cyrilzakka/clinical-trials huggingface dataset:
A Comparative Study of Clinical, Endoscopic and Histopathological Features of Colitis in Children

A Comparative study of clinical, endoscopic and histopathological features of colitis in children

To find out the role of ileoscopy in diagnosis of colitis and compare clinical , endoscopic and histopathological manifestations of colitis

Eligibility Criteria:
Inclusion Criteria:

* 1. All patients diagnosed as colitis during the study period. 2. Age from 1 month to 18 years.

Exclusion Criteria:

1. Patients with lower gastrointestinal manifestations and weren't diagnosed as colitis during colonoscope.
2. Patients less than one month and more than 18 years.
Simplified IUD Insertion Technique

This is a randomized controlled trial that compares traditional IUD insertion with that of a no uterine sound, no bimanual pelvic exam approach. The investigators hypothesis is that IUD placement is safe and effective without pre-procedural assessment of uterine size, direction, or depth.


Eligibility Criteria:
Inclusion Criteria:

* Women 18 years and older presenting to contraceptive clinic in Gaborone, Botswana for IUD insertion and have ability to give informed consent.

Exclusion Criteria:

* Known contradictions to copper IUD, inability to comply with study protocol
Beta-lactams Therapeutic Drug Monitoring in Critically Ill Patients

The population of these monocentric and retrospective study includes patients hospitalized in one of the critical care services of Nîmes' community hospital.

The objective is to determine the key factors that lead to satisfactory beta-lactams serum concentrations in critically ill patients.

Clinical and biological features, as well as risk scores are collected and recorded into an electronic Case Report Form.

The primary outcome is to show the main characteristics related to adequate beta-lactams serum concentrations in critically ill inpatients.

Secondary outcomes include the key factors related to inadequate beta-lactams serum concentrations in critically ill inpatients, Therapeutic Drug Monitoring (TDM) impact in the achievement of target beta-lactams serum concentration and the correlation between Aminoglycosides and Beta-lactams serum concentrations. Do both antibiotics have similar elimination kinetics ?


Eligibility Criteria:
Inclusion Criteria:

* Patient aged at least (≥) 18 years of age.
* Patient (or his representative for patients unable to give their consent) has given his free and informed consent and has signed the consent form.
* Patient affiliated to the health insurance scheme
* Patient hospitalized in one of the critical care services of Nimes' community hospital with at least one beta-lactam treatment
* Patient with at least one beta-lactam TDM during his stay

Exclusion Criteria :

* Patient who did not consent the use of his personal data
* Patients under maintenance of justice, tutelage or legal guardianship
* Patient previously included in the study.
Emergency Department-Based Palliative Care for Advanced Cancer Patients

The purpose of this study is to: 1) identify the palliative care needs of Emergency Department patients with advanced cancer, and determine if these needs can be rapidly assessed in the ED; 2) determine whether early palliative care consultation improves survival, quality of life and other burdensome symptoms and decreases utilization as compared to usual care.

As the population ages, the number of individual living with cancer will continue to rise, and the number of Emergency Department (ED) visits for this population will continue to increase. Cancer patients visit EDs because symptoms, such as pain or vomiting, can't be controlled at home, in an assisted living facility, or in their provider's office. The ED is often the only place that can provide the necessary treatments as well as immediate access to technologically advanced testing for those with cancer. However, palliative care (PC) services, such as relief of burdensome symptoms), attention to spiritual or social concerns, and establishing goals of care, is not standard care in the ED outside of a few medical centers. Most patients do not have well-defined goals of care, and are often subjected to painful and marginally effective tests and procedures, not because they are consistent with their goals but because it is less time-consuming than discussing other options and has less perceived legal risk. Until recently little emphasis has been placed on education, research, or guidelines for the delivery of PC services in this important setting. While emergency providers could provide some of these services themselves, knowledge and skills regarding PC as well as staffing are currently inadequate to provide comprehensive services. In addition to further decreasing days spent in the hospital and health care costs, consultation by a PC team for ED cancer patients might also reduce pain and other symptoms, aid in complex medical decision-making regarding testing and treatments, and facilitate transfer to hospice or home with visiting nurse services. To enable PC consultation for ED cancer patients, the investigators will first determine who could benefit from emergent consultation, what services they need, and what characteristics of emergency providers and hospitals are preventing them from being offered. To determine what affect PC consultation for patients with advanced cancer has on symptoms, discussions with patients and families about goals of care, and how long patients spend in the ED, the investigators will then randomly assign 200 ED cancer patients to targeted PC consultation versus usual or standard care.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years age
* Speak English or Spanish
* ED patient with an advanced solid malignancy

