cyrilzakka/clinical-trials huggingface dataset:
Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy

This study will evaluate the effect of OxyGenesys Dissolved Oxygen Dressing in wound complication rates of the nipple areolar complex after a nipple sparing mastectomy.

This study will recruit women who are undergoing a bilateral mastectomy for either cancer or a positive BRCA gene. Women will be randomized to a different treatment per breast. One breast will receive the OxyGenesys dressing and the other will receive the standard gauze dressing. The study will evaluate wound complication rates and compare the two treatments.

Eligibility Criteria:
Inclusion Criteria:

* Subject is able to give written consent
* Females \>21 years of age
* At least one breast diagnosed with cancer or mastectomy due to a positive BRCA gene mutation test.
* Subject is indicated for bilateral nipple-sparing mastectomy surgery with immediate breast reconstruction
* Subject is able to comply with the study protocol

Exclusion Criteria:

* Primary tumor(s) located within 2cm of the areola margins
* Inability to perform follow up assessments
* Radiation treatment within 30 days of surgery
* Dermabond or other forms of surgical glue is used in the peri-areola region
* Subjects who are known to be allergic to any of the test product(s) or any component of the test product(s)
* Women who are pregnant
* Subjects who have been treated with an investigational drug or device within the past 30 days prior to enrollment
Percutaneous Needle Electrolysis Versus Surgery in the Treatment of Carpal Tunnel Syndrome

The aim of this study is to compare the effectiveness of Percutaneous Needle Electrolysis (PNE) versus surgical treatment in the treatment of Carpal Tunnel Syndrome (CTS).


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years.
* CTS diagnosed by Electromyography (EMG)
* Symptoms of CTS + EMG

Exclusion Criteria:

* Difficulty expressing your feelings properly
* Unsurpassed fear of needles
* History of adverse reactions to needles
* Epilepsy and / or allergies to metals.
* Difficulty expressing your feelings properly
* Existence of diffuse peripheral neuropathy or cervical radiculopathy
* History of potential concurrent cause of idiopathic CTS (such as diabetes, thyroid, chronic rheumatoid arthritis, renal failure with hemodialysis, pregnancy..)
Efficacy and Safety of Chuna Manual Treatment as an Adjunctive Therapy After Total Knee Arthroplasty: A Study Protocol for a Single-Center, Randomized, Assessor Blind, Parallel-Group Clinical Trial

Evaluate the efficacy and safety of Chuna treatment as an adjunctive therapy in patients with moderate pain following total knee replacement.


Eligibility Criteria:
Inclusion Criteria:

* Patients with NRS of knee pain ≥4 during the 7 days after 3 months total knee replacement
* Patients who have agreed to trial participation and provided written informed consent

Exclusion Criteria:

* Those who have been diagnosed with certain serious diseases that can cause knee pain. : tumor, infectious or inflammatory disease, etc.
* Those taking analgesics for the purpose of relieving pain, fever and inflammation within 7 days
* Those with progressive neurological deficits or with severe neurological symptoms
* Those who have other chronic conditions that may interfere with the interpretation of treatment effects or outcomes : Cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.
* Those who are not fit or unsafe to chuna therapy: clotting disorders, Those receiving anticoagulant therapy, Severe diabetes patients who are at risk of infection, severe cardiovascular disease
* Those who are participating in other clinical trials
* Those who have a history of participating in other clinical trials within one month
* Those who are difficult to write a research consent form
* Those who are judged to be inappropriate for the clinical study by the researchers.
Changes of Dendritic Cells in Acute Lung Injury

To observe changes of circulating and tissue dendritic cells in acute lung injury,including invasive aspergillosis pneumonia

Change of circulating and tissular dendritic cells of patients with acute lung injury was still unclear, we used a flow cytometry-based assay to quantify circulating and tissular DCs and their HLA-DR surface expression at the time of diagnosis and during the first week of evolution in patients with acute lung injury, and healthy people as controls.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis induced acute lung injury

Exclusion Criteria:

* Younger than 18-year-old
* Pregnancy
* Cancer or organ transplant
* Asthma
* COPD
* Heart Failure
Phase IV Study to Evaluate the Efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo After Photorefractive Keratectomy (PRK)

Phase IV comparative, controlled, parallel group, open, randomized multicenter study to evaluate the efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo. Primary outcome measure is the time of corneal re-epithelialization after PRK surgery. Intervention includes administration of one of the experimental products quater per die (QID) for 14 days.


