cyrilzakka/clinical-trials huggingface dataset:
Ultra-early Identification of Fetal Chromosomal Characteristics From Extravillous-trophoblast Cells

Demonstrate the efficacy of an ultra-early, non-invasive prenatal diagnostic method adaptable to various genetic indications to detect fetal chromosomal abnormalities.

During pregnancy, biological screening for genetic diseases of the fetus cannot be implemented before the 11th week of amenorrhea whatever the technique used. This delay is long and distressing, particularly for people at high risk of transmission of genetic diseases. The presence of extravillous trophoblast cells to the cervix of the pregnant woman from the 7th week, accessible by a cervicovaginal smear non-invasive, represents new biological material representative of the fetal genome. This project aimed at evaluating the performance of a method for analyzing these trophoblast cells extra-villous at the start of pregnancy. The investigators want to evaluate performance analytical aspects of this method, that is to say, verifying that the genetic information resulting from these cells correspond to those of the fetus.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman
* Singleton pregnancy
* Pregnancy between 7 and 16 weeks of amenorrhea (WA)
* Woman ≥ 18 years
* Woman who has signed an informed consent
* Woman affiliated to social security or equivalent scheme

Exclusions Criteria:

* Person under guardianship or curatorship
* Person placed under legal protection
* Person unable to provide the participant with informed consent.
Clinical Comparison of Electrocardiograms Collected Using an Ambulatory Holter

The objective of the study is to compare electrocardiograms using ambulatory holter monitor with dry electrodes in a harness versus using an ambulatory holter with standard sticky electrodes (Red Dot) on monitored patients within the hospital. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour. One holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived.


Eligibility Criteria:
Inclusion Criteria:

* Any patient within the hospital either for procedure or for admission

Exclusion Criteria:

* Patients who cannot wear a Holter monitor
* Patients undergoing an MRI or have other contraindications for wearing an ambulatory Holter monitor.
Quality Improvement in Handover of General Internal Medicine In-patients

Miscommunication during patient handover can jeopardize patient safety and is the focus of Quality Improvement initiatives by many organizations. It is widely recognized that such miscommunication is preventable using a number of strategies identified in the literature.

Currently, there is no formal handover process of General Internal Medicine in-patients, otherwise known as the Clinical Teaching Unit (CTU) at Vancouver General Hospital, which is a major patient safety concern. This project will implement a formal handover program and evaluate whether there are changes in resident satisfaction with handover, but more importantly, whether the investigators can improve patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Residents, medical students, and patients
* Residents and medical students will be any rotating through General Internal Medicine at Vancouver General Hospital
* Patients will be any admitted to General Internal Medicine and cared for during on-call hours (defined as 18:00 - 07:00)

Exclusion Criteria:

* None for residents and medical students
* Patients who are not being cared for during on-call hours (defined as 18:00 - 07:00)
Omnibond vs Dermabond

This prospective, randomized, controlled, blinded clinical trial is designed to assess the incidence of all time and all types of wound-related complications following total joint arthroplasty (TJA) when two different types of topical skin adhesives are used to close the incision.

The aim of this study is to assess the incidence of incision healing complications in patients undergoing primary total knee replacement and total hip replacement treated with either Omnibond or Dermabond advanced topical skin adhesive. All patients undergoing a primary, elective TKA and THA at participating centers that sign a consent form will be followed up for a period of up to 30 days to determine if there are any incision healing complications.

Secondary outcomes will include dry time of the topical skin adhesive, user satisfaction, patient satisfaction, and incidence of adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Patient ≥18 years old
2. Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
3. Subjects scheduled to undergo primary, elective total knee arthroplasty or total hip arthroplasty
4. Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information
5. Subjects deemed able to understand and comply with study visit schedule and procedures

Exclusion Criteria:

1. Local skin conditions such as dermatitis, eczema, psoriasis that, in the opinion of the investigator, will make it difficult to assess wound complications or local skin reactions following surgery
2. Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception
3. Active or previous infection in the skin or the knee or hip to be operated, evidence of gangrene
4. Subjects who have participated in this trial previously and who were withdrawn
5. Subjects with known allergies to product components including cyanoacrylate, formaldehyde, benzalkonium chloride or have known allergies or skin sensitivity to the Convatec Aquacel dressing.
6. Inability or refusal to provide informed consent or follow study and wound care instructions
Clinical Study of Hypoxia-Stressed Bone Marrow Mononuclear Cell Transplantation to Treat Heart Diseases

