cyrilzakka/clinical-trials huggingface dataset:
A New Method of Surgically Treating Varicose Veins and Venous Ulcers - a Study to Assess Clinical and Economic Value

Varicose veins are a common problem, affecting up to a third of the western adult population. Most suffer with aching, discomfort, pruritis, and muscle cramps, whilst complications include oedema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding. This is known to have a significant negative effect on patient's quality of life (QoL).

Surgery has been used for many years, but it is known that there is a temporary decline in QoL post-op. This was demonstrated in our pilot study. Surgery leads to painful and prolonged recovery in some patients and has the risks of infection, haematoma and nerve injury.

Recurrence rates are known to be significant. Duplex of veins post surgery has demonstrated persistent reflux in 9-29% of cases at 1 year, 13-40% at 2 years, 40% at 5 years and 60% at 34 years.

26% of NHS patients were 'very dissatisfied' with their varicose vein surgery.

Newer, less invasive treatments are being developed. It would be advantageous to find a treatment that avoided the morbidity of surgery, one that could be performed as a day-case procedure under a local anaesthetic, a treatment that could offer lower recurrence rates and allow an early return to work. These should be the aims of any new treatment for varicose veins.

Endovenous Laser Treatment (EVLT) is performed under a local anaesthetic and uses laser energy delivered into the vein to obliterate it. The vein therefore need not be tied off surgically and stripped out.

The aim of this study is to compare the clinical, cost effectiveness and safety of Surgery and EVLT.


Eligibility Criteria:
Inclusion Criteria:

* Primary, symptomatic, varicose veins.
* Isolated Saphenofemoral junction (SFJ) incompetence leading to long saphenous (LSV) reflux on duplex ultrasound.
* LSV of 4mm diameter at the knee.
* Ability to give informed written consent.

Exclusion Criteria:

* Inability to give informed written consent.
* Symptomatic or complicated varicose veins not attributable to SFJ/LSV reflux.
* Evidence of deep venous reflux on duplex scan.
Ocular Surface Disease Changes After iStent or iStent Inject Implantation With Phacoemulsification

This prospective interventional single-arm trial evaluates measures changes in ocular surface disease parameters in eyes with mild to moderate open-angle glaucoma (OAG) on 1-4 glaucoma medications who undergo phacoemulsification and trabecular micro-bypass stent(s) implantation (iStent or iStent inject).

This study enrolled eyes with mild to moderate open-angle glaucoma (OAG) on 1-4 glaucoma medications who were scheduled to undergo phacoemulsification cataract extraction and trabecular micro-bypass stent(s) implantation (iStent or iStent inject). Study participation entailed measurement of key ocular surface data through 3 months postoperative including Ocular Surface Disease Index score (OSDI), corneal/conjunctival staining (Oxford Schema), fluorescein tear break-up time (FTBUT), and conjunctival hyperemia (Efron Scale); these measures were collected alongside standard postoperative glaucoma evaluations such as number of glaucoma medications and intraocular pressure (IOP).

Eligibility Criteria:
Inclusion Criteria:

1. Mild to moderate primary open-angle glaucoma
2. Currently treated with ocular hypotensive medication
3. Primary open-angle, pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
4. Subject scheduled to undergo cataract surgery in combination with one trabecular meshwork bypass stent
5. 22 years of age or older
6. Able and willing to attend scheduled follow-up exams for three months postoperatively
7. Able and willing to provide written informed consent on the IRB approved Informed Consent Form
8. Successful, uncomplicated cataract surgery
9. OSDI of 8 or more

Exclusion Criteria:

* 1. Primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma 2. Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:

  1. Cataract surgery
  2. Stent implantation
  3. Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits) 3. Fellow eye actively enrolled in this trial 4. Current participation in any study, or participation within 30 calendar days of screening exam 5. Unsuccessful, complicated cataract surgery 6. OSDI of 7 or less
Culturally Adapted iCBT for Arabic-speaking Refugee and Migrant Youth With Common Mental Health Problems

The aim of the current study is to explore whether culturally adapted internet-based cognitive behavioral therapy is effective in reducing the symptoms of various common mental health problems among Arabic-speaking refugee and migrant youth. We hypothesize that the symptoms of the psychological problems will significantly be reduced among youth who will receive iCBT compared to youth in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 15 and 29.
* A score above the cut-off 1.75 on HSCL-25
* Has a refugee or migrant background
* Has a good and stable internet connection
* Has access to a computer, a tablet or a smartphone
* Is fluent in reading and writing Arabic
* Has the ability to dedicate time to take part in the intervention for 6-10 weeks.

