cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Tolerance Evaluation of a Bio-revitalizing Product Containing Hyaluronic Acid With High and Low Molecular Weight

Primary end point of the study was to evaluate clinically and by non-invasive instrumental evaluations tolerance and efficacy of a bio-revitalizing product containing hyaluronic acid with high (H-HA) and low (L-HA) molecular weight; the micro-injection of the study product was performed by a specialized dermatologist, bilaterally on the face (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) of healthy female volunteers aged 30-60 years.

It was also aim of this study to evaluate efficacy by the volunteers and tolerance both by investigator and volunteers.


Eligibility Criteria:
Inclusion Criteria:

* female sex
* age 30-60 years
* agreeing to present at each study visit without make-up
* accepting to not change their habits regarding food, physical activity, make-up use, face cosmetic and cleansing products
* accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study, without appropriate sun protection
* accepting to sign the Informed consent form.

Exclusion Criteria:

* pregnancy
* lactation
* subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study
* subjects not in menopause who do not accept to perform the pregnancy test during the basal visit, 4 and 8 weeks after the first biomineralising treatment execution
* performing skin treatments for aesthetic correction (biomaterials implants, face lifting, botox injections, laser, chemical peeling) in the 12 months prior to the study start
* performing permanent filler in the past
* change in the normal habits regarding food, physical activity, face cosmetic, cleansing and make-up use during the month preceding the test
* sensitivity to the test product or its ingredients (an accurate anamnestic assessment will performed by the investigator)
* subjects whose insufficient adhesion to the study protocol is foreseeable
* participation in a similar study actually or during the previous 3 months.
* presence of cutaneous disease on the tested area, as lesions, scars, malformations
* recurrent facial/labial herpes
* clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.).
* diabetes
* endocrine disease
* hepatic disorder
* renal disorder
* cardiac disorder
* pulmonary disease
* cancer
* neurological or psychological disease
* inflammatory/immunosuppressive disease
* drug allergy.
* anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago)
* assumption of drugs able to influence the test results in the investigator opinion.
Physiotherapy in Hypoxic AECOPD Patients

Hypoxia is considered a key player in many of the comorbidities that characterize COPD, such as pulmonary hypertension, skeletal muscle dysfunction, and systemic inflammation. These comorbidities are worsened during an exacerbation due to prolonged bed rest and treatment with steroids, showing a reduction in the quality of life, exercise tolerance, and a greater risk of death in these patients. Therefore, a better understanding of the safety and effectiveness of exercise training for AECOPD patients with resting hypoxemia is needed.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes
* A diagnosis of COPD made according to the criteria of the American Thoracic Society (ATS)
* With hypoxemia at rest defined as mean arterial oxygen saturation below 90%
* Agreed to participate

Exclusion Criteria:

* Unstable cardiovascular disease
* Orthopedic diseases in the upper and lower limbs
* Being in ICU or use of mechanical ventilation
* Motor sequelae from a neurological or cognitive impairment that interfere with the evaluation and the treatment
* Contraindications of electrotherapy
12 Versus 20 mL PCB for D&E Cervical Prep

More research is needed to investigate methods of pain control for cervical preparation for abortion procedures. Women report pain with paracervical block injection as well as with osmotic dilator placement. This study seeks to compare a 12 mL, 2-site 1% plain lidocaine paracervical block for pain control during cervical preparation (osmotic dilator insertion) for Dilation and Evacuation (D\&E) to a 20 mL 1% lidocaine 2-site paracervical block.

This is a non-inferiority, single blinded, randomized controlled trial.This study will use a 2-site, 12 mL 1% plain lidocaine injection paracervical block (PCB) technique (2 mL for tenaculum placement, 10 mL for paracervical block) will provide non-inferior pain control compared to a previously established 2-site, 20 mL 1% lidocaine injection PCB (2 mL for tenaculum placement, 18 mL for paracervical block) when administered for dilation pain control during cervical preparation.

Eligibility Criteria:
Inclusion Criteria:

* Women 18 and older
* Intrauterine pregnancy ≥16 weeks gestation
* English speaking competency
* Willing and able to sign consent forms
* Agree to comply with study procedures

Exclusion Criteria:

* Women less than 18 years of age
* IV conscious sedation
* Known allergy to study medication (lidocaine)
* Any women not meeting inclusion criteria above will be excluded from participation
Are Neutrophil-Lymphocyte Ratio, Platelet-Lymphocyte Ratio, and Systemic Immune Inflammation Score Values Indicators for Postoperative Pain?

Postoperative pain status of patients who underwent elective laparoscopic cholecystectomy.

Subject Researched:

Postoperative pain is a result of the inflammatory response to surgical trauma. Local inflammatory mediator response triggered by surgical incision, dissection, retraction, etc. causes an increase in nociceptor sensitivity and hyperalgesia, resulting in the perception of postoperative pain. With the acute phase response caused by surgical trauma, tissue damage is brought under control, infection is limited and the healing process begins. During the inflammatory response, the level of leukocytes in the blood also changes. Neutrophil/Lymphocyte ratio (NLR), Platelet/Lymphocyte ratio (PLR) and Systemic immune inflammation score (SII) are inexpensive and easily accessible biomarkers calculated from routine hemogram parameters and shown to be helpful in disease investigations and evaluation of treatment response. In this study, the relationship between biomarkers and postoperative pain status due to surgery will be investigated

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-75 years who underwent elective laparoscopic cholecystectomy.
2. Patients with ASA status1-2-3

Exclusion Criteria:

1. Emergency operated patients
2. Patients switched to open surgery
3. Patients allergic to tramadol
4. Those allergic to paracetamol
5. Those allergic to tenoxicam
6. Patients who cannot use the patient-controlled analgesia device
7. Those with hematological disorders
8. Those receiving immunosuppressive therapy
9. Those with inflammatory disease
10. Those with gastrointestinal tumors
11. Those with rheumatic disease
12. Those with uncontrolled diabetes
13. Those with chronic organ failure
14. Those who use corticosteroids
15. Opioid users
16. Those who have recently had an attack of cholecystitis, pancreatitis
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of ACD856

The multiple ascending dose (MAD) design of the study is based on the aim to study safety, tolerability, PK and pharmacodynamics of selected doses of ACD856 in a limited number of healthy volunteers.

ACD856 will be administered orally.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent prior to any study-mandated procedure.
* Willing and able to comply with study requirements.
* Healthy male or female adults of non-childbearing potential aged ≥ 18 and ≤ 65 years at screening.
* Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 at screening.
* Only subjects of non-childbearing potential may be included in the study. Male subjects with partners of childbearing potential must be willing to use condoms, be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner, as well as refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP.
* Clinically acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.

Exclusion Criteria:

* Any exposure to ACD856 in the past.
* Treatment with another investigational drug within 3 months prior to or during the study.
* Positive screen for drugs of abuse or a positive alcohol result at screening or admission to the clinic.
* Clinically relevant findings in laboratory parameters, ECG or vital signs at screening.
* Current smokers or subjects who use nicotine products.
* History of alcohol abuse or excessive intake of alcohol.
* History of, or current use of, anabolic steroids.
* Excessive caffeine consumption.
* Plasma donation or blood donation prior to screening.
* Any planned night shift work within the duration of the study, from 48 h prior to randomisation until follow-up.
* Any planned major surgery within the duration of the study.
* Evidence of an active infection that requires treatment with antibiotics within 2 weeks of planned dosing.
Efficacy of a Digital Biofeedback System for Home-based Rehabilitation After Total Joint Replacement

The study was designed to assess the efficacy of a home-based rehabilitation program using a digital kinematic biofeedback system after total hip or knee replacement.

This is a single-arm prospective study. Patients will be enrolled pre-operatively and will perform an 8-week rehabilitation program starting between day 7 and 10 after surgery.

This program will consist of rehabilitation sessions performed independently by the patient at under remote monitoring from a physical therapist.

