cyrilzakka/clinical-trials huggingface dataset:
The Role of Intestinal Ultrasound in Monitoring the Response to Biological Therapy in Patients With Ulcerative Colitis

In this study, the investigators aim to evaluate the role of intestinal ultrasound in evaluation of the therapeutic response to biological therapy in patient with ulcerative colitis

Ultrasound examination is an easily accessible, non-invasive, radiation-free technique, and cheap imaging modality that is often chosen as the first diagnostic method in gastroenterology disease.

performance of bowel ultrasound use of two different probes: low-frequency convex probe (3.0-3.5 MHz) and high-frequency linear probe (5-17 MHz) .

Inflammatory bowel disease (IBD) is a chronic inflammatory disease of the gastrointestinal tract, which clinically contains Crohn's disease, ulcerative colitis, and other conditions. IBD is characterized by episodes of abdominal pain, diarrhea, bloody stools, weight loss, and the influx of neutrophils and macrophages that produce cytokines, proteolytic enzymes

Intestinal ultrasound has been shown to have high sensitivity and specificity in the detection or exclusion of intestinal inflammatory activity in IBD. advantages of intestinal ultrasound over other imaging modalities include non-invasiveness, rapid availability and low costs ,evaluation of bowel wall thickness, as well as stratification that reflects alterations in histopathology ulcerative colitis (UC). Visualization of the vascularization of the bowel using color Doppler sonography and, direct visualization of motility.

A study done : IUS is preferred for monitoring the disease course and for assessing short-term treatment response. Found that monitoring bowel wall thickening (BWT) alone has the potential to predict the therapeutic response.The primary therapeutic goal in UC is to induce and maintain long-term disease remission; however, there is no single treatment pathwayguidelines recommend the use of either conventional therapies (i.e., aminosalicylates ..etc)Or the use of biologic therapies ( infliximab.)

Eligibility Criteria:
Inclusion Criteria:

* Any patient above age of 18 years old and diagnosed to have UC and whom not responding to conventional medical therapy and eligible for biological therapy will be recruited in this study

  * moderate to severe UC patients
  * immunosuppressant or corticosteroid refractory disease
  * those with intolerance or contraindication to conventional therapies are eligible to be treated with biological therapy

Exclusion Criteria:

* Patients with UC who are under age of 18 years' old
* Patients with UC who aren't eligible to biological therapy
* patients with complication of UC(fistula , intestinal obstruction , intestinal perforation ,......)
* Patient refuse to participate in the study.
Contingency Management for the Treatment of Co-Occurring Alcohol and Drug Misuse

Contingency management (CM) is a type of treatment used in the substance abuse field. Patients' behaviors are rewarded for adherence to a treatment plan. As an approach to treatment, contingency management emerged from the behavior therapy traditions in mental health. By most evaluations, contingency management procedures produce one of the largest effect sizes out of all mental health and educational interventions.

The purpose of this study is to perform a randomized, controlled trial to evaluate the ability of a culturally-tailored contingency management (CM) intervention to increase alcohol and drug abstinence among American Indian (AI) tribal members from two rural reservations in the Northwest.


Eligibility Criteria:
Inclusion Criteria:

1. Self-identify race as American Indian (AI)
2. Are seeking alcohol dependence and drug abuse treatment at a participating reservation
3. Are age 18 or older
4. Meet criteria of DSM-IV diagnosis of current alcohol dependence
5. Current drug misuse
6. Are not pregnant or planning to become pregnant for the duration of the study
7. Are English speaking
8. Have the ability to provide written informed consent

Exclusion Criteria:

1. Have significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure during the last 12 months AND expression of concern by the patient and/or healthcare provider
2. Meet criteria for DSM-IV diagnosis of drug dependence
3. Have significant risk of dangerous drug withdrawal and/or self-reported or medically documented severe withdrawal from drugs in the last 6 months
4. Have any medical or psychiatric condition, such as organic brain disorder, dementia, or psychotic disorder, that the Principal Investigator determines would compromise safe study participation
5. Are receiving drugs under the direction of a physician for pain management or another medical condition for which drug abstinence is contraindicated
Nicotinamide and Glaucoma

The investigators will include different subgroups of open-angle glaucoma and healthy controls. The participants will attend two visits with two weeks apart. At each visit the participants will have blood drawn and will undergo OCT examination. In between the two visits, participants will receive a treatment of Nicotinamide 1,5g/day for one week and 3.0g/day for the second week.