Exclusion Criteria:

* Have already been seen by palliative care team
* Cognitive deficits
* Children or adolescents
* No confirmed history of active cancer
* Do not speak English or Spanish
* Reside outside the US
NovoTTF-100A Therapy for Refractory CNS Involved Small Cell Lung Cancer

The hypothesis of this study is that the addition of NovoTTF-100A System treatment to salvage chemotherapy will significantly increase time to treatment failure in the brain of small cell lung cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed small cell lung cancer histology with CNS metastases
* Parenchymal disease, ten or less lesions, and supratentorial
* PS 70% or greater
* Prior CNS radiotherapy.
* No previous or currently active second malignancy
* Age \> 22 years.
* Life expectancy of ≥ 3 months.

Exclusion Criteria:

* Significant liver function impairment - AST or ALT \> 3 times the upper limit of normal; Total bilirubin \> upper limit of normal.
* Significant renal impairment (serum creatinine \> 1.7 mg/dL).
* Coagulopathy (as evidenced by PT or APTT \>1.5 times in control patients not undergoing anticoagulation).Thrombocytopenia (platelet count \< 100 x 103/μL).
* Neutropenia (absolute neutrophil count \< 1 x 103/μL).
* Anemia (Hb \< 10 g/L).
* Severe acute infection. Serious non-healing wound or ulcer on scalp
* Significant co-morbidities within 4 weeks prior to enrollment.
* Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias.
* Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts).
* Skull defect (e.g. missing bone with no replacement).
* Shunt
* Bullet fragments
* Evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness).
* Sensitivity to conductive hydrogels.
* Pregnant or lactating women
A Novel Shape Memory Alloy-Based Orthosis for Proximal Interphalangeal Joint Stiffness

The goal of this clinical trial is to evaluate the applicability, effectiveness, and usability of a shape memory alloy-based orthosis for patients with finger proximal interphalangeal joint stiffness. This cutting-edge design incorporates shape memory alloy into the device for improving proximal interphalangeal joint stiffness and, secondarily, enhancing the ability to perform activities.

Half of the participants will be assigned to experimental group, receiving a shape memory alloy-based orthosis for home program. The other half will be assigned to control group, receiving a conventional stretching program. Three evaluations, examining range of motion and hand functional performance, will be conducted before intervention, 4 weeks and 8 weeks after baseline by the researchers.


Eligibility Criteria:
Inclusion Criteria:

* 18-79 years old
* Exhibit limitations in passive range of motion of the proximal interphalangeal joint, with extension less than 0 degrees or flexion less than 90 degrees.
* Beyond the acute phase of the hand condition, and it has been more than 8 weeks post-surgery (or post-injury).

Exclusion Criteria:

* Concurrently use other types of splints for PIP joint stiffness.
* Present with abnormal muscle tone, paralysis, or rigidity associated with central or peripheral nervous system dysfunction.
* Suffer from complex regional pain syndrome or progressive degenerative disease affecting finger joints, such as rheumatoid arthritis.
* Have an active infection or arthritis in their fingers.
* Unable to follow instructions.
Regulation of Branched-chain Amino Acid Metabolism in Pre-Diabetes

Elevated circulating levels of certain amino acids (the building blocks of protein) are strongly associated with insulin resistance. This study will investigate the metabolism of these amino acids in individuals with normal glucose metabolism compared to overweight or obese pre-diabetic individuals. The purpose of this study is to determine how elevated levels of the branched-chain amino acids may contribute to the development of insulin resistance and ultimately diabetes. An additional purpose is to determine whether exercise or gastric bypass (GBP) surgery intervention can correct aberrations in branched-chain amino acid metabolism as insulin sensitivity improves. This information will be used to further our understanding of the development of insulin resistance and type 2 diabetes in at-risk populations and potentially improve clinical treatment of such conditions.


