cyrilzakka/clinical-trials huggingface dataset:
Role of Platelet Rich Plasma in Enhancing Graft Take in Chronic Venous Ulcers

Chronic venous ulcers are considered a problem with a big morbidity impact on both the health facilities and patients, skin-grafting have shown not so perfect outcomes with such ulcers. In this study, the investigators compare combining autologous platelet rich plasma treatments with partial skin grafting in chronic ulcers, the results were compared to using only partial skin grafting, and among various types of chronic resistant ulcers.

Fourteen patients had bilateral lower limb ulcers, and 6 of them had single large ulcers as follows; Fourteen patients with chronic venous ulcers (12 of which had bilateral ulcers, 2 had single large ulcers) Four patients, each with a single chronic post-traumatic ulcer Two patients with bilateral chronic lymphatic ulcers.

After detailed history, physical examination and investigations (such as duplex),

* Each patient with bilateral ulcers included in the study (14 patients) received treatment A on one ulcer and treatment B on the other ulcer.
* In case of patients with single large ulcers (6 patients), treatment A was done on one half of the ulcer and treatment B on the other half of the ulcer (done in ulcers with an area greater than 10 x 10 cms).
* Treatment A included pre-operative intra-lesional PRP injections in 1-week intervals for 3 times, followed by intra-operative intra-lesional injection of PRP prior to meshed graft placement. PRP was injected into the ulcer bed and ulcer edges using a sterile syringe.

Treatment B included only placement of meshed graft, with no PRP treatment.

* Pre-operative preparation: Ulcers were prepared by proper dressings and followed up until acquiring a clean bed. Debridement was done as needed to obtain clean base ready for graft placement.
* PRP preparation:

  * 10 ml of blood was drawn from each patient intra operatively (autologous PRP).
  * Blood was collected in sterile tubes, Anticoagulant Citrate Dextrose (ACD) was used for anticoagulation, which is the same substance used to preserve viable platelets in blood banks for platelet transfer.
  * Tubes were centrifuged in Beckman Allerga X-12 centrifuge for 20 mins, 3000 rpm.
  * Each 10 ml of blood yielded an average of 3-4 ml of PRP. Calcium gluconate was added in a ratio of 1:10 to PRP. Post-operative assessment was carried out by follow up clinical examination, photography and weekly biopsy samples.

Eligibility Criteria:
Inclusion criteria:

* Patients with chronic ulcers for at least 6 months.
* Age ≧ 12 years.

Exclusion criteria:

* Patients younger than 12 years of age.
* Patients with diabetes or other diseases affecting tissue healing.
* Patients with current ongoing pathologies in arterial or venous systems.
* Patients with malignant ulcers.
* Patients on corticosteroids or other drugs affecting tissue healing.
* Patients with unrealistic expectations.
Serum Nesfatin-1 and Human Cartilage Glycoprotein-39 Levels in Knee Osteoarthritis

In this study, our objective was to assess the correlation between serum human cartilage glycoprotein-39 (YKL-40) and nesfatin-1 values, the patient's clinical condition, ultrasonographic cartilage thickness measurements, and the response to PRP treatment in knee osteoarthritis (OA)

The objective of this study is to assess the correlation between serum human cartilage glycoprotein-39 (YKL-40) and nesfatin-1 values, clinical condition, ultrasonographic cartilage thickness measurements, and response to PRP treatment in Knee Osteoarthritis (OA).

Thirty patients diagnosed with grade 2 and 3 knee osteoarthritis (OA) according to American College of Rheumatology (ACR) diagnostic criteria, and scheduled for leukocyte-poor platelet-rich plasma (LP-PRP) injections, were enrolled in the study. Patients were assessed at three time points: before treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28). The evaluation included the Numeric Rating Scale (NRS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), cartilage thickness measurement by ultrasonography (USG), 6-minute walk test (6MWT) parameters, and measurements of serum YKL-40 and nesfatin-1 levels.

