cyrilzakka/clinical-trials huggingface dataset:
Application of S26E for Diabetic Foot Ulcer Healing

A randomized, controlled open-label, parallel group study to examine the effectiveness of a local application of the kalahari melon (Citrullus lanatus) seed oil for the healing of non-infected diabetic foot ulcers.

This is a randomized, controlled open-label, parallel group study of 12 weeks duration aimed to examine the effectiveness of a local application of the kalahari melon (Citrullus lanatus) seed oil (S26E) for the healing of non-infected chronic (\>12 weeks) diabetic foot ulcers. The S26E is a natural extract rich in unsaturated (such as linoleic, oleic, palmitic and static) fatty acids which have shown promise in the promotion of wound healing by modulating the migration and functional properties of inflammatory cells in wound cites as well as the production of inflammatory cytokines. The safety of topical S26E application on human skin has been clinically demonstrated.

Eligible participants will be adults patients with diabetes mellitus (DM) type 1 or 2 and chronic (persistent for \>12 weeks after initial presentation) neuropathic or neuroischaemic non-infected diabetic foot ulcers. Following recruitment and randomization (on a 1:1 ratio) eligible patients will attend the study site on weekly intervals. After a run-in period of 2 weeks (visits 1-2) during which all participants will receive the optimal standard-of-care for neuropathic/neuroischaemic diabetic ulcers (incl. optimization of glycemic control, off-loading, local debridement as needed, atraumatic surface scrubbing, saline washing and sterile dressing) eligibility will be reassessed. Participants who will continue in the study will receive standard of care (control group) or standard of care plus daily local S26E application on ulcer (intervention group) (visits 3-12). After visit 12 the application of S26E will be terminated and all participants will receive an additional follow up visit 4 weeks later (final visit). Efficacy end-points will be assessed at the end of the of 12 weeks of observation (Visit 12)

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 Diabetes Mellitus
* Body Mass Index \<40 kg/m2
* Glycated Hemoglobin (HbA1c) \<10%
* Presence of a diabetic foot ulcer with the following features i) Owing to chronic peripheral sensorimotor diabetic neuropathy, with or without peripheral arterial disease (critical ischemia excluded as indexed by an Ankle-Brachial index \<0.4 ) ii) Persistence for \>12 weeks iii) Already following an adequate off-loading method

Exclusion Criteria:

* Presence of clinical signs of infection
* Inability or refusal to follow off-loading methods
* Ulcer surface area decline by \>15% during the run-in period
* Malignant disease (non-melanoma skin malignancy and healed thyroid malignancies excluded)
* Acute Charcot arthropathy
* Serious chronic Hepatic (Child-Pugh B or C), Renal (stage 4-5 CKD) or Heart (NYHA 3-4) disease
* Known hypersensitivity to the product or its contents
* Any random glucose measurement \>350 mg/dl during the run-in period
Risk Factors for Early POCD in the Patients With PSM Undergoing CRS-HIPEC

Objectives to investigate the incidence and associated factors for early postoperative cognitive dysfunction in the patients with peritoneal surface malignancies undergoing cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy(CRS-HIPEC).Methods fifty patients aged 18-65 yr were included in the research and were grouped base on the score of neuropsychological assessments which had done in the ward at 7 day before and after the surgery. The investigators monitored various indicators in the perioperative period, such as age, body weight, sex, education, duration of operation, intraoperative blood loss, cardiovascular events, amount of fluid infused per hour. Meanwhile, the concentration of serum amploid A (SAA),IL-1beta,TNF-alpha,HMGB1,S100b,cortisol and Abeta40 were measured at the various stage of the operation and 24 hours after the operation, and the differences of data between postoperative cognitive dysfunction(POCD) and Non-POCD groups were analyzed.


Eligibility Criteria:
Inclusion Criteria:

* age \< 65 years or \>18 years
* The patients with peritoneal surface malignancies willing to undergo the cytoreductive surgery with hyperthermic intraperitoneal chemotherapy

Exclusion Criteria:

* age \< 18 years or \>65 years
* several organ function severely abnormal and can not tolerate the surgery,such as suffering from severely anemia, liver and renal function disfunction, heart and cerebrovascular disease
* cognitive function was assessed by Mini-Mental State Examination (MMSE) at 1 day before operation and the score\<23
* people with neurological and psychiatric disease, such as anxiety, senile dementia, stroke sequela, cerebral hemorrhage, etc
* psychiatric drug abusers
* patients reluctant to go along with the trial
MonoMax for Abdominal Wall Closure

A great number of different suture techniques and suture materials are in use in order to reconstitute the abdominal wall integrity, but there is no surgical gold standard for abdominal wall closure until today. Various Meta-Analyses and randomized controlled trials have been performed, which compared non-absorbable or long-term absorbable versus rapid absorbable suture materials or monofilament versus multifilament suture materials, or continuous versus interrupted suture techniques respectively. This lack of evidence has the following outcome: burst abdomen is observed in 1-3% of patients within the first days after a laparotomy. The incidence of abdominal wall hernias 12 months postoperatively is estimated to be up to 20% (range 9 to 20%) . Wound infections develop in 3 to 21% of patients undergoing a median laparotomy within the first 30 days. At present most surgeons favour monofilament long-absorbable continuous sutures as the most suitable material for closing abdominal wounds after midline laparotomy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Elective primary laparotomy
* Written informed consent

Exclusion Criteria:

* Peritonitis
* Emergency surgery
* Severe psychiatric and neurologic disease
* Drug- and / or alcohol abuse according to local standard
* Lack of informed consent
* Current immunosuppressive therapy
* Chemotherapy within the 2 weeks before operation
* Radiotherapy of the abdomen completed less than 8 before surgery
* Pregnant or breast-feeding women
* Coagulopathy
Correlation Between Endothelial Function and Trans Radial-procedural Events

The aim of this study is to investigate the relation between the previous presence of endothelial dysfunction and the development of radial artery vasospasm during the trans-radial coronary evaluation.

All patient will undergo pre procedural endoPAT assessment for endothelial dysfunction

Eligibility Criteria:
Inclusion Criteria:

Patients without angiographic proof of coronary disease, with scheduled elective coronary angiographic evaluation by radial approach.

Exclusion Criteria:

Impossibility to perform radial approach; abnormal Barbeau test result (type C and D); previous important trauma of the upper limbs; presence of fistule for renal dialysis; lymphedema; acute myocardial infarction, severe valvular heart disease; patients with NYHA class III and IV heart failure; malignancy; active myocarditis; HIV infection or immunodeficiency state; chronic viral infection; acute systemic infection requiring antibiotics; systemic inflammatory disease; Raynaud's syndrome; refusal to sign the informed consent form. All participants must give a written informed consent
Training in Exercise Activities and Motion for Growth (TEAM 4 Growth) RCT

This is a Phase III randomized controlled trial of a passive ROM exercise program that will be performed in infants with HLHS and other single right ventricle anomalies following the Norwood procedure at PHN and Auxiliary Centers.

Growth is often impaired in infants with congenital heart disease (CHD). Nutritional interventions, drug therapy and surgical palliation have had varying degrees of success in enhancing growth. Passive ROM has improved somatic growth in preterm infants and has been demonstrated in a previous Pediatric Heart Network (PHN) to be safe and feasible in neonate's post-Norwood procedure. Improved growth may also favorably impact neurodevelopment, behavioral state, and time to hospital discharge.

This study's objectives are to evaluate growth in infants with hypoplastic left heart syndrome (HLHS) or other single right ventricle (RV) anomalies after the Norwood procedure who are randomized to a passive range of motion (ROM) exercise program vs. standard of care.

Eligibility Criteria:
Inclusion Criteria:

* hospitalized infants with HLHS or other single RV anomalies
* \>=37 weeks gestation
* \<=35 days of age
* planned Norwood procedure (or hybrid leading to Norwood within 35 days)
* parent or guardian willing to comply with protocol and provide written informed consent

Exclusion Criteria:

* birthweight \<3rd percentile for gestational age
* chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (for example Trisomy, Noonan, or Turner syndromes)
* non-cardiac diagnosis associated with growth failures
* listed for cardiac transplant
* anticipated discharge within 14 days of screening
DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers

Vitamin D can be made in the skin by exposure to sunlight and can be found in certain foods. Vitamin D levels are alarmingly low in many North American children. Several health issues have been linked with low vitamin D. These include colds caused by viruses and asthma attacks. However, no study has determined whether vitamin D supplementation can reduce the risk of these conditions in young children where they are most common and most severe.

The goals of this study are to determine whether wintertime high dose vitamin D supplementation of preschoolers can prevent colds and asthma attacks. The investigators also aim to work out how much money would be saved by the health care system and society if preschoolers were routinely supplemented with Vitamin D during the winter. The investigators believe that preschoolers receiving 'high dose' vitamin D supplementation during the wintertime will be less likely to have colds, asthma attacks, and low vitamin D levels and will be less likely to use the medical system and keep their parents away from work.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy children by parental report
2. Have reached their 1st birthday but not past their 6th birthday
3. Present to a TARGet Kids! practice for routine primary healthcare prior to viral season (September through November)
4. Parents provide informed consent to participate.

Exclusion Criteria:

1. Children with gestational age \< 32 weeks
2. Children with chronic illness (except for asthma) on parental report which is known to interfere with vitamin D metabolism and increase the risk of respiratory infection
3. Children with a sibling participating in the study to reduce clustering effects.
Values Affirmation to Improve Teachers' Outcomes

The purpose of this project is to examine whether a values affirmation intervention improves teacher-student relationships, classroom performance, and well-being of first-year teachers.


Eligibility Criteria:
Inclusion Criteria:

* Must be teachers (current or prospective) affiliated with the Relay Graduate School of Education in the targeted classes/programs
* Must consent to participate and begin the experimental (values affirmation or control) exercise

Exclusion Criteria:

* None

Note: Our primary hypotheses focus on the effects of values affirmation for first-year teachers, particularly White first-year teachers at majority minority schools. Participants who are not White first-year teachers will be permitted in the study, but will not be included in confirmatory analyses.
Multiple Risk Factor Intervention Trial

Ms. FIT pilot is a pilot study of a 3-arm RCT with equal recruitment and stratification of pre and postmenopausal women with risk factors for chronic disease to: 1) Canadian guidelines-based physical activity alone; 2) Canadian guidelines-based physical activity and healthy eating; or 3) stretching attention control. The purpose of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of the interventions. The objectives are to: 1) pilot test the intervention delivery protocol in a real-world application (management and technical capabilities of the research group); 2) evaluate adherence and participant acceptability of a combined in-person and virtual intervention delivery in both pre and post-menopausal women; 3) identify the preliminary efficacy of the interventions on select cardiometabolic risk markers.


Eligibility Criteria:
Inclusion Criteria:

* females
* pre- or postmenopausal
* aged 30+ years
* moderate or high Canadian Diabetes Risk Score score

Exclusion Criteria:

* diagnoses of cardiovascular diseases, type 2 diabetes, non-alcoholic fatty liver disease, cancer (except for non-melanoma skin cancer), or respiratory disease (i.e., COPD)
* major signs or symptoms (regardless of known diagnosis) of cardiovascular diseases, diabetes, or renal disease
* pregnant or lactating
* mobility limitations to exercise
* smoking cigarettes within the past 3 months
* using transdermal hormones, taking exogenous hormones or receiving exogenous hormones from other means (e.g. intrauterine device)
* self-report of \>30 min/week of MVPA
* following a specific dietary practice (e.g., vegan, ketogenic) in last 3 months
* presenting with any of the American Heart Association's absolute or relative contraindications for symptom-limited maximal exercise testing
* requiring and do not receive medical clearance for maximal exercise
* cannot read and understand the consent form or communicate in English
* individuals who are students in classes of the professors who are involved in the study or students with whom the professors have a supervisory relationship
Coronary CT Angiography Using 320-Row Volume CT in Patients With Atrial Fibrillation

The primary objective of this study is to analyze the diagnostic accuracy of coronary CT angiography using 320 simultaneous detector results in patients with atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Suspected coronary artery disease based on clinical findings or findings on other noninvasive imaging tests and planned coronary angiography within the next 14 days.
* Able to understand and willing to sign the Informed CF.

Exclusion Criteria:

* Creatinine of above 2.0 mg/dl
* Age below 50 years
* Women of child bearing potential (no hysterectomy, no menopause, or menopause since less than 12 months) must demonstrate a negative pregnancy test performed within 24 hours before CT.
* Inability to hold the breath for 10 seconds
ESP vs ESP With PECS

Patients scheduled for minimally invasive mitral valve repair. Each patient will be treated with intravenous (i.v.) oxycodone - patient-controlled analgesia (PCA). Patients will be allocated to one of the groups: erector spinae plane (ESP) block or EPS with pectoral fascia (PECS) block.

Only patients who are qualified for an elective procedure of mitral valve replacement may participate in the study. Each patient will be anesthetized generally. The same drugs will be used in each stage of anesthesia. The induction: etomidate, remifentanil, rocuronium, scolina as required. The maintenance: sevoflurane, remifentanil, rocuronium. The emergence: oxygen, sugammadex or neostigmine a required.

Patients will be randomly allocated to one of two groups: ESP or PECS. Among the patients from ESP group will have ESP blockade before the induction of general anesthesia. ESP blockade will be performed under ultrasound control. A single-shot technique will be used with 0.375 % solution of ropivacaine: 0.1 mL per patient KG. The maximum dose is 20 mL.

Patients from PECS group will receive ESP block and PECS I and II type block with 0.375 % solution of ropivacaine (up to 20 mL of local anesthetic).

Each patient, before the end of surgery, will be administered i.v. 0.1 mg of oxycodone. PCA with oxycodone (1mg/mL) will be utilized during the postoperative period: 7-minute interval. This is standard protocol in the investigator's department.

Only patients who are successfully awakened after the procedure may participate in the study.

The pain intensity will be assessed with visual-analogue scale (VAS) at 2, 4, 8, 12 and 24 hour after the end of anesthesia.

The total consumption of oxycodone will be also monitored.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled mitral valve replacement surgery
* obtained consent

Exclusion Criteria:

* allergy to oxycodone and local anesthetics
* depression, antidepressant drugs treatment
* epilepsy
* usage of painkiller before surgery
* addiction to alcohol or recreational drugs
* prolonged postoperative ventilation (over 2 hours)
The Efficacy of REHACOP Program in Schizophrenia

This study examined the efficacy of an integrative cognitive remediation program (REHACOP) to improve cognition, social cognition, clinical symptoms and functional outcome in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* diagnostic criteria for Schizophrenia according to American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)

Exclusion Criteria:

* evidence of alcohol or drug abuse in the last 30 days
* previous history of significant lack of consciousness
* mental retardation
* relevant neurological or medical condition
Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care

Up to 50% of obese patients are not interested in, or ready for, weight loss. Clinical practice guidelines clearly recommend that these patients avoid gaining weight. However, despite this clinical guideline, weight gain prevention interventions are not available in primary care practice. Balance is a pragmatic, randomized controlled effectiveness trial for weight gain prevention for patients within rural community health centers, using a digital health platform.

