cyrilzakka/clinical-trials huggingface dataset:
Comparison of Subcuticular Suture Versus Surgical Staples for Closure of Pfannenstiel Skin Incisions

This study compares methods of closure for Pfannenstiel incisions commonly used during gynecological and obstetrical surgery. Patients are assigned to closure by either surgical staples or a buried suture. Information is collected on the day of surgery, post-operative day two and at the six-week follow up visit. The amount of pain and cosmetic result are compared. Infection rates will also be monitored for the two groups.

The study hypothesis is as follows: subcuticular (buried) sutures as compared to surgical staples lead to decreased post-operative pain and improved cosmetic result. Infection rates are similar for both groups.

There is little evidence in the literature to guide the choice of closure material for Pfannenstiel laparotomy. Currently this decision is based primarily on physician preference. Physicians differ greatly in their view on which is better. This is based on personal habit and experience and not on scientific evidence. Specifically in the field of obstetrics and gynecology there has only been one randomized trial of approximately 60 patients undergoing cesarean section comparing subcuticular suture vs surgical staples for closure of their Pfannenstiel skin incisions (Frishman et al., 1997). This study showed that Pfannenstiel skin incisions closed with subcuticular closure following cesarean section result in less postoperative pain and are more cosmetically appealing as compared to incisions closed with staples.

This randomized controlled study will compare closure of Pfannenstiel incisions using either subcuticular absorbable suture or surgical staples. It will examine two separate populations - those undergoing cesarean section and those undergoing gynecological surgery such as hysterectomy. These patient groups will be analyzed separately as their demographic characteristics tend to be quite different. The primary outcome will be postoperative pain. Cosmetic result will be a secondary outcome. Cosmesis will be rated both by the patient and the physician. Infection rates are also of great interest although it is unlikely that this study will achieve adequate power to show a statistically significant difference in results. Other outcomes of interest include overall patient satisfaction, total operating room time and length of hospital stay. Patient's body mass index will also be recorded and analyzed to determine whether it affects results in both intervention groups.

There will be a minimum of 144 patients total in the cesarean section group and 144 patients total in the gynecological surgery group - 72 randomized to staples and 72 randomized to subcuticular suture for each group. Thus the entire study will involve approximately 288 patients.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing gynecological or obstetrical surgery
* Pfannenstiel skin incision
Use of Granulocyte Colony-stimulating Factor for the Treatment of Recurrent Implantation Failure in IVF Patients

The investigators use granulocyte colony-stimulating factor (GCSF) for the treatment of recurrent implantation failure in IVF patient with cause unknown or due to thin endometrium. Several studies showed that GCSF improves embryo development and implantation and increase pregnancy rate.

The investigators use granulocyte colony-stimulating factor (GCSF) for the treatment of repeated implantation failure (5 cycles) in IVF patient with cause unknown or due to thin endometrium. we intend to treat with GCSF during the IVF cycle if thin endometrium (\<6 mm) is the cause for the treatment failure, and during the implantation window if cause unknown.

Eligibility Criteria:
Inclusion Criteria:

1. women after 5 failures in IVF cycles with cause unknown.
2. women after 5 failures in IVF due to thin endometrium (\<6 mm) and unresponsive to estrogen supplements.

Exclusion Criteria:

1. history of hematology disease
2. allergy to GCSF
3. neutrophilia
4. severe lower back pain
5. liver dysfunction
6. hyperuricemia
7. a recent febrile disease or pneumonia
8. rheumatoid arthritis 9. sickle cell disease-
Changes in Leukotrienes During Cardiac Surgery in Patients With Chronic Obstructive Pulmonary Disease

The hypotheses of this study are that:

* Production and release of inflammatory substances called leukotrienes are increased during heart surgery with use of a heart-lung machine in humans;
* The increase in these leukotrienes levels after heart surgery is higher in patients with bronchitis and/or emphysema than in patients without previous history of lung disease;
* Levels of leukotrienes are directly correlated with worsening of lung function during and after heart surgery.

