cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A

The purpose of this study is to determine the relative bioavailability of ReFacto AF as compared to ReFacto, when each is administered as 2-minute bolus infusions.


Eligibility Criteria:
Inclusion Criteria:

* Severe hemophilia A (FVIII:C \< 1% at local laboratory)
* Previously treated patients (PTP) with at least 250 exposure days to any factor VIII product
* Age greater than or equal to 12 years\\

Exclusion Criteria:

* The presence of any bleeding disorder in addition to hemophilia A
* Concomitant therapy with immunosuppressant drugs (e.g., intravenous immunoglobulin (IVIG), routine systemic corticosteroid use)
* History of detectable factor VIII inhibitor
Perioperative Effects of Operating Room Virtual Tour

Preoperative anxiety is associated with adverse consequences such as emergence delirium, and postoperative behavioral changes. According to previous studies, providing information of anesthetic procedures helps to lessen preoperative anxiety. However, verbal explanation alone provides the limited effect, and the tour program of the operating room prior to surgery may not be possible for a number of hospitals due to organizational and financial reasons. Therefore, the virtual reality (VR) tour of the operating room may be an innovative and novel method to give children information about the preoperative process and to alleviate the preoperative anxiety. In this study, we intend to evaluate the effects of the operating room virtual tour on preoperative anxiety as well as emergence delirium and postoperative behavioral changes, in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgery
* American Society of Anesthesiologist (ASA) physical class I, II
* Informed consent; Children aged between 4 and 6 years old are allowed to have verbal consent and their parents provide informed written consent. Children over the age of 7 are required to obtain a written consent with parental permission.

Exclusion Criteria:

* ASA class ≥ III
* Major surgery needing postoperative intensive care unit (ICU) admission.
* Chronic disease or history of preterm birth
* Developmental delay
* Hearing or vision impairment
* Affective disorder
* History of epilepsy or seizure
* Previous experience of general anesthesia
MCAF and EMD With and Without CTG Wall Technique for the Treatment of Class III and IV Gingival recessions-a Randomized Control Trial

Research is to compare and evaluate the clinical outcomes of the Connective tissue graft wall technique with modified coronally advanced flap to improve root coverage and clinical attachment levels in Miller's class III and IV gingival recession.

Research is to compare and evaluate the clinical outcomes of the Connective tissue graft wall technique with modified coronally advanced flap to improve root coverage and clinical attachment levels in Miller's class III and IV gingival recession. The objectives is to assess the probing pocket depth reduction, clinical attachment level gain, patient esthetic evaluation, complete root coverage and mean root coverage. the control group will be treated with modified coronally advanced flap with connective tissue graft and enamel matrix derivative and the study group will be treated with modified coronally advanced flap with connective tissue graft wall and enamel matrix derivative. The total number of participants included will be 24 (Control-12; Study-12) with a 6 month follow up.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18-60 years
* Systemically healthy individuals
* Participants with Miller's Class III and IV or Cairo's RT3 gingival recession in maxillary and mandibular anteriors.
* Participants with Nordland and Tarnow's papillary recession of either I, II or III.
* Presence of interdental PPD, CAL and recession
* Radiographic evidence of interdental bone loss
* No prior experience of root coverage procedures
* Able to achieve good oral hygiene and control gingivitis in the whole of the dentition (FMPS \< 25% and FMBS \< 25%).

Exclusion Criteria:

* Grade III mobile teeth
* Pathologically migrated teeth
* Endodontically treated teeth
* Open contacts
* Pregnancy and lactating women
* Participants with systemic conditions
* Untreated periodontitis
* Persistence of uncorrected gingival trauma from tooth brushing
* Self-reported current smoking
* Presence of medical contraindications to elective surgery
VIsualization of Coronary Artery Disease for Modification of RISK Factors

The VICAD-RISK study assesses if visualization of coronary CT angiography (CTA) images in participants with non-obstructive coronary artery disease will improve LDL lowering, reduce reporting of side effects by cholesterol lowering medications, and modify the coronary artery disease phenotype over 12 months.

In Denmark non-obstructive coronary artery disease is found in 35-40% of patients undergoing coronary CT angiography for suspected coronary artery disease. Modification of risk factors is essential in patients with coronary artery disease to prevent major cardiovascular events. However, in non-obstructive coronary artery disease, initiation and adherence to treatment with lipid lowering therapy is poor.