Eligibility Criteria:
Inclusion Criteria:

* - Age ≥ 18 and ≤ 45 years old
* Being on PRK postoperative day 1 (right eye will be evaluated for efficacy)
* Presenting a PRK surgical corneal ablation surface of 5.5 to 6.0 mm
* PRK corneal output ≤ 60 µm
* Preoperative refraction of -1.0 to -4.5 D of myopia or myopic astigmatism (in this case, the sum of both values with a spherical equivalent no greater than -4.5 D)
* Being capable of voluntarily grant a signed informed consent.
* Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures.
* Being willing and able to modify the required lifestyle activities.
* Women in child-bearing age must assure the continuation (start ≥ 30 days prior to informed consent signing) of a hormonal contraceptive method or intrauterine device (IUD) during the study.

Exclusion Criteria:

* Having suffered any complications during and after PRK surgical procedure previous to inclusion in the study.
* Use of mitomycin during PRK
* Being subjected to PRK retreatment of previous history of any other kind of refractive surgery.
* Pregnancy, breastfeeding or planning to become pregnant during the time of the study
* Having participated in clinical trials within 30 days prior to signing this study's informed consent form.
* Having participated previously in this study.
* Diagnosis of any of the following:

  * Allergic, viral or bacterial conjunctivitis
  * Dry eye
  * Anterior blepharitis
  * Parasite infestation of ocular structures (Demodex, for example)
  * Previous history of ocular herpes
  * Previous history of ocular inflammation (such as uveitis)
  * Corneal or conjunctival ulcers
  * Glaucoma
* Previous history of drug addiction within the last 2 years previous to signing this study's informed consent form.
* Having a previous history of any ophthalmological surgical procedure, within the last 3 months prior to the informed consent signing date.
* Previous history of any medical affliction, acute or chronic (such as Diabetes Mellitus type I/II, autoimmune diseases or HIV), that according to the investigator may increase either the risk to the patient for participating in this study or the risk of interference of the accurate interpretation of results.
* Use of medications (such as retinoic acid) that according to the investigator's criteria may increase either the risk to the patient for participating in this study or the risk of interference of the accurate interpretation of results.
* Known hypersensitivity to any of the components of the products used in this study.
Cholecalciferol in Treating Patients With Myelodysplastic Syndrome

RATIONALE: Cholecalciferol (vitamin D) may improve quality of life by increasing blood counts, decreasing fatigue, and improving other symptoms of myelodysplastic syndrome.

PURPOSE: This phase II trial is studying how well cholecalciferol works in treating patients with myelodysplastic syndrome.

OBJECTIVES:

* Determine the efficacy of cholecalciferol, in terms of hematological improvement, in patients with low- or intermediate-risk myelodysplastic syndromes.
* Determine the effect of this drug on disease symptoms, fatigue, and the overall health-related quality of life of these patients.

OUTLINE: This is an open-label, pilot study.

