cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease

The purpose of this study is to learn about the safety and side effects of intralesional collagenase clostridium histolyticum (CCH) injected into the Peyronies Disease (PD) plaque after receiving prior treatment with intralesional Platelet Rich Plasma (PRP) injections.


Eligibility Criteria:
Inclusion Criteria:

1. Be able to provide written informed consent
2. Have a diagnosis of PD with evidence of stable disease as determined by the investigator
3. Patient must have palpable penile plaque
4. Penile curvature deformity of \>30° to \<90°
5. Agree to comply with all study related tests/procedures.
6. Prior intralesional platelet rich plasma treatment within the past 18 months and desire secondary treatment of penile curvature

Exclusion Criteria:

1. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting, penile prosthesis.
2. Previous intralesional injection therapy with CCH for PD within six months. Patients with failed therapy greater than six months ago may be included.
3. Previous history of priapism or penile fracture
4. PD characterized by a ventral plaque
5. Severe erectile dysfunction as characterized with an IIEF score ≤ 12
6. Hour-glass deformity
7. Unwilling to participate
8. Medically unfit for sexual intercourse as deemed by the principal investigator
9. Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy.
10. Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation

The primary objective of this study is to collect data to confirm the performance and safety of the True™ Flow Valvuloplasty Perfusion Catheter during dilatation of the aortic valve in the preparation for Transcatheter Aortic Valve Implantation (TAVI).

The BARD® True™ Flow Valvuloplasty Perfusion Catheter Study is a prospective, single-center, non-randomized, single-arm observational study intended to collect data to confirm the performance and safety of the BARD® True™ Flow Valvuloplasty Perfusion Catheter (True™ Flow catheter) when used for dilatation of the aortic valve in preparation for Transcatheter Aortic Valve Implantation (TAVI). This study will be conducted in conformance with the Declaration of Helsinki, applicable national privacy laws, and European, national regulations and International Organization for Standardization (ISO) requirements (ISO 14155:2011 (E)).

Eligibility Criteria:
Inclusion Criteria:

* The subject voluntarily provides written informed consent prior to the collection of study-specific data or performance of study-specific procedures using an Informed Consent Form (ICF) that is reviewed and approved by the Ethics Committee (EC) for the site.
* The subject is a male or non-pregnant female ≥ 18 years old.
* The subject is undergoing TAVI for treatment of aortic stenosis.
* The subject has an annulus diameter that can be treated with the available size device, in accordance with the Instructions For Use (IFU).

Exclusion Criteria:

* The patient is unable or unwilling to provide written informed consent.
* The patient has a known allergy or sensitivity to contrast media that cannot be adequately pre-medicated.
* The patient has had previous aortic valve replacement.
* The patient has a known congenital aortic valve abnormality (e.g., bicuspid aortic valve).
* The patient has echocardiographic evidence of intracardiac mass, or thrombus.
* The patient has vascular conditions that make insertion and endovascular access to the aortic valve impossible.
* The patient has another medical condition, which, in the opinion of the Investigator, may cause him/her to confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures.
* The subject is currently participating in an investigational drug, biologic, or another device study that has not completed the study treatment or that clinically interferes with the objectives of the study.
Efficacy, Safety and Tolerability of XBD173 in Patients With Generalized Anxiety Disorder

This study will test the efficacy, safety and tolerability of XBD173 in the treatment of generalized anxiety disorder in patients.


Eligibility Criteria:
Inclusion Criteria:

* Current doctor's diagnosis of generalized anxiety disorder
* In need of psychiatric treatment
* Willingness to complete all aspects of the study

Exclusion Criteria:

* Current doctor's diagnosis of major depression
* History of schizophrenia or schizoaffective disorders
* Drug dependence within 2 months prior to study start

For detailed information on eligibility, please contact the study center nearest to you (see below), or call 1-862-778-8300, or visit the following website:

www.novartisclinicaltrials.com
Effects of Peri Partum Integrated Nursing Care Versus Routine Care in Placenta Previa : A Randomized Controlled Trail

At our institution, the annual number of placenta previa was 494 cases (1.7%); of whom 95 cases (19.2%) were proved to have a placenta accreta. Perioperatively, they are subjected to regular care of a tertiary university hospital. This study aims to determine the effectiveness of peri partum integrated nursing care for the patients with placenta previa versus routine care.

Study design:

Experimental design: (randomized control trail)

Setting:

This study will be conducted at Woman's Health Hospital, Assiut University, emergency department and inpatient department.

Sample:

A convenience sample will be used, the total sample will include (100) patients with placenta previa, divided into two group1:1

* group 1: 50 patients study group
* group2: 50 patients control group

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with diagnosis of placenta previa.

