cyrilzakka/clinical-trials huggingface dataset:
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair

This study investigates on the effect of two different operative techniques to treat abdominal wall hernias.

The goal of this clinical trial is to learn if the eTEP (Extended totally extraperitoneal repair) technique leads to a better outcome than the IPOM (Intraperitoneal onlay mesh) technique.

The main questions it aims to answer are:

* pain after the operation
* rate of complications
* rate of recurrence and reoperations
* quality of life.

Participants will:

Either be operated using the eTEP or the IPOM technique. Be followed up either in person or via email / phone call at day 1, day 7, day 14, 6 weeks, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patient age \>18 years
* Informed consent obtained
* Primary or incisional ventral hernia
* Epigastric, umbilical or infraumbilical ventral hernias with transversal diameter \>1cm and \</= 4cm, +/- rectus diastasis which doesn't demand specific treatment
* If multiple hernias: cumulative transversal diameter \</= 4cm
* Considered eligible for minimally-invasive approach

Exclusion Criteria:

* Subxyphoidal or suprapubic hernias
* precedent hernia treatment with mesh placement in the retromuscular space
* liver disease defined by the presence of ascites
* end-stage renal disease requiring dialysis
* need of an emergency surgery
* pregnancy
* need of rectus diastasis treatment intraoperatively

Criteria for participating surgeons

- Each participating surgeon has performed 20 or more laparoscopic IPOM procedures and 20 or more eTEP procedures.
Immediate Bonding and Caesarean Section

The randomised study analyzes the effects of immediate bonding (skin-to-skin contact) on different psychobiological and somatic outcomes of mother and child. The investigators compare 3 bonding conditions. Cortisol and Oxytocin are also measured during the bonding process.


Eligibility Criteria:
Inclusion Criteria:

* Mothers with elective Caesarean Section and their partners

Exclusion Criteria:

* premature birth
* severe diseases
* drug abuse
Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer

This study aims to assess the 6- and 12-month venous thromboembolism (VTE) and bleeding incidence from the start of cancer diagnosis in a retrospective cohort of patients with esophageal cancer. Additionally, the predictive value of the Khorana score and several other VTE and bleeding prediction scores and risk factors will be evaluated.

Patients with cancer are at high risk of venous thromboembolism (VTE), including deep-vein thrombosis and pulmonary embolism. For cancer patients receiving chemotherapy the incidence of VTE is even higher.

Several predictive models were previously developed to identify and justify thromboprophylaxis for cancer patietns who are at highest risk of VTE, like the Khorana and PROTECHT score. The Khorana score is a risk-stratification tool to select patients at high risk of VTE for thromboprophylaxis. The PROTECHT score takes cisplatin-based chemotherapy into account in addition of the Khorana score.

Thereby, the incidence of bleeding and VTE in patients with esophageal cancer is not clear.

This study aims to assess the 6- and 12-month venous thromboembolism (VTE) and bleeding incidence from the start of cancer diagnosis in a retrospective cohort of patients with esophageal cancer. Additionally, the predictive value of the Khorana score and several other VTE and bleeding prediction scores and risk factors will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Esophageal cancer patients
* Receiving chemotherapy
* Age at least 18 years old

Exclusion Criteria:

- Death \<3 months after cancer diagnosis (baseline)
Contribution of Hepatic and Intestinal Lipoproteins to Human Atherosclerosis

This study will use excess tissue from endoscopic or surgical procedures to examine the elements of plaque that are found in the carotid walls of patients who have a type of heart and blood vessel disease called atherosclerosis. Tissue will be collected from patients undergoing carotid procedures as well as patients undergoing liver and/or intestinal biopsies. This lab study will examine the different types of proteins that play a role in developing heart plaque.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Scheduled for a clinically indicated, standard-of-care carotid endarterectomy (CEA) OR scheduled for a clinically indicated, standard-of- care surgical, laparoscopic or endoscopic intestinal biopsy or excision OR scheduled for a clinically indicated, standard-of-care surgical, laparoscopic or endoscopic liver biopsy or partial resection/excision
* Ability and willingness to consent and Authorization for use of PHI

