cyrilzakka/clinical-trials huggingface dataset:
Comparison of Endoscopy and Diffusion-weighted Enterography-MRI for the Diagnosis of Crohn's Disease Recurrence Following Ileocolic Resection: a Pilot Study

Nearly three-quarters of patients with Crohn's disease have small bowel involvement and 80% of them will have complications that will require a surgical procedure, usually an ileocolonic resection with ileocolonic anastomosis. The rate of recurrence at the anastomosis site and in the ileum after surgery, whether symptomatic or not, is high, at least 60% in one year and 80% within three years. The gold standard for monitoring being ileocolonoscopy, endoscopic surveillance is recommended in these patients, once between 6 to 12 months after surgery and then every 2 years.

The MRI enterography is a validated technique for the assessment of small bowel Crohn's disease. The enterography MRI is a validated technique for the assessment of small bowel Crohn's disease. The MRI enteroclysis was evaluated in two studies compared to endoscopy, with excellent performance in terms of recurrence detection sensitivity and suggested as an alternative to it to avoid an invasive procedure repeated in these patients. The MRI enterography (without enteroclysis) does not provide as good distension of the bowel loops as MRI enteroclysis because it relies on the principle of oral ingestion prior to the examination of large amounts of liquid. However, it is much better tolerated by the patient, does not involve radiation that exists with enteroclysis, is much simpler to use and requires no special equipment to magnetic fields.

Determine the diagnostic performances of MRI enterography for the diagnosis of recurrence at the anastomosis site and in the ileum in patients with Crohn's disease who have had ileocolonic resection.

Assess the value of diffusion sequences of MRI enterography for the diagnosis of recurrence at the anastomosis site and in the ileum in patients with Crohn's disease who have had ileocolonic resection.

Eligibility Criteria:
Inclusion Criteria:

* patients with Crohn's disease
* patients with ileocolonic resection more than 6 months ago and less than 4 years ago
* patients with indication of ileocolonoscopy
* patient consenting to participate to the study
* patient enrolled in the national healthcare insurance program
* patient older than 18 years

Exclusion Criteria:

* patients with contraindications for MRI
VITAMIN E, C and ZINC IN PATIENTS WITH SKIN CANCER: INFLUENCE ON OXIDATIVE STRESS AND INFLAMMATORY STATE

The objective of this study was to evaluate the effects of supplementary antioxidant therapy on the levels of biomarkers and inflamatory citocines in patients with a previous history of non-melanoma skin cancer treated with surgery. This was a double-blind, randomized, placebo-controlled trial. Patients were randomized into two groups, one receiving placebo (n=34) and the other receiving supplementary antioxidant therapy (n=26) with vitamin C (50 mg), vitamin E (60 mg), and zinc (40 mg) for 60 days. Blood samples were obtained from patients, and the levels of oxidative stress biomarkers, including 8-isoprostane, nitrite, thiobarbituric acid reactive substances, and total antioxidant capacity, were measured, as well as the inflamatory citocines (IL-1, IL-6, IL-10, TNF alfa) and it was evaluated at two different times: (1) one day before the start of supplementation or placebo administration and (2) at 60 days after intervention. Statistical analyses were performed with the SAS System for Windows 9.3 program and data were analyzed using ANOVA for repeated measures test.


Eligibility Criteria:
Inclusion Criteria:

* patients who had non-melanoma skin cancer (squamous cell carcinoma or basal cell carcinoma) and who were treated with surgery
* age ≥20 years
* absence of comorbidities such as type 1 diabetes, severe heart disease, hepatic dysfunction, renal failure requiring dialysis, HIV infection, and melanoma skin cancer
* no history of chemotherapy or radiotherapy in the previous 6 months
* absence of severe psychiatric disease that limited comprehension
* not taking any vitamin and/or mineral supplementation.

Exclusion Criteria:

* subjects did not complete the entire course of supplemental therapy.
The Effect of Saline Irrigation in the Peritoneal Cavity at Cesarean Delivery

The investigators hypotheised that irrigating the abdominal cavity with saline at the time of cesarean delivery will increase Gastrointestinal System Disfunction without maternal infectious morbidity(especially febril morbidity).


Eligibility Criteria:
Inclusion Criteria:

1. Elective cesarean delivery
2. Gestational age greater 38 weeks

Exclusion Criteria:

1. chorioamnıonıtıs
2. type 1 diabetes mellitus
3. placenta previa and acreata
4. prior severe gastrointestional disease
5. emergency cesarean delivery
Osteopathic Manipulation Therapy in the Treatment of Interstitial Cystitis

As a safe and noninvasive method of treatment, the intent of the study is to show that Osteopathic manipulation therapy is a beneficial treatment for the aggravating bladder symptoms seen in all patients with interstitial cystitis.

The management of interstitial cystitis is predominantly based on the reduction of the symptoms of frequency, urgency, and pain.In addition to Osteopathic manipulation Other conservative treatments frequently include dietary modification, pharmaceuticals, bladder training, neuromodulation, and stress reduction. The goal of Osteopathic manipulation is to relax the pelvic muscles used by the bladder and improve the flow of blood and lymph fluid to this region, which may result in easing pain and discomfort associated with cystitis.Some physicians have found that Osteopathic Manipulation works for some people as an alternative to surgery. A secondary objective will be to determine if the increased attention and power of touch are as effective as OMT in treating patients with interstitial cystitis based on the results of using attention control treatment in some patients.Thus, this is a pilot study comparing OMT to an attention control arm and standard of care arm of treatment.We will review palpatory visceromatic reflex changes as documented by tissue texture changes, asymmetry, restriction of motion and tenderness pre and post treatment.Physical examination including detailed musculoskeletal examination of the lumbosacral region will be performed pre and post and then compared the results.

Eligibility Criteria:
Inclusion Criteria:

* The criteria for treatment is that the patient must exhibit symptoms of IC for at least one year and have a known diagnosis based on history and clinical findings including glomerulations of the bladder wall seen on cystoscopic examination.

Exclusion Criteria:

* Patients who are not eligible are those who have contraindications to OMT such as hypersensitivity to palpation, indurations or mass/tumor, adenopathy, cancer, or local infection
Robotic Utility for Surgical Treatment of Groin Hernias

The purpose of this study is the measurement of the evolution of the operation time during the start-up phase of robotic-assisted surgery for the treatment of inguinal hernia's of 50 patients treated in Maria Middelares in laparoscopic rTAPP technique.

Minimally invasive hernia repair by laparoscopy is the standard treatment in adult patients in Maria Middelares, Ghent. A previously conducted study demonstrated that the symptoms of patients with inguinal hernias (verified via EuraHS Quality of Life score) can be effectively treated and the technique has a low recurrence rate and low frequency of long-term side effects.

Robot-assisted laparoscopic surgery has become standard in urology for resection of the prostate carcinoma. In general abdominal surgery, a large group of surgeons are currently working on the introduction of robotic-assisted surgery for resection of colon and rectal cancer in their daily practice. The third generation robot (DaVinci Xi), has extended the applicability of this technology within the field of general surgery.

For the surgical treatment of hernia's and other abdominal wall defects (umbilical or/and incisional hernia's), currently only surgeons in the US have experiences in structured treatment programs.

From September 1, 2016 Maria Middelares hospital will introduce robot-assisted surgery, including the laparoscopic TAPP inguinal hernia repair.

Main obstacles to the introduction of robot technology in abdominal wall surgery are prolonged preparation time in the operating room required for installation of the robot, and higher material costs related to the robot-assisted surgery. However, there are few precise data available on the exact size of extra time or increased costs related to the introduction of robotic assisted surgery in a program for abdominal surgery.

The purpose of this study is the measurement of the evolution of the operation time during the start-up phase of robotic-assisted surgery for the treatment of inguinal hernias by 50 patients in Maria Middelares hospital.

Eligibility Criteria:
Inclusion Criteria:

* 50 patients selected and operated by the PI.

Exclusion Criteria:

* patients under the age of 18
* pregnancy
* BMI \> 35
* recurrent groin hernia
* no Informed Consent
Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia

Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to accelerate neutrophil recovery and decrease the risk of febrile neutropenia and infection in patients receiving chemotherapy for acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic myeloid leukemia (CML), or high-risk myelodysplasia (MDS). In this study, the safety, tolerability and activity of CLT-008 administered after "standard of care" cytarabine-based consolidation or induction/re-induction chemotherapy will be determined by monitoring for adverse reactions, infusion reactions, graft-versus host disease (GVHD), neutrophil and platelet recovery, hMPC persistence, infections and complications.


Eligibility Criteria:
Key Inclusion Criteria:

* Hematological malignancy, including:

  * AML, ALL or MDS
* Planned treatment with cytarabine-based chemotherapy regimen
* Adequate hepatic, renal, hematologic, cardiac and respiratory function

Key Exclusion Criteria:

* Prior allograft or history of active GVHD within 3 years
* Pregnant or nursing
Family Preparation Study For Withdrawal of Mechanical Ventilation From Their Family Member

Using the self-regulation theory, an intervention to prepare families for that experience was developed. This study will assess the impact of the intervention on a family's evaluation of their preparation and their short-term coping. The site used for this study will be the Trauma and Life Support Center (TLC), University of Wisconsin (UW) Hospital. After a decision has been made to withdraw life support, a member of the TLC staff will approach the next of kin of the patient to inform him/her about the study and inquire about his/her interest to participate. Using an experimental design, 10 family members will be assigned to the control group and 10 to the intervention group. Upon agreement, a research nurse will use a "coin toss method" for group assignment of the subjects until there are ten in each group. Experimental group subjects will receive the intervention after the family meeting. Demographics of the next of kin will be collected at this time. Patient information such as demographics, diagnosis, and time of withdrawal and death will be collected too. Two to four weeks after death, a telephone interview will be conducted with the next of kin using the "Evaluation of the Experience of Withdrawal" questionnaire and the Profile of Mood State - shortened version.

Potential benefits are that the families will be prepared for the experience of the dying patient, which will help them cope better during withdrawal and after their loss. There are no major risks to the subjects but there might be an increase in psychological distress.


Eligibility Criteria:
Inclusion Criteria:

* Next of kin of a patient who will have withdrawal of life support
* Participant must be 18 years of age or older and read, write, and speak English

Exclusion Criteria:

* Family is unusually highly emotional
* Patient will be a living donor
* Patient is conscious
The Effectiveness of Covered Stent Viabahn and Drug-coated Balloon for Complex Femoropopliteal Artery Lesions

The purpose of this study is to evaluate the effectiveness of the covered stent Viabahn in treating long de novo femoropopliteal lesions (stenosis ≥ 25 cm, total occlusion ≥ 15 cm) or in-stent restenosis compared to drug-coated balloons (DCB) with or without a bailout bare nitinol stent.

This is a multicenter, observational prospective cohort clinical trial with clinical and image follow-up for two years post-procedure. Approximately 200 subjects will be enrolled into a Viabahn group (observe arm) or drug-coated balloons (DCB) group (contrast arm); Each group will include 100 patients.

All enrolled patients will be followed up for 12 and 24 months to assess the incidence of restenosis by duplex ultrasound and major adverse events. Follow-up visits occur at 12 and 24 months, as well as telephone visits after 1, 3,6 and 9 months.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is ≥ 18 years old.
2. Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
3. The patient is willing to comply with specified follow-up evaluations at the specified times.
4. The patient presented a score from 2 to 5 following Rutherford classification.
5. The patient has a projected life expectancy of at least 24 months
6. Subject has a de novo or restenotic lesion with ≥ 70% stenosis in femoropopliteal artery, and for de novo lesion, the total lesion length ≥ 25cm, or chronic total occlusion (CTO) length ≥15cm.

Exclusion Criteria:

1. Patients with known hypersensitivity or contraindication to any of the following medications: Contrast media, Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
2. Pregnant women or Female patients with potential childbearing
3. Patients who exhibit acute intraluminal thrombus at the target lesion vessel
4. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
5. The patient is currently participating in another investigational drug or device study that interferes with the study
A Comparison of Two Exercise Programs on Knee Motor Control

Pain at the front of the knee is a common condition treated by physical therapists. Treatment may consist of generalised strengthening exercises directed at the quadriceps muscle or specific retraining aimed at restoring motor control at the knee. This study compared these two exercise programs in a group of people who were painfree at the time to evaluate their effect on motor control. It was hypothesised that only the motor retraining program would influence motor control at the knee.


