cyrilzakka/clinical-trials huggingface dataset:
Protocol of Reintroduction of Beta-lactams in Children at Low Risk of Anaphylaxis.

The purpose of this study is to establish the rationale for the practice of performing an oral reintroduction test without previous skin tests in children at low risk of IgE-mediated reaction or drug-induced toxidermia, and to confirm the criteria for a drug reintroduction test could be performed without previous skin tests, without subsequent risk of reaction for the child. The primary endpoint will be the risk of a severe IgE-mediated or delayed hypersensitivity reaction in children who received beta-lactam drug reintroduction protocol prior to skin testing.


Eligibility Criteria:
Inclusion Criteria:

* Children under 16 years of age coming for a consultation for a beta-lactam oral reintroduction test.

Exclusion Criteria:

* Refusal of the legal representatives of the subject for their child to participate in the study,
* If his age permits, refusal of the subject to participate in the study,
* Subject aged over 16,
* Pregnancy,
* Absence of affiliation of the subject to a social security scheme,
* Skin tests with incriminated beta-lactam already made before the consultation,
* Existence of contraindications to the realization of oral reintroduction drug test with the suspected antibiotic,
* Existence of criteria in the initial reaction suggestive of a non-low risk of IgE-mediated or delayed hypersensitivity to the incriminated beta-lactam, Taking antihistamine, corticosteroids or beta-blockers within 5 days prior to the oral reintroduction drug test,
* Travel abroad of the child scheduled within 7 days of the oral reintroduction drug test.
Metabolic Effect of an Innovative Chitosan Formulation

Chitosan is a natural polysaccharide of β-1,4-linked glucosamine residues deriving from chitin, a dietary fiber primarily obtained from fungal cell walls and the exoskeletons of various crustaceans (e.g. crab, lobster, and shrimp) and whose cholesterol-lowering properties are due to the hydrophobic bonds it forms with cholesterol and other sterols, interfering with the emulsification process in the intestine.

In addition to reducing low-density lipoprotein cholesterol (LDL-C) levels, several studies showed that chitosan administration may help reduce body weight. For this reason, its use might be particularly useful as a strategy to simultaneously control two different risk factors for the development of CVDs.


Eligibility Criteria:
Inclusion Criteria:

* Subjects agree to participate in the study and having dated and signed the informed consent form;
* Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements;
* Male or female aged ≥ 18 years and ≤ 70 years old;
* Subjects free from cardiovascular diseases (CVDs) (primary prevention for CVDs);
* Subjects with sub-optimal serum levels of cholesterol (total cholesterol (TC) of 200-240 mg/dl OR LDL-C of 130-190 mg/dl);
* Subjects with body mass index (BMI) 25 -34.9 Kg/m2

Exclusion Criteria:

* Subjects already affected by CVDs (secondary prevention for CVDs);
* Subjects with serum levels of triglycerides (TG)\> 400 mg/dl;
* Type 1 or type 2 diabetes;
* Lipid-lowering treatment not stabilized since at least 2 months;
* Known current gastrointestinal diseases and use of medications for their treatment;
* Known clinically relevant decline in renal function;
* Women in fertile age not using consolidated contraceptive methods
* Pregnancy and Breastfeeding;
* History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
* Any medical or surgical condition that would limit the patient adhesion to the study protocol
fMRI and Appetite-Related Hormones Pre and Post Obesity Surgery

The investigators are looking at the differences in appetite and obesity between weight loss participants and patients undergoing bariatric surgery.

Obese persons between the ages of 18 \& 65 are eligible to participate in this study, whether or not they intend to undergo bariatric surgery.

Currently, the only effective long term treatment for severe obesity is bariatric surgery.2 Nearly 200,000 procedures are performed each year, with this number increasing rapidly.3 However, the mechanisms of reduced food intake and weight loss after obesity surgery, particularly Rouen-Y gastric bypass (RYGB), are not well understood. This study utilizes functional magnetic resonance imaging (fMRI) and measures of appetite-related gut peptide levels pre and post bariatric surgery to investigate the neurological and hormonal mechanisms involved in initiation and termination of meals.

