cyrilzakka/clinical-trials huggingface dataset:
Miromatrix Biological Mesh for Hiatal Hernia Repair

Miromatrix Medical has developed MIROMESH® - a new, noncrosslinked, acellular mesh derived from the highly vascularized porcine liver. MIROMESH received FDA 510(k) clearance with an indication for reinforcement of soft tissue on March 31, 2014 under K134033. This study will serve to provide clinicians with high-quality clinical data in order to provide them with a higher degree of confidence when selecting MIROMESH for hiatal hernia repair.


Eligibility Criteria:
Inclusion Criteria:

* between 18 and 80 years old on the day of study enrollment
* able and willing to sign the consent form and comply with all study visits and procedures
* able to undergo elective laparoscopic hiatal hernia repair
* free of cognitive or speech impairment
* documented, symptomatic type II or III hernia ≥5cm in the axial/vertical dimension
* commit to non-smoking for at least 4 weeks prior to procedure

Exclusion Criteria:

* previous operation of the esophagus or stomach
* sensitivity to porcine material
* pregnant or plan to be pregnant within next 2 years
* immunocompromised or at risk of immunosuppression (i.e. be HIV positive, be experiencing organ rejection, be a recent or anticipated chemotherapy recipient) as determined by the Investigator
* require emergent operation for acute gastric volvulus or strangulation
* American Society of Anesthesiology (ASA) class 4 or greater
* BMI ≥40
* life expectancy of less than 2 years at the time of enrollment
* associated gastrointestinal disease that requires extensive medical or surgical intervention that might interfere with the quality of life assessment (e.g. Crohn's disease)
* any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements
Preference for Clarinex Tablets vs. Zyrtec Tablets in Patients With Allergies (P03180)

This was a crossover study designed to see if patients with allergy symptoms preferred Clarinex® or Zyrtec®. Patients were randomized to take 7 days of Clarinex or Zyrtec treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked questions to determine which drug, Clarinex or Zyrtec, the patient prefers more.


Eligibility Criteria:
Inclusion Criteria:

* had at least a two-year history of seasonal allergic rhinitis and/or perennial allergic rhinitis;
* currently experiencing symptoms of AR, including nasal symptoms at Visits 2 and 4, prior to entering each treatment phase;
* had not taken Zyrtec® or Clarinex® within the previous year;
* were 18 years of age or older;
* had negative urine test (hCG) for females of childbearing potential;
* for women of childbearing potential, agreed to use a medically accepted method of birth control;
* were free of any clinically significant disease (other than AR) that would interfere with study evaluations.

Exclusion Criteria:

* were pregnant or nursing;
* had allergic or idiosyncratic reaction to antihistamines;
* had current or history of frequent, clinically significant sinusitis or chronic purulent nasal discharge;
* had rhinitis medicamentosa or nasal structural abnormalities (including large nasal polyps and marked septal deviation) that significantly interfered with nasal airflow;
* in the opinion of the Investigator, were dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids (ie, subjects who could or would not observe the washout period for these prohibited medications);
* had an upper respiratory tract or sinus infection that required antibiotic therapy with the last dose within 14 days prior to Screening, or had a viral upper respiratory infection within 7 days prior to Screening;
* had asthma, unless their symptoms could be controlled by a short-acting inhaled Beta2-agonist used on an "as needed" basis;
* were on immunotherapy, unless they were on a stable maintenance schedule prior to screening. The dose of immunotherapy should remain constant and subjects could not receive immunotherapy within 24 hours prior to any visit;
* had a history of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that were likely to limit the validity of consent to participate in the study;
* had a history of non-compliance with medications or treatment protocols;
* had any clinically significant deviation from normal in the physical examination that, in the Investigator's judgment, may have interfered with the study evaluations or affect subject safety;
* had any clinically significant metabolic, cardiovascular, immunologic, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease, or any other disorder which, in the judgment of the Investigator, might interfere with the study evaluations or affect subject safety;
* had liver or renal impairment.
Research on Risk Factors and Interventions of Polycystic Ovary Syndrome Complicated With Depression and Anxiety

The current study intends to establish a prediction method and evaluation system for polycystic ovary syndrome (PCOS) complicated with affective disorder, such as depression and anxiety, through the epidemiological investigation. Randomized controlled studies on the efficacy of various intervention methods should be carried out to develop early intervention measures and methods in order to reduce the harm of psychological disorders, to facilitate the mental health of PCOS patients, and thus to improve the quality of life.