The investigators plan to recruit four groups, each containing 30 subjects: 1) pseudoexfoliative glaucoma, 2) High tension open-angle glaucoma, 3) Normal tension glaucoma 4) Age-matched controls. Those enrolled will undergo two visits including an ophthalmic exam, blood sampling, and at the first visit, distribution of nicotinamide tablets. We plan to recruit participants amongst glaucoma patients already followed at the Eye Clinic at Umeå University Hospital. Furthermore, age-matched controls will be recruited through lists from the population register at Statistics Sweden. Before enrolling any subject, they will receive both oral and written information as well as sign a consent form. Furthermore, they will be evaluated to make sure that they fulfill the inclusion- and exclusion criteria prior to inclusion.

The ophthalmic exam includes measurement of IOP, perimetry, and OCT/A. Between visits, the participants will receive 1,5 grams of NAM per day the first week and 3 grams per day the second week. The blood drawn will initially be sent to Biobanken Norr for storage. Samples will then be sent to the Swedish Metabolomics Centre, Umeå University and Department of Medical Biochemistry and Biophysics, Karolinska University for analysis using high-resolution mass spectrometry.

Eligibility Criteria:
Inclusion criteria for glaucoma patients:

* Manifest glaucoma (PEXG, HTG, NTG) in one or two eyes,
* age \> 18 years,
* replicable visual field defects that cannot be explained by any other disease or insult,
* suspect/anomalous optic nerve head or abnormalities in the retinal nerve fiber layer.

Inclusion criteria for age-matched controls:

-A normal visual field and optic nerve, age \> 18 years.

Exclusion criteria for all:

* Any disease affecting retinal function (such as more than mild macular degeneration or diabetic retinopathy), neurological or other non-glaucomatous conditions that may affect the visual field,
* inability to perform a perimetric exam,
* resistance in quitting intake of multivitamins or B-vitamins,
* allergy to NAM or niacin, previous eye surgery involving the central retina,
* pregnant or breast-feeding women,
* fertile women not using reliable contraception,
* diagnosis of cancer in the last five years (not including treated squamous cell carcinoma), anamnesis of liver-disease or peptic ulcer,
* not able to speak and understand either Swedish or English.
Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients

The purpose of this study is to determine if the Life Recovery Systems Thermosuit(R) System is able to quickly and conveniently cool patients who are comatose after resuscitation from cardiac arrest.

The primary purpose of this study is to clinically evaluate the use of a new cooling device (the LRS ThermoSuit(R) System) to cool patients who are comatose following resuscitation from cardiac arrest. This device cools by circulating cold water directly against the skin of the patient. Cooling to a state of mild hypothermia (32 to 34 degrees C, maintained for 12 to 24 hours) is recognized by the American Heart Association, European Resuscitation Council, and the Canadian Association of Emergency Care Physicians as a promising therapy for such patients, and is likely to be most effective if administered quickly following resuscitation. It is hypothesized that this new device will cool patients much more quickly than by historical means. Patients will be monitored for physiologic parameters such as body temperature during the cooling therapy, and will be tracked for neurological outcomes following treatment.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrest prior to or during hospital admission, with restoration/return of spontaneous circulation (ROSC).
* Initial (pre-resuscitation) cardiac rhythm of ventricular fibrillation, non-perfusing ventricular tachycardia, pulseless electrical activity, or asystole.
* Estimated or known age \> 18 years.
* Intubation, ventilation and placement of esophageal probe.
* Persistent neurologic dysfunction i.e. comatose upon enrollment \[GCS ≤ 8\].

