cyrilzakka/clinical-trials huggingface dataset:
Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics

The purpose of this study is to determine optimal prophylactic antibiotics administration method in elective laparoscopic colorectal surgery.

The use of antibiotic prophylaxis in patients who undergo elective colorectal surgery is now accepted universally. But the rout of administration should be systematic, oral, or both is controversial. Furthermore, although many trails have been performed, no trial limited to laparoscopic surgery is performed. We compare 2 approaches - oral and systemic versus systemic antibiotic prophylaxis - in limited to elective laparoscopic colorectal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Colorectal tumor(cancer, adenoma and suspected cases) with planned elective laparoscopic colorectal resection

Exclusion Criteria:

* ECOG Performance Status \>=2
* Age\<20
* Any organ dysfunction
* Ileus
* Preoperative infectious disease
* Antibiotic administration before surgery
* Steroid administration before surgery
* Neo-adjuvant radiation and/or chemo therapy
* Severe diabetes mellitus
* Pregnancy/lactational woman
* Severe allergy
The Effect of The Use of a Videolaryngoscope and/or Stylet on Intubation Time in Obese Patients

Although many researchers would agree that obesity per se is not a risk factor for difficult intubation, there are many well known obesity-related challenges in airway management including difficulty with mask ventilation, more frequent and rapid oxygen desaturation, increased oxygen consumption, and increased sensitivity to the respiratory depressant effects of anesthetic and analgesic drugs. Hence, in these conditions, rapid and nontraumatic intubation gain higher interest. There is controversy about using videoaryngoscopy (VL) in obese patients in these difficult situations. The primary aim of this study is to compare, in terms of intubation time, VL,VL plus stylet and direct-laryngoscopy(DL) plus stylet combination with DL alone in obese patients.

Patients who will be scheduled for surgeries requiring endotracheal intubation, with a body mass index (BMI) more than 30 kg/m2, will be included to this study. During preanesthetic visit (performed by an anesthesiologist not involved in this study) history of difficult intubation, measurement of common predictive indices for difficult intubation (BMI, thyromental distance, neck circumference, Mallampati grade, interincisal \[or intergingival\] distances), and evaluation of status of dentition and neck movement will be noted.

In the operating room, all patients will be connected to standard monitoring devices. Anesthesia induction will be carried out according to our hospital obese patient anesthesia management protocol. Then, after induction of anesthesia, the patients will be intubated one of four pre-defined protocols that will be determined via randomization during a preanesthetic visit by a person who is unfamiliar with the research protocol.

Primary hypothesis of this study is; using a video-laryngoscope plus stylet will reduce the time required to achieve successful tracheal intubation in obese patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a documented body mass index (BMI) of ≥ 30.
* Patients scheduled to undergo inpatient surgery procedures under general anesthesia.
* Willingness and ability to sign an informed consent document 18 - 80 years of age

Exclusion Criteria:

* Patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation
* Patients with a history of facial abnormalities, oral-pharyngeal cancer, or reconstructive surgery
* Emergency surgeries
* Pregnancy
* Any other conditions or use of any medication which may interfere with the conduct of the study.
Study of Clinical Features of Patients With Autoimmune Liver Disease Complicated With Covid-19 and the Immune Mechanism Affecting Prognosis

With the decreasing virulence of omicrons strain, the current domestic epidemic prevention policy has been changed based on the health of the people and the development needs of the country. At present, the infection rate of the novel coronavirus in China is rising rapidly. Previous studies have found that patients with chronic liver disease are more likely to be co-infected with coronavirus disease 2019 and have a worse prognosis. Based on its unique immune mechanism and therapeutic drugs, patients with autoimmune liver disease also have very different manifestations after infection with the novel coronavirus. By observing the clinical characteristics and prognosis of patients with autoimmune liver disease complicated with coronavirus disease 2019, this study analyzed the roles of vaccines, immunosuppressive agents and ursodeoxycholic acid , and explored the immune mechanism behind them, so as to seek new anti-coronavirus disease 2019 drugs and provide new strategies for clinical prevention and treatment.


