cyrilzakka/clinical-trials huggingface dataset:
Intra Uterine Growth Restriction

Intrauterine growth restriction (IUGR) is associated with an increase in perinatal mortality and morbidity, as well as longer-term neurological, cognitive, cardiovascular and endocrine complications. In Europe, about 400,000 pregnancies per year are complicated by IUGR. However, antenatal diagnosis seems insufficient in clinical practice, making it impossible to recognize up to 75% of foetuses with IUGR. At a time when the use of good clinical practice has demonstrated a significant improvement in neonatal survival without severe morbidity, foetuses with IUGR are less likely to receive optimal care. Our hypothesis is that the rate of IUGR diagnosed underestimates the rate of actual IUGR.


Eligibility Criteria:
Inclusion Criteria:

* All birth more than 24 + 0 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant
* from 1st of january 2011 to 31 december 2017.

Exclusion Criteria:

* Infants born out of the hospital and secondarily hospitalized in the hospital Femme-Mère-Enfant .
* Multiple pregnancies,
* children with congenital fetal anomalies
* pregnancies without first trimester ultrasound (to date the pregnancy)
Intensive Care Unit and Secondary and Primary Immune Deficiency

Primary immune deficiencies (PID) are characterized by a failure of the immune system that is not explained by any infectious, neoplastic, or iatrogenic cause. In 2015, more than 300 different inherited rare disorders were described. The occurrence of PID in adult is rare and diagnosis may be supported by the 6 ESID signs for adult. However these warnings signs are based only on expert recommendations and do not include comprehensive symptoms of PIDs. Recurrent infections, more aggressive, are the most common mode of revelation of the PID. Less frequently, autoimmune manifestation, solid tumor, lymphoproliferation tumor, chronic granulomatosis or hemophagocytic lymphohistiocytosis syndrome (HLS) may also revealed a PID. The objective of this study was to evaluate the occurrence of unknown PID in adult admitted in critical care unit and to determinate if the investigation of PID in patients with severe infections or HLS should be routinely performed in MCIU.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65
* Hospitalized in medical intensive care unit for :
* Severe infection without pathogen identification
* Severe infection due to encapsuled pathogen
* Opportunistic infections or unusual pathogen
* Idiopathic hemophagocytic syndrome

Exclusion Criteria:

* primary immunodeficiency already known
* secondary immunodeficiency already known (HIV, cancer, immunosuppressive or immunomodulatory treatment, nephrotic syndrome, protein-losing enteropathy, severe malnutrition before admission, cirrhosis with hepatic failure, sickle cell disease, splenectomy and moderate chronic renal failure (clearance between 30 and 59 m² min/1.73 ml)
* local-regional factors which can be responsible for infections (history of ear, nose and throat surgery or neurosurgery, history of fracture of the skull base, cystic fibrosis, chronic respiratory insufficient)
Clinical Study of ET019002-T Cell Therapy for Refractory/Relapsed B-Cell Malignancies

This study is to determine the safety, including potential dose limiting toxicities, and efficiency of ET019002-T cells and the duration of in vivo survival of ET019002-T cells in patients with relapsed/refractory B-Cell Malignancies.

ET019002-T cell therapy is a novel chimeric T-cell therapy platform that in preclinical studies, functionally matches the efficacy of CAR-T cells, but dramatically reduces the release of cytokines upon killing of target-positive tumors.The arm of the study is experimental i.v. arm:ET019002-T cells administered by intravenous (IV) infusion.The intervention is ET019002-T cells(Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET019002)-expression construct).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed B cell malignancies including: B-cell Acute Lymphoblastic Leukemia (B-ALL) and B cell lymphomas (DLBCL、FL、MZL、LPL、HCL、CLL、BL、MCL)
* Refractory/Relapsed B cell malignancies:
* Age 6-80 years, male or female
* Nidus could be evaluated: minimum diameter of single nidus ≥10mm, and/or tumor cells in bone marrow ≥ 5%
* ECOG≤2 points
* Function of main organs or tissues were functional: Liver - ALT/AST≤3 normal upper limit, Serum total bilirubin (TBIL) ≤2 normal upper limit; Kidney - glomerular filtration rate (GFR) \> 60 mL/min/1.73 m2 or serum creatinine in normal range; Lunge - carbon monoxide diffusion capacity (DLCO) or forced expiratory volume in 1s (FEV) \>45% estimate; Heart - left ventricular ejection fraction (LVEF) ≥50%
* Expecting life span ≥3 months
* No chemotherapy, radiation therapy or immunotherapy in 2 weeks before enrollment
* Fertile females/males consented to use contraceptives during participation of the trial
* Patient or his/her custodia could understand and is willing to sign the written consent