The purpose of this study, is to determine the differences of clinical outcomes between hypoxic pre-treatment group and control group in bone marrow stem cell transplantation (BM-SCT) to treat acute myocardial infarction (AMI); and to evaluate the safety of both treatments. Heart failure patients underwent PCI treatment after AMI and with informed consent, are randomized allocation into hypoxic pre-treated BM-SCT group, normoxic pre-treated BM-SCT group, and control group. Cell resuspension is intracoronary injected into patients receiving coronary angiography, IL-6, CRP, TNF and BNP are detected; echocardiography, cardiac MRI and ECT are analyzed to evaluate heart function and alive myocardial cells. Holter's ECG monitor is employed to observe arrhythmia and embolism. We hypothesize that, by receiving hypoxic pre-treated BM-SCT, impaired heart function will be reversed in heart failure patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute Myocardial Infarction(within one month);
* Age under 65;
* Infarction related wall motion abnormality on echocardiography;
* Infarction related TIMI flow grades 3 on coronary angiography during cell injection;
* Informed consent;

Exclusion Criteria:

* Active infection, or hematopoietic malignancy;
* Patients have tumor or other lethal diseases;
* Informed refusal
A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects

A study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects

Subjects will be randomized in a 1:1 ratio to receive a single dose (162 mg) of either CT-P47 or EU-approved RoActemra.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Body weight of ≥60 and ≤100 kg for male and ≥50 and ≤100 kg for female and a BMI between 18.5 and 28.0 kg/m2 (both inclusive) when rounded to the nearest tenth

Exclusion Criteria:

* A medical history and/or condition that is considered significant
* Clinically significant allergic reactions, hypersensitivity
* History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis
* Active or latent Tuberculosis
* History of malignancy
* Previous exposure to tocilizumab or any drug that targets IL-6
Evaluation of the Simplified Treat And Extend Regimen Using Ranibizumab in Exudative Age Related Macular Degeneration

Recently studies have shown that intravitreal injection of ranibizumab is effective for age related macular degeneration. However there are problems about injection regimen of maintenance phase. We plan to perform new simplified treat and extend regimen using ranibizumab.

The purpose of the present study is to evaluate the simplified treat and extend regimen using ranibizumab in eyes with wet age related macular degeneration about best-corrected visual acuity, central retinal thickness, the disappearance rate of the morphological change and treatment continuous rate.

Eligibility Criteria:
Inclusion Criteria:

1. ability to provide written informed consent for this study
2. age\>=50years old
3. intravitreal injection of ranibizumab as a first therapy for neovascular age-related macular degeneration (typical age-related macular degeneration and PCV)
4. best corrected visual acuity\>=0.05 -

Exclusion Criteria:

1. past intravitreal anti-vascular endothelial growth factor therapy in the study eye
2. past intravitreal or subtenon injection of steroid therapy in the study eye
3. past vitrectomy therapy in the study eye
4. infection or suspicion of infection in eyes or periocular region
5. severe intraocular inflammation in eyes
6. past allergic reaction for ranibizumab
7. past allergic reaction for fluorescein, indocyanine green or iodine
8. pregnancy (positive pregnancy test) or lactating women
9. other conditions that the investigator believed would pose a significant hazard to the subject if investigational therapy were initiated.
A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult Males

The primary objective of this study is to evaluate the pharmacokinetics of various TRV734 formulations in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by a responsible physician or trained qualified designee
* Males: 18 - 55 years inclusive at screening
* Capable of giving written informed consent

Exclusion Criteria:

* Clinically significant conditions or history of fainting or syncope
* Medical or psychiatric illness that could interfere with the completion of treatment and follow up
* Major surgery within 4-weeks of screening
* Known difficulty with obtaining intravenous access
* History of sensitivity to the study medication, or intolerance to opioids, or a history of medication or other allergy that contraindicates their participation
* Use of prescription or non-prescription medications
* History of excessive alcohol use
* History of drug abuse within 6 months of screening
* Use of any illegal drug within 30 days of screening and throughout participation in the study
* History of smoking or use of nicotine containing products within 3 months of screening and throughout participation in the study
* Donation of blood or plasma 4 weeks prior to dosing
* Participation in a clinical trial and has received medication within 30 days
* Weight \<50 kg or BMI outside range of 18-32 kg/m2
* Positive for HIV antibody, hepatitis B virus surface antigen, or hepatitis C virus
* Unwillingness to abstain from sexual intercourse with a pregnant or lactating woman and, if engaging in sexual intercourse with a female partner of child-bearing potential, use a condom and spermicide, in addition to having their female partner use another form of contraception, and abstain from sperm donation
Effect of Modified Mirror Therapy in Patients With Upper Limb Hemiparesis After Stroke

This was a randomized controlled study in China conducted during Aug. 2022 to Aug. 2023. Totally, patients with upper limb hemiplegia after stroke, who were admitted in the Department of Rehabilitation Medicine of two hospitals, were enrolled. The study lasted 30 days for each participant. The patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy. Additionally, the patients in the experimental group were given modified mirror therapy.