Eligibility Criteria:
Group A: 1) Aged 18-75; 2) AIH patients diagnosed by AIH comprehensive scoring diagnosis system; 3) No history of other malignant tumors; 4) No metabolic diseases such as hypertension and diabetes; 5) No serious circulatory and respiratory diseases; 6) Non-alcoholic liver disease, drug-induced hepatitis, viral hepatitis and other liver diseases; 7) Exclude pregnant and lactating women.

Group B: 1) Aged 18-75 years; 2) Patients with PBC diagnosis; 3) No history of other malignant tumors; 4) No metabolic diseases such as hypertension and diabetes; 5) No serious circulatory and respiratory diseases; 6) Non-alcoholic liver disease, drug-induced hepatitis, viral hepatitis and other liver diseases; 7) Exclude pregnant and lactating women.

Group B: 1) Aged 18-75 years; 2) Patients with PBC diagnosis; 3) No history of other malignant tumors; 4) No metabolic diseases such as hypertension and diabetes; 5) No serious circulatory and respiratory diseases; 6) Non-alcoholic liver disease, drug-induced hepatitis, viral hepatitis and other liver diseases; 7) Exclude pregnant and lactating women.

Group B: 1) Aged 18-75 years; 2) Patients with PBC diagnosis; 3) No history of other malignant tumors; 4) No metabolic diseases such as hypertension and diabetes; 5) No serious circulatory and respiratory diseases; 6) Non-alcoholic liver disease, drug-induced hepatitis, viral hepatitis and other liver diseases; 7) Exclude pregnant and lactating women.

Group E: Those who had no previous history of COVID-19 infection and had been vaccinated against COVID-19.

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Determining Parental Attitudes Toward Day of Surgery Consent for Research

There are no studies examining parents' attitudes towards day of surgery consent for research. The purpose of the study is to determine the attitudes parents of potential research participants have toward being approached for day of surgery consent. The primary objective is to determine parental attitudes regarding day of surgery consent for anesthesia research. The secondary objective is to determine the boundaries for day of surgery consent (e.g., study types, interventions, risk factors).

This is a multi-phase prospective cohort study. In the first phase the investigators will interview parents and consult the Family Research Advisory Committee (FRAC) to determine their attitudes toward day of surgery research consent. The investigators will use the participants' responses and instruments already found in the literature to develop the questionnaire. In the second phase, the investigators will interview parents and consult FRAC about the questionnaire to determine which items to add, remove, or modify. In the third phase, the investigators will distribute the adapted questionnaire to clarify parents' attitudes surrounding day of surgery consent. The investigators will use the results of the third phase to develop a table of guidelines for day of surgery consent. In the final phase, the investigators will interview parents, healthcare professionals, and consult FRAC for feedback and modification of the table of guidelines.

Eligibility Criteria:
Inclusion Criteria:

* The parents of children undergoing elective surgical procedures at Sickkids will be invited to participate in the study.
* If multiple parents are present, they are permitted to participate jointly; however, their participation will count as a single response.

Exclusion Criteria:

-Parents of children who are undergoing urgent or add-on procedures will be excluded.
Neurology Inpatient Clinical Education Trial

The objective of this study is to compare the effectiveness of a personalized patient education program to the current hospital education and evaluate its impact using patient satisfaction scores.

The investigators hypothesize that a personalized patient education intervention will increase patient's understanding of their diagnosis and satisfaction with the care as reflected in the survey results.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* Must have the capacity to consent and understand the study related activities and education materials.