Exclusion Criteria:

* Age ≤18 years
* Inability or unwillingness to consent and Authorization for use of PHI
* FOR CAROTID PATIENTS - history of carotid trauma, that is determined by the Principal Investigator to significantly have changed the carotid tissue structure
* FOR CAROTID PATIENTS - history of middle- or large-vessel vasculitis, that is determined by the Principal Investigator to significantly have changed the carotid tissue structure
Outcome of Small Pupil Phacotrabeculectomy in Persons With Glaucoma and Cataract

Small pupils are not uncommon in situations requiring surgical intervention for glaucoma and cataract. Inadequate binocular view during combined trabeculaectomy and glaucoma surgery needs to be overcome by additional iris manupulations to dilate the pupils which increase the liklihood of inflammation, inraocular pressure rise after surgery and enhnced liklihood of failure of glaucoma surgery. The proposed trial is an observational study to analyse post operative outcome of eyes undrgoing trabeculectomy and phacoemulsification with intraocular lens implantation with small pupils in persons with glaucoma coexisting with cataract.

Small pupils are not uncommon in situations requiring surgical intervention for glaucoma and cataract. Inadequate binocular view during combined trabeculaectomy and glaucoma surgery needs to be overcome by additional iris manupulations to dilate the pupils which increase the liklihood of inflammation, inraocular pressure rise after surgery and enhnced liklihood of failure of glaucoma surgery. The proposed trial is an observational study to analyse post operative outcome of eyes undrgoing trabeculectomy and phacoemulsification with intraocular lens implantation with small pupils in persons with glaucoma coexisting with cataract

Eligibility Criteria:
Inclusion Criteria:

* Individuals with visually significant cataracts and medically uncontrolled primary open angle, angle clsoure, exfolaitive glaucoma

Exclusion Criteria:

* Complicated catracts and secondary glaucoma
Supraclavicular Blocks for Post-Operative Pain Control in Supracondylar Fracture Fixation, a Retrospective Analysis of Single Shot Catheter Techniques

We hypothesize that patients who receive a supraclavicular block via Angiocath, placed intra-operatively and dosed post-operatively following neurologic examination, will have lower pain scores, lower use of intravenous morphine equivalents in the post-anesthesia care unit, and lower rates of intervention for post-operative nausea and vomiting. We also hypothesize that patients receiving this nerve block had the same rates of nerve damage as the patients who did not receive a block and that there will be no demonstrable safety concerns with this block.


Eligibility Criteria:
Inclusion Criteria:

* Age under 18
* Undergoing supracondylar fracture fixation in operating room

Exclusion Criteria:

* Incomplete or inaccessable chart data
Study in Non-responder Hepatitis C Genotype 1 Patients With EMZ702, Pegylated Interferon and Ribavirin

The purpose of this study is to assess the safety and efficacy of repeated intravenous infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C genotype 1.

In this study, 28 patients with chronic hepatitis C genotype 1 who have failed previous treatment with pegylated interferon plus ribavirin will be treated. The study treatment will consist of the same type and doses of pegylated interferon and ribavirin to which the patient failed to respond plus EMZ702. EMZ702 will be administered intravenously twice a week during the first 12 weeks of treatment. Thereafter and according to viral response, patients will continue to receive pegylated interferon and ribavirin only for up to 36 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Hepatitis C virus (HCV) genotype 1
* Previous therapy with pegylated interferon and ribavirin
* Documented previous treatment failure

Exclusion Criteria:

* Hepatic dysfunction
* Coinfection with hepatitis B or HIV
* Other unrelated liver diseases
* Liver cancer
Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

This is a Phase III, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-TAZ vs. meropenem in the treatment of hospitalized adults with cUTI or AP.