Eligibility Criteria:
Inclusion Criteria:

* Age:

  * Lean and Overweight Pre-diabetic (PD) groups: 40-65 years
  * Obese Gastric Bypass (GBP) patients: 30-65 years
* Body Mass Index (BMI) within desired range for group:

  * Lean group: 18.0 - 24.9
  * Overweight PD group: 25.0 - 35.4
  * GBP group: 35.0 - 50.0
* Fasting Plasma Glucose level within desired range for group:

  * Lean: \< 99 mg/dL
  * PD: \> 105 - \< 126 mg/dL
  * GBP: \> 99
* Oral Glucose Tolerance Test, 2-hour Plasma Glucose results within desired range:

  * Lean: \< 139 mg/dL
  * PD: 140-199 mg/dL
* Low density (LDL) cholesterol: \< 190 mg/dL
* Triglycerides: \< 600 mg/dL
* Resting blood pressure: \<160/90 mmHg
* Inactive: Exercise \< two days/week (GBP and PD only);
* Peak oxygen use: \> 14.0 - \< 40.0 ml/kg/min (PD only)
* Medications: Stable use of all medications for \> three months
* Body Weight \< 495 lbs

Exclusion Criteria:

* Smoker: Tobacco use within the last 12 months
* Dieting or intending to diet (excluding intention for gastric bypass procedure in GBP group)- Not weight stable for \> six months or weight loss exceeding five pounds in last six months
* Use of potential confounding medications, e.g. Niacin containing drugs
* History of diabetes, heart disease or taking medication for those conditions
* History of hypertension (high blood pressure) not controlled with medication
* Pregnant or intending to become pregnant
* Unwillingness to participate in study visits, submit to skeletal muscle biopsies and all other study testing or continuously participate in the exercise training intervention program for six months if in overweight PD group
* Orthopedic limitations, musculoskeletal disease and/or injury
* Allergic to xylocaine
* Inability to give blood continuously through an intravenous catheter
* Unwillingness to exercise at least three times per week at the Duke Center for Living during staff supervised times (PD only)
* Exercise compliance less than 85% in any 6 week period (missing \> 3 exercise sessions in a 6 week period)
Comparison Between Desarda and Lichtenstein's Technique for Inguinal Hernia Repair Under Local Anaesthesia

Inguinal hernia repair is done by two methods. The conventional method uses a prosthetic mesh for strengthening the defect but has been associated with complications. Another new method uses a strip of the external oblique aponeurosis to do the same.There is a necessity to conduct studies comparing the two methods of hernia repair under local anaesthesia in terms of feasibility, economic benefits, faster ambulation with less complications. The purpose of the study is to find a method that will lead to faster disposal of patients and early return to activities, thereby reducing the waiting list of patients that compromises their financial and social spheres and overwhelms the welfare system.

Inguinal hernia is one of the most common treatable surgical conditions. The synthetic prostheses most often used in the inguinal area may in some cases create new clinical problems, such as foreign body sensation in the groin, discomfort, and abdominal wall stiffness, surgical site infections, migration of mesh and may affect procreation and sexual function, The cost and availability of mesh prostheses in smaller towns and underdeveloped regions proves to be a major hindrance. The requirement of the hour is to find a technique that is simple, cost effective, easy to perform, does not require extensive dissection or use of a foreign body, and also gives an acceptable recurrence rate without any major intra or post-operative complications and can be performed as a day care procedure to reduce the burden of cases in our community. A possible option for this is the Desarda method, presented in 2001, which uses an undetached strip of aponeurosis of the external oblique muscle instead of a mesh and has shown to have promising results in studies conducted so far. Several retrospective and randomized controlled trials have shown that local anaesthesia provides the best clinical and economic benefits to patients undergoing inguinal hernia repair. As there have been no studies till date comparing the outcomes for patients operated by these methods under local anaesthesia only, hence this study has been planned to assess if Desarda's technique is suitable to be used as a day care procedure with early return to normal activities after surgery, less post operative discomfort and minimum dose of analgesics and acceptable recurrence rates. This will help reduce the burden of the hospitals as these patients can be operated on a day care basis with minimal discomfort.

