cyrilzakka/clinical-trials huggingface dataset:
A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels

The purpose of this study is to see if testosterone solution 2% can impact symptoms of ejaculatory dysfunction in men with low testosterone.


Eligibility Criteria:
Inclusion Criteria:

* Total testosterone level \<10.4 nanomoles per liter (nmol/L) \[300 nanograms per deciliter (ng/dL)\] at screening
* Presents with 1 or more of the following symptom(s) of ejaculatory dysfunction: delayed ejaculation, anejaculation, decreased force of ejaculation, or decreased ejaculatory volume, as determined by investigator assessment
* Prostate-Specific Antigen (PSA) \<4 nanograms per milliliter (ng/mL) at screening

Exclusion Criteria:

* Sexual partner who is or becomes pregnant at any time during the study
* Premature ejaculation as determined by investigator assessment
* Currently receiving testosterone replacement therapy or have a history of insufficient response to testosterone replacement therapy for ejaculatory dysfunction symptoms
* Currently receiving treatment with cancer chemotherapy or antiandrogens
* History of use of estrogenizing agents
* Current use of warfarin
* History of selective serotonin reuptake inhibitor (SSRI) and/or serotonin-norepinephrine reuptake inhibitor (SNRI) treatment in the 6 months prior to screening
* History of frequent opioid use within 30 days prior to screening, with exception of treatment for chronic pain as determined by investigator.
* Body Mass Index (BMI) \>35 kilograms per square meter (kg/m\^2) at screening
* Significant peripheral neuropathy affecting erectile, ejaculatory, or orgasmic function
* Hematocrit ≥50% at screening
* Exhibit systolic blood pressure \>170 millimeters of mercury (mm Hg) or \<90 mm Hg or diastolic blood pressure \>100 mm Hg or \<50 mm Hg at screening (if stress is suspected, retest under basal conditions at screening), or have history of malignant hypertension
* History of any of the following coronary conditions within 90 days of screening: myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (for example, angioplasty or stent placement)
* Known or suspected carcinoma (or history of carcinoma) of the prostate or suspicious nodules on digital rectal exam at screening
* Known or suspected breast cancer (or history of breast cancer) or other active cancer (with the exception of nonmelanotic skin cancer)
Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS)

Eligible women will receive neoadjuvant single fraction radiotherapy followed by surgery performed after one year


Eligibility Criteria:
Inclusion Criteria:

1. Female aged 50 years or older.
2. Postmenopausal status (Defined as: age 60 OR bilateral ovariectomy OR amenorrhea \> 12 months prior to breast cancer diagnosis without using oral contraceptives/hormone replacement therapy) (65).
3. World Health Organization (WHO) performance status 0-2.
4. Invasive ductal carcinoma proven by biopsy done ≤ 12 weeks from treatment start.
5. Unifocal disease on preoperative staging ultrasound or MRI done ≤ 12 weeks from treatment start.
6. Tumors less than or equal to 2cm clinically on physical exam, as well as on breast ultrasound.
7. No clinical evidence of nodal disease (i.e. cN0), on physical examination done ≤ 12 weeks from treatment start, as well as on breast ultrasound.
8. Estrogen receptor status (ER) positive on biopsy ≥ 80%.
9. Progesterone receptor status (PR) positive on biopsy ≥ 20%.
10. Her2 negative on biopsy.
11. No lymphovascular invasion on biopsy.
12. Low Oncotype DX recurrence score performed on biopsy specimen (RS ≤18).
13. Planned surgery is a partial mastectomy with sentinel lymph node biopsy.