The general objective is to better understand the physiological changes resulting in weight loss from obesity surgery, particularly Roux-en-Y gastric bypass (RYGB). The main hypothesis is that the differential mechanisms of action in RYGB will alter the signals involved in the initiation and termination of meals, reflected by changes in both peptide hormone levels and regional brain activity in response to foods. The investigators anticipate that the trigger for meal initiation by potent food stimuli will be diminished following RYGB, as indicated by reduced brain activation in areas associated with food reward and motor planning, including the orbitofrontal cortex (OFC). RYGB will be compared to: a. Gastric Banding (GB), representing the restrictive component of surgery, which itself enhances fullness, but in the absence of any rerouting of the gut, should result in fewer changes in gut peptide levels and brain activation; b. Weight Loss (WL) on a formula diet over 3 mo, which represents the weight loss component of surgery; and c. No Treatment (NT), a general control, with no gastric restriction or weight loss. These group comparisons will help parse the contributions of RYGB surgery to weight loss.

The plan is to study clinically severe obese subjects (S's) pre surgery, and at 3 and 18 mo post surgery. The investigators will examine: 1) fMRI brain activation in response to food stimuli and 2) appetite-related gut peptide levels before and following a fixed meal prior to the fMRI. The findings should reveal potential mechanisms associated with the changes in appetite, eating behaviors, and body weight, both during the rapid weight loss phase at 3 mo post surgery as well as when weight typically stabilizes at a nadir at 18 mo post surgery. The investigators plan to enroll 160 patients: 40 with RYGB, 40 GB, 40 WL, and 40 NT (4-arm study). S's will be within the BMI range of 40-50 and matched across groups for BMI, gender (3:1, f:m), and BED status.

Eligibility Criteria:
Inclusion Criteria:

* BMI range 35-50 kg/m\^2

Exclusion Criteria:

* diabetes,
* smoking,
* pregnancy
Effect of Atorvastatin on Fractional Flow Reserve in Coronary Artery Disease

Natural course of intermediate coronary artery disease (CAD) is very important to predict the prognosis of the patient with such disease.

Several studies have well demonstrated the beneficial effect of lipid-lowering therapy on the progression of CAD with the modification of lipid profiles.

This effect can be also explained by intravascular ultrasound (IVUS) or optical coherence tomography. However, the effect of plaque modification on coronary physiology has been rarely evaluated.

This research is to evaluate the change of intermediate or nonculprit coronary lesion on lipid-lowering therapy via IVUS(optional) and FFR.

The patients who have intermediate CAD (30-80% diameter stenosis by visual estimation) with FFR≥0.80, or nonculprit coronary artery disease with FFR≥0.8 after culprit coronary artery disease intervention will be enrolled. FFR, IVUS(optional) and index of microcirculatory resistance (IMR) should be performed simultaneously. Atorvastatin 20mg is a starting dose, then up-titration will be done twice within each 4\~6weeks until LDL target goal (① LDL\<70mg/dl, or ② statin naive: \>50% reduction from baseline LDL, current statin user: \>30% reduction from baseline LDL). First titration will be atorvastatin 40mg, second will be atorvastatin 80mg. If patients have any adverse effect on atorvastatin, the dose of atorvastatin can be adjusted by investigator's decision. Official clinical follow-up except visit for statin dose titration will occur at 1, 12 months after index procedure. Follow-up coronary angiography, FFR,IMR,and IVUS(optional) will be performed 12 months after index procedure.