Exclusion Criteria:

* Is suffering from a severe mental illness, such as psychosis or severe depression.
* Is suffering from substance abuse
* Is undergoing a psychological treatment
* Has a high risk of suicide
Pain Relief Effects on Length of Labor

This study divides patients into two groups when they ask for medicine to help relieve the pain of contractions. One group will be selected to receive an epidural and another group will be selected to receive both a spinal dose and an epidural. The investigators will then measure how long it takes to deliver the baby. The investigators think that the group that has the combination spinal and epidural will have a faster labor.

In this randomized controlled trial, the investigators will evaluate conventional continuous lumbar epidural analgesia compared to the combined spinal-epidural analgesia. The primary outcome of interest will be duration of the active phase of the first stage of labor. Secondary outcomes include the cesarean delivery rate, operative vaginal delivery rate, analgesia requirements, maternal and neonatal safety profiles (incidence of maternal hypotension, post puncture dural headache, fetal acidemia and NICU admissions, respectively), Adequacy of maternal pain relief will also be measured using visual analog scores (VAS). The investigators hypothesize that the instantaneous pain relief that is achieved with combined spinal-epidural analgesia reduces catecholamines quickly and to a greater degree than the conventional epidural, leading to a more effective uterine contraction pattern thus decreasing the duration of the active phase of the first stage of labor.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women
* Term gestation, defined as equal to or greater than 37 weeks
* Ages 16-44 years
* Singleton gestation
* Cephalic presentation
* Induction of labor on Monday 0700 through Friday 0700 at Parkland Hospital
* Intact membranes on admission

Exclusion Criteria:

* Chorioamnionitis at randomization
* Intrauterine fetal death
* Coagulopathy
* Allergies to amide local anesthetics
* Localized back infection
Thyroid Surgery With the New Harmonic Scalpel: a Prospective Randomized Study

The objective of this study is to compare the results of total thyroidectomy using the new harmonic scalpel device (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE).

Although the harmonic scalpel has been shown to be safe and effective in thyroid surgery, several surgeons consider the previously available instruments to be large and cumbersome, especially in terms of tissue fine grasping and dissection capabilities. To this context, an innovative technical improvement of the device for thyroid surgery has very recently been implemented and has been made available in 2008. Utilization of this new device, however, has not been evaluated in any study. The objective of this prospective randomized study is to compare the results of total thyroidectomy using the new harmonic scalpel device (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE) in respect to hemostasis, operative time and postoperative complications. All patients submitted to total thyroidectomy are randomized into two groups: those submitted to total thyroidectomy using the FOCUS device (group Α) and those with HARMONIC ACE (group Β).

Eligibility Criteria:
Inclusion Criteria:

* total thyroidectomy

Exclusion Criteria:

* hemithyroidectomy
* additional surgical procedures together with the total thyroidectomy (i.e. parathyroidectomy or cervical lymph node dissection)
Treatment of Perianal Disease Using Adipose-derived Stem Cells

This study will compare healing and surgical outcomes in patients with chronic perianal disease treated with Adipose-derived Stem Cells (ASCs) to outcomes in patients treated in traditional surgical techniques without ASCs. The study will perform retrospective medical record analysis to clinically characterize patients that have undergone these surgical procedures and compare follow-up data and disease status to determine efficacy of treatment with ASCs compared to similar treatments without the use of ASCs. This will help determine overall efficacy of the treatment as well as determine patient characteristics that may predict treatment success. The study will also prospectively recruit patients with perianal disease that are planning to receive treatment with ASCs, and analyze their outcomes in the same way. Medical record review of outcomes in patients with perianal disease that received treatment with ASCs compared to those that did not will determine efficacy of this procedure.

Specific Aims:

1. Conduct a retrospective review of health information data from patients who have undergone surgery with a colorectal surgery attending at the University of California San Diego, including surgical treatment of perianal fistulas or other chronic perianal diseases, with or without injection of lipoaspirate containing adipose-derived stem cells. Patient data from December 2013 to April 1, 2018, will be obtained, with parameters including date of birth, sex, date of surgery, medical history, surgical history, laboratory values, perioperative data such as blood loss, length of surgery, operative complications, readmissions, and long-term complications and status of disease.
2. Conduct an observational study comparing outcomes of patients that plan to undergo treatment of perianal disease using ASCs compared to those that do not use ASCs. Patients identified as candidates for the procedure by the colorectal surgeons and are planning to undergo the procedure will give informed consent and be recruited into the study. Participants will undergo isolation of ASCs using the REVOLVE ™ System and injection of ASCs into perianal wounds. Clinical data will be analyzed to determine efficacy of the procedure as a means of treating perianal disease.
3. Use the above data to clinically characterize patients that undergo this surgical procedure and what patient characteristics may determine outcomes. Comparing follow-up data and disease status will determine efficacy of treatment with adipose-derived stem cells compared to similar treatments without the use of stem cells.