Exclusion Criteria:

1. Age less than 50 years.
2. Premenopausal or uncertain menopausal status.
3. A known deleterious mutation in BRCA 1 and/or BRCA 2.
4. Clinical tumor size \> 2.0 cm in greatest diameter on staging ultrasound.
5. Tumor histology limited to lobular carcinoma only.
6. Clinically positive axillary nodes (cN+).
7. Lymphovascular invasion on biopsy.
8. Pure ductal or lobular carcinoma in situ on biopsy.
9. Extensive intraductal component on biopsy.
10. Neoadjuvant hormonal manipulation or chemotherapy.
11. Prior non basal cell or squamous cell skin cancers within 5 years.
12. More than one primary tumor in different quadrants of the same breast.
13. Diffuse microcalcifications on mammography.
14. Paget's disease of the nipple.
15. Previous irradiation to the ipsilateral breast.
16. Presence of an ipsilateral breast implant or pacemaker.
17. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment.
18. Estrogen receptor status (ER) not known.
19. Currently pregnant or lactating.
20. Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol.
21. Geographic inaccessibility for follow-up.
22. Lack of preoperative staging with breast and axillary ultrasound.
23. Inability to adequately plan the patient for the experimental technique.
24. Prior breast cancer.
Anemia and Surgery: Indications For Transfusion

To estimate the risk of death for patients with different pre- and post-operative hemoglobin levels who do not receive blood transfusions and to derive a multivariate model using clinical information available pre-operatively that would predict the risk of death post-operatively.

BACKGROUND:

The AIDS epidemic has focused considerable attention on the risks associated with blood transfusions. Perhaps of more importance, hemolytic transfusion reactions and post-transfusion non-A non-B hepatitis continue to be significant concerns. However, guidelines for blood transfusions in the surgical patient vary considerably in the medical literature. Some recent texts stress the need to consider factors such as patient's age, surgical procedure, co-morbid illness, predicted blood loss, and cause of the anemia, as well as the hemoglobin level. Nonetheless, in practice many surgeons still adhere to the 10g/dl threshold for transfusion. The lack of consensus guidelines can probably be attributed to the dearth of studies exploring the indications for transfusion. The few studies which have examined this question are limited because they fail to analyze subsets of patients by age, co-morbid illness, or blood loss. The need to develop peri-operative transfusion guidelines based on multivariate analysis, therefore decreasing the frequency of unnecessary transfusions resulting from the common use of a hemoglobin threshold, is especially important in light of the hazards and costs associated with blood transfusions. Jehovah's Witnesses were chosen as the study population because they decline blood transfusion for religious reasons.

DESIGN NARRATIVE:

The retrospective case-control study explored the possible associations between peri-operative anemia and post-operative mortality status. Cases were defined as those who died within 30 days of the operative procedure and controls as all those who survived. There were approximately eight controls per case. Participating surgeons who operated on Jehovah's Witness patients within the preceeding five years provide a list of patients. Charts of patients were reviewed to determine if any died within 30 days of surgery. If the patient was discharged prior to 30 days postoperatively, then the National Death Index was used to assess the patient's status 30 days after surgery. The incidence of post-operative death, with 95 percent confidence levels, was calculated for strata of pre- and post-operative hemoglobin levels and operative blood loss. The death rate was calculated after stratifying the patients based on status with regard to co-morbid diseases or other possible risk factors.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Electro-physiological Findings and Symptoms Severity in Superior Canal Dehiscence

This research aims at assessing the validity of three different electro-physiological tests (Vestibular Evoked Myogenic Potentials, WideBand Tympanometry, Electrocochleography) used in the investigation of the symptoms severity in the case of superior semi-circular canal dehiscence syndrome.

Superior semi-circular canal dehiscence (SCD) syndrome can associate several cochlear and vestibular symptoms. Recent systematic reviews identified pulsatile tinnitus, autophony, sound-induced and pressure-induced vertigo as most specific signs of SCD. These signs are rarely all present and the symptomatology remains highly variable from a patient to another, with frequent though less evocative symptoms such as dizziness or ear pressure. A surgical treatment may be proposed when the symptoms become significantly incapacitating. Unfortunately to date, there is no objective marker of this severity and all surgical decisions rely on the importance of patients' complaints. High Resolution Computed Tomography (HRCT) of the temporal bone can confirm the diagnosis. Electro-physiological investigations such as Vestibular Evoked Myogenic potentials (VEMPs) have also been extensively described in the diagnosis of SCD but they have been reported as independent from the symptoms severity. Wideband tympanometry (WBT) and Electrocochleography (EcoG) have only been studied in few reports but the latter appears as a promising tool in the assessment of the symptoms because it explores inner ear biomechanics, directly involved in the pathophysiology of this condition.

