cyrilzakka/clinical-trials huggingface dataset:
Dexamethasone for Post Cesarean Delivery Analgesia

The purpose of this study is to assess the effectiveness intravenous (IV) dexamethasone when used as part of a multimodal regimen to manage post cesarean delivery pain.

We hypothesize that a single dose of IV dexamethasone administered, as part of a multimodal analgesia after spinal anesthesia will significantly reduce post cesarean delivery opioid consumption and pain

After the subjects consent to participate in the study they will be transferred to the operating room for their scheduled cesarean delivery. They will have their routine spinal anesthesia with the dosages of drugs used standardized, and a standardized regimen to manage hypotension. After delivery of the baby the subjects will be administered either the study drug or placebo depending on the randomization. The subjects will then be prescribed a standard post-operative analgesia regimen. The subjects will then be interviewed at 12,24 and 48 hours post cesarean delivery. During the interview the subjects will be asked to rate their pain, nausea and vomiting and pruritus. They will also be asked to rate their quality of recovery from the surgery using Quality of Recovery-40 questionnaire. The subjects will be contacted 6 months after the study to rate their pain using a Short-Form McGill Pain Questionnaire

Eligibility Criteria:
Inclusion Criteria:

* English Speaking
* Non-laboring women
* Scheduled Elective Cesarean section under spinal anesthesia
* American Society of Anesthesiologists I-II physical status

Exclusion Criteria:

* Contraindications to spinal anesthesia
* allergy to study medication
* patients with allergy to morphine
* patients with uncontrolled hypertension
* history of peptic ulcer disease
* liver cirrhosis
* diabetes mellitus
* glaucoma
* known IV drug abusers
* patients with chronic pain or on long term opioids
* patients administered steroids in the past week
* women with fetuses having known congenital abnormalities
* psychiatric illness such that they are unable to comprehend or participate in study questions
* patients on antiviral medications or live virus vaccines would also be excluded.
A Study of Imatinib and Valproic Acid in Patients With Chronic Myelogenous Leukemia (CML)

The aim of this study is to test the effect of the combination of valproate in combination with imatinib with an aim of achieving a maximal molecular response as the primary goal.

The aim of this study is to test the effect of the combination of valproate in combination with imatinib with an aim of achieving a maximal molecular response as the primary goal. Briefly, patients with CML who are taking imatinib and have been found to have a plateau in their level of the bcr-abl transcript will be eligible to participate in the study. Valproate will then be added to the imatinib, and subsequent bcr-abl transcripts will be monitored to see if the addition of valproate produced a further reduction. Patients will be monitored for efficacy and toxicity.

Eligibility Criteria:
Inclusion Criteria:

* All patients, 18 years of age or older, with a diagnosis of CML.
* Patients must have a life expectancy of at least 12 weeks.
* Patients must have an ECOG performance status of 0-2.
* Patients must sign an informed consent.
* Patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and SGOT or SGPT \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 1.5 x upper limit of normal.
* Patients with CML in chronic phase on imatinib as first line therapy who fulfill the following criteria:
* The patient has at least two tests for quantitative reverse transcriptase polymerase chain reaction (RT-PCR) for bcr-abl (peripheral blood or bone marrow aspirate). The results of these tests should demonstrate a relative plateau in the effect of imatinib on the detected level of the transcript (i.e. there should less than a ½ log difference between the last two values). Note: Patients will be eligible if the more recent study is greater than the previous study by any value.
* The last two quantitative RT-PCR studies should be at least 3 months apart.
* The patient should have received at least 9 months of imatinib since the diagnosis of CML.
* The patient is tolerating imatinib without any grade 3 or greater toxicity.

