cyrilzakka/clinical-trials huggingface dataset:
Preconception Maternal Iodine Status and Offspring Cognitive Function:

Little is known about maternal iodine nutrition before conception and its relation with the child's cognitive function. Using samples and data from the Southampton Women's Survey, iodine measurements from urine collected before the mothers became pregnant will be related to cognitive function measures in the children at age 6-7 years.

Adverse effects of severe maternal iodine deficiency in pregnancy on fetal brain development are well-established, but the effects of mild or moderate deficiency are not well understood. To date, most studies have examined iodine status in pregnancy; less is known about maternal iodine nutrition before conception, and this study aims to address that gap in information

The Southampton Women's Survey (SWS) is a prospective study of mothers and children, established in 1998. A general population sample of 12,583 non-pregnant women, aged 20-34 years resident in Southampton was recruited (1998-2002). All women were visited at home by a research nurse and characterised in detail, including assessments of diet, lifestyle and body composition. Between 1998 and 2007, 3158 of the SWS women became pregnant, and went on to deliver a live singleton infant. These women were followed up in through pregnancy and their children have been assessed in a number of follow-up studies in infancy and childhood. These have included repeated assessments of diet, anthropometry and body composition, as well as detailed functional measurements at specific ages, and are ongoing.

At the 6-7 year assessment, the children's cognitive function was measured and this is the primary outcome.

Spot urine samples were collected from the SWS women at clinic visits following their initial interviews (median 33 (IQR 15-87) days), in the period before conception. The time of day was recorded for each urine collection. Urine samples were split divided into aliquots on the day of collection. They were frozen and stored at -80⁰oC from the date of collection until being thawed and assayed for iodine and creatinine contents in 2016 by the Trace Element Unit, Southampton General NHS Trust Hospital, Southampton, UK.

Eligibility Criteria:
Inclusion Criteria:

* Offspring of women recruited to the Southampton Women's Survey
* Aged 6-7 years at time of measurement

Exclusion Criteria:

* Mother had not provided urine sample before conception of the child
Chimney Trial of Parastomal Hernia Prevention

Chimney trial is designed to compare the effectiveness and safety of specifically designated polyvinylidene fluoride mesh (PVDF, Dynamesh IPST) to controls in a multi center, randomized setting.

The European Hernia Society recommends the use of prophylactic mesh when permanent colostomy is made. The results of previous trials using keyhole technique are partially unsatisfactory. Specifically designed PVDF mesh used in this trial showed promising results in previous small trial.

Chimney trial is designed to compare the effectiveness and safety of mesh group to controls operated with no preventive mesh in parastomal hernia prevention after laparoscopic or robotic-assisted abdominoperineal resection or low Haartman's procedure for rectal adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Rectal adenocarcinoma with curative intent laparoscopic or robotic assisted abdominoperineal resection or low Hartmann´s operation and permanent colostomy
* Patient has a life expectancy of at least 12 months.
* Patient must sign Informed consent before any study procedures and agrees to attend all study visits

Exclusion Criteria:

* Abdominoperineal resection or Hartmann's operation by laparotomy or conversion to laparotomy
* Complication requiring laparotomy during post surgery treatment at surgical ward after APR
* Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 4-5).
* Patients with concurrent or previous malignant tumors within 5 years before study enrollment
* Patients with T4b tumors which impose a multi-organ resection
* Rectal malignancy other than adenocarcinoma
* Patient undergoing emergency procedures
* Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
* Metastatic disease with no possibility of curative surgery
* Pregnant or suspected pregnancy
* Patients living geographically distant and/or unwilling to return for follow-ups or comply with all study requirements
* Active abdominal infection at the time of surgery
* Previous surgery at the colostomy site
* Language barrier or other reasons why informed consent is not possible
Is Low Flow Anaesthesia Feasible?

Although low-flow anaesthesia (LFA) has been described for many years and its benefits are known, its clinical use has been limited. Concerns about the risk of hypoxia contributed to this situation. Although the risk of hypoxia is almost prevented with advanced anaesthesia machines, the use of LFA has not reached the desired levels. However, in recent years, as adverse developments related to climate change have started to affect us all, LFA has started to be on the agenda of anaesthetists again. In this study, our aim is to examine the feasibility of its clinical use in order to popularise the use of LFA.

ASA 1-2 patients who will undergo elective surgery under general anaesthesia in 38 operating rooms of Inonu University Faculty of Medicine will be prospectively recruited for 3 months (May-June-July). Emergency cases, patients under the age of 18 and over 65, laparoscopic surgeries, heart-lung surgeries that may impair oxygenation will not be included in the study.