Exclusion Criteria:

* Other high risk pregnancy cases
A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole

The purpose of this study is to determine the effect of an adrenocorticoid antagonist (ketoconazole), 600 mg per day for 4 weeks, in the treatment of patients with central serous chorioretinopathy (CSC).

A complete ophthalmic evaluation and tests: autofluorescence and Fluorescein angiography, Color Fundus Photography, OCT, including liver and adrenal functions and pregnancy test, if applicable will be done on the screening visit. If the patient is eligible, the patient will be started on ketoconazole 600 mg per day by mouth for the following next 6 weeks. The patient will be rechecked at weeks 5-6, 10,14 and 18. During all these visits a complete ophthalmic examination autofluorescence, OCT, and color fundus photographs will be done.

Repeat Liver and Adrenal function tests will be done at weeks 5-6 and 10 visits.

On the exit visit, all the ophthalmic tests and procedures on the baseline visit will be done. Adverse events, and concomitant medications and treatments will be reported on all visits.

Eligibility Criteria:
Inclusion Criteria:

1. Age less than 60 years
2. Must have clinical signs of CSC with leakage from the level of the RPE during fluorescein angiography and neurosensory detachment documented by optical coherence tomography (OCT).
3. Be able to return for all study visits for 3 months' duration.
4. Be able to provide written informed consent
5. Must have sufficiently clear media to allow for adequate fundus photography

Exclusion Criteria:

1. Have choroidal neovascularization.
2. Have any evidence of clinically significant intraocular inflammation, angioid streaks, presumed ocular histoplasmosis syndrome, or other precursor of choroidal neovascularization.
3. Have additional eye disease that compromises the visual acuity of the study eye.
4. Are receiving any systemic steroid therapy
5. Have any significant medical history
6. Have a history of severe hypersensitivity reaction to any of the dyes or the drug used in the study.
7. Have any history of ocular conditions that may mimic CSC
8. Are pregnant
Impact of Adherence Education and Monitoring on Community Pharmacy Star Ratings and Patient Satisfaction

Does monthly adherence monitoring and education by a pharmacy resident impact Kroger star ratings, compared to the current standard?

To evaluate if a monthly adherence monitoring and education service impacts the percent of patients adherent to oral diabetes and renin-angiotensin system antagonists (RASA) medications based on star ratings. It will also evaluate patient satisfaction of the adherence monitoring and education service, using a standard questionnaire.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Patients pre-identified by Kroger analytics in ClinicalQ - Patients with PDC \< 80%
3. Patient taking oral diabetes medications and/or RASA medications (ACE-I, ARB, direct renin inhibitor)

Exclusion Criteria:

1. Patients who are enrolled in MedSync or Autorefill program
2. Patients who are lost to follow-up
3. Incomplete/missing documentation of an encounter
4. Prisoners, children
Fetal Growth Restriction & Maternal Cardiovascular Risk

To determine whether or not women with a history of having a baby with intrauterine growth retardation (IUGR) was more likely to have risk factors for cardiovascular disease versus women with a pregnancy not complicated by IUGR.

BACKGROUND:

Intrauterine growth restriction leads to major neonatal morbidity and mortality. Moreover, recent birth registry studies have suggested that women bearing IUGR babies may have an elevated risk of cardiovascular disease.

DESIGN NARRATIVE:

This cohort study tested whether exposed women, with a previous intrauterine growth restriction (IUGR) baby, versus unexposed women, with a pregnancy not complicated by IUGR, had elevations in markers of cardiovascular risk. Exposure was defined among a geographically defined cohort as having had a singleton baby in the \< 5 %tile of weight for gestational age, in the absence of pre-pregnancy diabetes., hypertension, renal disease, or hypertension in pregnancy; controls had a singleton in the \> 20%tile. Four to twelve years postpartum, women were assessed for multiple markers of cardiovascular risk, including blood pressure, lipids, adiposity, glucose and insulin, homocysteine and folate, markers of inflammation, markers of endothelial function, markers of angiogenesis, and markers of vascular function. Data analysis consisted of ANOVA and ANCOVA analyses comparing the outcomes of cardiovascular markers among exposed and unexposed women.

