cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Double-layer Compression Therapy in the Healing of Chronic Venous Ulcers in Primary Health Care

The purpose of this study is to evaluate the effectiveness of a multilayer compression bandage (two layers), compared with the crepe bandage, on healing of venous leg ulcers, in patients attended in nursing Primary Care Health Centres, at 12 weeks follow-up.

This study also compares the effectiveness of the multilayer and the crepe bandage, on healing of venous leg ulcers measured by the Resvech 2.0 scale and evaluates improvement in quality of life, measured by the Charing Cross Venous Ulcer Questionnaire (CCVUQ-e) and analyze the sociodemographic, clinical, and treatment factors associated with complete healing of venous ulcers.

Design: Multicentre, controlled, parallel group, randomized clinical trial, with blind evaluation of the response variable.

Setting: Primary Care Health Centres (Madrid). Subjects: Patients with venous leg ulcers, treated by nurses at the participating centres.

Intervention: Experimental group: multilayer compression bandage (two layers). Control group: crepe bandage.

Sample size: 216 patients (108 in each group) Variables:Main: Complete healing after 12 weeks follow-up. Secondary: Degree of healing (Resvech 2.0). Quality of life (CCVUQ-e). Adverse reactions. Related to the healing process: comorbidities, topical and systematic treatments, exercise, BMI. Prognostic factors: location, number and duration of ulcer. Sociodemographic factors Data analysis: By intention to treat. Comparative analysis of the two groups (chi-squared or t-test). Effectiveness analysis sing Kaplan-Meier, log rank test and cox regression analysis

Eligibility Criteria:
Inclusion Criteria:

* People With a diagnosis of chronic venous ulcer over six weeks duration.
* Presence of a larger Ankle Arm index (ABI) of 0.8 and less than 1.3.
* People Able to follow the trial own demands, able to understand the questionnaires, with no intention of moving and localizable for the duration of the study.
* That give written informed consent to participate

Exclusion Criteria:

* Patients diagnosed with poorly controlled diabetes mellitus (last HbA1c greater than 7).
* In Antineoplastic therapy.
* Decompensated heart -insufficience .
* Dermatitis acute phase, at the time of the study.
* Rheumatoid-arthritis.
* Thrombosis Venosa (DVT) in acute phase.
* Patients with mixed ulcers
* Patients who participate simultaneously in another clinical trial.
Effects of a Pre-Workout Dietary Supplement on Training Adaptations

The purpose of this study is to examine the effects of a pre-workout dietary supplement during resistance training on training adaptations.

A number of nutritional strategies have been developed to optimize nutrient delivery prior to exercise. This includes providing carbohydrate and a number of ergogenic nutrients prior to, during and/or following exercise. As a result, a number of pre-workout supplements have been developed to increase energy availability, promote vasodilation and/or positively affect exercise capacity. The purpose of this study is to investigate the effects of ingesting a pre-workout dietary supplement during resistance training on training adaptations.

Eligibility Criteria:
Inclusion Criteria:

* you are an apparently healthy and recreationally active male between the ages of 18 and 40.
* you will need to have at least six months immediate prior history of resistance training on the bench press and leg press or squat.

Exclusion Criteria:

* you have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmia and/or cardiovascular disease;
* you are currently using prescription medications;
* you have an intolerance to caffeine and/or other natural stimulants;
* you have a history of smoking;
* you drink excessively (i.e., 12 drinks per week or more);
Computerized Brief Intervention vs. Delayed Computerized Brief Intervention

The purpose of the study is to determine whether a computerized brief intervention for moderate risk drug use among adult primary care patients is more effective than providing such patients with a substance abuse assessment alone.

The study will enroll 80 adult primary care patients who have moderate risk drug use. Eligible participants (N = 80) will be randomly assigned to immediately receive a computerized brief intervention focused on drug use or to receive the same computerized brief intervention at 3-month follow-up. All participants will be assessed at three time points: baseline, and at 3 and 6 month follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* (1) minimum 18 years of age
* (2) primary care or dental patients at the participating clinics
* (3) score between 4 and 26 (moderate-risk) for illicit drug and/or nonmedical use of prescription drugs on any of the single item drug use risk scores of the ASSIST.

Exclusion Criteria:

* (1) score in the high-risk range on the ASSIST for any drug (except tobacco) or alcohol use (i.e., ASSIST score \> 26)
* (2) no reported drug use within the past 3 months
* (3) drug abuse treatment within the past 12 months
* (4) a BI at the clinic with the behavioral health counselor within the past month
* (5) prior enrollment in the parent study;
* (6) plans to move out of New Mexico in the next 6 months
Study of FMT Combined With Nivolumab in Gastric Cancer

This study is a single-arm, single center study. The purpose of this study is to evaluate the efficacy and safety of FMT capsules XBI-302 combined with Nivolumab in the treatment of anti-PD-1/L1 resistant gastric cancer.

