cyrilzakka/clinical-trials huggingface dataset:
A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled, Flexible Dose Escalation Study To Evaluate Sexual And Relationship Satisfaction In The Female Partner Of Men With Erectile Dysfunction Treated With Sildenafil Citrate

To compare the effects of sildenafil versus placebo on the female partner's sexual satisfaction as assessed by Question 3 of Female Partner of Erectile Dysfunction (ED) Subject Questionnaire (FePEDS-Q): "Over the past 4 weeks, when you had sexual intercourse, how often was it satisfactory for you?" For ED subjects, determine difference in the Erectile Function domain of International Index of Erectile Function (IIEF) between sildenafil citrate and placebo at end of the treatment phase and determine the overall relationship between improved erectile function and increased ED subject and female partner satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* The male patient must have had a documented clinical diagnosis of erectile dysfunction (ED) confirmed by a Sexual Health Inventory-Male (SHI-M) score of less than or equal to 21
* a stable female partner at least 21 years of age for at least 6 months prior to screening
* the couple must have been married or living together at the time of screening.
* The female partner must have answered "no intercourse," "sometimes," "a few times" or "almost never" on Question 3 of the Female Partner of ED Subject Questionnaire (FePEDS-Q)

Exclusion Criteria:

* The male patient must not have had resting sitting and/or standing hypotension (BP \< 90/50mmHg) or hypertension (BP \> 170/110mmHg), or significant cardiovascular disease in the last 3 months, including cardiac failure, myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias.
* Female partners must not have had significant dyspareunia or lifelong significant sexual dysfunction based on female partner's medical and sexual history at screening.
The Effect of Grape Seed Extract on Estrogen Levels of Postmenopausal Women

The role of estrogens in the pathogenesis of breast cancer has been well documented. This has led to the development of "Anti-Estrogens" (selective estrogens receptor modulators and Aromatase Inhibitors), used for treatment and prevention of breast cancer. These agents, however, have significant side effects, which are not acceptable to many healthy high-risk women. There is preliminary evidence that grape seed extract acts as "natural" aromatase inhibitor (1). This study has the potential to quantify the effectiveness of a natural substance that mimics the action of pharmaceutical aromatase inhibitors.

Early detection of breast cancer with screening mammography and the use of more effective medical therapies have led to a decrease in breast cancer mortality. However, breast cancer is still the second leading cause of cancer death in women (2). Therefore, the future lies in not only early detection but prevention of breast cancer. Currently available chemopreventive agents are associated with potentially serious side effects and can be quite costly, especially when taken for extended periods of time. Therefore, they are usually targeted only to women at high risk of disease. Identification of an inexpensive, efficacious preventive therapy with few or no side effects would represent a major advance in reducing the morbidity and mortality due to breast cancer. One exciting possibility is grape seed extract. Grapes and grape seeds contain procyanidins, a highly active subclass of flavonoids with actions similar to pharmaceutical aromatase inhibitors (AIs). These procyanidin dimers have been found to suppress estrogen biosynthesis both in vitro and in animal models (1). Based upon this knowledge we proposed this dose finding pilot study.

Eligibility Criteria:
Inclusion Criteria:

* Age 55 - 75 years
* Able to understand and sign a consent form
* Postmenopausal (no menstrual period for 1 year or more)
* No personal cancer history (except for non-melanoma skin cancer)
* No hormone replacement therapy or anti-estrogens within 6 months of baseline

Exclusion Criteria:

* Known allergy to grapes or grape products
* Currently on ACE inhibitors, methotrexate, allopurinol, coumadin (Warfarin, Jantoven), heparin, clopidogrel (Plavix), or cholesterol lowering medication
EFFECT:Eccentric Fixation From Enhanced Clinical Training

