cyrilzakka/clinical-trials huggingface dataset:
Post-operative Ovarian Adhesion Study in Women With Endometriosis

Endometriosis is a common gynaecological condition which typically present with pelvic pain and fertility problems. It is caused by tissues which are similar to the lining of the womb growing inside the women's pelvis. Severe endometriosis is most effectively treated using keyhole surgery. During the operation, endometriosis tissue is removed. However, following successful removal of endometriosis, women may still experience pain because the ovaries sometimes become stuck to the bottom of the pelvis due to post-operative scarring. We want to see if coating one of the ovaries in an anti-scar tissue gel stops the post-operative scarring.

Endometriosis is a common benign condition, affecting women of reproductive age. The disorder is characterized by endometrial surface epithelium, endometrial glands or stroma, found outside the uterus at anatomically ectopic sites.

* Laparoscopic excision of the disease is frequently carried out for the treatment of severe endometriosis. Pelvic adhesions often develop following surgery, restricting the success of treatment. Commercially available anti-adhesive solutions are often used successfully for limiting post-operative adhesions following myomectomy surgery.
* This study aims to assess the effect of resorbable hydrogel anti-adhesive gel following laparoscopic surgery for severe pelvic endometriosis on the prevalence of postoperative ovarian adhesions.
* This is a prospective double blind randomized controlled trial for patients with severe pelvic endometriosis (as defined by the American Society for Reproductive Medicine classification system) requiring extensive laparoscopic dissection (open of one or both para-rectal spaces) with uterine and ovarian preservation.
* Disease severity and eligibility for inclusion into the study will be confirmed at surgery.
* Pre-operatively, all participants will complete a standardized symptom questionnaire detailing the presence and intensity of specific endometriosis symptoms Intra-operatively both ovaries are routinely elevated to the anterior abdominal wall using Prolene suture (ovarian suspension) to facilitate operative access. At the end of the procedure, each participant will be randomized to having only one ovary coated with 4mls of hydrogel anti-adhesive gel, before the ovaries are replaced to their anatomically correct position.
* Three months after surgery, all randomized patients will have a transvaginal ultrasound scan to assess for ovarian mobility and repeat symptom questionnaire.
* Both patients and the person performing the ultrasound scan will be blinded to the randomization process.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 19-55 years
* diagnosed with severe endometriosis on pre-operative transvaginal ultrasound
* severe endometriosis diagnosed in the surgical context is the opening of one or both para-rectal spaces

Exclusion Criteria:

* inability/unwillingness to provide written consent
* inability to tolerate a transvaginal ultrasound scan
* complications at surgery such as unplanned oophorectomies, bowel injuries or conversion to open surgery
Airway Inflammation and Remodeling in Asthma and COPD.

Asthma and chronic obstructive pulmonary disease (COPD) are inflammatory airway diseases. Although the clinical features of asthma and COPD may be similar, the pathogenesis of these diseases differs in many aspects.

The aim of this study is:

* to evaluate airway inflammation in asthma and COPD,
* to evaluate airway remodeling in asthma and COPD as compared to healthy subjects,
* to assess the relationship between markers of airway inflammation and airway remodeling in asthma and COPD patients.

Material and methods:

* mild to moderate asthma patients diagnosed in accordance with Global Initiative for Asthma (GINA) guidelines,
* mild to moderate COPD patients diagnosed in accordance with Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines,
* healthy subjects as controls.

Airway inflammation is assessed in induced sputum (IS), exhaled breath condensate (EBC), bronchoalveolar lavage fluid (BALF) and specimens from endobronchial forceps biopsy. Airway wall thickness is evaluated in high resolution computed tomography (HRCT), endobronchial ultrasound (EBUS) and basement membrane thickness (BMT) in biopsy specimens.

We plan to compare airway inflammation and features of airway remodeling in asthma and COPD patients.


Eligibility Criteria:
Inclusion Criteria:

* a clinical diagnosis of asthma or COPD in accordance with GINA or GOLD, respectively
* control group - healthy volunteers without any history of lung disease

Exclusion Criteria:

* age below 18 years
* exacerbation in the past 6 weeks
* inhaled corticosteroid therapy at least 6 weeks prior to study enrollment
* significant co-morbidities
Magnetic Resonance (MR) Spectroscopy of Breast Cancer Tissue

Breast cancer tissue is collected from women undergoing scheduled surgery for breast cancer. The tissue specimen are analyzed by MR spectroscopy. After MR, the intact tissue specimen can be analyzed by other methods, such as histopathology.