Patients receive oral cholecalciferol once daily. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed myelodysplastic syndromes (MDS)

  * Must have undergone bone marrow aspirate and biopsy with karyotype within the past 3 months
* International Prognostic Scoring System score of 0 or 1

PATIENT CHARACTERISTICS:

Age

* Any age

Performance status

* Any

Life expectancy

* More than 1 year

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* No history of hypercalcemia

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Prior stem cell transplantation allowed
* No concurrent hematopoietic growth factors

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* More than 6 weeks since prior cholecalciferol supplements or analogs
* More than 4 weeks since any prior therapy for MDS (except supportive care)
* No other concurrent therapy for MDS
SPL7013 Gel - Male Tolerance Study

The purpose of this study is to determine if SPL7013 Gel (VivaGel™) is safe when applied topically once a day for seven consecutive days to the shaft and glans of the penis in healthy male volunteers. The study will compare the safety of SPL7013 Gel on the penile epithelium and urethral mucosa to the safety of a placebo gel. The study will also assess the systemic safety of SPL7013 Gel, systemic absorption of the active ingredient of SPL7013 Gel, and the acceptability of the study products to the male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Healthy males aged 18 years or older
* HIV negative
* Reports vaginal intercourse in the past 12 months
* Agrees to abstain from vaginal, anal (receptive and insertive) and oral sexual intercourse, and agrees to refrain from masturbation during the 7 days of product use until after the End-of-Treatment (Day 7) study visit

Exclusion Criteria:

* Known or suspected allergy to any component of the study products or similar ingredients in other products
* History of significant drug reaction or allergy
* Recent history (within 12 months) or presence at screening of contact dermatitis or other dermatological condition
* Recent history (within three months of Screening) of a sexually transmitted infection (STI)
* Current signs or symptoms of UTI and/or STI at Screening or Baseline
* Positive urine leukocyte esterase test (≥ trace)
* Biochemical and/or haematological parameters outside the laboratory's normal reference ranges at Screening
* Evidence of genital piercing, ulceration, genital dermatoses, tinea cruris or other dermatological condition of the genitalia or upper thighs
* Genital pain or discomfort at Screening or Baseline
* Any other abnormal finding on physical examination or other medical condition
Open-Label, Pilot Study of TG100801 in Patients With Choroidal Neovascularization Due to AMD

Wet age-related macular degeneration (AMD) is caused by the formation and growth of abnormal blood vessels (angiogenesis) in the retina. The new blood vessels have fragile walls and can leak fluid into the retina. The build-up of fluid (edema) under the macula can distort vision or cause vision loss. TG100801 is a topical (eye drop) therapy that has been shown to inhibit ocular angiogenesis, vascular leak, and inflammation in laboratory studies. The primary purpose of this pilot study is to evaluate the ability of topical administration of TG100801 to reduce the amount of fluid in the retina in patients with AMD following 30 days of treatment. An additional objective is to evaluate the safety of TG100801 in patients with AMD.

Choroidal neovascularization (CNV) due to AMD is the leading cause of irreversible, severe vision loss in people 55 years and older in the developed world. TG100801 is a potent inhibitor of vascular growth endothelial factor (VEGF) and other kinases that contribute to CNV and macular edema. Animal models have demonstrated the ability of TG100801 to inhibit angiogenesis, vascular leak, and inflammation. TG100801 is being developed as a topical (eye drop) therapy for treatment of CNV due to AMD.

The primary objective of this multicenter, open-label, randomized, pilot study is to evaluate the effects of 30 days of dosing with two dose levels of TG100801 on central retinal/lesion thickness, as measured by optical coherence tomography (OCT). The safety of TG100801 in patients with AMD also will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Subfoveal CNV secondary to AMD in study eye
* CNV lesion size less than or equal to 12 MPS disk areas
* CNV \> 50% of lesion area
* Presence of intraretinal fluid causing an increase in central subfield thickness of at least 250 microns, confirmed by OCT in study eye
* Any lesion composition
* Best corrected visual acuity of 20/40 to 20/320 (73 to 24 ETDRS letters) at 4 meters in study eye
* Best corrected visual acuity of 20/800 or better (at least 4 ETDRS letters) at 4 meters in fellow eye
* Ability to administer and tolerate eye drops
* Able to give written informed consent

Exclusion Criteria:

* History of any treatment for subfoveal CNV in study eye
* Known or anticipated need for use of topical medication in study eye during 30-day dosing period
* Current or anticipated need for any available ocular anti-VEGF therapy in fellow eye for 30 days prior to and 30 days following baseline
* RPE rip or tear in study eye
* Blood \> 1 disk area, atrophy, or fibrosis (disciform scar) under foveal center of study eye
* Scarring/fibrosis of at least 25% of total CNV lesion in study eye
* Hemorrhage or PED \> 50% of total CNV lesion in study eye
* Glaucoma with visual field loss or IOP at least 25 mmHg in study eye or consistently at least 25 mmHg in fellow eye
Spica Cast Duration for DDH

This study looks at treatment for developmental dysplasia of the hip (DDH), a condition where there is abnormal development of a child's hip joint. While spica casts are shown to very effective in treating DDH, and potentially more effective than hip braces alone, other research shows that the outcomes from braces are equivalent to those of spica casts with the added advantage of greater patient satisfaction and less burden on families. Therefore, the 12-week experimental protocol in the study, with the first 6 weeks involving the spica cast and the second 6 weeks the hip brace, was designed to determine if both treatment methods can be combined for an optimal patient experience.

The primary objective of this study is to compare the clinical outcomes of patients who undergo closed reduction of a developmentally dysplastic hip and are treated with six weeks of supplemental casting to those treated with twelve weeks of supplemental casting.

The secondary objectives of this study are to determine if a shorter duration of postoperative casting affects family satisfaction and costs compared to the traditional pathway (12 weeks of spica casting).

The physician will meet with the patients during the regular standard of care follow-ups every 2-3 weeks to track patient progress. Following 6 weeks of recovery, the control group will have their spica cast replaced in the operating room, with the child anesthetized, by another cast for 6 weeks. The experimental group will have their cast removed in the clinic without anesthesia and will be placed into a full-time brace for 6 weeks. Participants will be instructed to complete the full 12 weeks of the protocols. Only patients who complete the full length of treatment in either group will be considered for the study. The physicians will keep track of patients during visits to ensure the protocols are being followed.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Diagnosed with DDH
* Require closed reduction of the hip and hip spica casting

  1. between 6-18 months old
  2. Alpha angle \<60 degrees, beta angle \>55 degrees

  i. Alpha angle is an angle created by lines along bony acetabulum and the ilium, normal is \>60 degrees

ii. Beta angle is an angle created by lines along the labrum and ilium, normal is \<55 degrees

c.Have either failed Pavlik harness or have dislocated hip on imaging

Exclusion Criteria:

* Patients over the age of 18 months
* Patients with DDH who do not require closed reduction surgery
* Patients with DDH who are initially consented for closed reduction surgery but their intraoperative findings necessitate conversion to open surgery
* Families that do not want to participate in the study
* Patients with dysplasia that need open reduction
Women's Experience of Premature Ovarian Insufficiency (POI) Diagnosis: Update on Actual Practices and Patient's Follow up

Premature ovarian insufficiency (POI) affects 2,8 to 3,5% of women before the age of 40. Previous foreign studies revealed that only half of POI disclosures occurred during a medical consultation and that the diagnosis was often discussed in less than 5 minutes. As a result, most of patients felt a lack of information, and consequently sought data on the internet. None of these studies were conducted in France. The aim of this study is to analyze current practices related to POI diagnosis and to assess women's satisfaction

POI is defined by the association of 1 clinical and 1 biological criterion: amenorrhea or spaniomenorrhea of \> 4 months with onset before 40 year of age, and elevated follicle-stimulating hormone (FSH) \> 25 IU/L on 2 assays at \> 4 weeks' interval, associated with low estradiol level. This condition affects approximately 2% of young women.

POI can first lead to infertility and various symptoms caused by a lack of estrogens. Thus, patients may experience vaso-motor flushes, genitourinary syndrome, sleep disturbance, humor disorder, decrease libido and dyspareunia. After several years, POI can lead to osteoporosis, increased cardiovascular risk, and dementia. The administration of hormone replacement therapy (HRT) can help prevent these complications. Otherwise, POI may result in psychological repercussions such as anxiety, anger, loss of self-esteem, even depression.