Approximately 1004 hospitalized adult subjects (≥18 years of age) diagnosed with cUTI or AP will be enrolled in the study. The diagnosis of cUTI or AP will be based on a combination of clinical symptoms and signs plus the presence of pyuria

Subjects will be randomized in a 1:1 ratio according to an Interactive Response Technology (IRT) electronic system to receive either FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV every eight hours (q8h) or meropenem 1 g IV q8h. FEP-TAZ will be administered as 2 consecutive infusions of 2 g (1 g cefepime + 1 g tazobactam)

Eligibility Criteria:
Inclusion Criteria:

Meet the following clinical criteria for either cUTI or AP:

A. cUTI:

1. Have at least TWO of the following new-onset or worsening symptoms or signs:

   Fever (oral, tympanic, or rectal temperature \>38°C \[\>100.4°F\]), which must be observed and documented by a health care provider Nausea or vomiting Dysuria, increased urinary frequency, or urinary urgency Lower abdominal, suprapubic, or pelvic pain
2. Have at least ONE complicating factor

B. AP, defined as acute flank pain (onset within 7 days prior to randomization) or costovertebral angle tenderness on physical examination, plus at least ONE of the following new-onset or worsening symptoms or signs:

3. Evidence of pyuria within 48 h prior to randomization,

Exclusion Criteria:

1. Known or suspected disease or condition that, in the opinion of the investigator, may confound the assessment of efficacy.
2. Receipt of potentially-effective systemic antibacterial therapy within 72 h prior to randomization
3. Rapidly progressive or terminal illness with a high risk of mortality due to any cause, including but not limited to acute hepatic failure, respiratory failure, or septic shock, such that the subject is unlikely to survive the study period
Investigation of the Usability of the Dynamic Scaffolding System

The aim of the present study was to compare the duration of use of the Dynamic Scaffolding System (DSS) in children with different levels of motor impairment, to report adverse events during use, and to examine parental satisfaction. One hundred children with special needs aged between 9 and 108 months who had used the DSS device for at least 6 months and their parents were included in the study. The duration of daily use of the DSS device by the children, any adverse events during use, and parental satisfaction were assessed using the Quebec 2.0 Assistive Technology User Satisfaction Assessment Questionnaire.

Children with special needs with mobility difficulties use various assistive devices to benefit from the beneficial effects of standing upright and moving. These devices have beneficial effects on improving children's motor skills and increasing their social interaction and participation. In addition, during the use of assistive devices, there are some limitations related to size, weight, usability, mobility, and adaptability to children. Considering these limitations, the Dynamic Scaffolding System (DSS) device was developed. The DSS device aims to position children with moderate to severe mobility impairment vertically (standing and sitting) and to step with support. The aim of the current study was to compare the duration of use of the Dynamic Scaffolding System (DSS) device in children with different levels of motor impairment, to report adverse events during use, and to examine parental satisfaction. One hundred children with special needs (60% cerebral palsy, 40% other diagnoses: genetic, metabolic, neuromuscular diseases) aged between 9 and 108 months (mean 44.94±17.59) and their parents (94% mother, 6% father) who had used the DSS device for at least 6 months were included in the study. Data were collected from the participants via telephone interview. Demographic data such as age, gender, diagnosis, and level of motor impairment were recorded. Children's daily use of the DSS device, any adverse events during use, and parental satisfaction were assessed using the Quebec 2.0 Assistive Technology User Satisfaction Assessment Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Children with motor disabilities

Exclusion Criteria:

* If children did not use Dynamic Scaffolding System for less than one month
Radiofrequency Ablation of the Superior Cluneal Nerve

Low back pain is one of the most common musculoskeletal disorders affects individuals at least one during lifetime. Chronic low back pain (CLBP) lasts more than 3 months and decreases quality of life and causes work loss all over the world. Most common causes of Chronic Low back pain (CLBP) are lumbar disc herniation and/or degeneration, degenerative facet joints and sacroiliac joint pathologies, However, superior cluneal nerve (SCN) entrapment is another cause of CLBP that is ignored. It was reported that Superior cluneal nerve entrapment prevalence is % 1,6 - % 14 in CLBP patients. The Cluneal Nerves originate from the cutaneous branches of the dorsal ramus at T11-L4 and SCN innervates the skin of the upper part of the gluteal region. The nerves pass over the iliac crest through a tunnel formed by the thoracolumbar fascia and the upper edge of the iliac crest, that is the entrapment area. There are methods such as nerve blocks, neuromodulations and surgery in resistant cases. However, SCN entrapment is an overlooked diagnosis that should be considered in differential diagnosis.

