and evidence of symmetrical testicular enlargement
* Clinical features of significantly advanced bone age (defined as bone age of at least 12 months beyond chronological age)
* Pubertal levels of serum testosterone
* Prepubertal levels of serum gonadotropins
* Lack of an increase in serum gonadotropin levels following GnRH stimulation
* Other pathology excluded by:
* Undetectable plasma b human chorionic gonadotropin (bHCG). Samples with values below the LOQ will be reported as "\<10 IU/L" which in the clinical setting equate to 'undetectable'.
* Normal levels of 17-hydroxyprogesterone (17-OHP)
* Normal levels of dehydroepiandrosterone sulphate (DHEAS)
* Naive to anti androgen receptor therapy:

(Note: Ketoconazole and Spironolactone are considered acceptable as is prior use of anastrozole or other aromatase inhibitors)

* A documented reliable height measurement taken \> 6 months prior to study enrollment. Additionally for subjects who have previously received ketoconazole or spironolactone treatment, a documented reliable height measurement taken immediately prior to beginning this treatment.

(Note: for subjects who received such previous treatment only a single assessment is needed if it was taken immediately prior to beginning treatment and \> 6 months prior to study entry)

* Subjects should be free of endocrine or other effects of previous treatment for testotoxicosis prior to study entry: to ensure this there should be 15 days or 4 drug half lives (whichever is the longer) washout period from prior medication for testotoxicosis.

Exclusion Criteria:

* Evidence of central precocious puberty as demonstrated by GnRH stimulation test
* Serum concentration of total or direct bilirubin, GGT, AST or ALT greater than 1.5 times the upper limit of normal for age
* Serum concentration of creatinine greater than 1.5 times the upper limit of normal for age
* Any concomitant medical condition that, in the opinion of the investigator, may expose a subject to an unacceptable level of safety risk or that affects subject compliance
* Known hypersensitivity to any of the study medications
* Participation in a clinical study at the time of enrollment
Preoperative Coadministration of Low-concentration Carbohydrate and Nitrates Loading vs Low- Concentration Carbohydrate Loading Alone in Patients Undergoing Open Gynecological Surgeries

Surgery is known to be associated with stress response affecting in a negative way the clinical outcome and patient experience. The stress response includes both sympathetic nervous system activation and systemic inflammatory response. The pituitary- sympathetic one leads to a number of metabolic changes as hyperglycemia, nitrogen loss and lipolysis on the other hand the systemic inflammatory response aggravates the perioperative metabolic changes. One of components of ERAS is preoperative carbohydrate load. Oral carbohydrate was associated with attenuation of the postoperative metabolic stress response. Nitrate rich drinks before exercises have a promising impact due to improving blood flow, mitochondrial efficiency, glucose uptake and the sarcoplasmic calcium handling all of which maximize resistance to fatigue and improved exercise performance.


Eligibility Criteria:
Inclusion Criteria:

* Patients ageing from 18 to 60 years,
* American Society of Anesthesiologists (ASA) physical status I,II
* scheduled for elective open gynecological surgeries

Exclusion Criteria:

Patients with

* Previous chemotherapy treatment,
* Disseminated malignant disease,
* BMI more than 40,
* Known allergy to one or more of the study medications
* Refusal to participate in the study
* Patients diagnosed with diabetes milieus either type I or type II,
* Patients with previous bariatric surgeries
* Patients under medications that delay gastric emptying (tricyclic anti-depressants, chronic use of laxatives)
Clinical Decision Support System (CADIMS) for MS Diagnostic

1. Background The results obtained in clinical research led to a new paradigm for the treatment of patients affected with multiple sclerosis (MS): "no evidence of disease activity". This means having each patient monitored with high quality imaging. To this purpose, researchers have developed segmentation algorithms for automated reading of MRIs, facilitating longitudinal comparisons, and allowing an accurate assessment of the number and the volume of focal lesions. We have thus a powerful strategic biomarker for the treatment of MS.