Exclusion Criteria:

* Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
* Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
* Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
* Patients who have a hypersensitivity to valproic acid, derivatives, or any component of the formulation. Patients with hepatic disease or significant impairment, or urea cycle disorders
Decitabine Plus mBU/CY for High Risk Acute Leukemia With MRD Pre-HSCT

Allogeneic haematopoietic stem cell transplantation (allo-HSCT) remains one of the currently available curative therapies for acute leukemia (AL). Leukemia relapse is one of the mainly causes of transplant failure. We reported previously that patients with high-risk molecular biomarkers who still have detectable minimal residual disease(MRD) pre-HSCT were at very high risk of relapse, with cumulative relapse rate of 50-80%. Decitabine has been demonstrated efficacy in the treatment of patients with recurrent or refractory leukemia and myelodysplastiv syndrome. It was reported that the combination of decitabine, with busufan and cyclophosphamide as a preparative regimen for allo-HSCT using HLA-matching donors was safe and effective. In this prospective, single-arm clinical trial, we aimed to examine the efficacy of combining decitabine with modified busulfan and cyclophosphamide (mBU/CY) as a preparative regimen for allo-HSCT in patients with very high-risk AL and detectable MRD pre-HSCT.

Patients enrolled in this study would receive decitabine 200mg·m-2·d-1 on day -12 and -11 pre-HSCT. The conditioning therapy for human leukocyte antigen (HLA)-mismatched HSCT patients was modified BU/CY plus ATG (thymoglobulin; Sang Stat, France) consisting of cytarabine (Ara-C 4 g·m-2·d-1) intravenously on days -10 to -9, busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, cyclophosphamide (CY 1.8 g·m-2·d-1), intravenously on days -5 to -4, semustine (Me-CCNU, 250 mg·m-2), orally once on day -3, and ATG (2.5 mg·kg-1·d-1) intravenously on days -5 to -2. In matched sibling transplantations, patients received hydroxycarbamide (80 mg·kg-1) orally on day -10 and a lower dose of Ara-C (2 g·m-2·d-1) on day -9, but otherwise an identical regimen to the HLA-mismatched patients without ATG.

BM samples from patients were obtained to assess leukemia status after HSCT. The time points that we monitored BM samples included at time of allo-HSCT; 1 month, 2 months, 3 months, 4.5 months, 6 months, 9 months, and 12 months after allo-HSCT; and every 6 months thereafter to the defined endpoints or for at least until 5 years after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* acute leukemia patients with MLL-r,TLS-ERG,or SIL-TAL1,whose minimal residual disease were detectable pre-HSCT

Exclusion Criteria:

* pregnancy women
* uncontrolled severe infection
Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery

Patients who underwent major gastrointestinal surgery is potentially at risk of malnutrition due to reduced oral intake, increased nutritional need, reduced gastrointestinal absorption function, and/or metabolic changes after surgery. The postoperative malnutrition is associated with low quality of life and seems to be related long-term nutritional status. This study is a multicenter, open-labeled prospective randomized clinical trial to examine the effect of postoperative oral nutritional supplements (ONS) after major gastrointestinal surgery by comparing the change of body weight and other nutritional parameters between the experiment group that is supplied with ONS and the control group without ONS.


Eligibility Criteria:
Inclusion Criteria:

* Male or female who are 20 or more years old and not more than 80 years old
* Discharge from a hospital is planned within 2 weeks after major gastrointestinal surgery (except when ileostomy is performed)
* oral intake is possible at the time of discharge
* no preoperative chemotherapy or preoperative radiotherapy
* voluntarily agreed with the informed consent of this clinical trial

Exclusion Criteria:

* Intravenous or other specific nutritional treatment is needed
* BMI \>25 and postoperative weight loss is not \> 5% of preoperative body weight at the time of discharge
* Allergy to milk, whey, bean, salmon, or the investigational product
* Residual of cancer in the abdominal cavity postoperatively if it is cancer case
* Presence of synchronous other cancers that needs treatment.
* When investigator judged that the patient is not eligible to the trial
Trama-Code (Two Analgesics-comparative Study)

Double-blind randomized study to compare the efficacy of two analgesic drugs(Ixprim®, Dafalgan-Codeine®) in the emergency unit.

The efficacy (relief of pain) would be assessed 2 hours after administration of one of the two drugs in a patient presented to the emergency unit with a moderate pain (4 to 6 on pain assessment score).


