cyrilzakka/clinical-trials huggingface dataset:
Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy

It is hypothesized that food allergy is preceded by atopic dermatitis (AD), due to a disruption of skin barrier which can predispose one to food sensitization through the skin. The central hypothesis is that increased transepidermal water loss (TEWL) assessment and skin tape strip analysis (STS) of lipid and filaggrin breakdown products will be predictive markers for the development of AD. Additionally, the associated changes in TEWL and STS will further improve the identification of infants at risk of early food sensitization, compared to family history alone.


Eligibility Criteria:
Inclusion Criteria:

* Women with physician confirmed pregnancy at a gestational age of ≥ 34 weeks. Infants at high risk for atopy will have one or both parents affected by an allergic disease. Infants at low risk for atopy will have no parent or sibling affected by allergic disease. Biologic parent(s) of infants at high risk of atopy will also be enrolled in the study.

Exclusion Criteria:

* Pregnancy loss or delivery prior to a gestational age of ≥ 34 weeks, a history of substance or alcohol abuse, psychiatric and developmental co-morbidities that would render a subject unable to provide informed consent or perform study-related procedures, AIDS and HIV infection, or a fetus with chromosomal or congenital abnormalities.
Pooled Analysis of Methodologically Harmonized Pragmatic Randomized Trials of High-Dose vs. Standard-Dose Influenza Vaccine Against Severe Clinical Outcomes

This prespecified analysis will pool the datasets from two pragmatic randomized trials evaluating the relative vaccine effectiveness of high-dose vs. standard-dose influenza vaccine against severe clinical outcomes: the DANFLU-2 (A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults) trial and the GALFLU (Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Adults Aged 65 to 79 Years in Galicia, Spain) trial. The purpose of the pooled analysis is to ensure adequate statistical power for evaluating relative vaccine effectiveness against severe clinical outcomes and to increase generalizability of the results by combining data from two countries.


Eligibility Criteria:
Inclusion Criteria:

* Pragmatic trials conducted to estimate the relative vaccine effectiveness of high-dose influenza vaccine compared with standard-dose influenza vaccine using the DANFLU-2 protocol or a protocol developed based on the DANFLU-2 protocol

Exclusion Criteria:

* Low data quality
* Influenza circulation threshold was not met in any of the study seasons
* Severe under-enrollment in all seasons
Study of the Role of G72 in Amyotrophic Lateral Sclerosis: Biomarker Discovery and Mechanism Investigation

G72 gene is located on the common linkage locus in bipolar disorder and schizophrenia, and it encodes D-amino acid oxidase activator (DAOA). There are evidences that elucidated G72 and D-amino acid oxidase(DAO) together playing a critical role in the pathophysiology of schizophrenia. Recently, reports discovered missense mutations in the DAO (R199W DAO and R38H DAO) are associated with familial amyotrophic lateral sclerosis (FALS), and our preliminary data showed that the level of G72 autoantibody decreases in patients with ALS compared with normal control. Thus, we want to find out whether G72 plays a role in ALS and neurodegenerative diseases including Alzheimer disease and Parkinson's disease. First, we detect G72 protein and its autoantibody in sera of neurodegenerative diseases patients using ELISA and Western blotting, and the data are compared with normal control. We hypothesize the levels of G72 protein and its autoantibody in neurodegenerative diseases are less than those in normal control. Then, we extract genomic DNA of neurodegenerative diseases patients, and use polymerase chain reaction(PCR) to detect single nucleotide polymorphism (SNP) of G72. We aim to detect G72 missense SNP variants presented in ALS, AD and PD.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Alzheimer's Disease, Parkinson's disease and amyotrophic lateral sclerosis

Exclusion Criteria:

-
Clinical Trial to Assess the Safety and Efficacy of Intravenous Administration of Allogeneic Adult Mesenchymal Stem Cells of Expanded Adipose Tissue in Patients With Severe Pneumonia Due to COVID-19

Phase I/II clinical trial to evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Stem Cells Expanded in patients with severe COVID-19 pneumonia


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. Clinical diagnosis of Pneumonia, severe or critical, caused by COVID-19 infection
3. Life expectancy \> 48 hours.
4. Commitment to use a contraceptive method of proven efficacy in both men and women during the duration of the clinical trial.