The study will include 273 patients from 5 different sites; patients will be randomized into 3 groups; standard follow up by general practice, structured disease education or the combination of the latter with visualization of coronary CT angiography images. A follow-up CT angiography will be performed at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of nonobstructive coronary artery disease
* No known coronary artery disease (no previous coronary revascularization)
* CAD-Rads score 1-3
* LDL cholesterol \> 2.0 mmol/l
* Life expectancy \>3 years
* Signed informed consent

Exclusion Criteria:

* Post CTA test indication for invasive coronary angiography
* Non-evaluable CTA exam
* Obstructive coronary disease (One or more coronary stenosis ≥70%, left main \>40%)
* Ongoing lipid lowering medical treatment (Patients already on lipid lowering medical therapy can be included if the treatment was initiated \<3 months before the time of the CTA test)
* BMI \>40
* Renal insufficiency (eGFR \<40 ml/min)
* Allergy to iodinated contrast media
* Contraindications to statins (Active liver disease Child-Pugh A, B and C, excessive alcohol consumption)
* Participation in a cardiac rehabilitation or lifestyle modification program
* Pregnancy
The Dallas Hereditary Spherocytosis Cohort Study

The purpose of this study is to

1. better characterize the short term and long term natural history of hereditary spherocytosis (HS) including diagnosis, complications, and indications for and response to splenectomy
2. evaluate and describe the health-related quality of life in children with HS.

Patients with a new or established diagnosis of HS seen at Children's Medical Center will be asked to enroll in the study. Previous and current medical records will be reviewed to systematically catalogue their history of HS, including diagnosis, complications, hospitalizations, medications and laboratory data. Health-related quality of life questionnaires will be given to the patients and their parents at enrollment and periodically during the follow-up. Those who agree will have up to three small samples of blood collected and frozen for future laboratory studies of complications associated with HS and/or splenectomy.

We anticipate enrolling approximately 200 children and young adults with HS in this study and following them until adulthood (age 18-21 years).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HS with or without prior splenectomy
* Age 0 - 21 years
* Spanish-speaking subjects are eligible to participate

Exclusion Criteria:

* Unable to provide contact information for follow-up
Exploration on the Value of MRD Based on ctDNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer

Based on the unique patented MONOD and Methyl Titan methylation sequencing technology on lung cancer tissue and blood samples, a lung cancer MRD monitoring panel is designed. The panel is used to detect molecular residual disease of stage IB-IIIB non-small cell lung cancer patients underwent radical surgery, explore personalized analysis models, and conduct research on recurrence monitoring for non-small cell lung cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old, regardless of gender;
2. Patients with pathological diagnosis of non-small cell lung cancer and clinical staging of stage IB-IIIB;
3. Able to undergo radical surgical treatment;
4. Physical condition score (ECOG) ≤1;
5. The expected survival time exceeds 24 months;
6. Volunteer to participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Individuals with a history of other malignant tumors within 5 years;
2. Those who have undergone neoadjuvant therapy before surgery;
3. Postoperative incision margin R1 or incision margin R2;
4. Those who have undergone a blood transfusion within 2 weeks before the surgery;
5. Individuals with systemic inflammatory response syndrome;
6. Those with serious diseases of important organs such as the heart, lungs, kidneys, and brain;
7. Participants in other clinical trials within the past 30 days and have taken investigational drugs;
8. Due to various reasons, sampling cannot be completed, samples do not meet the requirements, or baseline samples (preoperative and postoperative plasma samples, tumor tissue samples) are incomplete;
9. Researchers believe that it is not appropriate to participate in this experiment.
A Cross-sectional, Observational Multicenter Study to Assess the Reasons for Choosing the 3-year Hormonal IUD and Level of IUDs Knowledge Among Women Aged 18 to 29 Years

A cross-sectional, observational multicenter study to assess the reasons for choosing the 3-year hormonal IUD and level of IUDs knowledge among women aged 18 to 29 years. The study will be conducted in standard clinical practice conditions at public and private gynecology clinics and during a single study visit.

Approximately 1,000 women aged 18 to 29 years who have freely chosen the 3 year hormonal IUD as their contraceptive method will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 to 29 years.
* Women who decided to initiate treatment with a 3-year hormonal IUD for contraception after being adequately counseled and informed of all contraceptive options by their physician during a routine clinical visit, prior to the study visit (insertion visit).
* Women capable of reading and writing.
* Women who signed informed consent.

Exclusion Criteria:

* Women currently participating in an interventional clinical trial.
* Prescription of the 3-year hormonal IUD for non-contraceptive medical reasons.
Efficacy of Preconditioned Adipose-Derived Stem Cells in Fat Grafting

The aim of this study is to evaluate the comparison of therapeutic potential of curcumin preconditioned adipose derived stem cells (ASCs) enrichment fat grafting, naïve ASCs enrichment fat grafting and conventional fat grafting to correct facial contour deformities that cause aesthetic complications in patients.

