cyrilzakka/clinical-trials huggingface dataset:
Analysis of Immediate Urinary Continence Predictors After RS-RARP

This study is a retrospective, single-center clinical trial. It aims to retrospectively analyze the immediate postoperative urinary continence recovery in prostate cancer patients who underwent Retzius-sparing robot-assisted radical prostatectomy in the investigators' center. Based on the general conditions of patients, relevant perioperative clinical indicators, and parameters related to the sphincter and prostate gland measured by MRI, it explores the influencing factors of immediate urinary continence recovery after Retzius-sparing robot-assisted radical prostatectomy in prostate cancer patients and constructs a relevant prediction model, thereby providing clinical guidance value for predicting immediate postoperative urinary continence recovery.


Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer diagnosed by prostate biopsy and underwent Retzius-sparing robot-assisted radical prostatectomy in the investigators' hospital.
* Received plain and contrast-enhanced pelvic or prostate MRI examinations before surgery.
* Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 1.
* Complete clinicopathological data.
* In good general condition, without infections, autoimmune diseases, hematological diseases or other malignant tumors.
* Complete postoperative follow-up data, with a postoperative follow-up time of no less than 6 months.

Exclusion Criteria:

* The patient has surgical contraindications.
* The patient has contraindications for MRI examination.
* Preoperative presence of congenital urinary system malformations, urinary incontinence or severe lower urinary tract symptoms, and with a history of urinary catheter or previous transurethral resection of the prostate (TURP) surgery.
* Having received neoadjuvant treatments that may affect the results of this study, such as radiotherapy or hormonal therapy.
* The patient has other concurrent malignant tumors.
* The patient has delayed extubation (\> 14 days).
* The patient's clinical, imaging and pathological data are incomplete or the patient is lost to follow-up.
Risk Factors for Non-response to Hormonal Medical Therapy in Patients With Endometriosis

Determine the proportion of patients with endometriosis unresponsive to medical therapy and to compare the clinical and ultrasonographic characteristics of this group of patients (study group) with the clinical and ultrasonographic characteristics of patients responsive to medical therapy (control group).


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 50 years;
* patients with endometriosis-related pain symptoms (dyspareunia, dyschezia, dysmenorrhea, chronic pelvic pain, dysuria, periovulatory pain, with at least one of these symptoms presenting Numerical Pain Rating Scale intensity \> 5);
* indication for administration of oral hormonal medical treatment for endometriosis;
* acquisition of informed consent.

Exclusion Criteria:

* patients with contraindications to oral hormone treatment
* current or previous pelvic infections
* history of malignancy or current suspicion of gynecologic malignant lesions
* previous pelvic surgery (hysterectomy, salpingectomy, ovarian cyst removal, myomectomy, surgery for endometriosis, bowel resections)
* positive history of other causes of chronic pelvic pain
* post-menopausal status
OSA and Sudden Sensorineural Hearing Loss

This study studies the prevalence between obstructive sleep apnea syndrome and sensorineural hearing loss. We recruit patients who have been treated for sudden sensorineural hearing loss in Poitiers' University Hospital between 2010 et 2017, and we detect if they have OSA with a ventilatory polygraphy.


Eligibility Criteria:
Inclusion Criteria:

* past medical history of sudden hearing loss between 2010 and 2017
* no contraindication to a non supervised sleeping monitoring

Exclusion Criteria:

* past medical history of fluctuant hearing loss or pre-existant significative hearing loss
Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Patients With Crohn's Disease

The purpose of this study is to investigate the impact of enteral nutrition therapy on sperm quality of patients with crohn's disease.

The highest age- and sex-adjusted incidence rates for Crohn's Disease (CD) occur during the peak reproductive years. In addition, gastroenterologists frequently advise and manage patients with CD who desire to conceive. Enteral nutrition therapy is effective for induction and maintenance of remission in reproductive age men with CD. However, there is no available data on the effects of enteral nutrition therapy on semen quality. The purpose of this study is to investigate the impact of enteral nutrition therapy on sperm quality of patients with CD.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Crohn' Disease
* Male patients
* Age: 18-40 years old
* Receive 3-months exclusive enteral nutrition therapy

Exclusion Criteria:

* Used any experimental therapy in the 8 weeks before study entry date
* Had previously documented problems with male reproductive health, such as low sperm count, impotence, or malignancy
* The use of concomitant medication including sulphasalazine, 5-aminosalicylic acid or other immune-suppressives.
* Unable to complete the 3-months exclusive enteral nutrition therapy.
Use of Rituximab in Opsoclonus-Myoclonus in Children With Neuroblastoma

The purpose of this study is to evaluate the feasibility of giving four weekly doses of Rituximab (anti-CD20 antibody) in the treatment of children with refractory neuroblastoma associated opsoclonus-myoclonus. Patients must have continued symptoms of opsoclonus, myoclonus and or ataxia despite surgical resection and a minimum of one month of steroid therapy. Evaluations include clinical symptoms of opsoclonus-myoclonus and ataxia as well as detailed evaluation of learning and development.