PCOS is one of the most common reproductive endocrine and metabolic diseases in women of adolescence and childbearing age. The prevalence of PCOS in reproductive women is as high as 5-10%, about 50-80% of whom are infertile and need ovulation induction or in vitro fertilization-embryo transfer (IVF-ET). Ovulation/anovulation and hyperandrogenemia are two main features of PCOS. Moreover, about 50-60% of PCOS patients present insulin resistance/hyperinsulinemia. The probability of miscarriage in PCOS is also higher than that of control women. Pregnancy complications in PCOS patients, such as gestational diabetes, preeclampsia, etc., and long-term complications of metabolic syndrome and endometrial cancer are more likely to happen. These not only greatly affect women's reproductive health, but also seriously endanger their psychological status. A large sample of data has shown that the risk of depression in women with PCOS is 3.78 times higher than that of the control women, 5.62 times for anxiety, and 1.78 times for bipolar disorder. With the economic development, more and more attention is paid to the quality of life including their mental health. However, there is few data on the risk factors of depression, anxiety and other psychological disorders in women with PCOS. There is a lack of effective evaluation and prediction systems. It is urgent to establish a risk assessment system for PCOS complicated with psychological diseases through scientific and systematic research, to formulate comprehensive intervention measures to improve the quality of life of women with PCOS and to reduce the incidence of affective disorders.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as PCOS according to Rotterdam criteria 2003, aged between 18 and 40 years old, and no willing to get pregnant in a year.

At least two of the following three criteria were met: clinical and/or biochemical signs of hyperandrogenism, oligo- and/or anovulation, and polycystic ovary on ultrasonography,

Exclusion Criteria:

* Any other related diseases, such as adrenal congenital hyperplasia, Cushing's syndrome, androgen-secreting tumors, Hashimoto's thyroiditis, hyperthyroidism or hypothyroidism
Nerve Grafting Technique to Restore Erectile Function Post Radical Prostatectomy

A single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing a somatic to autonomic nerve grafting procedure for restoration of erectile function in patients who have lost erectile function following radical prostatectomy for prostate cancer. During this study a total of 10 patients who have persistent erectile dysfunction for more than 18 months post prostatectomy will undergo a post radical prostatectomy nerve restoration procedure (PRP-NR).

The investigators are proposing a single arm prospective pilot study evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing the PRP-NR procedure. A total of 10 patients will undergo the PRP-NR procedure, which is a novel nerve grafting procedure which will utilize a graft of the ilioinguial nerve to perform a bilateral end to side connection between the dorsal penile nerve and the corpora cavernosa with the intent to restore erectile function. Participants will have a baseline evaluation with IIEF-5 and SF-MPQ questionnaires, and then will have re-evaluation with these questionnaires at their standard of care post operative visits at 4 weeks, 3-, 6-, 12-, 18- and 24- months. Post operative safety will be assessed by recording any clinically detected complications during their peri- and post-operative care.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with persistent post prostatectomy erectile dysfunction more than 18 months from prostatectomy and which results in the inability to achieve intercourse with the aid of PDE5-I medications.
2. Patients must have had good pre-prostatectomy erectile function with a baseline IIEF score of ≥17 on self-reported assessment of historic function.

Exclusion Criteria:

1. Patients with previous pelvic radiotherapy
2. Patients aged \< 18 years at diagnosis
3. Legally incapable patients
4. Patients who are unable to complete questionnaires and have no companion to help complete them
5. Patients with pre-existing neurologic disease
6. Patients with a history of bilateral surgeries for inguinal hernia repair.
Comparative Urine Proteomic Studies of Overactive Bladder in Humans

This study is being done to evaluate the use of a new technology (urine proteomics) - the study of proteins in the urine to identify urine markers of overactive bladder (OAB) from a simple voided urine specimen.