Upper limb hemiparesis is a motor and sensory disorder that occurs after stroke, with an incidence rate of up to 55% to 75%. Effective upper limb rehabilitation methods help reduce the occurrence of disuse syndrome and complex regional pain syndrome. Therefore, finding active and effective limb rehabilitation methods has important practical significance.This was a randomized controlled study in China conducted during Aug. 2022 to Aug. 2023. Totally, patients with upper limb hemiplegia after stroke, who were admitted in the Department of Rehabilitation Medicine of two hospitals, were enrolled. The study lasted 30 days for each participant. The patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy. Additionally, the patients in the experimental group were given modified mirror therapy. The assessment was conducted respectively on day 1 and day 30.

Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnostic criteria of stroke, by CT or MRI.
* The first-onset stroke.
* Presenting with unilateral upper limb dysfunction, within Brunnstrom stage Ⅱ to Ⅳ on the affected side, and Ash-worth score ≤2.
* No obvious cognitive impairment, with Mini-Mental State Examination (MMSE) score \>21 points.
* National Institutes of Health Stroke Scale (NIHSS) score \>4 points.
* Stable vital signs, no severe diseases such as cancer, liver or kidney disorders.
* Aged 35-70 years.
* Courses of diseases 2-6 weeks.

Exclusion Criteria:

* Presence of aphasia, apraxia, or hemispatial neglect.
* Presence of hearing, vision, or comprehension impairments that hinder diagnosis and treatment.
* Complicate with traumas, fractures, or other progressive neuro-muscular system diseases.
* Severe spasticity in the upper limbs.
* Severe bone, joint, or muscle deformities or lesions.
* History of mental illness.
The Additional Role of Supplemental Oxygen Therapy in Accelerated Corneal Collagen Cross-linking in Progressive Keratoconus. A Randomized Clinical Trial

It is aimed to investigate the role of supplemental systemic oxygen therapy during accelerated corneal collagen crosslinking (CXL).

In this prospective randomized clinical trial, patients with progressive keratoconus who are candidates for receiving CXL will be included. The patients will be randomized and allocated to three different CXL protocol. In the first group (OA-CXL), CXL is performed using an accelerated protocol (9 mW/ CM2 for 10 minutes) in addition to the delivery of systemic oxygen with a rate of 5 liters/min through a nasal mask for 10 minutes during UV-A ablation. Patients in the second group (A-CXL) will receive CXL with the same accelerated protocol without additional oxygen therapy. Conventional CXL using 30 mW/CM2 UV-A ablation for 30 minutes is perfomed in the patients of the third goup (C-CXL). Maximum keratometry in Sirius corneal tomography as the primary outcome and uncorrected and corrected distance visual acuity (UDVA, CDVA) and corneal biomechanical properties including corneal resistance factor (CRF) and corneal hysteresis (CH) as secondary outcome measures are followed for a six- and 12-months period. A P-value of less than 0.05 is considered as statistically significance level.


Eligibility Criteria:
Inclusion Criteria:

* definitive diagnosis of progressive keratoconus for whom CXL is indicated were enrolled in this study
* The indication is identified by a cornea specialist and was considered as follows.
* Patients with the definitive diagnosis of KC who aged 18 or more were considered for the procedure if they had an increase of 1 D in Kmax or an increase of 1D in the manifest cylinder over the past 12 months.

Exclusion Criteria:

* patients with the previous history of corneal surgery
* corneal scar or pathologies like herpetic eye disease or severe dry eye
* corneal thickness less than 400 micrometers
* pregnant or nursing women
* corneal Kmax more than 60
* age over 35 years
* severe ocular surface disease
Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial)

This study will assess the safety and early efficacy of a newly developed device, bridge-enhanced scaffold (MIACH™,) used to repair a torn anterior cruciate ligament (ACL.) Ten participants will undergo surgery with the new device (Experimental Group) and 10 will undergo a standard ACL reconstruction surgery (Control Group.)

This is a first-in-human trial for evaluation of the safety (Primary Objective) and short-term efficacy (Secondary Objective) of the MIACH™ ACL scaffold and will be carried out in form of an observational study of 20 patients: 10 experimental and 10 control.