Eligibility Criteria:
Inclusion Criteria:

* patient \> 18 years of age and willing to participate
* patients who have stable intermediate CAD(30-80% diameter stenosis by visual estimation) on angiography with FFR≥0.8,or who have nonculprit CAD which is not planned revascularization
* Signed written Informed Consent

Exclusion Criteria:

* Patients who are in cardiogenic shock
* Patients with LVEF\<35%
* Patients with left main disease, restenotic, bypass grafted lesions
* Patients with platelet count \< 100,000 cell/mm3
* Patients who have co-morbidity which reduces life expectancy to one year
* Patients who have a history of stroke or transient ischemic attack within 6 months
* Patients who are planned discontinuation of medication due to surgery
* Patients with known adverse reaction to HMG CO-A reductase therapy (statins)
* Patients with liver disease (elevation of AST or ALT more than 2 times)
* Patient with creatinine \> 2.0 mg/dL
* Pregnant women and women of childbearing potential who intend to have children during the duration of the trial
* Patients who consistently must take drugs affecting lipid levels in blood except the investigational product
Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy

Impact of Intraoperative Spraying methylene blue In thyroidectomy

General anaesthesia ,supine position with hyperextension to the neck Low collar incision to the neck , incision to the skin and platysma muscle and fascia ,upper and lower flaps are developed ,separation of strap muscles and identification of the thyroid gland after freeing of investing fascia Ligation of the middle thyroid vein and ligation and separation of the superior pedicle away from the external laryngeal nerve At this point of operation and before ligation of inferior pedicle, methylene blue 0.05% spraying is applied to the field the amount varies according to size of the thyroid lobe and variation in population and neck size Thyroid gland stained by bluish color , recurrent laryngeal nerve not stained or minimally stained so we can avoid injury to it parathyroid glands get red of the stain after about 3 minutes so we can avoid injury to it thyroid gland lose its stain in about 15 minutes so we can remove any residual and decrease residual tissue or recurrence

Eligibility Criteria:
Inclusion Criteria:

* Both sexes
* Age more than 15 years
* All pathologies need surgery eg. (mutinodular goiter, malignancy , thyroid nodule,.....etc
* Total thyroidectomy

Exclusion Criteria:

* Pregnant females
* Previous neck surgery or recurrent thyroid surgery
* Subtotal or partial thyroidectomy
* Age less than 15 years
* Preoperative affection to vocal cord
* Preoperative hypocalcaemia
Institut Paoli Calmettes Lymphoma Database

Database of Institut Paoli-Calmettes patients diagnosed with lymphoma


Eligibility Criteria:
Inclusion Criteria:

* Hodgkin or non-hodgkin lymphoma

Exclusion Criteria:

* Non applicable
A Brief Marijuana Intervention for Adolescent Women - 1

The purpose of this study is to examine the efficacy of a brief motivational intervention on marijuana use and sex-risk behavior in young women.

This study holds the promise of developing a brief, efficacious intervention to reduce marijuana use and related sexual risk-taking behavior among the large populaton of late adolescent women who are regular marijuana users. In the abscence of intervention, these women are at heightened risk of contracting HIV and other sexually transmitted infections. Therefore it is crucial to develop an intervention that will reduce their marijuana and subsequent sexual risk taking behavior. The intervention employed in this study represents a novel adaptation of interventions that are well-supported with similar populations. If the current intervention is found to be efficacious, it can be readily integrated into a variety of treatment settings, particularly other primary care settings. In addition, this study will contribute valuable information about the relationship between marijuana use and sexual risk taking behavior and about the mechanisms of change in marijuana use in late adolescent women.

Comparison(s): Participants will be assigned, in this 6 month longitudinal study, to an assessment-only group or an assessment plus intervention group. Those in the intervention group will receive 2 motivational intervention sessions during the first 3 months of their study participation.

Eligibility Criteria:
Inclusion Criteria:

current marijuana use; currently sexually active; able to complete the study procedures in English

Exclusion Criteria:

pregnant; alcohol dependence; drug dependence
AZD8108 SAD/MAD in Healthy Volunteers

This is a randomized, double-blind, placebo-controlled study of single and multiple ascending dosage levels of AZD8108 in healthy volunteers. The study includes an up to 28-day screening period, an in-house period during which AZD8108 or placebo will be administered orally as a solution, and a 4- to 10-day follow-up period after discharge.