The objectives of the study are:

1. to improve the diagnosis of overactive bladder using a non-invasive technology (urine proteomics) and
2. to study how potential urine biomarkers changes with overactive bladder symptoms after patients have been treated with fesoterodine, an FDA approved drug for the treatment of overactive bladder.

Eligibility Criteria:
Inclusion Criteria:

For healthy volunteers the inclusion criteria are:

1. Females ≥ 18 years old
2. Not experiencing overactive bladder symptoms
3. Not experiencing frequency or urgency

For overactive bladder patients the inclusion criteria are

1. Females ≥ 18 years old
2. Overactive bladder symptoms for ≥ 3 months before screening ) Recurrent urinary tract infections (UTIS) \> 3/year

Exclusion Criteria:

For healthy volunteers the exclusion criteria are:

1. Overactive bladder symptoms, such as frequency and urgency
2. Intermittent/unstable use of bladder medications
3. Pregnant women or women unwilling to use contraceptives
4. Neurological conditions: stroke, Multiple Sclerosis (MS), Parkinson's, spinal cord injury
5. Significant pelvic organ prolapsed (grade 3 or above based on physical exam)
6. Lower urinary tract surgery within past 6 months
7. Known history of IC or pain associated with OAB
8. Urinary retention requiring catheterization, indwelling catheter of Self-cath
9. Recurrent UTIS \> 3/year

For overactive bladder patients the exclusion criteria are:

1. Contraindications to Fesoterodine use such as hypersensitivity, GI and urinary retention, and Glaucoma
2. Intermittent/unstable use of bladder medications
3. Pregnant women or women unwilling to use contraceptives
4. Neurological conditions: stroke, MS, Parkinson's, spinal cord injury
5. Significant pelvic organ prolapsed (grade 3 or above based on physical exam)
6. Lower urinary tract surgery within past 6 months
7. Known history of Interstitial Cystitis (IC) or pain associated with OAB
8. Urinary retention requiring catheterization, indwelling catheter of Self-cath
9. Recurrent urinary tract infections (UTIS) \> 3/year

Deferral Criteria:

Treatment with OAB medications within 2 weeks before baseline visit. If patient is currently on OAB medications the patient will be asked to stop OAB medication for 2 weeks and return for baseline visit.
Enhanced Outcome Prediction in Cutaneous Squamous Cell Carcinoma Using Deep-learning and Computational Histopathology

Evaluate a deep-learning model trained on computational histopathology for predicting outcomes in cutaneous squamous cell carcinoma


Eligibility Criteria:
Histologically-confirmed diagnosis of primary cutaneous squamous cell carcinoma
Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination

To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months and to investigate the bleeding pattern over a treatment period of one year


Eligibility Criteria:
Inclusion Criteria:

* Non-hysterectomised postmenopausal women
* Amenorrhoea for \>= 12 months
* Serum estradiol and follicle stimulating hormone (FSH) in the postmenopausal range

Exclusion Criteria:

* Known hypersensitivity to estradiol, dydrogesterone or any of the excipients of the study medication
* Baseline endometrial biopsy result other than described in the inclusion criteria (no endometrial tissue for diagnosis, hyperplasia, carcinoma).
* Insufficient endometrial tissue for diagnosis obtained at baseline biopsy and endometrial thickness \>= 5 mm (double layer) by transvaginal ultrasound.
* The presence of an endometrial polyp at baseline.
* Abnormal (un-investigated and/or unexplained) vaginal bleeding in the last 12 months prior to Screening Visit (Visit 1).
* Estradiol pellet/implant therapy during the past 6 months.
* Previous systemic unopposed estrogen replacement therapy over 6 months or more.
* History or presence of malignant neoplasms other than basal or spinal cell carcinoma of the skin
Thyroid Cancer Database

Thyroid cancer database collects clinical and laboratory data from patients with a thyroid tumor who received radioactive Iodine treatment. This database only records information based on patients' medical files in a structured manner.

