cyrilzakka/clinical-trials huggingface dataset:
A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects

To evaluate the safety and immunogenicity of a combination of microparticulate monovalent HIV-1 MN synthetic branched peptide candidate vaccine for oral administration and monovalent HIV-1 MN synthetic branched peptide vaccine in alum for intramuscular administration in intermediate or higher risk HIV-negative volunteers.

Volunteers receive one of two schedules of vaccines or placebo administered at days 0, 28, and 168. Specifically, group 1 receives oral microparticulate monovalent vaccine over 3 consecutive days on days 0, 1, and 2, and 28, 29, and 30, with the intramuscular monovalent vaccine given on day 168. Group 2 receives the intramuscular vaccine first, on day 0, followed by the oral form given on days 28, 29, and 30 and 168, 169, and 170. Volunteers are followed for 1 year.

Eligibility Criteria:
Inclusion Criteria

Volunteers must have:

* Normal history and physical exam.
* HIV negativity.
* CD4 count \>= 400 cells/mm3.
* Intermediate or high risk sexual behavior or a history of injection drug use within 12 months prior to study entry.
* Normal urine dipstick with esterase and nitrite.

Exclusion Criteria

Co-existing Condition:

Volunteers with the following symptoms or conditions are excluded:

* Active tuberculosis.
* Occupational or other responsibilities that would prevent completion of study.

Volunteers with the following prior conditions are excluded:

* History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
* Psychiatric, medical, or substance abuse problems within the past 6 months that would affect ability to participate in study.
* History of anaphylaxis or other serious adverse reactions to vaccines.
* History of inflammatory gastrointestinal disease, celiac disease, or intestinal malignancy.
* Acute gastroenteritis or gastrointestinal surgery within the past 12 months.

Prior Medication:

Excluded:

* Live or attenuated vaccine within the past 60 days.
* Illicit or experimental agents within the past 30 days. Intermediate or high risk sexual behavior. Injection drug use within the past 12 months.
Burnout and Approach to Bereavement Initiatives in a Medical Intensive Care Unit (ICU)

Given the stress, exhaustion and close interface with death that Intensive Care Unit (ICU) health care providers face, this study will evaluate burnout rates in intensive care unit (icu) physicians, nurses and ancillary staff. Investigators will also study the effect on a bereavement card on these burnout rates

This study will evaluate:

1. Burnout rates among nurses and ancillary staff with the Abbreviated Maslach burnout inventory. This is a well validated tool that is used to evaluate symptoms of burnout such as denationalization, emotional exhaustion and lack of personal accomplishment.
2. Burnout rates at the beginning of and at the end of the house staff's ICU rotation to gauge the effect of an ICU rotation on burnout rates amon medical trainees.
3. Determine whether the introduction of a bereavement card will improve symptoms of burnout as gauged by the abbreviated maslach burnout inventory
4. Staff perceptions and response to the introduction of a bereavement

Eligibility Criteria:
Inclusion Criteria:

* Health care providers who work in the Bellevue Hospital Medical ICU

Exclusion Criteria:

* NA
Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1

The purpose of this research study is to examine the role oxidants, substances produced in the blood that can damage blood vessel function, may play in blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).

Study #1 is made up of three sessions done on three separate days and the entire study can be completed in as little as two weeks. All testing sessions will take place at the Exercise Physiology Research Laboratory. Volunteers will be asked to participate in one initial testing session (Visit 1) lasting \< 1 hour that will help make them more familiar with the study equipment and procedures, determine body measures (height, weight, body fat), determine the maximum strength of their forearm and calf, and require one blood draw. The following two testing sessions (Visits 2 and 3) with each session lasting between 2-3 hours that will involve multiple tests designed to determine the health of their blood vessels. For Visit #2 they will be randomly given either antioxidant pills or placebo pills to determine the effect of oxidants on blood vessel health. For Visit #3, they will be given whatever set of pills (antioxidant or placebo) that they did not receive during Visit #2.

Eligibility Criteria:
Inclusion Criteria:

* apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease
* for PTSD group, a score of ≥ 33 on PCL-5 checklist
* for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist
* for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist

Exclusion Criteria:

* taking medications that could influence cardiovascular function
* current smokers who have recently quit smoking
* illicit drug use or excessive alcohol consumption
* pregnant women
* significant calorie restriction or vitamin/mineral deficiencies
* limited English proficiency
REBEAT Resynchronisation and Beta-Blocker European Trial

This protocol will evaluate the effect of cardiac resynchronization therapy (CRT) combined with beta-blocker therapy in patients with symptomatic heart failure in whom beta-blocker therapy was either not tolerated or could not be up titrated to optimal doses before CRT. Cardiac resynchronization therapy will be combined with automatic implantable cardioverter defibrillator (AICD, CRT-D) as it has been shown to be associated with an improvement in prognosis in the patients with left ventricular systolic dysfunction and heart failure.

