cyrilzakka/clinical-trials huggingface dataset:
Autologous Regeneration of Tissue (ART) for Wound Healing

The purpose of this research study is to learn about a new device, Autologous Regeneration of Tissue (ART), for collecting skin grafts from participant's own skin.


Eligibility Criteria:
Inclusion Criteria:

* Adults from 18 to 90 years of age.
* Patients that have a chronic wound in any area of the body defined as having been present for at least 30 days of duration.
* Able and willing to give consent for the study.

Exclusion Criteria:

* Pregnant women (Urine hCG test will be performed at baseline on women of child bearing potential).
* Adults unable to consent.
* Prisoners.
* Subjects requiring concurrent systemic antimicrobials during the study period for any infection.
* Subjects with leg lesions and clinically significant and unreconstructed peripheral arterial disease.
* Subjects who are receiving immunosuppressive agents, radiation therapy, or cytotoxic agents.
* Subjects who require treatment for a primary or metastatic malignancy (other than squamous or basal cell carcinoma of the skin).
* Subjects with other conditions considered by the investigator to be reasons for disqualification that may jeopardize subject safety or interfere with the objectives of the trial (e.g., acute illness or exacerbation of chronic illness, lack of motivation, history of poor compliance).
Desensitizing Effect and Tooth Color Change After Using Giomer-based Varnish Versus Bioactive Glass Air Polishing in Treating Cervical Hypersensitive Lesions

This trial is test the dentin hypersenstivity using Giomer based Varnish versus Bioactive glass air polishing system in patients with non-cervical lesions.

To investigate the clinical effectiveness of Giomer based varnish versus Bioactive glass air polishing System in the management of dentin hypersensitivity and tooth color change in the cervical lesions.

P:Patient/Population: Middle aged patients complaining of cervical dentin hypersensitivity. I: Giomer varnish containing surface pre-reacted glass fillers. C: Bio-active glass air polishing system: O:Dentin Hypersenstivity (Primary Outcome) was assessed by three different stimuli (evaporative , thermal and tactile) . O: Color Change (Secondary Outcome). T: Baseline, T1, T2, T3. S:a randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Participants complaining from dentin hypersensitivity.
* Middle aged patients.
* Good oral hygiene.

Exclusion Criteria:

* Pregnant women.
* Patients with allergy to any material used in this study.
* Smoking patients will affect the oral hygiene and periodontal health.
* Patients taking anti-inflammatory drugs that will affect the perception of hypersensitivity.
* Systemically compromised patients.
* Smokers.
* Patients received desensitization treatment in the last 6 months
Metabolic Disturbances in Polycystic Ovary Syndrome (PCOS)

The scope of the study was to investigate different metabolic aspects that may lead to or are a consequence of insulin resistance in premenopausal women with polycystic ovary syndrome (PCOS). We use gold standard methods for evaluation of insulin resistance. We take muscle and fat biopsies for investigation of gene expression of different cytokines associated with insulin resistance. We investigate the incretin hormones GIP and GLP-1. These two hormones play a central role in glycemic control, and diabetic subjects are known to have alterations in their incretin hormones. The incretin hormones have not previously been investigated in women with PCOS.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women that meet the Rotterdam criteria for PCOS (BMI \< 40)
* Age and BMI matched control women that do not have any signs or symptoms of PCOS

Exclusion Criteria:

* BMI \> 40. mani fest diabetes or other known diseases
Serratus Plain Block Versus Paravertebral Block Versus Serratus Plain Block and Paravertebral Block for Postoperative Pain Following Thoracoscopic Surgery

Acute and chronic postoperative pain remains a major concern following thoracoscopic surgery. Firstly because pain constitutes a serious concern for patients after surgery, and secondarily because an ineffective control of pain may lead to postoperative morbidity, especially in lung cancer surgery.

To date, several procedures have been described but the best modality of locoregional analgesia for thoracoscopic surgery has not been assessed yet. The main objective of this study is to evaluate efficiency of several validated approaches for preoperative locoregional analgesia, comparing serratus plain block versus paravertebral block versus serratus plain block and paravertebral block for postoperative pain following thoracoscopic surgery.

To this end, the investigators will conduct an interventional prospective monocentric, double blind, compared and randomized study. Previously to thoracoscopic surgery, patients will be randomized in one of the three following arms: serratus plain block, paravertebral block or serratus plain block and paravertebral block combined.


