cyrilzakka/clinical-trials huggingface dataset:
STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision

This study is being done to answer the following question: Are there types of early-stage vulvar cancer that require either less or more treatment than the usual approach?

This study is being done to find out if these approaches are better or worse than the usual approach for early-stage vulvar cancer. The usual approach is defined as care most people get for early-stage vulvar cancer.

The usual approach for patients who are not in a study is treatment with surgery. Tissue that is removed as part of this procedure is analyzed in the pathology laboratory to guide the doctor in deciding whether additional surgery should be recommended.

For patients deciding to take part in this study, the treatment that will be recommended will be based on laboratory testing of the cancer. The laboratory assessments include a test to determine if the cancer is caused by the Human Papilloma Virus (HPV) or not caused by HPV. If the laboratory test results show the vulvar cancer is caused by HPV, the study doctor will recommend the patient participate in sub-study A. In sub-study A, the patient will receive no additional surgery (observation). If the laboratory test results show the vulvar cancer is not caused by HPV, the study doctor will recommend the patient participate in sub-study B. In sub-study B, patients will receive either a second surgery or no additional surgery (observation).

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary diagnosis of vulvar squamous cell carcinoma (VSCC)
* Surgically staged FIGO I-II VSCC as per FIGO 2021 guidelines
* Vulvar resection according to standard of care guidelines
* Post-operative margin assessment of tumour clearance, dVIN and p53 status.
* Participants' age must be ≥ 18 years old
* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English or French
* Participant's consent must be appropriately obtained in accordance with applicable local and regulatory requirements

Exclusion Criteria:

* Recurrent vulvar squamous cell carcinoma
* Non-squamous cell carcinoma histotypes
* Participants referred for/receiving/or previously received adjuvant vulvar radiation or chemotherapy
* Primary tumour HPV-I p53 wild-type VSCC
* Surgical margins positive for invasive cancer.
* Participants with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years
* Lymph node positive VSCC
Longitudinal Effects of a Sexual Health Intervention: HEART

Randomized Controlled Trial to evaluate the eHealth program, HEART (Health Education and Relationship Training).

Randomized Controlled Trial to evaluate the eHealth program, HEART (Health Education and Relationship Training). Data collection will occur at pretest, posttest, 12m (primary endpoint) and 18m (to look at stability of effects over time).

Eligibility Criteria:
Inclusion Criteria:

* Current high school student
* Able to read English

Exclusion Criteria:

* Not able to read English
Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis

Chronic rhinosinusitis (CRS) affects up to 12.5% of the US population and has a significant disease burden. The recommended medical management of CRS includes large-volume, low-pressure saline lavage, systemic antibiotics, and intranasal corticosteroids (INCS). While the efficacy and safety of INCS are well-established for the long-term management of CRS, penetration of INCS beyond the nasal vestibule and into the paranasal sinuses is limited. The aim of this study is to evaluate the effectiveness of mometasone furoate large-volume, low-pressure nasal irrigation for surgery-naive CRS patients.

Mometasone furoate nasal spray (MFNS) is a INCS that is used in the management of CRS. The overall goal of this proposed research project is to optimize topical delivery of MF to the paranasal sinuses in surgery-naive CRS patients through the use of high-volume, low-pressure nasal saline irrigation. The investigators will be conducting a single-site, double-blinded, placebo-controlled randomized clinical trial (RCT) in which we propose to evaluate the effectiveness of MF nasal irrigation compared to MF nasal spray.

Eligibility Criteria:
Inclusion Criteria:

12-weeks or longer of two or more of the following signs and symptom consistent with CRS:

* mucopurulent drainage(anterior, posterior, or both)
* nasal obstruction (congestion)
* facial pain-pressure-fullness
* and decreased sense of smell

AND inflammation documented by one or more of the following findings:

* purulent mucus or edema in the middle meatus or ethmoid region
* radiographic imaging showing inflammation of the paranasal sinuses.

