cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness Evaluation of TEOSYAL® TPVM Versus COMPARATOR for the Remodeling of the Lower Face

The clinical study is designed to prospectively evaluate the safety and effectiveness of TEOSYAL® TPVM when compared to COMPARATOR for the remodeling of the lower face

This is a prospective, randomized, blinded evaluator, multicenter, clinical study to evaluate safety and effectiveness of TEOSYAL® TPVM versus COMPARATOR for the remodeling of the lower face.

Subject will be enrolled in the study based on evaluation of their chin retrusion severity.

For the purpose of this study, all injections will be done by principal investigators (PIs) with several years of experience in aesthetic treatment.

An external aesthetic and cosmetic surgeon will act as a BE to assess the performance of the treatment and the product based on photographs.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult subjects over 18 years old seeking correction of their lower face
* Subject scored grade 2 or 3 on the TCRS
* Female subjects of childbearing potential must have a negative UPT and practice a reliable method of contraception throughout the study.
* Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
* Able to follow study instructions and complete all required visits.
* Having given its signed informed consent

Exclusion Criteria:

* Known hypersensitivity or previous allergic reaction to any component of the study devices
* Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
* History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
* Subject exhibits any physical attribute that may prevent assessment or treatment of the lower face as judged by the PI
* Clinically significant alcohol or drug abuse.
* Subject has received any investigational product within 90 days prior to Visit 1 or planning to participate in another investigation during the course of the study.
Clinical Reasoning Process of Physiotherapists When Observing Hemiplegic Gait

The goal of this study is to find out what clinical reasoning process physiotherapists undergo when observing hemiplegic patients gait.

Physiotherapists don't usually use any assessments to evaluate gait but observe it without an instrument. The questions in this study are:

* what abnormalities can physiotherapists detect when observing a patient walking?
* what do they consider the main problem that has a negative effect on the patient's walking?
* what hypothesis do they generate?
* how is the inter-rater reliability for the "main problem" and the hypothesis?

Eligibility Criteria:
Inclusion criteria:

* chartered physiotherapists
* physiotherapists in training
* working with stroke patients

Exclusion criteria:

- other languages than German
Endobronchial Mucosal Biopsy in Patients With Suspected Pulmonary Sarcoidosis

This prospective interventional study was done between May and September 2020. We included 20 patients from the chest department, Alexandria Main University Hospital (AMUH) with the inclusion criteria of having suspected pulmonary sarcoidosis (based on clinical and radiological presentation) and being ≥18 years of age. The bronchoscopy procedure was done under local anesthesia. Endobronchial biopsies and bronchoalveolar lavage were obtained.

This prospective interventional study was done between May and September 2020. We included 20 patients from the chest department, Alexandria Main University Hospital (AMUH) with the inclusion criteria of having suspected pulmonary sarcoidosis (based on clinical and radiological presentation) and being ≥18 years of age. The patients who had any contraindication for flexible bronchoscopy (e.g. severe refractory hypoxemia, hemodynamic instability, uncorrectable bleeding diathesis, recent myocardial infarction or unstable angina) were excluded. The study was approved by the institutional ethics committee and an informed consent was taken from all patients before participation in the study according to the guidelines of ethics committee, Alexandria faculty of medicine.

All included patients were subjected to the followings: 1)full history taking including age, sex, history of other diseases and the presenting symptoms, 2)clinical examination including general examination and local chest examination, 3)routine laboratory investigations including complete blood picture, renal function tests, prothrombin activity and international normalized ratio (INR), 4)radiological evaluation including plain x-ray postero-anterior view and CT chest with IV contrast and 5) The bronchoscopy procedure that was performed by two experienced bronchoscopists.

