cyrilzakka/clinical-trials huggingface dataset:
Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy

The aim of this study is to assess:

1. Evaluation of the feasibility of laparoscopic nerve sparing radical hysterectomy type III/C1 as regard surgical technique, blood loss and operative time.
2. Evaluate patients' outcome as regard bladder function.

in order to preserve the function of the bladder and the rectum, it is necessary to modify the traditional procedures, so as to identify the precise anatomical information directing the technique for optimal preservation of bladder function at the time of radical hysterectomy.

The laparoscopic technique offers several well-known advantages. Under the magnified view of the laparoscope, the anatomy can be clearly visualized to allow for the meticulous and precise dissection of the para-cervical structures and areolar tissue, including the blood vessels and the nerves.

Laparoscopic identification (neurolysis) of the inferior hypogastric nerve and inferior hypogastric plexus is a feasible procedure for trained laparoscopic surgeons who have a good knowledge not only of the retroperitoneal anatomy but also of the pelvic neuro-anatomy as this qualification could prohibit long-term bladder and voiding dysfunction during nerve-sparing radical hysterectomy


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years.
2. Karnofsky \> 80, or American Society of anaethesiology (ASA) I-II
3. Stage IA2-IB1-IB2-IIA1-IIA2-IIB cervical cancer according to FIGO (International Federation of Gynecology and Obstetrics) staging.
4. Stage II, III endometrial cancer

Exclusion Criteria:

1. Non Invasive Cancer
2. Pregnancy
3. Bladder dysfunction detected prior to surgery.
4. Previous pelvic lymphadenectomy.
5. Tumour recurrence
6. Incomplete surgery, unresectable lesion.
Realistic Models of Gastrointestinal Bioelectromagnetism

The purpose of this study is to look at the electrical activity present in healthy and diseased smooth muscle of the intestines; and develop both mathematical and computer models.

The Superconducting QUantum Interference Device (SQUID)is a large cylinder machine located in a large shielded room that measures magnetic activity of the intestines. Subjects will be asked to lie underneath and get recordings of the electrical activity of their intestines. They will also be asked to have a CT scan done. From these two procedures, the mathematical and computer models will be developed to determine the difference between normal bowels and those that do not have adequate blood supply.

Eligibility Criteria:
Inclusion Criteria:

* Normal subjects and those with diseased bowel

Exclusion Criteria:

* Subjects with claustrophobia
Co-Administration of MK-4618 With Antihypertensive Agents (MK-4618-010)

This study will evaluate the safety and tolerability of MK-4618 when coadministered with antihypertensive agents and will evaluate changes in blood pressure following co-administration of MK-4618 with a beta blocker and a vasodilator. The primary hypothesis of the study is that MK-4618 does not result in a clinically meaningful change in systolic blood pressure relative to placebo when co-administered with a beta-blocker or with amlodipine.


Eligibility Criteria:
Inclusion Criteria:

* Male or female not of childbearing potential
* Not a nursing mother
* Must be on stable dose of a beta blocker (Panel A only) or amlodipine (Panel B only) for the treatment of hypertension for at least 6 weeks prior to enrollment. Must take the designated daily dose of metoprolol or amlodipine for the duration of the study
* In good health other than hypertension
* Nonsmoker
* Participant has a resting systolic blood pressure \<150 and \>95 mmHg and a diastolic blood pressure \<95 and \>75 mmHg at prestudy clinical evaluation

Exclusion Criteria:

* Any illness that might confound the results of the study or pose a risk by participation
* History of orthostatic hypotension (decrease in blood pressure upon standing accompanied by symptoms of lightheadedness or dizziness)
* History of cancer, excepting certain skin or cervical cancers or cancers that were treated successfully 10 or more years prior to screening
* Condition for which there is a warning, contraindication, or precaution against the use of extended release metoprolol (Panel A) or amlodipine (Panel B)
* Consumes excessive amounts of alcohol or caffeine daily
* Has multiple and/or severe allergies (including latex allergy) or has had an anaphylactic reaction or significant intolerance to drugs or food
* Uses illicit drugs or has a history of drug abuse
Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis

The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with ankylosing spondylitis