In Part 1 of the study (single ascending dose portion), approximately 32 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 4 dosage-level cohorts (AZD8108 or placebo). Within each cohort, 6 subjects will be randomized to receive AZD8108 and 2 subjects will be randomized to receive placebo. Each subject will receive only one dose of either AZD8108 or placebo on Day 1. In Part 2 of the study (multiple ascending dose portion), approximately 24 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 3 dosage-level cohorts. Within each cohort, 6 subjects will be randomized to receive AZD8108 and 2 subjects will be randomized to receive placebo. Each subject will receive twelve doses of either AZD8108 or placebo

Eligibility Criteria:
Inclusion Criteria: Inclusion Criteria: 1. Subjects must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-specific procedures. 2. Men and postmenopausal or surgically sterile women age 18-55 years inclusive. 3. Subjects must have a body mass index (BMI) between 19 and 30, inclusive and weigh between 50kg and 100kg inclusive. 4.Subjects must be fluent in English.

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Exclusion Criteria:1. A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality. 2. A clinically significant abnormality on physical examination, neurological examination, EEG, ECG, vital signs or laboratory evaluations at screen or between screen and dose administration. 3. A history of seizure. 4.A history of head trauma, including closed head injury with loss of consciousness. 5.Any history of suicide attempt or suicidal behavior, or, in the opinion of the investigator, clinically significant risk of suicide or violent behavior. 6. Urine drug screen positive for a drug of abuse 7. A family history of schizophrenia, schizoaffective disorder, or psychosis in first degree relatives.
Study of Applying Acupressure in Low-birth Weight Premature

The purpose of this study is to investigate the effects of acupressure application in very low birth weight premature.

A quasi-experimental study is designed. Sixty premature babies will be recruited by purposed sampling, according to the criteria of very low birth weight (\<1500gm) from a sick baby room in a medical center. The control group only receive routine care in sick baby room unite. The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for 15 days, and continuously recoding the observation and records until discharge. The intervention includes acupressure for 15 minutes each at 10Am, 1Pm and 4Pm.

Eligibility Criteria:
Inclusion Criteria:

* according to the criteria of very low birth weight (\<1500gm) from a sick baby room in a medical center.

Exclusion Criteria:

* Exclusion criteria of very low birth weight (\>1500gm) from a sick baby room in a medical center.
Validation of the Turkish Version of the Pain Sensitivity Questionnaire

The Pain Sensitivity Questionnaire(PSQ) is a self-rating measure for the assessment of pain sensitivity and has been developed by Dr. R. Ruscheweyh in Germany. It consists of 17 items rated from 0, not at all painful to 10, most severe pain imaginable. The validation of the Turkish version of PSQ is needed, in order to measure pain sensitivity among Turkish people.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2
* adult chronic low back pain patients having pain for greater than 3 months

Exclusion Criteria:

* Failed back surgery syndrome,
* Morbid obesity (body mass index, \>40),
* Being a non-Turkish speaker,
* Substance abuse disorder,
* Major psychiatric disorder (eg, severe depression, bipolar disorder, Axis II personality disorder, and schizophrenia).
Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study. (CXL)

The corneal collagen cross linking is currently used in the treatment of keratoconus but this procedure has also a sterilizing non-specific effect on bacteria and fungus. So the corneal cross linking in association with the antibiotic treatment could result in a reduction of the duration of epithelial complete healing of the cornea.


Eligibility Criteria:
Inclusion Criteria:

* Infectious bacterial or fungal keratitis with : size \> 2mm or within the central corneal area ( 3mm of the visual axis ) or with a reaction in anterior chamber.
* Being major responsible.
* Agreement in writing to participate in the study.
* Being affiliated to a national insurance scheme.

Exclusion Criteria:

* Present an infectious keratitis without all the previous criteria.
* Herpes or acanthamoeba keratitis
* preperforated or perforated cornea.

