cyrilzakka/clinical-trials huggingface dataset:
Effect of Esketamine on Perioperative Negative Mood in Patients Undergoing Cardiac Valve Surgery

A multicenter, randomized controlled, blinded prospective study to investigate the effects of esketamine on perioperative anxiety and depression in patients undergoing cardiac valve surgery.

Undergoing surgery can be a traumatic and painful experience for patients, often causing negative moods such as anxiety and depression. The size and type of surgery significantly impact the occurrence of anxiety and depression in patients. Approximately one-third of patients after cardiac surgery experience anxiety or depression, which increases the risk of recurrent cardiovascular events and death.

Ketamine is an anesthetic drug with comprehensive effects, including analgesia, sedation, and amnesia. Its primary mechanism of action is blocking N-methyl-D-aspartate (NMDA) receptors. Esketamine, the pure dextro isomer of ketamine, has a higher affinity for glutamate NMDA receptors and opioid receptors, offering stronger sedative, analgesic, and antidepressant effects. On March 4, 2019, esketamine was approved by the FDA for treatment-resistant depression. Given its analgesic, anesthetic, and antidepressant effects, esketamine may be an ideal drug for improving negative moods in patients undergoing cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, male or female
2. Patients undergoing heart valve surgery
3. Patients with ASA grade 1 to 4
4. BMI between 18-30 kg/m²
5. Able to participate in neuropsychological testing and receive follow-up visits
6. Clearly understand and voluntarily agree to participate in the study and sign the informed consent form

Exclusion Criteria:

1. Patients with significant preoperative neuro-psychiatric disease and cognitive impairment
2. Intellectual disability or a MiniMental State Examination (MMSE) score \&lt;24, or a speech disorder that may compromise their ability to undergo preoperative assessments
3. History of psychoactive drug abuse

5. Preoperative combined severe hepatic insufficiency or renal insufficiency 6. Any contraindications to ketamine or esketamine, such as refractory hypertension or hyperthyroidism
A Study to Investigate the Effect of Food on the Absorption, Distribution and Elimination of ASP1941

This study is to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects.

This will be a randomized, open-label, 3-way crossover design study to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects. Each subject will receive a single dose of ASP1941 "under fasting condition", "before meal" and "after meal".

Eligibility Criteria:
Inclusion Criteria:

* Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and laboratory tests
* Body weight ; ≥50.0 kg, \<80.0 kg
* Body Mass Index ; ≥17.6, \<26.4
* Written informed consent has been obtained

Exclusion Criteria:

* Received any investigational drugs within 120 days before the screening assessment
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or d components within 14 days before the screening assessment
* Received medication within 7 days before hospital admission
* A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission
* History of drug allergies
* With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
Barriers to Physical Activity in Patients With Cognitive, Neuromotor or Sensory Impairments During Aging

People with disabilities are less physically active than the general population. Their barriers to physical activity are multiple and include intrapersonal, organizational, societal and interpersonal reasons. Nevertheless, at present, the evolution of their barriers to physical activity and the short- and long-term impact of medical and medico-social treatments to limit them are unknown.

The aim of this study is to describe barriers to physical activity, or disability-related underperformance factors in competitive sports, in patients with cognitive, neuromotor or sensory impairments during aging.

This is an ambispective, monocentric, cohort study of subjects with cognitive, neuromotor or sensory impairments followed in a Physical Medicine and Rehabilitation Department.

All consecutive eligible outpatient subjects consulting to the Parasport Health Unit of the Physical Medicine and Rehabilitation Department of our university hospital will be included. Clinical activities related to the Parasport Health Unit and performed outside the hospital will also be included.

Data will be collected from the patients' medical records, in particular data related to their clinical, radiological, biological and physiological examinations.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>= 6 years old ;
* Consulting to the Parasport Health Unit of the Physical Medicine and Rehabilitation Department of our university hospital ;
* Having a neuromotor, cognitive or sensory impairment ;
* No opposition to be enrolled in the study from the patient, or from a legally authorized close relative if the patient's state of health does not allow it, or from each of the holders of parental authority if a minor ;
* Affiliation to a social security scheme.