Exclusion Criteria:

* inability to speak or understand English
* nasal polyps
* history of nasal or sinus surgery
* comorbid mucociliary conditions
* dependence on prolonged corticosteroid therapy for comorbid conditions, such as asthma and chronic obstructive pulmonary disease
* history of oral or systematic antibiotic use in the past 2 weeks
* history of allergy to MF or other topical steroids
* pregnant or breastfeeding
* participants with a baseline SNOT-22 score of 9 or less will be excluded due to inability to achieve a minimally clinically improved difference pre- and post-intervention.
Nose-close and Abdomen-compression in Pediatric Flexible Bronchoscopy

The nasopharyngeal oxygen (NPO) with Nose-close (NC) and Abdomen-compression (AC) technique may use for support or rescue asphyxiated infants during Flexible bronchoscopy.

OBJECTIVES: To evaluate the efficacy of a novel cardiopulmonary resuscitation (CPR) technique-nasopharyngeal oxygenation with nose-close and abdomen-compression (NPO-NC-AC)-in small infants during flexible bronchoscopy (FB).

METHODS: Infants with body weight (BW) \<5.0 kg and receiving nasal diagnostic or interventional FB (dFB, iFB) were enrolled. Under NPO (0.5 L/kg/min), when infant's heart rate (HR) \<80 beats/min or oxygen saturation (SpO2) \<85% for more than 10 seconds, rescue NC-AC was initiated. It was performed by (1) increased NPO flow to 0.5-1.0 L/kg/min; (2) NC 1 second for inspiration; and (3) AC 1 second for expiration with simultaneously released nostrils. Repeat doing steps (2) and (3) at a rate of 30 cycles/min until HR, SpO2, and blood pressure (BP) returned to normal. Cardiopulmonary parameters were monitored and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* body weight (BW) less than 5.0 kg;
* receiving nasal approach flexible bronchoscopy.

Exclusion Criteria:

* cannot nasal approach flexible bronchoscopy.
Analysis of All Stillbirths in Stockholm County 2017, a Multidisciplinary Audit

All stillbirths in Stockholm during 2017 were analysed according to the primary outcomes which were preventable/non-preventable deaths and the level of delay. The secondary outcomes were: causes of death, standard of care pre and post stillbirth and if a summary of the possible causes of death was made as well as the planning of supervision of the next pregnancy.

This is a retrospective cohort study. A multidisciplinary team consisting of three obstetricians, one midwife and one neonatologist was assembled. The team represented the largest hospitals in the region-Karolinska University Hospital and Stockholm Soderl Hospital. Each team member in the audit group had access to all the medical patient charts from the hospitals and also the majority of the charts from the antenatal care clinics (ANC). Each team member independently assessed each case regarding causes of death, preventable/non-preventable deaths, the level of delay if there was any and the standard of healthcare provided to the patients with stillbirth, the postmortem examination of infant and mother and if there were any recommendations given for the next pregnancy. Multiple meetings were organized for discussing the results of the individual assessment of each case. To enable an ethical discussion every member of the audit group signed a confidentiality form and all cases were assessed by comparison with local guidelines in praxis.

Eligibility Criteria:
Inclusion Criteria:

* All stillbirths in Stockholm 2017

Exclusion Criteria:

* Missed abortion
Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone

In the US, pain management after surgery for surgical treatment of osteoarthritis at the base of the thumb typically consists of prescription opioids during the early recovery phase. Given the highly addictive nature of prescription opioids, guidelines are being evaluated by hand surgeons to reduce opioid use while still maintaining pain control after surgery. A promising approach is to use non-narcotic medication as the first line of treatment. The purpose of this study is to demonstrate the efficacy of a combination of non-steroidal anti-inflammatory drugs (NSAIDs), ibuprofen and acetaminophen, in comparison to a morphine analogue substance (oxycodone) for pain management in the first 30 days after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing trapeziectomy for thumb osteoarthritis

English proficient,

Exclusion Criteria:

* Pregnancy

Current use of opioids

Concurrent surgeries (ex. trapeziectomy combined with carpal tunnel release)

Inability to complete study forms (education, cognitive ability, mental status, medical status)

Allergy or intolerance to Ibuprofen, Acetaminophen and/or Oxycodone

Liver or kidney dysfunction, abnormal liver enzymes restricting use of acetaminophen or ibuprofen

History of chronic heart failure, upper gastrointestinal bleeding or coagulopathy

History of complex regional pain syndrome
Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD.