Exclusion Criteria:

1. Coinfection with other viruses or bacteria (HIV, tuberculosis, influenza virus, adenovirus or other respiratory infections, active infection by HBV or C).
2. History of multiple allergies, including allergy to Penicillin or other Blactams.
3. Pregnant and lactating women.
4. Patients with malignant tumors or hemopathies or any state of immunosuppression considered as severe.
5. Patients with autoimmune diseases.
6. Chronic heart failure with ejection fraction less than 30%.
7. Any other condition for which, in the opinion of the main investigator, the subject is considered not to be in compliance with the study.
Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel

Since polyacrylamide hydrogel (PAAG) was used in cosmetic surgery in 1997, about 30 million women have received PAAG injection for breast augmentation. Although the use of PAAG has been prohibited in most countries due to its myriad complications, a large number of symptomatic patients and asymptomatic patients have continued to seek medical advice. The strategy of repairing secondary breast deformities after PAAG removal has increasingly become a concern for both doctors and patients, but there is no standardized algorithm yet. The purpose of the present study was to perform a retrospective study to compare the safety and effectiveness of different reconstruction timing and method after removing the gel.

The primary purposes of this study are to:

1. Compare the safety and effectiveness of IBR vs DBR after PAAG removal;
2. Compare the safety and effectiveness of breast implants with silicone gel prosthesis vs autologous fat transplantation after PAAG removal;
3. Evaluate the clinical characteristics associated with and rates of complications based on reconstruction timing and type.

The secondary purposes of this study are to：

1. Explore and summarize the characteristics of long-term complications of PAAG injection for breast augmentation;
2. Compare the rate of postoperative complications and reoperations between the patients who had breast reconstruction with implants and patients who had primary breast augmentation with implants.
3. Further refine the algorithm for breast reconstruction in patients with PAAG injections.

Eligibility Criteria:
Inclusion Criteria:

1. history of PAAG breast injection;
2. appeal to remove the gel;
3. availability of complete medical records;
4. accepting the potential complications of the operation and breast deformity after gel removal.
5. agreeing with medical history data collection, clinical follow-up investigation, and independent Complete the questionnaire.

Exclusion Criteria:

1. Patients who had other breast diseases;
2. Patients who failed to follow the standard diagnosis, treatment and follow-up;
3. Lost to follow-up due to various reasons or incomplete medical records;
4. Patients with cognitive disorders such as mental illness, understanding, memory, or orientation, and other serious diseases.
Video Education Intervention in the Emergency Department

The purpose of this study is to evaluate if an educational video viewed during the Emergency Department visit will improve parent knowledge of pain management, reduce parent anxiety, and change their use of analgesics at-home after discharge from the Emergency Department.

This study will investigate the use of a video instruction for parents just prior to discharge on pain treatment for their child. The investigators plan to investigate the effect of the video on knowledge because educational modules in the form of videotapes have been shown to be an effective method to improve a parent's knowledge about pain management prior to surgical procedures. Because parental anxiety has a significant impact on a child's experience of pain and video education has been shown to reduce parent anxiety before a procedure, the investigators will also evaluate if parental anxiety is reduced. Whether or not a short video will change the behavior of parents or their satisfaction with the outcome at home has not been investigated and will be an exploratory hypothesis for this study. This research will be a first step towards optimizing the outpatient care for common diagnoses in the Emergency Department.

Eligibility Criteria:
Inclusion Criteria:

* complaint of pain or injury and laceration, fracture or spring, contusion, crush injuries, head injury, motor vehicle collision, or burn.

Exclusion Criteria:

* non- English speaking parents
* primary caregiver not with child in Emergency Department
The Strategy of Implementation of the ERAS Protocol After Esophageal Surgery

Application of the perioperative enhanced recovery protocol has allowed to carry out esophagectomy to the patients with severe comorbidities and has led reducing the risks of severe postoperative complications.

The clinical trial included the parients who participated in the protocol ERAS since 2011, who uderwent esophagectomy with simultaneous reconstruction. The parients had benign or malignant esophageal diseases. The ERAS protocol consisted of components of perioperative recovery. The number of patients until now has reached 400 patients. During trial there was modifications of aspects of ERAS protocol such as a rejection of nasogastric tube or cervical drenage. The role of multidisplinary team is the main success of the result of the implemented ERAS protocol.

Eligibility Criteria:
Inclusion Criteria:

* all patients with esophageal diseases

Exclusion Criteria:

* before 18 years old
* who do not need surgery as a treatment
* who not underwent simultaneous recontruction
Sickle-cell Disease Registry of the GPOH

Sickle cell disease is one of the most common hereditary diseases. Most severe complications can be avoided if the disease is detected early and treated appropriately.

The sickle cell disease registry of the Society for Paediatric Oncology/Haematology aims at describing the epidemiology of sickle cell disease in German-speaking central Europe. Patients with sickle cell disease will be characterized clinically and genetically and treatment will be documented with the aim to find predictors of the course of disease.

In addition, the registry results should provide a solid evidence base to incorporate sickle cell disease into routine newborn screening and to update the national guidelines for the management of patients suffering from sickle cell disease in Germany.

A consortium of five university hospitals (Berlin, Frankfurt, Hamburg, Heidelberg, Ulm) has been mandated by the Society for Paediatric Oncology/Haematology to implement this registry.