Eligibility Criteria:
Inclusion Criteria:

* confirmed unilateral SCD (using specific HRCT settings and reconstructions) with or without SCD symptoms
* if present, SCD symptoms should be stable
* patients understanding and reading french
* affiliated to social security.

Exclusion Criteria:

* bilateral confirmed SCD
* doubtful SCD
* other otologic or neurotologic condition that might mimick SCD symptomatology : middle ear conditions, Meniere disease, vestibular migraine
Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received Three Doses of the Same Vaccine

The proposed study V72P9E1 is an Extension Study of V72P9. The objectives of this extension study will be to explore antibody persistence in children at approximately 40 months of age and to evaluate the safety, tolerability and immunogenicity of a booster dose of rMenB±OMV NZ administered to subjects at approximately 40 months of age. Antibody persistence will be subsequently measured at 18-20 months after these booster doses when the subjects are 60 months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be recruited in the study to serve as a baseline comparator for assessing antibody persistence at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ. Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations , if they have not already received these vaccines prior to enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Healthy 40 to 44-months-old children, who participated and completed the study V72P9 (follow-on subjects)
* Healthy 40 to 44-months or 60 to 62-months-old children (naïve subjects)

Exclusion Criteria:

* Previous ascertained or suspected disease caused by N meningitidis
* History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
* Any serious chronic or progressive disease
* Known or suspected impairment/ alteration of the immune system
* Receipt of, or intent to immunize with another vaccine, within 30 days prior and after vaccination with the investigational vaccines (within 14 days for licensed flu vaccines)
Transcatheter Aortic Valve Replacement (TAVR)-Pilot Trial

The primary purpose of this this randomized interventional study is to determine if increased level of home-based rehabilitation coupled with a pre-TAVR consultation visit in transcatheter aortic valve replacement patients will improve functional status and quality of life and will decrease hospital readmission.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of severe aortic stenosis (AS) as determined by echocardiography, who are deemed eligible for TAVR by the NYULMC Heart Valve Team

Exclusion Criteria:

* Decisional impairment as assessed by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
* Non-English/non-Spanish speaking.
FIBrinogen REplenishment in Surgery

This is a pragmatic, prospective, multi-center, randomized, active-control, single-blinded, non-inferiority phase 3 trial in adult cardiac surgical patients. Up to 12 Canadian hospitals will participate, and the trial will require up to 2 years for patient recruitment.

Twelve-hundred bleeding adult cardiac surgical patients who require fibrinogen supplementation due to acquired hypofibrinogenemia after CPB will be included. Patients will be randomized to receive equivalent doses of either fibrinogen concentrate (Octafibrin) or cryoprecipitate when the blood bank receives the first order for fibrinogen supplementation and deems it to be in accordance with accepted clinical standards. Thereafter, patients will be treated according to their assigned group each time fibrinogen supplementation is ordered during the treatment period (24 hours after termination of CPB). No other aspects of care will be modified.

The primary efficacy outcome will be the number of Allogeneic blood products (ABP) (red blood cells \[RBCs\], pooled or apheresis platelets, and plasma) administered during the first 24 hours after termination of CPB. Safety outcomes will be measured for the first 28 days after surgery, which is the duration of participation of each patient in the trial. Comparisons will be by intention-to-treat (ITT) (primary) and per-protocol (PP) analysis. One interim analysis will be conducted after 600 patients have been treated to determine whether the study should be terminated for safety reasons, demonstrated non-inferiority or futility reasons.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing index cardiac surgery with CPB in whom fibrinogen supplementation is ordered in accordance with accepted clinical standards (significant hemorrhage and known or presumed hypofibrinogenemia).

Exclusion Criteria:

1. Receipt of fibrinogen rich products (fibrinogen concentrate or cryoprecipitate) within 24 hours before surgery 2. History of severe allergic reaction to cryoprecipitate or fibrinogen concentrate 3. Refusal of ABPs, fibrinogen concentrate or cryoprecipitate due to religious or other reasons 4. Fibrinogen level known to be \>3.0 g/L within 30 minutes of IMP order (to eliminate the risk of raising patients' fibrinogen levels to \>4.0 g/L with supplementation 5. Known pregnancy
Sunitinib Malate Related Fatigue in Patients With Metastatic Kidney Cancer

The purpose of this research study is to determine how sunitinib (sunitinib malate) causes fatigue. Patients will be asked to complete a brief questionnaire (survey) to rate their levels of fatigue every two weeks while they are participating in this research study. The questionnaire takes approximately 10-15 minutes to complete and is 9 questions. A series of physical measurements for fatigue will be performed before the first dose of sunitinib and again (4) weeks later to see if there are any changes in physical level of fatigues

PRIMARY OBJECTIVES:

I. To determine the mechanisms associated with sunitinib related fatigue by recording EMG signals during a submaximal elbow contraction, twitch force and TMS prior to and at the end of 4 weeks of sunitinib in metastatic RCC patients.

OUTLINE:

Patients receive sunitinib malate orally (PO) daily for 4 weeks. Patients undergo neuromuscular testing at baseline and on day 28 and complete fatigue assessment at baseline and on days 14 and 28.

.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven renal cell cancer with metastases; pathology from either primary or metastatic tumor; no histologic subtype restriction
* Evidence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 or evaluable disease
* Eastern Cooperative Oncology Group (ECOG) performance score 0 to 1
* Hemoglobin \>= 9 gram/dL
* Common Terminology Criteria for Adverse Events (CTCAE) fatigue levels pre-treatment \< 2
* Signed and dated informed consent

Exclusion Criteria:

* Greater than 2 previous systemic treatments for RCC
* Heart failure, New York Heart Association (NYHA) class 3 and 4
* Unstable angina (defined as ongoing use of nitrates or cardiac ischemia in the prior 6 months)
* Arrhythmia uncontrolled by medication
* Hypertension (\> 160/90 mmHg) not controlled with medical management
* Brain metastases or previous cranial radiation, leptomeningeal cancer
* Surgery within 2 weeks of study entrance
* History of stroke, myasthenia gravis, multiple sclerosis, polyneuropathy
* Pregnancy or breast feeding
* Central-nervous system active medications, intake or withdrawal of which lowers seizure threshold (determination made in consultation with study's responsible treating physician)
* Any history of epilepsy, convulsion or seizure
* Medication-resistant epilepsy in a first-degree relative
* Cochlear implants or internal pulse generators or cardiac pacemakers or intracardiac lines
* Metallic implants in the vicinity of discharging coil in the head or cervical spine
* Unexplained fainting spells/syncope or multiple concussions
* History of severe head trauma (followed by loss of consciousness)
* Implanted brain or spinal cord electrodes/stimulation
* Medication infusion device
* Frequent/severe headaches or severe migraines
* Past or current medical history of diagnosed or undiagnosed tinnitus
Optimal Timing of Parasternal Intercostal Nerve Block Application for Acute Pain Management in Cardiac Surgery

Patients experiencing pain after undergoing cardiac surgery may also experience prolonged immobilization, insufficient respiratory functions, and the inability to cough due to median sternotomy. Therefore, duration of mechanical ventilation, length of intensive care unit (ICU) stay, and length of hospital stay of these patients will increase significantly.

many facial plane blocks have been introduced as simple and safe intervention for thoracic wall anesthesia and analgesia. Parasternal intercostal nerve block (PSIB) is a "superficial block" which involves local anesthetic (LA) infiltration in the intercostal space around the sternum where the anterior branches of intercostal nerves exist.

Intraoperative LA administration under direct vision of the surgeon ensures adequate delivery of drugs and minimizes bleeding complication or inadvertent administration in blood vessels. Meanwhile, Preoperative administration of LA guided by ultrasound imaging has been used in variable surgical settings with noticeable success because of preemptive inhibition of noxious stimuli.


Eligibility Criteria:
Inclusion Criteria:

* Age from 20-70 years,
* Scheduled to undergo elective cardiac surgeries through median sternotomy involving cardiopulmonary bypass (CPB).

Exclusion Criteria:

* Patients requiring preoperative inotropes, mechanical ventilation or intra-aortic balloon pump,
* patients who have previous cardiac surgery,
* prolonged CPB time (CPB\>120 minutes),
* Intubation time more than 12hrs or planned for overnight ventilation.
* Allergy to any of used drugs,
* opioids addiction,
* Chronic liver disease, chronic renal disease, and cognitive impairment.
Pharmacokinetics and Pharmacodynamics Study of Pegfilgrastim in Chemotherapy Patients

The purpose of this study is to examine the safety,tolerability,pharmacokinetics and pharmacodynamics of Pegfilgrastim in patients with chemotherapy-induced neutropenia.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18～70 years
* Confirmed malignant tumor patients by histopathological or cytological diagnosis, not previously treated with chemotherapy or radiotherapy,suitable for chemotherapy with carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin
* Karnofsky score ≥ 70
* Normal coagulation function, no evidences of hemorrhage,WBC ≥ 3,500 per cubic milliliter, ANC ≥ 1,500 per cubic milliliter, PLT ≥ 100,000 per cubic milliliter
* Normal liver, heart, kidney function
* Life expectancy \> 3 months
* Signed informed consent

Exclusion Criteria:

* Not adequately controlled infections(e.g. ANC ≥ 12,000 per cubic milliliter,temperature \> 38.2℃)
* Evidence of metastatic disease in bone marrow,or with other malignant tumors
* Subjects with symptomatic brain metastases
* Pregnant or breast-feeding or in menstrual period females
* Participated more than 3 clinical trials in nearly a year(as subjects)
* Currently participated in any other clinical trials,or Used any prescription medication could impact on the metabolism of investigational drug, or participated in any other clinical trial within one month from the date of the screening visit
* Donation of whole blood or a unit of blood within three months prior to the start of study
* Known hypersensitivity to filgrastim or any of the products to be administered during dosing
* Evidence of, or treatment for, drug or alcohol abuse within one year from date of screening visit
* Other conditions which in the opinion of the investigator preclude enrollment into the study
Cooking Classes for Young Adults With ID

The purpose of this study is to examine the feasibility and initial efficacy of a healthy lifestyles intervention for the prevention of weight gain and the promotion of basic life skills related to improving health in transition age young adults with intellectual disabilities.

This is a single arm, longitudinal trial. 30 young adults with intellectual disabilities will be recruited to participate in a 12-week, healthy lifestyles intervention, delivered in person to a group of individuals with ID at the Center for Children's Healthy Lifestyles and Nutrition. Participants will be asked to attend one 2 hr group session each week (\~5-6 participants per group). All sessions will have an education component, a hands-on nutrition/cooking lesson, and a group exercise session. Additionally, participants will be asked to attend a 20-minute monthly individual goal setting session conducted remotely over Zoom video conferencing. All sessions will be conducted by a trained health educator experienced in working with individuals with intellectual disabilities. Tablet computers and Fitbit wireless activity monitors will be provided to all participants, with study issued HIPPA compliant Zoom and Fitbit accounts. Outcome assessments will be collected at baseline and after the 12-week intervention.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of an Intellectual Disability.
* Age: 18-30 yrs.
* Functional ability sufficient to understand directions and to communicate through spoken language.
* Reside in a supported living condition either at home or with no more than 1-4 residents and have a study partner (i.e., parent, staff who agrees to serve as support partner).
* Wireless Internet access in the home.
* Ability to walk without assistance.
* Consent from physician to do physical activity.

Exclusion Criteria:

* Actively participating in another research study