cyrilzakka/clinical-trials huggingface dataset:
Effects of Iron Supplementation on Pediatric Vaccine Response

ID/IDA affects many young children in Africa. Vaccines provide tremendous benefits in LMIC; however, they currently fail to reach their full potential. We need to better understand the causes of vaccine failure, in order to develop new strategies to improve vaccine immunogenicity.

This study will contribute to children's health by: (1) providing updated guidelines to better define the prevalence of ID/IDA in early infancy, and its safe and effective control using iron; and (2) providing a new approach to improve response to pediatric vaccines in LMIC, by ensuring adequate iron status at time of vaccination.

Two major pediatric public health goals in LMIC are increasing immunization effectiveness and reducing ID/IDA in children. ID/IDA affects many young children in Africa. Current guidelines do not recommend routine testing of hemoglobin in early infancy, as it is generally believed that most infants are born with adequate iron stores to last 6 months. However, many African infants are born with low iron stores and ID/IDA may develop earlier than generally appreciated, within 2-3 months after birth. Vaccines provide tremendous benefits in LMIC; however, they currently fail to reach their full potential. We need to better understand the causes of vaccine failure, in order to develop new strategies to improve vaccine immunogenicity. Despite lower efficacy in LMIC, these vaccines provide a major benefit because the disease burden is so high; however, if approaches can be found to improve immunogenicity, these vaccines would be even more powerful.

For this study, 6 weeks old infants will be randomly assigned to two study groups. Group 1 will receive iron at time of pediatric vaccinations from age 6-24 weeks. Group 2 will receive no iron at time of pediatric vaccinations. All infants will receive a multivitamin syrup from age 6-24 weeks. All infants remaining ID/IDA at age 24 weeks will receive iron. Infants will be followed-up until age 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Mother at least ≥15 years of age.
* 6 weeks (+/- 3 days) of age
* Iron deficient (erythrocyte zinc protoporphyrin (ZnPP) \>61 μmol/mol heme)
* With or without anemia, but not severely anemic (Hb \>70 g/L)
* No malaria
* No medical condition that precludes study involvement
* Mother HIV negative
* Vaginal delivery
* No iron supplementation prior to study enrolment
* Not wasted (length for height z score of ≥-2)
* Not underweight (weight for age z score ≥-2)
* From the hospital record, term or late preterm delivery (≥34 weeks)
* Full-time breastfed at least until the screening
* No vaccines beyond the birth dose of OPV and BCG prior to enrolment
Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma

The purpose of this trial was to evaluate efficacy and safety of adding Rituximab to dose-dense and High-Dose Chemotherapy (HDC) with Autologous Stem Cell Transplantation (ASCT) as first line treatment in young patients with DLBCL at Intermediate-High and High risk aaIPI score


Eligibility Criteria:
Inclusion Criteria:

* previously untreated aggressive B-cell lymphoma (Diffuse Large B-Cell,
* Primary Mediastinal,
* Follicular grade III b Lymphoma);
* age 18 to 60;
* III-IV Ann Arbor stage;
* 0-2 Eastern Cooperative Oncology Group (ECOG) performance status (PS);
* intermediate-high (IH) and high (H) risk score according to age-adjusted International Prognostic Index (IPI).
* Patients with Primary Mediastinal Lymphoma were included only if they had advanced stage III or IV disease.

Exclusion Criteria:

* HIV,
* hepatitis B or C virus seropositivity;
* CNS involvement at diagnosis;
* abnormal renal, pulmonary and hepatic function;
* left ventricular ejection fraction less than 45%;
* pregnancy.
Interaction Research on Cognitive Impairment and Emotional Disorder in End-stage Renal Disease

End stage renal disease (ESRD) is the last stage (stage 5) of chronic kidney disease (CKD). Abnormalities of cognitive function and high levels of depression or anxiety incidence are characteristic of hemodialysis patients. In this research project, the investigators subject in ESRD patients starting hemodialysis as the carrier. Based on the longitudinal research design, using multimodal neuroimaging data，combining with the interact relationship between changes of brain morphology, the dysfunction of resting-state and-task state with cognitive impairment and abnormal emotions.Establish brain structure-function change model associated with dialysis progression, Explore imaging markers of central and disease development characteristics in ESRD patients. the investigators attempt to clarify the core mechanism of kidney-brain axis damage, thus provide evidence for early cognitive-behavioral therapy to CKD patient.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-50 years;
2. ESRD patients who will start hemodialysis
3. High quality MRI scan;
4. dextromanual

Exclusion Criteria:

1. Diabetes,Brain tumor,brain trauma
2. Neuropsychiatric disease
N-acetyl-cysteine (NAC) and Kidney Graft Function

The goal of this study is to evaluate the effect of N-acetyl-cysteine (NAC) administration in organ donors on the kidney graft function of recipients.