Age-related macular degeneration (AMD) is the leading cause of severe visual impairment in the UK, Europe and N America. Low vision patients with AMD have great difficulty reading, which leads to a loss of independence and reduced quality of life. Magnifiers alone do not compensate for loss of central vision in AMD. It has been proposed that special low vision training can improve reading ability in patients with AMD. Training programmes are widely available in the US and Scandinavia, but not in the UK, partly because there is a lack of evidence from Randomised Control Trials (RCT) showing that they are effective. The investigators are conducting a clinical trial comparing the conventional hospital-based low vision service to enhanced rehabilitation programmes that include Eccentric Viewing training. Eccentric viewing training involves teaching patients who have lost their central vision to use a new area of retina for visual tasks. Patients are either taught to improve the use of the part of the retina they naturally start using after their central vision is lost, their so-called preferred retinal locus (PRL), or, alternatively, they are taught to use a different retinal area that is thought to be better suited for everyday visual tasks, the so-called trained retinal locus (TRL). The investigators plan to compare the two types of eccentric viewing training to conventional hospital-based low vision care.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of age-related macular degeneration
* Visual acuity 6/12 to 3/60 inclusive in the better eye
* Dense central scotoma confirmed by microperimetry

Exclusion Criteria:

* Patients who are not fluent in English or are cognitively impaired
* Patients with serious hearing impairment
* Patients who are hospital inpatients, who are living in nursing homes or are otherwise non-independent
* Ocular co-morbidity (other than mild cataract) in the better eye
* Recent low vision assessment or eccentric viewing training
Qualitative Analysis of Photoplethysmography Waveforms for the Detection of Cardiac Arrhythmias

Single-lead electrocardiography (ECG) technologies and photoplethysmography (PPG) deriving smartphone apps are gaining interest in the heart rhythm detection space since these apps have the potential to capture and assess heart rhythms. Proprietary arrhythmia detection algorithms are proven to be reliable and accurate. However, insights into the readability of PPG waveforms by human reviewers remain limited. To the investigators' knowledge, there are no publications available regarding the readability of PPG waveforms by human reviewers. The objective of the study was to assess the readability of PPG and single-lead ECG analysis by medical professionals, with respect to the gold-standard 12-lead ECG diagnosis, and investigate whether additional information positively impacts PPG analysis.

During the study, the readability of PPG and single-lead ECG waveform analysis will be investigated. The objective of the study is to determine the readability of PPG and single-lead ECG measurements, with respect to the gold-standard 12-lead ECG, and investigate whether additional information positively impacts the readability of PPG. Medical professionals (cardiologists and cardiology residents), blinded for the patients' characteristics and history, are instructed to separately analyse the following signals, obtained from 30 patients.

* 30 outputs with PPG waveforms
* 30 outputs with PPG waveforms with tachogram and Poincaré
* 30 outputs with PPG waveforms with tachogram, Poincaré, and algorithm interpretation
* 30 outputs with single-lead ECG waveforms
* 30 outputs with 12-lead ECG waveforms

Participants report the results of the qualitative analysis via a digital questionnaire with multiple-choice questions. Medical professionals classify each rhythm trace as regular rhythm, one or more ectopic/missed heartbeats, atrial flutter, atrial fibrillation, unreadable, or other. The tachogram, Poincaré, and the algorithm interpretation are subsequently added to investigate whether the additional information improves the readability of PPG. Based on the provided answers, the study team will determine the readability of PPG and single-lead ECG analysis interpretation, with respect to the gold-standard 12-lead ECG diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Cardiologist or cardiology resident
* Able to understand Dutch or English
Evaluation of 3DCRT Versus IGRT and Analysis of Early Response in Head and Neck Cancer.

This study aims to study the impact image guided radiotherapy with Cone beam CT will have on the outcomes(toxicities and response) of head and neck cancer when compared to 3D conformal radiotherapy without CBCT based setup error verification.Also,the various dosimetric variations in Adaptive RT will be studied.