Inhaler anaesthesia will be administered after anaesthesia induction and tracheal intubation. Fresh gas flow (FGF) will be determined as 1 l/min, MAC=1, FiO2=40% with target controlled automatic gas control mode (AGC). FGF will be decreased to 0.5 l/min 10 minutes after surgical incision, if successful, it will be decreased to 0.3 l/min 10 minutes later and it will be checked whether it is successful. The study will be terminated and FGF will be increased to 1 l/min again.

Demographic data of the patients and FGF levels that can provide FiO2=40% will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery under general anaesthesia

Exclusion Criteria:

* Emergency operations
* Previously diagnosed heart, lung, liver and kidney disease
* Surgeries that may impair oxygenation (laparoscopic, Heart, Lung surgeries)
Study of Anti-CD22 CAR-T Cells Treating Leukemia Children

The investigators will conduct a phase II clinical trial of autologous humanized anti-CD22 chimeric antigen receptor T cells treating refractory or relapsed B acute lymphoblastic leukemia children in Beijing Boren Hospital. The study will be approved by the institutional review board of Beijing Boren Hospital, and informed consent will be obtained in accordance with the Declaration of Helsinki. All these participants will be matched the diagnostic criteria for (r/r) B-ALL according to the WHO classiﬁcation and complete morphological evaluation, immunophenotype analysis by flow cytometry (FCM), cytogenetic analysis by routine G-banding karyotype analysis and leukemia fusion gene screening by multiplex nested reverse transcriptase-polymerase chain reaction (PCR). Participants will be eligible if they are heavily treated B-ALL who failed from re-induction chemotherapy after relapse or continued MRD+ for more than three months, and had positive CD22 expression on leukemia blasts by FCM (\>95% CD19). After CAR T-cell infusion, clinical outcomes including overall survival (OS), Disease-free survival (DFS), adverse effects and relapse will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed as primary refractory or relapsed B-ALL. All the patients matched the diagnostic criteria of ALL according to the WHO classification and conducted morphological evaluation, immunophenotype analysis by flow cytometry (FCM), cytogenetic analysis by routine G-banding karyotype analysis, screen of 56 leukemia-related fusion genes by multiplex nested reverse transcriptase-polymerase chain reaction (RT-PCR), and quantification of fusion genes by real-time PCR with ABL1 as reference.
* Extramedullary diseases (EMDs) were confirmed CD22+ by FCM and evaluated by positron emission tomography/computed tomography (PET/CT), CT, MRI or ultrasonography.
* The patient relapsed during chemotherapy or failed from re-induction chemotherapy (including first and second-generation TKIs) after relapse or had a persistent positive minimal residual disease (MRD) for three months. Patients had positive CD22 expression on leukemia blasts by FCM (\>95% CD22 positive);
* Age from 0 to 18 years old;
* Children candidates can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form.

Exclusion Criteria:

* Intracranial hypertension or unconscious;
* Acute heart failure or severe arrhythmia;
* Acute respiratory failure;
* Other types of malignant tumors;
* Diffuse intravascular coagulation;
* Serum creatinine and/or blood urea nitrogen over 1.5 times than normal range;
* Sepsis or other uncontrolled infection;
* Uncontrolled diabetes mellitus;
* Severe psychological disorder;
* Obvious cranial lesions with cranial MRI;
* More than 20 counts/ul leukemic cells in cerebrospinal fluid;
* More than 30% leukemic cells in the blood;
* Stage III WHO/ECOG score;
* Organ recipients;
* Pregnant or breastfeeding;
* Active, uncontrolled infection, including hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
Intraperitoneal Mesh With 3cm Overlap Versus a Rives-Stoppa Repair With a 6cm Overlap in Hernia Umbilicalis

To study the advantages and disadvantages of a Ventralex prothesis versus Light Weight Vypro II prothesis in patients with a hernia umbilicalis.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic hernia umbilicalis
* \> 18 years old

Exclusion Criteria:

-
Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation - Effects on Physical Function

Critically ill, ventilator-treated patients rapidly loose much of their muscle mass and strength. This can attribute to prolonged admission, prolonged mechanical ventilation, increased mortality and might have a negative impact on the physical function, degree of independence and quality of life. The pathophysiological background for the loss of muscle mass as well as possible effective treatment is still not well established. In the NONSEDA-trial we randomise critically ill patients to non-sedation or sedation with a daily wake-up trial during mechanical ventilation in the intensive care unit (ICU). It has never been assessed whether non-sedation reduces the loss of muscle mass and strength.

Aim: To assess the effects of non-sedation versus sedation with a daily wake-up trial on physical function after discharge from ICU.

Hypothesis: that non-sedation during ventilator-treatment will improve the physical function after ICU-discharge, compared with standard treatment of sedation with a daily wake-up.