The bronchoscopy procedure was done under local anesthesia with help of sedation by gradual doses of midazolam via the intravenous line. Any abnormal endoscopic findings suggestive of endobronchial sarcoidosis were reported by the operators. Bronchoalveolar lavage (BAL) was obtained by endoscopic injection of at least 120 cc of sterile saline then suction of the whole possible yield. Four endobronchial biopsies were obtained from the described findings plus two other biopsies from the main carina. In absence of mucosal abnormalities, four specimens were taken from a secondary carina and two were taken from the main carina. Immediate and 2 hours' postoperative clinical evaluation was done to detect any possible complications.

Eligibility Criteria:
Inclusion Criteria:

* Having suspected pulmonary sarcoidosis (based on clinical and radiological presentation) and being ≥18 years of age.

Exclusion Criteria:

* any contraindication for flexible bronchoscopy (e.g. severe refractory hypoxemia, hemodynamic instability, uncorrectable bleeding diathesis, recent myocardial infarction or unstable angina)
Application of Cultured Autologous Keratinocytes for Burn Wound Healing

In this study the treatment of full thickness burn wounds with cultured autologous keratinocytes in combination with meshed split skin autograft versus meshed split skin graft alone will be compared. It is expected that the application of cultured autologous keratinocytes in combination with a meshed split skin autograft will improve wound healing and scar formation.

The standard treatment for extensive burn wounds is transplantation with meshed split skin graft. Disadvantages of this treatment are that healing of large full thickness burn wounds is still accompanied by scar formation. Even standard treatment, transplantation with a (meshed) split skin autograft, does not result in satisfactory functional and cosmetic appearance of the healed wound. Due to limited available donor sites meshes needs to be enlarged. Bigger enlargements of meshes give more scarring and mesh pattern are still visible in scars, probably because wound closure still needs several weeks. Application of cultured autologous keratinocytes may enhance wound closure and improve outcome of healing.

Primary objective: Does the application of cultured autologous keratinocytes on deep burn wounds accelerate wound closure Secondary objectives: Does the application of cultured autologous keratinocytes on deep burn wounds improve scar quality with respect to scar elasticity, colour/pigmentation and/or smoothness after 3 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Competent and temporarily incompetent patients 18 years of age or older with acute burn wounds that require widely meshed skin grafting, which do not need immediate excision
* Minimal study wound area 100 cm2
* Maximal study wound area 300 cm2
* Maximal TBSA 30% full thickness wounds
* Informed consent

Exclusion Criteria:

* Immunocompromised patients
* Infected wounds
* Use of high doses of (.20mg/pd) corticosteroids and/or cytostatica
* Known penicillin allergy
* Conditions where the patient is non compliant as judged by a medical specialist
Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured Patients

The new coronavirus pneumonia is an acute infectious pneumonia. The pathogen is a previously unknown new coronavirus, namely 2019 new coronavirus (2019 novel coronavirus, 2019 nCoV). However, there is no specific anti-viral drug. It has been found that the specific antibodies against virus antigen are produced after these patients were cured, which could block the infection of 2019 nCoV on the host cells. At present, immunoadsorption is the most direct, rapid and effective method to separate immunoglobulin from the cured patients. Therefore, the study aims to prepare the immunoglobulin from 2019-ncov pneumonia cured patients, evaluate the efficacy and safety of the immunoglobulin in 2019-ncov pneumonia cured patients on the treatment of acute severe 2019-ncov pneumonia, and provide a new strategy for the treatment of 2019-ncov pneumonia.


Eligibility Criteria:
Inclusion Criteria:

1. Volunteers who have understood and signed the informed consent;
2. Age ≥18 years, gender unlimited;
3. Patients diagnosed with acute severe 2019-nCoV pneumonia:

   1. Laboratory (RT-PCR) confirmed infection with 2019-nCoV.
   2. Lung involvement confirmed with pulmonary CT scan.
   3. At least one of the following conditions should be met: respiratory distress, RR ≥ 30 times/min; oxygen saturation ≤ 93% in resting state; PaO2/FiO2 ≤ 300mmHg; respiratory failure and mechanical ventilation are required; shock occurs; ICU monitoring and treatment is required in combination with other organ failure.