Ischemia-reperfusion is a major contributing factor for delayed renal function after transplantation. It has been shown that the administration of an antioxidant, i.e. NAC, in patients with chronic renal insufficiency may prevent radio contrast-induced nephropathy. Due to its antioxidant effects, organ donor pretreatment with NAC has demonstrated to improve renal graft function in two experimental studies. Study objectives: to compare the incidence of delayed graft renal function between two groups of patients, i.e., those receiving the graft from organ donors pretreated with NAC and a group control. The primary endpoint was the number of delayed graft function defined as the requirement of at least one sequence of dialysis during the first seven days following transplantation. Secondary endpoints: evolution of creatininemia, azotemia at day 1, 7, 14 and ,30 after surgery; acute and delayed transplant rejection; intrahospital mortality.

Patients inclusion: all organ donors and recipients were eligible Exclusion criteria: for organ donors were preexistent chronic renal insufficiency and contra-indications for kidney procurement; for recipient were transplantation outside our hospital The donors were randomized in a single-blind fashion into two groups : the control group and the group receiving 600 mg IV of NAC 1 hour before and 600 mg IV 2 hours after cerebral arteriography required to diagnose brain death. Sample size has been calculated delayed graft function by 50% leading to include 118 recipients in each group.

Follow up: one year after transplantation. Study beginning in september 2006. Length of inclusion during 36 months.

Eligibility Criteria:
Inclusion Criteria:

* all recipient for kidney graft in our hospital

Exclusion Criteria:

* transplantation out side our hospital
* refusal from the patient
Topical (Intra-Articular) Tranexamic Acid and Transfusion Rates Following Hip Hemiarthroplasty

This study is a double-blinded placebo-controlled clinical trial evaluating the efficacy of 1 gram of topically applied tranexamic acid vs. saline placebo for the reduction of transfusion following hip hemiarthroplasty surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing hip hemiarthroplasty surgery for a displaced femoral neck fracture

Exclusion Criteria:

* History of hemophilia, history of deep vein thrombosis, history of pulmonary embolism, history of thrombophilia, history of chronic renal failure
* Patients with coronary ischemia (active or within the past calendar year), patients who have suffered a myocardial infarction, undergone percutaneous coronary intervention, undergone coronary artery bypass grafting, or undergone any revascularization procedure within the past calendar year
* Patients with active subarachnoid hemorrhage, acquired defective color vision, patients who sustained a pathologic fracture (fracture through a neoplastic lesion), or patients who are pregnant
* Patients with a known allergy to tranexamic acid
* Patients taking Warfarin, Dabigatran, Rivaroxaban, Apixaban, and Fresh Frozen Plasma
Use of Ritual Epost Postnatal Multivitamins During the Postpartum Period

Multivitamin/multimineral supplements (MVI) provide important nutrition supplement to the diet of pregnant women to cover potential deficiencies and optimize nutrition status of both mom and baby, especially when the diet is suboptimal or nutrient demand is high while absorption is hindered by various factors such as genetic variance and gastrointestinal function. It is, however, largely unknown whether using an MVI during the lactating period helps improve nutrition status of mom and baby. In this double-blind, randomized, controlled trial, the investigators will recruit 7- postpartum women who exclusively breastfeed at week 5 postpartum and randomly assign them to either receive the Ritual MVI which is commercially available or a blank placebo for 10 weeks. A blank placebo is appropriate because there is currently no recommendation or scientific consensus that lactating women who are healthy and eat a normal diet would have improved nutrition status or maternal-infant health outcomes from a nutrition supplement. The investigators will collect blood and breastmilk samples at baseline and end of the study to assess nutrient status. The investigators hypothesize that consumption of a Ritual MVI leads to better nutrition status and biomarkers in maternal-child dyads compared to control.


