cyrilzakka/clinical-trials huggingface dataset:
A Study on the Safety and Effectiveness of Subcutaneous Silicone Penile Implant Surgery

This study will identify a patient population who wishes to address a variety of concerns about the size, shape, or appearance of their penis with the placement of a subcutaneous Silicone Block Penile Implant. Because the Silicone Block is placed subcutaneously, the device can provide immediate and permanent improvements to the appearance of a man's penis. The most notable improvements are enhanced penile cosmesis, improved penile girth, and improved exposure of the penile shaft outside the plane of the body.

The plan is to conduct a study to examine the outcomes of this procedure with respect to:

* Incidences of adverse events
* Changes in flaccid penile length (through physical measurements pre and post-operatively in a consistent manner)
* Changes in flaccid penile girth (through physical measurements pre and post-operatively in a consistent manner)
* Changes in satisfaction scores with respect to penile size and patient self-confidence/self-esteem (through validated questionnaires)


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria include men who are over 18 and under 65, circumcised, who have the perception of inadequate penile girth or appearance of length of penis, or penile deviation from straight plane in flaccid condition for whatever reason. Etiologies may include:
* A retractile penis or "buried penis" from infrapubic pannus
* A loss of length following radical prostatectomy or other trauma
* Congenital or acquired (e.g., Peyronie's Disease) mild curvature of the penis with indentation deformity and with curvature less than 30 degrees with no plan to have other corrective procedures (e.g. surgery, intralesional injection of collagenase clostridium histolyticum)
* Patient perception of a penis of inadequate size and patient desire for cosmetic enhancement

Exclusion Criteria:

* Men who are unable to give informed consent
* An uncircumcised penis
* Micro-penis (stretched flaccid penile length \<6cm)
* Prior penile girth enhancement procedure of any sort, including grafts or subcutaneous injections, previous Xiaflex injection
* History of immunosuppression and/or HIV
* Men who are on anti-coagulation medication which cannot be stopped
* Uncontrolled diabetes
* Active genitourinary skin infection
* History of recurrent or active urinary tract infection (UTI)
* Patients unwilling to comply with post-operative instructions
* Patients who smoke and are unwilling to stop 2 weeks before surgery and for at least 6 weeks after surgery.
Dose-effect of SSR180575 in Diabetic Neuropathy

The primary objective of this sudy is to assess the effect of two doses of SSR180575 on the rate of regeneration of epidermal nerve fibers following denervation of the epidermal layer with capsaicin in patients with diabetes mellitus and mild peripheral neuropathy. Secondary objectives are to explore the efficacy of SSR180575 on clinical assessment, nerve function measures and to assess the tolerability and safety of SSR180575. The treatment period is 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Diabetes Mellitus, type I or II, treated or untreated
* Diabetic neuropathy treated or untreated

Exclusion Criteria:

* Patients with unstable glycemic control
* Patients who have been hospitalized for a diabetes complication in the 3 months prior to randomization
* Patients with peripheral neuropathy attributable to any cause other than diabetes
* Non-measurable sural nerve sensory response on nerve conduction studies
* Amputation of any part of lower extremity
* Patients with a history of myocardial infarction or known coronary artery disease
* Grade III or IV heart failure on New York Heart Association criteria

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Phase 1 Biomarker Study of Anti-PDL-1 in Advanced Melanoma

The purpose of this study is to evaluate pharmacodynamic changes of BMS-936559 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with unresectable Stage III or IV Melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) status = 0 to 1
* Subjects with unresectable Stage III or IV Melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic Melanoma
* Subject must have histologic or cytologic confirmation of advanced Melanoma
* Subjects must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
* Subjects must have at least 1 tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and post-treatment biopsies

Exclusion Criteria:

* Active or progressing brain metastases
* Other concomitant malignancies (with some exceptions per protocol)
* Active or history of autoimmune disease
* Positive test for human immunodeficiency virus (HIV) 1\&2 or known acquired immunodeficiency syndrome (AIDS)
* History of any hepatitis
* Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti Programmed cell death 1 (PD-1), anti Programmed cell death ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40 or anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibodies
A Novel Approach to Infantile Spasms

This study proposes to assess the efficacy of Cosyntropin Injectable Suspension, 1 mg/mL compared to vigabatrin. Additionally, this study proposes to determine efficacy of combination therapy of Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin to monotherapy Cosyntropin Injectable Suspension, 1mg/mL in children with new onset infantile spasms (IS).