Exclusion Criteria:

* Under court protection.
COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS

A phase IV, observational, survey-based study to measure compliance with Avonex® PS therapy in patients with Relapsing-Remitting Multiple Sclerosis, and to compare persistence on therapy 22 months after initial prescription of AVONEX® PS between patients enrolled in the current MS AllianceTM program versus patients enrolled in this program prior to October 2007.

Study Design

Five hundred patients will be enrolled in the prospective portion of the study, all of whom will receive AVONEX. Patients will join the study by signing the attached Informed Consent Form (Appendix 1) at their doctor's office at the time of prescription. Innomar will provide the drug to approximately 40 new patients per month, so it will take about twelve to fourteen months to enroll all of the study subjects, assuming that all agree to participate. Once the recruitment period is over, it will take another 22 months to complete the study to the 22-months point for the last subject.

In the retrospective arm of the study, 500 chart reviews will be completed for patients who had participated in the MS Alliance program two (2) to three (3) years ago to determine persistence to therapy over a similar 22 month period.

Study Objectives

Primary Objectives:

- To assess patients' compliance (as defined above) with AVONEX therapy in the prospective arm using self-reported patients questionnaire, as well as to compare patients' persistence on therapy (as defined above) between prospective and retrospective arms.

Secondary Objective:

- Evaluate patients' satisfaction with new MSA program.

Patients and Methods

Only patients enrolled in the MSA program will be included in this study. There will be no interventions above the current standard of care with the MSA program. Two distinct patient arms will exist for this study: the prospective arm and the retrospective (chart review) arm.

Inclusion Criteria

* Diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS)
* Prescription of AVONEX® PS (prefilled syringes)
* Enrolment in the MS AllianceTM program

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS)
* Prescription of AVONEX® PS (prefilled syringes)
* Enrolment in the MS AllianceTM program
Effect of Functional Exercises on Pain and Quality of Life in Females With Primary Dysmenorrhea

The aim of the study will be to investigate the effect of functional exercises on pain and quality of life in females with primary dysmenorrhea.

Primary dysmenorrhea and menstrual pain are significant health, social and economic problems. It involves a broad spectrum of physical and emotional manifestations, with 50% to 91 % prevalence in young women.

Women with primary dysmenorrhea report significantly lower quality of life because of bodily pain, general health condition, and physical and social functioning. It compromises the most common gynecological alternations and is the primary cause of women's academic and work absenteeism, which reduces the quality of life, daily activities, and economic situation due to decreased working hours.

Non-Steroidal Anti-Inflammatory Drugs are the first therapeutic line for primary dysmenorrhea; however, they might be accompanied by undesirable side effects, such as dyspepsia, headache, and drowsiness.

So, there is a need for safe interventions with no side effects. Therefore, this study aims to investigate the effects of functional exercises on pain and quality of life in females with primary dysmenorrhea.

Eligibility Criteria:
Inclusion Criteria:

1. Their ages will be ranged from 18 to 25 years
2. They will be suffering from primary dysmenorrhea based on the Menstrual Distress questionnaire.
3. Their BMI will be ranged from 20 to 25 kg/m2.
4. Having regular menstrual cycles (one every 28-34 days).
5. They will be sedentary virgin females.
6. They are non-smokers.
7. They have not been in any exercise program for three months.