Eligibility Criteria:
Inclusion Criteria:

1. Adult men and women, age 18 years of age
2. Diagnosis of perianal disease with tissue defect or chronic wound
3. Underwent, or candidate for, surgery for perianal disease with colorectal surgery attending at UCSD
4. Any ethnic background
5. Any health status
6. Minimum of 30 days postoperative follow-up

Exclusion Criteria:

1. Pregnant women
2. Children less than 18 years old
3. Prisoners
Ciprofloxacin Utilization and Adverse Events Occurrence in Community Pharmacy Setting

Background: Ciprofloxacin is a fluoroquinolone that is commonly used to treat a variety of diseases. Ciprofloxacin resistance is rising, resulting in suboptimal patient care. The goal of this study was to evaluate ciprofloxacin use in the community in terms of acceptable prescription, dose, frequency, and duration of use.

Methods: A cross-sectional research was done in Egyptian community pharmacies by community pharmacists. Patients who were administered oral ciprofloxacin during the research period were included.

From September 2021 to February 2022, a cross-sectional, research was undertaken to evaluate ciprofloxacin usage. The investigation was carried out by community pharmacists in seven Egyptian community pharmacies.

Data Collection: data gathered from pharmacy patients' records on a data collection form that included the factors indicated. The General Symptoms Questionnaire, physical examination, and blood testing were used to identify adverse occurrences.

Study variables:

* age, gender, pregnancy/lactation
* Department/indication
* Dose, Frequency, Duration, Adverse events, Drug interactions.

Data was categorized and analyzed using appropriate software.

Eligibility Criteria:
Inclusion Criteria:

* All ciprofloxacin included prescription during the study period.

Exclusion Criteria:

* un included ciprofloxacin prescription.
Continuous Glucose Monitoring and Hypoglycemia Unawareness in Type 1 Diabetes

Looking for strict normoglycemia in type 1 diabetes increases the risk of hypoglycemia, exposing to hypoglycemia unawareness. It has been shown that the early correction of hypoglycemia can help recovering the perception of hypoglycemia. The purpose of this prospective study was to assess the value of sensor-augmented insulin-pump therapy to treat hypoglycemia unawareness.

To confirm hypoglycemia unawareness, patients answered a questionnaire based on the items explored by the model of Clarke 19 about hypoglycemia and hypoglycemia awareness. The eligibility of patients was confirmed by a blinded CG M recording using the trademark iPro ™ 2 sensor for 6 days. During this period the patient reported on a logbook the perception of their hypoglycemia, symptoms and how any hypoglycemia was corrected. Hypoglycemic manifestations were divided into adrenergic (shakiness, anxiety, palpitations, sweating, hunger, nausea, headache, coldness and pallor) and neuroglycopenic effects (impaired judgment, moodiness, paresthesia, emotional lability, confusion, ataxia, double vision, amnesia, seizures and lethargy). The confrontation of hypoglycemia detected by the blinded CG M and self-reported hypoglycemia validated the diagnosis of hypoglycemia unawareness.

Patients used the Paradigm® Veo™ pump and glucose sensors (trademark : Enlite®) with an hypoglycemia alarm set at sensor glucose value of 70 mg/dL while the LG S option was set to suspend insulin delivery at a sensor glucose value of 50 mg/dL or less. These thresholds allowed an active correction of hypoglycemia by the patient between 50 and 70 mg/dL. Patients were educated to use the system and to treat and manage hypoglycemia. Pump data were uploaded using the trademark Medtronic CareLink™ Management Software for Diabetes during visits at 10 days (D10), 2 months (M2) and 3 months (M3). Hypoglycemia awareness was assessed by an initial quiz that was repeated at M3 and 6 months (M6). A blinded CGM iPro ™ 2 was also realized at M3 to validate the modifications after sensor-augmented insulin-pump therapy.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* type 1 diabetes
* had been treated with insulin pump for more than three months
* had hypoglycemia unawareness with a hypoglycemia perception threshold below 60 mg/dL and/or had had at least one severe hypoglycemia event in the previous year

Exclusion Criteria:

* \> 18 years
* any serious disease that could interfere with the study
* pregnancy,
* incompatibility with monitoring,
* irregular management of diabetes,
* hearing loss and low vision,
* preventing them from using the devices
Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC

This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR for patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy for prevention or treatment of breast cancer.