Thyroid database is used for retrospective non-interventional research projects.


Eligibility Criteria:
Inclusion Criteria:

* patients with a thyroid tumor (metastatic or not)
* patients who received radioactive Iodine treatment.
* age \>= 18

Exclusion Criteria:

* Objection to collect medical data records
Study on the Use of Cinacalcet in Phosphocalcic Context.

Currently, the indications used for MA (Marketing Authorization) Cinacalcet in France are hyperparathyroidism (hyperPTH) in adults, whether primary (for patients in whom parathyroidectomy is theoretically indicated but in whom it is contraindicated or not is not clinically appropriate) or secondary to a chronic kidney disease, and parathyroid carcinomas.

In pediatric patients, data on its use are restricted due to its recent marketing authorization (2017) and limited to dialysis patients suffering from secondary hyperPTH.

Nevertheless, some patients with phosphocalcic pathologies without renal insufficiency must be treated off-label by cinacalcet in the presence of severe hyperPTH, without any other chronic treatment available to date.

The objective of this study is therefore to evaluate the use in France of cinacalcet in phosphocalcic pathologies without renal insufficiency, in order to obtain efficacy and safety data in order to improve our knowledge on the management of these orphan diseases.


Eligibility Criteria:
Inclusion Criteria:

* Patients with phosphocalcic pathology without end-stage renal failure
* Patients followed in one of the hospitals of the centers of reference and competence of the diseases of the metabolism of calcium and phosphate
* For children under 18: patient and parent (s) / parent having been informed of the study and having expressed their on-opposition
* For adults: patient / legal guardian of the patient under guardianship having been informed of the study and expressing his or her non opposition

Exclusion Criteria:

* Patient suffering from parathyroid cancer,
* Patient suffering from primary hyperPTH in whom parathyroidectomy would theoretically be indicated but contraindicated or clinically inappropriate,
* Patient suffering from hyperPTH secondary to end-stage renal failure
* No social security support
Utilizing Ultrasound for Residents as an Aid in Epidural Placement

This randomized controlled trial will evaluate the use of ultrasound as an aid for epidural placement in residents performing all epidural techniques under direct staff anesthesiologist supervision.

The purpose of this study is to assess the abilities of the "Accuro" to assist in lumbar epidural placement in patients. It is hypothesized that the use of the Accuro will result in an increase of first-attempt success rates, defined as successful epidural needle placement on the first needle insertion attempt.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for vaginal delivery
* ASA-1, ASA-2, and ASA-3
* Patients with no known back deformities
* Ability to sit upright for epidural placement
* No prior lumbar surgery
* No allergies to ultrasound gel
* Pre-pregnancy BMI \>= 30

Exclusion Criteria:

* Patients \< 18 years of age
Evaluation of DEXTENZA in the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids

This a prospective study review of the clinical efficacy of DEXTENZA for the treatment of anterior uveitis compared to the standard of care topical corticosteroid treatment

Patients with anterior uveitis are typically treated aggressively with every 1-2 hour (while the patient is awake) potent topical steroid agents, during initial stage of inflammation, and evaluated at frequent intervals, with a schedule of steroid tapering dictated by clinical response. The most common topical corticosteroid prescribed for the treatment of anterior uveitis are prednisolone acetate 1%, dexamethasone 0.1%, prednisolone sodium phosphate 1% and Difluprednate 0.05%. However, topical treatments are limited by the potential for patient non-adherence and variation in drug concentrations due to the intermittent or suspension of use nature of application. A corticosteroid insert placed in the inferior and superior canaliculi provides the advantages of reliable and continuous drug delivery for 24 hours a day for 30 days without the need for patients to adhere to a treatment regimen. Dextenza is a sustained-release dexamethasone intracanalicular insert recently approved by the FDA for pain and inflammation post ophthalmic surgery. Dextenza was shown to decrease inflammation and pain compared with placebo following cataract surgery in a multicenter randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Active non-infectious anterior uveitis
* Able to provide signed written consent prior to participation in any study-related procedures.