Outcomes will be measured at baseline, 4 weeks into the rehabilitation program and at the end of the program.

The primary outcome is the change in patient performance measure through the Timed-up-and-Go (TUG) test in comparison with the pre-operative score. Secondary outcomes will be measured in terms of: a) patient reported outcomes (Hip or Knee Osteoarthritis Outcome Score) and b) range of motion of the relevant joint (hip or knee).


Eligibility Criteria:
Inclusion Criteria:

* Clinical and imaging evidence of hip/knee osteoarthritis
* Indication for total hip/knee replacement according to the patient´s orthopedic surgeon
* Ability to walk unaided, with unilateral or bilateral support
* Availability of a carer to assist the patient after surgery

Exclusion Criteria:

* Patients admitted for revision of total hip/knee replacement
* Contralateral hip or knee osteoarthritis severely limiting patient mobility and ability to comply with a rehabilitation program
* Aphasia, dementia or psychiatric comorbidity interfering with the communication or compliance to the rehabilitation process
* Respiratory, cardiac, metabolic or other condition incompatible with at least 30 minutes of light to moderate physical activity
* Major medical complications occurring after surgery that prevent the discharge of the patient within 10 days after the surgery
* Other medical and/or surgical complications that prevent the patient from complying with a rehabilitation program
* Blind and/or illiterate patients
Effect of the Sequence of Dilatation and Lithotripsy on the Treatment of Choledocholithiasis With ERCP

Choledocholithiasis is a common and frequently occurring disease in China, accounting for 15.3% \~ 31.7% of the total cholelithiasis.According to its source, can be divided into primary and secondary choledocholithiasis.For large choledocholithiasis, it is difficult to remove all calculi after dilatation of large diameter balloon or mechanical stone following alone.Therefore, we used the method of balloon dilation combined with mechanical lithotripsy after EST.There are few researches on the sequence of balloon dilation and mechanical lithotripsy at home and abroad, and there is no unified standard.

Through the ERCP balloon expansion of duodenal papilla sphincter and mechanical lithotripsy in the treatment of common bile duct calculi in patients with clinical observation, the balloon expansion and mechanical lithotripsy time order of take stone, stone residues rate and the influence of recent complications such as postoperative pancreatitis, ERCP in the treatment of huge stones optimization procedure was formulated.


Eligibility Criteria:
Inclusion Criteria:

1. \>18 years of age
2. For patients with choledocholithiasis found by MRCP and feasible ERCP lithotomy, the diameter of calculi ≥1cm should be indicated (number of calculi should be indicated \>5 or\<5)
3. During ERCP, the surgeon determined that the calculi should be removed by combining EPBD and mechanical lithotripsy, and the calculi could be removed by a single ERCP
4. Previous cholecystectomy or planned recent cholecystectomy or liver lobectomy can also be included
5. Subjects voluntarily participate in this study and sign the informed consent

Exclusion Criteria:

1. Coagulation disorders (INR\>1.3) and peripheral blood plate count significantly decreased\<50x10\^9/L
2. Preoperative complicated with acute pancreatitis
3. Preoperative biliary hemorrhage
4. Complicated with severe liver disease and primary sclerosing cholangitis
5. Mirizzi syndrome and intrahepatic bile duct stones
6. Complicated malignant tumor of hepatobiliary and pancreatic system
7. Complicated with obvious stricture of the lower segment of the bile duct
8. intraoperative bile duct duodenal fistula was found
9. Previous EST or EPBD
10. Previous history of gastrointestinal reconstruction surgery 11. Other ERCP contraindications
Effect of PD-1 /PD-L1 Inhibitor Therapy Before Liver Transplantation on Acute Rejection After Liver Transplantation in Patients With Hepatocellular Carcinoma

