cyrilzakka/clinical-trials huggingface dataset:
Video Capsule Examination in Patients With Lynch Syndrome

Surveillance for colorectal cancer (CRC) in patients predisposed to develop CRC during their lifetime has been impacted by access to colonoscopy suites and endoscopy specialists in the past couple of years. An alternative method, namely the colon capsule, has been proposed, however this investigation is time consuming for the clinician and the images require up to one hour (30-60 minutes) reading to issue a result. The investigators propose to obtain images from paired colonoscopies and colon capsules with the purpose of developing an AI algorithm which could aid the clinicians in reading the colon and expand access to this investigation.

The main aim of the study is to determine whether it is possible to obtain usable paired images from patients with Lynch and other cancer predisposition syndromes. This will depend on the willingness of the patients to take part in the study and the technical ability of obtaining data from paired images of colonoscopies and colon capsule.

At recruitment, participants will undergo a colon capsule investigation, followed by a routine colonoscopy as per their normal standard of care. Paired endoscopic images from colonoscopies and colon capsules will be collected and anonymised data will be accessed by the bioinformatician for analysis.

If the study will be successful in reaching the primary endpoint, further trials will be opened, allowing for a larger population to be included and to obtain more robust data, which eventually can lead to validated AI algorithms and application of computer-aided video-capsules examination as a screening tool in at-risk population.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 years old with no active cancer
* No previous resection of the colon and/or rectum
* Carriers of a pathogenic/likely pathogenic variant in any of the following cancer-predisposition genes: Lynch syndrome (MLH1, MSH2, MSH6, PMS2), APC (FAP syndrome); biallelic MUTYH; STK11 (Peutz-Jeghers syndrome); PTEN, CDH1, CHEK2, TP53, BMPR1A and SMAD4 (Juvenile polyposis syndrome)
* Able to consent to the study and undergo colonoscopy.

Exclusion Criteria:

* Extensive surgery which poses a high risk of video-capsule blockage or narrowing of the bowel due to extensive tumour. Extensive surgery implies any removal of large portions of the small or large bowel that might cause a narrowing (stricture) in the digestive tract.
* Previous irradiation to abdomen or pelvis (risk for small bowel obstruction)
* Carriers of a variant associated with reduced penetrance (in the view of a geneticist) or a variant of uncertain significance.
* Patients with a PS of 3 or 4 and/or mobility issues
* Pregnancy
* Pacemaker or internal electro-medical device (artificial heart valve, cochlear implant or an internal electromedical device).
* Insulin-dependent diabetes
* Patients who require deep sedation for colonoscopy
Chromosome 9 P Minus Syndrome

Patients with deletion of chromosome 9 P are rare (\~200 in the medical literature) and have a diverse set of phenotypic characteristics. We propose using state of the art genome sequencing methods to define the location and size of the deleted portion of chromosome 9 P as well as the genetic background in affected patients (whole genome sequencing) and correlate the genes in the deleted portion of chromosome 9 P with specific phenotypic characteristics of each patient. Enrolled participants will be asked to complete a detailed questionnaire, complete a medical release form, and provide a biospecimen sample.


Eligibility Criteria:
Inclusion Criteria:

* Having 9P minus syndrome/ deletions on the 9th chromosome
* Parents and siblings of affected individuals may also be included to determine contribution of genetic background to phenotypic characteristics

Exclusion Criteria:

* No exclusion criteria for either affected individuals or their parents or siblings.
Medications for the Treatment of Dysthymic Disorder and Double Depression

The purpose of the study is to evaluate the efficacy and safety of flexible doses of escitalopram (Lexapro) compared to sertraline (Zoloft) for treatment of Dysthymic Disorder.

Dysthymic Disorder is a common, chronic type of depression that is often seen as a mild condition and is under-treated. Because of its chronic course, it is often complicated by episodes of major depression and may require long-term treatment.