The purpose of this investigation is to evaluate the effect of CRT combined with beta-blocker therapy in patients with symptomatic heart failure in whom beta-blocker therapy was either not tolerated or could not be up-titrated to optimal doses before CRT.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic heart failure and indication for cardiac resynchronization therapy (CRT), Hemodynamic stability with documented intolerance to beta-blocker therapy or treatment with beta-blocking agents at sub-optimal dosages (\<25% of optimal dosage).

Exclusion Criteria:

* chronic atrial fibrillation; indications for permanent antibradycardia pacing; mechanical tricuspid valve; Severe aortic stenosis or other primary valve disease causing cardiomyopathy
Study the Feasibility of Permanent Use of inControl for the Treatment of Type 1 Diabetes

A new version of the DiAs artificial pancreas (AP) system has been developed in view of wide scale outpatient trials. Denominated as inControl , it includes improved user interface and communication modules while closed-loop algorithms remain similar. During this pilot study, the investigators will evaluate this new version of AP for a two-week period during which the patients will use it for closed-loop insulin delivery 24/7 The main goal is train the clinical team with the new system and collect patient opinions on system acceptance from questionnaires. If this trial is conclusive, a randomized 6-month multicentre study including 240 patients will be initiated. A total of 5 patients will be included in this training study over a 4-week period.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus since more than one year, treated by insulin since at least one year
* Treatment by insulin pump since at least 6 months
* Glycated hemoglobin (HbA1c) below 10.5% at inclusion visit
* For women of child bearing age, no current pregnancy and use of an efficient contraception during the whole research participation
* Agreement on no use of drugs or products used for reduction of blood glucose levels, such as metformin or GLP1 analogs, except if this therapy has been used for at least 3 months before study start
* Agreement on stopping closed-loop insulin delivery after acetaminophen use and 4 following hours
* Agreement on suspending use of patient CGM device during the study period while study CGM will be used
* Access to the internet and a mobile phone network at home
* Agreement on following study procedures
* Affiliation to the French social security system or a similar healthcare coverage system
* Mandatory written informed consent

Exclusion Criteria:

* Need for chronic use of acetaminophen
* Start of use of drugs or products used for reduction of blood glucose levels, such as metformin or GLP1 analogs during the 3 months before inclusion
* Hemophilia or other coagulation disorders
* Psychological and/or cognitive troubles which may impair the appropriate following of study procedures
* Diabetic ketoacidosis during the last 6 months
* Acute cardiovascular event during the last 12 months
* Severe hypoglycaemia with convulsions or loss of conscience during the last 12 months
* Use of a therapy with significant impact on glucose metabolism
* Cystic fibrosis
* Lack of nearby third-party assistance availability in case of troubles
* Malignant disease, except if considered as cured since at least 10 years
* Impaired kidney function (serum creatinin \> 150 umol/L)
* Impaired liver status (ALAT or ASAT \> 2-times upper normal limit)
* Active gastroparesis
* Acute adrenocortical event
* Alcohol or narcotics abuse
The Influence of Hearing Discrete Phonemes in Mother's Voice in the Infant's Natural Environment and With Natural Melody on Developing Phonetic Categories Between 4-10 Months Old

The purpose of this study is to record voice samples of infant's mothers, process in samples to a phonetic musical piece, play the phonetic musical piece to 4-10 month old infants, and then test the infants in a conditioned head turning test in lab, and to analyze the results.


Eligibility Criteria:
Inclusion Criteria:

* normal newborn infants
* males and females
* age 4 months to 10 months old

Exclusion Criteria:

* chronic illness
* hearing loss
* history of otitis media
* serious otitis media
Nano Drug Interventional Therapy Using Digital Subtraction Angiography（DSA） for Pancreatic Carcinoma

The purpose of this study is to evaluate the safety and efficacy of nano drug interventional therapy using digital subtraction angiography（DSA） for pancreatic cancer. The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection.

By enrolling patients with pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of nano drug interventional therapy using digital subtraction angiography（DSA）for pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Age:18-80
2. Karnofsky performance status \>60
3. Diagnosis of pancreatic cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive interventional therapy
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except pancreatic cancer
2. History of coagulation disorders or anemia
Comparison of Absorption of Budesonide and Formoterol From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler

The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females aged 18-60 years.
2. Normal weight, at least 50 kg.