The primary purpose of this single-arm, open-label, single center trial is to evaluate the efficacy and safety of XBI-302 combined with Nivolumab in the treatment of anti-PD-1/L1 resistant gastric cancer.

During treatment period, all eligible subjects will receive XBI-302 with Nivolumab following gut preparation. The imaging evaluation of efficacy will be performed every 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily participate in this study and provide written informed consent
* Age ≥ 18 years and ≤70 years, male or female
* Pathological confirmed locally advanced, unresectable or metastatic gastric adenocarcinoma, esophagogastric junction adenocarcinoma and lower esophagus adenocarcinoma that are resistant to anti-PD-1/L1 antibodies
* Able and willing to provide tumor tissue
* At least one measurable extracranial target lesion according to iRECIST
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy ≥3 months

Exclusion Criteria:

* History of other primary malignancies within 5 years except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin
* Had systemic diseases that were difficult to control within 4 weeks prior to screening
* History of anti-PD-1 antibodies related adverse reactions that led to the permanent withdrawal of anti-PD-1 therapy
* History of coagulation disorders
* Mechanical or paralytic obstruction of the gastrointestinal tract
* Anticipated to receive a great number of antibiotics during study period
Perioperative Music Therapy Plus Oxycodone in Perioperative Management of Lung Surgery

To explore the feasibility and effectiveness of Perioperative Music Therapy Plus Oxycodone in pain management after thoracic surgery, patients will be randomly assigned into two groups. The experimental group will receive perioperative music therapy and the control group will not. We will record and contrast the postoperative oxycodone usage to evaluate the effect of music therapy in relieving the pain. We will also use visual analogue scale, questionnaire and EEG to evaluate patients' anxiety and depression.


Eligibility Criteria:
Inclusion Criteria:

* Enhanced CT or PET/CT indicate primary malignant pulmonary nodule;
* The clinical stage belongs to cT1-4N0-2M0 before treatment or ycT1-4N0-2M0 after neoadjuvant treatment (AJCC/TNM 8th Edition);
* Suitable for video-assisted thoracoscopic surgery after evaluated by thoracic surgeon;
* FEV1 \> 1.5L and DLCO \> 60% pred;
* Hearing loss lesser than 35 decibels (dB) in the better hearing ear;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2;
* American Society of Anesthesiologists Score of 1 or 2;
* Confirmed eligibility for R0 resection for curative intent by thoracic surgeon assessment;
* Adequate cardiopulmonary function, confirmed to meet the requirement for surgical resection for curative intent;
* Able to provide written informed consent and able to understand and agree to comply with study requirements and evaluation forms;
* Life expectancy greater than 12 months

Exclusion Criteria:

* Enhanced CT or PET/CT indicate metastatic malignant pulmonary nodule;
* Hearing loss greater than 35 decibels (dB) in the better hearing ear;
* Active autoimmune disease or history of autoimmune disease that may recur; Note: well-controlled type 1 diabetes is allowed; hypothyroidism (controlled with thyroid hormone replacement only); well-controlled celiac disease; skin disease not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia); any other condition that is not expected to recur in the absence of an external trigger.
* History of interstitial lung disease, pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease;
* Serious infection occurred before grouping, including but not limited to hospitalization due to infectious complications, bacteremia or severe pneumonia; severe chronic or active infection (including pulmonary tuberculosis infection, etc.) requiring systemic (oral or intravenous) antibiotics within 14 days before grouping;
* Simultaneous participation in another therapeutic clinical study;
* Pregnant or lactating women, or male and female patients planning to have children during the study;
* Other conditions that the investigators consider inappropriate for participation in this trial, such as poor compliance.
Left Atrial Appendage Closure With the LAmbre

The study was to retrospectively analyse the efficacy and safety of LAA closure using the LAmbre in our center from April 2014 to November 2015.

The study was to retrospectively analyse the efficacy and safety of percutaneous left atrial appendage (LAA) closure using the LAmbre (Lifetech Scientific Co., Ltd., Shenzhen, China) in our center from April 2014 to November 2015. 89.4% has finished the 12-month esophageal ecllocardiogrhy (TEE) examination. The average followup was 2-years.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is ≥18 years of age;
2. Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular AF;
3. CHADS2-VAS score 2 or higher;
4. Patient can understand the trial purpose, voluntarily join this clinical trial with informed consent;
5. Patient voluntarily completes the follow-up and follow-up inspection in accordance with the clinical trials process.

