cyrilzakka/clinical-trials huggingface dataset:
Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest

To study the effects of ubiquinol as a "metabolic resuscitator" in post-cardiac arrest.

Cardiac arrest (CA) occurs in more than 400,000 patients in the United States each year with an estimated mortality of greater than 90%. The majority of patients who are resuscitated from CA will succumb to the neurologic morbidity associated with the post-CA syndrome and ischemic-reperfusion injury. Currently, there are no pharmacologic agents known to offer survival benefit or to prevent devastating neurologic injury in post-CA patients.

A potential therapeutic target following ischemia-reperfusion injury is mitochondrial function in the injured cell and/or reduction of oxygen free radicals. Coenzyme Q10 (CoQ10) is an essential mitochondrial co-factor and free radical scavenger that has been proposed as a neuroprotective agent in various neurodegenerative disorders as well as a cardioprotective agent. CoQ10 have furthermore shown exciting preliminary results as a potential therapy in post-CA.

In order to test the effects of ubiquinol as a "metabolic resuscitator" in post-CA patients and to provide additional preliminary data for a large-scale clinical trial, the investigators are conducting a randomized, double-blind, place-controlled trial of ubiquinol in post-CA patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years)
* Cardiac arrest defined by cessation of pulse requiring chest compressions
* Not following commands after ROSC
* Admission to the ICU
* Naso/orogastric tube
* Ability to receive enteral medication

Exclusion Criteria:

* Protected populations (pregnant women, prisoners, the intellectual disabled)
* Current CoQ10 supplementation
* Anticipated death within 24 hours
* \> 12 hours from ROSC to estimated randomization
* Jejunostomy tube (J-tube)
Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer

RATIONALE: Less invasive types of surgery may help reduce the number of side effects and improve recovery. It is not yet known which type of surgery is more effective for colon cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of laparoscopic-assisted colectomy with open colectomy in treating patients who have colon cancer.

OBJECTIVES:

* Compare the disease-free and overall survival rates of patients with colon cancer treated with laparoscopic-assisted colectomy vs open colectomy.
* Compare the safety of these regimens in terms of early and late morbidity and 30-day mortality of these patients.
* Compare the differences in costs and cost effectiveness between these treatments in this patient population.
* Compare the differences in quality of life of patients treated with these regimens. (closed as of 4/30/99)

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, primary surgeon, site of primary tumor (right vs left vs sigmoid), and American Society of Anesthesiologists disease classification (I and II vs III). Patients are randomized to one of two treatment arms.

The extent of colon resection is identical for both arms.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Clinical diagnosis of primary adenocarcinoma

  * Involving a single colon segment:

    * Right colon from the ileocecal valve up to and including the hepatic flexure
    * Left colon from the splenic flexure to the junction of the sigmoid and descending colon
    * Sigmoid colon between the descending colon and the rectum (at least 15 cm from the dentate)
* Diagnosis based on physical exam plus either a proctosigmoidoscopy and barium enema or a colonoscopy
* No advanced local disease that renders laparoscopic resection impossible
* No acutely obstructed or perforated colon cancer requiring urgent surgery
* No transverse colon cancer (i.e., between distal hepatic flexure and proximal splenic flexure)
* No stage IV disease
* No rectal cancer (i.e., below the peritoneal reflection, lower edge of tumor less than 15 cm from dentate)
* No American Society of Anesthesiologists IV/V disease classification
* No associated gastrointestinal diseases (i.e., Crohn's, chronic ulcerative colitis, or familial polyposis) that require additional extensive operative evaluation or intervention

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Other:

* No other prior or concurrent malignancy within the past 5 years except superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Surgery:

* No prohibitive scars/adhesions from prior abdominal surgery

Other:

* No concurrent investigational treatments or invasive diagnostic procedures within 30 days after surgery
Sleep, Glycemic Control, and Insulin Resistance in Adolescents With Type 1 Diabetes

Despite advancements in care, most adolescents with T1D have higher BMI and significantly higher HbA1c than recommended and are markedly IR, placing them at increased risk for CVD1,2. Thus, alternative approaches to improve and maintain glycemic control, IR, and BMI for adolescents with T1D are urgently needed. This proposal moves beyond the current insulin and carbohydrate counting-focused lifestyle change paradigm to focus on sleep and circadian misalignment, which will allow for identification of new mechanisms that can be directly translated into future intervention and prevention trials. The goal of the current study is to utilize multiple objective measures of sleep duration, timing (actigraphy), and circadian rhythm (melatonin) in adolescents with type 1 diabetes (T1D; N = 40) and examine relationships with glycemic control, IR, vascular health, and BMI. Further, qualitative methodology will be used to identify barriers and facilitators to healthy sleep in adolescents with T1D.