General criteria:

* Pregnant woman.
* Minors(miners).
* Adults under guardianship.
* Patient can not be followed during 3 necessary months.
* French speaking patient.
* Unaffiliated patient in a national insurance scheme.
* HIV infected patients
ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)

The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.


Eligibility Criteria:
Inclusion Criteria:

* Are at least 18 years of age at time of consent
* Have a body mass index (BMI)of 19 to 35 kg/m2 at screening
* Are receiving prescribed opioid medication for the management of chronic, non-cancer pain
* Meet the criteria of OIC
* Agree to use an acceptable method of contraception for the duration of the study

Exclusion Criteria:

* Pregnancy and/or currently breastfeeding
* Clinically significant medical condition or illness (other than the condition for which the pain medication is being prescribed)
* Receiving treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction
* Any gastrointestinal (GI) disorder (other than opioid-induced constipation) or GI structural abnormality known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction
* Use of naloxone, Subutex or Suboxone, Revia, Vivitrol, Relistor, or Entereg starting 15 days before the first study visit following screening until the end of the study
* Participation in a clinical trial of a pharmacological agent within 30 days before screening
Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Coronary Angiography

The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

GEHC has decided not to provide this detail

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a combination of diabetes mellitus (type I or II) and renal impairment, defined as serum creatinine (SCr ) ≥150 µmol/L (1.7 mg/dL) for men and ≥133 µmol/L (1.5 mg/dL) for women or creatinine clearance (CrCl) ≤ 50 mL/min calculated according to Cockroft-Gault formula, referred for coronary angiography with or without PCI.

Exclusion Criteria:

* Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplant will not be included.
Effect of Breathing Circuits on Intraoperative Body Temperature

To evaluate differences in intraoperative body temperature between heated huimid breathing circuit and conventional breathing circuit


Eligibility Criteria:
Inclusion Criteria:

* aged 18-70 years,
* ASA I or II
* patients scheduled for craniotomy under general anesthesia

Exclusion Criteria:

* ASA III or IV
* Duration of anesthesia time less than 4 hours
* emergency operation
Efficacy of Virtual Reality Exercises on Sarcopenia in Patients With Liver Transplantation

This study will be conducted to investigate the effect of virtual reality exercises on hand grip strength, pinch strength, quadriceps muscle strength, exercise capacity, fatigue, and quality of life in patients with liver transplantation.

Liver transplantation (LT) continues to prove to be the best choice for curing patients with end-stage liver disease (ESLD) . Management strategies in peri-transplantation care have significantly improved the outcomes of patients after LT. One of the most challenging tasks of LT is defining which patients are clinically appropriate for this therapy. Evaluating disease severity for patients with ESLD is a serious challenge for liver transplant surgeons, and there is a critical need for better methods of risk stratification. The most common complications involved include ascites, hepatic encephalopathy, and variceal bleeding; however, severe muscle wasting or sarcopenia is the most common and frequently undiagnosed complications that negatively impact survival, quality of life, and response to stressors, such as infections and surgeries. Virtual reality (VR) is an interactive, 3-dimensional computer experience occurring in real time. It allows the users to participate in multisensory and multidimensional virtual environments . It provides the participants with real-time auditory, visual, and proprioception sensory feedback. It also provides a safe virtual exercise environment. sixty patients with liver transplantation will be assigned randomly to two groups; experimental group will receive virtual reality exercise plus traditional therapy for six weeks, control group will receive traditional therapy alone for six weeks

Eligibility Criteria:
Inclusion Criteria:

Sixty patients suffer from sarcopenia with liver transplantation. The age of patients ranges from (18:65) years. All patients must be conscious. Patients suffer from muscle weakness Patients suffer from fatigue Patients with low muscle endurance Patients' cases must be stable to deal with them

Exclusion Criteria:

Patients will be excluded if they have any of the following:

Any sign of acute rejection of the transplanted organ Acute hemorrhage Electrolyte imbalance Physiological instability Sever neurologic complication Sever cardiovascular co-morbidities