This is a twelve week study during which daily doses of escitalopram (10-20 mg) or sertraline (50-200 mg) will be given to outpatients meeting criteria for Dysthymic Disorder or Double Depression. Medications will be assigned 1:1 and clinicians will be blinded to treatment. Efficacy will be based on scores for the Hamilton Depression Rating Scale, patient subjective reporting, and clinician observation. The study will have a total of 8 visits over 12 weeks, with a one-week medication taper period at the end. Subjects will have a physical exam, labs, and vital signs monitored at first visit and vital signs monitored at every subsequent visit. Women of childbearing potential must have a negative urine pregnancy test at screening. All subjects will remain on the lowest medication dose for the first four weeks of the study.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Dysthymic Disorder or Major Depressive Disorder with Antecedent Dysthymia
* Women of childbearing potential must have negative pregnancy test at screen and agree to practice acceptable method of birth control
* Score of at least 12 on the 24-item Hamilton Depression Scale at study entry
* Initial screening labs grossly within normal limits
* Signed written informed consent

Exclusion Criteria:

* Other Axis-I diagnoses such as delirium, dementia, and substance dependence (active in last year) or any substance abuse including alcohol within the past six months
* Actively suicidal
* CNS neoplasm, demyelinization disease, degenerative neurological disorder, active CNS infection, or any progressive CNS disorder that may confound interpretation of study results
* History of seizure disorder, or EEG showing paroxysmal activity or head CT showing gross structural abnormality
* Acute systemic medical disorder
* Use of any psychotropic medications within 2 weeks prior to screen or 4 weeks prior to screen in the case of fluoxetine
* Current use of any herbal medication such as St. John's wort,
* Uncontrolled renal, hepatic, endocrine, cardiovascular, pulmonary, immunological, hematological or gastrointestinal disease
* Any other abnormal medical screening tests judged by the investigator to be clinically significant
* Received any experimental medication within 30 days prior to study entry
* Patients presently in or soon to be starting psychotherapy
* Prior treatment non-response to an adequate trial of citalopram, escitalopram, or sertraline
* History of allergy to citalopram, escitalopram or sertraline
Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients

Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Ability to give informed consent
* Stage I-III breast malignancy

Exclusion Criteria:

* Unable to tolerate venipuncture
Eastern Caribbean Health Outcomes Research Network (ECHORN)

The Eastern Caribbean Health Outcomes Research Network (ECHORN) is a collaborative research study that examines the lifestyles, eating habits, and health behaviors associated with cancer, diabetes and heart disease in adult men and women living in the Eastern Caribbean.

The Eastern Caribbean Health Outcomes Research Network (ECHORN) has two aims: (1) To form a research collaborative across the Eastern Caribbean islands of Puerto Rico, the U.S. Virgin Islands, Barbados, and Trinidad \& Tobago to recruit and follow a community-dwelling adult cohort to estimate the prevalence of known and potential risk factors associated with the development of heart disease, cancer, and diabetes and (2) To enhance health outcomes research leadership capacity in the region through a series of dedicated activities locally and abroad. ECHORN will expand clinical research with racial/ethnic minority populations in a transitioning part of the globe now threatened with an epidemic of noncommunicable chronic diseases (NCD). ECHORN's findings will have direct implications for the health disparities research and policy agenda in the mainland United States. In the long term, the links ECHORN will facilitate with local health policy delegations and global strategic organizational partners will promote the translation of research to improve health outcomes across the region. The collection and storage of biological specimens will also contribute to national biomonitoring projects and has the potential to identify unique risk and protective factors in the development of NCD.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 40 years of age
* English or Spanish language speaking
* Resident of island at least 10 years
* Able to provide informed consent
* Non-institutionalized at the time of data collection
* Stable contact/residential information
* No plans to relocate from island within the next 5 years
Analgesic Response to Opioids in Patients With Fibromyalgia After Conventional Acupuncture Versus Sham Acupuncture

This study aims to see whether acupuncture can help fibromyalgia patients by giving them acupuncture treatment and seeing whether acupuncture helps enhance the effects of an opioid.

The investigator hypothesizes that traditional acupuncture (TA) enhances binding of the MOR receptor which will then enhance the pain-reducing effects of opioids compared to sham acupuncture (SA). The investigator will test the hypothesis by giving participants a validated Brief Pain Inventory to complete during the pre-therapy opioid challenge and one week after TA or SA therapy is completed.