Eligibility Criteria:
Inclusion Criteria:

* attending high school
* diagnosis of type 1 diabetes \>1 year

Exclusion Criteria:

* current diagnosis of a sleep disorder (e.g., insomnia, OSA) or abnormal scores on sleep disorders screening measures
* regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin, other sleep aids)
* HbA1c ≥11 or \>14% for the previous 2+ measurements
* IQ\<70 or severe mental illness
BE FAST vs. FAST: A Study in the General Public.

A randomized, blinded prospective study assessing retention of two stroke mnemonics (BE FAST and FAST) in the general public after receiving brief stroke education. Participants were randomized to one of two education arms and retention was tested at 3 different time intervals.


Eligibility Criteria:
Inclusion Criteria:

1. Subject 18 years of age or older
2. Subject speaks English (Does not need interpreter)
3. Subject able to read English
4. Subject willing to provide a phone number for future follow up
5. Subject willing and agreeable to up to 2 phone follow up calls
6. Subject willing to provide verbal consent to participate

Exclusion Criteria:

1. Subject non-English speaking (needs interpreter)
2. Subject has visual or hearing impairment
3. Subject has history of Dementia or a learning disability
4. Subject had stroke education within the past year
5. Subject had a previous stroke
Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children/Young Adults With AML

The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells for children/young adults with primary high risk or refractory AML and relapsed AML.

Immunotherapy with NK cells may improve the treatment results in AML. For better efficiency high cell doses or several infusions of NK cells are required. For this purpose, donor NK cells are expanded in the presence of feeder K562-mbIL21-41BBL cell line.

For patients with high-risk primary AML a cycle of immunotherapy includes chemotherapy (HD-ARA-C+IDA) followed by three doses of NK cells infusion.

For patients with refractory/relapsed AML a cycle of immunotherapy includes chemotherapy (FLAG - fludarabine, cytarabine, G-CSF) followed by three doses of NK cells infusion.

A 2nd cycle of therapy may be administered if a recipient continues to meet the eligibility criteria.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* primary high risk AML
* primary refractory AML
* relapsed AML
* Karnofsky or Lansky performance scale greater or equal to 70
* written informed consent

Donors:

* haploidentical family donor
* donor suitable for cell donation and apheresis according to standard criteria
* written informed consent

Exclusion Criteria:

Patients:

* uncontrolled infection
* severe hepatic dysfunction: SGOT or SCPT \>=5x upper limit of normal for age
* positive serology for human immunodeficiency virus (HIV)

Donors:

* pregnancy
* positive serology for HIV, hepatitis B or C
Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery

The purpose of this clinical investigation in open, elective, spine surgery is to collect data to support the removal of the neurosurgical exclusion from the currently approved indication for the use of HEMOBLAST™ Bellows. This study is primarily designed to assess safety of the device for use in spine surgery, although efficacy information will also be captured and reported.


Eligibility Criteria:
Inclusion Criteria:

* Subject is undergoing open, elective, spine surgery
* Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation
* Subject is 22 years of age or older
* Subject does not have an active or suspected infection at the surgical site
* Subject in whom the Investigator is able to identify a Target Bleeding Site (TBS) for which any applicable conventional means for hemostasis are ineffective or impractical
* Subject has a TBS with a Surface Bleeding Severity Scale (SBSS) score of 1, 2, or 3

Exclusion Criteria:

* Subject is undergoing an emergency surgical procedure
* Subject is undergoing a laparoscopic surgery
* Subject is undergoing a cervical spine surgery
* Subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding
* Subject has a platelet count \< 100,000 per microliter or International Normalized Ratio \> 1.5 within 4 weeks of surgery
* Subject receiving intravenous heparin within 12 hours before surgery or oral Coumadin within 2 days before surgery
* Subject receiving antiplatelet medications within 5 days prior to surgery
* Subject receiving aspirin within 7 days prior to surgery
* Subject has an active or suspected infection at the surgical site
* Subject has had or has planned to receive any organ transplantation
* Subject has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent
* Subject has a known sensitivity or allergy to Gadolinium
* The subject has a contra-indication for MRI or gadolinium contrast agent according to clinical guidelines, local regulations or manufacturer's recommendations
* Subject suffers from claustrophobia or fear of MRI, or has any contraindication to MRI (e.g., metal implants, spinal cord stimulator, etc. not suited to MRI)
* Subject has American Society of Anesthesiologists classification of \> 4
* Subject has a life expectancy of less than 3 months
* Subject has a documented severe congenital or acquired immunodeficiency
* Subject has religious or other objections to porcine, bovine, or human components
* Subject is currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent
* Per investigator opinion subject is unable to fully cooperate with the study protocol.
* The product will be placed in at the site where the dura is open
* The product will be placed in the intradural or cranial space
Apollo Device for Metastatic Breast Cancer (MBC)

This is a single-arm, open label pilot intervention study with outcomes measured by electronic survey and chart review evaluating a wearable device called Apollo, which is similar to a FitBit but emits vibrations. Our primary objective is to assess whether or not Apollo can help with symptoms of fatigue and pain in patients with Metastatic Breast Cancer (MBC).