Exclusion Criteria:

* Height greater than 188 cm.
* Elbow-to-elbow width greater than 60 cm (as measured above the supine patient).
* Core temperature less than 35°C after ROSC (as measured at the tympanic membrane, esophagus, sub-lingual space,nasopharynx, or central blood vessel).
* Comatose state before the cardiac arrest due to the administration of drugs that depress the central nervous system.
* Known pregnancy.
* Response to verbal commands after ROSC (but before enrollment).
* Known terminal illness that preceded the arrest.
* Known enrollment in another study of a device, drug, or biologic.
* Major trauma or other co-morbidity requiring urgent surgery.
* Improving neurologic status.
* \> 4 hours since return of spontaneous circulation.
* Unknown time of arrest.
* Severe or known coagulopathy (with active bleeding).
* Hemodynamic instability despite vasopressors (SBP \< 90 mmHg or MAP \< 60 mmHg for \> 30 minutes after ROSC and before enrollment).
Implementation of a qSOFA Score in the Emergency Department

The Quick-SOFA score (qSOFA), identifies septic patients with a mortality risk higher than 10%. In our study all adult patients coming to the emergency for suspected infection are screened according to the qSOFA score on arrival. If qSOFA ≥ 2, the patient should be referred to emergency vital room, if the score \<2, the patient will be in the box. The objectives are : 1) to evaluate the mortality at 28 days with the orientation, 2) to compare support time of medical contact and initiation of antibiotics according to the orientation in the emergency department.


Eligibility Criteria:
Inclusion Criteria:

* body temperature below 36 °C or above 38 °C
* require hospitalization

Exclusion Criteria:

* hospital transfer,
* patients with pre hospital care
* language barrier,
* refusal to participate
New Therapeutic System of Unruptured Intracranial Aneurysms Based on Big Data From Chinese Population

This is a prospective, multicenter, observational study, aiming at comparing the Safety and effectiveness among the different surgical treatment of unruptured intracranial aneurysms in China, so as to improve the diagnosis and treatment of unruptured intracranial aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with unruptured intracranial saccular aneurysm on CTA, MRA or DSA.
* patients willing to participate in this clinical trial and attach to regular follow up.

Exclusion Criteria:

* intracranial aneurysm correlating to AVM.
* intracranial non-saccular aneurysm.
* the rupture or unrpture of the aneurysm confirmed on CTA、MRA or DSA.
* patients unwilling to participate in this clinical trial and attach to regular follow up.
Treatment of Steroid Dependent Idiopathic Nephrotic Syndrome in Children With Low Doses of Interleukin 2: a Pilot Study

NIL-2 is a clinical trial designed to evaluate the efficacy and safety of low doses of Interleukin2 in the treatment of recently diagnosed, steroid dependent idiopathic nephrotic syndrome in children. Recent data suggest that Interleukin 2 could be an effective therapy via an increased production of regulatory T cells.

The study will include 10 children (age: 3-15 years old). Patients will receive low doses of Interleukin 2 (0.5 million UI/m²/ injection, subcutaneously).

The treatment will be initiated with an induction phase of one injection per day for 5 consecutive days, followed by a maintenance phase in which patients will receive one injection every 14 days for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Children between 3 and 15 years of age (included) with a steroid responsive idiopathic nephrotic syndrome
* Idiopathic nephrotic syndrome progressing for less than 1 year
* Steroid dependent idiopathic nephrotic syndrome (at least 1 relapse when steroids are tapered off or within 3 months after their withdrawal, and reliance on steroids \> 15 mg/m² every other day)
* Steroid dose at inclusion between 15 and 60 mg/m²every other day
* Patient with a stable dose of steroids within the 8 days before and after the first injection of IL2
* Patient in remission for more than 15 days
* Patient affiliated to a French health insurance
* Signed consent of parental authority

Exclusion Criteria:

* Hypersensitivity to IL2 or to one of its excipients
* Significant history or presence of cardiopathy
* Signs of evolving infection requiring an antibiotic treatment
* Respiratory distress, respiratory infection or chronic respiratory failure
* Serious dysfunction of one of the vital organs
* Leukocytes \< 4000/mm3 ; platelets \< 100 000/mm3; hematocrit \<30%
* Anomaly of serum bilirubin and creatinin levels
* History of organ allograft
* Other pre-existing autoimmune disease
* Male and female pubescent teenagers under the age of 15
* Male and female teenagers whose puberty has begun for more than one year
* Asthmatic patient
* Pregnant or breastfeeding female patient
* Participation in another therapeutic trial concurrently or 30 days prior to inclusion
Role of TXA in Patients Undergoing Breast Free Flap Reconstruction

Tranexamic acid (TXA) is a synthetic, competitive lysine receptor inhibitor on plasminogen. It ultimately stabilizes the fibrin matrix, therefore used as a hemostatic agent for various indications. While there has been indications for orthopedic and trauma surgery, there is no clear data for its role in patients who are undergoing free tissue transfer. Studies have shown that patients undergoing free tissue transfer can have transfusion rates ranging from 7.2% to 34.9%, which data also showing association between transfusion requirement and higher free flap failure rate. There has been a few retrospective studies that evaluated the effect of TXA in free tissue transfer and the results showed no increased risk of microanastomosis failure but some showing decreased blood loss. This study aims to further analyze the role of TXA in patients undergoing breast free flap reconstruction with randomized, prospective trial. Control group will not receive TXA while experimental group will receive TXA. Both groups will receive standard of care breast free flap surgery as well as post-op care, which is streamlined with Early Recovery After Surgery (ERAS) protocol. Their pre and post-op hemoglobin will be compared, as well as rates of transfusion, surgical outcome and surgical complications including hematoma, flap failure, and any other medical complications such as Deep Vein Thrombosis (DVT)/ Pulmonary Embolism (PE).


Eligibility Criteria:
Inclusion Criteria:

* All female patients who are 18 years or older who will undergo unilateral or bilateral abdomen-based free flap breast reconstruction at UVA Medical Center

Exclusion Criteria:

* Subjects with ages \<18 years
* Allergy to TXA
* Subjects who has contraindications to TXA: anyone who has active intravascular thrombosis or anyone with subarachnoid hemorrhage
* Subjects who have anemia (defined as baseline hemoglobin \<8 g/dL
* Subjects who cannot read or understand English
* Subjects who are pregnant
Evaluation of Standard and Robot Assisted Total Knee Arthroplasty with a Bicrucatie Retaining Prosthesis

The first study goal is to compare the outcomes between Posterior Stabilized and Bicruciate Retaining TKA. Additionally, the second goal is to evaluate the effect of robot assisted surgery in both Posterior Stabilized and Bicruciate Retaining TKA.


Eligibility Criteria:
Inclusion Criteria:

* End stage osteoarthritis of the knee joint with failed conservative treatment

Exclusion Criteria:

* Previous ligament trauma
* Previous fracture of femur or tibia
* Fixed flexion contracture \> 10°
* Flexion \< 110°
* Coronal deformity \> 15°
* Previous infection of the knee joint
* Ligament insufficiency
* Neurologic conditions
Response to SLT vs. ALT in Patients Under 60 Years of Age

Laser trabeculoplasty is a routine treatment for glaucoma and can be performed with either argon (ALT) or selective Yag (SLT) lasers. The effectiveness of each has not been studied in patients under 60 years, which is younger than average for the procedure. The study hypothesis is that there will be no difference between the two laser types.