Exclusion Criteria:

1. Viral pneumonia with other viruses besides 2019-nCoV.
2. Patients are not suitable for immunoglobulin therapy.
3. Participation in other studies.
4. Other circumstances in which the investigator determined that the patient is not suitable for the clinical trial.
Circulating Tumor DNA After Neoadjuvant Chemotherapy

Trial assessing the prognostic value of ctDNA mutations from samples taken sequentially in patients with invasive breast cancer initially treated with neoadjuvant chemotherapy and whose tumor is not in complete histological response.

Patients with an invasive breast cancer on neoadjuvant chemotherapy (with the exception of cT2cN0 tumors) are preselected before the surgical procedure. They are definitely included during the post-surgery visit following the analysis of the surgical specimen (only patients whose tumor did not achieve a complete pathological response are included).

Sequential plasma samples for ctDNA mutations analysis will be taken during the post-surgery visit (within 2-5 weeks after surgery) and every 6 months (+/- 1 month) thereafter for 5 years.

In case of relapse patients will be proposed to participate to an optional research program with a blood test for ctDNA assessment and biopsies from a metastasis (when these biopsies are clinically indicated).

Eligibility Criteria:
Inclusion Criteria :

1. Age ≥ 18 years (no age limit).
2. Women or men.
3. Invasive breast cancer proven histologically at diagnosis (before neoadjuvant chemotherapy):

   1. Locally advanced tumor known to be inoperable from the start:

      * cT4a, b, c, d whatever the cN
      * or cN2 or cN3 whatever the cT.
   2. Operable tumors:

      * cT2cN1 or cT3cN0 or cT3N1,
      * or cT2cN0 for which ganglionic invasion has been proven by cytology or histology.
4. Lack of clinically or radiologically detectable metastases in the initial diagnosis before the neoadjuvant chemotherapy (M0).
5. Unilateral or bilateral breast cancer. Multifocality is accepted.
6. Patients who received 6 to 8 cycles of neoadjuvant chemotherapy.
7. Preoperative radiation therapy allowed.
8. Breast surgery performed and pathology report of a non-complete histological response (i.e. all the different results of ypT0 /is ypN0).
9. Signed informed consent.
10. Patients affiliated to a French social security scheme in accordance with Article 1121-11 of the French Code of Public Health.
11. Possible inclusion in another interventional research (surgical, radiotherapy or drug study).

Exclusion Criteria :

1. cT2cN0 tumor without cytological or histological lymph node involvement.
2. Progression during neoadjuvant chemotherapy.
3. Exclusive neoadjuvant hormone therapy.
4. Complete blood transfusion within 120 days prior to 1st sampling.
5. History of invasive cancer regardless of the time elapsed since the diagnosis of this cancer, including a history of contralateral invasive breast cancer. However, patients who have been treated for in situ breast cancer, basocellular skin cancer or cervical cancer treated in situ are eligible.
6. Patient unable to follow and comply with research procedures for geographical, social or psychological reasons.
7. Patient deprived of liberty or subject to a legal protection measure.
The Effect of Aquacel® Ag+ Extra Dressing on Wound Biofilms

The purpose of the research is to assess the effects of Aquacel Ag+ Extra dressing on chronic wound bacterial biofilms

Background: Chronic wounds and wound infections can be costly, resulting in prolonged hospital stays and an increased risk of secondary infection and septicaemia. In the UK the management of chronic venous leg ulcers is estimated to cost £1 billion/year, with surgical site infections requiring approximately 6.5 days additional hospital stay. Chronic wounds typically harbour a wide variety of bacteria; heavy bacterial colonisation and subsequent biofilm formation has been cited as a factor which induces a chronic inflammatory state and delays healing times.

AQUACEL®Ag+ Extra is a soft conformable flat sheet nonwoven fabric dressing, which forms a gel when it becomes wet. Its physical characteristics have the potential to increase the speed of antimicrobial action of silver and its effectiveness against any recalcitrant wound bioburden. Removing these potential barriers to healing may help towards wound progression.