Eligibility Criteria:
Inclusion Criteria:

* adult patient over18 years old
* without guardianship
* video-assisted thoracoscopic surgery with 3 trocars
* No cons-indications to loco-regional anesthesia (allergy, skin condition)

Exclusion Criteria:

* patient under 18 years old
* patient under guardianship
* pregnant
* rejection of consent
* rejection of loco-regional anesthesia
* chronic pain antecedents under morphine medication
* pain assessment impossible
Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules

This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future. This study will also investigate how the body handles AZD5363 (ie, how quickly the body absorbs and removes the drug). This study will also investigate anti-tumour activity of AZD5363 in patients with advanced / metastatic breast, gynaecological cancers or other solid cancers bearing either AKT1 / PIK3CA or PTEN mutation.

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 under Adaptable Dosing Schedules in Patients with Advanced Solid Malignancies.

Eligibility Criteria:
Inclusion Criteria:

* Aged at least 18 years.
* Parts A,B: The presence of a solid, malignant tumour, excluding lymphoma, that is resistance to standard therapies or for which no standard therapies exist.
* ER+/HER2+ breast, ovarian, cervical, endometrial cancer, or other solid cancers, resistance to standard therapies with a PIK3CA gene mutation (Part C), AKT1 gene mutation (Part D) or a dysregulatory aberration on the PIK/AKT pathway (Part D), advanced or metastatic ER+ positive breast cancer that has an AKT1 gene mutation (Part E) or advanced or metastatic ER+ positive breast cancer that has a PTEN gene mutation (Part F).
* The presence of at least one lesion that can be accurately assessed at baseline by CT, MRI or plain X-ray and is suitable for repeated assessment. Estimated life expectancy of more than 12 weeks.
* Estimated life expectancy of more than 12 weeks.

Exclusion Criteria:

* Clinically significant abnormalities of glucose metabolism.
* Spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids).
* Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
* Evidence of clinically significant cardiac abnormalities, uncontrolled hypotension, left ventricular ejection fraction below the lower limit of normal for the site or experience of significant cardiac interventional procedures.
* A bad reaction to AZD5363 or any drugs similar to it in structure or class.
Pulmonary Rehabilitation and Self-esteem in Patients With COPD

the aim of this study is to evaluate the evolution of self-esteem during a pulmonary rehabilitation program, in COPD patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient with stage 2 to 4 (A to D) COPD admitted to a pulmonary rehabilitation program
* Patient aged 18 or over
* Patient able to consent and having signed a consent form

Exclusion Criteria:

* Patient with pain, osteoarthritis or shoulder surgery
* Patient with a history of Pneumonectomy, lobectomy less than 6 months old
* Refusal of participation
* Patient with an inability to complete a pulmonary rehabilitation program in totality
* Pregnant or breast-feeding women
* Patient under tutorship or curatorship
Protective Effect of Beraprost Sodium Tablets on Reperfusion Therapy for Acute STEMI

Protective effect of Beraprost Sodium Tablets on coronary microcirculation function and ventricular remodeling after reperfusion therapy for acute ST segment elevation myocardial infarction


Eligibility Criteria:
Inclusion Criteria:

* It meets the diagnostic criteria of acute ST segment elevation myocardial infarction: ischemic chest pain lasts for more than 30 minutes and can not be relieved by taking nitroglycerin; ST segment elevation of ECG with two or more adjacent leads, limb lead ≥ 1mm, chest lead ≥ 2mm; Or new left bundle branch block; The serum markers of myocardial necrosis increased at least twice the normal value
* Acute myocardial infarction was confirmed by coronary angiography
* The clinical and angiographic data were complete
* Direct PCI was performed within 12 hours after onset

Exclusion Criteria:

* Those who do not cooperate in the inspection, have poor compliance and cannot guarantee the completion of the test
* Conscious disorder, obvious intellectual disorder and mental disorder
* With metal foreign bodies, such as metal prosthesis, intraocular metal foreign bodies, intracranial aneurysm clamp, etc
* People with claustrophobia
* Had a history of myocardial infarction, PCI and coronary artery bypass grafting
* Factors affecting ST segment changes of ECG: complete left bundle branch block, preexcitation syndrome, pacemaker ECG, etc
Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate-to-Severe Plaque Psoriasis

This is a randomized, double-blind, placebo-controlled, multicenter clinical trial in participants with moderate-to-severe plaque psoriasis .


Eligibility Criteria:
Inclusion Criteria:

1. Subject voluntarily takes part in the study after being fully informed,signs a written ICF, and agrees to follow procedures specified in the study protocol;
2. Plaque psoriasis assessed by the investigator as suitable for systemic treatment and stable (defined as stable as no significant outbreak of morphological change or disease activity assessed by the investigator) for at least 6 months prior to signing informed consent;
3. During the screening period and before taking the investigational drug for the first time, psoriatic surface area (BSA) ≥10%, PGA score ≥ 3, PASI score ≥ 12;
4. Hematology, Blood chemistry and Urinalysis examination were basically normal.