Eligibility Criteria:
Inclusion Criteria:

* Having patient consent,
* Having stage 2-3 knee osteoarthritis according to the Kellgren-Lawrence scale,
* Being diagnosed with knee osteoarthritis according to ACR (American college of Rheumatology),
* Being over the age of 18 - under the age of 75,
* Having NRS 4 and above

Exclusion Criteria:

* Those who have had knee surgery before,
* Those who have had any local injections such as physical therapy, intra-articular steroid or hyaluronic acid injection in the knee area in the last 3 months,
* Malignancies,
* Those with local infection, wound, scar in the relevant area,
* Infections, Hepatitis, Immunosuppression,
* Inflammatory arthropathies,
* Uncontrolled Hypertension, uncontrolled Diabetes Mellitus, decompensated heart failure, coronary artery disease, asthma
* Recent trauma,
* Epileptic patients,
* Pregnant women,
* Corticosteroid use,
* Avascular necrosis
* Anemia, bleeding coagulation disorder
Comparability of Transesophageal Echocardiography and FloTrac/Vigileo System Three Different Positions

The use of cardiac output monitoring to guide intraoperative fluid management and inotropic drugs as part of a hemodynamic therapy algorithm reduce the complication rate in major abdominal surgery. The FloTrac/Vigileo system (© Edwards Lifesciences) (Edwards Lifesciences, Irvine, CA) device estimate cardiac output by using arterial pulse contour analysis. The accuracy of FloTrac/Vigileo have been proven in patients with normal cardiac index. Most of studies regarding FloTrac/Vigileo were performed in patients in horizontal supine position, which is not usually the reality in the operation theater during abdominal surgery. Therefore, the investigators realized this monocentric prospective clinical trial to study the accuracy and trending ability of the fourth generation FloTrac/Vigileo system cardiac output estimation in three different positions (horizontal supine, Trendelenburg and reverse Trendelenburg positions) in anesthetized patients undergoing elective major abdominal surgery. The reference method of cardiac output measurement used was the transesophageal echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for elective pancreatic, bladder or liver surgery requiring invasive monitoring and Trendelenburg position during the procedure

Exclusion Criteria:

* age under 18 years
* weight under 40 kg
* preoperative left ventricular ejection fraction (LVEF) less than 45%
* severe heart valve disease
* known intra-and/or extracardiac shunt
* pulmonary hypertension
* preoperative circulatory shock with need for hemodynamic inotropic support
* redo surgery
* pregnancy
Prevention of Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery Through the Use of Tranexamic Acid

Purpose of the study:

* To evaluate the effect of tranexamic acid (TXA) of intraoperative blood loss in patients subjected to bi-maxillary orthognathic surgery
* To evaluate the potential effect of TXA on fibrin structure
* To evaluate the potential effect of TXA of binding of plasminogen to fibrin
* To evaluate the potential effect of TXA on postoperative edema formation.

Hypothesis:

H0: Intraoperative bleeding cannot be significantly reduced by preoperative administration of tranexamic acid

H0,1: Postoperative edema cannot be significantly reduced by preoperative administration of tranexamic acid

The study population consists of patients referred to simultaneous mandibular and maxillary osteotomy at the Department of Oral and Maxillofacial Surgery, Hospital of South West Denmark in 2014.

Hundred patients (50 men and 50 women) will be enrolled in the study. Reportedly, the mean intraoperative blood loss in the placebo group is expected to be 436 ml with a standard deviation of 208 ml. The difference in blood loss between the TXA-group and the placebo group to be detected is 100 ml. The dropout frequency is estimated to 10%. To fulfil these assumptions a minimum of 40 patients should be included in each group to reach a power of 0.8 and an alpha of 0.05. In order to accommodate an even gender distribution a block randomization is performed resulting in the randomization of 100 patients.