This is a prospective randomized trial comparing 3 treatment arms:

1. Cosyntropin Injectable Suspension, 1 mg/mL
2. Vigabatrin
3. Combination of both these therapies, Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin for treatment of new onset infantile spasms. Outcome measures include resolution of clinical spasms, improvement of hypsarrhythmia as well as longer term outcomes of development and subsequent seizures.

The data is expected to demonstrate greater efficacy with Cosyntropin Injectable Suspension, 1 mg/mL than vigabatrin for the treatment of IS.

Eligibility Criteria:
Inclusion Criteria:

* New onset infantile spasms
* Age \> 2 months
* Age\< 2 years
* Hypsarrhythmia on video-EEG
* Normal renal function

Exclusion Criteria:

* Prior treatment given for infantile spasms
* Diagnosis of Ohtahara syndrome or Early Myoclonic Epilepsy
* Absence of hypsarrhythmia
* Inability for the parent or caregiver to provide consent
* Inability for the parent or caregiver to complete seizure diary
* Diagnosis of:

  * scleroderma,
  * osteoporosis,
  * recent systemic fungal infections,
  * ocular herpes simplex,
  * recent surgery,
  * history of or the presence of a peptic ulcer,
  * congestive heart failure,
  * uncontrolled hypertension
Evaluating the Efficacy of the Mediterranean Diet to the Low- Fermentable, Oligosaccharides, Disaccharides, Monosaccharides, and Polyols (FODMAP) Diet in Treating Irritable Bowel Syndrome(IBS)

This study is being completed to determine if the Mediterranean (MD) and low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) diets are comparable in the effectiveness to treat Irritable Bowel Syndrome (IBS).

The study team hypothesizes that:

* The low FODMAP and Mediterranean groups will achieve a similar improvement in abdominal pain
* Both groups will achieve similar improvements in bloating, overall IBS symptom severity, and adequate relief


Eligibility Criteria:
Inclusion Criteria:

* Patients with IBS-D (diarrhea-predominant IBS) or IBS-M (IBS with mixed subtype) diagnosed per Rome IV questionnaire and without any unexplained alarm features (rectal bleeding, weight loss, nocturnal symptoms, personal history of celiac disease, microscopic colitis, inflammatory bowel disease)
* Aged 18-70 years at the time of screening
* Weekly average of worst daily (in the past 24 hours) abdominal pain score of ≥3.0 on a 0-to-10-point scale
* At least 80 percent compliance in daily questionnaire entries during the 7-day screening period

Exclusion Criteria:

* Subjects adhering to any dietary IBS treatment such as the low-fodmap diet, or gluten-free diet, Mediterranean currently or within the past 6 months
* Subjects with a known food allergy to eggs, seafood, peanuts, tree nuts or milk (subjects with lactose intolerance that are experiencing IBS symptoms while on a lactose-free diet will not be excluded from the study).
* Subjects with a history of poorly controlled insulin-dependent or non-insulin-dependent diabetes
* Subjects with a known history of organic Gastrointestinal (GI) disease (i.e., celiac disease, inflammatory bowel disease or microscopic colitis)
* Subjects with a history of an eating disorder requiring medical or behavioral treatment within the past 10 years.
* Subjects with prior small bowel or colonic surgery (excluding appendectomy or cholecystectomy if over 6 months since these 2 procedures)
* Oral antibiotic use in the past 3 months
* Any planned significant changes in dietary or exercise regimen within 30 days prior to Screening or during the study.
* Currently pregnant or breastfeeding.
BIOLUX P-III BENELUX All-Comers Registry