This study is a single-center, prospective, non-interventional cohort study based on the real world data.In this study, 30 patients with a history of PD-1/PD-L1 monotherapy prior to liver transplantation and 30 patients without a history of PD-1/PD-L1 monotherapy prior to liver transplantation were recruited from the group of patients with hepatocellular carcinoma who had undergone allogeneic liver transplantation.Collected patient data included demographics, oncology and immunotherapy history, evaluated index before liver transplantation, laboratory, pathological and imaging results at specific time points after transplantation (1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 16 weeks, 24 weeks), as well as the occurrence of acute rejection (AR) , grading of severity, and anti-rejection treatment plan at the same time. Endpoints included relapse-free survival and overall survival (OS). These data aims to assess: 1) the incidence of acute rejection after liver transplantation in patients with hepatocellular carcinoma; 2) the time of acute rejection, Banff classification, and acute rejection-related mortality after liver transplantation in patients with hepatocellular carcinoma; 3) the cellular immune function after liver transplantation;; 4) the dose and drug concentration of tacrolimus after liver transplantation in patients with hepatocellular carcinoma; and 5) the overall survival (OS) and relapse-free survival(RFS) after liver transplantation in patients with hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 70 years,
2. Eastern Cooperative Oncology Group (ECOG) performance score ≤3,
3. voluntarily participate, totally understand in the study and sign the Informed Consent Form (ICF),
4. hepatopathology confirmed hepatocellular carcinoma after liver transplantation, 5）patients with hepatocellular carcinoma treated with PD1/PD-L1 monoclonal antibody prior to liver transplantation,

6）PD-1/PD-L1 monotherapy needs to be used ≥ 2 times (The patients were divided into observation and control group according to whether received PD-1/PD-L1 monoclonal antibody treatment before liver transplantation)

Exclusion Criteria:

1. patients with incomplete clinicopathological data,
2. post-transplantation ≥6months,
3. PD-1/PD-L1 monotherapy required for oncological reasons after liver transplantation.
Flexible Composite Next Generation Tissue Separating Mesh in Laparoscopic Incisional/Ventral Hernia Repair

This is a multi-center, observational study of incisional/ventral hernia repair with NG-TSM laparoscopically. The study is not randomized and has a single treatment design assessing NG-TSM intra-operatively, its ease of use and handling characteristics.

The objectives of the study are to evaluate the ease of use of NG-TSM intra-operatively in laparoscopic incisional/ventral hernia repair, and assessing early outcomes post-operatively following mesh implantation, including seroma formation, hematoma, wound complications, infections, early recurrences, adverse events, and subject comfort, as well as health economic data to include quality of life, subject satisfaction data, time of procedure, length of stay, re-hospitalization, and extended hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be able to provide written informed consent
* Male or female subjects that are ≥ 18 years of age
* Female subjects must be using adequate contraception, or be surgically sterile, postmenopausal or practicing abstinence, and not planning to become pregnant
* Planned laparoscopic procedure to repair an abdominal incisional/ventral hernia that requires the addition of reinforcing or bridging material to obtain the desired surgical result

Exclusion Criteria:

* Subjects with a potential growth as NGTSM will not stretch significantly
* Female subjects who are pregnant on the day of implantation
* Surgical site (mesh implantation site) that is classified as contaminated (acute, non purulent, inflamed) or dirty/infected (containing retained devitalized tissue and those that involve existing clinical infection or perforated viscera)
* Subjects who have received investigational articles less than 30 days prior to enrollment or who are currently receiving investigational products or devices
* Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center
Evaluation of the Efficacy of Electromagnetic Therapy on Postoperative Surgical Pain After Uni- and Bilateral Inguinal Hernia Repair.

A monocentric interventional randomized placebo controlled trial evaluating the efficacy of the post surgical and wound care recovery kit.

It's a small device that consists of a thin metal ring that is placed on the skin surface, non-invasively. It's connected with a small battery. When the plastic tag is removed and the button is pushed the device is activated. Within the ring a Pulsed Electromagnetic Field is created. It influences the receptor-ligand binding at the cell surface and might improve wound healing by diminishing wound edema and inflammation. It possibly helps reducing the inflammatory reaction induced by surgery.