Exclusion Criteria:

* Pregnancy or lactation
* Couldn't use contraceptives during participation of the trial
* Couldn't collect enough monocyte
* Active and/or severe infection
* HIV infection, active Hepatitis B or Hepatitis C infection
* Had active autoimmune disease
* Had non-melanoma skin carcinoma (NMSC) or Carcinoma in situ (e.g. cervix, bladder, galactophore)
* Obvious clinical encephalopathy or novel neuron function damage
* Organ failure: Heart - upper than NYHA level III or had uncontrolled malignant arrhythmia; Liver - upper than level III of Wuhan conference classification; Kidney - kidney failure stage3 or worse
* Using immunosuppressive drugs or adreno-cortical hormone (ACH) within two weeks of enrollment
* Insufficient T cell number or T cell transfection rate
* Needed urgent disease controlling due to tumor load
* Patients had biological treatment, immunotherapy or radiation therapy within 6 weeks prior to enrollment or are currently under these treatment
* Substance abuse or drug addiction
* lack of compliance, communication deficit or other unaccommodated situations
Relationship Between Communication and Gross Motor Function in Quadriparetic Cerebral Palsy

Communication problems are frequently encountered in quadriparetic cerebral palsy. Additionally, motor impairments often accompany this condition. Communication problems can also reduce the benefits gained from treatments, which in turn negatively affects individuals functional independence as motor impairments persist. In this study, the researchers aimed to examine the relationship between communication function, gross motor function and functional independence level.

This study is an observational study conducted with data obtained from assessment scales and does not involve any treatment. The target population of the study consists of individuals diagnosed with quadriparetic cerebral palsy (QCP). Individuals with QCP aged 0-17 years were included in the study. Detailed medical histories were taken from the participants, and they were evaluated using the Communication Function Classification System (CFCS), the Pediatric Functional Independence Measure (WeeFIM), and the Gross Motor Function Measure-88 (GMFM-88). The aim of this study is to examine the effect of communication function on gross motor function and independence.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 0-17,
* Diagnosed with quadriparetic cerebral palsy,
* Participants and parents willing to participate in the study voluntarily.

Exclusion Criteria:

* Having different types of cerebral palsy such as dyskinetic, ataxic and mixed type,
* Having spastic diparetic or hemiparetic type cerebral palsy,
* Having any history of surgery on the musculoskeletal system,
* Having received Botulinum Toxin injections in the last 6 months
A Study of Naltrexone SR/ Bupropion SR in Overweight or Obese Subjects With Major Depression

The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in the treatment of major depression in overweight or obese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Female and male subjects must be 18 to 65 years of age;
* Have body mass index (BMI) greater or equal to 27 and less than or to equal 43kg/m2;
* Meet criteria for major depression
* Women of child-bearing potential, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug;
* Able to comply with all required study procedures and schedule;
* Able to speak and read English;
* Willing and able to give written informed consent

Exclusion Criteria:

* Obesity of known endocrine origin
* Serious medical condition
* History of drug or alcohol abuse or dependence
* Use of excluded concomitant medications
* History of surgical or device (e.g. gastric banding) intervention for obesity;
* History or predisposition to seizures
* Pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug;
* Planned surgical procedure that can impact the conduct of the study;
* Use of investigational drug, device or procedure within 30 days prior to Screening;
* Participation in any previous clinical trial conducted by Orexigen Therapeutics;
* Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
Better Arterial Cannulation Technique With Different Hemodynamics

Purpose Two techniques of radial artery cannulation, ultrasound guided (USG) and conventional method (CM) were compared to find the better technique in general and in different hemodynamic subsets of patients.