Forty-two young patients (age 29 to 60) had one eye randomized to ALT (n = 22) or SLT (n = 20). Intraocular pressure was measured prior to laser and 1 hour, 1 day, 6 weeks, 3 months, every 3 months until 2 years, and then yearly post-laser. χ2 analysis and student's t-test were used to determine statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 60 years
* Intraocular pressure not adequately controlled

Exclusion Criteria:

* Prior laser treatment
Fatherhood Focused Family Violence Education Program

The purpose of this study is to explore the feasibility of a novel intervention approach for fathers arrested for an initial episode of intimate partner violence (IPV) by systematically developing an alternate version of a standard, statewide, court-mandated Family Violence Education Program (FVEP) to focus specifically on the importance of fathering within a cognitive-behavioral intervention to be called Fatherhood Focused FVEP (F3).

This study will aim to modify the treatment as usual FVEP framework to be father focused. Materials will be developed to accommodate the change in scope of program focus for the purposes of training and supervising group leaders. An evaluation of the fidelity to the original FVEP model will be assessed through the review of service delivery.

In addition, the acceptability of Fatherhood Focused FVEP (F3) will be compared to the treatment as usual, FVEP as it is presently implemented. To do this, fathers who participate in FVEP will be compared to men who participate in F3 around the constructs: group cohesion, motivation to change, satisfaction with the program and rates of successful completion. Tertiary outcomes will include the assessment of: aggression toward intimate partners and hostile-aggressive parenting behaviors as reported on assessment measures and subsequent arrest records.

Eligibility Criteria:
Inclusion Criteria:

* Fathers referred to the FVEP program as a pretrial diversion following their first arrest for an incident of IPV with a female partner.
* Fathers must have at least one biological child under the age of 18.
* Fathers must have at least monthly contact with one of their biological children.

Exclusion Criteria:

* Fathers will be excluded if they are arrested for violence perpetrated against someone other than a current or former female partner.
* Fathers will be excluded if there is evidence of psychotic of suicidal symptoms on the Brief Symptom Inventory.
* Fathers will be excluded if they unable to complete questionnaires and group intervention in English.
Starting Healthy Staying Healthy Pilot Trial

The purpose of this study is to determine whether a reduction in toddlers' and preschoolers' exposure to television advertising leads to a change in their diet.

TV viewing is among the most significant features of childhood. In the past generation or two, new technologies have made media viewing more ubiquitous and frequent: 30% of children eat regularly in front of TV, one-third under 6 have TVs in their bedrooms, and 30% make TV part of bedtime routines. By the age of 2 years, 90% of children watch TV or videos regularly. Among those who watch, average viewing is 1.5 hours daily by age 2.

Yet the effects of this early viewing are poorly understood. In this study, we focus on children's diet, because children's food preferences have been shown to be easily influenced by advertising, and children's non-educational programming is heavy with advertising for poor nutritional-quality foods.

We will recruit 70 families with children ages 24-30 months and randomize them to either a television-minimization intervention (the intervention arm) or a toddler safety and injury prevention arm (the control arm). A case manager will actively work with the intervention arm participants to strategize ways of minimizing their media exposure. In addition, families in the intervention arm will get access both to a study website and to a monthly newsletter. The website and newsletter will inform participants of the potential hazards of early media exposure, and will offer tips for alternative activities and strategies for keeping children occupied while the parent gets a much-needed break. The control arm will have no case manager, but will have access to a website and newsletter that will emphasize toddler safety and injury-prevention themes. At the conclusion of the 4-month trial, we will assess (a) whether the study participants regularly accessed their respective websites; (b) whether the intervention-arm participants have different beliefs and attitudes about television for toddlers; and (c) whether fewer intervention-arm children watch TV compared to control-arm infants.

The comparison group will receive a similar intervention, except that it will not mention television viewing, and will instead focus on toddler and preschooler safety and injury-prevention topics, such as the appropriate use of car seats, smoke detectors, hot water heater temperature, safe gun storage, and other similar topics.

Eligibility Criteria:
Inclusion Criteria:

* Must watch at least 1.5 hours of television a day on average
* Must speak English at home
* Residence in or near Seattle

Exclusion Criteria:

* Developmental delay