Exclusion Criteria:

1. Having secondary dysmenorrhea.
2. Using regular medication or contraceptive pills.
3. Having neuromuscular, metabolic, or cardiac diseases.
4. Having a preexisting condition prevents them from engaging in an exercise program.
Endometrial Cancer Biomarker Changes Following Exposure to Metformin

The investigators will explore the chemopreventive role of metformin. The purpose of this study is to determine whether, among patients with endometrial cancer, treatment with the currently approved insulin sensitizing drug metformin increases or decreases pathway activation distal to the insulin receptor in endometrial cancer tissue. This is a phase IIa study of metformin to be used to the pre-operative period of women diagnosed with endometrial cancer by comparing their endometrial biopsy specimens taken at their initial visit and after 4-6 weeks of treatment of metformin on the day of their surgical staging.

Aim 1 To determine whether, among patients with endometrial cancer, treatment with the currently approved insulin sensitizing drug metformin increases or decreases pathway activation distal to the insulin receptor in endometrial cancer tissue.

Aim II To compare specified biomarkers in each endometrial cancer patient before and after receiving metformin. Our goal is to compare the following biomarkers in each patient before and after metformin administration: Ki-67, TUNEL assay for apoptosis level, phosphor-AMPK, phosphor-IGF-1R, phosphor-IRS1, phospho-Akt, phospho-S6, phosphor-mTOR, pACC.

All patients diagnosed with endometrial cancer presenting to the Jewish General Hospital for surgical treatment will be invited to participate.

Eligibility Criteria:
Inclusion Criteria:

* Have a confirmed diagnosis of endometrial cancer based on an endometrial sampling though biopsy or dilatation and curettage
* Must be able to undergo appropriate surgical staging for endometrial cancer
* Must consent to be in the study and must have signed and dated an IRB-approved consent form conforming to government and institutional guidelines

Exclusion Criteria:

* Patients with a contraindication to receiving metformin treatment
* Patients with cognitive impairment
* Renal or hepatic functioning \> 125% upper limit of normal
* Currently on medications for metabolic diseases, such as diabetes mellitus
* History of lactic acidosis
* Treatment with medications that may increase metformin levels: cationic drugs, e.g., digoxin, amiloride, procainamide, trimethoprim, vancomycin, triamterene, and morphine
* History of chronic alcohol abuse
Mapping the Endocrine Determinants of Ovarian Stimulation to Optimize Outcomes in Fresh Embryo Transfer Cycles

The goal of this project is to identify autocrine, paracrine and endocrine factors which are associated with intercycle variation in cyclical follicle recruitment.

Patients will be monitored in a natural cycle, a stimulated cycle and a follow up. In the stimulated cycle patients will be randomized to co-treatment with aromatase inhibitor or placebo during ovarian stimulation.

The primary aim of this project is to explore the putative cyclic recruitment 'gatekeeping' functions of gonadotropins, sex steroids, anti-muellarian hormone and pregnancy associated plasma protein A in normal ovulatory cycles, and the impact of ovarian stimulation on cyclic follicle recruitment in the following cycle.

It is further proposed that supra-physiological levels of estradiol and progesterone which arise from ovarian stimulation may modulate the size of the secondarily recruited follicle cohort in the next cycle. In order to explore the relative contribution of sex steroids as determinants of the size of the next cycle 'wave' of recruitment further, a second aim of this study will be investigate whether limiting the rise in sex steroid levels during ovarian stimulation, by co-treatment with aromatase inhibitor impacts on cyclic recruitment.

Eligibility Criteria:
Inclusion Criteria:

* Indication for IVF/ICSI treatment
* Eligible for IVF/ICSI treatment according to local criteria
* Regular cycles 21-35 days (both included)
* Age \<40 years
* AMH 8-32 (both included)
* Written consent
* Willing to undergo intensive monitoring in a natural cycle (the cycle prior to the monitored natural cycle must be hormone treatment free), stimulated cycle and follow up in the subsequent cycle

Exclusion Criteria:

* Any contraindication for IVF/ICSI treatment according to local criteria
* Previous stimulation for IVF/ICSI with \< 4 oocytes obtained
* PCOS
* Undergoing IVF/ICSI for the purpose of fertility preservation
* Allergy towards study drug
Novel Arm Restraint in the Intensive Care Unit

The goal of this pilot is to evaluate a novel restraint device in 8 older mechanically ventilated patients to demonstrate that 1) the revised novel restraint prototype is safe and 2) a future randomized controlled trial (RCT) is feasible.