Eligibility Criteria:
Inclusion Criteria:

* Primary uncomplicated inguinal hernia
* Male patients aged more than 18 years and less than 80 years
* BMI less than 30kg/sq m
* American Society of Anaesthesiologists (ASA) scale less than III

Exclusion Criteria:

* Patients with recurrent, irreducible or strangulated inguinal hernias
* Patients unable to interpret VAS or give consent
* Patients participating in other clinical trials
* Patients with infection in the inguinal region or epididymo-orchitis
* Patients allergic to local anaesthetics
Study Of The Effects Of A New Antidepressant Therapy In Patients With Major Depressive Disorder (MDD)

The purpose of this study is to assess the efficacy, safety and tolerability of GW679769 patients with Major depressive Disorder (MDD).


Eligibility Criteria:
Inclusion criteria:

* Primary diagnosis of Major depressive Disorder as defined in DSM-IV.
* Capable of giving informed consent and willing to comply with the study requirements.
* Women of childbearing potential must agree to one of a number of defined acceptable methods of birth control.

Exclusion Criteria:

* Primary diagnosis within the past 6 months of another Axis 1 disorder such as an anxiety disorder.
* Use of medications for a psychiatric condition including herbals in the past 2-12 weeks according to medication type.
* Subjects who, in the investigator's judgement, pose a current, serious suicidal or homicidal risk or have made a suicide attempt within the past 6 months.
* Subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance abuse or subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance dependence (other than nicotine).
* Significantly abnormal blood or urine laboratory tests or electrocardiogram (ECG).
Immunotherapy for Lymphoproliferative Diseases Associated With Epstein-Barr Virus in Patients Who Have Undergone Organ Transplants

RATIONALE: Donor lymphocytes that have been exposed to Epstein-Barr virus may be able to help the body kill cancers associated with this virus.

PURPOSE: Phase I trial to study the effectiveness of Epstein-Barr virus-specific T cells derived from matched donors in organ transplant patients with lymphoproliferative diseases associated with Epstein-Barr virus.

OBJECTIVES: I. Examine the toxic effects of allogeneic Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTL) for the treatment of EBV lymphoproliferative diseases (LPD) in organ transplant recipients. II. Determine the level of in vivo expansion of allogeneic CTL and the period of time during which these CTL's can be detected in the blood of recipients of the T cell infusions.

OUTLINE: Donors undergo leukapheresis, and Epstein-Barr virus (EBV) specific cytoxic T lymphocytes are cultivated in vitro. Patients receive infusions of EBV specific cytotoxic T lymphocytes over 5 to 10 minutes on weeks 0, 2, and 4. Patients with stable disease and those achieving partial remission are followed weekly for signs of disease progression.

PROJECTED ACCRUAL: 10 patients will be accrued in this study.

Eligibility Criteria:
Inclusion criteria:

* Radiographic evidence of lymphadenopathy or lymphomatous lesions combined with clinical signs of Epstein-Barr virus lymphoproliferative disease (EBV LPD), such as fevers and lymphadenopathy
* following an organ transplant Persistent, progressive, or unresponsive disease despite decreased immunosuppression, chemotherapy, or radiation therapy EBV LPD must be of host origin
* At least 4 weeks
* Patients serologically hepatitis B and C positive may receive cytotoxic
* T- lymphocytes (CTL) from donors who are serologically positive for the same virus
* Must have an HLA identical or HLA haploidentical donor

Exclusion

* hepatic dysfunction SGOT/SGPT less than 2.5 times upper limit of normal (unless liver metastases present)
* Bilirubin less than 2.0 mg/dL
* renal dysfunction
* Creatinine clearance at greater than 50 mL/min
* cardiac dysfunction
* neurologic dysfunction
* pulmonary dysfunction
* patients developing EBV LPD who have a donor origin lymphoma
* HIV-1 positive
* Not capable of undergoing leukapheresis
XM-One Study for Living Donor Program

Donor-Specific Antibody (DSA) (HLA) levels and non-HLA antibody levels in recipients prior to living kidney transplantation and randomize these individuals into a desensitization protocol in order to evaluate shifts that can occur with the Luminex and XM-One assay after treatment and up to 6 months post transplant.

