cyrilzakka/clinical-trials huggingface dataset:
Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With High Level of Resistance to Carbapenems

Enterobacterales resistant to carbapenem are cause of severe concern in hospital-acquired infections since therapeutic options are limited. Recently approved drugs, such as bela-lactam/beta-lactamase inhibitor, have been the drug of choice. However, its use is limited in low- and middle-income countries. Thus, therapy of these infections mostly relies on polymyxins and other old drugs.

The role of adjuvant carbapenem therapy in combination with polymyxins, aminoglycosides and other drugs is under investigation. From a pharmacokinetic/pharmacodynamic (PK/PD), there is an elevated probability that high-dose, extended infusion administered meropenem reach the PK/PD target of 40% above the minimal inhibitory concentration (MIC) of the pathogen when the MIC is 32mg/L or lower (non-susceptible isolates have MICs of 4mg/L or higher). However, the MIC is not routinely determined in clinical laboratories. In addition, high-level (above 32mg/L) resistance to carbapenems have been reported in many studies.

This open-label, randomized clinical trial aim to assess if the addition of meropenem to the best available therapy can increase the number of days alive and free of hospitalization in patients with bloodstream infections by Enterobacterales with MIC of meropenem above 32mg/L.


Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary bloodstream infections by any specie of the Enterobacterales family with minimum inhibitory concentration (MIC) for meropenem \>32mg/L;
* Agreement of the assistant team with the inclusion of the patient in the study;
* Agreement by the patient or legal guardian to sign the informed consent form.

Exclusion Criteria:

* Known pregnancy;
* Patients belonging to the population deprived of their liberty;
* Known allergy to meropenem;
* Use of ceftazidime-avibactam (or any other new antimicrobial agent that become available in Brazil during the study period) for the treatment of the current infection;
* Infection by an Enterobacterales isolates without in vitro susceptibility to at least one antimicrobial drug;
* Bloodstream co-infection by another gram negative bacilli;
* Concomitant infection at any site by a pathogen which meropenem is indicated;
* Neutropenia (\<1000 neutrophils cells/mm3)
* Death expected within 48 hours of eligibility assessment.
Does Style of Pre-sedation Instructions Improve Patient Outcomes in Ambulatory Anesthesia for Oral and Maxillofacial Surgery?

This randomized controlled trial aims to evaluate the impact of a brief guided visualization exercise on anesthesia-related outcomes in oral and maxillofacial surgery in patients scheduled for ambulatory anesthesia in the oral and maxillofacial surgery clinic. Researchers will compare these patients, who will receive the guided visualization exercise in addition to standardized pre-operative instructions, to patients who will only receive the standardized pre-operative instructions. The following outcomes will be measured for both groups:

* A seven-point Anesthesia Experience Survey
* Face-Legs-Activity-Cry-Consolability (FLACC) scores at three points in time during the anesthetic - during local anesthesia, during surgery, and fifteen minutes after surgery has concluded
* Amount of medications used during the sedation
* Length of sedation


Eligibility Criteria:
Inclusion Criteria:

* Subjects within ages 8 to 70.
* Subjects planned for ambulatory intravenous sedation in the oral and maxillofacial surgery clinic.
* Ability to understand verbal English or understand instructions using a sign-language or voice interpreter of their native language.

Exclusion Criteria:

* Subjects who cannot understand the instructions, even with an interpreter (extremes of age, cognitive impairments, severe psychiatric disease that may affect participation)
* Subjects not undergoing intravenous sedation (oral sedation, nitrous oxide, local anesthesia)
* Subjects undergoing anesthesia in other environments (gastrointestinal suite, operating rooms, interventional radiology)
Effects of Laying on of Hands in Fibromyalgia

Fibromyalgia is conceptualized as non-inflammatory syndrome with manifestation in the musculoskeletal system associated with chronic generalized pain, fatigue, mood and sleep changes. Laying on of hands therapies are intended to prevent injuries, promote health recovery and harmony between the physical, mental and spiritual dimensions. The aim of this study is to evaluate the effects of laying on of hands with and without a spiritual connection on the mental and physical health, well-being and quality of life of women with fibromyalgia. 72 patients will be divided into 3 groups: control - without imposition of hands, imposition without spiritual presence with the intention of healing and imposition with spiritual presence through the spiritist passe.