The goal of this Fast-Track Small Business Technology Transfer (STTR) project is to optimize and test a novel arm restraint in older critically ill mechanically ventilated patients that may increase mobility; reduce agitation, use of sedative medications, and delirium; and exhibit high satisfaction and acceptability among hospital staff, family members, and patients. Older mechanically ventilated patients are often immobilized with wrist restraints to prevent self-extubation and are sedated to reduce agitation caused by their restraints and endotracheal (breathing) tube. This sedation and immobility lead to complications, including delirium and muscle weakness, that are independently associated with long term cognitive impairment, reduced physical functioning, and mortality. Specifically, the incidence and duration of delirium in the ICU are strongly and independently associated with long-term cognitive impairment that is similar to Alzheimer's Disease and Related Dementias.

Healthy Design has developed a novel restraint device that allows arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines. Because it permits mobility, the novel restraint may reduce agitation and the need for sedatives. The objectives of this pilot study are to evaluate the novel restraint in 8 older mechanically ventilated patients to demonstrate that 1) the revised novel restraint prototype is safe and 2) a future RCT is feasible.

Eligibility Criteria:
Inclusion Criteria:

1. \>65 years old
2. Physician order for use of bilateral wrist restraints
3. Requiring mechanical ventilation with actual or expected total duration of \>48 hours
4. Expected ICU stay \>3 days after enrollment (to permit adequate exposure to proposed intervention)
5. Not deeply sedated (Richmond Agitation Sedation Scale \[RASS\] score \> -2)

Exclusion Criteria:

1. Upper extremity impairments that prevent use of novel restraint device (e.g. amputation, arm injury)
2. Limited mobility of either upper extremity prior to admission (e.g. frozen shoulder, severe arthritis)
3. Pre-existing primary systemic neuromuscular disease (e.g. Guillain-Barre)
4. Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met)
5. Pre-existing severe cognitive impairment or language barrier prohibiting outcome assessment
6. Expected death or withdrawal of life-sustaining treatments within 6 days from enrollment
7. Incarcerated
8. Severe skin breakdown on either upper extremity
Role of Antibiotics to Reduce Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax

The purpose of this study is to examine the efficacy of prophylactic antibiotics in patients with chest tubes for management of thoracic injuries in the reduction of the incidence of empyema as compared to placebo.

In this study, the medication (an antibiotic which is used to treat or prevent infections) will be compared with a placebo. A placebo is something that looks like a "real" medication, but it doesn't contain any active medication. As a participant in this study, you may receive the active medication (Cefazolin Sodium Injection or Clindamycin) or you may receive a placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 16 years of age.
2. Admission to Trauma, General Surgery, and/or Surgical Critical Care services.
3. Traumatic pneumothorax, hemothorax or hemopneumothorax

Exclusion Criteria:

1. Pregnancy
2. Open fracture
3. Immunocompromised
4. Require antibiotics for treatment of other injuries
5. Chest tube placement greater than 72hrs after admission
Continuous Dosing of BAY73-4506 in Patients With Advanced Malignancies

Continuous dosing of BAY73-4506 in patients with advanced cancer


Eligibility Criteria:
Inclusion Criteria:

* 18 years
* Patients with advanced, histologically or cytologically confirmed solid tumors, malignant lymphomas, or multiple myeloma refractory to any standard therapy
* Radiographical, hematological or clinically evaluable tumor
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
* Life expectancy of at least 12 weeks
* Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements:

  * Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN)
* Signed informed consent must be obtained prior to any study specific procedures

Exclusion Criteria:

* History of cardiac disease: congestive heart failure (CHF) \> New York Heart Association (NYHA) Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months or unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
* Uncontrolled hypertension defined as systolic blood pressure \> 150 mm Hg and/or diastolic blood pressure \> 90 mmHg, despite optimal medical management
* History of HIV infection or chronic hepatitis B or C
* Active clinically serious infections (\> Grade 2 NCI Common Terminology Criteria for Adverse Events v3.0)
* Symptomatic metastatic brain or meningeal tumors unless the patient is \> 6 months from definitive therapy, has no evidence of tumor growth on an imaging study within 2 weeks prior to study entry and is clinically stable with respect to the tumor at the time of study entry. Patients with brain metastases must not be undergoing acute steroid therapy or steroid taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
* Substance abuse, medical, psychological or social conditions that may interfere with the patient178s participation in the study or evaluation of the study results
* Radiotherapy to the target lesions within 3 weeks prior to Day 1, Cycle 1 (first dose of study drug). (Palliative radiotherapy will be allowed). Radiotherapy to the target lesions during study will be regarded as progressive disease
* Previous or concurrent cancer which is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors \[Ta, Tis and T1\] or any cancer curatively treated \> 3 years prior to study entry.
Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's Disease

Laser therapy is increasingly showing promising results in dental field including oral ulcers.This trial will assess the usefulness of Diode Laser compared to corticosteroid on oral ulcers of patients diagnosed with Behcet's disease.

The enrolled patients will be divided randomly into two groups.one group will receive Diode Laser (power:100 milli Watt,wavelength:980 mmm, delivery system:biostimulation probe) and other group will receive topical corticosteroids(Kenacort A Orabase: triamcinolone acetonide 0.1% 5 gram adhesive paste - Dermaphor) four times daily.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with Behcet's Disease according to International Criteria for BD.
* patients with active oral ulcers.
* patients free from any visible oral lesions other than the oral ulcers of BD.
* patients who agreed to take the supplied interventions.
* patients who will agree to participate in the study.
* patients who will accept to sign the informed consent.

Exclusion Criteria:

* patients not physically able to participate in survey or clinical oral examination.
* patients with organ or life-threatening disease.
* patients with history of a severe or chronic medical condition including tuberculosis, hepatitis and human immunodeficiency virus.
* patients under immunosuppressive drugs.
* patients with organ transplantation.
Predictive Value of Serum Uric Acid to HDL Cholesterol Ratio for Diabetic Kidney Injury in Type 2 Diabetes

An prospective observetional study to asses the predictive value of serum uric acid to high density lipoprotein cholesterol ratio for diabetic kidney injury in type 2 diabetes

Diabetic Kidney Injury (DKI) is a serious microvascular complication of diabetes mellitus occuring in about 20 % to 50% of diabetic patients and is the single commonest cause of ESRD.DKI is asociated with arterial HTN and increased cardiovascular morbidity and mortality. outcomes for both type 1 DM and type 2 DM who develop DKI are significantly worse than who do not .Serum uric acid was reported to be asociated with inflamatory and metabolic diseases such as metabolic syndrome , type 2 DM,thyroiditis and NAFLD while HDL-cholesterol decreased the odds of developing DKI by 20%.It is generally accepted that hyperuricemia and low HDL-c were considered to be a risk factor of other indicators for development of DKI.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients
* willing and agreed to be included in the study

Exclusion Criteria:

* Type 1 DM patients
* patients with active urinary sediment
* patients with glomerulonephritis
* patients with diagnosis or clinical features that are suspicious for another systemic disease that commonly causes kidney disease
* patients with evidence of alternative kidney disease
* patients with history of kidney transplantation
* patients with end stage renal disease
* patients with family history of non diabetic forms of kidney disease
* patients with active malignancy
* patients with established hemolytic disease
* CKD patients requiring dialysis
* patients taking drugs that interfere with serum uric acid level
* patients taking drugs that alter serum lipids level
* pregnancy
* Refused to consent to this study