Exclusion Criteria:

* Under the age of 18
* Have a condition that impairs the ability to understand the study, its risks, and appropriately consent for the study
Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer

The purpose of the study is to evaluate the efficacy and toxicity of anlotinib in patients with platinum resistant or refractory ovarian cancer

Ovarian cancer is the leading cause of death for patients with gynecologic malignancies. In most cases, the disease is diagnosed at an advanced stage and approximately 75% of patients will eventually experience disease recurrence. However, the overall response rates of second-line chemotherapy for recurrent ovarian cancer are only 20-27%. Therefore, it is important to seek alternative agent that can improve the outcome. Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets VEGFR,FGFR,PDGFR,and c-kit,. The preclinical studies suggest anlotinib may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of the study drug anlotinib.

Eligibility Criteria:
Inclusion Criteria:

1. Female, age ≥18 years and ≤70 years, signed informed consent.
2. Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary.
3. Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy)
4. At least treated with one line of platinum-based chemotherapy
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
6. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version or CA125
7. Patients must have a life expectancy of at least 3 months.
8. Patients must have adequate organ function.

Exclusion Criteria:

1. Had prior exposure to anlotinib or has known allegies to any of the excipients, Inadequately controlled hypertension
2. History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
3. History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1
4. Major surgical procedure within 28 days prior to Day 1, Serious, non-healing wound, active ulcer, bowel obstruction within 28 days prior to Day 1
5. Symptomatic central nervous system (CNS) metastasis
Assessment of the Implementation of the ResQGARD® Impedance Threshold Device by the San Antonio Fire Department

This study is attached to a comprehensive quality assurance/quality improvement (QA/QI) program conducted by the Office of the medical director, and is designed to contribute to generalizable knowledge to determine effectiveness and tolerability of an FDA approved Impedance Threshold Device (ITD) device in a large urban emergency medical service (EMS) system. The cohort will comprise a convenience sample of patients that are being treated by EMS for a hypotensive emergency.


Eligibility Criteria:
Inclusion Criteria:

* adults between the ages of 18-120 years
* presenting to EMS with or development of Hypotension during EMS interaction
* treated by EMS with the ITD

Exclusion Criteria:

* pediatric patients
* patients that do not present with or develop hypotension
* patients who the ITD will not form a secure seal due to anatomical abnormalities
HEParin Antagonisation in Transcatheter Aortic Valve Implantation

Unfractioned heparin is usually given in a defined dosage during transfemoral TAVI. Activated Clotting Time (ACT) is usually used to measure the heparin effect. ACT-analysis is easy to perform at the bedside, but susceptible to interference effects. At the end of the procedure, protamine is given to reverse eventual residual heparin effect. An overdose of protamine can impair the coagulation itself. The investigators want to analyse the effect of a partial heparin reversal by ROTEM Analysis.


Eligibility Criteria:
Inclusion Criteria:

* Severe aortic valve Stenosis
* transfemoral TAVI as best therapy option
* unfractioned heparin for periprocedural anticoagulation

Exclusion Criteria:

* known hypersensitivity /allergy to unfractioned heparin or protamine
* acute systemic infection
* pre procedural started and ongoing intravenous therapy with unfractioned heparin
* severe periprocedural adverse event with the need for emergency surgery (with or with our CPB)
* refusal of the patient to participate
DNA Analysis of Bone Marrow and Blood Samples From Young Patients With Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at DNA in bone marrow and blood samples from young patients with acute myeloid leukemia or acute lymphoblastic leukemia.

OBJECTIVES:

* Characterize the clinical, morphologic, immunologic, cytogenetic, and molecular heterogeneity of acute lymphoblastic leukemia or acute myeloid leukemia (AML) in infants and monoblastic variants of AML in young patients.
* Characterize the clinical, morphologic, immunologic, cytogenetic, and molecular heterogeneity of secondary AML in young patients.
* Compare secondary AML vs de novo AML at the level of Southern blot, breakpoint sequence, and DNA topoisomerase II cleavage sites.

OUTLINE: This is a multicenter study.