Human subcutaneous adipose tissue along informed consents will be collected in a lipoaspirate container or 20 cc B.D syringes under the sterilized conditions during the surgery. Fat aspirate collection will be based on certain selection criteria including pre-requisitioning non-diabetic, negative viral status patients. Adipose derived stem cells (ASCs) will be isolated from adipose tissue under sterile aseptic conditions. Firstly, the lipoaspirate container will be opened in the biosafety cabinet and drain off the blood carefully with the help of serological pipette. Then, fat will be washed thrice with 1X phosphate buffer saline (PBS) containing antibiotic and anti-mycotic solution, in order to get rid of blood vessels, hair and other type of connective tissue. After that, the tissue will be enzymatically digested with collagenase type I solution (1mg/ml prepared in Low Glucose Dulbecco's Modified Eagle Medium (LG-DMEM) and incubate for 45 minutes at 37°C on a shaker. After digestion, the enzyme will be inactivated by LG-DMEM augmented with 5% freshly isolated human serum and spin at 1200 rpm for 10 minutes. After centrifugation, fat will be discarded and the infranatant will be passed through 100 µm cell strainers to remove the debris. The filtrate will be centrifuged again for 1200rpm for 8 minutes. Pellet will be resuspended and plated in a sterile T-75 cm2 flask containing 10 ml LG-DMEM supplemented with 5% human serum. The flask will be placed in a humidified incubator at 37°C, 5% carbon dioxide (CO2). The media will be replenished after every third day until the cells got 80-90 % confluency. Cells of P2-P3 stage will be used in this study for immunocytochemistry, and intervention as well. For preconditioning, ASCs will be incubated with curcumin preconditioned medium for 24 h. Cell sterility and viability will be assessed prior to transplantation. For transplantation, 1,00,000 cells per ml of fat will be mixed, transferred to 10 cc syringes and injected at deformity site. Amount of fat will be predetermined by the clinician on the basis of facial asymmetry.

Eligibility Criteria:
Inclusion criteria

* Age 18-50 years (male or female)
* Body-mass index 20-30 kg/m²
* Suitable for liposuction as assessed by the expected cosmetic results
* Provided signed informed consent

Exclusion criteria

* Systemic disorders include autoimmune diseases, hemorrhagic diseases, bone marrow aplasia, sepsis, cancer, and others
* Local disorders include acne, infections and others
* Risk factors include smoking, uncompensated diabetes, hypertension, and allergy to the drugs used for general anesthesia
* Microbiological contamination of either the cell culture or the transplanted tissue
Influence of Perception of Patients Suffering of Knee Osteoarthritis Regarding Effectiveness of Intra-articular Injection

Introduction; reception must be understood as the offered attention within the relationship between a healthcare worker and the patient, including attitudes of inclusion, hearing, valorization of complains and identification of needs, being these individual collective. As a part of this process, communication is a primary and indispensable toll through which the healthcare team and the patient interchange information.

Objective: to evaluate the influence of perception of patients suffering of knee osteoarthritis over fear, catastrophizing of pain and effectiveness, related to intra-articular injection od corticosteroids.

Material and method: it will be performed a prospective, controlled and randomized study eith a blind evaluator on patients with symptomatic knee osteoarthritis submitted to joint injection. A hundred patients suffering of symptomatic knee osteoarthritis coming from the outpatient area of Rheumatology Division of Federal University of Sao Paulo (UNIFESP) will be evaluated, 50 belonging to the intervention group (reception) and 50 to a control group.


Eligibility Criteria:
Inclusion Criteria:

* knee osteoarthritis according to american college of rheumatology criteria
* no previous experience of joint injection
* stable use of drugs for osteoarthritis treatment for at least 3 months
* stable dose of corticosteroids, non hormonal anti-inflammatory and analgesics in the previous month
* pain on knee between 3 and 7 in the visual analogue scale
* signe the informed consent term
* radiologic classification between 1-3 (kellgren and Lawrence classification)

Exclusion Criteria:

* joint disease of different etiology
* coagulation alteration
* non treated fibromyalgia
* litigation
* diabetes mellitus and systemic arterial hypertension out of control
* allergy of lidocaine or triamcinolone hexacetonide
Using Preoperative Anxiety Score to Determine the Precise Dose of Butorphanol for Sedation

Pre-operative anxiety usually lead to increased anesthetics during the surgery. The precise sedative requirement which can keep adequate sedative state and avoid adverse effects caused by excessive drugs still needs further study. Therefore, our purpose was to confirm the sedative effect of butorphanol and to explore the relationship between pre-operative anxiety and intra-operative butorphanol requirement to evaluate the precise sedative requirement which can keep adequate sedation for patients by pre-operative anxiety score.

