cyrilzakka/clinical-trials huggingface dataset:
Salpingectomy During Cesarean Section

Based on the accumulated literature, salpingectomy may significantly reduce the risk for ovarian cancer. If investigators can prove that there is no increase in surgical complications and morbidity during salpingectomy in CS, compared to tubal ligation, investigators can recommend for women who are interested in sterilization- salpingectomy during cesarean section .

Until recently, ovarian resection was considered the only option to prevent ovarian cancer. Recently new evidence showing that the fallopian tube itself may be the source of certain types of ovarian cancer. So salpingectomy, may offer some protection. However, the extent of this protection has not been determined. Therefore, and based on the foregoing, the investigators think there is an advantage in removal of fallopian tubes rather than tubal ligation Cesarean sections. Given the lack of evidence in the literature about the complications of this procedure, currently the investigators organize a study examines the rate of complications of salpingectomy compared to tubal ligation during cesarean section.

Therefore, the main objective of the study is to assess the incidence of intra-operative complications during cesarean section.

The effect of the procedure will be examined on the following indicators:

1. The duration of the operation,
2. The rates of bleeding during the operation as estimated by the surgeon,
3. hemoglobin before and after the surgery,
4. Rates of giving blood or after surgery
5. The technical difficulty in performing tubal resection according to surgeon assessment
6. The need for further surgical intervention

A secondary objective of the study is evaluating the long-term complications:

1. Assessment of pain intensity at three months after surgery
2. Evaluation of menopausal symptoms, three months after surgery
3. Test ovarian sonar and Doppler three months after surgery
4. Testing the value of AMH three months after surgery

Eligibility Criteria:
Inclusion Criteria:

* Women planned for cesarean section , according to medical or obstetric indication , and seek sterilization
* Women aged 30 and older
* Women who are capable to understand , read and sign an informed consent form

Exclusion Criteria:

* women aged less then 30 years
* women who disagree to participate in the research
A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study is to assess the comfort of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* Adults of either sex and any race diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)

Exclusion Criteria:

* Under 18
Surgical Ablation of AF Efficacy Trial

SAFE is an international multicentre RCT of concomitant surgical atrial fibrillation (AF) ablation in patients with paroxysmal or persistent AF undergoing cardiac surgery.

Atrial fibrillation (AF) affects more than 1% of the general population and is an important risk factor for stroke. AF prevalence increases with age, occurring in 10 to 15% of patients older than 80 years of age, which is important with the aging population. Of patients undergoing cardiac surgery, 10.8% have a history of AF. AF is believed to cause the left atrium to dilate and lose its transport function. AF significantly increases the risk of ischemic stroke of cardioembolic origin, but is also associated with heart failure and impairs quality of life. Although the causal relationship between the 2 clinical entities has not been fully elucidated, AF is believed to cause heart failure via several mechanisms.

Ablation of AF is the application of scars to the atrial tissue to disrupt faulty electrical signals that cause the arrhythmia. If surgical ablation of AF yields a benefit similar to catheter-based AF ablation, thousands of people undergoing cardiac surgery could benefit from this procedure each year. SAFE will be a landmark trial in cardiac surgery, definitely establishing surgical AF ablation's impact on cardiovascular outcomes. Cardiac surgery is the optimal setting to establish whether maintenance of sinus rhythm through AF ablation yields clinical benefit, and is a setting where sham-control is possible. This will not only provide evidence for the cardiac surgical patients but will bolster the evidence for ablation (catheter or stand-alone surgical) in other AF patients.

The intervention under investigation is concomitant surgical AF ablation which is compared to no surgical AF ablation. The primary outcome is hospital readmissions with heart failure during 4 years of follow-up. This study will enroll 2000 patients from 50 centres, globally. Patients will be followed at hospital discharge, 4 to 6 weeks after surgery, 6 months after surgery, and then at 6-month intervals until the final follow-up visit, for a median follow-up for 4 years.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Undergoing a clinically indicated cardiac surgical procedure: CABG, AVR, ascending aorta replacement, or combinations thereof;
* Documented history of paroxysmal or persistent AF
* Provide informed consent

Exclusion Criteria:

* Dominant atrial arrhythmia is atrial flutter;
* Documented left atrial diameter ≥ 6 cm;
* Previous cardiac surgery requiring opening of the pericardium;
* Patients undergoing any of the following procedures:

  1. Heart transplant
  2. Complex congenital heart surgery
  3. Sole indication for surgery is ventricular assist device insertion
  4. Mitral valve repair or replacement
  5. Tricuspid valve repair or replacement
* Patient resides in a long-term care facility
Using TRAP to Evaluate the Effect of Zometa on Bone Metastasis Due to Lung Cancer

The purpose of this study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases due to lung cancer.