The purpose of the BIOLUX P-III BENELUX Registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Ballon when used in daily clinical practice for the treatment of isolated atherosclerotic lesion (vessel narrowing) in popliteal arteries


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years or minimum age as required by local regulations
* Subject must be willing to sign a Patient Data Release Form (PDRF) or Patient Informed Consent (PIC) where applicable
* Lesion(s) in the popliteal arteries suitable for endovascular treatment, treated with or scheduled to be treated with the Passeo-18 Lux drug coated balloon.
* Isolated popliteal artery lesion: at least 2 cm of healthy segment between lesion(s) in the popliteal artery and lesion(s) in distal superficial femoral artery
* Inflow free from flow-limiting lesion. Patients with flow-limiting inflow lesions (\> 50% stenosis) can be included if lesion(s) have been treated successfully before or during the index procedure, with a maximum residual stenosis of 30% per visual assessment
* At least one native artery with direct outflow artery to the foot
* Rutherford classification 2-5
* Patient with bypass surgery in the same limb can be enrolled if there is at least 2 cm healthy segment between popliteal artery and anastomosis

Exclusion Criteria:

* Life expectancy ≤ 1 year
* Rutherford classification 6
* Lesion involving the superficial femoral artery (arterial intersection with the femur in an anteroposterior view) or extending in infra-popliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk)
* Aneurysm at the level of the popliteal artery
* Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations)
* Intraprocedural decision not to proceed with the Passeo18 Lux DCB for any reason not related to the device (for instance blood flow limiting dissection after predilatation)
* Subject is currently participating in another investigational drug or device study that has not reached its primary endpoint yet
* Subject is pregnant or planning to become pregnant during the course of the study
Collecting Tissue Samples for Future Research From Women Undergoing Surgery for Breast Cancer

RATIONALE: Collecting and storing samples of tumor tissue from patients with breast cancer to study in the laboratory may help doctors learn more about cancer.

PURPOSE: This phase I study is collecting tissue samples for future research from women undergoing surgery for breast cancer.

OBJECTIVES:

Primary

* Collect breast tissue for future research from women undergoing surgery for breast cancer.

Secondary

* Create microarrays by tumor type for internal use by Specialized Program of Research Excellence.

OUTLINE: Tumor tissue is collected and analyzed to create microarrays by tumor type for future research studies.

PROJECTED ACCRUAL: A total of 1,250 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Undergoing surgery for breast cancer
Outcomes of Swallowing Rehabilitation After Stroke

This project proposes to evaluate the relative effectiveness of four therapy protocols for pharyngeal phase swallowing impairment in the stroke population. Data derived from this study should contribute significantly to our understanding of the rehabilitative process in the neurogenic dysphagic population and will provide the foundation for the establishment of efficacious, cost-efficient patient services.

1. Research Question to be addressed

1. The utilization of SEMG biofeedback monitoring in dysphagia rehabilitation facilitates more rapid and complete recovery than traditional rehabilitation using the same swallowing exercises without exteroceptive feedback.
2. Swallowing rehabilitation provided in an intensive rehabilitative programme (10 hrs of treatment in the 1st week) facilitates more rapid and complete recovery than traditionally scheduled swallowing rehabilitation (twice weekly).