The patients will be randomized to receive blindly either 10 ml tranexamic acid (100 mg/ml) (Pfizer, Ballerup, Denmark) or 10 ml saline (9mg/ml) preoperatively. Intraoperative blood loss will be determined by deducting the total volume of irrigation fluids from the volume of the contents of the surgical suction device. Postoperative edema formation will be determined by 3D surface scanning and volumetric analysis will be carried out in the "Landmarker" software.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years or older
* Patients must be eligible for elective bi-maxillary orthognathic surgery
* No severe reduction of kidney function
* No known medical conditions
* Signed informed consent

Exclusion Criteria:

* Hypersensitivity to tranexamic acid
* A medical history of acute venous thrombosis and/or arterial thrombosis
* The presence of fibrinolytic conditions as a result of disseminated intravascular coagulation, with the exception of a predominant activation of the fibrinolytic system with acute severe bleeding.
* Severe kidney deficiency
* Cramps in the medical history
* Intake of Omega-3 fatty acids, Gingko Biloba, ginger and garlic supplements within 3 months of surgery.
* Pregnancy (female participants will be tested on the day of surgery)
Research on the Key Technology of Burn Wound Treatment

Burns are common injuries in the daily life and wars. With the development of medical techniques, the mortality has been significantly reduced. However, the deformity and disability caused by hypertrophic scar have not been improved effectively since the wound repair technology is limited and controversial, especially on the early treatment of deep second degree burns. The prognosis of burns is of great difference. In recent years, the promotion of wound repairing technologies provides a new opportunity for improving the quality of wound healing and solving the problem of scar formation. Although some new methods and techniques have shown significant efficacy in clinic, clinical researches with large samples conducted in multiple centers are still deficient, impeding the evaluation of their superiority. Therefore, the current protocol focuses on the repair of deep second degree burns based on previous researches. There are four types of treatment protocols for wounds. Patients were divided into four groups randomly, including regular dressing change group, controlled debridement + biological dressing covering group (xenogeneic acellular dermal matrix), controlled debridement + epidermal cell cultivation group, controlled debridement + bFGF treatment group. The wound healing rate, healing time and scar formation were observed. The availability and security were evaluated. Further more, treatment guidelines and expert consensuses on deep second degree burn wounds were concluded. Above studies are important to promote the treatment of deep second degree burns to be scientific, standardized and professional in China.


Eligibility Criteria:
Inclusion Criteria:

1. Area of deep second burn wound \>=10cm×10cm，total burn area ≤50% TBSA.
2. Within 96 hours after burns and could be managed within 24 hours after included.
3. Ages from 18 to 60.
4. No serious breathing, circulation and other systemic diseases, no surgical contraindications.
5. Agrees to participate in this trial and has signed an informed consent form.

Exclusion Criteria:

1. Have severe inhalation injury or shock, or acute respiratory failure；
2. There are serious heart (especially the recent myocardial infarction, myocardial damage, etc.), brain, liver, kidney, lung and other organ disease;
3. Susceptible to allergies；
4. Islamic believers
5. Pregnant women
6. Other cases that are not suitable for study
Lactobacillus Rhamnosus and PCOS Treatment

The effect of Lactobacillus rhamnosus supplementation on body weight, hyperandrogenism and insulin resistance in overweight and obesity women with Polycystic Ovary Syndrome will be analysed.


Eligibility Criteria:
Inclusion criteria:

* patients diagnosed with PCOS,
* BMI\> 28 kg/m2 (overweight or obesity),
* patients not participating in other similar research programs at the same time,
* no previous operations on ovaries such as: laparoscopy, ovarian cautery etc.,
* written agreement to take part in the research.