In this project, we will test the hypothesis that cys-leukotrienes are released and correlated with the impairment of the lung function after cardiac surgery in patients with COPD. If such hypothesis is substantiated in the study, it would allow us to propose the use of leukotriene inhibitors in the peri-operative period to improve pulmonary function and to decrease complications after cardiac surgery in COPD patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients schedules to undergo cardiac surgery with use of CPB.

Exclusion Criteria:

* inability to provide consent;
* previous diagnosis of asthma;
* acute pre-operative respiratory failure;
* emergency surgery.
Irinotecan Liposome(II) Combined with Ivonescimab As Second-line Treatment for Small Cell Lung Cancer : a Prospective, Single-arm, Multicenter Clinical Study

This study will evaluate the efficacy and safety of irinotecan liposome(II) in combination with Ivonescimab as second line treatment for SCLC.

This is a prospective, single-arm, multicenter clinical study assessing the efficacy and safety of irinotecan liposome(II) in combination with Ivonescimab as second line treatment for SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years;
2. Histologically or cytologically confirmed SCLC;
3. Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors;
4. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
5. Life expectancy of ≥3 months;
6. At least one measurable lesion is present according to the efficacy evaluation criteria for RECIST 1.1（Lesions that have received radiotherapy within 6 months prior to the first dose cannot be used as target lesions）
7. No untreated central nervous system (CNS) metastases or CNS were stable for ≥1 month after treatment
8. Have adequate organ function;
9. All female must have had a negative serum pregnancy test within 72 hours of the first dosing and not be lactating, and study participants and their partners must use effective contraception during the trial and for 6 months after the last dosing of the trial drug.
10. Able and willing to provide a written informed consent;

Exclusion Criteria:

1. Known allergy to irinotecan hydrochloride liposome injection (II) and eboxizumab or drug excipients
2. History of severe active autoimmune disease
3. Participated in other drug studies within 4 weeks before enrollment
4. Imaging during the screening period showed that the tumor surrounded important blood vessels or had significant necrosis and voids, and the investigators determined that entering the study would cause bleeding risk
5. History of major illness within 1 year before the first medication
6. History of esophageal and gastric varices, severe ulcers, unhealed wounds, abdominal fistula, intraperitoneal abscess, or acute gastrointestinal bleeding within 6 months prior to initial administration
7. History of surgery or severe trauma within 4 weeks prior to initial dosing
8. Evidence and history of severe bleeding tendency;
9. Participants who had received or planned to receive a live vaccine within 4 weeks prior to the first study treatment
10. Patients with other cancer in 3 years,exceptions are adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
11. History of alcohol abuse, psychotropic substance abuse or drug abuse. Other conditions considered unsuitable for this study by the investigator.
The HAM Infliximab Study

An open-label, non-randomised, uncontrolled, proof-of-concept study of eight patients with 'definite' HTLV-I-associated myelopathy/Tropical Spastic Paraparesis (HAM/TSP). Eligible patients will have either early disease (of less than 2 years duration) or progressive disease (with observed clinical deterioration during the preceding 3 months.

Following 2 baseline assessments including Magnetic Resonance Imaging (MRI) of the spinal cord and a lumbar puncture for examination of the fluid around the brain (CSF) participants will be treated with a total of 7 infusions of the anti-TNF-alpha antibody infliximab over a period of 48 weeks. After the last on therapy assessment at 48 weeks participants will be followed up for a further 24 weeks. Study assessments will be clinical, virological, immunological and radiological. MRIs of the spinal cord will be obtained at weeks 12 and 72. CSF will be examined, on therapy, at week 12.