Opsoclonus-myoclonus ataxia syndrome (OMS) is a rare immune mediated paraneoplastic syndrome that occurs in approximately 2 to 3% of children with neuroblastoma. Children with neuroblastoma associated opsoclonus-myoclonus tend to have a favorable prognosis from the standpoint of the cure of their cancer. Unfortunately,approximately two-thirds of this subgroup of patients are left with long term sequellae of the syndrome, including residual symptoms of opsoclonus, myoclonus, ataxia, learning difficulties and disturbance of sleep and mood.

Multiple lines of evidence indicate an immune mechanism to this rare disorder. This includes occurence of OMS in the post-infectious state, aggressive lymphocytic infiltration of the tumor in children with OMS, and documented responses to therapries that act through suppression of the immune system.

The current study utilizes four weekly doses of anti-CD 20 antibody (rituximab) to treat children with refractory OMS. Refractory disease is defined as continued symptoms of OMS despite surgical resection of the tumor and a minimum of one month of steroid therapy.

All patients have baseline OMS evaluation and detailed neurocognitive testing with all studies being repeated at the completion of the four weekly infusions. OMS testing is repeated at Month 3. OMS testing and detailed neurocognitive testing is conducted at 6 months intervals until 2 years from the initial infusion.

The goal of the study is to utilize this novel therapy to improve long term neurologic and neurodevelopmental outcome in children with refratory neuroblastoma associated opsoclonus-myoclonus.

Eligibility Criteria:
Inclusion Criteria:

Pathologic confirmation of diagnosis of neuroblastoma Surgical resection of primary tumor Symptoms of OMS despite a minimum of one month of steroid therapy Must meet all laboratory criteria to demonstrate adequate organ function -

Exclusion Criteria:

Patients currently receiving systemic chemotherapy for treatment of neuroblastoma Patients with documented active infection Patients who are HIV, Hep B or Hep C positive Organ toxicity from any prior therapy or surgical intervention must be resolved prior to study entry

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Comparison of Salivary Interleukin-1β and Matrix Metalloproteinase-8 Levels in Individuals With Chronic Periodontitis

Periodontitis is an infectious inflammatory disease affecting the periodontal tissue (Gingivae, alveolar bone, periodontal ligament and cementum). Chronic Periodontitis is considered to be the most prevalent disease after dental caries which is linked to increased levels of C- reactive protein, interleukins and matrix metallo-proteinases. Interleukin- 1β and Matrix metalloproteinase-8 have been shown to be robust markers of inflammatory cascade of chronic periodontitis.Various treatment modalities including scaling and root planing, toothpastes and chlorhexidine based mouthwashes have been are known to be associated with various side effects like teeth staining, altered taste sensation, mucosal burning. Hence,the use of natural medicaments could provide a better alternative because of their fewer side effects and cost effectiveness.

Periodontal disease is one of the most common diseases in humans and is responsible for most of the tooth loss in adults. World health Organisation report of 2005 described that the global problem persisted with the worldwide oral diseases such as dental caries, periodontal disease, tooth loss, oral mucosal lesions and oro-pharyngeal cancer. According to a local study the prevalence of periodontitis is found to be more in males of older age group and more in rural areas owing to the lack of awareness of importance of oral hygiene.

Apart from various conventional treatment option for periodontitis a number of herbal medicinal intervention have been used for its treatment. Plant extracts and herbs that have been used previously used for periodontal therapy include Salvadora persica, Arnica Montana and Hamamelis virginiana which have been shown to exhibit antibacterial activity against periodonto-pathic bacteria. Phytomedicines (Medicines derived from herbal plants) like indian gum arabic, aloe vera, nim, carvacrol, garlic, wild coffee and propolis resin have been used in dentistry as anti-inflammatory, antibiotics, analgesic and hypnotic agents. Propolis resin, guava and triphala have been also been used for the treatment of periodontitis

Eligibility Criteria:
Inclusion Criteria:

* Male and female healthy individual
* Individuals diagnosed with chronic periodontitis according to the WHO criteria.
* Age 19 to 40 years.

Exclusion Criteria:

* Patients with gingivitis only.
* Patients using tobacco products and alcohol.
* Underlying systemic pathology such as diabetes mellitus, cardiovascular disease, arthritis etc.
* Oral mucosal pre-neoplastic lesions (leukoplakia, erthroplakia, lichen planus) and oral carcinomas.
* Obese patients.
* Pregnant females.
* Xerostomia.
* Previous history of radiotherapy or chemotherapy.
* Positive history of oral prophylactic procedures (mouthwashes and antibiotics).
* Positive history of any periodontal treatment during last 6 months.
* Positive antibiotic therapy history within last month of study.
A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

The purpose of this study is to evaluate the safety and IOP-lowering efficacy of Travoprost (0.004%) compared to Latanoprost (0.005%) in patients with chronic open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Adult patients of any race and either sex with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or ocular hypertension.
A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer

The study is being conducted to evaluate the safety and tolerability of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets in patients with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and select the Recommended Phase 2 Dose (RP2D).