A controlled randomized, open-label, multi-centre study evaluating if an immunosuppressive protocol, based on ATG-induction, once daily tacrolimus-dose (Advagraf®), mycophenolate mofetil and corticosteroid reduces the incidence of chronic lung allograft dysfunction (CLAD) after lung transplantation, in comparison with a standard cyclosporin-based protocol.

Study purpose:

To evaluate whether the use of a once-daily tacrolimus-dose regimen (Advagraf®), based on anti-thymocyte globulin (Thymoglobulin®) induction, mycophenolate mofetil (MMF) and corticosteroids, reduces the cumulative incidence of CLAD after de novo lung transplantation at 36 months, in comparison with a twice-daily cyclosporin-based protocol, otherwise identical between groups.

Eligibility Criteria:
Inclusion Criteria

1. Male or female lung recipients 18-70 years of age undergoing primary double (including size reduction) lung transplantation.
2. Patient willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 36 months.

Exclusion Criteria

1. Recipients of multiorgan transplant, and or previously transplanted with any organ, including previous lung transplantation.
2. Patients with hypersensitivity to, or other reasons to not be able to take the immunosuppressive drugs used in the study.
3. Donor lung cold ischemic time \> 12 hours.
4. Patients who previously have been treated with anti-thymocyte globulin preparations (e.g. ATG-Fresenius®, Thymoglobulin®).
5. Patients who are recipients of ABO-incompatible transplants.
6. Patients with platelet count \< 50,000/mm3 at the evaluation before transplantation.
7. Patients who are unlikely to comply with the study requirements.
8. Patients, and/or those receiving organs from donors, who are positive for HIV, Hepatitis B surface antigen or Hepatitis C virus.
9. Patients with donor greater than 75 years.
10. Patient who have received an unlicensed drug or therapy within one month prior to study entry or if such therapy is to be instituted post-transplantation.
11. Patient unable to participate in the study for the full 36-month period
12. Patients with any past (within the past 3-5 years) or present malignancy (other than excised basal cell carcinoma).
13. Females capable of becoming pregnant must have a negative pregnancy test prior to randomization.

Females are recommended to practice a medically approved method of birth control for the duration of the study and a period of 8 weeks following discontinuation of study medication, even where there has been a history of infertility
Comparison of Genicular Nerve Block and Intraarticular Injection for Postoperative Pain in Knee Arthroscopy

This prospective double-blinded randomized study will be conducted to compare ultrasound-guided intra-articular injection and ultrasound-guided genicular nerve block for postoperative analgesia after knee arthroscopy.

Arthroscopic knee surgery has become increasingly popular in modern orthopedics. Post-operative knee pain management has become a challenge to provide early relief and pain-free postoperative care to the patient.

Pain management has become a priority for management as a daycare procedure. Patients operated as a daycare procedure should have minimal postoperative pain which influences the timing of discharge. Pain is due to multifactorial causes such as irritation of free nerve endings of the joint capsule, synovial tissue, anterior fat pad.

Effective pain relief allows the patients to obtain early knee mobilization and optimal rehabilitation and thus improves patient satisfaction.

Postoperative pain after knee arthroscopy is commonly moderate to severe and can affect the patient's activity level and satisfaction.

In an effort to provide safe, effective, and long-lasting post-arthroscopy pain relief, many drug regimens were injected intra-articularly including local anesthetics alone or with additive drugs to prolong and improve the quality of postoperative analgesia.

Genicular nerve block (GNB) and ablation have been used for managing chronic pain from knee osteoarthritis with good success.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for unilateral knee arthroscopy surgery (ligament reconstruction, cartilage procedures, and diagnostic arthroscopic procedures)
* aged between 18 and 50 years
* of both genders,
* have ASA physical status I and II.

Exclusion Criteria:

* Revision knee arthroscopy,
* previous surgery or trauma to the knee,
* drug allergy,
* regular narcotic use,
* renal \&/ or hepatic impairments,
* neuromuscular diseases
* and coagulopathy disorders.
National Prospective Cohort for Monitoring Children With Severe Autoimmune Cytopenia.