   Due to the relevance of comparing over time the evolution of lesions (lesion load) and brain atrophy, the French Society of Neuroradiology edited standardized national recommendations. The MS French Observatory (OFSEP) has adopted these recommendations, in order to harmonize exams for all patients all over the country. At an international level as well, MRI have been put at the heart of the therapeutic strategy.

   Therefore, we need now to create the conditions able to implement, collect and analyze imaging data according to these recommendations.

   This is the meaning of the MUSIC project, which aims to develop and assess a standardized monitoring MRI control tool for therapeutic decision.

   CADIMS is this tool. It is based on an integration of several segmentation algorithms developed by INRIA and an image viewer developed by b\<\>com and included in a regional images-sharing server ETIAM Nexus. This tool is a help showing segmented brain T2 lesions, gadolinium-enhanced T1 lesions and news T2 lesions appeared from the previous MRI exam, in a multicenter clinical context.
2. Objective To evaluate the accuracy of MS lesions detection on cerebral MRI by comparing the CADIMS tool to the expert consensus.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years-old
* Patient with relapsing-remitting multiple sclerosis, according to the 2010 Mc Donald's criteria
* EDSS\<4
* Disease duration \< 10 years
* To insure a clinical demand of 2 brain MRIs within 12 months of the installation of an immunomodulatory therapy
* MRI brain scanner acquired according to the OFSEP recommendations installation of an immunomodulatory therapy

Exclusion Criteria:

* Progressive MS
* no consent of the patient
Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican and US Blood Donors - CTS

The objective of this study is to test individual donor samples (IDSs) with the investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue Assay in the clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* Donor must meet all the blood collection sites' standard eligibility requirements.
* Donor and/or legally authorized representative must be willing to undergo the site's routine informed consent process prior to study participation.
The Use of Platelet Derived Growth Factors in Total Knee Arthroplasty, a Randomized Trial

The objective of this study is to evaluate the effect of autologous platelet concentrate on blood loss (post-operative decrease of haemoglobin concentration), wound healing complications, range of motion, pain reduction and outcome scores when used in total knee arthroplasty.

The short-term functional recovery after a total knee arthroplasty (TKA) is largely dependent on initial wound healing. Haematoma formation may lead to prolonged wound drainage and tissue necrosis1, which can have a negative effect on early range of motion, post-operative pain and length of hospital stay. In addition, studies have suggested that prolonged wound drainage also leads to a higher infection rate.

To decrease haematoma formation, primary soft tissue homeostasis and adequate tissue repair are essential. During the immediate reaction of tissue to injury, haemostasis and inflammation occur. Growth factors, especially PDGF (platelet derived growth factor) and TGF-β (transforming growth factor-beta), play a crucial role in the biochemical cascade at the site of repair. These growth factors are mostly derived from platelets. They act as chemotactic agents for polymorphonuclear leucocytes, macrophages, fibroblasts and lymphocytes. Both factors stimulate angiogenesis and fibroplasia. PDGF also has a role in wound contraction and remodeling. When applying large concentrations of growth factors in a wound, faster tissue repair and homeostasis can be expected, thus leading to less haematoma formation.

Treatment with autologous platelet concentrate involves direct application of concentrated platelets, growth factors and fibrin in the operation wound. A small volume (55-110 ml) of the patient's own blood is taken to derive a platelet rich gel which can be sprayed directly into the wound.

The objective of this study is to evaluate the effect of autologous platelet concentrate on blood loss (post-operative decrease of haemoglobin concentration), wound healing complications, range of motion, pain reduction and outcome scores when used in total knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary total knee arthroplasty for primary osteoarthritis

Exclusion Criteria:

* Coagulation disorder
* Abnormal pre-operative levels of APTT, PT and/or thrombocytes
* Homologous blood transfusion last 4 weeks
* Coagulation disorder
* Use of anticoagulation medication
* Use of any iron supplements or erythropoietin at time of operation or during 1 week prior to operation
* Primary bone tumor or metastatic bone disease
* Unable or unwilling to participate in follow-up
* Unable to give informed consent
* Previous infection in knee
* Use of corticosteroids at time of operation or during 4 weeks prior to operation
* Any neuromuscular disorder
* Active infection or osteomyelitis
Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Unresectable Esophageal Squamous Cell Carcinoma

Patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) who failed to induction chemo(immuno)therapy had poor prognosis. Radiotherpy was an important and effective treatment in treating ESCC. The present study is a one-arm trial that seeks to evaluate the efficacy in patients with unresectable ESCC. The study objectives include R0 resection rate, complete pathological response and treatment toxicity, etc.

Nimotuzumab is a recombinant humanized monoclonal antibody against EGFR. Its efficacy and safety in patients with esophageal cancer have been confirmed by many studies.

The current prospective phase II study aimed to evaluate the efficacy and safety of a combination regimen comprising chemotherapy with nimotuzumab and S-1 and concurrent radiotherapy for patients who are not sensitive to induction chemo(immuno)therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed esophageal squamous cell carcinoma. Tumor response was evaluated as stable or locoregionally progresive disease or assessed by surgeons being unresectable (without distant metastasis) after induction chemo(immuno)therapy.
* Cycles of induction chemo(immuno)therapy was 2-4.
* KPS score ≥70.
* Main organs and bone marrow function are normal: routine blood tests: hemoglobin (Hb) ≥100g/L ; absolute neutrophil count (NEUT)≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell (WBC)≥3.5×109/L,biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×UNL; serum total bilirubin (TBIL) ≤1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN≤1.0×UNL;

Exclusion Criteria:

* Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
* At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites
* There are active infections, such as active tuberculosis and hepatitis
* There are contraindications to targeted therapy.
ICL and LASIK for Hyperopic Astigmatism

This study investigates a two-step treatment for people with severe farsightedness combined with astigmatism. The first step involves implanting a specially designed lens inside the eye (a spherical Implantable Collamer Lens, or ICL) to improve vision. Later, a laser procedure (LASIK) is performed to fine-tune the results for even better clarity.

To assess refractive and visual outcomes of a spherical Implantable Collamer Lens (ICL) followed by planned postoperative adjunctive laser-assisted in situ keratomileusis (LASIK) in the treatment of high compound hyperopic astigmatism. In this prospective, multi-center, multi-surgeon, single-arm study, eyes with ≥3.50 D hyperopia and ≥2.00 D of astigmatism underwent surgery receiving a spherical Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively. Outcomes measures included postoperative uncorrected (UDVA) and corrected distance visual acuity (CDVA), manifest refraction, spherical (SEQ) and defocus equivalent (DEQ), efficacy index, safety index, and astigmatism vector analyses.

Eligibility Criteria:
Inclusion Criteria:

* Preoperative hyperopic sphere of ≥+3.50 D
* Astigmatism of ≥+2.00 D
* Stable refraction for the previous 12 months
* Age older or equal to 18 years
* Anterior chamber depth (ACD) from corneal endothelium to anterior lens capsule of 3.0 mm or greater

Exclusion Criteria:

* Age younger than 18 years
* Patients lost to follow-up
* Cataract formation
* History of glaucoma or retinal detachment
* Macular degeneration
* Diabetic retinopathy
* History of ocular inflammation
* Signifcant irregular corneal topography
* Evidence of inconsistent imaging from dry eyes
Effects of Slump Stretching vs Lumbar Mobilization With Exercises in Relieving Non-radiculating Low Back Pain

This study will be conducted to determine the effects of slump stretching vs lumbar mobilization with exercises in relieving non-radiculating low back pain. There will be two groups; Group I will receive Slump stretching along with standardized exercises and Group II will receive Lumbar mobilizations along with standardized exercises.

