cyrilzakka/clinical-trials huggingface dataset:
Immune-modulation Effects of an Arginine Rich Nutritional Supplement in Surgical Patients

The primary objective of this study is to characterize the immune-modulatory effects of arginine-rich nutritional supplements in patients undergoing surgery. Numerical and functional changes of all circulating immune cells will be assessed with mass cytometry.


Eligibility Criteria:
Inclusion Criteria:

1. Colon surgery for cancer
2. Patients ≥ 18 and ≤65 years of age
3. Patients willing and able to sign an informed consent form and Health Insurance and Portability Act (HIPAA) authorization and to comply with study procedures

Exclusion Criteria:

1. Patients on immune-suppressant therapy within the last 6 months (e.g. azathioprine or cyclosporine)
2. Patients pretreated (6 months) or currently on chemotherapy for cancer
3. Patients on radiation therapy (within 6 months)
4. Patients on chronic medication with potential immune-modulatory effects (e.g. daily oral morphine-equivalent intake \> 30 mg)
5. Patients with metastatic disease
6. Patients with active infectious disease (within 2 months)
7. Patients with significant metabolic disease (e.g. diabetes type I)
8. Patients with clinically significant organ dysfunction including renal and hepatic dysfunction
9. Patients with significant cardiovascular and respiratory comorbidities resulting in impaired function and frailty
10. Patients with autoimmune disease (e.g. lupus)
11. Patients with Hx of substance abuse (e.g., alcoholism, drug dependency)
12. Undernourished patients as indicated by a weight loss \>10% during the last 6 months
13. Patients with galactosemia
14. Patients who had undergone previous major abdominal surgery
15. Participation in another clinical trial of an investigational drug or device within the last 30 days prior to the first day of study that, in the investigator's opinion, would create increased risk to the participant or compromise the integrity or either study
16. Pregnancy
17. Other conditions compromising a participant's safety or the integrity of the study
A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair

The purpose of this study is to identify a dose of intrathecal hydromorphone (opioid pain medicine) that optimizes pain control but minimizes side effects historically seen with this class of pain medications.

This study is a sequential coin based up-down dose allocation method with the goal of identifying the ED90 for intrathecal hydromorphone (ITH) in idiopathic adolescent scoliosis repair via the posterior approach. A starting dose of 3.5 mcg/kg of hydromorphone was determined by current practice at the institution as well as upon review of available literature of previously used ITM doses in pediatric spine patients. Subsequent participants will receive higher (step "up") or lower (step "down") from this starting dose. Steps "down" from the starting dose will be smaller than steps "up" to ensure maintenance of adequate analgesia and to allow more accurate estimate of the optimal dose should it decrease beyond our starting dose. Steps "up" from the starting dose were chosen based on commonly used weight-based doses in our current practice. A maximum dose of 400 mcg, despite patient weight, was determined based on expert consensus and review preparatory to research query. The anesthesiologist covering the case (high lumbar or thoracic corrections) or the surgeon (low lumbar corrections) will administer the medication at the low lumbar level.

ITH dose adjustments for subsequent study patients will be based on the efficacy of the dose used with the prior patient. Efficacious ITH administration will be defined as all NRS scores ≤5 within the first 18 hours after administration (binary outcome). If the NRS score was \>5 within 18 hours or if the patient required supplemental opioid administration for pain control (suggestive of insufficient analgesia), the dose will be increased for the next enrolled study patient. If the pain score remains ≤5 within 18 hours of opioid administration, the next patient will receive the next lower dose or the same dose as the previous patient. Patients excluded after randomization will be removed from the study.

Eligibility Criteria:
Inclusion Criteria:

- Undergoing spinal surgery with a posterior approach for idiopathic scoliosis.

Exclusion criteria:

* Patients with pre-surgical elevated pain scores (≥ 3/10 on Numeric Rating Scale (NRS)), history of chronic pain, or pre-surgical opioid use will not be included.
* Patients with contraindications to spinal anesthesia (anatomical abnormality or elevated bleeding or infection risks) will not be included.
* Patients for whom the protocol is violated (inability to perform postoperative data collection), or the study/procedure was aborted will not be included in analysis.
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate

The aim of this study is to analyze total lenght of the sick leace and functional outcome (PRWE) at 2 months between 2 weeks casting and immediate mobilization following volar plating for a DRF.