Eligibility Criteria:
Inclusion Criteria:

* Patients of 18 - 75 years of age
* Presented to the emergency unit of FOCH hospital
* Complaining of moderate pain (4-6 on pain assessment scale) evaluated by the reception nurse

Exclusion Criteria:

* Patient already had received another type 2 analgesia or already received one of the study drugs in the last 4 hours
* pregnant or lactating females
* Patient with one or more contraindication to one of the study drugs
* Patients for whom the pain assessment scale can not be performed (unconscious, confused ...)
* Patient cannot be included for legal reasons
* Patient required urgent management
* Patient for whom it is considered difficult to be reassessed 2 hours later
* Patient unable to swallow
Plasmatic Catecholamines: Randomized Controlled Trial Comparing Epidural Versus Combined Spinal-epidural

Combined spinal-epidural (CSE) for labor analgesia has been associated with fetal bradycardia and uterine hypertonia, possibly due to asymmetric decrease in catecholamine levels, when compared with epidural analgesia (EP).

Background: Combined spinal-epidural technique for labor analgesia has been associated with fetal bradycardia and uterine hypertonia, when compared with epidural analgesia, possibly due to asymmetric decrease in catecholamine levels (epinephrine and norepinephrine) following neuraxial block. However, there are no studies comparing plasmatic catecholamine levels between those two techniques. This study aimed to compare spinal-epidural versus epidural regarding pre and post-analgesia catecholamine levels, uterine tone and fetal heart rate.

Methods: Randomized clinical trial with 47 laboring patients divided in two groups. Primary outcome was plasmatic catecholamine measurements before and after neuraxial block. Secondary outcomes were fetal heart rate changes, uterine hypertonia, hypotension episodes, pain relief and fetal outcomes.

Eligibility Criteria:
Inclusion Criteria:

Parturients aged over 18 years were included when they requested labor analgesia. The inclusion criteria were: patients between 37 and 42 gestational weeks, single pregnancy, in active labor (induced or spontaneous), requesting analgesia with 7 cm or less of cervical dilation. As it is a center that attends only high-risk pregnancies, ASA II or III

Exclusion Criteria:

Contraindications to interventions, either due to severe comorbidity or contraindication to neuraxial block; previous use of systemic opioids during labor, maternal amniotic infection or known fetal diseases
Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp

The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an hyperglycemic clamp

Assignment: Each study subject will serve as their own control. The order of the visits will be randomized.

Delivery of Interventions:

Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.

During the inpatient study, the subjects will

Undergo a 16-hour kisspeptin infusion Undergo a hyperglycemic clamp

Eligibility Criteria:
* over the age of 17
* normal pubertal development
* regular menstrual cycles
* stable weight for previous three months
* normal body mass index
* blood pressure systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg
* normal hemoglobin
* hemoglobin A1C \< 6.5%
* BUN, creatinine not elevated
* AST, ALT \< 3x upper limit of normal
* negative serum pregnancy test

Exclusion Criteria:

* active illicit drug use,
* history of a medication reaction requiring emergency medical care,
* difficulty with blood draws.
* history of hypertension, diabetes, heart disease, high cholesterol, cancer, or clotting disorders.
* history of chronic disease that has required hospitalization
* recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug) unless it is birth control
* history of diabetes in a first degree relative
* hyperlipidemia by fasting lipid panel
FoodImage 3 Free-Living

Participants will be asked to use the app to capture data on food purchases, food waste that occurs during food preparation, food waste that is present after eating, and food waste from cabinet and refrigerator/freezer clean-outs. During collection of much of the food waste data, participants will record in the app if food waste will be disposed of via composting, disposal, fed to pets, or garbage/landfill. They will also indicate if the food was spoiled, past the expiration date, etc. This will occur for 4-8 days. Participants should perform the prep and eat occasions 4-8 days. The shopping and toss occasions should be completed for at least 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female, age 18-65 years
* Willing to be recontacted
* Conducts some of the food shopping, food purchasing, and/or food preparation for their household.
* Internet and/or Wi-Fi availability to complete surveys and send images.
* Ownership of an iPhone 9S or later, operable Apple ID, password, and email address that they are willing and able to use to collect data during the study. Subject acknowledges data usage and associated charges are a result of study.
* Willing to complete all study procedures and adhere to study visit timelines -