Eligibility Criteria:
Inclusion Criteria:

* Are 18 - 80 years old
* have been diagnosed with Fibromyalgia for more than 6 months
* Are already using chronic, continuous opioid therapy, including but not limited to the use of Hydrocodone (Norco), Oxycodone (Percocet), morphine, methadone or Tylenol #3 daily
* Have moderate to excruciating pain at baseline, determined by a 5 or greater score on the Visual Analogue Scale (VAS)

Exclusion Criteria:

* Are younger than 18 or older than 80 years old
* Have been diagnosed with a Substance Use Disorder (SUD)
* Pregnant
* Have an active litigation or worker's compensation case
* Have an active mental health diagnosis, such as bipolar disorder, psychosis, or suicidal ideation
* Are prescribed and actively using low dose Naltrexone . Have tried acupuncture in the last 6 months
Renal Impairment Study With ASP1941

A study to investigate if the pharmacokinetics of ASP1941 is different in Type 2 Diabetes Mellitus (T2DM) patients with different grades of renal failure compared with T2DM patients with normal renal function and healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Patient with stable type 2 diabetes mellitus or healthy subject
* Subject must have pre-dose estimated Glomerular filtration rate (GFR) values (Modification of diet in renal disease (MDRD) method) at screening of:

  * \>90 (normal renal function)
  * 60-90 (mild renal impairment)
  * 30-60 (moderate renal impairment)
  * 15-30 (severe renal impairment)
* BMI between 25.0-40.0 kg/m2, inclusive
* Fasted plasma glucose (FPG) \<11.5 mmol/l (type 2 DM patients) or \>5.6 mmol/l (Healthy volunteers)

Exclusion Criteria:

* Patients with Type 1 diabetes
* Pulse \<40 or \>90; SBP \>160 mmHg; DBP \> 100 mmHg
* T2DM patients who are not on a stable regimen for their current medication (1 month or 5 half lives, whichever is longer) to control their disease
* Healthy Volunteers: Any of the liver function tests above the upper limit of normal
* T2DM: The liver function tests should be within the following ranges:

  * AST/ALT: \<2 x ULN
  * Bilirubin: \<1.5 x ULN
  * Alk Phos: \< 1.5 x ULN
* Patients with renal impairment who have a history of a clinically significant illness (other than renal diseases and T2DM and associated clinical symptoms), medical condition, or laboratory abnormality within 3 months prior to screening
* Patients with renal impairment who have not been on a stable dose of concomitant medications for at least 2 weeks for at least 2 weeks (or 5 halflives, whichever is longer) and/or for whom dose changes are likely to occur during the study
* Patients with T2DM treated with a diet only
* T2DM patients with recent evidence (e.g within the last 6 months) of severe hypoglycemia, for example plasma glucose \< 3mmol/l (\<55 mg/dl), help from others to resolve the hypo or requiring hospitalization
* T2DM patients with a Hemoglobin value \< 9 g/dl (5.6 mmol/l)
COVID-19 Booster Dose Reminder/Recall for Adolescents

A single COVID-19 booster dose has been recommended in the United States for adolescents aged ≥12 years to enhance protection against SARS-CoV-2 infection. This study will assess the efficacy of a one-time reminder/recall for COVID-19 booster dose among eligible adolescents in a regional healthcare system.


Eligibility Criteria:
Inclusion Criteria:

* Marshfield Clinic Health System patient aged 12-17 years with at least one preventive visit or two evaluation \& management visits with a Marshfield Clinic Health System provider in the last 36 months
* Due for a COVID-19 booster dose (completed the COVID-19 primary series and it has been ≥5 months since their second dose)

Exclusion Criteria:

* Primary care provider is not affiliated with Marshfield Clinic Health System
* Opted out of Marshfield Clinic Health System centralized vaccine reminder notifications
* Received COVID-19 vaccine off label
* Missing or invalid contact information
* Deceased
Telitacicept in Primary APS Patients

This is a single-arm pilot study in Peking Union Medical College Hospital. Telitacicept will be added on traditional antithrombotic and immunosuppressive treatment in primary antiphospholipid syndrome (APS) patients with three positive antiphospholipid antibodies (aPL) and at least one extra-criteria manifestations, including thrombocytopenia, autoimmune hemolytic anemia, aPL associated nephropathy, heart valvular disease, non-stroke neurological manifestations. This study aims to evaluate the efficacy of Telitacicept in preventing thrombosis and improving extra-criteria manifestations on high-risk APS patients.

The study started on July 2021 and will last 1.5 years. Primary APS patients with three positive aPL and extra-criteria manifestations with be enrolled. This is a single-arm pilot study. Telitacicept 160mg once a week for 24 weeks will be added on traditional antithrombotic and immunosuppressive treatment. Patients will be followed on week 12 and week 24. The primary endpoint is new thrombotic event. The secondary endpoints are improvement of extra-criteria manifestations, and titer change of aPL.

Eligibility Criteria:
Inclusion Criteria:

* meet 2006 Sapporo classification criteria of APS;
* diagnosis of primary APS, exclude other etiologies of thrombosis;
* with three aPL medium-to-high titer positivity, namely lupus anticoagulant, anti cardiolipin antibody, and anti-β2 glycoprotein antibody;
* with at least one extra-criteria manifestations of APS, including thrombocytopenia, hemolytic anemia, aPL nephropathy, valve heart disease and neurological manifestations.

Exclusion Criteria:

* overlap with other connective tissue diseases, such as systemic lupus erythematosus;
* during pregnancy;
* can not follow-up.
An Investigation of the Effects of a Royal Jelly and Bee Venom-Derived Skin Serum on Skin Health and Signs of Aging

This is a virtual, single-group clinical trial that will last 8 weeks. Participants will use the Manuka Health Eternal Renewal Regenerating Face Serum with Royal Jelly and Bee Venom twice daily and complete questionnaires at Baseline, Week 2, Week 4, and Week 8. Participants will also undergo skin analysis via the Optic Elite facial skin analysis system at Baseline and Week 8.


Eligibility Criteria:
Inclusion Criteria:

* Female.
* 40-55 years of age.
* Must be in good general health.
* Must have concerns with overall skin health and appearance, including:

Fine lines and wrinkles The appearance of dark spots

* Must be using the same cleanser, toner, and moisturizer for at least one month prior to starting the study.
* Must be willing to keep using the same cleanser, toner, and moisturizer for the duration of the study.
* Must not be using oral or topical retinoids.
* In the last three months, has not introduced any new medications or supplements that target skin health.
* Must be willing to comply with the protocol.

Exclusion Criteria:

* Anyone with an allergy to bees or bee products.
* Females who are pregnant or breastfeeding.
* Unwilling to follow the protocol.
* Unwilling to maintain use of the same cleaner, toner, and moisturizer for the duration of the study.
* Currently participating in another study.
* Use of oral or topical retinoids.
* Individuals with cystic acne or otherwise self-reported very acne-prone skin.
* Use of a prescription medication relevant to the skin.
* Anyone undergoing cosmetic procedures during the study, including Botox, laser, or chemical peel treatments.
* Anyone sensitive or allergic to any ingredients found in the products.
* Anyone with severe chronic conditions, including oncological conditions, psychiatric disorders, or diabetes.
Pilot Evaluation of the FilmArray® Childhood Systemic Infection (CSI) Panel

The purpose of this study is to collect data to support decisions made by BioFire regarding assay development, panel composition, and intended use for the final FilmArray CSI reagent pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients under 18 years of age that present with acute fever.


Eligibility Criteria:
Inclusion Criteria:

* Subject has presented to the ED and is suspected of a systemic infection as indicated by a clinician order for blood culture
* Parent/guardian gives written permission (and assent is obtained from children of sufficient maturity)
* Blood specimen can be collected at the same time as the blood culture during the ED visit (or within 12 hours of being admitted from the ED)
* Specimen is at least 500 µL (1.5 mL collection desired)

Exclusion Criteria:

* Parent/guardian is unavailable or unable to give permission, or assent is not obtained (from children of sufficient maturity)
* Physician determines that participation in the study is an unacceptable health risk
* Minimum volume requirement is not met
Impact of Uterine Closure Techniques on the Cesarean Scar Thickness After Repeated Cesarean Section

We compares two techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. We will evaluate myometrial thickness by transvaginal ultrasound six months after cesarean.