Exclusion Criteria:

* Have active intermediate, posterior uveitis, or panuveitis
* Have infectious anterior uveitis
* Have used topical corticosteroid treatment up to 48 hours prior to the baseline visit
* Have used oral corticosteroid within the past 14 days prior to baseline visit (Patients using stable doses of inhaled corticosteroids for 30 days prior to baseline visit can be included in the study)
* Have received intravitreal or sub-Tenon corticosteroid treatment prior to baseline visit or Ozurdex ® in the study eye within the 6 months prior to the baseline visit
* Are currently using prescribed nonsteroidal anti-inflammatory agents or prescribed immunosuppressive agents, unless the dose has been stable for the last 6 weeks and no change in dosing is anticipated for the duration of the study
* Have severe/serious ocular pathology or medical condition which may preclude study completion
* Dacriocystitis
* Are pregnant or lactating female, or female of childbearing age using inadequate birth control method
* Have participated in another investigational device or drug study within 30 days of the baseline visit
Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease

This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study.


Eligibility Criteria:
Key Inclusion Criteria:

1. Subjects aged 18 to 75 years with a diagnosis of CD for at least 3 months;
2. Moderately to severely active CD as defined by: a CDAI score of 220 450, and an SES-CD scored ≥ 6 ( ≥ 4 for isolated ileitis) (centrally read);

Key exclusion criteria:

1. Ulcerative colitis;
2. Known current bacterial or parasitic pathogenic enteric infection; live virus vaccination within 12 weeks of screening.
Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia

The purpose of our study is to examine the effects of a second antibiotic, daptomycin, in combination with a beta lactam antibiotic on treating bloodstream infection caused by methicillin-susceptible S. aureus.

When patients have a blood infection with methicillin-susceptible S. aureus, they will all be treated with the usual standard of care, including abeta-lactam antibiotic, have their blood tested daily for the presence of the infection until they test negative, as well as an ultrasound of the heart to rule out an infection of the heart valves, as well as have any catheters removed (if possible) to ensure adequate control of the infection.

This study involves adding a second antibiotic, daptomycin, to the treatment regimen of half of the patients enrolled in this study. Daptomycin is approved by Health Canada for treating blood infections due to Staphylococcus aureus. It is currently not used in combination with a beta-lactam for these infections because there is insufficient evidence of benefit to justify the cost.

The study participants will receive an additional daily iv therapy which will consist of either daptomycin or a placebo for a total of five days while admitted to the hospital. During this time, the participants will continue to have their blood drawn to assess for the presence of bacteria. The participants' liver and muscle enzymes will also be measured on the first and fifth day of therapy to test for potential side effects of the daptomycin.

Eligibility Criteria:
Inclusion Criteria:

* Patient has a methicillin susceptible Staphylococcus aureus bacteremia.

Exclusion Criteria:

* Underlying terminal illness
* Significant contraindication to beta-lactam therapy (i.e. severe allergy, severe adverse drug reaction)
* Expected death before 5 days
* Microbiologically confirmed need for concomitant VANCOMYCIN or DAPTOMYCIN
Convalescent Plasma in Hospitalized COVID-19 Patients

The study assesses the efficacy and safety of administration of hyperimmune plasma in hospitalized COVID-19 patients. Efficacy was measured as 28-day mortality following convalescent plasma transfusion. Safety was measured as the rate of adverse reactions. to plasma infusion.

Inclusion criteria:

Adult inpatients with a severe form of COVID-19 have been enrolled, with at least one of the following inclusion criteria: 1) tachypnea with respiratory rate (RR) \> 30 breaths/min; 2) oxygen saturation (SpO2) ≤ 93% at rest and in room air; 3) partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) ≤ 200 mmHg, 4) radiological picture and/or chest CT scan showing signs of interstitial disease and/or rapid progression of lung involvement.

Primary outcome:

Overall mortality at 28 days after hospitalization

Secondary outcome:

Adverse reaction to plasma transfusion.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted for severe COVID-19

Exclusion Criteria:

* \< 18 years
* participation in any other clinical trial of an experimental treatment for COVID-19