Golimumab is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body, and this substance may cause long-term inflammation. Golimumab may help fight disease by blocking the activity of TNF in the body and reducing inflammation and pain. Each patient who is allowed to join the study will be put into a group randomly, like flipping a coin. Patients may get either golimumab or placebo (which looks like the drug being studied but has no active ingredients, for example a sugar pill). The chance that the patient will get golimumab is 1 to 1, so 50% chance to receive golimumab and 50% change to receive placebo. Patients who do not have an improvement in total back pain and morning stiffness at the Week 16 visit compared to when the patients entered the study, and are in Group 1 (placebo group), will receive golimumab 50 mg every 4 weeks starting at Week 16. If the patient is in Group 2 (golimumab 50 mg), they will continue to receive golimumab every 4 weeks starting at Week 16. If the patient is in Group 1 and still receiving placebo injections, because there was improvement in total back pain at Week 16, they will receive golimumab 50 mg every 4 weeks starting from Week 24. If the patient is in Group 2 (golimumab 50 mg) or are already receiving golimumab injections at week 24, they will continue to receive golimumab every 4 weeks. Safety will be monitored throughout the study, including drawing blood and looking at laboratory tests, vital signs (eg, blood pressure), and the frequency and type of adverse events (side effects). The patient will be in the study approximately 56 weeks. Patients will receive placebo or active compound (golimumab 50 mg subcutaneous injections) every four weeks until Week 48.

Eligibility Criteria:
Inclusion Criteria:

- Have a diagnosis of definite akylosing spondylitis for at least 3 months

* Have symptoms of active disease at screening and at baseline
* no active infections

Exclusion Criteria:

* Have other inflammatory diseases that might confound the evaluations of benefit from the golimumab therapy
* Have complete ankylosis of the spine
* Have a history of latent or active granulomatous infection
* Have had a serious infection, or have been hospitalized for an infection, or have been treated with intravenous (IV) antibiotics for an infection within 2 months prior to first administration of study agent.
Mynx M5 One Hour Ambulation Study

The Mynx Vascular Closure Device (Mynx M5) is a sponge-like material used to close the hole in the artery after patients undergo a diagnostic endovascular procedures

Key Inclusion:

1. Patients \>18 yrs of age
2. Patient underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath via the common femoral artery.
3. Patient is able to ambulate (routinely walk 6 meters or 20 feet without assistance for any reason) as assessed by investigator.

Eligibility Criteria:
Inclusion Criteria:

* Patient is \> 18 years of age
* Patient underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath in the common femoral artery
* Patient has been informed and understands the nature of the study and provides written INformed COnsent approved by the appropriate Institutional Review Board (IRB) prior to enrollment
* Patient is able to ambulate (routinely walk 6 meters or 20 feet without assistance for any reason) as assessed by the investigator

Exclusion Criteria:

Pre-Procedure Exclusion Criteria

* Patient had a prior surgical procedure, PTA, stent placement, or vascular graft in the common femoral artery
* Patient has a bleeding disorder such as thrombocytopenia
* Patient has uncontrolled hypertension
* Patient is morbidly obese (BMI \>40 kg/m2
* Patient is pregnant or lactating
* Patient has a documented INR \>1.5 or patients currently receiving glycoprotein IIb/IIIa platelet inhibitor
* Patient has a known severe allergy to contrast medium
* Patient has a known allergy to PEG
* Patient is unable to ambulate at one hour secondary to a co-morbid condition
* Patient is know to require an extended hospitalization or re-hospitalization (e.g.patient is undergoing coronary artery bypass graft (CABG) surgery) or patient is scheduled to have a CABG surgery \<30 days following the procedure

Intra-Procedure Exclusion Criteria

* Common femoral artery is \<5mm in diameter
* Patient with clinically significant peripheral vascular disease in the vicinity of the puncture
* Puncture site is located above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks
* Patient has a posterior puncture or multiple punctures in an attempt to gain access
* Patient has an ipsilateral venous sheath
* Patient has a pre-existing arterial bleed/extravasation identified on pre-procedure femoral arteriogram, hematoma, pseudoaneurysm or arteriovenous fistula present prior to sheath removal
* Patient has intra-procedural bleeding around the access site prior to sheath removal
Anti-CEACAM5 ADC M9140 in Chinese Participants With Solid Tumors (PROCEADE-CRC-02)

The purpose of this study is to evaluate the safety and early clinical activity of M9140 in Chinese participants with locally advanced or metastatic colorectal cancer (CRC).