Eligibility Criteria:
Inclusion Criteria:

* Women are qualified to participate if they are over 10 years of age, having singleton pregnancy, and are exclusively breast feeding and intending to exclusively breast feed for at least 10 more weeks.

Exclusion Criteria:

* Exclusion criteria include diabetes, cardiovascular conditions and liver disease prior to and during pregnancy because these diseases affect metabolism of several nutrients and thus may lead to differences in the MVI intake and nutrient status relationship.
Cocaine Use Disorder and Cortical Dopamine

The goal of this study is to use \[C-11\]FLB 457 and amphetamine (oral, 0.5 mg/kg) to measure cortical dopamine transmission in cocaine dependent individuals and healthy controls

This study seeks to examine dopamine (DA) transmission in vivo, using positron emission tomography (PET) with \[C-11\]FLB 457, in cortical regions of interest in subjects who have a history of cocaine dependence. We hypothesize that cocaine dependence is associated with decreases in dopamine in the prefrontal cortical regions compared to controls. This may explain the impulsivity and cognitive deficits that underlie relapse in this disorder.

Eligibility Criteria:
Subjects with Cocaine Dependence INCLUSION CRITERIA

1. Males or Females 18-40
2. Fulfill Diagnostic and Statistical Manual (DSM-IV) Diagnosis for Cocaine Dependence
3. Medically Healthy MAJOR EXCLUSIONS

1. Major medical, psychiatric, co-morbid drug \& alcohol use disorders 2. Pregnancy or lactation, 3. Contraindications to MRI 4. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year 5. Family History of a psychotic illness or manic episode in first-degree relatives

Healthy Subjects INCLUSION CRITERIA

1. Males or Females 18-40
2. Absence of present or past psychiatric conditions (including alcohol or drug dependence)
3. A negative urine drug screen
4. Medically Healthy

MAJOR EXCLUSIONS

1. Any medical, psychiatric, co-morbid drug \& alcohol use disorders
2. Pregnancy or lactation,
3. Contraindications to MRI
4. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
5. Family History of a psychotic illness or manic episode, or drug and alcohol Abuse/Dependence in first-degree relatives
Development of a Predictive Score for Local Complications of Femoral Bifurcation Surgery

No prospective study has yet evaluated the factors influencing the complications of femoral bifurcation surgery in France. Daily practice of investigators suggests that conventional surgical treatment has had a higher rate of local complications in recent years for a variety of reasons that remain to be assessed (aging, overweight, chronic renal failure, diabetes, or other), but as of yet, investigators do not have proof of such an effect. The proposed study would follow a prospective, continuous, multicentre cohort of patients to describe the type, frequency and factors that contribute to local and general complications of surgery on the femoral bifurcation. This information is essential in the choice of the best revascularization technique for the femoral artery, which is frequently the site used for interventions in vascular conditions.

Surgeries will be performed in the normal manner. The research will be based on medical data collected during patient management. A measurement of the incision/scar will be taken once the procedure has been performed, either immediately after surgery or after a period of time, during post-operative consultation. Participation in this research will last 3 months from the day of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patient who has not opposed participation in the study
* Age \> 18 years old
* All patients with an open surgical approach to the common femoral artery and/or femoral bifurcation, uni or bilateral, with or without endovascular or open procedure

Exclusion Criteria:

* Patient with homolateral surgery of the femoral triangle which has not yet healed
* Person subject to court-ordered protection (curatorship, guardianship)
* Pregnant, parturient or breastfeeding woman
* Adult unable to consent
* Patient who refuses to participate in the study
Genetic Variation in Organic Cation Transport 1 (OCT1) and Its Significance for Morphine Pharmacokinetics

The main objective of the trial is to investigate the effect of known genetic variants in organic cation transporter 1 (OCT1) on the effect of morphine after major surgery

The purpose of the experiment is to investigate the effect of known genetic variants in organic cation transporter 1 (OCT1) on the effect of morphine after major surgery. This is primarily done by investigating systemic exposure of morphine in a cohort of patients undergoing scheduled laparoscopic colon or laparoscopic rectum surgery, and as pain treatment with intravenous (iv) morphine at the end of and after surgery (primary endpoints). As a secondary endpoint, we will investigate the effect (pharmacodynamics) of morphine in the same patients by registering pain during rest and activity, side effects and the degree of sedation at appropriate time intervals.