Eligibility Criteria:
Inclusion Criteria:

1. Histologically diagnosis of local advanced or metastatic breast cancer
2. Women must be postmenopausal, or pre-/peri-menopausal women must be on ovarian suppression
3. At least 1 line of endocrine therapy in the metastatic or advanced setting
4. ECOG performance status score: 0-1;
5. Adequate organ functions as defined
6. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.

Exclusion Criteria:

1. the investigators judged that it was not suitable to endocrine therapy
2. patients with active brain metastasis (without medical control or with clinical symptoms),
3. History of clinically significant cardiovascular or cerebrovascular diseases
4. The subject has one of many factors affecting oral 、absorption, distribution, metabolism and excretion of drugs
5. Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation
6. Have received other similar drugs in the past;
7. Known history of allergy to HRS-1358 ingredients
IPI-926 Extension Protocol for Continuation of Treatment With IPI-926

A treatment protocol that enables patients to have continued access to IPI-926.

The extension protocol is a continuation of treatment with IPI-926, as administered to each individual patient during participation in their original IPI-926 protocol.

Patients who are completing their participation in the original IPI-926 protocol in which they enrolled, as defined in the original protocol, and, have stable disease or confirmed complete or partial response as defined by the original protocol may continue to receive treatment with IPI-926 in the extension protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily sign the informed consent form
2. Currently receiving IPI-926 while participating in an Infinity-sponsored IPI-926 study. Note: For blinded studies, patient's treatment assignment must be unblinded according to the instructions in the original protocol to confirm they are receiving IPI-926.
3. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
4. Documented response or stable disease, as defined in the original protocol, at the time of entry to the extension study.
5. Willingness and ability to continue IPI-926 dispensation and follow-up procedures at the current investigational site.
6. Willingness and ability to comply with scheduled visits, treatment plans, and laboratory tests and other study procedures.
7. Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum or urine pregnancy test prior to treatment. All WCBP, all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study.

Exclusion Criteria:

1. Discontinued IPI-926 or withdrew informed consent to participate in original Infinity-sponsored IPI-926 study.
2. Require addition of or change to a new concomitant therapy to adequately treat the malignancy under study.
Blopress Tablets Specified Drug-use Survey "Hypertension: Survey on Patients With Metabolic Syndrome"

The purpose of this survey is designed to investigate the treatment status of hypertensive patient with metabolic syndrome-related risk factors treated with candesartan cilexetil tablets (Blopress Tablets), as well as to assess relationships between risk factors (example, visceral fat accumulation) and the incidence of cerebrovascular/cardiovascular events in an exploratory manner.

This survey was designed to investigate the treatment status of hypertensive patients with metabolic syndrome-related risk factors treated with candesartan cilexetil tablets (Blopress Tablets), as well as to assess relationships between risk factors (example, visceral fat accumulation) and the incidence of cerebrovascular/cardiovascular events in an exploratory manner.

For adults, 4-8 mg of candesartan cilexetil is typically administered orally once daily. The dose is increased up to 12 mg, as necessary. For patients with complications of renal damage, however, administration of candesartan cilexetil should be started at 2 mg once daily, and, as necessary, the dose increased up to 8 mg.

Eligibility Criteria:
Inclusion Criteria: Hypertensive patients with at least one of the following risk factors:

* Waist circumference greater than or equal to (≥) 85 centimeter (cm) for male and ≥ 90 cm for female
* Fasting triglyceride level ≥ 150 milligram per deciliter (mg/dL)
* High-density lipoprotein (HDL) cholesterol level less than (\<) 40 mg/dL
* Fasting blood glucose level ≥ 110 mg/dL
* Body-mass index (BMI) ≥ 25.0 \* Patients currently taking medications for hypertriglyceridemia, hypo-HDL-cholesterolemia, or diabetes mellitus are also regarded as meeting the criteria for inclusion in the surveillance

Exclusion Criteria: Hypertensive patients who meet all of the following conditions (\[1\] to \[3\]):

1. Patients receiving continuous therapy with Blopress Tablets
2. Patients aged \< 20 years or ≥ 75 years
3. Patients with a history of cerebrovascular or coronary artery disease within 6 months before the start of the surveillance
Measuring Quality of Decisions About Treatment of Depression

The purpose of this randomized controlled trial is to examine the impact of a patient decision aid on the quality of decisions about managing symptoms of depression. In particular, we will examine whether the decision aid increases knowledge about depression/managing depression symptoms and concordance between goals and treatment choices.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18+
* In the last 12 months, talked to a health care provider about starting or stopping a treatment (prescription medicine for depression or counseling)

Exclusion Criteria:

* none
Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Metastatic Colorectal Cancer.

To compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and are seeking first chemotherapy treatment


Eligibility Criteria:
Inclusion criteria:

* Patients with metastatic colorectal cancer coming for initial chemotherapy
* Documented metastatic colorectal cancer
* WHO Performance Status of 0, 1, or 2
* Measurable tumors
* Adequate hematologic status, liver and kidney function
* Life expectancy greater than 12 weeks
* Written informed consent obtained

Exclusion criteria:

* History or presence of central nervous system disease
* Patients with a history of another primary cancer within 5 years
* Prior chemotherapy for metastatic colorectal cancer
* Prior full field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks before entry to study
* Major surgery within 4 weeks or minor surgery within 2 weeks before entry to study
* Investigational drugs within 4 weeks before entry to study
* Prior therapy with anti-VEGF agents
* Any prior therapy with oxaliplatin or allergy to platinum-containing drugs
* Peripheral neuropathy with functional impairment
* Female patients who are pregnant or breast feeding
* Any severe or uncontrolled medical conditions which could prevent participation in study
* Patients who are taking Coumadin

Other protocol-defined inclusion / exclusion criteria may apply
Tractography Pilot Study Leipzig

In this pilot study participants will undergo routine magnetic resonance imaging and routine neurosurgical care. By prospectively collecting data from both MRI and patient records we want to investigate biomarkers derived from tractography and diffusion tensor imaging to predict rehabilitation potential.

Patients will undergo MRI before and after surgery with DTI. With CSD-tractography, fiber bundles and their volumes will be identified. By measuring fractional anisotropy (FA) within these volumes, a correlation with clinical outcome and recovery will be tested. Also, FA frequency distributions will be used to describe white matter integrity and to thereby improve future tractography algorithms. Fiber bundles of interest will be the arcuate fascicle (AF), the corticospinal tract (CST), frontal aslant tract (FAT), the inferior fronto-occipital fascicle (IFOF), the inferior longitudinal fascicle (ILF) and the uncinate fascicle (UF).

Eligibility Criteria:
Inclusion Criteria:

* intracranial lesion
* elective neurosurgical procedure

Exclusion Criteria:

* MRI not applicable
* cerebral ischemia during study period
* pregnancy during study period
* encephalitis during study period
* spontaneous intracerebral hemorrhage during study period
Photopill Treatment in Healthy Volunteers

Photo-bio-stimulation by Low Level Light therapy(LLLT) has demonstrated its clinical use in chemotherapy/radiotherapy oral mucositis.

Unpublished study (Melzer, Ben-Yehuda et al. UEGW 2012) with the Photopill (LLLT) capsule treatment in mice showed a significant beneficial effect on the endoscopic severity of DSS-induced colitis in mice.

Therefore a phase 1 trial is designed to assess the safety and feasibility of the Photopill treatment in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are generally healthy.
* Signed informed consent.

Exclusion Criteria:

* Subjects with any known GI related symptoms complaints or GI diseases.
* Subjects with cancer or other life threatening diseases or conditions.
* Subjects with cardiovascular or pulmonary diseases.
* Pregnant women.
* Subjects who underwent any colon surgery.
* Morbid Obesity (BMI \> 40).
* Drug abuse or alcoholism.
* Bed-ridden patient.
* Any rectal therapy.
* Participation in current clinical study or clinical study within 30 days prior to the study.
Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy

The primary objective of this study was to evaluate the effect of eleclazine (GS-6615) on exercise capacity as measured by Peak oxygen uptake (VO2) achieved during cardiopulmonary exercise testing (CPET), in participants with symptomatic hypertrophic cardiomyopathy (HCM).


Eligibility Criteria:
Key Inclusion Criteria:

* Established diagnosis of hypertrophic cardiomyopathy defined by standard criteria as a maximal left ventricular wall thickness ≥ 15 mm at initial diagnosis
* Exertional symptoms including at least one of the following:

  * New York Heart Association (NYHA) Class ≥ II dyspnea
  * Canadian Cardiovascular Society (CCS) Class ≥ II angina
* Screening (baseline) peak VO2 \< 80% of predicted for age, sex, and weight
* Ability to perform an upright treadmill cardiopulmonary exercise test (CPET)

Key Exclusion Criteria:

* Known aortic valve stenosis (moderate or severe)
* Known coronary artery disease
* Left ventricular systolic dysfunction (ejection fraction \< 50%)
* Recent septal reduction procedure (ie, surgical myectomy or alcohol septal ablation) within six months prior to screening or such a procedure scheduled to occur during the study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.