Few studies analyzed POI diagnosis and the way it was perceived by patients. Alzubaidi et al. and subsequently Groff et al. reported that only half of POI notifications occurred during a medical consultation. Moreover, 35% of the consultations lasted less than 5 minutes. Thereby, Singer et al. founds that 68% of women felt inadequately informed. The majority of patients sought additional information on the internet.

No recent study focused on the disclosure of POI diagnosis, and none of the existing studies were conducted in France. The purpose of this study is to analyze the circumstances surrounding POI diagnosis and to evaluate women's experience.

In other ways, in 2016, Bachelot et al. emphasized that after more than 5 years after POI diagnosis, only 61,7% of women were undergoing HRT whereas only 6% had no regular follow-up. Moreover, among the treated patients, 42,6% had already stopped HRT for more than 1 year without any medical recommendation. Therefore, this study aims to examine the association between women satisfaction regarding POI disclosure and their compliance to HRT and medical follow-up

Eligibility Criteria:
Inclusion Criteria:

* woman aged 18 years and older,
* diagnosed with POI following ESHRE 2016 criteria,
* speaking and reading French language,
* woman's oral consent,
* affiliated or beneficiary of health insurance.

Exclusion Criteria:

* iatrogenic POI (surgery, radiotherapy, chemotherapy linked),
* chromosomic POI (Turner Syndrome),
* inability for the woman to understand the nature or risks or significance and implications of the study,
* woman under legal protection
The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients

This study evaluates the outcomes of patients who have been treated with Strattice or Gore Bio-A mesh for the repair of complicated abdominal wall hernias. The purpose of this study is to collect information and evaluate the outcome of your surgery. Synthetic (man made) mesh has been shown to provide durable long-term outcomes; however, this type of mesh should not be used in patients at risk of developing an infection. Therefore, to address the challenge of finding an artificial strengthening material to repair complicated hernias in patients that could potentially develop surgical infection, two types of non-permanent materials have been developed, including biologics and bioabsorbables. Biologic mesh is made of living tissue and bioabsorbable mesh is made of synthetic material that is gradually absorbed by the body over time. The purpose of this study is to allow surgeons to compare the postoperative course of patients associated with these two mesh types to decide which material will improve the outcomes of their patients with complicated abdominal wall defects. To date there is no evidence to suggest that either mesh type is superior or safer than the other.

The goal of the proposed study is to evaluate the outcomes of patients implanted with Strattice® (LifeCell Corporation, Branchburg, NJ, USA) and Gore® Bio-A® (W. L. Gore \& Associates, Inc., Newark, DE, USA) for the repair of abdominal wall defects in at-risk patients. Primary endpoints of the study will include hernia recurrence, duration of postoperative drains, the incidence of systemic and wound-related complications, the need for percutaneous intervention or reoperation and quality- of-life with 3 years of follow-up. The study will be prospective and randomized, and the evaluator and patient will be blinded as to the type of mesh implanted.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Grade II or III ventral hernia according to Ventral Hernia Working Group (VHWG)
* Pre-operative informed consent is obtainable

Exclusion Criteria:

* Return to the operating room within the next 1 year for additional open abdominal surgery is anticipated
* Absence of fascial defect or fascial defect less than 3 cm in greatest dimension
* Presence of previously place mesh (synthetic or biologic) at the site of surgery, which will not be completely removed and will, in part or whole, remain at the site of implantation of the study mesh
* Concurrent placement of another mesh (synthetic or biologic) at the site where the study mesh is placed
* Grade IV ventral hernia according to VHWG system
* ASA score IV or above
* Any disease or condition along with the surgeon's clinical judgment that contraindicates the use of either study mesh
* Pregnancy