Aims and Objectives

1. To assess the patient's radiation dose planning for GTV, CTV and PTV for primary and nodal regions and derive comparison between IGRT and 3D-CRT.
2. To assess the dosimetric variation in different phases of adaptive RT due to changes in tumor shape and volume during the course of entire treatment in IGRT arm in head and neck cancer patients.
3. To evaluate the optimal setup correction methodology using planar (EPID) and volumetric images (CBCT) in HNSCC between 3D-CRT and IGRT treatment delivery respectively.
4. To compare the early tumour response and acute and chronic radiation morbidities between IGRT and 3D-CRT.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically proven cases of Carcinoma Oropharynx,Larynx,Hypopharynx, stages T1-4 N0-2a M0
* Informed Consent
* KPS score \> 70

Exclusion Criteria:

* Uncontrolled medical comorbidity
* Not ready for follow up
* Previous cancer directed therapy
Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

To combine oxaliplatin and taxotere in patients who have had prior cisplatin therapy in bladder cancer.

To test the combination of oxaliplatin chemotherapy in combination with taxotere chemotherapy in patients with advanced bladder cancer who have failed one prior chemotherapy.

Eligibility Criteria:
* Patient Population Type: Advanced Muscle Invasive Bladder Cancer
* Prior Therapy: One prior therapy for advanced disease
* Disease: Measurable disease
* ECOG Performance: 0,1
* Indication: Histologically Proven Carcinoma of the bladder
* For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
* Allergies: No known allergy to one of the study drugs
* Patient Status:
* No CNS metastases
* No peripheral neuropathy \> grade1
* No other serious concomitant illness
* Fully recovered from any prior therapy
* Informed Consent: Patient and doctor have signed informed consent
* Lower Age Limit: Lower age limit \>18
* Upper Age Limit: Upper Age Limit \<70
* ANC: ANC \>1500/mm3 or WBC \> 3000/mm3
* Platelets: Platelets \>100,000/mm3
* Creatinine: Creatinine \<1.8mg/dL
* Bilirubin: Bilirubin \<=2.0 x ULN
* SGPT: SGPT (ALT) \<=1.5 x ULN (\<4xULN if liver metastases present)
* RBC: Hemoglobin \> 9.0g/dL
* Cardiovascular: No active congestive heart failure, no uncontrolled angina, no myocardial infarction within the past 6 months
* Patients with metastatic cancer of the urothelial tract (TCC, Adenocarcinoma)
* No prior exposure to Oxaliplatin
* No cytotoxics or radiation 4 weeks prior to enrolling on protocol
* PT/PTT normal
Exploring the Effect of Colonic J-pouch in Anorectal Preservation Surgery for Ultra-low Rectal Cancer.

The occurrence of colorectal cancer has increased from the third most common cancer in 2018 to the second most common cancer in 2023. The practice of anal preservation surgery for ultra-low rectal cancer is being adopted gradually. Ultra-low rectal cancer patients who have undergone anal preservation are at an increased risk of developing significant bowel complications. The objective of this study was to examine the relationship between the type of bowel reconstruction following anal preservation surgery, and the subsequent outcomes of bowel function, quality of life and complication rates in patients with ultra-low rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. A confirmed diagnosis of intestinal cancer, with the lower edge of the tumour \&amp;lt;5 cm from the anus or \&amp;lt;3 cm from the dentate line, and treated with anus-preserving surgery;
2. No distant metastasis;
3. Age \&amp;gt;18 years old;
4. Voluntary enrollment in the study and signing of an informed consent.

Exclusion Criteria:

1. A combination of severe cardiopulmonary, hepatic, renal, and other underlying diseases with a greater anaesthetic risk (ASA ≥ grade 4);
2. preoperative anal stenosis and anal nonfunction;
3. temporary stoma diversion.
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC

NUV-422-03 is a randomized, non-comparative Phase 1/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant monotherapy. The study population is comprised of adults with HR+HER2- aBC. Patients will self-administer NUV-422 orally in 28-day cycles and receive 500 mg fulvestrant intramuscularly (IM) on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women with diagnosis of locally advanced inoperable or metastatic HR+HER2- breast cancer
2. Evidence of disease progression on immediate prior therapy as determined by the Investigator per standard criteria
3. Patients must have received standard of care treatments for their breast cancer and be eligible to receive fulvestrant