This study aims to provide preliminary data on the efficacy and tolerability of the Apollo device in the management of fatigue and pain in patients with Metastatic Breast Cancer (MBC).

Apollo is about the size of an Apple Watchand can be worn on the ankle, wrist, or armwith two adjustable fabric straps. Apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy. In addition to the wearable, Apollo is a software system that curates music for the body, rather than for the ears. The scientific principles guiding the use of Apollo and mechanistic understanding of its effects on the body are consistent with the understanding of how music and therapeutic touch effect the body to convey feelings of energy, focus, or relaxation by sending safety signals to the emotional cortex (limbic system) in the brain. Similar to music and touch used to facilitate a healing response in the body, there are no known side effects to this type of therapy.

The PROMIS-Fatigue scale and the Functional Assessment of Cancer Therapy Fatigue (FACT-F) are instruments that have been previously validated in multiple diseases and will be used in this study. Preliminary data on indices of pain, use of PRN pain medications, health-related quality of life, sleep, anxiety and depression and tolerability/frequency of use with the Apollo device in MBC will also be evaluated using:

* PROMIS pain scale
* Use of pain medications
* Health-related quality of life (HRQOL) using PROMIS-29
* PROMIS Sleep
* Hospital Anxiety and Depression Scale (HADS)
* Usage data from Apollo app

This study aims to identify improvement of fatigue symptoms from baseline after 4 and 8 weeks of Apollo use. Improvements in pain, quality of life, use of PRN pain medication, anxiety and sleep.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic breast cancer diagnosis
* Fatigue score of 4 or greater at last clinic visit

Exclusion Criteria:

* Not able to read and understand English
* Use of Beta Blockers,
* Use of medications for serious mental illness
New Therapy for Advanced Stage Leukemia After Stem Cell Transplantation

Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia, particularly for patients with advanced-stage leukemia. However, relapse rate was still very high for advanced-stage leukemia.

It was found in our previous study that infusion of granulocyte colony-stimulating factor (G-CSF)-primed peripheral blood progenitor cells (GPBPC) instead of non-primed lymphocytes exhibited a comparative or stronger graft-versus-leukemia (GVL) effect and comparative or less incidence of GVHD, rarely being complicated with pancytopenia. When GPBPC infusion was combined with the use of short-term immunosuppressant for GVHD prophylaxis, the incidence of fatal GVHD complicated with GPBPCI was further reduced. Our primary data showed the GPBPCI combined with the use of short-term immunosuppressant was feasible in patients with advanced leukemia to prevent relapse after HLA-mismatched HSCT.

The study hypothesis:

Prevention of relapse using granulocyte colony-stimulating factor-primed peripheral blood progenitor cells following hematopoietic stem cell transplantation in patients with advanced-stage acute leukemia can

* reduce relapse rate
* improve survival

A G-CSF-primed PBPCI was planned within day 60 post-transplantation before hematologic relapse was diagnosed in patients for which no GVHD occurred or free of GVHD after 2 weeks off immunosuppression for patients receiving GPBPCI after day 90 post HSCT. Before administration of GPBPCI, serious infection had to be cleared and no serious organ failure could be present. The GPBPCI regimen was comprised of G-CSF-primed PBSCs instead of harvested non-primed donor lymphocytes and short-term immunosuppressive agents for prevention of GVHD after GPBPCI. Chimerism status was examined before and after prophylactic treatment with GPBPCI.

Eligibility Criteria:
Inclusion Criteria:

* high-risk leukemia after HSCT

Exclusion Criteria:

* active GVHD
* early relapse
Low-dose Atropine for the Prevention of Myopia Progression in Danish Children

Myopia (nearsightedness) is increasing in prevalence throughout the world. It is associated with a risk of potentially blinding complications such as retinal detachment and myopic maculopathy. There is a direct association between the degree of myopia and the risk of complications. Myopia develops in childhood and during adolescence. To prevent higher degrees of myopia, we need to halt disease progression in children and teenagers. Low-dose atropine eye drops have been shown to reduce myopia progression by 50% in Asian populations but its effect in non-Asian populations is unknown. The aim of this study is to investigate if low-dose atropine can reduce myopia progression in Danish children and teenagers. The study is an investigator initiated randomized clinical trial conducted as a collaboration between three Danish Eye Departments covering all of Denmark.