Eligibility Criteria:
Inclusion criteria:

* women 4 to 12 years after delivery of singleton infant
* women who gave birth between 1997 and 2002 at Magee-Womens Hospital in Pittsburgh, Pennsylvania

Exclusion criteria:

* women who had preeclampsia
* women who had prepregnancy hypertension
* women who had diabetes
* women who were currently pregnant or reported a prepregnancy chronic condition
Dose-Guided Radiotherapy in Oesophageal Cancer: Managing the Real Dose

This study will prospectively collect patients undergoing the standard CROSS regimen in the neoadjuvant setting of the treatment for gastro-oesophageal cancer. The investigators will focus on the potential geometric differences between the OAR and target volume on the initial planning CT and on the kilovolt (kV) cone-beam computed tomography (CBCT). They expect a potential difference in the abdominal part of the planned target volume (PTV) and/or gastro-oesophageal junction part. Furthermore, the impact of gastric filling , potential tumor regression and the accuracy of 5 mm PTV margin in the thoracic PTV will be monitored.

Optimal radiotherapy planning and delivery is essential for irradiation of gastro-oesophageal junction tumors. There is a need for individualized radiotherapy delivery to the upper abdomen, because of mobility. Likewise, controlling gastric filling by instructing patients about fluid and food intake before treatment, may contribute to positional reproducibility. There is evidence that missing microscopic disease in treating the clinical target volume (CTV) results in a worse prognostic outcome. The investigators want to evaluate wether positional difference of stomach, with and without fasting prescription, has an impact of the delivered dose. They will focus on the part of the CTV extending in the stomach. The investigators hypothesize that measurement of the dose using verification kilovoltage cone beam CTs will provide information on potential cold/hot spots of dose delivery and monitor potential geometric differences during treatment. This may result in a suboptimal treatment and a reconsideration of matching target volume on soft tissue instead of bony landmarks. The investigators will evaluate the first clinical results with DGRT in patients with esophageal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma of the gastro-oesophageal junction
* Age 18 years or older
* International Union Against Cancer (UICC) T2-4 N0-2 M0, potentially resectable disease treated by the CROSS regimen
* WHO 0-2

Exclusion Criteria:

* Thoracic adenocarcinoma/squamous cell carcinoma
* Palliative treatment for the oesophageal cancer
Determine Effects of Adjunctive Levetiracetam on Sleep Architecture in Adults With Partial Onset Epilepsy.

Effect of adjunctive levetiracetam on polysomnography in adults with partial-onset epilepsy receiving a classical antiepileptic drug


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have partial onset epilepsy and have been taking carbamazepine or phenytoin at a stable dose for a period of 4 weeks prior to the selection visit
* Subjects must have controlled partial onset seizures which can potentially benefit from adjunctive treatment

Exclusion Criteria:

* Subjects dosing with LEV two weeks prior to the selection visit
* Subjects using more than one AED
* Subjects with specific and non-specific sleep disorders
Percutaneous Needle Electrolysis (PNE) in Soleus Injury

This study evaluates if the physiotherapy treatment based on eccentric exercise, ultrasound-guided PNE or a combination of both therapies on chronic soleous injuries may cause changes in pain, functionality, dorsal flexion of the foot, balance and muscle fatigue in dancers.


Eligibility Criteria:
Inclusion Criteria:

* Over 16 years.
* at least 5 years of formal dance training.
* at least 20 hours of training per week.
* Pain in the back of the leg
* diagnosis of chronic soleus injury

Exclusion Criteria:

* Unsurpassed fear of needles
* History of adverse reactions to needles
* Immune system disorder
* Difficulty expressing your feelings properly
* Epilepsy and / or allergies to metals.
* Other lower limbs pathology
Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery

This is a Phase 1, open-label, dose escalation study in women with primary, non-recurrent breast cancer undergoing surgery. AVB-620 will be administered prior to surgery.

This study will examine the safety and tolerability of AVB-620 administered as an IV infusion to women with primary, non-recurrent breast cancer undergoing surgery. The study will also characterize the pharmacokinetics of AVB-620 in this subject population and determine the dose of AVB-620 needed to generate a fluorescence signal in tumor and lymph node tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of AVB-620 administration, relative to surgery, on fluorescence characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Ductal carcinoma in situ (DCIS) or Stage I-III, primary invasive carcinoma of the breast
* Primary surgical treatment is planned to be a mastectomy or lumpectomy. Sentinel lymph node (LN) biopsy or axillary LN dissection (ALND) is planned as part of the subject's therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Adequate renal function
* Lab values (hematology and chemistry) within institution's normal laboratory limits
* Willing to remain on-site for approximately 24 hours after administration of AVB-620 or, if required, stay overnight after the surgical procedure
* If the subject received neoadjuvant therapy, residual tumor is present (to be determined by the primary surgeon)
* If the subject received prior anthracycline therapy, the left ventricular ejection fraction (LVEF) must be within institution's normal limits
* Subject has the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Recurrent ipsilateral breast cancer
* Prior neoadjuvant chemotherapy or biologic therapy for current clinically or biopsy-proven node positive breast cancer within 4 weeks before the planned surgery.
* Open surgery in the ipsilateral breast within 1 year of AVB-620 administration
* History of radiation therapy to ipsilateral breast
* Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events, and/or heart failure within 1 year of AVB-620 administration
* Diagnosis of autoimmune disorders
* History of drug-related anaphylactic reactions or allergic reactions; subjects with an active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids will be excluded
* History of renal disease or current evidence of renal disease
* Current diagnosis of any other active or clinically significant non-breast cancer
* Systemic investigational drug of any kind within 6 weeks of AVB-620 administration
* Pregnant or breast feeding
Zileuton and Exhaled Nitric Oxide in Asthmatics