Physical therapist commonly examines and treats patients with low back pain. For this purpose, they utilize a wide range of interventions for the management of Low back pain.

The rhythmical movement is thought to modulate pain and muscle spasm by stimulating receptors within the mobilized structures while, In recent years, neurodynamic test procedures, have also been used as interventions to potentially resolve abnormal physiology within the nervous system.

So for this purpose not only the present study can provide an additional evidence to the literature but also can can also demonstrates a structured Physiotherapy plan for treating the Non-Radiculating Low back pain

Eligibility Criteria:
Inclusion Criteria:

Individuals with Non-Radiculating Low back pain

Test:

i. Slump test=positive ii. Straight leg raise=negative

Exclusion Criteria:

Individuals with Radiculating Low Back pain,History of spinal surgery, Disc herniation,Pregnant women, Major diseases (e.g. stroke)
Effect of Albumin Versus Routine Care on Hemodynamic Response and Stability in Patients With Preeclampsia Guided by a Non-invasive Hemodynamic Monitoring System During Cesarean Delivery With Spinal Anesthesia

The purpose of this study is to compare the effect of albumin versus routine care on hemodynamic response and stability in pre-eclamptic patients during cesarean delivery. The hypothesis is that volume replacement with albumin guided by stroke volume variation (SVV) using a ClearSight-Acumen (CS-A) monitor, before cesarean delivery (CD), improves hemodynamic stability in preeclamptic patients with severe features compared to routine care, under neuraxial anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age greater or equal to 24 weeks
* Diagnosis of preeclampsia with severe features \[Pre-eclampsia is defined as high blood pressure after 20 weeks with or without proteinuria. Pre-eclampsia with severe features is defined as the presence of preeclampsia with any of the following features: severe hypertension (blood pressure ≥160/110 mmHg on two separate occasions); thrombocytopenia (platelet count \<100,000 per microliter); impaired liver function (elevated liver transaminases to twice the normal concentration or severe persistent right upper quadrant or epigastric pain not responsive to medications); progressive renal insufficiency with a serum creatinine level of \>1.1 mg/dl or doubling of the serum creatinine level in the absence of other renal disease; pulmonary edema or unexplained new-onset cerebral symptoms (headache) unresponsive to medications or visual disturbances.\]
* Scheduled Cesarean Delivery
* Unscheduled Cesarean Delivery with the goal to proceed to the operating room within no less than 30 minutes due to concern for maternal or fetal status that is not immediately life threatening.
* Requiring Neuraxial Anesthesia (spinal or CSE)

Exclusion Criteria:

* Patient declines to participate in the study
* Labor
* Contraindications to the use of neuraxial anesthesia (coagulopathy, infection at the insertion site, intracranial mass etc.)
* Unscheduled Cesarean Delivery with the goal to proceed to the operating room immediately for delivery of the baby due to imminent/unavoidable threat to the life of the mother or fetus.
* The use of or conversion to General Anesthesia
* Non-reassuring fetal status including the presence of cardiac or multi-system anomalies, category III tracing etc.
* Significant maternal cardiopulmonary disease including pulmonary hypertension, ischemic heart disease with systolic dysfunction, pulmonary edema etc.
* Significant intraoperative events (such as hemorrhage) requiring administration of multiple blood products and ICU admission.
External Oblique Intercostal Plane Block for Laparoscopic Sleeve Gastrectomy

The external oblique intercostal (EOI) plane block is a novel approach upper abdominal wall analgesia. The EOI plane block can provide dermatomal sensory blockade of T6-T10 at the anterior axillary line and T6-T9 at the midline. It may be used for postoperative analgesia in obese patients because it is superficial and rapidly identifiable and performed in the supine position. the aim of this study is to investigate the postoperative analgesic efficacy of external oblique intercostal plane block in obese patients undergoing laparoscopic sleeve gastrectomy.

Researchers will compare the external oblique intercostal plane block group with control group to see if the EOI plane block is effective for postoperative analgesia in patients undergoing sleeve gastrectomy.