Exclusion Criteria:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
2. Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
3. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
4. Known hypersensitivity to the active substance(s) or the excipient of the drug.
5. Pregnant or lactating females.
Evaluation of the Effect of Botulinum Toxin Type-A Injection Prior to Surgical Correction of Complete Unilateral Cleft Lip Repair by Modified Millard Cheiloplasty

Evaluation of the effect of botulinum toxin type-A injection prior to surgical correction of complete unilateral cleftlip repair by modified millard cheiloplasty


Eligibility Criteria:
Inclusion Criteria:

* Primary cleft lip

Exclusion Criteria:

* Cleft palate
Efficacy and Safety of Modified Gegen Qinlian Decoction for Ulcerative Colitis With Damp-heat Syndrome

Ulcerative colitis(UC) seriously affect the quality of life in patients. Clinically, it is effective to apply therapeutic method of clearing heat and promoting diuresis to the common syndrome of dampness-heat. Dysbiosis of intestinal microbiota is closely related to the immune imbalance and intestinal mucosal barrier injury. C1orf106/CYTH-1/ARF6 signal pathway, which derive from intestinal micro environment changes,is the mainly cause of intestinal mucosal barrier injury, and this is may be the common pathogenesis of dampness-heat syndrome in UC . Based on the clinic, the project is to study the effect and mechanism of Chinese compound formula of clearing heat and promoting dieresis in modulating intestinal microbiota dysbiosis, repairing intestinal mucosal barrier and reconstructing intestinal microenvironment. With the combination of metagenomics and metabonomics, the study compare the differences of co-metabolites of intestinal microbiota and host within the healthy people, UC patients with dampness-heat syndrome, to explore the relevance between intestinal flora and host co-metabolites. Furthermore, the experimental study is to clarify the drug targets via C1orf106/ CYTH-1/ARF6 signal pathway.Through the study of association between dampness-heat syndrome in UC and intestinal microbiota, it is of important academic significance to reveal the Chinese theory intension of "homotherapy for heteropathy ".


Eligibility Criteria:
Inclusion Criteria:

* (1) It meets the diagnostic criteria of UC (left semi-colon type, active period, mild) and meets the diagnostic criteria for damp-heat syndrome.

  (2) Age between 18 and 70 years old. (3) Not taking antibiotics, steroids and other hormones, Chinese herbal preparations in the past week (including) Probiotics such as oral and intravenous), microecological preparations or yogurt.

  (4) The subject informed and voluntarily signed the informed consent form. ; (5) Have a certain reading ability

Exclusion Criteria:

* (1) Patients with severe organ, liver, kidney and other major organ diseases, hematopoietic system, nervous system or mental illness; (2) combined with other digestive systemic lesions (such as peptic ulcer), or systemic diseases affecting digestive tract motility (eg hyperthyroidism, diabetes); (3) Those who are or need to continue to use drugs that may affect gastrointestinal function (antidiarrheals, antidepressants, anxiolytics, intestinal flora regulators, antibiotics, etc.); (4) Those with a history of allergic reactions to related drugs and a history of severe food allergies.
Dose Low Dose Ketamine in Casesarian

The results of ketamine, ketamine and midazolom and placebo can be copied after birth in cesareans subjected to spinal anesthesia.

Postpartum depression will be evaluated by dividing the patients into 3 groups: group 1 as ketamine, group 2 as ketamine and midasom, and group 3 as placebo group.

Eligibility Criteria:
Inclusion Criteria:

American Society of Anesthesiologists 2-.3 18 -45years old Patients planned to be born by cesarean section The patient requests a cesarean section with spinal anesthesia

ExclusionCriteria:

Pathological obstetric complications

Hypertension

Contraindication for ketamine Contraindication for spinal
NO During CPB in Neonates to Reduce Risk of AKI

Acute kidney injury (AKI) following cardiac surgery for congenital heart defects (CHD) in children affects up to 60% of high risk-patients and is a major cause of both short- and long-term morbidity and mortality. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Nitric oxide is an intricate regulator of acute inflammation and coagulation and is a potent vasodilator. The investigators hypothesize that nitric oxide, administered during cardiopulmonary bypass (CPB), may reduce the incidence of AKI.


Eligibility Criteria:
Inclusion Criteria:

* All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.

Exclusion Criteria:

1. Failure to obtain informed consent from parent/guardian
2. Clinical signs of preoperative persistent elevated pulmonary vascular resistance,
3. Emergency surgery,
4. Episode of cardiac arrest within 1 week before surgery,
5. Recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for CPB),
6. Use of inhaled NO (iNO) immediately prior to surgery,
7. Structural renal abnormalities by ultrasound,
8. Preoperative AKI,
9. Use of other investigational drugs,
10. Weight less than \<2 kg,
11. Gestational age \<36 weeks,
12. Major extracardiac congenital anomalies,
13. Non-English speakers.
Evaluation and Physical Therapy for Patients With Degenerated Cervical Spine

The specific aims are as follows:

1. To investigate the degree of impairment, such as range, proprioception, sensation, and electromyography (EMG) pattern of healthy, older subjects.
2. To investigate the relationship of these impairment measurements, the functional outcome and disability in patients with cervical spondylosis.
3. To develop an exercise program with an emphasis on proprioception, stability and coordination for patients with neck-shoulder complaints to decrease the impairment and increase the functions of patients.