This is a triple-blind, randomized, controlled clinical trial of 10 weeks, with a minimum sample of 72 participants, to be carried out at the Center for Integrative and Complementary Practices of the Hospital de Clínicas da UFTM. Participants will be informed about the research objectives, their voluntary participation and anonymity. Then, they will be randomly placed in one of the groups: control, imposition by volunteers with healing intent (GIM) and spiritist passe. All participants will lie on a stretcher for about 5 minutes, then vital signs (blood pressure and heart rate and pain assessment by VAS) will be measured before, immediately after the intervention on days D1, D8 and D10. During the laying on of hands, they will receive the following verbal command: "Mentalize relief of pain and improvement of symptoms". After the end of the intervention, they will receive systemic acupuncture: the acupuncture application method will be standardized in all participants, insertion of a systemic needle 0.20 x 0.40 perpendicularly in the following points: pericardium 6, heart 7, spleen, pancreas 6, large intestine 4, liver 2, stomach 36 bilaterally and will remain for about 20 minutes. Participants will receive interventions lying on stretchers in a room prepared for this purpose. The eyes will be blindfolded with a visor made for the study.

Eligibility Criteria:
Inclusion Criteria:

* women with fibromyalgia
* up to 18 years
* diagnosis of fibromyalgia according to ACR 2010 criteria

Exclusion Criteria:

* pregnant women
* treatment for cancer
* inability to understand the questionnaires
* refusing to sign the informed consent
Transthoracic vs Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer

The study aims to compare the efficacy and safety of transthoracic cryoablation to transbronchial cryoablation in the treatment of early-stage peripheral lung cancer.

Ablation therapy has been widely used in the treatment of peripheral lung cancer. Among various ablation techniques, cryoablation has been demonstrated to be therapeutic efficacy with several advantages, including high safety, clear ablation borders, and minimal local pain. With the development of navigational bronchoscopy, pilot study on transbronchial cryoablation for peripheral lung cancer has proved its efficacy and safety, but there is a lack of prospective randomized controlled trials to verify its near-term as well as long-term efficacy and safety. This study was designed as a prospective, randomized controlled, multicenter clinical trial. A total of 110 participants will be randomly assigned to either the transbronchial group or the transthoracic group in a 1:1 ratio. The primary endpoint is the complete ablation rate at 12 months post-ablation. Secondary endpoints include technical success rate, complete ablation rate at 6 months post-ablation, local control rate at 1, 2 and 3 years post-ablation, progression-free survival, overall survival, and safety.

Eligibility Criteria:
Inclusion Criteria:

1. Age older than 18 years.
2. Primary peripheral lung cancer diagnosed by pathology and pre-procedure staging examination suggesting clinical stage T1N0M0, stage IA (including postoperative new and multiple primary).
3. The target lesion was evaluated to be feasible for both CT and bronchoscopy-guided ablation.
4. Patients who are not suitable for surgery or refuse surgery, agree to undergo initial ablation therapy and sign informed consent form.

Exclusion Criteria:

1. Patients with platelets \<70×109/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short term.
2. Patients with severe pulmonary fibrosis and pulmonary arterial hypertension.
3. Infectious and radioactive inflammation around the lesion, skin infection at the puncture site that is not well controlled, systemic infection, high fever \>38.5°C.
4. Patients with severe hepatic, renal, cardiac, pulmonary and cerebral insufficiency, severe anaemia, dehydration and serious disorders of nutritional metabolism that cannot be corrected or improved in a short term.
5. Those with poorly controlled malignant pleural effusions.
6. Anticoagulation therapy and/or anti-platelet drugs (except dabigatran, rivaroxaban and other new oral anticoagulants) have not been discontinued more than 5\~7d before ablation.
7. Eastern Cooperative Oncology Group (ECOG) score \>2.
8. Combination with other tumors with extensive metastases and an expected survival of \<6 months.
9. Patients with episodic psychosis.
10. Pregnant women, or patients with pregnancy plan during the study period.
11. Have participated or are participating in other clinical studies within 30 days.
12. Any other condition that the investigator considers inappropriate for participation in this study.
Matrix Therapy And Bacterial Keratitis

The purpose of this study is to evaluate efficiency of CACICOL20 for bacterial keratitis. It is a double blinded comparison of epithelial defect in two groups of patients randomized between CACICOL20 and physiological salt solution.