Eligibility Criteria:
Inclusion Criteria:

* previous two or three cesarean
* gestational weeks \>=36 weeks

Exclusion Criteria:

* risk of obstetric haemorrhage
* suspicion or diagnosis placenta previa or accrete syndrome
* chorioamnionitis
* uterine myoma in the anterior uterine segment
* hysterotomy other than lower segment uterine incision at previous cesarean
"Iatrogenesis Imperfecta"- Extent and Characteristic in NICU in Israel.

Iatrogenesis is inevitable in the NICUs.

In the first 3 months of the study we will document Iatrogenic events in 3 NICUs in Israel without informing the medical and nursing staff. In the second 3 months of the study we will try to draw the attention of the medical and nursing staff that we are documenting iatogenesis, and we will assess wether this intervention will decrease the events of Iatrogenesis.

Eligibility Criteria:
Inclusion Criteria:All infants in NICU -

Exclusion Criteria:None

-
Cytokine Response in Septic Shock

This study is designed to examine the early sequential cytokine responses during antibiotic therapy and resuscitation of septic shock in relation to clinical manifestations of disease.

The specific objective is to obtain sequential serum samples from patients with septic shock, examine a broad range of cytokine responses (TNF, IL-1, IL-6, MIF, LIF, HMGB1, etc) in a rigorous manner and correlate these responses to administration of antibiotics, resuscitative efforts and physiologic responses to illness (temp, HR, blood pressure, WBC, etc).

Patients must be on vasopressors Patients cannot be on pressors for \> 24 hrs prior to consent

Eligibility Criteria:
Inclusion Criteria:

* Adult ICU patients: . 18 years admitted with septic shock
* Receiving Vasopressors \< 24 hrs

Exclusion Criteria:

* Consent refused by patient or SDM
* Received Vasopressors \> 24hrs
A Brief Appetite Awareness Intervention for Eating and Weight Regulation Among College Freshmen

The proposed study is a randomized clinical trial investigating the effects of a weight gain and eating dysregulation prevention intervention among college freshmen women. It will compare Appetite Awareness Training (AAT) to a standard nutritional education group and a no treatment control group. Appetite Awareness Training approach to increasing eating regulation through training individuals to eat in response to their appetite cues rather than external or emotional cues.

All female freshmen students residing in the university dorms were recruited to participate in this study. After completing the baseline assessment, eligible participants were randomly assigned to one of the three arms. Those in the AAT condition received guided administration of AAT over the course of three weekly group sessions, with an additional booster session three weeks after completion (week 6). The standard treatment comparison group received four similarly timed group sessions of psychoeducational/nutrition information facilitated by a registered dietician. A manualized approach to administration of the intervention was created based on the AAT treatment and was strictly followed in order to standardize the implementation of the prevention groups. The no-treatment control group only participated in the assessments.

Eligibility Criteria:
Inclusion Criteria:

* Incoming University of Minnesota Duluth freshmen women residing in on campus dormitories

Exclusion Criteria:

* Males, non-dormitory residing, non-freshmen.
Gene Expression in MS Patients Before and During Treatment With Interferon-beta

Clinical and experimental evidences suggest that there is a variability in therapeutic response to immunomodulating therapies in Multiple Sclerosis patients.

Microarrays is a technology that permits to monitor the expression levels of thousands of genes at a time.

The specific aim of this study is to identify predictive factors of therapeutic response in MS patients treated with high-dose Interferon-Beta.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of relapsing-remitting MS (McDonald criteria)
* age between 18-55
* EDSS less or equal to 5.5

Exclusion Criteria:

* use of any other disease modifying drugs
* use of corticosteroids during 3 months before starting protocol
* clinical relapse during 1 month before starting protocol
* serious heart, renal, hepatic or haematological dysfunction defined by laboratory exams