Aim: This is a pilot study to investigate the effects of Aquacel Ag+ Extra dressing on chronic wound bacterial biofilms. Wound debridement tissue will be assessed for the presence/absence of in situ biofilms which will be monitored over 4 weeks and compared to the baseline (non-treatment) sample. Additionally, we will evaluate reductions in wound volume over the treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Provided written informed consent
* Be over 18 years of age
* Must have a chronic foot wound greater than 4 weeks in duration
* Be willing and able to attend the clinic for the required study visits -

Exclusion Criteria:

* Subjects with a history of sensitivity to any one of the components of the device being studied
* Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
* Subjects who are currently participating in or have been on a clinical study within the last 4 weeks.
Performance Evaluation of Clinical Ultrasound in Management of Acute Pulmonary Edema in Elderly Patient

The main objective is to assess the validation of the diagnosis early acute pulmonary edema in elderly patients with acute respiratory distress, admitted in a host of vital emergency services by lung ultrasound associated with the measurement of the inferior vena cava.


Eligibility Criteria:
Inclusion Criteria:

* Patient with compatible episode with acute edema (tachypnea with respiratory rate\> 25/min and/or oxygen saturation on room air \<90%, auscultation, dyspnea, sudden onset of symptoms)

Exclusion Criteria:

* Vital signs of distress requiring intubation tracheal immediately
* Myocardial infarction lower seat with extension to the right ventricle, in the acute phase
Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo

The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced disease.

The primary evaluation criterion is clinical benefit response.

The study will include patients with a variety of solid tumors (i.e. esophageal, colon, pancreatic, bronchial, gastric, hepatocellular, gall bladder, prostate and gynaecological carcinomas.)

The clinical benefit response - CBR, is an end point that provides a clinical measure for symptom improvement in patients. The key evaluation parameters for CBR will be assessment of pain, the ability to perform daily activities and weight change.

Eligibility Criteria:
Inclusion Criteria:

* Cancer confirmed by histology or cytology
* At least one measurable lesion
* Advanced disease refractory to standard therapy or for which no standard therapy exists
* Life expectancy at least 3 months

Exclusion Criteria:

* Known secondary neoplasia or central nervous system (CNS) metastases, acute or chronic leukemia, lymphoma or multiple myeloma
* Body weight below 45 kg
* Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective birth control methods
* Concurrent severe or uncontrolled medical disease
* Acute or chronic liver disease
* Confirmed diagnosis of HIV
* Insulin dependent diabetes mellitus/abnormal glucose tolerance test (GTT)/latent diabetes mellitus type I or II
* Chemotherapy or radiotherapy less than 4 weeks prior to entry
* Surgery less than 2 weeks prior to entry (or not recovered from effects of surgery)
* Participation in a clinical trial less than 30 days prior to entry into this study
Ultrasound Elastography in Diagnosing Patients With Kidney or Liver Solid Focal Lesions

This clinical trial studies ultrasound elastography in diagnosing patients with kidney or liver solid focal lesions. New diagnostic procedures, such as ultrasound elastography, may be a less invasive way to check for kidney or liver solid focal lesions.

PRIMARY OBJECTIVES:

I. To determine the utility of ultrasound elastography in correlation with kidney or liver biopsy or magnetic resonance imaging (MRI) or computed tomography (CT) results.

OUTLINE:

Patients undergo ultrasound elastography.

Eligibility Criteria:
Inclusion Criteria:

* There are no restrictions on life expectancy
* Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will not be employed
* Patients of any ethnic background
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients should not be taking other investigational agents
* No requirements due to co-morbid disease or intercurrent illness, as needed
* No restrictions on allergic reactions as no imaging agent will be used
* Concomitant medications for treatment of the target lesion
* Pregnant or nursing patients will be excluded from the study
Resection Margin of Transverse Colon Cancer With Extracorporeal Versus Intracorporeal Anastomosis

The approach of anastomosis in laparoscopic resection of transverse colon cancer (TCC) has rarely been discussed. This study aims to compare the resection margin of TCC with extracorporeal anastomosis (ECA) versus intracorporeal anastomosis (ICA).