Eligibility Criteria:
Inclusion Criteria:

* Planned Colectomy / Hemicolectomy, sigmoid resection, rectal resection or abdominal perianal amputation of the rectum with stoma, good general health (ASA 1 -2), Informed consent given, Age 18-90 years and BMI 18,5 - 35kg/m².

Exclusion Criteria:

* Abdominoperineal resection (APR) - ad modum Holm (abdominal perianal amputation of rectum with stoma)
* Daily use of opioids
* Indicator for the use of an epidural catheter
* Alcohol abuse
* Hypersensitivity for morphine
* A known serious disease (Terminal cancer, severe dementia, significant heart, liver, lung or renal failure or severe psychiatric disease)
* Women of childbearing age who do not use safe contraception
* Women who are breastfeeding
* Pregnant women
Text Education About Cardiovascular Health and HIV (TEACH-HIV)

The overall objective is to evaluate the efficacy of educational text messages to reduce cardiovascular risk among persons living with HIV (PLWH).


Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* At least 40 years of age
* English-speaking

Exclusion Criteria:

* Existing clinical atherosclerotic cardiovascular disease (ASCVD)
* Pregnant
* Unwilling/unable to provide informed consent
* Does not own a smartphone
Adsorbtion of Cytokines Early in Septic Shock: the ACESS Study

The aim of the study is to investigate the effect of CytoSorb® treatment within the first 48 hours of septic shock on organ dysfunction, microcirculation and on the cytokine storm as monitored by leukocyte activation and inflammatory mediators.


Eligibility Criteria:
Inclusion Criteria:

* Signs of hypoperfusion: serum lactate \>2 mmol/L, low central venous oxygen saturation (ScvO2) (\<70%) or high ScvO2 (\>85%), metabolic acidosis, oligo-anuria, high venous-to-arterial CO2-gap (dCO2 \>6 mm Hg)
* Hemodynamic support with vasopressors
* Procalcitonin level ≥ 3 ng/ml
* Invasive hemodynamic monitoring
* Written informed content

Exclusion Criteria:

* Patients under 18 years
* Pregnancy (bHCG test positivity)
* Surgical intervention in context with the septic insult
* New York Heart Association IV heart failure
* Acute coronary syndrome
* Need for acute or chronic hemodialysis
* Acute haematological malignancies
* Cardiogenic shock
* Post cardiopulmonary resuscitation care
* Immunosuppression, systemic steroid therapy (\>10mg prednisolon/day)
* Human immunodeficiency virus infection (HIV) and active AIDS
* Patients with donated organs
* Thrombocytopenia (\<20.000/ml)
* More than 10%-of body surface area with third degree burn
Enhancing Empathy in Medical Communication Through Perspective-Taking

Background: Empathy is critical to clinician-patient communication and patient outcomes. Perspective-taking, an intervention demonstrated in other contexts to induce empathy, has never been studied in a medical context. As a first step in evaluating its potential clinical value, the studies described below assess perspective taking in a series of clinical skills examinations. These examinations are simulated clinical encounters: students encounter and are evaluated by standardized patients (SPs)--actors trained to take on patient roles. Though not real clinical encounters, clinical skills examinations have been demonstrated to test clinical competency well enough to be incorporated into the licensure examination of the National Board of Medical Examiners.

Objective: To assess if perspective-taking improves the satisfaction of standardized patients in three clinical skills examinations.

Hypothesis: Students receiving a perspective taking intervention will receive better standardized patient satisfaction scores than control students.

Design and Setting: Three randomized, controlled studies. Studies 1 and 3: Junior medical students(N = 503), 6-station clinical skills examination. Study 2: physician assistant students (N = 105), 3-station clinical skills examination.

Intervention: The intervention students received a perspective-taking instruction prior to their examination asking them to put themselves in their "patients" shoes and to imagine what they were thinking and feeling. The control students received standard pre-examination instructions. Simulated patients were blind to study condition. Main Outcome Measure: Simulated patient satisfaction scores.