Eligibility Criteria:
Inclusion Criteria:

* aged between 16-40 years, with the upper age limit to reduce the likelihood of osteoarthritic changes in the patellofemoral joint
* a self-reported history of anterior or retropatellar knee pain with insidious onset of symptoms and with at least one episode of pain in the past 12 months where pain was aggravated by at least two of the following: prolonged sitting, stairs, squat, running, kneeling and hopping/jumping
* currently asymptomatic for at least 8 weeks prior to assessment
* delay in the onset of VMO EMG relative to that of VL of greater than 10 ms during either the ascent or descent of a stair stepping task

Exclusion Criteria:

* current knee pain
* history of knee surgery or other knee injury in previous 12 months
* physiotherapy treatment for knee pain in the past 12 months
* history of patellar dislocation/subluxation
* clinical evidence of meniscal lesion, ligamentous instability, traction apophysitis around the patellofemoral complex, patellar tendon pathology, chondral damage, osteoarthritis and spinal referred pain
* current lower limb pathology affecting their ability to satisfactorily complete the testing or exercise protocol
* current use of non-steroidal anti-inflammatory or corticosteroid drugs
* inability to communicate and comprehend written or verbal instructions in English
Feasibility Study of the Aliya System in the Treatment of Early Stage Non-small Cell Lung Cancer

A prospective, two-arm, non-randomized, concurrently controlled, multi-center, open-label, treat and resect study following patients to 1 year. The study is designed to evaluate the safety and feasibility of the Aliya System for the ablation of solid tumors using pulsed electric field (PEF) energy delivery. The study is intended for adult patients with suspected or confirmed NSCLC 8th ed. Stage IA2, IA3 or IB (\>1 to ≤4 cm solitary lesion) who are surgical candidates and have not received treatment for the index tumor in the last two years.

This study is to evaluate the safety and initial feasibility of Pulsed Electric Field (PEF) treatment of NSCLC tumors prior to surgical resection.

Treatment may be delivered via either an endoluminal (bronchoscopic) or percutaneous approach at the discretion of the clinical investigator utilizing two available device configurations:

* Endoluminal: Galvanize Aliya System with commercially available TBNA Needle (e.g., PeriView FLEX) and RF probe electrode
* Percutaneous: Galvanize Aliya System with compatible commercially available RF needle and RF probe electrode

The study will enroll and treat up to 30 adult patients with early stage NSCLC at up to 5 clinical sites. Patients meeting all eligibility criteria who elect not to undergo the PEF treatment will be offered the opportunity to participate in a concurrent control arm. Up to 10 patients will be included in the control group. A total of up to 40 patients will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Presence of solitary NSCLC nodule 8th ed. stage IA2, IA3 or IB
* Nodule measuring \> 1 cm and ≤4 cm diameter by CT size estimate (e.g. T1b, T1c, T2a), with a minimum 1 cm solid component
* High pre-procedure probability of malignancy as determined by the investigator
* Patient has been evaluated by a thoracic surgeon and deemed a candidate for definitive lung tissue resection
* Patient is, in the opinion of the principal investigator, able to adhere to and undergo bronchoscopy, surgical procedure and post-treatment care

Exclusion Criteria:

* Additional pulmonary nodules requiring intervention
* Patient is receiving concurrent cancer treatment (e.g. external beam radiation therapy, brachytherapy, chemotherapy, targeted therapy, immunotherapy, other focal therapy) or has received treatment for the index tumor in the last two years
* Patient has implanted lung devices or electronic devices
* Patient has N1 disease
* Patient is immune compromised or receiving immune modulating medication
* Recurrent NSCLC within 2 years of initial definitive treatment
* Previous checkpoint inhibitor treatment for another cancer
Parotid-gland Stem-cell Sparing Intensity-modulated Radiotherapy

Rationale:

Radiation-induced parotid gland dysfunction, often leading to xerostomia is the most-frequently occurring side-effect with a major impact on patient-reported quality of life after radiotherapy for head and neck cancer (HNC). Therefore, treatments for HNC are currently optimized to minimize the mean dose to the parotid glands. Though this resulted in a significant reduction of toxicity, 30%-40% of the patients still develop sustained parotid gland dysfunction and xerostomia.