Eligibility Criteria:
Inclusion Criteria:

* Are able to give informed consent
* Are 16 years or older
* Have 'definite' HAM/TSP according to the criteria of "Definite HAM/TSP" agreed in Belem 200361
* Have early or progressing disease as defined here:

  * "Early HAM/TSP": Patients must have motor disability (minimum of stiffness or weakness) for less than 2 years. (Bladder symptoms if the original and only presenting symptoms as assessed by history are not included)
* "Progressing HAM/TSP"
* New or worsening motor symptoms in a patient with definite HAM of \> 2 years duration within the last 3 months

Exclusion Criteria:

* Hepatitis B or hepatitis C infection
* HIV infection
* Overt sepsis, abscesses or opportunistic infections
* Active TB (untreated or on treatment)
* Strongyloides stercoralis (untreated)
* Known hypersensitivity to inflixmab, other murine proteins or to any of the excipients
* Malignancy
* Moderate or severe heart failure (NYHA class III/IV)
* Pregnancy or breastfeeding
* Unhealed surgical wounds
* Planned impending surgery - treatment would be withheld for 2-4 weeks prior to major surgery and started/restarted post-operatively if no evidence of infection and wound healing is satisfactory
* Current immunosuppressive or immunomodulatory therapy
A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez

In patients with epidermolysis bullosa (EB), collagen does not form properly, so their skin is very fragile and blisters easily. Such patients are also at greatly increased risk of developing skin cancers. Filsuvez is a topical gel used to promote healing of skin lesions in patients with certain types of EB. In this observational study, patients with either dystrophic EB (DEB) or junctional EB (JEB) will receive standard of care treatment, whether Filsuvez or something else, and will be followed for up to 5 years. The main purpose is to see if the use of Filsuvez affects the likelihood of developing skin malignancies in these patient populations.

Some forms of EB are associated with a greatly increased incidence of aggressive skin and mucosal squamous cell carcinoma (SCC), as well as increased incidence of other skin malignancies including basal cell carcinoma (BCC) and malignant melanoma (MM). This long-term non-interventional study will assess all types of skin malignancies (SCC, BCC, and MM) in DEB and JEB patients. It is an observational study of real-world treatment practices, in which patients will receive standard of care therapy whatever that may entail. Data will be obtained from two sources: clinical study centers in the European Union (EU) and the United Kingdom (UK), and pre-existing EB registries in the EU. Participants will be followed for up to 5 years, and information about the development and nature of skin malignancies will be collected over this time period both from patients who are taking and those who are not taking Filsuvez.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of dystrophic EB or junctional EB

Exclusion Criteria:

* None
Comparison of Oxygenation and Ventilation With a Novel Nasal Mask Versus Standard of Care During Colonoscopy

Nasal continuous positive airway pressure (nCPAP) has been shown to effectively relieve upper airway obstruction in patients with OSA as it creates a pneumatic stent in the hypopharynx that reduces obstruction and allows for continuous oxygenation. Nasal ventilation was also proven to be more effective than combined oral-nasal ventilation during induction of general anesthesia in adult subjects. However, it is not clear if nasal mask can be used safely for oxygenation and ventilation in patients undergoing colonoscopy.

The SuperNO2VA™ device is a new commercially available nasal mask that provides both nasal CPAP and nasal mask ventilation. The objective of this study is to compare the efficacy of oxygenation and ventilation during colonoscopy using the novel nasal mask, SuperNO2VA™, and standard care with nasal cannula.

Colonoscopy has become an essential part of the patient management, especially in the field of colorectal cancer prevention. About 15 million colonoscopies were done in the United States in 2012. Data from United States and European countries suggest that the majority of investigations are performed with the aid of sedation. Since sedation can cause significant respiratory depression, resulting in hypoxia, especially in obese and elder populations who are more likely to undergo colonoscopy, usually oxygen is provided to patients via a nasal cannula to minimize the risk of hypoxia.

Nasal continuous positive airway pressure (nCPAP) has been shown to effectively relieve upper airway obstruction in patients with OSA as it creates a pneumatic stent in the hypopharynx that reduces obstruction and allows for continuous oxygenation. Nasal ventilation was also proven to be more effective than combined oral-nasal ventilation during induction of general anesthesia in adult subjects. However, it is not clear if nasal mask can be used safely for oxygenation and ventilation in patients undergoing colonoscopy.