Extracellular matrix, composed of glycosaminoglycans (GAG) and matricial proteins, has a key role in tissular homeostasis.

The matrix therapy is a new class of medical substance, called RGTAs, ReGeneraTing Agents, consist of chemically engineered polymers adapted to interact with and protect against proteolytic degradation of cytokines.

OTR4120 (CACICOL20) is an heparan sulphate (HS) mimetic that can replace the degraded HS and protect and improve the bioavailability of cytokines. It aims to facilitate and potentiate the wound healing by restorating the natural microenvironment.

CACICOL20 was used in treating corneal dystrophies and chronic corneal ulcers. It significantly favored corneal healing. It was well tolerated with no side effects.

Bacterial keratitis is a serious ocular condition that may result in significant sight-threatening corneal sequelae. The common risk factors for infectious keratitis include ocular trauma, contact lens wear, recent ocular surgery, preexisting ocular surface disease, dry eyes, lid deformity, corneal sensational impairment, chronic use of topical steroids, and systemic immunosuppression. Serious cases of keratitis are hospitalized to administrate an intensive hospital-made local antibiotic.

The purpose of this study is to evaluate efficiency of CACICOL20 for bacterial keratitis. It is a double blinded comparison of epithelial defect in two groups of patients randomized between CACICOL20 and physiological salt solution.

Eligibility Criteria:
Inclusion Criteria:

* - Hospitalized patients for bacterial keratitis in Ophthalmology Department, Clermont-Ferrand university hospital .with a controlled local infection after 48 hours local antibiotics.

  * with a corneal ulcer diameter \> 2 millimeters

Exclusion Criteria:

* - Ulcers deeper than the superficial stroma, perforated ulcers or pre-perforated, requiring a surgical intervention \< 15 days.
* Clinical suspicion and/or microbiological evidence of fungal or parasitic infection
* Non controlled infection in spite of 48 hours intensive local antibiotics
* Allergy
* Silver or copper salts treatment
* Ocular surgery within the last 1 month
* Unable to follow up medical examinations for geographical, social, physical or psychological reasons
* Patient already included in another clinical trial
* Pregnant patients or breastfeeding
* Person under a legal protection measure, under guardianship
* Not cover by social insurance.
Safety, Tolerability and Pharmacodynamics of AP214 Acetate in Patients Undergoing Cardiac Surgery

The purpose of the present research study is to investigate for the first time, the safety and tolerability of infusion doses of AP214 in subjects having heart surgery such as coronary bypass graft and/or valve repair or replacement surgery. AP214, the investigational drug, is being developed to potentially prevent post-surgical kidney injury after thoracic aortic aneurysm repair.


Eligibility Criteria:
Inclusion Criteria:

1. Has signed the trial specific informed consent form.
2. Patients ≥ 18 years old, male or female, not of childbearing potential (postmenopausal or permanently sterilized e.g., tubal occlusion, hysterectomy, bilateral salpingectomy), regardless of ethnicity.
3. Patients undergoing CABG, valve(s), CABG/valve and/or aortic root or ascending aortic aneurysm repair surgery.
4. Cleveland Clinic Renal Score ≥ 2 (higher than average risk for AKI).
5. EF ≥ 30%, evaluated within 2 months prior to screening visit.