This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR for patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy for prevention or treatment of breast cancer.The aim is to adhere to standard of care as much as possible to follow the pragmatic trial design to generate data that are applicable to today's practice. Therefore, surgeons are allowed to use their preferred Acellular Dermal Matrix (ADM), synthetic meshes, expanders and implants, thereby offering practitioners considerable leeway in deciding how to perform the procedure. For the same reason, both the one- and two-staged IBBR approaches are allowed when studying pre- versus sub-pectoral IBBR.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent according to ICH/GCP regulations prior to any trial specific procedures
* Patients undergoing NSM or SSM and IBBR in the therapeutic or risk-reducing Setting
* Ability to complete the Quality of Life questionnaires

Exclusion Criteria:

* No indication for IBBR according to clinical judgment of the treating surgeon
* Skin flaps inadequate for pre-pectoral IBBR.
Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients

The purpose of this study is to determine whether autologous bone marrow mononuclear cells transplantation after stroke is safe and/or effective to improve neurological outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cerebral embolism.
* NIHSS score is more than (or equal to) 10.
* On day 7 after onset of stroke, the improvement of NIHSS is less than (or equal to) 5, compared with the level at administration.
* Bone marrow aspiration can be done in 10 days after onset of stroke

Exclusion Criteria:

* Patient with cerebral hemorrhage or symptomatic hemorrhagic infarction.
* Patient who expects brain surgery.
* Patient with acute myocardial infarction.
* Patient with coagulation disorder.
* Number of Platelet \< 100000/mm3
* Serum creatinine level \>2.0mg/dl
* Patient with malignancy.
* Patient with uncontrolled proliferative diabetic retinopathy.
* Patient suspected infective endocarditis.
* HBV, HCV, HIV or HTLV positive
Standard Temodal (Temozolomide) Regimen Versus Standard Regimen Plus Early Postsurgery Temodal for Newly Diagnosed Glioblastoma Multiforme (Study P05572)

The primary purpose of the study is to evaluate the efficacy and safety of early postsurgery temozolomide chemotherapy followed by the standard temozolomide regimen, compared to the standard regimen alone, for the treatment of patients with newly diagnosed glioblastoma multiforme.


Eligibility Criteria:
Inclusion Criteria:

Only the patients who meet all these criteria can be enrolled in the study:

* Patients with prior histological confirmation of newly diagnosed primary glioblastoma multiforme in supratentorial cerebral hemisphere.
* Gross total resection or partial resection (imaging) \>70%.
* At least be capable to obtain a tissue sample for MGMT analysis during surgery.
* Chemo-radiotherapy to be expected from Week 5 (Day 29) after surgery.
* Age \>=18 and \<=70 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Life expectancy \>=9 months.
* Laboratory test values must satisfy the following criteria:

  * absolute neutrophil count \>=1.5 x 10\^9/L;
  * platelet count \>=100 x 10\^9/L;
  * hemoglobin \>=80 g/L;
  * blood urea nitrogen and creatinine \< 1.5 x upper limit of normal value (ULN);
  * total bilirubin and direct bilirubin \< 1.5 x ULN;
  * alanine aminotransferase and aspartate aminotransferase \< 3 x ULN;
  * alkaline phosphatase \< 2 x ULN.
* Patients must be willing to provide written informed consent.
* Patients of child-bearing potential (including female subjects and the female partners of male subjects) must use an effective method of contraception.

Exclusion Criteria:

Patients will not be enrolled if any of the following criteria apply:

* Patient with previous or current malignancies (except melanoma) at other sites, unless disease free for at least 3 years.
* Patient who received chemotherapy, radiotherapy for study indication, or other medications for antitumor indication prior to surgery.
* Patient with recurrent or multiple malignant glioma (including gliomatosis cerebri).
* Patient with metastatic lesions at the subtentorial or outside of calvaria.
* Patient who received chemotherapy or radiotherapy sensitizers for head or neck tumor.
* Patient who received radiotherapy at head or neck which leads to radiotherapy domain overlapping.
* Patient with acute infections requiring intravenous antibiotics.
* Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction).
* Known human immunodeficiency virus (HIV)-positive or acquired immune deficiency syndrome (AIDS)-related illness.
* Woman who is pregnant or breastfeeding.
* Patient with a history of hypersensitivity to temozolomide or other analogic alkylating agents.
* Patient with any other conditions under which investigators think the subject is not suitable for enrolment, such like having known that the subject may not have good compliance.
Study of Autologous Neo-Bladder Construct in Subjects With Neurogenic Bladder Following Spinal Cord Injury

Subjects with neurogenic bladder secondary to spinal cord injury that is refractory to medical treatment and requires augmentation cystoplasty will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will reduce maximum detrusor pressure.


Eligibility Criteria:
Inclusion Criteria:

* subjects with neurogenic bladders secondary to spinal cord injury

Exclusion Criteria:

* prior augmentation procedures or urinary diversion
* recent urologic or intraperitoneal surgery or device implantation
* recent history of spinal cord injury of less than a year
* recent neurologic surgery
* requirement for concomitant urological surgical procedures