The SuperNO2VA™ device is a new commercially available nasal mask that provides both nasal CPAP and nasal mask ventilation. The objective of this study is to compare the efficacy of oxygenation and ventilation during colonoscopy using the novel nasal mask, SuperNO2VA™, and standard care with nasal cannula.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older
* BMI of 30-50
* ASA 1-3 Scheduled for colonoscopy with sedation

Exclusion Criteria:

* Untreated ischemic heart disease
* Acute and chronic respiratory disorders, including COPD and asthma
* Emergent procedures
* Planned use of an invasive airway (ie: supra-glottic device, LMA, etc)
* Pregnant women
* Nasal or oral disease resulting in difficulty of either nasal breathing or mouth breathing
* Patient refusal
Effect of ZT-01 on Glucagon During Hypoglycemia in Type 1 Diabetes Mellitus

The purpose of this study is to determine whether ZT-01 increases the glucagon response to hypoglycemia in type 1 diabetes (T1D). ZT-01 is a specific somatostatin (SST) type 2 receptor antagonist hypothesized to increase the counterregulatory glucagon release during hypoglycemia, which is impaired in diabetes, and may thus reduce the occurrence of hypoglycemia.

Approximately 25 participants with well-controlled type 1 diabetes will be recruited to a crossover study and be randomized to the order in which they receive a single administration of placebo, low dose and high dose ZT-01 during three euglycemic-hypoglycemic clamps 2 to 6 weeks apart, with a follow-up visit approximately 1 week after the final clamp.

Participants will stay overnight in the clinic before each clamp, and their plasma glucose (PG) will be kept at euglycemic levels with IV insulin and dextrose as needed. The following morning, the clamp will begin and the subject's PG will be kept at 5.5 mmol/L (euglycemia) with variable IV insulin (and dextrose as needed). Study treatment will be administered during this euglycemic period, and then insulin will be increased so that PG falls to a plateau of mild hypoglycemia, and then increased further to clinically significant hypoglycemia. Release of glucagon and other counterregulatory hormones will be measured, and a symptom score will be completed, during euglycemia before and following study treatment, and during each level of hypoglycemia. Following the clamp, the participant's blood glucose will be returned to normal levels prior to leaving the clinic.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for at least 5 years and receiving insulin as the only T1D therapy
* HbA1c ≥6.0 and ≤9.0 %
* BMI ≥18 to ≤27 kg/m\^2
* Normal thyroid function

Exclusion Criteria:

* Impaired hypoglycemia awareness
* Severe hypoglycemia or diabetic ketoacidosis (DKA) within 3 months
* Abnormal blood pressure or ECG, clinically significant cardiovascular, cerebrovascular or peripheral vascular disease
* History of pheochromocytoma, insulinoma, glucagonoma, acromegaly, Cushing's disease, glycogen storage disease or adrenal insufficiency; ongoing or previous treatment with octreotide, lanreotide or pasireotide
* Current use of systemic corticosteroids or beta-blockers
Assessment of Ovarian Reserve After Laparoscopic Cystectomy Versus Aspiration/Electrocoagulation in the Treatment of Ovarian Endometrioma

This is a prospective, multicentric (three centers: 1: Shanghai First Maternity and Infant Hospital, Shanghai, China; 2: International Peace Maternity and Child Health Hospital, Shanghai, China, 3: Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai ,China), randomized clinical trial that includes patients undergoing laparoscopic surgery for primary unilateral ovarian endometriomas. Eligible patients will be subjected to transvaginal ultrasound before surgery to perform cyst classification (central type, marginal type and outcrop type). Patients are divided to two group: laparoscopic cystectomy group versus laparoscopic aspiration/electrocoagulation group. Biopsy samples in aspiration/electrocoagulation group and excision samples in cystectomy group are all subjected to histopathological examination. Follicular stimulating hormone (FSH), Anti mullerian hormone (AMH) and antral follicular count (AFC) will be measured pre-operative and post-operative.