This study is a prospective, randomized, controlled trial. The aim of this study will be to compare the early postoperative outcomes of the patients enrolled in the early mobilization with those patients in post-operative 2-week casting following volar plating for a DRF. Co-primary outcome in this study will be the total lenght of sick leave and Patient-Rated Wrist Evaluation (PRWE) 2 months after the operation.

Eligibility Criteria:
Inclusion Criteria:

* Intra- or extra articular DRF (Colles, Smith, Volar barton)
* operative treatment justified

Exclusion Criteria:

* Refusal to participate in the study
* Open fracture with a severity greater than Gustilo grade 1
* Patient aged less than 18 or over 65
* Patient does not understand written or spoken guidance in local languages
* Pathological fracture
* Previous fracture in the same wrist or forearm in the last 10 years, that has led to impairment of function
* Ipsilateral fracture in upper extremity
* Associated fractures of the ulna (except fractures of the PSU)
* Polytrauma
A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease

The proposed study is a randomized, double-blind, placebo-controlled, multi-center Phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active Crohn's Disease. The study aims to evaluate the optimal dose of SHR0302 and time needed in inducing clinical remission in active CD. This is an 12+12 weeks study, in which participants who complete the first 12 weeks treatment phase, will have the option to enter a blinded active arms 12-week extension phase. Early withdrawn subjects during the first treatment phase cannot enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 26 weeks.

With the wealth of scientific evidence on JAK/STAT involvement in IBD, the data from similar class of new drugs and the current data on SHR0302 (JAK1 inhibitor), support the rationale to proceed with phase II studies to evaluate the efficacy and safety of SHR0302 in patients with moderate to severe active CD.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female subject at ≥18 and ≤ 75 years of age at randomization.
* Subjects with a documented three-month history of diagnosed ileal, colonic, or ileocolonic Crohn's Disease at the time of randomization.
* Currently having Crohn's Disease with Crohn's Disease Activity Index (CDAI) score ≥ 220 to ≤450.

Exclusion Criteria:

* Diagnosis of indeterminate colitis, or clinical findings suggestive of Ulcerative Colitis.
* Subject with CD with stoma, gastric or ileoanal pouch, proto-colectomy or total colectomy, symptomatic stenosis or stricture, history of bowel perforation, suspected abscess; actively draining fistula.
* Treatment naïve subjects diagnosed with Crohn's disease, (without previous exposure to treatment).
Awareness Based Stress Reduction Program Applied to Breast Cancer Patients Receiving Chemotherapy

Implementation of awareness-based stress reduction program in breast cancer patients receiving chemotherapy and examining its effects on psychological resilience, symptom management and quality of life.

The conscious awareness-based stress reduction program is a program that lasts eight weeks, each session lasting 2-2.5 hours and including a 6-hour silence day. In order to apply the mindfulness stress reduction program to the experimental group, the 'Conscious Awareness Stress Reduction Program day and time were determined for 30 breast cancer patients receiving chemotherapy who met the inclusion criteria and were sampled. It was applied to the patients in the experimental group, once a week for 150 minutes, lasting 8 weeks, and consisting of 8 times in total. Then, an intermediate test was applied to the patients. After the interim test, patients were asked to repeat the It applications individually for 8 weeks (between weeks 8-16). In addition, after It was applied to the patients in the experimental group by the researcher, the 'Conscious Awareness Stress Reduction Program booklet prepared by the researcher was given to the patients in order to provide a guide for the patients in the experimental group. During the implementation of the research, no intervention was applied to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age
* Ability to communicate adequately
* No psychiatric problems
* Implementation of the Awareness-Based Stress Reduction Program is an obstacle
* Volunteering to participate in the research

Exclusion Criteria:

* Those who have communication problems
* Those with psychiatric problems
* Not agreeing to participate in the study.
Alcohol Research in HIV: Relapse Prevention

3-arm type 1 pilot implementation-efficacy trial for people with alcohol use disorders to examine the preliminary effectiveness and feasibility of an adapted 2-session, computerized and person delivered relapse prevention intervention.

This study will develop a brief counseling intervention for people with HIV who have resumed alcohol use or resumed hazardous alcohol use after a minimum of 3 years of alcohol abstinence or 'lower risk' alcohol use. The investigators will develop a 2session person delivered and a 2-session computer delivered intervention which the investigators will then compare with the usual treatment for alcohol counseling offered at the HIV clinic. The investigators will also study the acceptability and feasibility of implementing both types of counseling in the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of HIV
* Aged 18 years or older
* Must be enrolled in clinical care at Johns Hopkins HIV Clinic.

