cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis

This is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC).

This is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC).

Approximately 16 women with fluconazole-resistant VVC will be randomized to either 200 mg or 400 mg oral CAMB for 14 days. The primary objectives of this study are to assess the clinical cure rate, mycology eradication and responder outcome. The secondary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral CAMB.

Eligibility Criteria:
Inclusion Criteria:

* Female 18-65 years
* Informed Consent
* Clinical diagnosis of fluconazole-resistant VVC
* Negative pregnancy test
* Vaginal pH ≤ 4.5

Exclusion Criteria:

* Intolerance or hypersensitivity to any amphotericin B (AMB) product or to azole antifungal drugs
* Receiving antifungal therapy unrelated to VVC or has evidence of systemic fungal infections requiring antifungal therapy
* Received antifungal treatment for VVC within past 10 days except fluconazole, subjects must discontinue fluconazole after informed consent
* Has another cause or suspected cause of vulvovaginitis
* Has active HPV
* Has other urogenital infection
* Has other vaginal or vulvar condition that would confound interpretation of clinical response
* Has significant laboratory abnormality at screening
* Has Type I diabetes, use of insulin, HbA1c\>10
* Exposure to any investigational product within 30 days of screening
* Has other condition that would interfere with subject ability to provide informed consent or put subject at undue risk
Screening of Healthy Adults for Genetic Variations That Control Fatty Acid Processing

The purpose of this research study is to screen healthy African American and Caucasian persons for specific differences in genes that control how fats are processed in the body.

Healthy African American and Caucasian persons will be screened for specific differences in genes that control how fats are processed in the body. Persons with the needed genotypes will be added to a database of healthy persons who may be asked to join a larger study comparing differences in diet on lipid metabolism and inflammatory biomarkers as well as future studies. A key hypothesis for the larger study is that variations in genes involved in lipid metabolism play a role in determining levels of long chain polyunsaturated fatty acids (LC-PUFAs).

Eligibility Criteria:
Inclusion Criteria:

* Be Caucasian or African American between 21-65 years of age
* Be healthy and free of any major illness
* Be a nonsmoker
* Have an intact gallbladder
* Have TG \< 150 and blood pressure less than 130/90
* Must be willing to be re-contacted for future studies

Exclusion Criteria:

* Not have: myocardial infarction, vascular surgery or stroke within the past year
* Not be taking niacin, more than 100 mg aspirin/day or montelukast allergy medications
* BMI equal to or greater than 30 or less than 19
* Fasting glucose greater than 125 mg/dl
* Pregnancy
Operating Room Outcomes After Resident Training on a Virtual Reality Simulator

The purpose of this study is to compare outcomes of patients undergoing laparoscopic cholecystectomy before and after a laparoscopic training curriculum was implemented.

All general surgery interns and PGY-2's AND PGY 3's will be enrolled in a laparoscopic surgery training curriculum that includes practicing surgical skills on a laparoscopic simulator. The PI has constructed an examination on the simulator that will document a significant level of laparoscopic skill. Each general surgery intern, second, AND THIRD year general surgery resident will be required to pass this examination on the simulator prior to being given more responsibility during cases of laparoscopic cholecystectomy. Specifically, interns, second, AND THIRD year residents must pass the examination on the simulator before they are allowed to function as primary surgeon in a supervised setting during laparoscopic cholecystectomy. These interns, PGY-2's, AND PGY 3'S would then be allowed to function as primary surgeon under the supervision of an attending surgery for laparoscopic cholecystectomy cases. The outcomes of these cases would be compared to a matched group of laparoscopic cholecystectomy cases performed by second year general surgery residents in the same supervised environment (but without having trained on the simulator) one year prior.

Eligibility Criteria:
Inclusion Criteria:

* General Surgery residents at NewYork Hospital/Columbia in PGY 1, 2, or 3.

Exclusion Criteria:

* persons who are not General Surgery residents at NewYork Hospital/Columbia in PGY 1, 2, or 3.
Hydroxyapatite (HA) Coating Versus Plasma Porous Spray (PPS) in Press-fit Acetabular Components Early Outcomes With DEXA

The study design comprises a randomized trial of patients undergoing primary total hip arthroplasty using the G7 acetabular system and Taperloc Complete stem comparing regular plasma porous spray with HA coating using Bonemaster (BM) in an uncemented cup. DEXA scanning will be used to measure periprosthetic bone mineral density. Clinical evaluations will be conducted .

The study design comprises a randomized trial of patients undergoing primary total hip arthroplasty using the G7 acetabular system and Taperloc Complete stem comparing regular plasma porous spray with HA coating using Bonemaster (BM) in an uncemented cup. DEXA scanning will be used to measure periprosthetic bone mineral density preoperatively and post-operatively at 6 weeks, 12 weeks, 26 weeks, and 12 months for both the treated and contralateral hip joint. Clinical evaluations will be conducted preoperatively, and postoperatively at 6, 12, 26 weeks, 12 months and 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with osteoarthritis who are candidates for a primary total hip replacement with uncemented acetabular and femoral components as determined by the surgeon.
2. Male and non-pregnant female patient aged 18 to 70.
3. Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up.