   * Prior standard of care treatments must include treatment with hormonal therapy in combination with an approved CDK4/6 inhibitor
4. Patients must have endocrine-resistant disease
5. Have no known active or symptomatic central nervous system (CNS) disease
6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1
7. Life expectancy of \> 6 months
8. Eligible to receive fulvestrant
9. Adequate bone marrow and organ function

Exclusion Criteria:

1. Have received chemotherapy, hormonal therapy (with the exception of ongoing LHRH analogs in male patients and premenopausal women), radiation, or biological anti-cancer therapy within 14 days prior to the first dose of NUV-422 and fulvestrant
2. Received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent or 21 days (of \< 5 half-lives) for myelosuppressive agent prior to first dose of NUV-422 and fulvestrant
3. Moderate liver impairment which would require a reduced dose of fulvestrant
4. Requires medications that are known to be strong inducers and/or inhibitors of CYP3A4/5 enzymes

   * For Phase 1b only: requires medications that are known to be moderate inducers and/or inhibitors of CYP3A4/5 enzymes
5. Known allergy or hypersensitivity to fulvestrant
6. For Phase 2 only: prior therapy with fulvestrant and/or investigational ER targeted agent
7. Females who are pregnant or breast feeding
Therapy Adherence of APAP Therapy Initiation in Sleep-lab Versus at Home

Primary hypothesis:

The objective compliance ( # of hours per night of APAP therapy) is higher in patients who get the APAP treatment initiation at home due to the fact that they get better support by telemetric control and the possibility of prompt interventions.

Secondary hypothesis:

Based on the higher support at the home APAP initiation the following parameters will be better in comparison to the standard supply in laboratory:

Objective measures:

* mask leakage
* pressure
* Apnea-Hypopnea-Index (AHI)

Subjective measures:

* quality of life
* sleepiness


Eligibility Criteria:
Inclusion Criteria:

* written informed consent from patients after verbally and written informing
* Age between 18 and 80 Years
* obstructive sleep apnea syndrome (OSAS) with an AHI \> 15/h and without previous therapy

Exclusion Criteria:

* Intolerance to wear the PAP therapy mask
* sleep breathing disorders (SBD) with central apneas \> 20% and other sleep disorders
* disabilities who prevents the wear of a therapy mask
* initiated PAP therapy
* pre-treatment of OSAS incl. UPPP (uvulo palato pharyngo plasty)
* modified Mallampati Score T3 and T4
* participation on clinical studies 4 weeks before start of the study
* known or acute psychiatric/neurological or psychological disorders, who impairs the compliance to take part of the study.
* chronical or new clinically significant pneumological or cardiovascular disease (exception: effectively therapies of hypertension, cardiac arrhythmia and coronal cardiac disease)
* acute internistic disease
* neuromuscular disease
* condition after Apoplexy
* oncological disease in recent 5 years
* drug/alcohol consumption
* consumption of von psychotropic drugs, hypnotics and other drugs who are able to influence the sleep/wake cycle
Dasatinib in Combination With Revlimid (and Dexamethasone)

The purpose of this study was to determine the safety and tolerability of dasatinib when given in combination with lenalidomide and a low dose dexamethasone for the treatment of relapsed or refractory multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent
* Men and women age ≥ 18 years
* Confirmed diagnosis of multiple myeloma (MM) with measurable disease assessed within 1 month prior to treatment initiation
* Evidence of relapsed or refractory disease and at least one prior therapy for MM
* Eastern Cooperative Oncology Group Scale (ECOG) Performance Status of 0 - 2
* Last MM treatment at least 21 days prior to treatment initiation• Bone marrow transplant (BMT) at least 3 months prior to treatment initiation
* Required baseline hematology and chemistry parameters
* Resolution of acute toxicity due to prior therapy to Grade \<2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Men whose sexual partners are women of child bearing potential (WOCBP) or WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) before and for at least one month (4 weeks) after the last dose of study medication.
* Clinically significant cardiac disease (New York Heart Association \[NYHA\] Class III or IV)
* Abnormal corrected QT interval using Fridericia's formula (QTcF) interval prolonged (\> 450 msec)
* Medications that are generally considered to have a risk of causing "Torsades de Pointes"
* Malabsorption syndrome or uncontrolled gastrointestinal toxicities
* Clinically significant pleural effusion in the previous 12 months or current ascites
* Clinically-significant coagulation or platelet function disorder
* Dementia, chronic medical or psychiatric condition, or laboratory abnormality
* Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality, serious uncontrolled medical disorder or active infection
* Intolerance to dasatinib and/or lenalidomide
* Subjects with a history of severe rash, hypersensitivity reaction or anaphylaxis related to prior thalidomide treatment
Biobank For MS And Other Demyelinating Diseases