Exclusion Criteria:

• A. Clinical exclusion criteria

1. Presence of rheumatic, degenerative or congenital valvular heart diseases,
2. The diameter of left atrial ≥65 mm;
3. LAA size \< 12mm or \> 30 mm
4. Left atrium has been removed;
5. Heart transplantation patients;
6. Symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%);
7. Acute myocardial infarction or unstable angina;
8. Decompensated heart failure (New York Heart Association functional class III-IV);
9. Recent myocardial infarction (\< 3 months);
10. Patients with an atrial septal defect or received an atrial septal occluder. The patient has an ablation procedure planned within 30 days of potential LAmbre Occluder implant
11. The patient has a planned cardioversion 30 days post implant of the LAmbre Occluder
12. Patient who after artificial mechanical heart valve replacement operation;
13. Uncontrolled Heart rate ≥ 110 beats / min17) History stroke or TIA within 30 days;
14. Presence of complex aortic plaque(4mm) in ascending aorta;
15. Cardiac tumors or other malignancy with estimated life expectancy u less than 2 years;
16. Have thrombocytopenia (platelet 《105 / μl) or anemia（Hb\<10g/dl）;
17. Women who is pregnancy or plan to pregnancy during the trial period;
18. Presence of active sepsis or endocarditis;
19. Patient participated in the other trials;
20. The investigators expect the patient not be able to complete the trial according to requirements.

B. Esophageal ultrasonic exclusion criteria

1. LVEF≤30%;
2. Presence of left atrial appendage thrombus;
3. High risk PFO patients(presence of atrial septal aneurysm);
4. Have obvious mitral valve stenosis (the area of mitral valve≤ 2 cm2);
5. Have obvious and unexplained pericardial effusion(≥4 cm2).
6. Presence of complex aortic plague(≥4 mm) in ascending aorta.
Skeletal Muscle and Platelet Mitochondrial Dysfunction During Sepsis

The primary aim of the study is to demonstrate that mitochondrial dysfunction occurs in both skeletal muscle and circulating platelets of severely septic and septic shock ICU-admitted patients. Secondary aims are to clarify the pathogenesis and the clinical relevance of mitochondrial damage during sepsis.

The primary aim of the study is to demonstrate that mitochondrial dysfunction occurs in both skeletal muscle and circulating platelets of severely septic and septic shock ICU-admitted patients, as compared to otherwise healthy surgical ones. In order to better clarify the pathogenesis of mitochondrial dysfunction during sepsis, cardiogenic shock patients (suffering from systemic hypoperfusion) will act as additional controls. Markers of oxidative stress will be measured in tissue samples from septic patients. The clinical relevance of mitochondrial dysfunction during sepsis will be assessed in terms of both skeletal muscle and platelet function.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive ICU-admitted severely septic or septic shock patients.

Exclusion Criteria:

* Severe thrombocytopenia.
* Severe coagulopathy.
* Pre-existing mitochondrial disease
FM-SRP and Tooth Extraction Improve Type 2 Diabetes Mellitus in Periodontitis

This intervention study is designed to evaluate the effects of non-surgical procedure in addition to surgical procedure on systemic inflammation and glycemic control in with type 2 diabetes mellitus patients with periodontitis in comparison with non-diabetic periodontic patients.

In a randomize, prospective study 200 patients from the endocrinology department of "Peja's Regional Hospital" and Dental Polyclinic at city of Peja, will be assessed and examined for eligibility. Personal interviews will be used to collect the baseline data from each participant using a pre structured questionnaire.

After clinical examination, 160 patients aged 30-70 years will be selected for the study. These will be further divided in four groups: type 2 diabetes mellitus group (with or without initial periodontal therapy) and non-diabetic group (with or without initial periodontal therapy).

All the patients will be with periodontal disease and at least one tooth extraction will perform. Previous to surgery procedures, in particular in the two groups with an adjunctive non surgical periodontal treatment such as full mouth tooth cleaning will be included: full-mouth scaling and root planing (FM-SRP) with ultrasonic device (UDS-J Ultrasonic Scaler, Guilin Woodpecker Medical Instrument) and periodontal curets for mechanical debridement of the supra- and sub-gingival plaque and calculus.

Post operative rinsing will be followed with antiseptic solution Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) as a mouthwash thrice a day for 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 Diabetes Mellitus; having a baseline HbA1c ≥ 6.5%, at least 10 teeth in the functional dentition (excluding third molars) and a clinical diagnosis of periodontal disease with at least one site with probing depth (PD) ≥ 5mm, and two teeth with attachment lost ≥ 6mm and no modification in the pharmacological treatment of diabetes during the study period.