Exclusion Criteria:

* Refusal or unable to use an iPhone for study related purposes.
* Not willing to adhere to study procedures and study visit timelines.
* PBRC employee
* Any condition or circumstance that in the judgement of the PI could interfere with study participation
Genetics of Uveitis

In order to improve the investigators knowledge about uveitis and the underlying mechanism of disease, the investigators propose collecting blood from patients with uveitis, isolating DNA and sequencing the DNA to identify genetic mutations or associations in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Any patient above with the diagnosis of uveitis.
* Any patient with a diagnosis of infectious uveitis such as toxoplasmosis retinochoroiditis, herpes associated retinitis.

Exclusion Criteria:

* Patients who are unable to give consent
* Patients in whom an adequated blood sample can not be obtained.
Impact of Genetic Polymorphism on Propofol Requirement and Recovery for Total Intravenous Anesthesia for Clipping of Unruptured Cerebral Aneurysm in Korean Population

In neurosurgical anesthesia, propofol based total intravenous anesthesia (TIVA) is frequently used due to brain relaxation and less effect on electrophysiologic monitoring. Response to propofol can vary between individuals and be associated with clinical factors including age and weight, and genetic polymorphism. Because the importance of rapid recovery in neurosurgery with long operation time is emphasized recently, the choice and dose adjustment of anesthetics should be determined according to clinical and genetic factors. Recently, researches about genetic variations have been performed with single nucleotide polymorphism (SNP). The aim of this study is to determine SNPs associated with propofol recovery and response in Korean adult population undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm.


Eligibility Criteria:
Inclusion Criteria:

1. Korean adult population undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm

Exclusion Criteria:

1. patients not able to read, or understand the consent form
2. ethnicity, other than Korean population
3. patients refusal
4. patients not to perform total intravenous anesthesia
Diagnosis of Adenoid Cystic Carcinoma on 68Ga-PSMA-617 PET-CT and Therapy With 177Lu-EB-PSMA-617

Adenoid cystic carcinoma (ACC) accounts for 24% of salivary gland malignant tumors, is characterized by frequent local recurrences and distant metastasis, mainly to lungs. Considering its origination from salivary glands, an organ with intense physiological uptake of 68Ga-PSMA-617, this study aims to evaluate 68Ga-PSMA-617 uptake in local recurrent or metastatic ACC in comparison with 18F-FDG uptake in the same patients, and assess the feasibility of 177Lu-EB-PSMA-617 treatment in patients with the advanced ACC.

Adenoid cystic carcinoma (ACC) is a rare tumor entity with a yearly incidence of 3-5 cases per million. ACC arises in the major salivary glands and more often in the minor salivary glands of the oropharynx, lip, nasopharynx, oral cavity, nasal cavity, paranasal sinus, larynx and tracheobronchial tree. ACC is characterized by frequent local recurrences and distant metastasis, mainly to lungs. 18F-FDG PET/CT is considered to be a viable tool to assess ACC at initial presentation. However, FDG uptake in ACC is lower than in squamous cell carcinoma (SCC) and not all ACC lesions show detectable FDG uptake. So, it is necessary to find another effective way to detect ACC and its metastases. As in known, PSMA is highly expressed in salivary glands, and Wim van Boxtel et al had demonstrated high PSMA-ligand uptake in a patient with recurrent and metastatic ACC using 68Ga-PSMA PET/CT. 68Ga-PSMA has been developed as a targeting imaging agent widely used in prostate cancer in prostate cancer. Thus, this prospective study is going to investigate whether 68Ga-PSMA PET/CT may be superior for diagnosis, therapy response assessment and follow-up of ACC than 18F-FDG PET/CT. Furthermore, peptide receptor radionuclide therapy has been widely used in the treatment of prostate cancer lesions that showed high PSMA uptake on 68Ga-PSMA PET/CT, we'll try to assess the safety and therapeutic response to 177Lu-EB-PSMA-617 in patients with ACC.