Method This is a prospective randomized, single center study of 100 patients. The details of the primary cannulation technique, number of attempts, time taken, failure and cross-over technique were recorded for three different hemodynamic subsets with Systolic blood pressure \<80 mm hg, 80-100 mm hg and \> 100 mm hg.


Eligibility Criteria:
Inclusion Criteria:

* All adult Patients worthy of radial artery cannulation, who consented

Exclusion Criteria:

* No consent
A Randomized Trial of Exparel vs Saline in Opioid Reduction of Pain Management Following Lumbar Spine Surgeries.

The purpose of this study is to establish a relationship between liposomal bupivacaine surgical site injection and postop opioid utilization.

Multiple studies have shown that people who are taking opioids for acute pain have a greater likelihood of long-term opioid use. Many efforts have been made to reduce postop pain and opioid use, including developments in incisional site injections of local anesthetics, continuous incisional site anesthetic pain pumps, as well as multimodal comprehensive pain management, yet patients undergoing lumbar spine surgeries continue to depend on opioids for relief. Liposomal bupivacaine (LB) (Exparel) is a novel formulation of long-acting bupivacaine, lasting for up to 72 hours following injection. LB has been shown to be efficacious in reducing postop pain and opioid utilization in several different surgical settings, however its utility in spine surgeries has still yet to be established. The goal of this study is to determine the efficacy of liposomal bupivacaine vs saline in lumbar spine surgeries in reducing opioid utilization as well as determine if there difference patient reported outcomes and length of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing isolated lumbar spine procedures using a posterior approach.
* Surgical spine procedures include:
* Single-level lumbar spine surgeries with or without fusion
* Multi-level lumbar spine surgeries with or without fusion

Exclusion Criteria:

* Procedures involving intrathecal space
* Patients with documented allergy to local anesthetics (bupivacaine, lidocaine, procaine, benzocaine).
* Acute lumbar trauma that requires immediate spine stabilization
* Revision of failed back surgeries (including nonunion and malunion)
* Revision of wound or hardware
* Contraindication to regional anesthesia
* Patients with chronic use of opioid medications
* Liver dysfunction (INR \> 1.5, albumin \<2.8g/dl, bilirubin \>2mg/dl)
* Renal dysfunction (eGFR \< 60ml/min/1.73m2)
* Severe chronic obstructive pulmonary disease requiring continuous oxygen supplementation
* Unable to give informed consent
* Pregnancy
Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes

This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Ongoing treatment with metformin on a stable dose of ≥1500 mg/day for at least 12 weeks prior to enrolment
* Inadequate glycemic control, defined as HbA1c ≥6.5% and ≤8.5%
* ≥30 years for males
* ≥55 years for females

Exclusion Criteria:

* Type 1 Diabetes
* Body weight change \>5% within 3 months prior to enrolment
* Renal and liver impairment
Psyllium in Pediatric IBS

The goal of this clinical trial is to learn if a fiber (psyllium) can change the way bacteria use fructans (a type of sugar) and whether psyllium can help decrease childhood irritable bowel syndrome (IBS) symptoms when eating fructans. The main questions it aims to answer are:

Aim 1: The effect of psyllium at two doses given with a fructan meal on microbial fructan fermentation (intracolonic pH; H2 gas production; gut microbiome composition; fecal short-chain fatty acids, lactate, glycomics).

Aim 2: Determine the impact of psyllium given with a fructan meal on fructan-induced GI symptoms.

Participants will first be asked to eat a specific diet over two three-day periods to determine if fructans worsen their IBS symptoms. Those with worsening symptoms with fructans will be asked to participate in the second part of the study. This includes two weeks of baseline (no change in diet) and two weeks of eating a specific diet with fructans with either psyllium or glucose. Participants will be asked to complete pain and stool diaries, submit stool specimens, swallow a pill to capture gut acid levels, and give breath samples.


Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 12-17 years meeting pediatric Rome IV criteria for IBS

Exclusion Criteria:

* Children who have had previous bowel surgery, have documented GI disorders (e.g., ulcerative colitis), or a serious chronic medical condition (e.g., diabetes)
* weight and/or height are \&gt; or \&lt; 2 SD for age
* have chronic conditions with GI symptoms (e.g., cystic fibrosis)
* have been on antibiotics or probiotics within 3 months (because of potential alterations to the GI microbiome0
* girls who are pregnant (tested with urine beta-human chorionic gonadotropin at the initial visit)
Surgical or Medical Treatment

This study will test the hypothesis that metabolic bariatric surgery will be more effective at providing durable glycemic control and reduce co-morbidities than intensive medical therapy in youth with type 2 diabetes.

Youth-onset type 2 diabetes (T2D) leads to early dependence on exogenous insulin and progression of T2D co-morbidities, including dyslipidemia, hypertension, non-alcoholic fatty liver disease and diabetic kidney disease. The pathophysiology of T2D in youth differs considerably from adults and current treatment approaches are in-adequate for youth. Thus, exploration of innovative approaches to reduce co-morbidities is critical. Metabolic bariatric surgery (MBS) significantly improves multiple outcomes in adults with T2D. Initial small, uncontrolled studies of Roux-en-Y gastric bypass also suggest beneficial effects in youth with T2D, but definitive studies and understanding of mechanisms in youth-onset T2D are lacking, especially with the now more common form of MBS, vertical sleeve gastrectomy (VSG).

We will test the hypothesis that VSG will be more effective in reducing glycemia and comorbidities than the best currently available medical treatment: advanced medical therapy (AMT), via pancreatic, enterohepatic and/or metabolic changes. To test this hypothesis, 90 adolescents with T2D will be studied to compare the effects of VSG vs. AMT on glycemic control and T2D-associated comorbidities, as well as underlying mechanisms.

Eligibility Criteria:
Inclusion Criteria for the medical or surgical type 2 diabetes groups

* Age 13-19.9 years of age at time of signing the consent
* Type 2 diabetes by the American Diabetes Association criteria
* Negative diabetes-associated antibodies

Exclusion Criteria for the medical or surgical type 2 diabetes groups Known type 1 diabetes, maturity onset diabetes of the young (MODY), or secondary diabetes

* Any chronic oral steroids use within 60 days of enrollment
* Current pancreatotoxic drugs
* Chronic kidney or liver disease (except NAFLD or DKD)
* Pregnancy, breast-feeding or intension of becoming pregnant
* Prior bariatric surgery
* History of malignancy
* Current participation in another clinical trial that may affect study outcomes
* Other conditions, that in the determination of the study investigator, may interfere with study participation
* Inclusion Criteria for the Obese control group
* Age 13-19.9 years of age at time of signing the consent
* Clinical indication to receive bariatric surgery

Exclusion Criteria for the obese control group

* Known diabetes
* Any chronic oral steroids use within 60 days of enrollment
* Current pancreatotoxic drugs
* Chronic kidney or liver disease (except NAFLD or DKD)
* Pregnancy, breast-feeding or intension of becoming pregnant
* Prior bariatric surgery
* History of malignancy
* Current participation in another clinical trial that may affect study outcomes
* Other conditions, that in the determination of the study investigator, may interfere with study participation
Turkish Version of the Cognitive Functioning Self-Assessment Scale

Self-report scales used in the assessment of cognitive functions can serve as an initial screening tool for the general population, aside from specific neuropsychiatric tests, which are more costly and time-consuming. This study is designed to examine the validity and reliability of the Turkish version of the Cognitive Functioning Self-Assessment Scale (CFSS). Permission for the study has been obtained from the developer of the scale, Dr. Maria Antonietta Annunziata. The Turkish translation of the scale will be made, and approval will be obtained from the original author for the final version. Subsequently, the Turkish version of the CFSS, the Hospital Anxiety and Depression Scale, and the Cognitive Failures Questionnaire will be administered to participants. Surveys will be completed either online via Google Forms or in written form. To assess the reliability of the scale, the Turkish version of the CFSS will be re-administered to the same participants 7-14 days later.