Evaluate the additive role of zileuton 600mg qid to clinically stable asthmatics on Advair 250/50 bid. Since asthma is an endogenous inflammatory disease there usually is increased total exhaled, bronchial and alveolar nitric oxide which are markers of eosinophilic driven pathways of inflammation. The addition of zileuton which is a leukotriene synthesis inhibitor by itself or together with inhaled corticosteroids should reduce nitric oxide gas exchange.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking
* Moderate to severe persistent asthmatics
* Clinically stable X 6 weeks on Advair 250/50 bid for at least 12 months

Exclusion Criteria:

* No leukotriene synthesis inhibitors or receptor antagonists for 6 weeks
Therapeutic Education by Telemedicine in Chronic Heart Failure

The purpose of the SEDIC study is to test a home based heart failure patient clinical follow-up and therapeutic education using telemedicine. This educational follow-up is based on an interactive information system (SCAD) including a touch screen personal computer for heart failure patient at home. An interactive algorithm has been developed to allow a self management teaching to the patient.Furthermore, a specialized nurse provide a clinical data follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 65 years old hospitalized for acute heart failure
* Left ventricle systolic Dysfunction with ejection fraction \< 45 %, documented in the previous 6 months
* And at least one of the following criteria:

BNP before discharge from hospital \> 350 pg/ml / EF \< 35 % / Hospitalization for acute heart failure informed in the previous 6 months

Exclusion Criteria:

* NYHA 4 at hospital discharge
* Planned cardiac surgery or coronary revascularization
* Hospitalization for ST-elevation acute coronary syndrome
* Depressive syndrome with score \> 20 at geriatric depression scale
* Therapeutic education impossible
* Technical problems with the device
* Limited autonomy for device use
* Patient not living in Basse-Normandie
* Ongoing participation in another clinical trial
Cognitive Behavioural Therapy/Metacognitive Therapy for Low Self Esteem

The goal for this clinical trial is to explore the effect of CBT/MCT on the treatment of low self esteem. 20 patients with low self-esteem will be selected and distributed into two either MCT or a CBT

We aim in this study to (1) evaluate the accessibility and effectiveness of MCT and CBT in treating low self-esteem, (2) investigate the patterns of change and the mechanisms of action involved during treatment, and (3) examine the impact of meta-cognitions and neuropsychologial processes in the treatment response and any relapse prevention of low self-esteem.

The association between low self-esteem and psychiatric disorders indicates that low self-esteem is an important transdiagnostic construct. People who report having a low self-esteem seem to experience more mental health problems and a reduction in quality of life.

There have been a few trials considering the effect of Cognitive Behavioural Therapy (CBT) for low self-esteem, however, there are few randomized controlled studies. Recently, Meta Cognitive Therapy (MCT) has been introduced as a new, specific treatment for MDD, showing promising and lasting results. This treatment approach also has proven more effective than CBT for GAD or worry disorder. So far, no study has examined MCT for low self-esteem in a randomized controlled trial.

For the present clinical trial, 20 patients with low self-esteem will be selected and distributed into two treatment conditions. The first group (n=10) will be treated with MCT, whereas the second group (n = 10) will be treated with CBT. The patients will be assessed with different outcome measures at pre-treatment, at the end of treatment, and at six months follow up. In addition, they will also be assessed weekly using various measures.

We aim in this study to (1) evaluate the accessibility and effectiveness of MCT and CBT in treating low self-esteem, (2) investigate the patterns of change and the mechanisms of action involved during treatment, and (3) examine the impact of meta-cognitions and neuropsychologial processes in the treatment response and any relapse prevention of low self-esteem.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent obtained prior to entry in the study.
2. Scores below 15 on the Rosenberg Self-esteem Scale (RSE)
3. 18 years or older.

Exclusion Criteria:

1. Psychosis
2. Bipolar type 1
3. Current suicide intent
4. PTSD
5. Cluster A or cluster B personality disorder
6. Substance dependence