This study aims to study prospectively the clinical and paraclinical evolution and prognostic factors of autoimmune haemolytic anemias, Evans syndromes and chronic immunological thrombocytopenic purpura of children in France.

These autoimmune haematological diseases are rare diseases affecting the child, often very young, and serious and potentially life-threatening. International literature data are scarce, and include individual cases or small series.

They do not allow to determine an optimal therapeutic strategy in case of escape from the first-line treatments. Existing treatments (long-term corticosteroid therapy, immunoglobulins, splenectomy, immunosuppressants, chemotherapies, and more recently anti-CD20 antibodies) are inconsistently effective, and often associated with serious side effects.

The seriousness of these diseases, the therapeutic difficulties, and the absence of a targeted research project in France, led to the implementation of this study.

This study aims to study prospectively the clinical and paraclinical evolution and prognostic factors of autoimmune haemolytic anemias, Evans syndromes and chronic immunological thrombocytopenic purpura of children in France.

Eligibility Criteria:
Inclusion Criteria:

* Age strictly below 18 years of age at initial diagnosis
* Affiliate child or beneficiary of a social security scheme
* Child residing in metropolitan France
* Diagnosis of autoimmune haemolytic anemias, Evans syndrome and / or chronic Immune thrombocytopenic purpura
* Free, informed, written and signed consent

Exclusion Criteria:

* Diagnosis of constitutional haemolytic anemia
* Diagnosis of platelet constitutional disease
Safety & Efficacy Study of the Adiana System for Women Who Desire Permanent Birth Control (Sterilization)

The purpose of this study is to demonstrate the safety \& efficacy of the Adiana Transcervical Sterilization System for women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes.

Participants who demonstrated to be bilaterally occluded by hysterosalpingogram (HSG) evaluations are allowed to rely on the Adiana System for pregnancy prevention and enter the Wearing Period of follow-up.

Secondary endpoints inlcude safety of device placement procedure and safety of device wearing. The adverse events recorded during the course of the study are entered under adverse events.

Eligibility Criteria:
Inclusion Criteria:

* • Women aged 18 to 45

  * Women who are seeking permanent contraception
  * Women who are at risk of becoming pregnant
  * Willing to risk becoming pregnant when relying on the Adiana device for contraception
  * Relatively normal uterine cavity, uterine wall thickness, and uterine size as demonstrated by pelvic sonography
  * Willing to keep a coital/menstrual log
  * Have at least one confirmed pregnancy and one living child
  * Monogamous relationship with a partner who has proven fertility
  * Sexually active (at least 4 acts of intercourse per month)
  * Willing to use alternate contraception (either a barrier method or oral contraceptive pills or other monthly, cyclic, hormonal birth control) during the three months following device placement prior to relying on the Adiana device for contraception
  * Willing and able to maintain in regular contact with the investigator
  * Women with regular, cyclical menses within 2 months prior to the device placement procedure
  * Able to provide informed consent

Exclusion Criteria:

* Women who are unsure of their desire to end their fertility
* Presence of gross genital infection, including sepsis
* Presence of chlamydia, gonorrhea or syphilis
* Presence of genital cancer (note: CIN1 is acceptable)
* Intra-uterine pathology which would prevent optimal access to the tubal ostium and intramural portion of the fallopian tube, such as large submucous fibroids or uterine adhesions
* History of chronic pelvic pain (present within the previous year), prior ectopic pregnancy, or fallopian tube surgery, or currently diagnosed severe dysmenorrhea, severe dyspareunia, endometriosis, adenomyosis, or pelvic inflammatory disease
* Women with unresolved tubal, ovarian or endometrial pathology
* Uterine neoplasia or precursors to neoplasia
* Dysfunctional uterine bleeding or intermenstrual bleeding within the prior three months
* Women who have not had at least two normal periods after the following events: irregular periods treated with oral contraceptives (or other monthly, cyclic, hormonal birth control) which have since been discontinued, IUD removal, childbirth, or termination of pregnancy
* Currently taking immunosuppressive medications including steroids
* Pregnancy
* Uterine perforation within the last 3 months
* Contraindications for surgical methods of sterilization
* Less than three months have passed since the last delivery or abortion
Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

The study will assess safety and tolerability of different doses of topical gel containing a new chemical entity, NVN1000, and the vehicle (gel without drug) applied to the face of healthy volunteers with high counts of Propionibacterium acnes. The test product will be applied once daily for 4 weeks. Exploratory measures include whether the topical product decreases the amount of a bacteria associated with acne (P. acnes).