Eligibility Criteria:
Inclusion Criteria:

* Participants with documented histopathological diagnosis of locally advanced or metastatic CRC, who were intolerant/refractory to or progressed after standard systemic therapies for the advanced/metastatic stage that included and are restricted to a fluoropyrimidine, irinotecan, a platinum agent (e.g. oxaliplatin), an anti-EGFR agent (if clinically indicated, i.e. RAS/BRAF wt), and an anti-VEGF agent. Participants may have received previous treatment with trifluridine/tipiracil and/or regorafenib or fruquintinib, if locally indicated and available. Participants with a known MSI-H status must have received treatment with an immune checkpoint inhibitor (if locally indicated and available) unless contraindicated
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1
* Participants with adequate hematologic, hepatic and renal function as defined in protocol
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participant has a history of malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years)
* Participants with known brain metastases, except those meeting the following criteria: Brain metastases that have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment; No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
* Participants with diarrhea (liquid stool) or ileus Grade \> 1
* Cerebrovascular accident/stroke (\< 6 months prior to enrollment)
* Other protocol defined exclusion criteria could apply
Combined Endophthalmitis and Orbital Cellulitis in Patients With Novel Coronavirus Disease (COVID-19)

To report on cases presented with combined endophthalmitis and orbital cellulitis as a first presentation of covid-19 infection.

This observation case series study included 5 patients referred to the Ophthalmology Department, Minia University with severe ophthalmic manifestations in the form of combined endophthalmitis and orbital cellulitis. On doing the work-up of covid-19 infection according to the recommendations of Egyptian Ministry of Health, patients proved to be infected by the novel Corona virus. In addition to the Corona work-up, all patients were subjected to full ophthalmological evaluation, ocular ultrasound and orbital CT examination.

Eligibility Criteria:
Inclusion Criteria:

* Patients with endophthalmitis and orbital cellulitis with covid-19

Exclusion Criteria:

* Patients without endophthalmitis and orbital cellulitis.
* Patients with endophthalmitis and orbital cellulitis not having covid-19 infection.
Treatment of Severe Fear of Childbirth With CBT, Comparison of ICBT With Traditional Live Therapy

The purpose of this project To study the efficacy of Internet-based guided self-help program of Cognitive Behaviour Therapy (ICBT) compared to traditional individual live CBT in a group of women with severe fear of childbirth (S-FOC). The treatment groups are compared with a control group receiving individual support at their antenatal clinics.

In Sweden, every year, about 6000 pregnant women suffer from severe FOC with consequences for the women's psychological health before, during and after birth, the way they manage the childbirth, and for their postpartum mother-child interaction.

In this project we want to examine the effect of CBT on SFOC given in two different ways. We compare these results with a group receiving support given traditionally on the clinics. But also a group without S-FOC. In case there is a significant effect of CBT, that is comparable given live as well as ICBT, we should have developed an adequate way of treatment that could be implemented in ordinary health care.

Hypothesis: S-FOC decreases in same extent (30 units on the W-DEQ) in both of the treatment groups. The group with S-FOC,that gets treatment as usual is consuming more healthcare than the groups receiving therapy.

One hundred and twenty pregnant women with severe fear of childbirth (S-FOC) according to their sum score on the Wijma Expectancy/Experience Questionnaire (W-DEQ vers. A) ≥85, and 40 women without S-FOC (W-DEQ \<85) are recruited at 7 participating clinics in Sweden. In a first baseline measuring phase 40 women with S-FOC and 40 women without S-FOC are followed as control groups, receiving, if necessary, treatment according to the local routine. In the intervention part of the study 80 women with S-FOC are randomized either into ICBT or live CBT.

1. ICBT is as effective as traditional live therapy.
2. ICBT is as efficient as traditional live therapy

   .
3. The effect will remain after the childbirth The successful therapy leads to

   * less fear after childbirth
   * less traumatic events during delivery
   * less cesareans or instrumental deliveries
   * less postpartum depressions
   * less appointments in urgency during pregnancy
   * better Mother-child relation at 3 months
   * better self-estimated quality of life

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in 16-30weeks of pregnancy at time for enrolment
* Able to read and write Swedish language
* having the possibility to use the internet during the therapy.

Exclusion Criteria:

* Suicidal, psychotic or schizophrenic symptoms.
* Not motivated to work with their fear.
* Ongoing psychological therapy because of fear of childbirth
* Non Swedish- speaking women
BReLLS: A Prospective Belgian Registry on Laparoscopic Liver Surgery

Setting up a Prospective Belgian National Registry of patients undergoing minimally invasive liver resections will allow the constitution of a national network able to get updated information on indication and results. Data will be of great importance for additional scientific projects aimed to clarify the role of minimally invasive approach in surgical liver pathology, especially malignancies.

During recent years we saw over the world a consistent growth of laparoscopic liver surgery (LLS), essentially due to progress of the surgical techniques, technology and diagnostic imaging. During the Louisville conference on LLS (2008) the technique was thoroughly described and defined. One of the most important statements was the promotion of national registries, taking into account the logistics and feasibility problems of randomized trials in this setting. The main purpose to hold a Belgian national registry is to define the role of LLS in our country, looking for short and long-term outcomes, especially in case of liver tumors.