In addition, meet the following alcohol use criteria:

1. lifetime alcohol use disorder
2. patient reported outcomes (PRO) assessment collected by the Center for AIDS Research (CFAR) Network of Clinical Systems as part of usual clinical care that show in the last 3 years: periods of no or lower risk drinking (e.g. women/men who are drinking \<11/22 drinks per week) and periods of lapse to higher levels of drinking (=\>11/22 drinks per week for women/men)
3. current PRO showing alcohol abstinence or alcohol use at \<11/22 drinks per week for women/men.

Exclusion Criteria:

* Acutely suicidal, homicidal, psychotic or otherwise unable to provide informed consent
* Non-English speaking because interventions are currently available in English only
R2 in the Treatment of Follicular Lymphoma

Lenalidomide Based Immunotherapy in the Treatment of FL

Lenalidomide Based Immunotherapy efficacy related molecular biomarker in follicular lymphoma

Eligibility Criteria:
Inclusion Criteria:

Patients diagnose as de novo or relapse refractory FL grade 1-3A .

No history of stem cell transplantation.

Written informed consent.

Exclusion Criteria:

Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.

Clinically significant active infection.

Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.

Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.

Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.

Patients who are pregnant or breast-feeding.

HIV infection.
Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder

The purpose of this study is to find out whether atomoxetine (also called Strattera) helps teenagers (12-19) with Attention Deficit Hyperactivity Disorder (ADHD) and drug/alcohol problems.

Evidence-based psychosocial treatments have recently been developed. However, very little data exist on the use of pharmacotherapy for adolescents SUD (Substance Use Disorder). One promising pharmacotherapy approach is to treat co-occuring psychiatric disorders. A common co-occurring disorder in adolescent SUD is attention-deficit/hyperactivity disorder (ADHD). Fortunately, new ADHD medications, such as atomoxetine, that do not have addictive potential are now available. However, all controlled studies of atomoxetine have specifically excluded teens with SUD. Therefore, little data exist on the safety and efficacy of the medication in this population. This research project will address the important research gap with the specific aim: to conduct a randomized, placebo-controlled trial of atomoxetine for ADHD in teens with SUD.

Eligibility Criteria:
Inclusion Criteria:

* Age 12-19
* Provided assent/consent
* attention-deficit hyperactivity disorder (ADHD) by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS)
* Diagnostic and statistical manual of mental disorders, 4th edition (DSM-IV) checklist \<=22
* At least one non-nicotine substance use disorder (SUD) by KSADS
* Plans to live locally for 4 months
* Willing to participate in cognitive behavioral therapy (CBT)

Exclusion Criteria:

* No mental illness that cannot be managed as an outpatient or without concurrent psychotropic medication
* No allergy to atomoxetine
* No narrow angle glaucoma
* No serious medical illness
* Not pregnant
* Not unwilling to use an effective form of contraception during the trial
* No SUD that cannot be managed as an outpatient or without concurrent psychotropic medication
Performance and Safety of a Novel Ostomy Ring to Improve Ileostomy and Colostomy Management

In this study, a novel ostomy ring device will be assessed for safety and efficacy in increasing the lifespan of ostomy pouching equipment.

In this crossover design trial, patients will be asked to first wear their normal ostomy pouching equipment for 28 days followed by 28 days with the OstoRing®. Patients may choose to continue using the OstoRing for an additional 19 days. Study visits will occur between each section of the trial and will involve a skin assessment and quality of life questionnaires. Additionally, over the course of the trial, participants will be asked to fill out a survey and take a picture of their stoma with ostomy pouching change.

Eligibility Criteria:
Inclusion Criteria:

* Are at least 18 years of age and have full legal capacity
* Have had an end or loop ileostomy or colostomy for at least 6 months.
* Have used a Hollister 2 piece New Image pouching system for at least 8 weeks
* Able to provide informed consent
* Have a stoma with a diameter of 57mm or less
* Change their pouching system at least two times in seven days

Exclusion Criteria:

* Unable to give informed consent.
* Are pregnant or currently breastfeeding.
* In the last 2 months has received or is currently receiving, chemotherapy or radiation therapy.
* In the last month has received or is currently receiving systemic or local steroid treatment in the peristomal area.
* Currently suffering from severe peristomal skin problems such as peristomal pyoderma, abscess.
* Currently suffering from a peristomal hernia.
* Known hypersensitivity toward any of the test product (OstoRing® is made of surgical grade stainless steel)
* In the last 30 days has participated or is currently participating in a clinical study
* Assessed with an ostomy skin tool score of ≥3
Study of Food on Evacetrapib (LY2484595) in Healthy Participants

The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.