Patients scheduled for elective laparoscopic sleeve gastrectomy will be separated into 2 groups: Control Group and External Oblique Intercostal Plane Block Group. Patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia. Patients in External Oblique Intercostal Plane Block Group will be performed bilateral External Oblique Intercostal Plane Block before the surgery and received patient controlled analgesia with morphine for postoperative analgesia. Morphine consumption for first postoperative 24 hours, visual analog scale scores, time to need for first rescue analgesia, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* Patients with American Society of Anesthesiology (ASA) physical status II-III
* Patients scheduled for a laparoscopic sleeve gastrectomy

Exclusion Criteria:

* Allergy to local anesthetics
* Coagulopathy
* Skin infection at the EOI Plane Block area
* Advanced hepatic or renal failure
* Chronic pain syndromes
* Alcohol or drug abuse
* Severe pulmonary and/or cardiovascular disease
* Psychiatric disorders
Effect of Plant Stanol Esters on Blood Lipids

This study aims to measure the effect of plant stanol esters on serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins in subjects with elevated fasting blood lipid concentrations

The link between high serum low-density lipoprotein (LDL) cholesterol and cardiovascular disease has long been recognized. Dietary plant stanol esters have been shown to effectively reduce serum levels of total and LDL cholesterol. Plant stanols decrease the absorption of both biliary and dietary cholesterol from the small intestine and thereby reduce serum LDL cholesterol levels.

This study aims to verify the effect of plant stanol esters on blood lipids. Subjects with elevated fasting blood lipid concentrations will be randomized to study groups. The groups consume yoghurt type minidrink containing plant stanol ester (2 g plant stanols per day) or similar minidrink without plant stanol esters. After 10 weeks study period serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins will by analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Elevated blood lipids
* Body Mass Index \< 35 kg/m2
* Stable body weight

Exclusion Criteria:

* Receiving medications or supplements other than stable statin therapy known to affect lipid metabolism
* Severe obesity
* Hyperglycemia
* Severe diseases (inc. diabetes, unstable CVD, malignant disease, inflammatory disease, gastrointestinal disease)
* Hepatic, kidney or thyroid disease or disorder
* Pregnancy or breast feeding
* Severe intolerance or allergy to any ingredient of test product
Psoas Tenotomy Under Ultrasound

The ilio-psoas conflict is a commonly accepted complication after total hip replacement, often linked to a mispositioning of the acetabular prosthetic component that conflicts with the ilio-psoas tendon. To correct these pains, a psoas tenotomy can be proposed. The results proven by the literature are very satisfactory. Psoas tenotomy is performed endoscopically, arthroscopically, or more rarely open.

The contribution of echo surgery allows to limit the scar ransom but also to free itself from a complex infrastructure to the operating room including an arthroscopy column and an intraoperative fluoroscopy for a conventional tenotomy, This also saves procedural and installation time.

No studies to date have described ultrasound-assisted psoas tenotomy Yhe investigators conducted a cadaveric study of the feasibility of psoas tenotomy under ultrasound that confirms the feasibility of this technique and the safety of the gesture for the surrounding anatomical structures.

The objectives of this study are to assess the feasibility, pain and functional outcomes of ultrasound-assisted psoas tenotomy in patients with ilio-psoas conflict after total hip replacement.


Eligibility Criteria:
Inclusion criteria:

* Patients 18 years of age or older
* Indication of psoas tenotomy for ilio-psoas conflict after total hip replacement
* Signature of the written informed consent form by the patient
* Affiliation to a French health insurance scheme or equivalent

Non Inclusion criteria:

* Vulnerable people: pregnant or breast-feeding women (patients will undergo a pregnancy test: urinary test), adult under guardianship or deprived of freedom.
* Allergies to local anesthetics
* Patient on anticoagulant or antiplatelet agents
* Contraindication to surgery
* Refusal of patient involvement