Eligibility Criteria:
Inclusion Criteria:

* Individuals over 18 years old

Exclusion Criteria:

* Taking antidepressants
* Having a neurological or psychiatric disease
An Evaluation of Healthy Marriage and Relationship Education Program: Elevate

The purpose of this study is to determine whether the healthy marriage and relationship education program Elevate: Taking Your Relationship to the Next Level results in improved couple, parenting, and co-parenting behaviors that lead to reduced child abuse/neglect potential.

The descriptive study is based on the theory that couples can learn skills through participating in the Elevate curriculum that will help them function better as a couple resulting in improved relationship quality/stability, improved co-parenting skills, improved financial management, and reduced financial stress. As a result of improved relationship skills and better management of stress, couples will then provide more supportive, safe, and stable family environments for children.

Individuals who are eligible (biological and foster parents of children 0-18) and agree to participate in the study will complete surveys at three time points--before participating in Elevate, 4-6 weeks after participating, and 8-10 months after participating in Elevate. The surveys include items related to couple functioning behaviors, relationship quality/stability, parenting/co-parenting skills, and financial management and distress.

Eligibility Criteria:
Inclusion Criteria:

Biological parents of children 0-18 Parents must be in a committed couple relationship

Exclusion Criteria:

Incarceration
Change Clubs for African American Women

African American women have among the highest rates of overweight and obesity and few meet dietary or physical activity guidelines. The investigators seek to develop a new intervention strategy that will help alleviate health disparities, thereby improving quality of life, health care costs, and disease burden. The African American Collaborative Obesity Research Network (AACORN) recommends an eco-social, community-engaged approach to behavior change that is in line with cultural values of interconnectedness and care for others. The purpose of this study is to operationalize the AACORN paradigm to promote improvements in weight status and health through a civic engagement approach. To achieve this, participants will meet in church-based Change Clubs and be led through a 6 month curriculum, which includes both lessons in cardiovascular risk reduction and a civic engagement project. Civic engagement may lead to change in individual health behaviors by increasing self-regulation and self-efficacy. The investigators will measure club members' adherence to the Change Club intervention, defined as average number of sessions attended, retention in the clubs, satisfaction with the Change Club experience and achievement of at least 50% of self-identified benchmarks for community change within 6 months. In addition the investigators will compare anthropometric factors, diet and physical activity behaviors, blood pressure, cardiorespiratory fitness, and psychosocial factors before and after participation in the Change Club intervention.


Eligibility Criteria:
Inclusion Criteria:

* female;
* age 30-70 years;
* self-identified as African American;
* English-speaking;
* BMI ≥25.0;
* currently sedentary (not meeting Physical Activity Guidelines for Americans);
* safe to initiate moderate physical activity per the PAR-Q.

Exclusion Criteria:

* failure to provide informed consent;
* participation in any other lifestyle modification program;
* current use of either prescription or over-the-counter weight loss medications;
* inability to communicate due to severe,
* uncorrectable hearing loss or speech disorder;
* severe visual impairment (if it precludes completion of assessments and/or intervention);
* planning to move outside of area within 6 months;
* pregnancy (since weight loss, the primary outcome, is inadvisable in this population).
Codeine on Pharyngeal and Esophageal Motility

Opioids act on opioid receptors located in the brain as well as in the gastrointestinal (GI) tract to induce changes in motility. A variety of studies have linked chronic opioid use with changes in intestinal and to a lesser extent esophageal motility. Less is known about acute administration effects on distal esophageal motility and LES and even less with respect to proximal esophagus, UES and pharynx. Codeine, an opioid receptor agonist, by acting both centrally as well as in the periphery may induce changes in parts of the GI tract implicated in deglutition. Therefore, to evaluate the hypothesis the researchers will study motility patterns in the pharynx, UES, proximal and distal esophagus and LES in 22 healthy volunteers receiving placebo or codeine (60 mg) in a double-blind randomized cross-over controlled fashion. Motility patterns will be studied using state-of-the-art criteria and analytic tools (Chicago 3.0, AIMPlot analysis).


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged between 18-60 years old
* Written informed consent

Exclusion Criteria:

* No chronic disease/medication
* No GI symptoms
* Not pregnant or breast-feeding
* No history of head/neck surgery
* Not allergic to codeine