The purpose of this research study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases. The blood test will look for a protein, called TRAP, which is released into the blood stream by the breakdown of bone. This study will compare the TRAP blood test with other blood tests for bone destruction.

Eligibility Criteria:
Inclusion Criteria:

* invasive lung cancer (small cell or non-small cell lung cancer)
* osteolytic bone metastasis determined by clinical exam, bone scan/XR
* age \> 18 years

Exclusion Criteria:

* concurrent malignancy with a second primary
* renal failure (serum creatinine \> 3mg/dl)
* pregnancy
* active rheumatoid arthritis
* intolerance to zoledronic acid
A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium

IPM 018 is a double-blind, randomized, placebo-controlled study conducted at one site in Belgium among 24 healthy, HIV-negative women to evaluate dapivirine release for 28 days from matrix and reservoir intravaginal rings, each containing 25 mg of dapivirine, and to assess safety and tolerability compared to placebo


Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 35 years of age
* Willing and able to give written informed consent
* Available for all visits and consent to follow all procedures scheduled for the study
* Healthy and HIV-negative as determined by a HIV-1 ELISA test at time of enrollment;
* Willing to abstain from sexual activity for the duration of the study
* Willing to use oral contraceptives to avoid menstruation while taking part in this study or on long-acting progestins for 6 months prior to enrollment
* Upon pelvic / speculum examination at enrollment, the cervix and vagina appear normal
* Willing to refrain from use of vaginal products or objects for the duration of the study.

Exclusion Criteria:

* History of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation, or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact compliance with protocol requirements;
* History of sensitivity / allergy to latex, dapivirine or to the constituents of the vaginal ring (i.e. silicone elastomer)
* Currently pregnant or breast-feeding, or within three months of last pregnancy outcome
* Currently or within one month of participating in any other clinical research study
* History or diagnosis of and / or treatment for a sexually transmitted disease within the last three months
* History of genital tract surgery within the last month
* Current diagnosis of sexually transmitted infections (Gonorrhea, Chlamydia and Trichomonas)
* Current vulvar or vaginal symptoms / abnormalities that could influence the study results
* History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last three months;
* Smoking more than 10 cigarettes per day
Ultrasound-Guided Aspiration of PTA vs Conventional Landmark Technique - a RCT

The study is a prospective randomized controlled trial conducted at two different centers at the Department of ORL - Head \& Neck Surgery, Odense University Hospital and the Department of Otorhinolaryngology, Head and Neck Surgery \& Audiology, Rigshospitalet.

The research question is:

In a group of patients referred to an otolaryngology department with objective findings of peritonsillar abscess, what are the effects of using intraoral ultrasound to diagnose and guide needle aspiration compared to the traditional landmark-based technique, when measured by the number of performed needle aspirations, procedure-related pain and days on sick leave?

The secondary outcomes measured are

* Number of hospitalization days
* Number of Quincy tonsillectomies
* Number of visits to an outpatient clinic
* Patient-reported outcome (measured using an 11-point numeric rating scale)


Eligibility Criteria:
Inclusion criteria:

* Patients referred to the Department of Otorhinolaryngology suspected for peritonsillar abscess
* Clinical findings of peritonsillar abscess by one of the following:

  1. Trismus
  2. Unilateral tonsillar/peritonsillar swelling

Exclusion criteria:

* Compromised airways or suspected retro / parapharyngeal abscess
* Needle aspiration of pus already performed (or participated in the study once earlier)
* Cannot understand the written information
The Role of Indocyanine Green to Identify Sentinel Lymph Node in Uterine Cancer

Endometrial cancer is the most common gynecologic malignancy in developed countries and the second one in developing countries following cervical cancer. The primary treatment for endometrial cancer involves total hysterectomy and bilateral salpingo-oophorectomy, with adjuvant radiotherapy and/or chemotherapy reserved for patients with advanced disease or who have risk factors for relapse. The tumor is confined to the uterus in 85% of endometrial cancers. Hence, it's controversial to perform systematic lymphadenectomy to all patients. The primary purpose of the present study is the to investigate the feasibility of sentinel lymph node determination in endometrial cancer patients operated via conventional laparoscopy. To determine sentinel lymph nodes cervical indocyanine green will be injected prior to the surgery. During the surgery using fluorescent imaging systems sentinel lymph nodes will be removed and examined by frozen section. Afterwards, systematic pelvic lymphadenectomy will be performed. In case of type II endometrial cancer, grade 3, metastatic sentinel lymph nodes or macroscopically enlarged paraaortic lymph nodes, paraaortic lymphadenectomy will also be performed. The secondary purpose of the study is to compare the conventional laparoscopy in sentinel lymph node mapping of endometrial cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of endometrial cancer
* Clinical stage I or II

Exclusion Criteria:

* Contraindications for operation (hematological or coagulation disorders)
* Advanced stage
* Pregnancy or puerperium
* Fertility preserving surgery
Clinical Investigation of Buttermere (LENS 271) Soft Contact Lenses

The purpose of the study is to compare clinical performance between two soft contact lenses.