Patients who underwent laparoscopic resection of TCC from August 2019 to July 2021 in 13 participating centers are included in this study. According to the approach of anastomosis, patients are divided into two groups, ECA group and ICA group respectively. The clinical characteristics, the perioperative outcomes and the pathological results (especially the length of resection margin) are compared between the two groups. The length of two-sided resection margins (long margin, short margin) are measured on formalin-fixed specimens and those with short margin less than 4.0 cm are defined as unqualified specimens.

13 participating centers are as follows: Ruijin Hospital, Shanghai Jiaotong University School of Medicine；Zhejiang University Medical College Affiliated Sir Run Shaw Hospital；Zhongshan Hospital Affiliated to Fudan University；Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University; Jiangsu Provincial People's Hospital; Xiangya Hospital of Central South University; The First Affiliated Hospital of Chongqing Medical University; The first hospital of Jilin University; Beijing Friendship Hospital Affiliated to Capital Medical University; Tangdu Hospital; Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology; Cancer Hospital of Chinese Academy of Medical Sciences; Henan Provincial People's Hospital

Eligibility Criteria:
Inclusion Criteria:

* 1. pathologically confirmed adenocarcinoma of colon
* 2. The tumor is located in the transverse colon (including hepatic or splenic flexure);
* 3. One of the following procedures was performed: transverse colectomy, right hemicolectomy, enlarged right hemicolectomy, left colectomy, enlarged left colectomy;
* 4. Laparoscopic surgery (laparoscopy-assisted surgery or complete laparoscopic surgery) from August 2019 to July 2021;
* 5. Radical resection (R0) was accomplished;

Exclusion Criteria:

* 1. Simultaneous multiple colorectal cancer;
* 2. history of colorectal surgery (except endoscopic surgery);
* 3. robot-assisted surgery;
* 4. palliative resection (non-R0 resection) or palliative bypass;
* 5. the approach of anastomosis could not be determined from the documents;
* 6. the length of resection margin was not recorded in pathological report;
Cluster, Randomized Trial on Long Acting Reversible Contraception (LARC) Education and Training

The purpose of the study is to measure whether an education and training intervention for clinicians and contraceptive counselors on long-acting reversible contraception (LARC) will result in greater use of the methods among contraceptive patients.

Unintended pregnancy is extremely high in the United States among young women, and use of contraceptives with top-tier effectiveness, intrauterine contraception and implants, is low. Contraceptive providers in the US have low knowledge of current scientific evidence on LARC methods, and do not routinely include these methods in counseling patients at highest risk of unintended pregnancy. This intervention provides evidence-based education and hands-on training to clinicians and contraceptive educators in Planned Parenthood affiliated Title X clinics throughout the US on LARC methods.

Eligibility Criteria:
Inclusion Criteria:

This study involves two groups of human subjects: patients and staff at participating Planned Parenthood (PP) clinics in the United States.

Patient participants are young women receiving contraceptive counseling at Planned Parenthood clinics and staff participants are the clinicians and health educators serving these women.

Patients must be:

Female;

* Age 18-25;
* Fluent in English or Spanish;
* Not wanting to become pregnant in the next 12 months;
* Sexually active in past 3 months;
* At risk of pregnancy;
* Received contraceptive counseling;
* Not pregnant;
* Willing to be contacted by telephone over the next 12 months.

Clinic staff must be:

* Employed by a participating PP clinic; and
* Offer clinical care, counseling or education for abortion or contraception at the clinic. (This may include physicians, advance practice clinicians, nurses, social workers and health educators.)

For clinics to be eligible to be study sites, they must:

* Not share staff
* Have no active LARC interventions ongoing
* Have \>400 clients/year