These studies assess the interaction of students and simulated patients (actors)--no real patients were involved.

Eligibility Criteria:
Inclusion Criteria:

* All third year medical and first and second year physician assistant students, George Washington University School of Medicine and Health Sciences

Exclusion Criteria:

* None
Imaging of Facial Neuritis

Improved means of positive diagnosis of facial neuritis, the leading cause of peripheral facial palsy


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Subject giving their consent for their participation
* Patients with neuritis facial (neuritis group) who benefited, between 2009 and 2016, from an MRI of the internal auditory ducts, with gadolinous product injection and on the MRI 3 Tesla
* Patients with a perception deafness, without neuritis sign (control group) who also benefited from an MRI with gadolinous product injection on the MRI 3T with the same protocol.

Exclusion Criteria:

- Refusal to participate in the study
Detection of Loco-regional Invasion of Cervical Cancer With 7 Tesla MRI

Background of the study: The accurate assessment of local cervical cancer spread (i.e. invasion) is of clinical importance for staging and treatment considerations. For example, if parametrial invasion is absent, radical surgery is the treatment of choice for tumors less than 4cm in diameter. However, if such invasion is present, the patient has become inoperable and (chemo)radiotherapy is warranted. Unfortunately, regular 1.5T MRI as a part of staging work-up has a limited accuracy for detecting loco-regional tumor invasion. Due to relatively frequent false-negative findings a risk of understaging and under-treatment occurs. For such cases adjuvant treatments with (chemo)radiotherapy are indicated after the initial surgery, causing increased morbidity and treatment associated risks. For higher stages, with primary (chemo)radiotherapy, a more reliable MRI based delineation of local tumor spread could enable individualized dose(volume) and field modifications.

Hypothesis/aim of the study: To develop and in vivo optimize T2w ultra high field (7T) MRI sequences, which use a combination of an endorectal and external coil, to image the (para)cervical area for assessment of the loco-regional tumor status in cervical cancer.

Study design: The proposed study is an investigator initiated, single center, prospective pilotstudy.

Study population: 20 patients with histological proven cervical cancer stage IB1, IB2, IIA of IIB will be included.

Primary study parameters/outcome of the study: Optimized T2w ultra high field (7T) MRI sequences of the (para)cervical area which allow qualitative assessment of the loco-regional invasion of cervical cancer.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven primary malignancy of the cervix uteri;
* FIGO stage IB1, IB2, IIA or IIB;
* ≥18 years;
* Written inform consent provided.

Exclusion Criteria:

* Contra-indications for MRI: Any non-removable electronic or ferromagnetic object present in the body; Pregnancy; Severe claustrophobia; Unable to lie still and completely horizontal for minimally 45 minutes;
* Body weight \>150kg;
* Any type of neo-adjuvant chemo- and/or radiotherapy for cervical cancer;
* Uterine prolapse with C ≥ -6 cm (POP-Q).
Study of Remimazolam Tosilate in Patients Undergoing Colonoscopy

The purpose of this study is to evaluate the safety and efficacy of the sedation for Remimazolam or Propofol in patients undergoing colonoscopy.

This is a multi-center, parallel-group, single blind study using Remimazolam or propofol for sedation in patients undergoing colonoscopy.Subjects are randomized to different treatment groups (including 1 for Remimazolam Tosilate and 1 for propofol). Fentanyl are permitted before colonoscopy. Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* subjects aged 18-65 years；
* intending to undergo colonoscopy;
* ASA( American Society of Anesthesiologists) I or II；
* 18 kg/m²\<BMI(Body Mass Index)\<30 kg/m²;
* the operation time of gastroscopy is not more than 30 min；
* Signed informed consent.

Exclusion Criteria:

Patients need to be Complicated colonoscopy;

* Patients need to be Tracheal intubation;
* Patients with respiratory management difficulties (Modified Mallampati grade IV）;
* one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
* A history of drug abuse and / or alcohol abuse 2 years prior to the screening period；
* allergic to drugs used in the study;
* pregnant women or those in lactation period
* The subject has participated in other clinical trial within the 3 months prior to randomization.