However, in animal studies the investigators found that the dose to the sub-volume of the gland containing the parotid gland stem cells is a better predictor for dysfunction than the mean dose to the whole gland. Subsequently, this finding was confirmed in a retrospective analysis in patients. Therefore, a reduction of dose specifically in this sub-volume of the parotid glands of patients is expected to further reduce the risk of parotid gland dysfunction and xerostomia.

Objective:

To test the hypothesis that parotid gland stem cell sparing intensity modulated radiotherapy in HNC patients reduces the risk of parotid gland dysfunction and xerostomia as compared to conventional parotid gland sparing intensity modulated radiotherapy.

Study design:

Double-blind prospective randomized trial (51 patients per arm). Study population: Patients treated for tumours in the head-and-neck region with curative radiotherapy, with or without the addition of chemotherapy or cetuximab.

Intervention: Patients randomized into the experimental arm will receive a treatment in which the radiation dose to the parotid gland is re-distributed to minimize dose to the sub-volume containing the stem cells, while keeping the same mean dose to the parotid gland as a whole.

Main study parameters/endpoints:

Primary endpoint is parotid gland salivary secretion. Secondary endpoints are patient- and physician-rated xerostomia.


Eligibility Criteria:
Inclusion Criteria:

* Squamous cell carcinoma originating from the mucosa of the head and neck area or nasopharyngeal carcinoma originating from the nasopharynx;
* The radiotherapy includes prophylactic or therapeutic irradiation of both sides of the neck (at least level II to IV);
* Age ≥ 18 years;
* WHO performance 0-2;
* To reduce the uncertainty in the assessment of relative flow after treatment, pre-treatment parotid gland saliva production stimulated with 5% citric acid should exceed \>0.1 ml/min

Exclusion Criteria:

* Postoperative radiotherapy;
* Previous radiotherapy of the head and neck region (re-irradiation);
* Unilateral radiotherapy;
* Primary salivary gland tumours
The Role of the EKG in Anticancer Drug Development

Primary Objective:

-Evaluate incidence of cardiac complications in Phase I patients.

Secondary Objective:

-To identify variables (i.e. number of electrocardiograms (EKG) performed) that lead to the detection of cardiac events.

The research plan includes a retrospective review of the chart of past UT MD Anderson Cancer Center (MDACC) patients and the experience in treating them.

All studies analyzed will be Phase I clinical trials.

Analysis is designed to collect information on the number of and timeframe within which ECGs are performed on these trials. Data on adverse events and serious adverse events, dose modifications based on ECG changes, attribution to drug, incidence and types of ECG changes specifically QTC prolongation as well as their influence on study procedures like dose limiting toxicities (DLTs) in dose escalation phase of the studies.

Study conducted using clinical records of patients treated on Phase I protocols in the MDACC Department of Investigational Cancer Therapeutics. The demographic data to be collected from patients whose charts will be analyzed will include variables such as age, gender, primary cancer, stage of the disease, performance status, treatment characteristics (i.e., number and type of prior therapies), disease status, adverse events, laboratory data (i.e., complete blood count/differential/platelets, tumor markers), and treatment outcomes.

The analysis will allow identification and descriptive analysis of the occurrence of cardiac events in the phase I population and will help define the role of protocol required EKGs in their detection.

HIPAA privacy and confidentiality guidelines will be followed. The database will be secured in the Department server. A Data coordinator has been recruited to undertake this project. The information derived from these observations will help the investigators formulate research questions and projects to develop future prospective studies.

The statistical analysis will be performed in a descriptive fashion with paired and multivariable analyses.

The analyses will be reported using summary tables, figures, and data listings. Continuous variables will be summarized using the mean, standard deviation, median, minimum, and maximum.

This study will be conducted at the MD Anderson Cancer Center in Houston, Texas.

Eligibility Criteria:
Inclusion Criteria:

* All types of advanced cancer

Exclusion Criteria:

* N/A