Exclusion Criteria:

1. Erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, reverse psoriasis, drug-induced psoriasis;
2. Have other skin lesions that affect the evaluation of treatment outcomes, such as eczema;
3. History of herpes zoster/herpes simplex, or presence of herpes zoster/herpes simplex infection during the screening period;
4. Have a history of tuberculosis, or active tuberculosis, or latent tuberculosis, or suspected clinical manifestations of tuberculosis infection;
5. Other conditions that the investigator considers inappropriate for participation in the study.
A Clinical Trial on Whole-brain Radiotherapy With Temozolomide Concurrent Chemotherapy or Avoidance of Hippocampus for Patients of Brain Metastases

The purpose of this study is to evaluate the effects on neurocognitive function of whole-brain radiotherapy (WBRT) with/without TMZ concurrent chemotherapy or avoidance of hippocampus for patients of brain metastases, as well as the feasibility and risk of avoidance of hippocampus during whole-brain radiotherapy.

This is a phase II randomized clinical trial. It is reported that avoidance of hippocampus during whole-brain radiotherapy (WBRT) had benefits in preservation of memory for patients, and the use of concurrent TMZ in radiotherapy for patients with brain metastases benefited for treating outcome.

The purpose of this study is to evaluate the effects on neurocognitive function of whole-brain radiotherapy with/without TMZ concurrent chemotherapy or avoidance of hippocampus for patients of brain metastases, as well as the feasibility and risk of avoidance of hippocampus during whole-brain radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Primary lesions diagnosed by pathology or cytology
* Brain metastases confirmed by brain MRI or CT(\>3 brain metastases）
* Brain metastases beyond 5mm of hippocampus
* Male or female patients with age between 18 and 75 years old
* Karnofsky Performance Scores ≥ 60
* Expected survival ≥ 6 months
* No previous brain surgery or brain radiotherapy
* Without dysfunction of heart, lung, liver, kidney and hematopoiesis
* The primary carcinoma is under control

Exclusion Criteria:

* MMSE score \<27
* Dysfunction of heart, lung, liver, kidney or hematopoiesis
* Severe neurological, mental or endocrine diseases
* History of alcohol or drug abuse within 3 months
* Visual or hearing dysfunction, low education level, or other reasons leading to not capable of taking the MMSE test
* Currently under treatment may effect patients' neurocognitive functions
* Patients participated in clinical trials of other drugs within last 3 months
* Other unsuitable reason
Preoperative Dexmedetomidine & EC50 of Propofol

Dexmedetomidine is a useful anaesthetic adjuvant for general anaesthesia. In this prospective randomised study, we determined whether preoperative dexmedetomidine administration could reduce the half maximal effective concentration (EC50) of propofol for successful i-gelTM insertion without muscle relaxants.

Propofol is a useful induction agent for LMA insertion without muscle relaxants because it profoundly inhibits pharyngeal and laryngeal reactivity. A previous report showed that the effect-site concentration of propofol for successful classic LMA insertion in 50% of adults (EC50) without muscle relaxants in healthy male patients was 8.72 (0.55) µg ml-1. The EC50 of propofol may be dependent on the type of LMA used. A previous study comparing the EC50 of the propofol concentration between classic and proseal LMA insertions demonstrated that the EC50 of propofol needed for proseal LMA insertion was 35% greater than that needed for classic LMA insertion. Unfortunately, no investigation has been performed to determine the EC50 of the propofol concentration required for i-gel insertion without muscle relaxants.

Dexmedetomidine (DEX), a selective alpha-2 agonist, has sympatholytic, sedative, and analgesic properties. Such beneficial characteristics make DEX a useful anaesthetic adjuvant for general anaesthesia. Many reports have revealed the beneficial effects of DEX in terms of reducing intraoperative anaesthetic requirements, postoperative analgesic demand, and increased haemodynamic responses to noxious stimuli such as endotracheal intubation. A previous investigation showed that preoperative clonidine, an alpha-2 agonist, decreased the EC50 required for LMA insertion.

We hypothesised that preoperative DEX administration can reduce the propofol concentration required for i-gel insertion. In this study, we compared the EC50 of propofol needed for successful i-gel insertion without muscle relaxants between DEX and placebo groups

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II patients who were 20-65 years old and scheduled for general anaesthesia for urologic surgery

Exclusion Criteria:

* Patients with an allergy to alpha-2 adrenergic agonists or propofol
* Patients who anticipated difficult airway (cervical spinal disease, Mallampati score of III or IV, a mouth opening of \<2.5 cm, and/or body mass index of \>30 kg m-2), unstable teeth
* Patients with bradycardia of \<50 beats/min, heart block greater than first degree, severe cardiorespiratory dysfunction
* Patients with symptoms of upper respiratory infection
Immune Response Elicited by Concomitant Administration of Oral Typhoid Fever (Vivotif®) and Cholera (Dukoral®) Vaccines