Patients will be treated for uni or bilateral inguinal hernias and at the end of surgery, at the time of bandage, a kit will be applied at the level of the incision. One group will at random receive a working device, the other half will have a kit without active electromagnetic field.

Postoperative analgesic consumption will be measured in a diary and pain and quality of life will be measured using Visual Analogue Scale and EuraHS-Quality Of Life questionnaires.

The aim of this study is to evaluate whether the placement of the device reduces the acute postoperative pain and whether it reduces the incidence of chronic groin pain.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from the patient
* Primary, unilateral and bilateral groin hernias

Exclusion Criteria:

* No written informed consent
* Recurrent hernias
* 'Incarcerated' hernias
* pregnant women: reaction of a Pulsed Electromagnetic Field on the foetus is unknown
* Patients with pacemaker or Internal defibrillator
Endoscopic Complications After Gastric Bypass

Endoscopic complications such as gastro-esophageal reflux disease, ulcera, gastritis, bile reflux, anastomotic stricture and so on are described after gastric bypass surgery. The incidence of these complications after RYGB versus MGB/OAGB are getting observed.

All patients who were readmitted to our centre of excellence for obesity and metabolic surgery (October 2014 - March 2018) are observed regarding endoscopic complications in s.a. RYGB and MGB/OAGB.

Eligibility Criteria:
Inclusion Criteria:

* all patients who underwent RYGB or MGB/OAGB as a primary surgery and were readmitted to tho hospital undergoing upper endoscopy are included

Exclusion Criteria:

-
Accuracy of Multi-organ Ultrasound for the Diagnosis of Pulmonary Embolism

Patients with suspected Pulmonary Embolism (PE) and a high clinical probability or a high D-dimer level should undergo a second level diagnostic test such as Multidetector Computed Tomography Angiography (MCTPA). Unfortunately MCTPA involves radiation exposure, is expensive, is not feasible in unstable patients and has contraindications. UltraSound (US) is safe and rapidly available even in unstable patients. Many authors evaluated the diagnostic role of Compression Ultrasound Scan (CUS) for detecting limbs Deep Vein Thrombosis (DVT), TransThoracic Echocardiography (TTE) for detecting Right Ventricular Dysfunction (RVD) or Thoracic UltraSound (TUS) for detecting subpleural infarcts in patients with suspected PE. No previous studies have investigated the diagnostic accuracy of CUS, TTE and TUS combined (multiorgan US) for the diagnosis of PE. This study evaluates the diagnostic accuracy of multiorgan US.

Methods. Consecutive patients that underwent MCTPA in the Emergency Department for clinical suspicion of PE and with a simplified Well's score\>4 (PE likely) or with a D-dimer value ≥500ng/ml were enrolled in the study. MCTPA was considered the gold standard for PE diagnosis. A multiorgan US was performed by an emergency physician sonographer before MCTPA. PE was considered echographically present if CUS was positive for DVT or TTE was positive for RVD or at least one pulmonary subpleural infarct was detected with TUS. The accuracy of the single and multiorgan US was calculated.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical suspected pulmonary embolism
* Simplified Well's score\>4 (PE likely) or D-dimer value ≥500ng/ml
* Patients that undergo MCTPA in the Emergency Department for suspected pulmonary embolism

Exclusion Criteria:

* Refused consent
* Less than 18 years old
* Not possible to perform ultrasound scan within 3 hours before MCTPA
Vaginal or Laparoscopic Hysterectomy, Persistent Postsurgical Pain

Previous studies have shown that chronic pain after hysterectomy is common. The aim of this study is to investigate the incidence of chronic pain after vaginal or laparoscopic hysterectomy for benign reasons. The aim of this prospective study is also to study the role of anesthetics, surgery and other possible predictors for pain 6 months after hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo vaginal or laparoscopic hysterectomy for benign conditions
* Age 18-69 years
* Gender: female
* ASA status 1-3

Exclusion Criteria:

* Body Mass Index over 35
* Diabetes mellitus
* Liver disease
* Preoperative use of opioids