Exclusion Criteria:

1. Cardiac surgery to be performed "off pump" without cardiopulmonary bypass.
2. Circulatory arrest in connection with aortic root or ascending aortic aneurysm repair surgery.
3. Confirmed or suspected endocarditis.
4. Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure.
5. Receiving Aprotinin during the trial, from Screening to Day 90.
6. Having undergone cardiovascular catheterization ≤ 48 hours prior to scheduled surgery.
7. Active peptic ulcer disease and gastritis.
8. Hemoccult positive stools, hematological, bleeding, and coagulation disorders.
9. Receiving dopamine at renal doses (2-4 mcg/kg/min), from Screening to Day 90.
10. S-Creatinine greater than 2.1 mg/dl.
11. Known or suspected hypersensitivity to the investigational medicinal product.
12. Known or suspected hypersensitivity to ondansetron or other selective 5-hydroxytryptamine 3 (5-HT3) receptor antagonists.
13. Current participation in any other interventional clinical trial.
14. Previously dosed with AP214.
15. Use of investigational medicinal products within the previous 6 months.
16. Body weight above 140 kg.
17. History of any organ transplant.
18. Women who are of childbearing potential, pregnant or breast-feeding.
19. Current abuse of alcohol or substance, according to the investigator's medical judgment
20. Has a mental incapacity or language barriers precluding adequate understanding of trial procedures.
21. Is considered by the Investigator unsuitable to participate in the trial for any other reason for instance due to a significant serious underlying condition
Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome

Dehydrated fruit and vegetable concentrates provide an accessible form of phytonutrient supplementation that may offer cardioprotective effects. This study assessed the effects of encapsulated fruit and vegetable juice powder concentrates on endothelial function and cardiac risk markers in subjects in a randomized, double blind, placebo controlled crossover clinical trial with three treatment arms.


Eligibility Criteria:
Inclusion Criteria:

* metabolic syndrome defined by AHA/NHLBI criteria
* nonsmoker
* not taking any other vitamins or dietary supplements
* able to have blood pressure measured bilaterally at the brachial artery

Exclusion Criteria:

* any unstable medical condition that would limit the ability to participate fully in the trial
* rheumatologic disease requiring regular use of NSAIDs
* preexisting cardiovascular disease
* diagnosed eating disorder
* inability to complete endothelial function assessment.
* use of insulin, glucose sensitizing medication, vasoactive medications (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators), nutriceuticals, fiber supplements, and tobacco.
Effect of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast Density

This is a randomized, double-blinded, placebo-controlled dose-response efficacy study of oral (Z)-endoxifen in premenopausal women with measurable breast density. There will be 5 in-clinic visits (Screening, Day 1, Months 1, 3 and 6) and 3 self-report visits (Months 2, 4 and 5). Standard of care mammograms will be used for the screening mammogram as well as the 24-month follow up visit.


Eligibility Criteria:
Inclusion Criteria:

1. Premenopausal women (defined as having at least one menstruation during the prior 12 months; women with an intrauterine device are considered premenopausal if \<52 years)
2. Women of childbearing potential using a highly effective method of birth control\* throughout the study period and willing to comply with monthly pregnancy testing
3. Screening mammogram performed within 3 month of study inclusion
4. Mammographic density assessed as BI-RADS® score B, C, or D
5. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects

Exclusion Criteria:

1. Mammographic BI-RADS® malignancy code ≥3 at baseline mammography
2. Any previous diagnosis of breast cancer, including carcinoma in situ, or any other cancer (non-melanoma skin cancer and in situ cancer of the cervix are not exclusion criteria)
3. A history of breast surgery, e.g., reduction or enlargement, which might affect mammographic density measurements
4. Current medical conditions:

   1. APC (activated protein C) resistance, an inherited coagulation disorder
   2. Systolic pressure higher than 160 mm Hg or diastolic higher than 100 mm Hg
   3. Cataract(s)
   4. Uncontrolled diabetes (defined as HbA1c \>50 mmol/mol)
   5. Abnormal lab values deemed clinically significant by Investigator
5. BMI \> 30
6. Women who have an increased risk of venous thrombosis due to immobilization, e.g., using wheelchair
7. Agents that have the potential to decrease endoxifen levels through increased metabolic clearance:

   1. Certain anti-epileptic therapies (carbamazepine, fenytoin, fenobarbital, lamotrigine)
   2. Certain antibiotics (rifamycins)
   3. St John's wort (in Swedish: johannesört)
   4. Certain HIV medications (efavirenz, ritonavir)
8. Lactating, pregnant, or plan to become pregnant in the next year
9. History of thromboembolic disease such as embolus, deep vein thrombosis, stroke, TIA (transient ischemic attack) or myocardial infarction
10. Allergy to endoxifen or any of its components
11. Previous treatment with an anti-oestrogen, including experimental drug studies (e.g., Karma CREME, Karisma-1 or Karisma-2)
12. Prescribed and regular use of anticoagulants (defined as substances included in group B01A in the ATC-system)
13. Participation in another investigational clinical trial in the last 6 months
14. Not willing or able to understand the study information and/or informed consent
Focal Thermal Therapy Acupoint OA Knee RCT

Osteoarthritis of the knee is a common degenerative joint disorder in our ageing population. A combination of thermal therapy with a self-management exercise have shown a positive effect in the management of osteoarthritis of the knee. This study aimed to compare the effectiveness of topical heat pack versus focal application of heat therapy at the acupressure points in the treatment of osteoarthritis of the knee.

Osteoarthritis of the knee is a common degenerative joint disorder in our ageing population. A combination of thermal therapy with a self-management exercise have shown a positive effect in the management of osteoarthritis of the knee. This study aimed to compare the effectiveness of topical heat pack versus focal application of heat therapy at the acupressure points in the treatment of osteoarthritis of the knee.

A randomized control trial was conducted in 76 patients with osteoarthritis of the knee, diagnosed by an experienced orthopedic surgeon. Following inclusion and exclusion selection, patients were randomly allocated to group 1 (Heat Pack) or group 2 (Thermal Gun). All patients received 30 minutes of treatment in each session, twice a week for 4 weeks. They also received an education program and taught home knee exercises. Outcome measurements were Visual Analog Scale (VAS) for pain intensity, muscle power, knee ROM, WOMAC and SF-12v2.

Eligibility Criteria:
Inclusion Criteria:

* male or female patients aged 40 years old or older
* clinical and radiological diagnosis of osteoarthritis of the knee based on the OA Knee clinical guidelines and radiological evidence
* normal skin sensation to heat, cold, pins and pricks (i.e. passed the required Skin Sensation Test)
* not participating in any other clinical trial at time of this study
* be able to complete the whole trial period
* no cognitive dysfunction and was able to sign the consent form

Exclusion Criteria:

* received bilateral knee arthroplasty before this study
* polyarthritis affecting more than both knee
* active skin lesion
* women in pregnancy or breasts feeding
* received acupuncture and/or moxibustion within one month of the study
* unable to comply with the study protocol
Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults

The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric Bypass (RYGB) subjects


Eligibility Criteria:
Inclusion Criteria:

* Previously undergone Roux-en-Y gastric bypass (RYGB) surgery at least 6 months prior to screening
* Previous diagnosis of post-bariatric hypoglycemia (PBH), requiring intake of oral carbohydrates.
* Body mass index (BMI) ≤ 40 kg/m2
* Fasting plasma glucose between 72-106 mg/dL (4.0-6.0 mmol/l)

Exclusion Criteria:

* History of hypersensitivity reactions to glucagon or dasiglucagon or any of the excipients
* History of insulinoma, pheochromocytoma, MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease.
* Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m2 or end-stage renal disease at screening
* Hepatic disease, including serum alanine aminotransferase or aspartate aminotransferase ≥ 2.5 times the upper limit of normal (ULN)
* Active malignancy, except for basal or squamous cell skin cancers
* History of a cerebrovascular accident within 6 months prior to screening
* History of myocardial infarction, unstable angina, or revascularization within 6 months prior to screening.
* Congestive heart failure, New York Heart Association Class III or IV
* Concurrent administration of β-blocker therapy
* Clinically significant ECG abnormalities at screening