This multi-site, multi-national project will evaluate the relative effectiveness of four therapy protocols for pharyngeal phase swallowing impairment in the stroke population. For this study, patients with chronic dysphagia secondary to stroke will be assigned to one of four treatment protocols. These four protocols differ in respect to the intensity of treatment and the inclusion of surface electromyography (SEMG) biofeedback as an adjunct to treatment. All patients will complete a total of 30 hours of therapy with data collection to assess progress at intervals of every 10 sessions. Treatment outcomes will be measured using a combination of physiologic and behavioral measures. Data derived from this study should contribute significantly to our understanding of the rehabilitative process in the neurogenic dysphagic population and will provide the foundation for the establishment of efficacious, cost-efficient patient services.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will represent the diagnostic categories of single event brain stem injury, right cortical stroke and left cortical stroke.
* Chronic dysphagia at least 6 months post onset secondary to single neurological event, brain stem, right cortical or left cortical stroke confirmed with CT or MRI
* Diagnosis of chronic pharyngeal phase dysphagia based on clinical and videofluoroscopic evaluation completed within 3 weeks of beginning treatment.
* Must be at least 12 months post onset with no substantial recovery of swallowing function. If patients have received prior swallowing treatment, they must be at least three months post the termination of direct treatment.
* Mini Mental Status Exam score \>21

Exclusion Criteria:

* history of pre-existing dysphagia or neurologic disease prior to the onset of the current disorder.
* MMSE score \< 21
Estrogen and Propofol Injection Pain

This prospective observational study investigates the relationship between serum estrogen concentration and the incidence and severity of propofol injection pain (PIP) in female patients undergoing general anesthesia. The study will include 90 ASA I-II female patients aged 18-45. One group will consist of IVF patients with elevated estrogen levels, while the control group will include patients with normal estrogen levels undergoing other elective procedures. Pain will be assessed using a standardized four-point behavioral pain scale. The findings may enhance understanding of hormonal influences on pain and contribute to improving patient comfort during anesthesia induction.

This prospective observational study aims to evaluate the association between serum estrogen levels and the incidence and severity of propofol injection pain (PIP) in adult female patients undergoing general anesthesia. Although propofol is a widely used intravenous anesthetic, it frequently causes pain upon injection. Estrogen is believed to play a role in modulating pain perception and inflammatory responses, yet the effects of elevated estrogen levels on PIP are not well understood.

The study will be conducted at a single tertiary hospital and will include 90 ASA I-II female patients aged 18-45 years. One group will consist of IVF patients with elevated serum estradiol levels due to controlled ovarian stimulation. The control group will include patients with normal estradiol levels scheduled for elective procedures under general anesthesia. Preoperative serum estradiol levels will be recorded, and injection pain will be evaluated using a validated four-point behavioral pain scale based on vocal response, facial expression, limb movement, and tearfulness.

Anesthesia induction will follow standard clinical practice without additional interventions. Pain data will be collected through routine clinical observation. The results may offer new insights into hormonal modulation of acute nociceptive responses and help improve patient experiences during anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged between 18 and 45 years
* American Society of Anesthesiologists (ASA) physical status I or II
* Scheduled for surgery under general anesthesia
* Availability of a preoperative serum estradiol (E2) level
* For Group 1: Undergoing IVF procedure with supraphysiological E2 levels (\>350 pg/mL)
* For Group 2: Undergoing elective surgery with normal E2 levels (15-350 pg/mL)

Exclusion Criteria:

* ASA physical status III or IV
* Pregnant patients
* Perimenopausal women
* Male patients
* Patients younger than 18 or older than 45 years
* History of psychiatric disorders
* Patients undergoing emergency surgery
Clinical High and Genomic Low Hormone Receptor-positive Early Breast Cancer Patients With or Without Adjuvant Chemotherapy

A prospective, randomized, comparative study to evaluate efficacy of anticancer chemotherapy in predicting prognosis and determining chemotherapy method in early Hormone Receptor-positive breast cancer patients with clinicopathological high risk and GenesWell™ BCT low risk at multi-center in Korea


Eligibility Criteria:
Inclusion Criteria:

1. Adult women aged 19-80 at screening
2. Histologically invasive carcinoma
3. Hormone receptor positive (Estrogen, ER+ and/or Progesterone, PR+)
4. Human epidermal growth factor receptor 2 negative (HER2-)
5. Axillary lymph node assessment: pN0 or pN1
6. Tumor size≥0.5cm
7. Clinical high risk (based on modified Adjuvant! Online)
8. Patients who agree to genetic testing
9. Patients who have adequate organ function
10. Genomic low risk (based on GenesWell BCT)
11. De novo primary cancer
12. Patients how performed surgery with curative aim
13. Patients who have provided written informed consent themselves