The MR spectral profiles are compared to clinical findings such as the patients diagnosis, lymph node status and tumor size.


Eligibility Criteria:
Inclusion Criteria:

* Palpable breast cancer lesion
MISHA Post-Market Clinical Study

Prospective evaluation of the safety and effectiveness of the MISHA Knee System.

The study will collect data on the procedural and long-term adverse events, WOMAC pain and function scores, KSS satisfaction, subsequent surgical interventions, BMI levels, range of motion, UCLA activity level of the subjects, and perform radiographic/x-ray evaluations at clinical visits through 5 years post-procedure.

The primary analysis of this study is freedom from device- and procedure-related SSIs at five (5) years post-implantation.

This study will also assess device performance in subjects with intact and retained devices and subjects with devices removed prior to study termination and freedom from conversion to arthroplasty through 5 years.

Study subjects will be followed over a five-year post-implant period.


Eligibility Criteria:
Key Inclusion Criteria:

1. Subjects aged 25 to 65 years at time of index procedure
2. Body Mass Index (BMI) of \< 35
3. Activity exacerbated knee pain isolated to the medial compartment and not global in nature
4. WOMAC pain ≥ 40
5. Failed non-operative OA treatment

Key Exclusion Criteria:

1. Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device
2. Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis)
3. Ligamentous instability
4. Active or recent knee infection
5. Inflammatory joint disease, including sequalae of viral infections
6. Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals
7. History of keloid, hypertrophic or contracture scaring
8. Propensity for restrictive scar formation or adhesions with prior procedures
Neurogenic Overactive Bladder Treatment on Parkinson's Disease Through Back Tibial Nerve Electrostimulation

Dysfunctions of the lower urinary tract are non-motor symptoms common engines in Parkinson's disease (PD). Urodynamic changes in PD include overactive bladder (OB), characterized by urgency with or without urge incontinence , usually with frequency and nocturia . The aim of this study is to evaluate the efficacy and effectiveness of the treatment of OB in patients with PD with the use of a specific treatment: Posterior Tibial Nerve Electrostimulation (PTNE).

Introduction: Dysfunctions of the lower urinary tract are non-motor symptoms common engines in Parkinson's disease (PD). Urodynamic changes in PD include overactive bladder (OB), characterized by urgency with or without urge incontinence , usually with frequency and nocturia . The aim of this study is to evaluate the efficacy and effectiveness of the treatment of OB in patients with PD with the use of a specific treatment: Posterior Tibial Nerve Electrostimulation (PTNE). Materials and methods: This is test-clinical, double-blind, randomized, controlled comparison with placebo. The research will be conducted with patients diagnosed with PD and symptoms of OB in the Clinical Hospital of Porto Alegre, in the Movement Disorders and Urogynecology Ambulatories. The patients are divided into two groups, one of which receives placebo stimulation (often below the therapeutic threshold). They will be assessed before and after 12 weeks of treatment with home PTNE through specific form of questionnaires assessing incontinence, quality of life and voiding diary. After the end of treatment will be made up of patients to verify the effectiveness of treatment in 30 to 90 days. Hypothesis: Through this research the investigators hope to determine the true efficacy of this treatment method with PTNE in OB in PD with a high level of evidence, seeking to improve urinary symptoms and quality of life in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PD according to the criteria of the London Brain Bank
* Complaint urinary storage symptoms such as urinary urgency (sudden urge, abrupt and imperious to urinate, which is difficult to be inhibited), with or without urge incontinence (urine leakage after emergency), frequency (number of urination\> 7 / day) and nocturia (the number of micturitions\> 1 / night).

Exclusion Criteria:

* Damage to the peripheral sacral nerves
* Infection of the lower urinary tract untreated;
* Diabetes Mellitus;
* Chronic pulmonary disease worsened;
* Pregnancy and postpartum;
* Urinary Incontinence of pure stress incontinence or urinary Mixed with predominance of the stress component;
* Pacemaker or defibrillator;
* Metal prostheses;
* Application of botulinum toxin into the bladder and / or pelvic muscles last year;
* Current TENS treatment in the pelvic region, lower back and / or legs;
* Prior Urinary incontinence surgery;
* Current bladder carcinoma;
* Cognitive impairment likely to prevent implementation of the proposed treatment;
* Not understand / sign informed consent.
Application of Combined Lumbar Plexus and Sciatic Nerve Block

The research is to study the effectiveness and safety of combined lumbar plexus and sciatic nerve block by the guide of peripheral nerve stimulator (PNS) in unilateral knee replacement.There have be some papers which supported that combined lumbar plexus and sciatic nerve block may be more suitable for the old men.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of American Association of anesthetists（ASA）Grade 1、2 or 3
2. Aged between 18 and 85 years
3. Undergoing elective total knee replacement.