Eligibility Criteria:
Inclusion Criteria:

* confirmed treated or untreated adenoid cystic carcinoma patients;
* 18F-FDG PET/CT within two weeks;
* signed written consent.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* known allergy against PSMA
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Analysis of the Glutathione Cycle in Children With Rett Syndrome

Analyis of the Glutathione Cycle in Children with Rett Syndrome

To analyze the levels of glutathione and relevant glutathione metabolites in children with Rett syndrome in an effort to better understand disease pathology and biochemistry.

Eligibility Criteria:
Inclusion Criteria:

* Age between 2 and 10, inclusive
* Genetically-confirmed diagnosis of Rett syndrome with MeCP2 mutation
* No change in dietary supplements in three months prior to the initial blood draw
* No participation in interventional pharmaceutical clinical trials in prior 12 months

Exclusion Criteria:

* None other than meeting Inclusion criteria
TA-8995: Its Use in Patients With Mild Dyslipidaemia (TULIP)

The primary objective of this study is to evaluate the efficacy of different doses of TA-8995, a cholesteryl ester transfer protein (CETP) inhibitor, on the elevation of high-density lipoprotein cholesterol (HDL-C) and reduction of low-density lipoprotein cholesterol (LDL-C), alone and in combination with statin therapy.

The secondary objectives of this study are to determine the safety and tolerability of TA-8995 in patients with mild dyslipidaemia.


Eligibility Criteria:
Inclusion Criteria:

* Fasting LDL-C levels \>2.5 mmol/L and \<4.5 mmol/L, HDL-C levels \<1.8 mmol/L and \>0.8 mmol/L, and TG levels \<4.5 mmol/L after run in or washout of existing therapies
* Not on lipid-altering therapy at screening or on lipid-altering treatment regimens at screening

Exclusion Criteria:

* Body mass index \>32 kg/m2;
* Participation in another clinical study involving an investigational or marketed drug within 30 days prior to enrolment (Visit 2);
* Any clinical manifestation of atherosclerotic vascular disease;
* Diagnosis of type 1 diabetes;
* Uncontrolled type 2 diabetes: haemoglobin A1c \>8%;
* Uncontrolled hypertension: sitting systolic blood pressure \>160 mmHg and/or sitting diastolic blood pressure \>90 mmHg;
* History of hyperaldosteronism;
* Active muscle disease or persistent creatine kinase concentration \>3 × the upper limit of normal (ULN). One retest will be allowed after 1 week to verify the result;
A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis

This study is intended to find out whether treatment with rosiglitazone improves the state of the liver and related blood markers in patients with nonalcoholic steatohepatitis (NASH).

Phase one : A double blind randomized placebo controlled trial of rosiglitazone

* 64 pts with biopsy proven NASH will be randomized to receive either rosiglitazone 8 mg/day or placebo for one year.
* after one year of treatment patients will undergo a liver biopsy then a 4 month follow off treatment

Primary endpoint: improvement of at least 30% of the histological score of steatosis Secondary endpoints: improvement in ALT values, in necrosis and inflammation and fibrosis

Phase II extension open label trial

All participants to the phase one regardless of the drug received in the first year will be treated with rosiglitazone for 2 additional years. A liver biopsy will be performed at the end of these two additional years in order to find out whether prolonged rosiglitazone therapy further results in improvement of liver injury in NASH patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven NASH with steatosis \>= 20%
* Increased serum ALT

Exclusion Criteria:

* bland steatosis
* daily alcohol \> 20/30 g (women/men)
* any other cause of liver disease
* secondary NASH including drug-induced steatohepatitis
* treatment with insulin or glitazones
* cardiac insufficiency
* Hb \< 10 g/dl