The number of participating centers is constantly increasing and new centers that take care of either pediatric or adult patients with sickle cell disease are encouraged to support the registry.

For further information please refer to: http://www.sichelzellkrankheit.info/


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* current residency in either Germany, Austria or Switzerland
* sickle cell disease confirmed by hemoglobin analysis or molecular genetic analysis

  * Homozygous sickle cell disease (HbSS)
  * HbSC disease
  * Sickle cell disease HbS / bThal
  * Other, rare sickle cell syndromes such as HbS/OArab, HbS/HPFH, HbS/E, HbS/D Punjab, HbS/C Harlem, HbC/S Antilles, HbS/Quebec-CHORI, HbA/S Oman, HbA/Jamaica Plain

Exclusion Criteria:

- isolated heterozygous trait for HbS
Upper Extremity Force-velocity Profile in Swimmers

The aim of this study was to measure the changes in the upper extremity force-velocity profile of young swimmers at different training periods during a training season

Tested at each experimental test time point (Baseline: E1, post-general preparation: E2, post-specific E3 and post-competition season: E4). To measure the upper extremity force-velocity parameters, the countermovement push-up test was performed using the force plate

Eligibility Criteria:
Inclusion Criteria:

* 15-18 age
* go to training regularly

Exclusion Criteria:

* upper extremity surgery in the last 1 year
* pain during the tests
Improved Outcomes Associated With Inositol Dietary Supplementation in Women With Gestational Diabetes Mellitus

Objective: Insulin resistance during normal pregnancy and in gestational diabetes mellitus (GDM) are unknown. New criteria are based on fasting glucose levels since the beginning of pregnancy. Inositol, a putative second messenger of insulin, correlates with the degree of insulin resistance. Dietary supplementation of inositol improves insulin resistance in patients with GDM.

Methods: A randomized double-blind study was carried out in women with GDM. Patients were randomly exposed to inositol and placebo. Increase of BMI, blood glucose at 75 grams oral glucose tolerance test (OGTT), fetal and neonatal adverse outcome, and insulin treatment were correlated to inositol exposure.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnant women
* random fasting glucose above 92 mg%

Exclusion Criteria:

* BMI \>30
* random fasting glucose above 126 mg%
Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children

The aim of this study is to compare the efficacy, tolerability, acceptance and compliance of a PEG-only formulation compared to a reference PEG-EL formulation in resolving faecal impaction and in the treatment of chronic constipation

Constipation is a very common complaint in childhood. Inadequate daily fiber intake, insufficient fluid intake, and withholding behavior are considered as factors leading to constipation.

Painful defecation is considered a common trigger to faecal retention wich leads to reabsorption of fluids and increase in the size and consistency of stools.

It is often necessary to use laxative therapy to achieve comfortable defecation. PEG-based laxatives are considered today the gold standard for treatment of constipation in children. PEG formulations differ for composition in inactive ingredients which may have an impact on acceptance, compliance and adherence to treatment.

Eligibility Criteria:
Inclusion Criteria:

* out-patients children with diagnosis of functional constipation or have faecal impaction on medical history and physical examination

Exclusion Criteria:

* children with organic causes for defecation disorders, such as Hirschsprung disease, spina bifid, hypothyroidism, or other metabolic or renal abnormalities;
* Children receiving medication influencing gastrointestinal motility;
* Children with suspected gastrointestinal obstruction or stenosis
Recovery After Fast Track THA / TKA

The development and implementation of "fast-track" principles in total knee and hip arthroplasty have resulted in early recovery and rehabilitation alongside a reduced length of hospital stay. This without a concomitant increase in morbidity or readmissions for medical or surgical complications and with reduced mortality. However, only little is known about function in the subacute period after arthroplasty, and there is a need for further data on physical and psychological functioning following discharge from hospital.This to ensure, that the positive results from the perioperative setting are carried forward in the subacute phase.

Data will be published in three papers:

1. "Physical function and related factors following discharge from THA and TKA" Luna IE, Kehlet H, Aasvang EK.
2. "Postoperative hypoxemia following fast-track hip and knee arthroplasty" Luna IE, Kehlet H, Aasvang EK.
3. "Cognitive dysfunction after fast-track hip- and knee arthroplasty - prevalence and related factors". Luna IE, Kehlet H, Aasvang EK.

Eligibility Criteria:
Inclusion Criteria:

* Primary total hip or knee arthroplasty
* Age 55 to 80 years

Exclusion Criteria:

* Deficient written or spoken danish
* Alcohol abuse (\>21 U per week)
* Immunocompromised
* Anticoagulant therapy
* ASA class 4-5
* Functional impairment from psychological or neurological disease
* Sleepapnea
Comparison Between Partial Nephrectomy and Ablation for Renal Tumor

The therapeutic effectiveness of ultrasound guided cooled-probe microwave ablation and laparoscopic partial nephrectomy on T1a renal cell carcinoma is compared to find a better approach for renal tumor.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the RCC of ≤4 cm maximum diameter were included in the study.