In Belgium approximately 1000 liver resections are performed each year, however, the rate and results of LLS are unknown. The prospective data collection will highlight the role and incidence of LLS. Eventually, the registry will serve as support for scientific projects on different topics.

The evolution of the national practice will be measured by looking to the ratio between laparoscopic and open procedures registered in the electronic CRF (eCRF) in a single center during a time period.

The registration of additional parameters (as per below) will be necessary for comparing outcomes between conventional and laparoscopic techniques.

The registered cases will be recorded prospectively and consecutively.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing hepatic resection with minimally invasive approach (laparoscopic and robotic assisted)
* minimum age of \> or = 18 years
* Signed informed consent.
* Cysts deroofing
* Laparoscopic resections combined to ablation procedures
* Ablation procedures (RFA, MWA, other)

Exclusion criteria:

* Laparoscopic staging procedures of the liver with/without intraoperative ultrasonography and/or biopsy.
* Solely others therapeutic procedure of the liver (RFA, MWA, PV ligation, etc.)
Coroflex® ISAR NEO PMCF Study

International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.

The objective of this international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Coroflex® ISAR NEO coronary stent system Sirolimus Eluting Stent in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Eligibility Criteria:
Inclusion Criteria:

Coroflex® ISAR NEO is intended to be used for

* Patients must be at least 18 years of age AND
* The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment AND
* Patients with Novo lesion length 2-4 mm AND
* Informed consent signed

Exclusion Criteria:

* Patients with express refusal by the patient to participate in the study.
* Patients pregnant women and lactating women.
* Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4).
* Patients with contraindications or hypersensitivity to sirolimus.
* Patients with a life expectancy of less than 2 years.
* Patients included in other clinical trials.
Long-Term Outcome of Children and Adolescents With Anti-Phospholipid Antibodies

This is a study about why some people have certain types of proteins in their blood, called anti-phospholipid antibodies. The presence of these antibodies and associated complications (e.g. blood clots) are known to change over time. The purpose of this study is to evaluate these changes and improve our ability to determine the long-term outcome of affected individuals.

Aim:

1. Determine the incidence, and time frame, for aquiring aPL in a cohort of aPL-negative pediatric SLE subjects.
2. Determine the incidence, and time frame, for developing a first APS-associated complication among SLE subjects with detectable aPL.
3. Determine the incidence, and time frame, for developing a second APS-associated event among subjects with a history of an APS-associated event.
4. Determine the incidence, and time frame, for developing SLE among subjects with a history of an APS-associated event in the absence of SLE.
5. Identify laboratory and clinical predictors for the events described in aims 1-4.Research Design and Methods:

This is a prospective cohort study to determine the risk of developing aPL or APS-related symptoms in a young group of SLE and APS subjects. Patients will be followed over a ten year period and will undergo annual serologic and clinical evaluations to identify disease progression.

Eligibility Criteria:
Inclusion Criteria:

Age: Less than 21 years at baseline exam

* Diagnosis: patients must meet criteria for one of five diagnostic categories based on classification according to three parameters; aPL positivity, APS criteria, and SLE criteria.

The five diagnostic categories are:

* SLE with no aPL
* SLE with aPL, but without manifestations of APS
* SLE-like APS
* SLE with APS
* Primary APS.

Exclusion Criteria:

* none
Effects of Head Elevation on Intracranial Pressure in Children

Head injury is the most common cause of mortality and acquired disability in childhood. It is common to elevate the head of patients at risk for increased intracranial pressure, although it is not clear if it is always beneficial. Every severe pediatric traumatic brain injured patient will have an optimal head position that prevents rising pressure in the brain.

Head injury is the most common cause of mortality and acquired disability on childhood. Management of children at risk for intracranial hypertension is both complex and increasingly controversial. Also, effect of head position on intracranial pressure, cerebral perfusion pressure, adn cerebral venous outflow in the pediatric population has not been studied. We will examine the effect of head positioning on ICP, CPP, and cerebral venous outflow in pediatric patients at risk for intracranial hypertension. The hypothesis is that ICP will be reduced with improvement in cerebral venous outflow by each patient having their own optimal head position.

Eligibility Criteria:
Inclusion Criteria:

* Neonates, children, and adolescents
* Intracranial pressure monitor in place

Exclusion Criteria:

* Severe multiorgan system failure
* Hemodynamic instability sufficient to preclude changes in head position