Exclusion Criteria:

1. Mental illness can not match
2. Nerve block, epidural anesthesia contraindicated
3. People who have Slow-type arrhythmias
4. History of chronic headaches and long-term use of analgesic drugs
5. People who were postoperative consciousness, language or hearing impaired
Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Docetaxel in Platinum-Resistant Non-Small Cell Lung Cancer

The purpose of this study is to determine the effectiveness and safety of TLK286 given intravenously once every three weeks in combination with docetaxel (Taxotere) in the treatment of patients with non-small cell lung cancer that is resistant to platinum-based chemotherapy.


Eligibility Criteria:
Inclusion criteria include:

* Histologically confirmed non-small cell bronchogenic carcinoma, including squamous cell carcinoma, undifferentiated carcinoma, adenocarcinoma, mixed (adenocarcinoma with squamous cell carcinoma), bronchoalveolar carcinoma, or large cell carcinoma
* Stage IV or Stage IIIB
* Progressed during or after first-line therapies with platinum-containing regimens in the advanced or metastatic treatment regimen
* At least 18 years of age
* Good performance status (ECOG 0 to 1)
* Adequate liver, renal, and bone marrow function

Exclusion criteria include:

* Pregnant or lactating women
* Treatment with more than one cytotoxic therapy
* Prior radiation to the whole pelvis
* Unstable medical conditions such as uncontrolled cardiac arrhythmia
* Patients with known history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80
Formation and Severity of Pressure Ulcers Associated With 4% Albumin vs. 0.9% Sodium Chloride

Patients resuscitated with 4% Albumin will have less incidence and reduced severity of pressure injuries than patients resuscitated with 0.9% Sodium Chloride due to the improved intravascular oncotic pressure effected from higher albumin levels.

Pressure ulcers incur multiple risks to the patient. The disruption of the skin is a portal of entry for infection , which may remain localised to the site or become blood borne. A pressure ulcer can lead to protein and fluid losses from the wound exudate. Many authors have theorised the existence of a relationship between the development of pressure ulcers and low serum albumin levels however, there is no strong evidence to prove this correlation. The literature does demonstrate a clear relationship between people with existing pressure ulcers and the presence of low serum albumins. Specifically serum albumin levels \<30mg/dl have been associated with the incidence of pressure ulcer development.

Eligibility Criteria:
Inclusion Criteria:

Randomisation to the SAFE study -

Exclusion Criteria:

In addition to the SAFE exclusion criteria, pre-existing pressure ulcers (developed prior to ICU admission) will also be excluded-
Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation

A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Registered male or female primary Liver transplant candidate
* Age ≥18 years old
* Signed: written informed consent

Exclusion Criteria:

* Acute, fulminant liver failure;
* Prior solid organ or bone marrow transplant;
* Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of \>3 mg/dl (\>265 mmol/L) for \>2 weeks and/or requiring hemodialysis;
* Multi-organ transplant;
* Ventilator dependent;
* Dependent on \> 1 IV inotrope to maintain hemodynamics;
* Malignancy excluding HCC;
* Infection.
Study to Evaluate the Effects of the Cooling Bolero in Women With Common Menopause Symptoms

The Cooling Bolero is a a vest filled with a new material (not ice or a gel) that provides controlled cooling by absorbing heat. The vest is manufactured by Nanohealth. It intended to provide moderate cooling (\~15C/59F) through indirect contact with the skin. The material in the device is safe, non-toxic, and eco-friendly.

Recent anecdotal studies of women with common peri-menopausal and menopausal symptoms (hot flashes, night sweats, flushing/sweating of face and neck, and intermittent sleep disturbances) have shown a reduction in both the frequency and intensity of those symptoms after using the Cooling Bolero. Specific (moderate) temperature cooling of the neck and upper torso appears to target and mitigate these common menopausal symptoms. This pilot study attempts to collect additional data on the effects of the Cooling Bolero.

Participants who have consented for this study will first be asked to complete a Baseline Assessment of their menopausal symptoms, including documentation of their baseline weight. If the assessment indicates that the participant has at least 'moderate' menopausal symptoms, then she will then enter the Run-In Period.

During the two-week Run-In Period, participants will use a Symptom Diary for to document the frequency and severity of their menopausal symptoms. At the start of Week 3, participants will return their completed Run-In Period Symptom Diary and receive their Cooling Bolero with instructions on how to use the product during the Treatment Period.