The goal of this clinical trial is to explore the coadministration of oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines in healthy volunteers aged 18-65 years. The main question it aims to answer is:

• Does coadministration impact the immune responses to Vivotif® and Dukoral® vaccines

Participants will:

* receive either oral typhoid fever (Vivotif®) or oral cholera (Dukoral®) vaccines or both simultaneously
* give blood samples for immunogenicity analyses
* participate in adverse event follow up

Researchers will compare those receiving only one of the vaccines to those receiving both simultaneously to see if coadministration has an impact on antigen-specific responses measured with:

* ELISPOT (plasmablast responses specific to Salmonella typhi, Vibrio Cholerae and Enterotoxigenic Escherichia coli)
* ELISA (antibodies in lymphocyte supernatants (ALS) and serum antibodies specific to vaccine antigens)


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged ≥18 to ≤65 years.
2. General good health as established by medical history and physical examination.
3. Written informed consent.
4. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study (14 days before immunization to day 28 ± 3). Abstinence is acceptable.
5. Available for all visits scheduled in this study.

Exclusion Criteria:

1. Vaccination against typhoid fever or cholera within 5 years before dosing.
2. History of clinical typhoid fever or cholera.
3. Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study period or vaccination planned during it.
4. Current intake of antibiotics or end of antibiotic therapy \<8 days before first IMP administration.
5. Chronic (longer than 14 days) administration of immunosuppressants or other immunemodifying drugs within 6 months before the first dose of IMP; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids allowed.
6. Acute or chronic clinically significant gastrointestinal disease.
7. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
8. Pregnancy or lactation.
9. Acute disease at the time of enrolment (defined as the presence of a moderate or severe illness with or without fever (fever defined as body temperature of ≥38 °C).
10. Alcohol or drug abuse.
11. Suspected non-compliance.
12. Use of any investigational drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
13. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator.
14. Employee at the investigational site or relative or spouse of the investigator.
15. Any other criteria which, in the investigator's opinion, would compromise the ability of a subject to participate in the study, a subject's well-being, or the outcome of the study.
The Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision

The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.

Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.

Eligibility Criteria:
Inclusion Criteria:

* age: 20-80 years
* biopsy-proven adenocarcinoma of the rectum
* clinical staging, (T1 or T2 or T3) with N0M0
* Rectal cancer located 4-12 cm from the anal verge
* ECOG performance status 2 or less

Exclusion Criteria:

* Synchronous colon cancer or other malignancy
* Obstructing rectal cancer
* Pregnant or breast-feeding
* Receiving any other study agents
* Fecal incontinence
* History of prior colorectal cancer or inflammatory bowel disease
* BMI \> 30
* T3 rectal cancer not treated preoperatively with full-course chemoradiation
Central Mechanism of Manual Therapy for Low Back Pain

The purpose of this study is to examine the change of nervous system activity before and after spinal manipulation treatment program in people with low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of subacute low back pain
* Ability to read and understand English

Exclusion Criteria:

* Previous low back surgery
* Severe structural spinal deformity
* Neurological compromise resulting in current nerve root entrapment
* Spinal cord compression
* Tumor
* Severe spinal instability
* Severe osteoporosis
* Psychiatric disease
* Head trauma
* Spinal infection
* Known cardiovascular or metabolic disease
* Known neurological, neuromuscular or orthopedic problems that might prevent them from participating in manual therapy interventions
* Pregnancy
* Mini-Mental State Examination score \< 25
* Body Mass Index (BMI) \< 18 or \> 30
* Pain or paresthesia below the knees
* Systemic illness known to affect sensation i.e. diabetes
* Acute and/or chronic pain condition unrelated to LBP
Prebiotic Effects of a Polyphenol-rich Food Product

The specific aim for this project will be to investigate a cranberry beverage as a means to restore balance in terms of the relative proportions of the various bacteria that inhabit the large intestine.


Eligibility Criteria:
Inclusion Criteria:

* BMI 27-35 kg/m2
* High waist circumference (men \>102 cm and women \>88 cm)

Exclusion Criteria:

* Cigarette smoking
* Regular intensive exercise
* Pregnancy or lactation
* Chronic diarrhea, constipation, or other gastrointestinal complaint
* Diabetes mellitus, autoimmune disease, or other chronic disease known to alter the gut microbiota
* Use of medications that affect inflammation or the gut microbiota
* Use of prebiotics, probiotics, synbiotics, vitamins, or other dietary supplements known to affect the gut microbiota
* Aversion to cranberries
* Food allergies
* Lactose intolerance
* Vegetarianism