The main hypotheses tested in this study are:

* 0.01% atropine one drop nightly reduces the progression of childhood myopia in Danish children.
* 0.01% atropine one drop nightly is safe and with no significant side effects.
* A 6-month loading dose of 0.1% atropine followed by a 0.01% atropine maintenance dose is superior to single 0.01% atropine.
* 0.1% atropine one drop nightly is safe and has tolerable side effects.
* The rebound effect after stopping both atropine regimens is limited.
* Choroidal thickness is a predictor for the progression of childhood myopia.

Eligibility Criteria:
Inclusion Criteria:

* Children aged ≥6-\<9 years: myopia ≤-1 (spherical power) in at least one eye
* Children aged ≥9-≤12 years: myopia ≤-2 (spherical power) in at least one eye
* Cylinder less than 1.5 diopters

Exclusion Criteria:

* Myopia related to retinal dystrophies
* Collagen syndroms (Ehlers-Danlos syndrome, Marfan syndrome and Stickler syndrome)
* Other ocular pathology (e.g., amblyopia, strabismus)
* Previous eye surgery
* Previous use of agents thought to affect myopia progression, e.g. atropine, pirenzepine or 7-methylxanthine (metabolite of caffeine and theobromine) and orthokeratology contact lenses
* Known allergy to atropine or any of the contents of the trial medication (active and in-active ingredients) used in the study
* Non-compliance to eye examinations
* Serious systemic health troubles (e.g., cardiac or respiratory illness) and developmental disorders and delays
Pharmacy-based Testing and Treatment for Gonorrhea and Chlamydia

Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the first and second most commonly reported sexually transmitted infections (STI) in Canada, respectively, and rates are increasing. While CT and NG can cause a variety of non-specific symptoms, an estimated 77% of CT and 45% of NG cases are asymptomatic. Consequently, many individuals remain undiagnosed, or have delayed diagnosis and consequently miss effective and well-tolerated therapies and may transmit the infection(s) to sexual partners. Untreated CT infection may result in serious sequelae. Also, CT and NG infection are associated with increased risk of acquiring HIV and some cancers. Access to STI testing and treatment are two of the core pillars in the Pan-Canadian Sexually Transmitted and Blood Borne Infections (STBBI) Framework for Action. Currently many Canadians lack a primary care physician and many STI specific clinics are centered in urban areas, further challenging access in rural communities. Increasing access to these core pillars is paramount to reduce the health impact of STBBIs in Canada by 2030.

The purpose of this study is to implement and evaluate a novel pilot project including pharmacy-based CT and NG management (including specimen self-collection \[pharyngeal, anorectal and/or vaginal swabs, and/or urine sample\], assessment, treatment, and linkage to care) by community pharmacists in Nova Scotia.


Eligibility Criteria:
Exclusion Criteria:

* Symptomatic
* Age less than 18 years
* Does not understand English
* Does not have a valid Nova Scotia health card
* Is not able to provide informed consent to participate in research
Multi-Center Pilot Study of truSculpt Device

An exploratory pilot study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device

This is a multi-center, pilot study in approximately 40 subjects, ages 18 to 65. Subjects will receive treatments and will be followed at 12 weeks post final treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be able to read, understand and sign the Informed Consent Form.
2. Female or Male, 18 to 65 years of age (inclusive).
3. Subject has visible fat bulges in the area to be treated.
4. Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.
5. Subject must agree to not undergo any other procedure(s) in the treatment region during the study period.
6. Subject must adhere to the follow-up schedule and study instructions.
7. Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study.
8. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, (educational and/or marketing), publications, and any additional marketing purposes.
9. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.

Exclusion Criteria:

1. Participation in a clinical trial of another device or drug within 3 months of study participation, or during the study period.
2. Any type of prior cosmetic treatment to the target area within 6 months of study participation.
3. Any prior invasive cosmetic surgery to the target area, such as liposuction.
4. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
5. Has metal implant(s) within the body, such as artificial heart valves.
6. Significant uncontrolled concurrent illness that in the opinion of the Investigator would make the subject unsuitable for inclusion.
7. History of any disease or condition that could impair wound healing.
8. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.
9. Skin abnormality in the treatment area that in the opinion of the Investigator would make the subject unsuitable for inclusion.
10. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
11. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study or a condition that would compromise the subject's ability to comply with the study requirements.