During the Treatment Period, participants should use the Cooling Bolero at least two times per day (morning and evening) for one hour. As feasible, the participant should start to wear the product 30 minutes prior to meal time for these two applications. The participant may also wear the product at additional times, as desired. All applications of the Cooling Bolero during the four-week Treatment Period are to be documented in the Product/Symptom Diary. During the Treatment Period, the participant will also continue to document the frequency and severity of their menopausal symptoms in the Product/Symptom Diary.

At the end of Week 6, the participant will stop using the Cooling Bolero. She will be asked to complete a Product Assessment and have her weight documented.

Participants will be contacted at Week 10 to ask about the status of menopausal symptoms after four weeks of not using the Cooling Bolero.

Eligibility Criteria:
Inclusion Criteria:

* Female, who is at least 18 years old.
* Self-reports having at least two (2) daily hot flashes associated with menopause.

Exclusion Criteria:

• Has another existing medical condition that would prevent study compliance.
Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition

The goal of this sequential study design is to increase genetic testing in those meeting national clinical guidelines. The main question it aims to answer is: which intervention is most effective in uptake of genetic testing for the target population? Participants will receive genetic testing and counseling that may initiate life-saving screenings.

Germline genetic testing is recommended by the National Cancer Center Network (NCCN) for individuals with a personal history of ovarian cancer, young-onset (\<50 years) breast cancer, and a family history of ovarian cancer or male breast cancer, among others. Recent publications demonstrate that the uptake of genetic testing is under-utilized, overall, and rates are consistently lower in minority populations. EHR-based algorithms will be used to identify patients of two Penn Medicine Ob/Gyn practices for whom genetic testing is recommended based on NCCN guidelines and to test pragmatic methods using messages delivered to patients or clinicians to encourage testing. The ACC Electronic Phenotyping Core developed the algorithms based on cancer registry data along with family history fields and this study will develop and test messages directed at patients and clinicians to encourage testing. The aims are:

1. Identification of at-risk populations through electronic health record (EHR) searches followed by patient nudges (MPM and then Way To Health) to increase the uptake of genetic counseling referral and testing in patients at gynecology practices at Dickens Center and Penn Medicine Radnor.
2. In patients who have not responded to patient nudges (Aim 1), test a provider nudge to increase the uptake of genetic counseling referral and testing in gynecology practices at Dickens Center and Penn Medicine Radnor (Aim 2).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with serous ovarian cancer diagnosed more than two years prior to study contact
2. Patients with breast cancer diagnosed at \<50 years of age more than two years prior to study contact
3. Patients with triple negative breast cancer diagnosed more than two years prior to study contact
4. Unaffected individuals reporting a family history of ovarian cancer
5. Unaffected individuals reporting a family history of male breast cancer
6. Unaffected individuals reporting a family history of breast cancer \<50 years

Exclusion Criteria:

1. Patients who have previously received genetic counseling and/or testing
R. I. S. POS. T. A

A failed operative vaginal delivery is associated with increased risk of maternal and perinatal complications. It is very important the determination of the fetal head position prior to instrumental delivery.

Generally,diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. There is a paucity of studies on the accuracy of digital examination but the general consensus is that reproducibility is low and diagnostic uncertainty remains high even for operators with much experience.

As the traditional clinical evaluation has many limitations, a new tool capable of increasing diagnostic objectivity and accuracy would be of great interest.

The aim of our study was to evaluate, in a prospective study, if the complementary use of ultrasound scan, to diagnose the fetal head position prior to instrumental delivery, may play a role in labor outcome.


Eligibility Criteria:
Inclusion Criteria:

* women with singleton cephalic pregnancies at term (≥37 weeks' gestation), who require an instrumental delivery

Exclusion Criteria:

* under 18 years of age
* women with contraindications for vacuum delivery
* women with sonography evaluation of fetal head position before randomization
* fetal head station \> +3
* discretion of the responsible obstetrician in cases where there is urgency due to suspected fetal compromise("fetal distress")
Risk Factors for Linezolid Resistance in Staphylococcus Aureus

This is a retrospective chart review study. The proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally, the adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be assessed.

This is a retrospective chart review study. The proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally, the adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be assessed. This research is important because identification of risk factors may allow earlier initiation of appropriate therapy in patients infected with these bacteria. Additionally, we will identify whether horizontal spread is responsible for this increasing trend.

Eligibility Criteria:
Inclusion Criteria:

* patients with linezolid resistance to staphylococcus aureus

Exclusion Criteria:

* those that don't meet entry criteria