Exclusion Criteria:

1. Hormone receptor negative (Estrogen, ER- and Progesterone, PR-)
2. Human epidermal growth factor receptor 2 positive (HER2+)
3. Axillary lymph node assessment: pN2 or pN3
4. Patients who are received chemotherapy prior to operation
5. Patients who are received radiotherapy prior to operation
6. Tumor size\<0.5cm
7. Clinical low risk
8. FFPE tumor sample is not available
9. Patients with following conditions:

   * Patient with chronic liver disease
   * Patient with cerebrovascular disease
   * Patient with chronic mental disorder
   * Pregnant women, women of childbearing potential or lactating women
10. Patients who are deemed inappropriate as study participants by investigators
11. Patients with recurrent breast cancer or treatment history of breast cancer
12. Patients who have not undergone surgery
Effect of Endometrial Thickness on IVF Outcome

Although many studies have evaluated the relationship between endometrial thickness and IVF outcome, the results are still controversial. We notice that, during our daily work, for patients undergoing cleavage stage embryo transfer, endometrial thickness seems to have a huge impact on IVF outcome; however, for blastocyst stage embryo transfers, IVF outcome seems to have little association with endometrial thickness. Thus, the aim of this prospective observational study is to explore the relationship between endometrial thickness and IVF outcome in patients undergoing cleavage stage and blastocyst stage embryo transfers, respectively.


Eligibility Criteria:
Inclusion Criteria:

* age between 22-38 years old;
* the first cycle of IVF treatment with standard long protocol;
* transfrred with at least two high quality cleavage stage embryos, or with at least one high quality blastocyst stage embryo.

Exclusion Criteria:

* PGD cycles;
* gamete donation cycles
Effect of Olivomed (Olive Extract) on Endothelial, Cardiac and Vascular Function

Olive extracts are considered to have antioxidant properties. The investigators will study the effect of olive extracts containing hydroxytyrosol (HT)-olivomed and combination of Oleuropein (OL), Hydroxytyrosol (HT), Oleocanthal (OC) - olivomedSmart on endothelial, cardiac and vascular function in patients with coronary artery disease .

30 patients with stable angiographically documented coronary artery disease will be randomized to receive olive extracts with high concentration of hydroxytyrosol (5 mg po twice per day included in Olivomed capsules) or placebo for one month and then they will be switched off to the alternate treatment (placebo or Olivomed capsules) for another one month.

30 patients with stable angiographically documented coronary artery disease will be randomized to receive OlivomedSmart - olive extracts with Oleuropein (OL), Hydroxytyrosol (HT), Oleocanthal (OC) (OL:HT:OC 2:1:3) or placebo for one month and then they will be switched off to the alternate treatment (placebo or Olivomed capsules) for another one month.

the same quantity of hydroxytyrosol was contained in two supplements.

Eligibility Criteria:
Inclusion Criteria:

1. Age \<70 years
2. Stable coronary heart disease
3. Patients with acute coronary syndrome who have undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), 2 months must have passed since the incident
4. High LDL levels, low HDL, high triglycerides

Exclusion Criteria:

1. Age\> 70 years
2. Patient with diabetes
3. Patient with hypertension
4. Patient with liver disease
5. Patient with thyroid disease
6. Patient with active malignancy
7. Patient with a disease that affects inflammatory markers (rheumatic diseases, etc.)
8. Patient with chronic renal failure (creatinine\> 2 mg / dl)
9. Patient treated chronically with corticosteroids
10. Patient who has joined a weight loss program or any dietary intervention or intensive exercise programme within the previous 2 months or consumes multivitamin preparations with antioxidant properties.