Bone marrow or blood are collected and analyzed by Southern blot for chromosome 11q23 breakpoints and translocations. Samples from patients with secondary acute myeloid leukemia are also examined for MLL gene rearrangements.

PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of leukemia meeting 1 of the following criteria:

  * Acute lymphoblastic leukemia OR acute myeloid leukemia (AML) (\< 1 year of age at diagnosis)
  * M4 OR M5 AML (\< 5 years of age at diagnosis)
  * Secondary leukemia (\< 21 years of age at diagnosis)
* Bone marrow sample, peripheral blood (WBC \> 10,000/mm³ and 20% peripheral blasts), or pheresis bag available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
DELTA DESCRIBE: the French Collaborative Project

Our global objective is to draw up a photograph of HDV patients over one year in metropolitan France and identify the barriers of screening and care. The investigator suspects a mismatch between HBV and HDV screening, the first step for specialized care pathway in metropolitan France.

Hepatitis Delta virus (HDV) infection is a significant public health disease causing up to 18% of cirrhosis and 20% of hepatocellular carcinoma (HCC) and new therapeutic options are now available. In France, very few epidemiological studies, mainly focused on specific pre-selected hospital populations, are available. There is a crucial need for data in terms of Delta knowledge, suitability of screening, type of prescribers and treatment access. The investigator proposes a retrospective study in order to describe the number of HDV tests (anti-HDV and HDV RNA) performed in metropolitan France and compare it to the potentially expected one, estimated from the number of HBV screening tests performed in one year, from 2016 to 2020. The investigator will also evaluate the number of HCV and HIV screening tests prescribed over the same period and the HDV PCR techniques used. This study will be based on one hand on data from the French Health insurance (first step) and on the other hand on data from private and hospital laboratories (second step). The second step will allow to identify the prescriber of the Delta tests and the HDV positive patients and precise their profile and their medical care. After an initial analysis of the results, The investigator will propose solutions to the barriers encountered and adapted to the identified targets.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years at the second step
* HDV RNA positive patients identified at the second step
* Patients non opposed to the collection of their data

Exclusion Criteria:

* Opposition expressed by the patients for the collection of their data
Non-Interventional Study to Evaluate Safety and Efficacy of NOVOCART 3D in Patients With Cartilage Defects

Non-interventional study to evaluate safety and efficacy of NOVOCART 3D in adult and adolescent patients with full thickness cartilage defects after the treatment with NOVOCART 3D.

A 36-month post treatment follow up of adverse and serious adverse effects as well as the measurement of efficacy with the International Knee Documentation Committee (IKDC) Score.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adult patients
* Children and adolescents with closed epiphysial plate
* Defect size ≥2.5 and ≤10 cm2 post-debridement
* Localized full thickness articular cartilage defect of the knee (Grade 3 \& 4 International Cartilage Repair Society (ICRS) classification)

Exclusion Criteria:

* Radiologically apparent degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade \>2
* More than 2 defects or 2 corresponding lesions
* Ankylosis
* Arthrofibrosis
* Diffuse chondromalacia
* Total/subtotal resected meniscus
* Insufficient Ligament guidance
* Patella malignement
* Inflammatory joint disease
* General cartilage degeneration or increased joint deterioration
* Cancer, present or within the last 5 years
* Primary treatment in children and adolescents with open epiphysial plate
* Chronical infection diseases
* Untreated coagulation disorder
* Pregnancy and lactating
* Known history of allergies against ingredients of NOVOCART® 3D
Skin and Blood Research Samples From Healthy Volunteers and Patients With Hematologic Diseases

The investigators plan to obtain skin and blood samples from healthy volunteers and patients with a benign, inherited hematologic disease to use for research to use homologous recombination to correct β-globin gene mutations in therapeutically useful cells, like autologous induced pluripotent stem cells from sickle cell anemia patients.