The purpose of this study is to compare clinical performance of two soft contact lenses in a crossover study over a period of 7 days of wear.

Eligibility Criteria:
Inclusion Criteria:

i. Age 8 to 18 years; at least half the population will be children or adolescents aged 8 to 15 years.

ii. Have experience with soft contact lens wear and able to insert and remove soft contact lenses.

iii. Parent/guardian and participant have read and understood the Participant Information Sheet.

iv. Parent/guardian and participant have read, signed and dated the Informed Consent and Assent (when applicable).

v. Best corrected visual acuity of at least 20/25 in each eye.

vi. Have normal eyes with the exception of the need for visual correction.

vii. Spectacle refraction:

* Age 8 to 12: -0.75D to -4.00D spherical equivalent, with cylinder ≤ -0.75D and maximum anisometropia of \<1.00D
* Age 13-18: -0.75D to -7.00D spherical equivalent, with cylinder ≤ -0.75D and maximum anisometropia of \<1.00D.

viii. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule.

Exclusion Criteria:

i. Acute and subacute inflammation or infection of the anterior chamber of the eye.

ii. Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.

iii. Severe insufficiency of lacrimal secretion (dry eyes).

iv. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.

v. Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.

vi. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.

vii. Any active corneal infection (bacterial, fungal, or viral).

viii. The patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so.

ix. Newly prescribed use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator.

x. Monocular participants (only one eye with functional vision) or participants fit with only one lens.

xi. Subjects with slit lamp findings greater than grade 1 (e.g., edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980:2012, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit.

xii. History of herpetic keratitis, ocular surgery or irregular cornea.

xiii. Enrolment of the family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
Endoscopic Sclerotherapy and/or Ligation Versus Portacaval Shunt for Bleeding Gastric Varices

In unselected cirrhotic patients with bleeding gastric varices to compare the influence on mortality rate, duration of life, control of bleeding, quality of life, and economic costs of treatment of: portacaval shunt, endoscopic variceal sclerotherapy and/or variceal ligation.

BACKGROUND: In patients with cirrhosis, bleeding gastric varices (BGV) are associated with a high mortality rate, but have received much less investigation than bleeding esophageal varices. Various therapeutic measures have been used to treat BGV, including endoscopic, radiographic, and surgical procedures, but there have been few prospective evaluations of therapy involving sizable groups of patients that have received acceptable follow-up. Management of this serious disorder has been uncertain and often unsuccessful. Herein is a prospective randomized controlled trial in unselected cirrhotic patients with BGV that compared the effectiveness of endoscopic therapy (ET) and portacaval shunt (PCS) during follow-up for more than 5 years or until death.

STUDY DESIGN: 518 unselected patients with cirrhosis and BGV were randomized to ET or PCS performed as an emergency in 220 and electively in 298. All patients received the same diagnostic workup, initial therapy, post-treatment therapy, and rigorous follow-up. One-, 5-, 10-, and 15-year follow-up rates were 100%, 97%, 97%, and 92%, respectively. ET consisted of repetitive sessions of intravariceal injection sclerotherapy and/or variceal band ligation aimed at variceal obliteration. PCS consisted of a direct anastomosis, side to side in 95%. ET and PCS were compared specifically with regard to control of bleeding, survival rate, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* All patients with upper gastrointestinal bleeding (blood in the upper gastrointestinal tract) of a magnitude that required 2 or more units of blood transfusion and entered the emergency room directly, or were referred from an area hospital, or developed bleeding while in the hospital, and were shown to have cirrhosis of the liver, and were shown by endoscopy to have bleeding gastric varices, absence of bleeding from esophageal varices, and absence of any other lesion that could reasonably account for the bleeding were included ("all comers").