Exclusion Criteria:

1. Patients requiring total hip replacement surgery for a fresh hip fracture.
2. Patients with inflammatory arthritis
3. Patients with metabolic bone disease or taking drugs that affect bone turnover. 4 .Patients requiring revision surgery of a previously implanted total hip replacement system or patients requiring a conversion surgery from a previous fracture fixation or hip fusion.

5. Patients with presence of malignancy in the area of the involved hip joint. 6. Patients who, as judged by the surgeon, are mentally incompetent or are reasonably unlikely to be compliant with the prescribed postoperative routine and the follow-up evaluation schedule.

7. Patients with other concurrent illnesses that are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis.
Respiration and Applied Tension Strategies to Reduce Vasovagal Reactions to Blood Donation

For a number of years, researchers have examined the effects of the muscle-tensing technique, Applied Tension (AT), on blood donation-related vasovagal symptoms and donor retention. AT was developed originally to reduce symptoms and avoidance behaviour in people with strong fears of blood and needles (phobics). It was based on the idea that exercise-related increases in blood pressure might be able to counteract the effects of stimuli that lead to a decrease in delivery of blood to the brain. AT was adapted for non-phobic blood donors and significant reductions in self-reported vasovagal symptoms and the need for nurse-initiated treatment as well as increases in donor retention were observed in some groups.

That said, individual response to AT is quite variable. This is probably related to recent research indicating that exercise-related maintenance of heart rate and blood pressure plays only a minor role in reducing vasovagal symptoms. Rather, AT appears to be working at least in part by regulating breathing and reducing the possibility of hyperventilation. Pilot results suggest that a novel intervention aimed specifically at breathing may be more effective and reliable than traditional AT. To evaluate this idea, 408 blood donors at mobile clinics in colleges and universities will be assigned randomly to four conditions. In brief, 5-minute preparation sessions using a notebook computer, donors will either learn a respiration control technique to avoid hyperventilation, AT, both, or neither. As a manipulation check and also a means of examining mechanisms of the interventions, e.g., the possibility that AT may work by regulating breathing and CO2, participants will wear non-invasive portable capnometers while they are giving blood. Outcome will also be assessed by self-report of vasovagal symptoms, observational data, and number of return visits to a blood clinic in the following year verified by the provincial blood collection agency, Héma-Québec. As a secondary aim, the research will examine possible moderating effects of pre-donation anxiety and sex.

The development of simple, effective approaches to reduce vasovagal symptoms during blood donation has the potential to improve the blood donation experience and blood donor retention as well as encourage people who have never given blood to consider the procedure. It will also improve medical and dental care more generally given the use of needles in so many procedures.

See above.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer blood donors.

Exclusion Criteria:

-
Evaluate the Safety and Efficacy of Tafasitamab and Lenalidomide in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

This is a Randomized, Multi-center, Phase 3 Study of Tafasitamab and Lenalidomide in Combination with Gemcitabine and Oxaliplatin versus Rituximab in Combination with Gemcitabine and Oxaliplatin in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphom


Eligibility Criteria:
Inclusion Criteria:

1. 18 Years and older.
2. One of the histologies of DLBCL confirmed by participated sites below with，not otherwise specified;T-cell/histiocyte-rich large B-cell lymphoma;Epstein-Barr virus (EBV) positive DLBCL (EBV-positive DLBCL); Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse; Disease transformed from an earlier diagnosis of low-grade lymphoma into DLBCL with DLBCL treatment failure.
3. Availability of tumor tissue biopsied post last line of therapy and prior to current study treatment for the patients enrolled in safety and tolerability stage.
4. Relapsed/refractory (R/R) DLBCL, at least one (≥1) but no more than three (≤3) line of prior systemic therapies.
5. Patients who have not received high dose therapy/stem cell transplantation (HDT/SCT) must be ineligible for HDT/SCT.
6. At least one measurable site of disease per CT or magnetic resonance imaging (the longest axis of the lymph node lesion is \> 1.5 cm, and the longest diameter of the extra-nodal lesion is \> 1.0 cm).
7. ECOG PS score of 0 to 2.
8. Subject must have adequate organ functions, and the laboratory values comply with the protocol requirements.
9. Life expectancy of ≥ 3 months.
10. Informed consent before screening and can understand and comply with the requirements of the study.