Clinical practice guidelines emphasize recommend weight gain prevention, but evidence-based treatments are not available in primary care. Balance, a pragmatic effectiveness trial, will test a scalable treatment approach for medically-vulnerable adults, those who suffer disproportionately from obesity and its adverse health effects. Balance builds on the design and findings of the Shape study (NCT00938535) to test a pragmatic intervention within rural community health centers. Balance will randomize overweight adults and adults with obesity who are patients a local community health center network (Piedmont Health Services) to either: 1) a 12-month weight gain prevention intervention or 2) usual care. Intervention group components include tailored behavior change goals; mHealth self-monitoring and feedback; skills training videos; and stepped responsive coaching from clinic Registered Dietitians. The usual care group will receive standard primary care offered by their providers and automated text messages and health information about maintaining a healthy weight. All intervention components and materials will be provided in Spanish or English.

Eligibility Criteria:
Inclusion Criteria:

* Patients of Piedmont Health Services' community health centers in central North Carolina only
* BMI between 25 and 40 kg/m2 and weighs less than 380 lbs
* Speaks English or Spanish
* Had a non-urgent outpatient visit at a participating community health center clinic at Piedmont Health Services within the last 2 weeks
* Has a cell phone
* Willing to receive 3-12 study-related text messages per week

Exclusion Criteria:

* Current Piedmont Health Services employee
* Has past bariatric surgery or planned bariatric surgery (within next 2 years)
* Diagnosed with cancer in the last 6 months and is in active treatment
* Has a history of cardiovascular event (stroke/MI) in the last 12 months
* Was hospitalized for a mental health issue in the last 12 months
* Diagnosis of end stage renal disease
* Currently participating in a weight loss program/research study
* Plans to move out of area and not receive care within community health center network (within the next 2 years)
* Currently or recently pregnant (within the last 6 months) - Females only
* Currently or recently lactating (with the last 2 months)- Females only
* Plans to get pregnant in the next 12 months - Females only
the Clinical Trial of Teicoplanin for Injection

1. Primary study endpoint Security Effectiveness
2. Secondary study endpoint Extensive use of population characteristics Clinical drug characteristics appropriate crowd characteristics Adverse reactions susceptible population characteristics Reveal rare, new, unanticipated and long-term adverse drug reactions bacterial resistance Explore the advantages of teicoplanin in combination with other antimicrobial agents Explore the opportunistic use of teicoplanin for injection

Research purposes

1. To explore the safety and efficacy of different doses of teicoplanin for injection in the real world
2. To explore the characteristics of different doses of teicoplanin for injection, the clinical characteristics of drug use and repeated use of bacterial resistance;
3. Reveal rare or even very rare, new, unanticipated, and adverse drug reactions associated with long-term use;
4. To explore the advantages of different doses of teicoplanin in combination with other antimicrobial agents;
5. To explore the use of teicoplanin in the treatment of infectious diseases on the rational use of drugs time;
6. To reveal the risk factors of adverse reactions and susceptibility to people, to identify the characteristics of the crowd;
7. To investigate the clinical use of teicoplanin injection for the real situation, for further risk management, to expand the indications and expert consensus dose study to provide clinical clues and basis;
8. To provide reference for revision of clinical guidelines and consensus, clinical pathway design;
9. To further enhance the level of safe use of teicoplanin injection, basic medical support and market vitality.

Research design

1. National, large-scale, standardized, standardized, real-world research;
2. Prospective, single - arm open, non - interventional, registration, multi - center clinical study;
3. In the hospitals using teicoplanin for injection, 200 were selected on the basis of voluntary principles;
4. Registration of teicoplanin in patients with injection;
5. Target sample size of 100,000 cases;
6. Exemption from informed consent for ethical review applications;
7. Study of teicoplanin and large-scale data on the safety and effectiveness of antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Prescription for teicoplanin in patients

Exclusion Criteria:

* NO