Recently, radiofrequency ablation (RFA) of the SCN was performed under fluoroscopic guidance, total of 78% of patients reported nearly full analgesia for an average of 3 months. Although ultrasound-guided imaging and blocking of SCN is well described, there was not enough study that shows the effectiveness of ultrasound-guided SCN RFA and compares it to conventional physical therapy (CPT) in the treatment of CLBP.


Eligibility Criteria:
Inclusion Criteria:

1. Suffering from chronic low back pain more than 3 months
2. Age ≥ 18
3. VAS score ≥ 3/10
4. According to the blood samples, there should not be any detected bleeding diathesis (INR ≤1.2)
5. Patients detected positive 'iliac crest sign' included in the study

Exclusion Criteria:

1. Patients have pain score \<3 according to the Visual Analog Scale (VAS)
2. INR \>1.2 in blood samples
3. Radicular pain accompanying progressive neurological deficit
4. Sphincter disorder due to neurologic conditions
5. Local infections
6. Sepsis
7. Malignancy
8. Uncontrolled diabetes or other comorbidities leading general condition disorders
9. Allergic history related to used materials
10. Pregnancy
11. Mental disorders worsen cooperation were excluded from the study.
Safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration : A Prospective Study

The purpose of this study is to find all kinds of complications and it's frequency related to the Endobronchial Ultrasound- Transbronchial Needle Aspiration (EBUS-TBNA) and to evaluate associated risk factors in patients who developed complications. The investigators performs EBUS-TBNA examination on all subjects that need mediastinal evaluation. All complications during or after the procedure will be recorded prospectively.


Eligibility Criteria:
Inclusion Criteria:

* Mediastinal lymph node enlargement on chest CT or PET-CT

Exclusion Criteria:

* Inadequate oxygenation during procedure
* uncontrolled cardiac arrythmia
* Bleeding diathesis
* Severe thrombocytopenia
* Recent use of clopidogrel
* Uncooperative patients
Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients

The primary objective of this Post-Marketing Study is to monitor the safety of a novel smoking cessation drug Varenicline (Champix™) 0.5 mg and 1 mg tablets as used in clinical practice for 12 weeks among Filipino smokers.

The secondary objective is to further evaluate the effectiveness of Varenicline (Champix™) as an aid in smoking cessation based on the 7-day point prevalence of smoking cessation

The study will enroll smoking patients.

Eligibility Criteria:
Inclusion Criteria:

* Smoking adults aged ≥ 18 years intending to quit tobacco use who are prescribed Varenicline (Champix™) by their Physicians and those who are prescribed with Varenicline (Champix™) for the first time.

Exclusion Criteria:

* Subjects in whom varenicline (Champix™) may be taken in a manner that is not according to the approved local product document.
* Pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception
* Subjects with known hypersensitivity to varenicline.
Ultrasound vs. Predetermined Distance Techniques for Paravertebral Nerve Block in Patients Having Breast Surgery

The purpose of this study is to compare ultrasound and predetermined distance techniques for finding the paravertebral space to inject the local anesthetic (numbing medicine) when you are given anesthesia for surgery. The paravertebral space is located on either side of the spinal cord and contains the nerves that provide sensation to the chest wall. The predetermined distance technique is a series of measurements taken to determine the location of the paravertebral space where the local anesthetic is injected. The ultrasound technique uses direct visualization of the local anesthetic being placed in the paravertebral space. This type of anesthesia has many benefits including decreasing your pain after breast surgery.