To establish a large, longitudinal collection of high quality samples and data from subjects with MS, selected other demyelinating diseases (Transverse Myelitis (TM), Neuromyelitis Optica (NMO) or Devic's, Acute Disseminated Encephalomyelitis (ADEM), and Optic Neuritis (ON)), and related and unrelated unaffected controls. Samples and data will be available as a shared resource to scientists researching the causes, sub-types, and biomarkers of MS and related demyelinating diseases.


Eligibility Criteria:
Inclusion Criteria:

* age 18+ able to give informed consent or individuals younger than 18 with parental permission and able to give assent
* willing to provide up to 110 ml (50 ml for \< 18 years old) of blood via venipuncture
* experienced at least one CNS demyelinating event characteristic of MS, TM, NMO, ADEM, or ON

Exclusion Criteria:

* history of blood borne pathogens
* allogeneic bone marrow transplant
* clinical or radiological evidence of stroke, meningitis, or other well characterized diseases of the nervous system (with the exception of MS, TM, NMO, ADEM, or ON).
* weight less than 37 pounds
Prospective Carotid Artery Stenosis Trial

Researchers are collecting information and blood from subjects undergoing carotid artery interventions.


Eligibility Criteria:
Inclusion Criteria:

* All subjects undergoing carotid artery intervention that presents to our clinic

Exclusion Criteria:

* None
Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan

This protocol is being conducted to comply with the direct request from the Taiwan Food and Drug Administration (TFDA) for a 60-month intensive pharmacovigilance protocol of patients with known hepatitis B (HBV) or hepatitis C (HCV) infection, regardless of control on antiviral therapy in Taiwan and who are treated with ipilimumab for advanced (unresectable, recurrent or metastatic) Melanoma.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Age of 18 years or older on date of first dose of Ipilimumab
* Patients who received at least 1 dose of Ipilimumab for the treatment of unresectable, recurrent or Metastatic Melanoma in Taiwan
* Patients with advanced Melanoma and HBV or HCV who are initiating Ipilimumab under the discretion of their physician

Exclusion Criteria:

* Patients who received Ipilimumab as part of a clinical trial
* Patients who are receiving Ipilimumab for any indication other than local approval (ie, unresectable or Metastatic Melanoma)
* Patients who are not infected with HBV or HCV
Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure.

According to literature data, Endocan can detect the onset of respiratory failure. The investigators aim to prove its value also for cardiac surgery patients.

Endocan is an endothelium derived soluble dermatan sulfate proteoglycan. Literature data shows that alterate levels of its blood concentration correlate with the onset of pulmonary failure in patients with major trauma and septic shock.

In cardiac surgery respiratory failure and infections are threatening complications leading to mortality rates up to 80%. A rapid diagnosis and treatment of this pathology is crucial to improve the clinical outcome.

Unfortunately specific data for the efficacy of Endocan predictive value in cardiac surgery patients are not available.

The investigators aim to determinate if Endocan can be a helpful tool to identify patients developing acute respiratory failure after cardiac surgery and anticipate specific treatment in order to improve survival.

Eligibility Criteria:
Inclusion Criteria:

* Able to give written consent
* Elective cardiac surgery
* More than 18 years old

Exclusion Criteria:

* Less than 18 years old
* urgency / emergency cardiac surgery
* pregnancy
* refusal
* unable to give written consent
* oncologic patients
* concomitant inflammatory or infective pulmonary disease