Eligibility Criteria:
Inclusion Criteria:

* Endotracheally intubated
* Expected time on ventilator \> 24 hours
* Age ≥ 18 years
* Informed consent

Exclusion Criteria:

* Severe head trauma where therapeutic coma is indicated
* Therapeutic hypothermia where therapeutic coma is indicated
* Status epilepticus where therapeutic coma is indicated
* Patient has participated in the study before
* Patient is transferred from another ICU with length of stay \> 48 hours
* Patient is comatose at admission
* PaO2/FiO2 ≤ 9, if sedation is necessary for oxygenation
H&N Cancer; Survivorship and Late Effects

A cross-sectional study on late effects after modern treatment in long-term survivors of head and neck cancer (HNC). Participants fill in questionnaires and participate at a one day visit at the hospital including blood sample with biomarkers, clinical examination, audiometry, oral radiological examination and oral examination. Data on patients' medical history collected from medical records including radiology images and digital radiotherapy plans.This will allow adjustments of treatment planning and improved treatment decisions for patients at risk, and improve information and follow up for future patients.

The purpose of this study is to provide knowledge on late effects and mortality risk after modern treatment in long-term survivors of head and neck cancer (HNC). This will allow adjustments of treatment planning and improved treatment decisions for patients at risk, and improve information and follow up for future patients. For head and neck cancer (HNC) survivors of today, with the rising proportion of HPV induced cancer and with improved modern treatment, the late effects and mortality risk has changed compared to survivors previous decades.

The investigators will assess the prevalence and severity of a broad range of late effects and identify associated risk factors for the following late effects;

* Chronic fatigue
* Hearing loss and tinnitus
* Oral late effects, including taste and smell disturbances and osteoradionecrosis
* Dysphagia and malnutrition
* Body image, intimacy and endocrine dysfunction

In addition,possible biological explanatory mechanisms for fatigue and possibly other selected late effects will be explored. Data will be compared to age and gender matched reference data for those where this is available.

Design: a cross-sectional study

Assessments: Patient-reported questionnaires, blood sample with biomarkers, clinical examination, audiometry, oral radiological examination and oral examination. Data on patients' medical history collected from medical records including radiology images and digital radiotherapy plans.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically verified invasive carcinoma of the head and neck region; ICD10: C01, C02.0 - C02.9; C03.0 - C03.9; C04.0 - C04.9; C05.0 - C05.9; C06.0 - C06.9; C07; C08.0 - C08.9; C09.0 - C09.9; C10.0 - C10.9; C11.0 - C11.9; C12; C13.0 - C13.9; C14.0 - C14.9; C30; C31.0 - C31.9; C32.0 - C32.9, C77.0
* Diagnosed 2006- 2012
* Ability to understand and respond to the questionnaires
* Ability to attend the clinical examination
* Informed consent received

Exclusion Criteria:

* Unwillingness to answer HRQL questionnaires
* Patients under ongoing treatment for secondary cancer or relapse at the time of the survey
The Effect of the Position Given to the Child After Weaning from Noninvasive Mechanical Ventilation on Physiological Symptoms

The aim of this clinical trial was to investigate the effect of the position given to children after weaning from noninvasive mechanical ventilation on the physiological symptoms (heart rate, oxygen saturation, respiratory rate and blood pressure) of children aged six months to six years in the Pediatric Intensive Care Unit.


Eligibility Criteria:
Inclusion Criteria:

* Between 6 months and 6 years of age
* Being monitored for respiratory diseases
* Weaning from noninvasive mechanical ventilation during the research process
* Body temperature within the normal range (36 centigrade-37,5 centigrade)
* Verbal and written consent to participate in the study given by their parents

Exclusion Criteria:

* Congenital anomaly
* Surgical intervention that prevents supine/prone positioning
* Development of pneumothorax during research
* Hypoxia during the research
IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

The goal of this clinical trial is to determine whether an upfront invasive strategy of TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy with surveillance for deterioration in patients with uncomplicated type B aortic dissection.