Eligibility Criteria:
Inclusion Criteria:

* Females age 25 - 85
* ASA Physical status I-III
* Scheduled for primary mastectomy
* Ability to give informed consent

Exclusion Criteria:

* Allergy to:

Local anesthetics Fentanyl Hydromorphone Propofol Midazolam

* Patient refusal
* Infection at the injection site
* Peripheral Neuropathy
* Bilateral breast surgery
* Prior thoracic surgery on surgical side
* Severe spinal deformity
* Coagulopathy
Study of orBec® as Monotherapy in the Treatment of Patients With Upper GI Symptoms Caused by Chronic Graft Versus Host Disease (GVHD)

Use of an oral topically-active glucocorticoid with limited side effects may control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.


Eligibility Criteria:
Inclusion Criteria:

* Receipt of allogeneic hematopoietic cell transplant \>100 days prior to consent
* Documented cGVHD as defined by the NIH consensus criteria in at least one organ system other than the GI tract (for example, cGVHD of the oral cavity would qualify as a criterion)
* Endoscopic findings consistent with GI GVHD
* Must be able to swallow tablets
* Must be able to read and understand informed consent
* Adequate birth control methods for the duration of the study

Exclusion Criteria:

* \>500 mL/day of diarrhea on any 1 day within 3 days prior to the first dose of study drug
* GI infection
* Multi-organ failure or other condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
* HIV seropositivity
* Pregnant or nursing female
* Use of any investigational drug to treat chronic GVHD within 28 days of the first dose of study drug
* Evidence of recurrent or progressing malignant disorder that was the indication for HCT
Long-Term Treatment of Collagenous Colitis With Budesonide

The aim of the trial is to examine the effect of budesonide treatment on collagenous colitis. All patients is treated for 6 weeks with budesonide and thereafter randomised to 24 weeks treatment with placebo or continued budesonide. The end poit is effect on clinical symptoms (number of daily stools)


Eligibility Criteria:
Inclusion Criteria:

* Histological criteria of Collagenous colitis
* Clinical activity (\> 3 stools/day)

Exclusion Criteria:

* Treatment of Collagenous colitis within the last 3 months
Transdermal Fluid Removal in Fluid Overload

The proposed study seeks to explore the possibility of significantly increasing the success rate (from the current rate of 28%) of clinically significant Transdermal Fluid Removal (TFR) in heart failure patients. It seeks to further understand the device and patient characteristics influencing successful clinically relevant fluid removal and to measure any patient-defined benefits. It also wishes to explore the patient experience of the removal.

Fluid overload is distressing and is particularly prevalent in patients with vital organ dysfunction such as in kidney and heart disease. Due to the patient's inability to remove excess wastes and water, these accumulate in their body fluid compartments. Such excess fluid and toxins have to be removed with high dose diuretics (water tablets or injections) or by frequent dialysis. Treatment with diuretics is effective initially in some patients but is fraught with risks and side effects. The retained fluid and wastes are mainly lodged within the extracellular compartment (interstitial or tissue fluid) and exert deleterious effects on cell functions. Much of this excess fluid collects relatively superficially within the skin, especially in the lower extremities or other dependent body parts as oedema.

The proposed study seeks to explore the possibility of significantly increasing the success rate (from the current rate of 28%) of clinically significant Transdermal Fluid Removal (TFR) in heart failure patients. It seeks to further understand the device and patient characteristics influencing successful clinically relevant fluid removal and to measure any patient-defined benefits. It also wishes to explore the patient experience of the removal.

Principal aim of the research: To investigate whether the TFR device can remove clinically viable or relevant volumes of fluid transdermally in advanced heart failure and other patients with significant oedema. "Clinically viable" volume is defined as the removal of 200ml or more of fluid in a session of up to 10 hours (or 0.43 ml/h per 1cm2 of the skin area treated with microneedles).

Eligibility Criteria:
Inclusion Criteria:

* Participants aged \>18 years
* Diagnosis of heart failure
* Presence of visible oedema

Exclusion Criteria:

* Inability to give consent
* Patient on warfarin or simthrome (acecoumarol) with International Normalised Ratio (INR) \>3 or other bleeding disorders
* Extensive skin disease, infected or broken skin over intended study area
* Pregnancy NB: Patients with pacemakers or implantable cardiac devices (ICD) may be recruited but will not have bioimpedance measurements