Exclusion Criteria:

* None
Incorporation of Photobiomodulation Therapy in an Exercise Program With Blood Flow Restriction for Knee Osteoarthritis

Knee osteoarthritis (OA) is one of the most common musculoskeletal disorders in the world. The aim of this project is to evaluate the additional effect of photobiomodulation therapy on the quadriceps muscle and knee joint in a blood flow restriction exercise program for individuals with knee OA. To this end, volunteers will be selected at random, aged between 40 and 65 years with pain in one knee, at least in the last 6 months, diagnosed with unilateral knee OA based on the criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification, will be randomized into the following groups: (Exercises with blood flow restriction, n = 20), (Exercises with blood flow restriction + photobiomodulation, n = 20) and Exercises with blood flow restriction + placebo photobiomodulation (n = 20). 12 consecutive weeks of treatment will be carried out, with the volunteers being evaluated before and after, using the following instruments: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), sit and stand test, Timed up and Go (TUG), numerical scale pain assessment (END), pain-to-pressure threshold (LDP), skin temperature: quadriceps musculature, knee joint and maximum voluntary isometric contraction (MVIC) of the muscles: quadriceps, middle gluteus. For data analysis, normality test will be used to verify the data distribution and statistical test consistent with the appropriate comparisons within and between groups, thus, two factors are considered in the comparisons, time and group. A significance level of 5% will be adopted.


Eligibility Criteria:
Inclusion Criteria:

* knee pain to at least six months and minimum of 4 points in pain scale
* diagnosis of unilateral knee OA based on criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification.

Exclusion Criteria:

* Score on the numerical visual analog of knee pain less than 1 or greater than 8;
* knee trauma;
* Cognitive impairment;
* Psychological disorder;
* Neurological disorder (sensory or motor);
* Cancer;
* Diabetes any acute adverse health condition;
* Signs of hip OA;
* Sings cardiopulmonary disease that could prevent exercise and use of a walking assist device.
* Have undergone any form of treatment involving: physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotectors in the last year.
* If the size of the circumference of the thigh and knee does not allow the proper positioning of the photobiomodulation mesh.
Neuropsychological Evaluation for Early Diagnosis of PSP

The aim of this study is to better understand the nature of the cognitive decline in Progressive Supranuclear Palsy, the time of its development and the relation with the other cardinal features of the disease.

Progressive Supranuclear Palsy (PSP) is a neurodegenerative disease characterized by vertical supranuclear gaze palsy, early balance dysfunction and falls. Tau-protein aggregation, mainly in the brainstem, is the disease hallmark. Because of the similarities with Parkinson's disease (PD), the diagnosis is made approximately 4 years after the symptoms onset. Cognitive deficits are a leading feature of PSP and they actually represent one of the four functional core domains in the revised diagnostic criteria. The aim of this study is to better understand the nature of this cognitive decline, the time of its development and the relation with the other cardinal features of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling the criteria for idiopathic PD
* Patients fulfilling the criteria for PSP

Exclusion Criteria:

* Any other neurodegenerative disorders or medical conditions different from PD / PSP
Acute and Chronic Metabolic Flexibility in Individuals Living With Obesity: The i-FLEX Study

Regular exercise is a cornerstone in the prevention and the management of cardio-metabolic risk factors. Some of the beneficial effect of exercise training occurs through metabolic flexibility' enhancement. Metabolic flexibility is the ability to respond or adapt to conditional changes in metabolic demand, and previous literature has shown that individuals living with obesity have an impaired metabolic flexibility compared to lean individuals. However, there is a lack of empirical evidence on the impact of sprint interval training on metabolic flexibility and whether this translates into clinically meaningful outcomes.

This study will evaluate the impact of 4-week sprint interval training in normal weight individuals as well as individuals living with obesity on acute and chronic metabolic flexibility, irisin secretion and insulin sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Adults (Ages 19-60)
* Physically inactive for individuals living with obesity (not meeting Canadian Physical Activity Guidelines)
* Normal Weight (BMI ≥ 18.5 \< 25.0 km/m2)
* Obesity (BMI ≥ 30.0 km/m2)

Exclusion Criteria:

* Individuals with Type 2 Diabetes.
* Individuals with impaired glucose tolerance.
* Individuals living with obesity that partake in regular exercise training / meet the Canadian Physical Activity Guidelines.
* Individuals with a condition or injury that may impact the ability to perform exercise or may be worsened by exercise.
* Individuals currently being treated with corticosteroids or atypical antipsychotics, as these agents significantly influence carbohydrate metabolism.
* have experienced \>10% weight loss or enrolled in weight loss program within six months of enrolment.
* require use of medication(s) known to affect insulin sensitivity or secretion within the last 30 days.
* Medication(s) known to cause weight gain.
* weight loss medication(s).