Eligibility Criteria:
Inclusion Criteria:

* Group one: participants without degenerated disease in the cervical spine
* Group two: participants with degenerated disease in the cervical spine

Exclusion Criteria:

* Grade III, IV of degenerated cervical spine
Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation

Dysphagia is a common reason for referal to the investigators Gastoenterology service. As many as 14% of patients undergoing radiological studies for dysphagia are found to have schatzki rings. Current recommendations for treatment of patients with symptomatic Schatzki rings are based on ancedotal experience and uncontrolled studies. The only randomized study on comparison of techniques the investigators were able to locate was published in 2000 and included only 26 patients. This study demonstrated that the biopsy techinque was as effective as and better tolerated than the standard dilation technique. Considering that the cost and time required for dilatation is greater than the basic biopsy technique, significant cost savings could be achieved using the biopsy technique. As well, patient satisfaction is an important factor considering that Schatzki rings can recur and repeated endoscopy is often required. Therefore, a study that shows a technique to be as or better than the current standard in effectiveness, cost, time, and patient comfort could lead to shift in current practice.

None available, study was withdrawn

Eligibility Criteria:
Inclusion Criteria:

* Presenting to endoscopy unit with symptoms of dysphagia or known history of schatzki ring

Exclusion Criteria:

* Prior esophageal or gastric surgery, severe esophagitis, coagulopathy
Compare Effects of Flax Seed Oil, and Fish Oil on Blood Sugar Levels

Flax seed oil, fish oil, and soy bean oil, are commonly recommended supplements for Polycystic Ovarian Syndrome (PCOS). These oils have different chemical structures and biological actions. It is not yet known which of these oils has the most beneficial effects in PCOS patients because they have never been compared to each other head to head. In this study the researchers hope to learn more about the effects of these oils on blood sugar and insulin levels.

The aim is to investigate whether n-3 PUFA's can be used to prevent postprandial hypoglycemia and its unfavorable consequences, such as stimulation of cortisol and adrenal androgen secretion, in women with polycystic ovarian syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Females ages 18-45
* Women who are overweight, and have irregular periods or have been diagnosed with Polycystic Ovarian Syndrome

Exclusion Criteria:

* Use of oral contraceptives
* Impaired glucose tolerance
* Diabetes mellitus, and any other systemic illnesses such as renal, hepatic, gastrointestinal, severe hyperlipidemia and hypertension that require medication
* Schizophrenia
* Having a pacemaker
* Current viral infection
* Smoking alcohol intake (more than 2 drinks/week)
Fertility Preservation in Young Women With Cancer

The researchers aim to record the incidence, treatment and long term follow up of fertility preserving cancer treatment. Both the oncological and fertility outcome are recorded.

Study population: All patients with a cancer for whom a fertility preserving cancer treatment is applied. The results of the study population are compared to young women undergoing standard cancer treatment.

Cancer is the second leading cause of death during the reproductive years. The long term survival improves for most cancers, reaching 80% for pediatric cancer and more than 70% for cancers in adults between 20 and 49 years of age. Early detection and improvements in cancer treatment contribute to these figures. As a result, quality of life of which preservation of fertility is one aspect, becomes more important. Fertility may however be influenced by surgery and by the gonadotoxic effects of chemo and/or radiotherapy. Therefore, fertility sparing treatments are offered to young patients in order to maintain the wish to conceive after cancer treatment. This however is associated with deviation of standard treatment and many different strategies are applied among different centers. In addition, there is a lack of studies investigating the oncological safety of these fertility sparing treatment protocols. The results of this study will enable us to better inform clinicians and patients on the efficacy of fertility sparing cancer treatment.

Objective:

To record the incidence, treatment and long term follow up of fertility preserving cancer treatment. Both the oncological and fertility outcome are recorded.

Study design: International multicentre prospective observational trial

Study population: All patients with a cancer for whom a fertility preserving cancer treatment is applied. The results of the study population are compared to young women undergoing standard cancer treatment.

Main study parameters/endpoints:

Registration of cancer diagnosis, treatment and outcome. Both the oncologic and fertility outcome is registered.

All patients receive fertility sparing cancer treatment on their specific request.

Eligibility Criteria:
Inclusion Criteria:

* Young women who want to preserve their fertility during cancer treatment. Patients need to give their signed and written informed consent to participate in the study.

Exclusion Criteria:

* Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent