cyrilzakka/clinical-trials huggingface dataset:
Observational Study of Pharmacological Treatment for Premature Ejaculation Concurrent With Erectile Dysfunction

Premature ejaculation (PE) is a common disease in the andrology clinic. Currently, the effectiveness and outcome differences of drug treatment still need to be studied and demonstrated. Premature ejaculation concurrent with erectile dysfunction (ED) is common in outpatient clinics. The preferred treatment plan for these patients still needs to be further studied and explored, and the difference in the efficacy of different treatment regiments remain to be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. PE concurrent with ED: the IELT is less than 3 minutes, the PEDT score is ≥11 points, and 5≤IIEF-5≤21 points.
2. 18-60 years old, outpatient or physical examination population, with regular sex partners and regular sex life;
3. Having the data below,and willing to participate in the trial（1）Demographic information: age, gender, nationality, birthplace, etc;(2) Physical examination data: height, weight, abdominal circumference, blood pressure, heart rate, etc ;(3) Medical history data: history of present illness, past medical history, family history, etc;(4) Scale evaluation: Premature Ejaculation Diagnostic Tool (PEDT), Premature Ejaculation Profile (PEP), International Erectile Function Score-5(IIEF-5), Erectile Hardness Grading Score (EHGS), Clinical Global Impression of Change (GICC);

Exclusion Criteria:

1. Age \<18 years or\> 60 years;
2. There is a history of acute and chronic diseases, major trauma and surgery, etc;
3. A long history of medication;
4. There is a history of unstable myocardial infarction and cerebral infarction;
5. A history of cardiogenic shock, severe heart failure, severe ventricular arrhythmia, etc;
6. There are serious diseases such as malignant tumors, chronic liver and kidney diseases, etc.
NICUSeq: A Trial to Evaluate the Clinical Utility of Human Whole Genome Sequencing (WGS) Compared to Standard of Care in Acute Care Neonates and Infants

Prospective, multi-site, study to evaluate the clinical utility of cWGS in a proband. One group will receive cWGS and a clinical report approximately 15 days after blood samples are received, while the other group will continue to receive standard of care until Day 60. The standard of care group will receive cWGS and a clinical report at Day 60 as part of secondary and tertiary analyses. Both groups will be followed for a total of 90 days.

This is a prospective, multi-site, randomized study to evaluate the clinical utility of cWGS in each proband. Throughout this study, each proband will receive SOC testing as determined by the site clinical team. Upon enrollment in the study, each proband will be randomly assigned to the 15 day cWGS group or the SOC group. SOC is defined as the management of the proband's care under the same or similar conditions as if the proband was not enrolled in this study. A blood sample from each enrolled proband will be collected and shipped to the Illumina Clinical Services Laboratory ("ICSL"), which is Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited. ICSL will conduct cWGS testing with the TruGenome Undiagnosed Disease Test ("TruGenome Test"). The TruGenome Test cWGS results will be provided to the Principal Investigator (PI) or designee who will evaluate each proband test outcome based on the aggregate medical information, informed by the cWGS or SOC results.

Eligibility Criteria:
Proband Inclusion Criteria

1. Current admission in a Neonatal Intensive Care Unit/Intensive Care Unit at a participating clinical site at the time of enrollment from day of life 0 to 120 days
2. A suspected genetic etiology of disease, based on objective clinical findings or other phenotypic defects for which a genetic test would be considered
3. Must be able to have 1 - 1.25 ml tube of whole blood drawn for testing
4. One parent of the proband must be able to provide written informed consent
5. At least one biological parent must agree to participate and provide at least 4 ml of whole blood for testing

Exclusion Criteria:

Proband Exclusion Criteria

1. Known non-genetic cause(s) of disease, disorder, or phenotypic defect
2. The phenotype is fully explained by complications of prematurity
3. Trisomy 13, 18 or 21 or Turner Syndrome is the likely diagnosis; such a proband will be eligible if a diagnostic karyotype is normal
4. Blood transfusion within 48 hours (each proband will be re-eligible 48 hours after the most recent transfusion)
5. The PI decides that the study is not in the best interest of the proband (for example, the neonate or infant is at a high risk of severe morbidity or mortality within the next 7 days and these risks could be mitigated by alternative testing). Subsequent eligibility for enrollment of each proband is at the discretion of the site PI.
A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC

The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).


Eligibility Criteria:
Inclusion Criteria:

* Progressive metastatic (M1) disease on androgen deprivation therapy
* Detectable AR-V7 from circulating tumors (CTCs)
* ECOG performance status 0 or 1

Exclusion Criteria:

* Prior treatment with second generation anti-androgens (e.g. abiraterone, enzalutamide)
* Prior treatment with chemotherapy for CRPC
Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety

Cranial electro stimulation (CES) provides safe, adequate, side-effect free sedation without excessive drowsiness in preoperative settings.

CES Alpha-Stim is a non-invasive device which has been in place and has been approved for patients to reduce anxiety by the FDA. This study involves the use of CES Alpha-Stim device applied to the patient 30 minutes before and through-out cataract surgery procedure and then to measure the level of anxiety and discomfort by using a visual analog scale (VAS). We propose that by applying the device the patients will be able to have markedly less level of anxiety and discomfort before and during the surgery and will ultimately avoid the traditional use of sedative or analgesic drugs being used for these kinds of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders between 50 and 90 years old scheduled for an outpatient "first eye" cataract phacoemulsification with topical anesthesia.
* ASA classification I II and III

Exclusion Criteria:

* ASA classification IV (patients with a chronic or severe disease).
* Hypersensitivity to midazolam or benzodiazepines
* acute narrow-angle glaucoma
* untreated open-angle glaucoma
* Patients with any sort of psychiatric or neurological disorder
* Patients on anti-anxiety medication
* Patients who have demand-type pacemakers installed before 1999\* \*Note: These are the exclusions listed for liability purposes by Alpha-Stim. There are no FDA exclusions.
Riluzole in Fragile X Syndrome

The purpose of this study is to investigate the effectiveness and tolerability of riluzole in adults with Fragile X Syndrome.

Fragile X Syndrome (FXS) represents the most common inherited form of intellectual disability. FXS is more common in males and the symptoms associated with the disorder are more marked in males. FXS is associated with characteristic physical features, behaviors, and comorbidities. Those with FXS often suffer from behavioral difficulties that include anxiety-related symptoms (shyness, social phobia, obsessive-compulsive disorder (OCD) symptoms), attention deficit hyperactivity symptoms (overarousal, hyperactivity, distractibility, impulsivity) and aggressive/self-injurious behaviors.

Riluzole is approved by the FDA for use in treating amyotrophic lateral sclerosis (ALS) in adults. Recently, riluzole has been the subject of several open-label studies describing the use of the drug in treatment-resistant depression and OCD.

Given the overlap between repetitive behavior in FXS and symptoms of OCD, it is logical to study riluzole in FXS given the compound's promise in ameliorating treatment-refractory symptoms of OCD.

Eligibility Criteria:
Inclusion Criteria:

* Males and females age 18 years or older.
* Confirmed molecular diagnosis of Fragile X Syndrome.
* Clinical Global Impression Severity (CGI-S) score of 3 or greater.
* Significant interfering repetitive behavior as determined by the principal investigator.
* Must be in good health as determined by screening procedures including a detailed medical history, and complete physical and neurological examination.
* Dosing of concomitant medications during the study must remain stable.

Exclusion Criteria:

* Pregnancy.
* Concomitant use of another glutamatergic agent (memantine, topiramate, amantadine, among others.
* Evidence of prior trial of riluzole and/or hypersensitivity/allergic reaction to riluzole.
* Abnormal baseline liver function tests at screen or by history; or complete blood count abnormalities at screen or by history.
Ethnic Differences in the Impact of Breast Cancer on Employment Status, Financial Situation, and Quality of Life

The purpose of this study is to learn more about how being treated for breast cancer affects patients' employment, financial situation, and quality of life on a short-term basis and on a long term basis. Most studies of employment after breast cancer have focused on Caucasian women.This study will evaluate the impact of breast cancer on the lives of women from different ethnic groups.


Eligibility Criteria:
Inclusion Criteria:

Breast cancer survivors

* Pathologic diagnosis of stage I-III breast cancer
* Paid employment (full time or part time) at time of consent or in the three months prior to diagnosis
* Age 18 to 64 years (inclusive)
* The ability to give informed consent in Chinese (Mandarin), English, Korean, or Spanish.at MSK, New York Presbyterian Queens and Queens Medical Associates At NYC Health \& Hospitals/ Lincoln Medical Center, patients must be able to give consent in English or Spanish.
* At the time of enrollment, participants must still be undergoing chemotherapy, undergoing radiation therapy, or planning surgery unless surgery is to be the only treatment modality. Those for whom treatment consists of surgery alone may have had their operation no more than 2 months prior to study enrollment. Participants need not have undergone surgical reconstruction prior to enrollment if the plan is to delay this procedure until after primary treatment is completed.

Comparison group

Paid employment (full time or part time) at the time of consent

* Age 18 to 64 years (inclusive) and within an age range that is 5 years above or below that of the nominating or matched survivor
* The ability to give informed consent in the same language as the nominating survivor
* Membership in the same ethnic group as the nominating survivor
* Not treated for cancer in the past year (other than non-melanoma skin cancer)

Exclusion Criteria:

* N/A
Normal Pediatric Liver and Spleen SWE

This observational study aims to determine normal liver and spleen stiffness values in healthy children using shear wave elastography (SWE). The study will include participants from the pediatric age group without known liver or spleen disease. SWE measurements will be performed non-invasively to establish reference values. The results may contribute to improving diagnostic accuracy in pediatric elastography applications.

Shear wave elastography (SWE) is a non-invasive imaging method used to assess tissue stiffness. While reference values for SWE have been established in adults, data regarding normal liver and spleen stiffness in children are limited. This single-center, cross-sectional observational study aims to establish normative SWE values for the liver and spleen in the pediatric age group. Children with no known liver or spleen pathology will undergo standardized SWE measurement under controlled conditions. Age-specific and sex-specific reference ranges will be analyzed, which may contribute to enhancing the clinical utility of SWE in pediatric practice.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children aged 0-18 years
* No known liver or spleen pathology
* Written informed consent obtained from parents or guardians

Exclusion Criteria:

* Known liver disease (e.g., hepatitis, cirrhosis)
* Known spleen disease (e.g., splenomegaly)
* Any history of liver or spleen disease
* Age outside the 0-18 years range
Applicability of Techniques of Lung Expansion

The survival of patients with lesions in the central nervous system is usually accompanied by physical and mental sequelae. These impairments favor the prolonged restriction to the bed, which may contribute with changes in respiratory function. In this context, lung re-expansion techniques are used to prevent or treat the various respiratory complications.

The survival of patients with lesions in the Central Nervous System is usually accompanied by physical and mental permanents sequelae. This impairment of cognitive status associated with motor injury favors prolonged restriction of these patients to the bed, which may contribute to the emergence of other health damages. In the clinical practice, lung expansion techniques has been used as a prophylaxis and treatment of respiratory conditions that involve volumetric reductions. However, the deficit of awareness and cooperation difficult the use of several therapeutic resources. There are few interventions that could be proposed due to no need the collaboration to be performed, such as Breath Stacking technique (BS) and Expiratory Positive Airway Pressure (EPAP). The BS is characterized by execution of inspiratory cycles through a one way valve, which allows stacked volume of gas during each inspiration, until it reaches values approximate to maximum inspiratory capacity. While in the EPAP, alveolar pressure is elevated to breath against a expiratory flow resistance generated by a spring load valve. The effects on lung volume promoted BS and EPAP can be safely measured using an electrical impedance tomography (EIT). This recent imaging modality offers information about lung air volumes distribution and have a strong linear correlation with regional ventilation within the thorax. The effects on lung volume promoted BS and EPAP can be safely measured using an EIT monitor. This recent imaging modality offers information about lung air volumes distribution and have a strong linear correlation with regional ventilation within the thorax. Until this moment, there is not description about the effect of lung expansion techniques on regional lung parameters.

Eligibility Criteria:
Inclusion criteria:

1. Patients undergoing neurosurgery restricted to bed for more than 14 days;
2. Aged between 18 and 65 years;
3. Glasgow Coma Scale \< 10 points;
4. Breathing spontaneously through the tracheostomy tube;
5. No respiratory infection;
6. Chest circumference between 88 and 98 centimeters;

Exclusion criteria:

1. Presence of chronic lung diseases;
2. Chest deformity;
3. Rib fracture;
4. Asymmetrical chest expansion;
5. Abdomen distension;
6. Spasticity in any hemisphere with Ashworth Scale score more than 2 points for upper limbs;
7. Uncoordinated movements of the limbs;
8. Cardiorespiratory instability (heart rate \< 60 or \> 120 bpm; respiratory rate \> 35 ipm; mean arterial pressure \< 60 mmHg or \> 120 mmHg; oxygen saturation \< 90%).
RAltegravir Switch STudy: Effects on Endothelial Recovery

Treatment with HIV-infection with protease inhibitors is associated with high blood lipids and higher chance for cardiovascular complications. The RASSTER study aims to investigate the effect of switching the protease inhibitor lopinavir/ritonavir to raltegravir on vessel wall function and inflammation,and activation of the immune system. we hypothesize that with this intervention these parameters will improve. Since decreased vessel wall function and inflammation are initial steps in the process of atherosclerosis, it is important to know this data when treating HIV-infected patients.

Fixed dose combination lopinavir/ritonavir (LPV/r) is a widespread used antiretroviral drug belonging to the class of protease inhibitors (PIs). PIs are associated with an increased risk of myocardial infarction. However, data is available suggesting increased levels of plasma lipids are not the sole explanation for this observation. Treatment with LPV/r might lead to a decrease of endothelial function as well, thus explaining the increased risk of myocardial infarction besides increased plasma lipids. Raltegravir is a registered antiretroviral drug with no known cardiovascular side effects. We hypothesize that switching LPV/r to raltegravir in HIV-infected patients with suppressed plasma viral load (\<50 copies/ml) will lead to an improvement of endothelial function.

Objective:

* First, to assess the effect of the switch of lopinavir/ritonavir to raltegravir on endothelial function.
* Second, to assess the effect of the intervention mentioned above on markers of endothelial function; immune activation; chronic inflammation; and, on plasma HIV-RNA below the cut-off of 50 copies/ml.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* HIV-1 infection
* Treatment with antiretroviral regimen containing lopinavir/ritonavir for at least the previous 3 months
* No other protease inhibitors besides lopinavir/ritonavir in antiretroviral regimen
* Subjects must have a minimum period of viral suppression (plasma HIV-RNA \< 50 copies/ml) of 6 months
* Subjects will not have a history of virological failure on antiretroviral therapy
* Results of previous resistance testing allowing replacement of lopinavir/ritonavir by raltegravir
* CD4+ cell count \> 200 cells/µL
* Signed informed consent

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Raltegravir hypersensitivity
* Treatment of underlying malignancy
* Renal insufficiency requiring dialysis
* Acute or decompensated chronic hepatitis (Child-Pugh score C)
* Modification of antiretroviral regimen in the previous 3 months
Structural and Functional Networks in ALS: An Insight Into Pseudobulbar Affect

The investigators aim to elucidate characteristics of structural and functional brain connectivity in patients with amyotrophic lateral sclerosis (ALS) and pseudobulbar affect (PBA) using diffusion kurtosis imaging (DKI) and magnetoencephalography (MEG).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ALS in the last 6 months according to Gold Coast Criteria

Exclusion Criteria:

* - Lack of ability to answer survey through own ability or through a surrogate, for example by hand controlled, eye-controlled computer and/or tablet, or through telephone interview.
* Lack of ability to cooperate.
* Pregnancy
* Drug addiction defined as the non-prescribed use of cannabis, opioids, or other narcotics.
* Alcohol addiction defined as over 21 units weekly.
* Lesional neurological diseases, such as stroke, tumor or multiple sclerosis
* Epilepsy
* Neurodegenerative diseases other than ALS
* Severe psychiatric disease such as major depression disorder, bipolar disease or schizophrenia
* Contraindication for MRI and MEG scan according to hospital guidelines
* Severe liver or kidney disease
* Dysregulated heart disease
* Ongoing treatment with any antidepressants or any antipsychotics at recruitment.
* Diagnosed with frontotemporal dementia.
Aromatase Inhibitors for Treatment of Uterine Leiomyomas

Fibroids are benign tumors that might results in bleeding. Surgery is their definitive treatment. Some medical therapies have been tried for women who wish to preserve their uterus. Recent reports have demonstrated a role for a new category of drugs called aromatase inhibitor (such as Femara) in the treatment of fibroids. This study is conducted to assess the effect of Femara (letrozole) on the size of fibroids in women around menopause.

Fibroids (leiomyomas) are benign tumors that originate in the musculature of the uterus. They are the most common cause for removal of the uterus in women. Surgery is the final definitive treatment of fibroids. However, surgery is relatively risky. Hence, a few medical therapies have been tried for women who wish to preserve their uterus. However, most of those therapies have side effects that prohibit their routine use. Recent reports have demonstrated a role for a new category of drugs called aromatase inhibitor ( such as Femara) in the treatment of fibroids. To the best of our knowledge, this drug has not been studied yet in the management of fibroid of the uterus apart from one case report.

The objective of the current study is to assess the effect of aromatase inhibitors, specifically Femara (letrozole) on the size of fibroids in women around menopause. We are hoping that by decreasing their size, we could avoid having patients undergo surgery. The data generated is invaluable in that sense.

Eligibility Criteria:
Inclusion Criteria:

1. Perimenopausal women (≥ 50 years) with symptomatic uterine leiomyomas (menometrorrhagia, pressure symptoms, urinary retention, pelvic pain) or those with large leiomyomas ≥ 7 cms

Exclusion Criteria:

1. Women \<50 years of age
2. Postmenopausal women
3. Women with impaired renal function
4. Oral treatment with any type of estrogen or progesterone more recently than 1 month
5. History of venous thromboembolism
6. Any contraindication for Magnetic Resonance Imaging (MRI)