Exclusion Criteria:

* Patients having RCCs with vascular invasion, extrarenal spread or with benign renal tumors were excluded.
Haploidentical Transplant With NK Cell Infusion for Pediatric Acute Leukemia and Solid Tumors

This study will assess the feasibility of utilizing a reduced intensity conditioning regimen, in the setting of haploidentical transplantation, for patients with recurrent acute lymphoblastic leukemia (ALL), AML and high risk or refractory solid tumors. In addition, the feasibility and safety of administering post-transplant NK cell infusions will be evaluated. Data obtained from this study will help determine the efficacy of allogeneic HSCT in the treatment of pediatric sarcomas and add to the small body of literature utilizing haploidentical HSCT to treat acute leukemia in pediatric patients. This study will also further elucidate the role of NK cells in mediating a graft vs. tumor effect in allogeneic HSCT. The main benefit to society is that this study will explore a novel therapy for children with highly refractory cancer who are felt to be incurable with conventional approaches. If feasibility is demonstrated, and there is evidence of anti-tumor activity, then this will open up a new area of clinical research to better define the efficacy of this approach for specific childhood malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Solid tumors that have failed auto transplant or are ineligible to receive auto transplant
* Relapsed AML in 1st relapse or 2nd or 3rd CR
* Relapsed ALL if they fail to attain an initial remission or if they relapse within 1 year following the discontinuation of chemotherapy.
* Greater than or equal to 6 months and \<26 years old
* Suitable haploidentical donor available

Exclusion Criteria:

* Leukemia with \>25% blasts in bone marrow at the time of admission to the HSCT unit.
* Serum bilirubin \>3 mg/dl
* GFR \<40 ml/min/1.73 mw
* Cardiac left ventricular ejection fraction \<40%
* HIV+
* Pregnant
Partnerships to Address COVID-19 Inequities

This study evaluates the impact of an intervention to increase COVID-19 prevention behaviors, including COVID-19 testing. The intervention will be developed through a crowdsourcing contest.

a. The surge of COVID-19 cases has been accompanied by glaring racial disparities in COVID-19-related morbidity and mortality; disparities in outcomes have been most pronounced for African Americans who, despite comprising only 13% of the US population account for about 30% of all COVID-19 cases in states for which race-related data are reported. Infectious disease modelers, epidemiologists, and other public health experts believe that COVID-19 is here to stay and suggest that annual surges may persist through 2025 and beyond. With vaccine hesitancy and delay compromising our ability to attain herd immunity, the best means for controlling the spread of COVID-19 according to public health experts is mass adoption of the 3 Ws (Wear a mask, Wait 6 feet apart, and Wash your hands) and increasing awareness of one's status through testing. As such, non-pharmaceutical interventions (NPIs) are currently our best options for viral control and containment. NPIs that are community-driven and developed in collaboration with diverse partners, including community members, public health agencies, and researchers may offer an acceptable and effective approach to reducing COVID-19 transmission and addressing individual and socio-structural barriers that lead to worse COVID-19-related outcomes among African Americans. Our study goals are to use a crowdsourcing open call to identify exceptional ideas (e.g., messages, videos, communication and dissemination strategies) that promote COVID-19 testing and encourage the public to practice the 3 Ws, referred to as health-promotive behaviors.

Eligibility Criteria:
Inclusion Criteria:

* specific zip codes in North Carolina (specific zip codes to be determined)
* no self-reported history of COVID-19 infection
* have not tested within the past 14 days

Exclusion Criteria:

* live outside of study area
* under 18
Prophylactic Administration of Alpha Blockers for Prevention of Urinary Retention in Males Undergoing Inguinal Hernia Repair Under Spinal Anaesthesia.

Open inguinal hernia repair is one of the most common surgical procedures. Despite the fact that different of anesthetic procedures are proposed as alternatives to spinal anesthesia, the combination of spinal anesthesia with open inguinal hernia repair is preferred from both surgeons and patients. One disadvantage of this combination is the high incidence of post-surgery urinary retention, especially in men above 50 years old. This complication is partially attribute to overstimulation of the a1 adrenergic receivers of the bladder and the prostate. Preoperative administration of elective a1 blockers could inhibit this effect without side effects, since this drugs don't have systemic effect.


Eligibility Criteria:
Inclusion Criteria:

* unilateral inguinal hernia

Exclusion Criteria:

* ASA score \>3
* hypotension
* prostatic hypertrophy
* complicated inguinal hernia
* neurological diseases
* inguinal hernia repair under general or local anaesthesia