A total of 142 patients (aged 18-75 years) who were scheduled for elective low limb orthopedic procedures under spinal anesthesia were included in this study. Patients were divided into two groups based on pre-operative anxiety score evaluated by the Amsterdam pre-operative anxiety and information scale before the surgery. And intramuscular midazolam 0.05mg/kg as a premedication in preoperative room was given to patients before shifting into operation room. Patients in each group were randomly divided into butorphanol group and 0.9% saline group. The sedation score, the duration of reaching adequate sedation state and postoperative recovery were recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA Ⅰ-Ⅱ
* age 18-75 years
* surgical operation of lower extremities in orthopedics
* no contraindication of epidural anesthesia

Exclusion Criteria:

* with central system disease
* with cardiovascular disease
* with autonomic nervous system disease
* long term use of analgesic drugs ,sedative drugs,and anti-anxiety drugs
* language barrier
* unwilling to cooperate with the experimenter
The Feasibility of Different Doses of Etomidate Admixed With Propofol in Induced Abortion: A Randomized, Double Blind Controlled Trial

To explore the feasibility of different doses of etomidate admixed with propofol in induced abortion: a randomized, double blind controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 20 and 35 years
* American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ
* Singleton pregnancy and the gestational period is 6 to 8 weeks
* Expected operation duration is within 60 minutes
* The body weight should be within 15% around the standard weight
* Signed informed consent form

Exclusion Criteria:

* Serious cardiac, cerebral, liver, kidney, lung, endocrine disease
* Upper respiratory infections within 4 weeks
* Long use of hormone or history of adrenal suppression
* History of use of glucocorticoids, aprotinin or immunosuppressant
* Manifestation of immunodeficiency
* History of use of sedatives or opiates
* Needs of Neuromuscular blocker (except intubation)
* Allergy to trial drug or other contraindication
* Pregnant or breast-feeding women
* Attended other trial past 30 days
Study of Duodenal-Jejunal Bypass(DJB) as a Potential Cure for Type 2 Diabetes Mellitus

Premise: Complete resolution of Type 2 Diabetes Mellitus with normalization of blood glucose and HbA1c in the abscence of medication support is possible with a surgical procedure named the "Duodenal-Jejunal Bypass (DJB)" a modification of an established duodenal switch procedure and is performed utilizing the laparoscopic approach.

Hypothesis: The duodenum plays a major role in glucose homeostasis through mechanisms largely unknown at this time. Evidence of this hypothesis comes from accumulated data in bariatric surgery patients who underwent Roux-en-y Gastric Bypass or Biliopancreatic Diversion (BPD) with or without a Duodenal Switch. Current evidence strongly supports this hypothesis with a long term (over 10 years) Type 2 Diabetes Mellitus(T2DM) resolution rate of 84-86% following the gastric bypass and over 95% for the duodenal switch.

The clinical resolution of T2DM is defined as independence of all anti-diabetic medications and maintaining a HbA1c less than 6.0. Recent rodent experiments by Francesco Rubino and subsequent human case reports by Cohen et al. supports the validity of this hypothesis. The modified procedure involved a roux-en-y bypass of the duodenum and 30-50cm of proximal jejunum, unaltering the stomach and pylorus resulted in resolution of T2DM with no weight loss in all subjects.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of Type 2 diabetes mellitus
* Body Mass Index(BMI) less than 35
* Insulin usage duration less than 10 years
* Negative anti-GAD
* Fasting C-peptide level over 1.0 mcg/ml
* Ability and willingness to follow up for a period of 1 year
* Willingness to consent for utilizing personal results without individual identifier information to be published in medical studies and other media as determined by the study investigators
* Ability to understand and describe the risks, benefits and mechanism of action of the procedure

Exclusion Criteria:

* Current pregnancy or positive pregnancy test
* Liver Cirrhosis
* Coagulopathy
* Type 1 Diabetes Mellitus
* HIV
* Previous abdominal surgery preventing laparoscopy
* Previous vagotomy
* Previous gastric or small intestine surgery
* Inability to comply with study requirements
* Currently active medical malpractice lawsuit/s
* Diseases of the exocrine pancreas: pancreatitis trauma, pancreatectomy, neoplasia, cystic fibrosis, hemochromatosis
* Endocrinopathies: acromegaly, glucagonoma, Cushing's Syndrome, pheochromocytoma, hyperthyroidism, somatostatinoma, aldorestanoma
* Chemical Induced Diabetes: vacor, pentamidine, nicotinic acid, glucocorticoids, thyroid hormones, diazoxide, beta-adrenergic agonists, thiazides, phenytoin, alfa-interferon
* Genetic Syndromes with Diabetes: Down's, Klinefelter's, Turner's, Wolfram, Lawrence-Moon- Beidel, Prader-Willi, Friederich's ataxia, Huntington's Chorea, Myotonic Dystrophy, Porphyria,
* If a candidate is deemed to be not an appropriate candidate based on investigators recommendation.