Exclusion Criteria:

1. Existing or prior history of other malignant tumor within 3 years, except for those who have received curative treatment.
2. Current or history of central nervous system (CNS) lymphoma.
3. Known high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements.
4. Primary mediastinal B-cell lymphoma.
5. History of allogeneic stem-cell transplantation.
6. Prior exposure to anti-CD19 treatment, and (or) failed with gemcitabine plus platinum-based agent combination therapy.
7. Current toxicity of ≥ Grade 2 from prior anti-cancer therapy (except for alopecia, neutrophil, hemoglobin and platelets).
8. Clinically significant cardiovascular disease or nervous system disease.
9. History of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or are at a high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period.
10. Uncontrolled systemic infection requiring parenteral intravenous anti-infective therapy.
11. Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B or C infection.
PTEN-AKT-FOXO3 Gene Expression Relation With Low-ovarian Reserve in Endometriomas

In this study, we aimed to investigate the relationship between PTEN-AKT-FOXO3 gene expression and decrease in ovarian reserve in the presence of endometrioma and other benign ovarian pathologies.

It is known that the presence of endometrioma negatively affects ovarian reserve. The development of endometriosis and the effect of the presence of endometrioma on ovarian reserve due to decreased PTEN expression are considered. This study was designed to compare ovarian PTEN-AKT-FOXO3 gene expression and ovarian reserve in patients with underwent surgery caused by endometrioma and those who had ovarian pathology due to other benign causes and PTEN-AKT-FOXO3 gene expression level will be evaluated by RT-PCR analysis.

Eligibility Criteria:
Inclusion Criteria:

* 1) To be in the range of 18-40 years 2) Patients with an operation indication with \>=5 cm endometrioma 3) Patients with operation plan due to non-endometrioma ovarian pathologies

Exclusion Criteria:

* 1)Patients over the age of 40 2)Patients with suspected malignancy 3)Follow-up patients without indications for operation
Erector Spinae Plane Block as a Rescue Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy, one of the most commonly performed abdominal surgeries, is a gold standard therapy for surgical treatment of benign biliary diseases.

Erector spinae plane block (ESPB) was first presented in 2016 as the treatment of neuropathic pain in a case series, and gained popularity very quickly due to its safety applicability, and effect on both the visceral and parietal component of pain by providing paravertebral, transforaminal and epidural spread. Preoperative application of ESPB has taken its place as a part of multimodal analgesia in laparoscopic cholecystectomy cases over time and has been shown to reduce postoperative pain scores and opioid consumption and to improve quality of recovery scores. However, there is no data regarding the use of ESPB in the postoperative period as a rescue therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic cholecystectomy
* Patients with NRS\>3 scores in the PACU

Exclusion Criteria:

* ASA \> 2
* Violation of standart protocol (anesthesia and analgesia)
* application of ESPB preoperatively
* age \> 65
* Surgery duration \>90min or \<45min
On Versus Off Pump Myocardial Revascularization Study

Compare completeness and modality of revascularization, operative and postoperative results and 1 year clinical outcomes in unselected high risk patients referred for primary coronary artery bypass surgery. Patients will be randomized to undergo off-pump coronary artery bypass graft (OPCAB) or coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB).

The initial application of off-pump coronary artery bypass in the early nineties was mainly directed to highly selected and relatively low risk surgical patients. Since then there has been a growing body of evidence suggesting many potential advantages of the OPCAB technique over the conventional cardiopulmonary bypass (CPB) technique in different groups of high-risk patients.

On-off study is a multicentre, prospective, randomized, parallel, trial.Patients indicated for elective or urgent isolated coronary artery bypass graft with additive European System for Cardiac Operative Risk Evaluation ≥ 6 were enrolled. Patients in cardiogenic shock were excluded. Patients were randomly assigned either to coronary artery bypass surgery with cardiopulmonary bypass (ON arm) or to off-pump coronary artery bypass graft (OFF arm). The composite primary end point included operative mortality, myocardial infarction, stroke, renal failure, re-operation for bleeding and adult respiratory distress syndrome, within 30 days after surgery. The total planned sample size was 693 patients; the actual number of enrolled patients was 411,according to the results of the interim analysis scheduled at 400 enrollments (alfa-spending=0.029, Pocock method).

Eligibility Criteria:
Inclusion Criteria:

* Pts candidate to a myocardial revascularization for any patter of coronary artery disease, ventricular dysfunction or any other co-morbidity
* EUROSCORE ≥ 6
* Pts who signed the Informed Consent
* Age ≥ 18 years

Exclusion Criteria:

* Patients in cardiogenic shock requiring emergency surgery or preoperative intra-aortic balloon pump
* Patients requiring additional surgical procedures
* Porcelain Aorta
* Lack of informed consent
Diagnosis of Transient Tachypnea of Newborn

Transient tachypnea of the newborn (TTN) is the most common cause of respiratory distress in fullterm newborn. TTN is a diagnosis of exclusion, It is primarily diagnosed based on medical history and typical clinical presentation. Lung ultrasonography is an accurate, non invasive and reliable tool for diagnosing TTN. Cardiometry is presently the only tool to evaluate thoracic fluid content continuously and noninvasively at the bedside.