The study will be a prospective, pragmatic, randomized clinical trial of the comparative effectiveness of an initial strategy for the treatment of uncomplicated type B aortic dissection (uTBAD). Patients with uTBAD and no prior history of aortic intervention will be randomized within 48 hours to 6 weeks after index admission to one of the two initial strategies. Follow-up will be ascertained via a centralized call center and ascertainment of medical records, as well as remote blood pressure monitoring. Recommendations regarding medical therapy will be made to enrolling centers and feedback on the quality of medical care given, however, all subsequent care, with the exception of aortic interventions, will be at the discretion of the responsible clinical care team. Aortic interventions will allowable only as per protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 21 years
2. Stanford type B aortic dissection not involving the aorta at or proximal to the innominate artery, without rupture and/or malperfusion (renal, mesenteric, or extremity)
3. Acuity: within 48 hours - 6 weeks of index admission
4. Ability to provide written informed consent and comply with the protocol
5. Investigator believes anatomy is suitable for TEVAR

Exclusion Criteria:

1. Ongoing systemic infection
2. Pregnant or planning to become pregnant in the next 3 months
3. Life expectancy related to non-aortic conditions \< 2 years
4. Unwilling or unable to comply with all study procedures including serial imaging follow-up
5. Known patient history of genetic aortopathy
6. Penetrating Aortic Ulcer and Intramural hematoma
7. Iatrogenic (traumatic) aortic dissection
8. Prior surgery for aortic dissection
Effects of Cognitive Training on Children With Attention Deficit Hyperactivity Disorder

Using a single blind, randomized controlled design to study the additional therapeutic effects of cognitive training on traditional rehabilitation programs for children with attention deficit hyperactivity disorder and developmental delays.

A total of 30 children with attention deficit hyperactivity disorder and developmental delays who are receiving traditional rehabilitation programs will be enrolled.

The participants will be randomized into two groups, including study group (traditional rehabilitation program with additional cognitive training: 2 times per week, 15 min per session, a total of 24 sessions) and control group (traditional rehabilitation program without additional cognitive training).

Memory related functions, quality of life, and physical function evaluations will be performed at baseline, 3 months and 6 months later, respectively.

Evaluator will be blinded to the group's classification during the whole course of study.

Eligibility Criteria:
Inclusion Criteria:

* children diagnosed with attention deficit hyperactivity disorder with developmental delay receiving regular rehabilitation programs intelligence quotient 70 or greater

Exclusion Criteria:

* age less than 4 years or elder than 8 years children diagnosed with attention deficit hyperactivity disorder receiving regular rehabilitation programs intelligence quotient less than 70
The Response of the Immune System of Patients With End Stage Kidney Disease on Dialysis and Kidney Transplant Recipients Vaccinated for COVID-19

Observational study of patients with End Stage Kidney Disease on dialysis and Kidney Transplant Recipients, before and after vaccination for SARS-COV 2, after written consent, with the aim of laboratory efficacy of the vaccine and safety regarding the clinical outcome of patients and possible complications.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Covid 19 vaccination

Exclusion Criteria:

* previous covid infection
* recent infection
* chronic infection
* HBV, HCV, HIV
* Active malignancy
Comparing the Efficacy of 10-day Reverse Hybrid Therapy and 10-day Triple Therapy Plus Bismuth Therapy.

Reverse hybrid therapy achieves a higher eradication rate than triple therapy plus bismuth therapy remains unanswered.

With the rising prevalence of antimicrobial resistance, the failure rate of the 7-day standard triple therapy has declined to unacceptable level (\<80%) worldwide. Several regimens were suggested to replace standard triple therapy in the area with high clarithromycin resistance, including sequential therapy, concomitant therapy, hybrid therapy and bismuth containing quadruple therapy. A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving eradication rates of 95%. A clinical trial by Hsu et al from our hospital showed 12-day reverse hybrid therapy also achieved high eradication rate, and improved the compliance of patients. Even prolong the treatment duration of standard triple therapy from 7 days to 12 days, the efficacy of eradication was still \< 90% (85-88%). The limitation of triple therapy in against resistant-stains was still existed. The addition of bismuth (triple therapy plus bismuth) can improve cure rates despite a high prevalence of antimicrobial resistance. The major bismuth effect is to add an additional 30%-40% to the success with resistant infections. However the direct compare the efficacy between 10-day reverse hybrid therapy and 10-day triple therapy plus bismuth is still insufficiency in Taiwan and worldwide. Choosing a navel therapy or a modifying triple therapy can get better efficacy, it is remained to be determined. Besides genotyping polymorphism of CYP2C19 influenced the metabolism of proton pump inhibit, and could cause decreasing of eradication rate of standard triple therapy. But the influence in 10-day reverse hybrid therapy and 10-day triple therapy plus bismuth is unclear.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria:

* previous H pylori-eradication therapy
* ingestion of antibiotics or bismuth within the prior 4 weeks
* patients with allergic history to the medications used
* patients with previous gastric surgery
* the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
* pregnant women
Drug Interaction Study With Rifampicin and Afatinib

The objective of the current study is to investigate the effect of the P-gp inducer rifampicin on the pharmacokinetics (PK) of afatinib in healthy male volunteers


Eligibility Criteria:
Inclusion criteria:

Healthy male volunteers

Exclusion criteria:

Any relevant deviations from healthy conditions