This is a single center, observer blinded, randomized, multiple dose study with 3 doses of NVN1000 and vehicle applied once daily for 4 weeks. There are 4 arms to the study (3 active and 1 vehicle).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers
* Age 18 or older
* High degree of fluorescence of facial skin under Wood's lamp

Exclusion Criteria:

* Acute or chronic skin disorders
* Use of topical or systemic antibiotics within 4 weeks of study
* Concomitant use of nitroglycerin or other nitric oxide donor drugs
* Females who are pregnant, planning pregnancy or breast feeding
Effect of Procedural Variables on Outcome of Surgical Treatment of Vitiligo

ORSHFS grafts yielded lower cell counts than NCECS but the M-K ratio and resultant repigmentation did not show significant difference with better healing of the donor site. Compared to cryoblebs, CO2 gave more homogenous pigmentation. The acral sites showed better results using combination of donor NCECS and recipient cryoblebs.

Background: Melanocyte-keratinocyte suspension (M-K susp) is gaining popularity for vitiligo treatment. Few studies have addressed procedure-related variables.

Objective: To assess the effect of different M-K susp procedure-related variables on the clinical outcome in stable vitiligo.

Methods: This retrospective study included 40 cases with stable non-segmental vitiligo treated by M-K susp followed by narrow band- ultraviolet B phototherapy twice weekly. Donor site was either a skin graft in non-cultured epidermal cell suspension (NCECS) (34 cases) or hair follicle unit in Outer Root Sheath Hair Follicle Suspension (ORSHFS) (6 cases). Recipient site was prepared by either cryoblebbing (24 cases) or carbon dioxide (CO2)laser resurfacing (16 cases). Cell counts and viability were recorded in the cell suspensions, and tissue melanocytes and keratinocytes were examined by Melan A and Cytokeratin respectively. Assessment of repigmentation was done 18 months after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Stable non-segmental vitiligo

Exclusion Criteria:

* Active vitiligo
The Effectiveness of Acupressure for Managing Postoperative Pain and Anxiety in Patients With Thoracoscopic Surgery

The purpose of this study is to explore the effectiveness of acupressure for managing postoperative pain, anxiety, analgesia consumption, early ambulation, and comfort in patients with thoracoscopic surgery.

Thoracoscopic surgery is the surgical used to removal of a section or a segment of a lung lobe. One US national survey reported that 80% of patients undergoing pulmonary surgery experienced acute pain. 75-86% of these patients pointed out that experienced moderate, severe, or extreme pain, especially, on the 1st day after thoracoscopic surgery. However, inappropriate pain management after surgery is associated with limited the healing process, increased workload of heart, prolonged pulmonary rehabilitation, and increased medical costs, and can be a prediction of developing chronic pain. Acupressure is a nonpharmacological treatment for the management of postoperative pain. Recent studies have found that the application of acupressure is effective in decreasing operative pain intensity, morphine related side effects, and opioid consumptions after surgery. However, there was no further research about the role of acupressure applied to thoracoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* pulmonary lung disease and will be scheduled to undergo a thoracoscopic wedge resection, segmentectomy, or lobectomy.
* American Society of Anesthesiologist physical status of Classes I-II,
* both forearms without missing limbs or arteriovenous fistula
* ability to communicate in Taiwanese or Chinese, and
* agreement to participate in this study.

Exclusion Criteria:

* diagnosed as malignant neoplasm with lung meta,
* Had a stroke or peripheral vascular disease
* Platelet count less than 20 x 10\^3/mm\^3
* Using the patient controlled analgesia, and
* any known mental illness or memory dysfunction.