The study has 2 periods. In each period, participants will take the study drug for 10 days, either with or without a meal. There is a minimum 14-day washout between each period.

This study is approximately 50 days, not including screening. Screening is required within 28 days prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants as determined by medical history and physical examination
* Have a body mass index of 18 to 32 kilograms per square meter (kg/m²)
* Are able to eat a high fat breakfast and abide by the food restrictions throughout the study

Exclusion Criteria:

* Have known allergies to evacetrapib, related compounds or any components of the formulation
* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Are participants who currently smoke cigarettes or use tobacco or nicotine substitutes
Glowing and Expecting Follow Up

This study will help us learn more about how a mother's health during pregnancy may influence her child's growth and development later in life.

This study will follow participants who participated in the Glowing and Expecting study. 514 people who are 5 to 14 years of age who agreed to be contacted for future studies will be part of this study.

Eligibility Criteria:
Inclusion Criteria:

* Former Glowing and Expecting study participants aged 5 to 14 years of age

Exclusion Criteria:

* Participants who were dropped from the Glowing and Expecting studies.
BreinZorg: Feasibility Study Into an Online Lifestyle Platform for MCI and SCD

Dementia is the most common disease in older individuals and this century's biggest healthcare challenge. Many patients who visit the memory clinic with memory complaints do not have dementia but instead are diagnosed with mild cognitive impairment (MCI) or subjective cognitive decline (SCD). MCI or SCD may be a pre-dementia stage. Many patients with MCI or SCD often leave their consultation with unanswered questions, and unsure what they, themselves can do to reduce dementia risk. Patients with MCI and SCD have a heightened risk of developing dementia. Therefore, this group would possibly benefit most from preventive strategies. Around 40% of dementia cases is attributable to modifiable factors. Thus, managing a healthy lifestyle may reduce dementia risk.

To answer the information request many patients have when leaving the memory clinic and to fill the knowledge gap an online tool has been developed.

The goal of this mixed-method feasibility study is to investigate the usability, feasibility, patient experience, and effectiveness of the personalized, multi-domain online website in older adults with MCI or SCD.

The main questions it aims to answer are:

* Is the new website being used by the target population?
* How does the target population experience the use of the website?
* What is the effect of using the website?

Participants will have access to the website and are free to use the website in any way they want.


Eligibility Criteria:
Inclusion Criteria:

* Visited a memory clinic;
* Recent (no longer than 4 months) diagnosis of MCI or SCD according to the guidelines used in the memory clinic;
* \>60 years of age;
* Sufficient fluency in Dutch;
* Internet access at home and a working e-mail address;
* Sufficient hearing and vision to read, watch and hear content on the website.

Exclusion Criteria:

* Diagnosis of Dementia according to the guidelines of the memory clinic;
* Any condition to hinder successful 6-month follow-up;
* Diagnosis of Major depression;
* Coincident participation in any other intervention trial at time of pre-screening.
PIIR Study: Comparison of Genetic Tests for Age-Related Macular Degeneration

This study is being conducted to compare two different genetic tests developed to determine an individuals risk of developing serious vision threatening complications from age-related macular degeneration (ARMD).

There are currently two different genetic tests that have been developed for this purpose. They both look at specific DNA components to determine the risk. Participants in the study will be over the age of 60 years and caucasian as this is the population of people in which these tests have been validated. Each participant will have the study explained to them and then will be asked to sign the informed consent document if they agree to participate. They will have a dilated exam of their eyes along with photographs taken of the retina. If their doctor sees that it is necessary they will also have a special scan or a special angiogram of their eyes to look at their retina in more detail. For the genetic testing a member of the research team will use two swabs from each of the genetic companies to gently scrap some cells from the inside of the cheek. These cells will be sent to each respective lab for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian race
* Age \>/= 60 years
* Patient's written informed consent
* Ability to comply with the protocol procedures

Exclusion Criteria:

* Race other than Caucasian
* Age \< 60 years
* Macular or retinal pathology other than ARMD
* Known hypersensitivity to any drug included in the treatment protocol
* Any other severe clinical condition that in the judgment of the local investigator would place the patient at undue risk or interfere with the study completion
* Prisoners