Exclusion Criteria:

* Pregnancy or lactation, major diabetic complications, uses of antibiotic therapy or non-steroidal anti-inflammatory drug therapy 4 months before the first visit.
Safety, Tolerability and Efficacy Study of TT-173 in Healthy Volunteers After Tooth Extraction

The purpose of this study is to evaluate the safety, tolerability and efficacy of TT-173 in healthy volunteers after tooth extraction.

As the TT-113 has been cleared for use as a topical hemostatic agent, the proposed study will further investigate the safety, tolerability and efficacy of TT-113 in healthy volunteers after tooth extraction.

Eligibility Criteria:
Inclusion Criteria:

* Subjects to be undertaken for the simple extraction of at least one tooth (incisor, canine, premolar, molar different of third molar) that cause bloody wound, located in the upper or inferior maxillary area of the mouth either
* Subjects who are able and willing to provide written and signed informed consent
* All subjects willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits. Negative pregnancy test result in the screening visit.

Exclusion Criteria:

* Subjects with personal and family history that could affect correct hemostasis
* Subjects with any clinically-significant coagulation disorder including including deficiencies in any of coagulation factors, thrombocytopenia and vascular purpura
* Subject with hipersensivity of TT-173 of any of its components or has a known allergy.
* Subjects who are unable to adequately follow or understand the instructions and requirements of the study.
* Subjects that are not fully free to give informed consent, or any other obstacle in the opinion of investigator support the conclusion that the subject is not fully reasoned.
A Trial of Enteral Colostrum on Clinical Outcomes in Critically Ill Patients

Enteral administration of immune-modulating nutrients such as glutamine, omega-3 fatty acids, selenium, and antioxidants has been suggested to reduce infections and improve recovery from critical illness. However, the effects of colostrum on clinical outcomes in critical ill patients has not been investigated. In current trial, intensive care unit patients with enteral feeding will receive either enteral colostrum or maltodextrin as placebo.

A randomized, double blind, controlled trial will be conducted in general intensive care unit (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. Intervention patients will be received 20 g/day of colostrum along with enteral formula and control patients will be received maltodextrin along with enteral formula. Patients will be assessed for occurrence of new infection, organ failure, duration of stay in ICU, 28 days and 6 months mortality and inflammatory and immune markers.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years old) admitted to ICU
* Start of study intervention within 48 hours after ICU admission
* Expected to require enteral nutrition for at least 72 hours aiming for full enteral nutrition and receive at least 80 percent of enteral formula during the first 48 hour
* Written informed consent of patient or written informed consent of legal representative

Exclusion Criteria:

* Enrollment in a related ICU interventional study
* Requiring other specific enteral nutrition for medical reason
* Death or Discharge before 5th day
* Having any contra-indication to receive enteral nutrition
* Pregnant patients or lactating with the intent to breastfeed
* BMI \<18 or \> 40.0 kg/m2
* Have life expectancy of \<6 mo
* Patients who are moribund
* History of allergy or intolerance to the study product components
* Receiving colostrum during two weeks before start study product
* Have other reasons
Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma

Determine if genotype-directed neoadjuvant chemoradiation, using information from the thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging in high risk patients compared to historical controls.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven adenocarcinoma of the rectum
* Lesion evaluated by surgeon and found to be resectable
* Stage T3 or T4 disease on radiography or ultrasound
* Karnofsky Performance Status at \>60
* Laboratory criteria:

  * Absolute neutrophil count \>= 1.5 K
  * Platelets \>= 100 K
  * Total Bilirubin \<= 2.0;
  * SGOT and Alkaline Phosphatase \<= 2 x upper limit of normal
  * Creatinine \< 2.0
* Informed consent signed
* Patients with distant metastatic disease will be eligible if they satisfy all other conditions.

Exclusion Criteria:

* Pregnant women, children \< 18 years, or patients unable to give informed consent
* Patients with a past history of pelvic radiotherapy.
* Patients with prior malignancy in the past 5 years except: skin cancer or in-situ cervical cancer. However, patients with synchronous adenocarcinomas are eligible provided either (a) the synchronous adenocarcinoma was in a removed pedunculated polyp and did not invade the stalk or (b) the synchronous adenocarcinoma was in a removed polyp that lay within the surgical field (extent of resection would not be changed) or (c) the synchronous adenocarcinoma is smaller than the index rectal cancer and lies completely within the radiation field (clinically favorable second lesion and the extend of radiation and surgery would not be changed).
* Patients with known allergy to 5-fluorouracil or irinotecan