The aim of the study is to determine whether and to what extent the two surgical procedures for ovarian endometrioma, cystectomy and aspiration/electrocoagulation, affect ovarian reserve. The investigators intend to confirm the clinical utility of ultrasonic classification of ovarian endometrioma, FSH, AMH and AFC in the assessment of ovarian reserve, and to promote their use in predicting decreased ovarian reserve.

The surgical excision of cystic wall, cystic fluid and peritoneal fluid will be subjected to transmission electron microscope, high resolution mass spectrometry and single-cell RNA sequencing to investigate their cellular and molecular features.


Eligibility Criteria:
Inclusion Criteria:

* Female with age between 18-40 years.
* Regular menstrual cycles
* Female diagnosed by ultrasound with unilateral ovarian endometrioma ≥4cm and ≤6cm.

Exclusion Criteria:

* Hormone, Gonadotropin-releasing hormone analogues or contraceptive therapy within 6 months before the current surgery and 6 months after surgery.
* Suspected or proven ovarian malignancy.
* Previous ovarian surgery.
* Evidence of polycystic ovary syndrome.
* Evidence of premature ovarian failure or premature menopause.
* Endocrinological diseases affecting ovarian reserve e.g. Diabetes mellitus, hypothyroidism.
* Pregnancy test is positive.
* Lactation.
* Unable or unwilling to give written consent.
Imaging Evaluation of Central Nervous Autoimmune Diseases

Multiple sclerosis (MS) is the most common demyelinating disease of the central nervous system and the most common cause of non traumatic disability in young and middle-aged people. Neuromyelitis optica spectrum disease (nmosd) is an independent disease different from Ms. the pathogenesis and the mode of brain and spinal cord injury are different from MS, and the prognosis and optimal treatment are different. It is difficult to distinguish the two diseases in the early stage. Early diagnosis and treatment of the two diseases can greatly improve the quality of life of patients. Therefore, it is an urgent problem to clarify the difference between MS and nmosd injury patterns and to find sensitive imaging markers for early clinical intervention. With the continuous progress of computer aided diagnosis (CAD), it is more and more widely used in medicine, which is expected to help solve the above problems.

The purpose of this study is to create a neuroimmune disease evaluation database based on image data. By combining brain and spinal cord imaging, and based on Zhang quantum space learning computer-aided technology, we can achieve accurate segmentation of MS and nmosd brain and spinal cord lesions, analyze the evolution characteristics of the disease at different time points, and screen the imaging indexes related to clinical scores combined with clinical and laboratory indexes Objective: to determine the different prognosis and its influencing factors at the clinical, imaging and molecular levels, and establish the model for predicting disease progression and prognosis, so as to provide the basis for early identification and assistance in guiding treatment and judging prognosis.

Clinical information was collected: age, gender, course of disease, MMSE, EDSS disability score, nine hole test, 25 foot walking test. Assess the patient's information processing ability. Blood samples were collected. Imaging examination was performed. The patients were followed up regularly.


Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years old;
2. Nmosd was diagnosed according to wingerchuk standard revised in 2015, MS was diagnosed according to McDonald standard revised in 2017, and 100 normal people were diagnosed;
3. In the acute stage, within 1 month of the onset or stable stage, there was no GD enhanced lesion on MRI, and EDSS score had no significant change within 6 months, which was more than 1 month from the last attack;
4. MRI examination was complete: baseline, 6 months, 1 year, 2 years;
5. Sign informed consent.

Exclusion Criteria:

1. The course of disease was more than 30 years;
2. History of brain injury or spinal cord injury;
3. History of central nervous system infection or immunodeficiency syndrome;
4. HBV, HCV patients, syphilis, HIV-1, HIV-2 patients;
5. Suffering from mental illness;
6. Pregnant and lactating women or patients planning to conceive within one year;
7. Unable to cooperate to complete the follow-up due to geographical or other reasons;
8. Patients also participated in other randomized controlled trials.