* To obtain skin biopsy samples from normal healthy volunteers and patients with a benign, inherited hematologic disease, such as sickle cell anemia, to create induced pluripotent stem cells. Pluripotency will be confirmed by injecting potential iPS cell lines into immunodeficient mice, assessing the ability of each line to cause cystic teratomas in recipient mice.
* To define the efficiency of homologous recombination in induced pluripotent stem cells derived from skin biopsy samples.
* To define the efficiency of homologous recombination in human embryonic stem cells using NIH-approved cell lines.
* To establish the genetic consequences of the derivation of human induced pluripotent cells in normal controls or patients with benign, inherited, hematologic diseases, by genomic analysis, including whole genome sequencing.
* To establish the genetic consequences of homologous recombination in human induced pluripotent stem cells and embryonic stem cells by genomic analysis, including whole genome sequencing.
* To obtain blood samples to confirm genetic mutations in patients with an inherited hematologic disease (and to confirm no mutations in healthy volunteers).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18.
* No active systemic skin infection at biopsy site.
* No allergy to lidocaine or other local anesthetics

Exclusion Criteria:

ALL PATIENTS

* History of a bleeding disorder, easy bleeding, or bruising.
* Inability or unwillingness to provide informed consent.

SICKLE CELL PATIENTS

* Platelets ≤ 50,000
* INR ≥ 1.5
* Currently bing given intravenous heparin
Plantar Pressure Values in Patients With Ankylosing Spondylitis

this study was discovered that clinical and radiological characteristics were related to plantar pressure assessments in patients with AS.

Determine the correlation between the plantar pressure readings of AS patients and the clinical and radiological measures utilized in the monitoring of the condition.

Method: This study covered 75 participants. The quality of life was measured using ASQoL, BASMI, BASFI, and BASDAI, and demographic information was also recorded. The pedobarographic evaluations included the recording of static and dynamic plantar pressures

Eligibility Criteria:
Inclusion Criteria: patients diagnosed with AS -

Exclusion Criteria: Patients with cognitive dysfunction, vision loss that would prevent walking on the pedobarography platform, history of surgery and neurological deficit in the lower extremity, and patients who could not walk independently

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INDIcators for Clarifying the bAckground of exTreme Obesity in childRen

The study investigates the genetic backgrounds of extreme childhood obesity (using saliva sample) and contains short online questionnaires on family history, phenotypical characteristics and hunger behavior. It is an observational study in a predefined cohort (subjects with data in CrescNet aged 0-18 with BMI measurement(s) above the 99.5th percentile). Recruitment will initially be from CrescNet data through the cooperating pediatric and adolescent medical institutions associated with these initiative of data collection in Germany.

In order to be able to investigate the genetic background of extreme obesity, current BMI developments above the 99.5 BMI percentile (extreme obesity) are selected in the existing CrescNet register. Pediatricians (submitting the data) will be informed about these cases. They will be ask to re-identify the patient using the pseudonym (CrescNet-ID) maintained in the registry and to contact the family with a request to participate in the study. The study physician of the study center at the Leipzig University Hospital will take over the study inclusion as well as all necessary clarifications and consents for the study and the genetic examination contained therein. Since the potential probands may live anywhere in Germany, telemedical contact between the study center and the family (interested in participation) will be used.

In addition to the above-mentioned study inclusion, the study physician is also responsible for instructing the family on the correct drawing, collection and sending of saliva samples to the study center, as well as instructing them on how to complete the hyperphagia questionnaire.

At this appointment, the proband is assigned an internal study identification number (INDICATOR-ID). Saliva sample and all questionnaires are assigned to this number.

Eligibility Criteria:
Inclusion Criteria:

* Test subjects older 5 years:

BMI SDS between 0-5 years \> 1.881 (= p97) BMI SDS between 5 and 18 \>2.567 (=p99.5) Parents and subjects agree that the study information will be provided during a telemedical consultation by the study physician

Exclusion Criteria:

* Known cause of servere early obesity