If desensitization is needed prior to transplantation in individuals with a negative crossmatch but positive DSA and/or XM-one - patients will be evaluated clinically with routine lab tests (serum creatinine levels, spot urine protein and spot urine creatinine levels) as well as protocol biopsy evaluations.

1. Rates of acute rejection including subclinical rejection - acute T cell mediated (cellular) rejection, antibody mediated acute rejection, and chronic antibody-associated injury (i.e.: Transplant Glomerulopathy, Chronic allograft arteriopathy) between the groups.
2. Evaluation of endothelial cell activation and injury on biopsies by checking markers for endothelial cell activation and injury (intercellular adhesion molecule-1, ICAM-1/CD54; vascular cell adhesion molecule-1, VCAM-1/CD106; and E-selectin, ELAM-1/CD62E) in two-color stains of tissue with classical endothelial markers (CD34 and Factor VIII).
3. Measurement of serum/plasma levels of TNF-alpha and VEGF and decreased levels of protein C and protein S in the circulation, as an assessment of graft vascular perturbation.
4. Circulating Endothelial Cells (CECs) will be measured by flow cytometry with markers for endothelial cell activation.

Eligibility Criteria:
Inclusion Criteria:

* Recipients receiving deceased donor transplants.
* Living donor transplant that is T-cell flow crossmatch positive.
* HIV, Hepatitis C and B positive patients.

Exclusion Criteria:

* Pregnant women and children will be excluded from the study.
Optimizing High Flow Nasal Cannula Oxygenation in Pediatric Airway Procedures

The purpose of this study is to investigate which flow rate (higher versus lower) is most effective at increasing apneic time and preventing greater than 5% drop in desaturation, as well as assessing transcutaneous carbon dioxide (CO2) levels during airway procedures in children


Eligibility Criteria:
Inclusion Criteria:

* undergoing laryngoscopy and bronchoscopy procedures at Children's Memorial Hermann Hospital (CMHH)
* weight greater than or equal to 5 kilograms and using flow rates between 5 to 45 liters per minute (BTPS)

Exclusion Criteria:

* Emergency type cases, tracheostomy patients, unrepaired cyanotic heart disease, nasal deformity/choanal atresia, or cautery/laser type procedures
Transcutaneous Electrical Acupoint Stimulation(TEAS) for Postoperative Nausea and Vomiting in Laparoscopic Operation

This is a single center, randomized, double-blinded, controlled clinical trial.The purpose of this study is to compare the effect of TEAS pretreatment with single acupoint or two acupoints for postoperative nausea and vomiting in patients undergoing laparoscopic operation.

Patients were randomly assigned to four groups, receiving TEAS 30 minutes before induction.The stimulation was applied until the end of the operation. Postoperative nausea and vomiting was recorded 30 minute, 2 hour, 6 hour and 24 hour after the operation. The adverse events were recorded as well.

Eligibility Criteria:
Inclusion Criteria:

1. ASA I-III
2. Aged 18 to 65 years old
3. Scheduled for general anesthesia
4. BMI index is between 18 to 30
5. Informed consented

Exclusion Criteria:

1. ASA IV
2. Hypertension that is not controlled
3. Severe hepatic or renal dysfunction
4. Ever had received electrical stimulation treatment
5. Severe systemic infection
6. With contraindications to the use of TEAS, such as skin damage or infection at the acupoints
7. For any reason one can not cope with the studies, such as the following:

   language comprehension, mental illness
8. Participate in the other clinical trial 3 month before the enrollment
Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose

* Whether a combination of three therapies - metformin and a sulfonylurea plus Exubera, an investigational drug, controls your diabetes at least as much as a triple combination therapy of metformin and a sulfonylurea plus Avandia, a Food and Drug Administration (FDA) approved drug.
* Whether a combination of two therapies - metformin plus Exubera controls your diabetes at least as much as a as a triple combination therapy of metformin and a sulfonylurea plus Avandia.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Currently treated and on a stable doses of drugs for the preceding two (2) months

Exclusion Criteria:

* Type 1 Diabetes
* Smoking