Eligibility Criteria:
Inclusion Criteria:

* fifty newborns with gestational age ≥ 34 weeks (calculated from the first day of last menstrual period and using New Ballard score) diagnosed with TTN

Exclusion Criteria:

1. Gestational age less than 34 weeks.
2. Major congenital abnormalities.
3. Congenital heart diseases.
4. Neonatal sepsis.
5. Neonatal pneumonia.
6. Other causes of respiratory distress (RD)
The Role of Lactate in Lipolysis and Catabolism in Humans

Lactate may have anti-lipolytic effects when plasma concentrations of lactate reach levels similar to those seen during high intensity exercise.

This study aims to investigate how lactate concentrations similar to those achieved during high intensity exercise affects lipolysis in humans. In addition to this, to investigate how increased lactate concentrations affects glucose- and amino acid metabolism.

8 healthy males will be included. Study participants will undergo two separate investigation days that will be identical except for the interventions:

1. Intravenous sodium D/L-lactate
2. Intravenous sodium chloride.

The study consists of a 3-hour basal period followed by a 3-hour hyperinsulinemic euglycemic clamp. During the study we will:

* Estimate insulin sensitivity during the hyperinsulinemic euglycemic clamp (M value)
* Use tracer kinetics to estimate lipid-, glucose and amino acid metabolism using \[9,10-3H\]-palmitate, \[3-3H\]-glucose, \[15N\]-phenylalanine, \[15N\]-tyrosine, \[2H4\]-tyrosine and \[13C\]-Urea.
* Do muscle- and adipose tissue biopsies for analyses of signaling pathways involved in regulation of lipid-, glucose and amino acid metabolism.
* Do blood samples of relevant hormones, metabolites and cytokines.
* Use indirect calorimetry to estimate study participants' resting energy expenditure and respiratory quotient during the basal period.
* Estimate cardiac ejection fraction by echocardiography and measure blood pressure during both the basal- and clamp period.


Eligibility Criteria:
Inclusion Criteria:

* male
* \>18 years of age
* BMI \>19 and below 30
* Written and verbal consent to participation

Exclusion Criteria:

* Chronic illness
* daily use of medicine
* affected blood samples at screening, as assessed by the PI
* does not speak and understand Danish
* Assessed unsuitable by PI.
Pilot Study on Cytokine Filtration in COVID-19 ARDS

Background: There are no proven therapies for COVID-19 infection. COVID-19 infects the respiratory epithelium of the lower airways, causing widespread damage via cytopathic effects, resulting in severe inflammation and Pneumonitis. High local and circulating levels of cytokines, or cytokine storm, can lead to capillary leak syndrome, progressive lung injury, respiratory failure and acute respiratory distress syndrome (ARDS).

Methods: This is a pilot randomized, controlled, uni-center study testing safety and efficacy of cytokine filtration on patients with severe ARDS. Eligible patients will be randomized to 72 hours filtration or no filtration on top of the standard treatment for ARDS. Indications for randomization are patients with moderate or severe ARDS with need of ventilation support (either invasive or non-invasive), with inflammatory markers. The primary outcome will be days on mechanical ventilation (MV) support. Secondary outcomes are 30-day mortality, ICU days, need for extracorporeal membrane oxygenation (ECMO) support, duration of renal replacement therapy (RRT) and catecholamine therapies, hospital length of stay, multi-organ failure. All analysis will be done according to the intention to treat principle.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Positive revere transcription polymerase chain reaction (RT-PCR) for COVID-19 in a respiratory track sample
3. Acute (less than 36 hours) onset of moderate to severe ARDS, as defined by Berlin criteria:

   * Having pneumonia or worsening respiratory symptoms
   * Bilateral pulmonary infiltrates on chest imaging (X-ray of CT scan)
   * Pulmonary wedge pressure \<18 mmHg or no clinical signs of left heart failure
   * Hypoxemia: arterial oxygen pressure/Fraction of inspired oxygen (PaO2/FiO2 ratio) \<200mmHg, moderate dyspnea with signs of important respiratory workload, tachypnoea \>30bpm
4. Rise of inflammatory biomarkers: C-reactive protein (CRP) \>10 mg/L

Exclusion Criteria:

1. Patients with a known contraindication for anticoagulation
2. Pregnancy or breast feeding
3. Patient already included in another research study
4. Decision by a physician that involvement in the study is not in the patient's best interest
5. Failure to have patient's authorization. In case of a mechanical intubated patient, lack of authorization from a first line family member
6. Multi-organ failure
7. Patients treated with Tocilizumab at the time of start filtration