Exlusion criteria:

* the use of antibiotics or probiotics within 6 months before the start of the experiment,
* the use of pharmacological agents or hormones that may affect the course of the menstrual cycle or metabolic rate within 3 months,
* the use of medicament that may affect on carbohydrate metabolism within 4 weeks,
* failure to comply with dietary recommendations established during the nutritional intervention,
* the use of weight loss supplements during the study,
* clinical diagnosis of digestive disease (for example: irritable bowel syndrome, ulcerative colitis, Crohn's disease, celiac disease),
* pregnancy and breast feeding.
Effect of Video-based Game and Aerobic Exercise on Knee Osteoarthritis

This randomized controlled trial was conducted by the CONSORT guidelines for non-pharmacological treatments. Participants were randomly assigned to control, gaming, or aerobic groups using the closed-envelope randomization method. All groups received conventional physiotherapy for 8 weeks. In addition, the gaming group played active video games 3 days per week, while the aerobic group engaged in cycling-based aerobic exercise (20 minutes per session) 3 days per week. The control group received only conventional physiotherapy and continued their daily activities. Evaluations were performed by the same assessor at the baseline and after eight weeks.


Eligibility Criteria:
Inclusion Criteria:

* Participants, aged 30-65 years who were diagnosed with unilateral or bilateral osteoarthritis based on the clinical and radiological criteria of the American College of Rheumatology.
* The severity of osteoarthritis was classified as stage 2-3 according to the Kellgren-Lawrence grading system for gonarthrosis.
* Participants were required to be able to walk independently for at least 15 meters and to refrain from using non-steroidal anti-inflammatory drugs (NSAIDs) during the study period.

Exclusion Criteria:

* A history of lower extremity surgery within the past 6 months,
* The presence of neurological or systemic diseases,
* Other inflammatory joint diseases,
* Getting classic physiotherapy and rehabilitation within the past month,
* Intra-articular corticosteroid injections within the past 3 months,
* Severe joint deformities or movement restrictions,
* Severe visual impairments.
Obesity Intervention "Obeldicks" for Obese Children, Adolescents and Their Parents

The intervention program "Obeldicks" was developed for obese children aged 6 to 16 years. This intervention is gender- and age specific. The 12-months intervention is based on nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality of structure, process and results of the intervention. Primary outcome measure is change of weight status as standard deviation score of BMI. Furthermore, cardiovascular risk factor profile, hormones (e.g. iGF-I, thyroid hormones, vitamin D status)adipocytokines, GI- hormones, intima media thickness are measured prior to and after the one-year intervention. The changes of these hormones and adipocytokines will allow to answer the questions whether the alterations of these hormones are a cause or consequence of overweight. Additionally, a genetic screening is performed to characterize the participants to probably predict response to intervention.


Eligibility Criteria:
Inclusion Criteria:

* BMI\> 97. percentile for age and gender

Exclusion Criteria:

* Psychiatric disorders
* Endocrine disorders
Evaluation of New Different Herbal Mouthwashes Against Caries Forming Bacteria, RCT

The goal of this randomized controlled trial is to compare three different types of mouthwash, Moringa, Star anis, and Indian Costus 90 children participated in this study divided into 3 groups according to the type of mouthwash used and then subdivided in each group into 3 subgroups according to the concentration of the mouthwash 5,10,15%. the children were asked to rinse with the mouthwash 3 times per day for 1 week. bacterial count for streptococcus mutans was measured before and after the use of mouthwash to see the most effective concentration.

The powdered of Moringa, Star anis, and Indian Costus leaves (250 g) were extracted using 90% ethanol then filtered using Whatman Filter paper No.1 and dried under reduced pressure using rota vapor. The crude ethanolic extract was (200 mg). ninety children will be randomly distributed into three groups (1,2,3) (30 children each). each group was divided into further 3 groups (10 children each) according to the concentration of each herbal mouthwash (5,10,15%). each participant will be given a new bottle of a specific effective amount of herbal extract to be used as a mouthwash. Children will be instructed to rinse with 5ml of mouthwash. All groups were instructed to rinse three times a day with specific mouthwash for each group for about one minute and participants will be advised to use the mouthwash for seven days. Collection of saliva samples Prior to the start of the experiment, samples of unstimulated saliva were taken when the child spit a suitable amount of unstimulated saliva in a sterile container in the morning before breakfast. Initial salivary samples were collected to establish base levels (S1) using selective culture media, The salivary samples (S2) were collected after one week of using the mouthwash when the child spit a suitable amount of unstimulated saliva in a sterile container in the morning before breakfast.