Eligibility Criteria:
Inclusion Criteria:

* Complete ACL tear, confirmed by MRI
* Time from injury to screening must be less than or equal to 90 days
* ACL tissue present on pre-operative MRI

Exclusion Criteria (before surgery):

* Prior surgery on affected knee
* History of prior infection in affected knee
* Regular use of tobacco or nicotine in any form
* Use of corticosteroid within last 6 months
* Ever underwent chemotherapy treatment
* History of sickle cell disease
* History of anaphylaxis
* Any condition that could affect healing (Diabetes, inflammatory arthritis, etc)
* Diagnosis of posterolateral corner injury (LCL complete tear, Biceps femoris tendon avulsion, tear of the arcuate ligament, tear of the popliteus ligament)
* Diagnosis of Grade III medial collateral ligament injury
* Diagnosis of complete patellar dislocation

Exclusion Criteria (during surgery):

* ACL deemed normal on arthroscopic inspection
* Time from injury to surgery is greater than 90 days (for Comparator group) and greater than 30 days (for Experimental group)
* Experimental Group: Less than 50 percent of ACL remaining
* Displaced bucket handle meniscal injury requiring repair
* Diagnosis of full-thickness chondral injury on either condyle
* Grade III medial collateral ligament injury
Normal Pressure Hydrocephalus (NPH) Registry

The overall aim of the registry is to develop a longitudinal, observational database that is focused on adult patients with Normal Pressure Hydrocephalus (NPH) that can be used as a source of clinical information for individual surgeons, as well as a national data repository for scientific inquiry and publications.

This is a prospective, multi-center, observational database to collect data on the characteristics, management practices, and patient outcomes of NPH patients. It will be offered to a geographically representative group of U.S. physicians who will enroll NPH patients. The physician makes his/her own clinical decisions; thus, the data captured provides current practice patterns related to diagnosis, management, and results. The registry may also assist physicians in patient follow-up and certain practice management tasks. The data collected will serve to inform the medical community on optimal care for this patient population

Eligibility Criteria:
Inclusion Criteria:

* Patient meets the diagnosis criteria for Normal Pressure Hydrocephalus
* Patient is a candidate for a hydrocephalus shunt system, per the discretion of the investigator
* Patient or legal representative has signed an informed consent form. Competency to sign the consent form will be left up to the discretion of the investigator

Exclusion Criteria:

* Patient is under the age of 18 years
* Patient has a known contraindication for a shunt
* Patient has an expected life span of less than 24 months
* Patient has an unwillingness or inability to return for required follow-up visits
TheEffect of pH on Misoprostol in Induction of Labor

Misoprostol is a synthetic analogue of the naturally occurring prostaglandin E1. It was initially marketed for the treatment of peptic ulcers due to its mucosal protective and anti-secretory properties, but has commonly been used for the induction of abortion and labour .

Although initially having been established for oral use, misoprostol tablets are commonly used as vaginal suppositories for the previously purposes. Water or saline are frequently used in common practice to moisten the tablets prior to their administration, however, according to the pharmacokinetics of the drug, it should liquefy better in an acidic medium

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies. Gestational age 38-41 weeks. Cephalic presentation

Exclusion Criteria:

* 1. Multi-fetal pregnancy. 2. Pregnant women less than 38 weeks gestation.
Assessing Her2/Neu Expression in Gastric Cancer With Dual or Multiple Tumor Tissue Paraffin Blocks

One paraffin block is routinely used for Human Epidermal Growth Factor Receptor 2 (Her2/neu) immunohistochemistry (IHC) assessment. Here, investigators investigated if picking two or multiple paraffin blocks for Her2/neu evaluation is an economical, efficient and practical method, which may reduce false-negativity of Her2/neu IHC assessment due to intratumoral heterogeneity.


Eligibility Criteria:
Inclusion Criteria:

Age between 18 to 80; Received curative surgery with primary gastric adenocarcinoma; Did not receive any preoperative treatment.

Exclusion Criteria:

None.
Daily Vitamin K in Patients on Warfarin With Unstable INRs

The purpose of this study is to determine if daily Vitamin K supplementation stabilizes INRs in patients taking warfarin with a history of frequent dose changes or variable INRs.

Consistent daily Vitamin K intake may contribute to the stabilization of INR values in patients with unstable INRs on warfarin therapy. Subjects with unstable INRs will be identified from the existing patient records of the UNC Anticoagulation Clinics. Eligible subjects will sign an informed consent form and will receive a point-of-care (POC) INR monitoring device. They will undergo 9 weeks of home INR monitoring via the POC device (with monthly clinic follow-up). They will subsequently be provided with 500 mcg Vitamin K tablets to be taken once daily. Weekly POC INR monitoring with monthly clinic follow-up will continue for an additional 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patient of UNC Anticoagulation Clinic with INR target of 2.0-3.0 and at least 9 months on uninterrupted warfarin
* Unstable INRs for the past 6 months, defined as a minimum number of warfarin dose changes of 3
* Patient demonstration of proper POC device technique on 2 measurements during one teaching session with investigator
* Age greater than or equal to 18 years

Exclusion Criteria:

* Stroke or TIA within the previous 12 months
* VTE within the last 3 months
* Antiphospholipid antibody syndrome
* Pregnant patients, since warfarin is contraindicated during pregnancy