Eligibility Criteria:
Inclusion Criteria:

* - Children with no systemic disease, no history of recent antibiotic administration (last 2 weeks), antimicrobial mouth-rinse (last 12 hours), topical fluoride treatment within 4 weeks prior to baseline, children with no untreated active carious lesion, no orthodontic appliance or with low caries index (DMF\& def \< 4)

Exclusion Criteria:

* Children using antibiotics, medications or mouthwashes at the time of the study, children with oral or systemic disease, children undergoing any dental treatment
Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat

Niclosamide (2000 mg QD) and Camostate (600 mg QID) are expected to be safe and well-tolerated as a combination therapy and to show clinically beneficial for COVID-19 patients.

Niclosamide is an approved drug for the treatment of intestinal worm infections that can potentially induce the process of autophagy and thus significantly limit viral replication in cells.

Camostat is approved in Japan for the treatment of chronic pancreatitis and reflux esophagitis. It has been shown to effectively block viral replication in a SARS-CoV-2 animal model.

Since the mechanisms of actions are different, it was hypothesized that a combination of both substances might have an additive or even synergistic effect in the treatment of patients with COVID-19.

This study is designed to investigate the safety, tolerability and preliminary efficacy of the treatment combination niclosamide and camostat in mild and moderately affected COVID-19 patients.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients in the age of 18 to 70 years
* Having a recent positive direct test for Sars-CoV-2
* Having mild or moderate COVID-19 symptoms with no indication for hospitalization due to SARS-CoV-2 infection (WHO Ordinal Scale 1-2)

Exclusion Criteria:

* Severe respiratory symptoms related to COVID-19 requiring oxygen or intensive care (high flow oxygen or mechanical ventilation or ECMO)
* Patients with preexisting pulmonary diseases requiring oxygen supply
* Patients with history of hypersensitivity to Camostat or Niclosamide or to any ingredients to any of the two drugs
* Patients with heart failure (NYHA III or NYHA IV)
* Patients with proven malignant tumor
* Patients diagnosed with influenza infection
* Pregnancy or breastfeeding
* Immunocompromised patients
* Creatinine clearance \< 60 mL/min
* aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \> 2 times upper limit of normal (ULN)
Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection

The purpose of this research study is to addresses the challenge of managing the unique perioperative needs of older cancer patients undergoing surgical resection.

In the proposed study, the investigators will conduct a randomized controlled trial of a perioperative geriatrics intervention versus usual care in older patients with gastrointestinal (GI) cancers undergoing surgical resection. The perioperative geriatrics intervention will entail pre- and post-operative geriatric care for patients age ≥65 undergoing surgery for gastrointestinal cancers. Specifically, geriatric clinicians will evaluate and manage patients preoperatively in the outpatient setting and postoperatively in the inpatient setting as a consultant.

The investigators will evaluate the effect of the perioperative geriatrics intervention on postoperative length of stay (primary outcome) and readmissions in a sample of 160 patients. The investigators will also assess the impact of the perioperative geriatrics intervention on patient-reported outcomes, including quality of life (QOL) and symptom burden.

The study will take place at Massachusetts General Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 or older
* Diagnosed with pancreatic, esophageal, rectal, colon, hepatobiliary, or gastric cancer (including patients with prior diagnosis of another cancer)
* Planning to receive surgical resection at MGH (including both curative and palliative resections)
* Verbal fluency in English

Exclusion Criteria:

* Unwilling or unable to participate in the study
* Significant uncontrolled psychiatric disorder (e.g. psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g. dementia, cognitive impairment) which the treating clinician believes prohibits informed consent or participation in the study