cyrilzakka/clinical-trials huggingface dataset:
Efficacy Study of Femoral Nerve Block in Children With a Femur Fracture

The purpose of this study is to examine the efficacy of the use of Marcaine in femoral nerve blocks and hematoma blocks for post operative pain relief for femoral shaft fractures in a pediatric population.

Children with femur fractures can have severe pain after elastic nail fixation. The current national standard for post operative pain control would be intravenous narcotics. In addition to the use of intravenous narcotics, there are two alternative methods used during the surgery in order to potentially decrease the pain post-operatively. These methods are hematoma block or a femoral nerve block. Both are proven safe and effective in children, however little research has been done to look at the effectiveness of these various methods compared to one another.

Eligibility Criteria:
Inclusion Criteria:

* A child with a femoral shaft fracture requiring surgical treatment and the placement of intramedullary nails
* Weight of 30-100 Kg
* Child must be older than 6 years old

Exclusion Criteria:

* Any child that had an open fracture
* A child that has a pain abnormality
* Any child with an allergy to local anesthetic
* Any child with a neurological injury
* Any child with the inability to report pain
* Any child that is unable to use a PCA post-operatively
Functional Performance of Voluntary Opening and Closing Body Powered Prostheses

This study will compare the functional performance of voluntary opening (VO) and voluntary closing (VC) body powered prostheses. We hypothesize that the ability to sense cable tension and produce progressively higher pinch from shoulder force will result in advantages for the VC terminal device (TRS, Grip 3) in terms of proprioception and overall function. The specific aims of this clinical trial are to:

1. Determine if accommodation with a VC Grip 3 prehensor will result in reduced compensatory motion during activity.
2. Determine if accommodation with a VC Grip 3 prehensor will result in improved function in activities of daily living.

To evaluate the performance of the prehensors, subjects will complete a randomized A-B crossover study with a subjective follow-up. Two subject categories will be evaluated: 1.) healthy non-amputees, and 2.) unilateral transradial amputee subjects who currently use, or are interested in using a body-powered prosthesis. We anticipate data collection data with 10 non-amputee subject, and 8 amputee subjects.

Eligibility Criteria:
Inclusion criteria

* Unilateral transradial or wrist-disarticulation amputee
* 18 to 85 years of age
* At least 1 year from date of amputation
* Be able to independently provide informed consent
* Be willing to comply with study procedures Exclusion criteria
* History of acute or chronic skin breakdown on the residual limb
* Prosthetic socket adjustment within 90 days
* Any condition that would prevent participation and pose increased risk (e.g. shoulder impingement, sub-acromial bursitis, severe arthritis of the shoulder, elbow, wrist, or fingers)
* Injuries of the upper limb within the past 90 days (surgeries, sprains, strains, or fractures).
* Unwillingness/inability to follow instructions Inclusion criteria for able-bodied subjects
* 18 to 85 years of age
* Able to provide independent, informed consent
* Independent function by self-report
* Free of any health ailment that would impair physical function Exclusion criteria for able-bodied subjects
* Younger than 18 or older than 85 years of age
* Any condition that would prevent participation and pose increased risk (e.g. shoulder impingement, sub-acromial bursitis, severe arthritis of the shoulder, elbow, wrist, or fingers)
* No injuries of the upper limb within the past 90 days (surgeries, sprains, strains, or fractures).
* Unwillingness/inability to follow instructions
Keratinocyte Growth Factor to Prevent Autoimmunity After Alemtuzumab Treatment of Multiple Sclerosis

The purpose of this study is to test a novel strategy to prevent the clinical problem of secondary autoimmunity following alemtuzumab treatment of multiple sclerosis.

The hypothesis is that autoimmunity after alemtuzumab can be prevented by giving a drug that promotes thymic T cell regeneration (Palifermin, Kepivance®).

This is a single-centre, double-blinded, randomised controlled trial of palifermin (Kepivance) vs. placebo in the prevention of autoimmunity following alemtuzumab treatment of multiple sclerosis.

The dose of palifermin (kepivance)used in this trial will be informed by a dose-escalation study.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating female patients
* \> 18 years of age, and \<50 years of age inclusive
* Diagnosis of MS using McDonald's 2010 criteria, including MRI abnormalities consistent with McDonald's 2010 criteria.
* Onset of first MS symptoms within 10 years on the date the ICF is signed
* EDSS score 0.0 to 5.0 (inclusive) at screening
* At least 2 clinical episodes of MS in the 2 years prior to study entry, with at least 1 attack within 12 months, which may have occurred whilst on disease-modifying therapy, namely any beta interferon or glatiramer acetate.
* Serum IL-7≤7pg/mL

Exclusion Criteria:

* Any progressive form of multiple sclerosis
* Previous thymectomy
* Previous treatment with alemtuzumab, natalizumab, mitoxantrone, cyclophosphomide, cladribine, rituximab or any other immunosuppressant or cytotoxic therapy (other than steroids and disease-modifying therapies listed above)
* History of malignancy
* Personal history of clinically significant autoimmune disease, other than multiple sclerosis (including but not limited to: thyroid disease, immune cytopenias, inflammatory bowel disease, diabetes, lupus, severe asthma)
* Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
* Major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the interpretation of study results.
* Seropositivity for human immunodeficiency virus (HIV)
* Past or present hepatitis B infection (positive hepatitis B serology)
* Pregnant women or male and female patients who do not agree to use effective contraception during the study.
* Medical, psychiatric, cognitive or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study.
Remote Exercise Video Adaptations to Maximize Physical Activity in Childhood Cancer

The goal of this observational study is to leverage childhood cancer survivor input to adapt video content of a digital video disc-(DVD) delivered evidence-based PA intervention, originally designed for community-dwelling older adults.

Primary Objective:

- To leverage childhood cancer survivor input to adapt video content for an evidence-based remote exercise intervention.

This study is being done to update existing exercise videos to suit adult survivors of childhood cancer to help them exercise at home. Patients will be asked to watch exercise videos designed for older adults and provide feedback during an interview to help researchers update the videos to childhood cancer survivors' preferences

Eligibility Criteria:
Inclusion Criteria:

* Participants enrolled in the St. Jude Lifetime Cohort (SJLIFE), aged 18- 39.
* Identifies as low active (self-reports \<2 days/week of Physical Activity (PA) for at least 30 minutes over the past 6 months.
* Participant or legal guardian is able and willing to give informed consent.
* Internet access

Exclusion Criteria:

* Individuals who cannot speak, read, and/or understand English.
Safety and Efficacy Study of Single-port Robotic Versus Multi-port Robotic Radical Rectal Cancer Surgery

This study is designed to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.

Surgical robots were born in the 1980s and have the advantages of being precise, flexible, less invasive and remotely operable than traditional surgical methods. The single-port robot is a further extension of minimally invasive surgery by placing multiple instruments through a single incision. Most studies have reported on the perioperative outcomes of robotic versus conventional laparoscopic surgery in the treatment of colorectal cancer. However, there are limited data comparing the perioperative outcomes of single-port robotics and multi-port robotics in the treatment of colorectal cancer，especially in rectal cancer surgery. The purpose of this study is to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* 18 years \< age ≤80 years
* Tumor located in the mid to high rectum (lower edge of tumor ≥ 5 cm from anal verge)
* Pathological rectal carcinoma
* Clinically diagnosed c/ycT1-3N0-1M0 lesions according to the 8th Edition of AJCC Cancer Staging Manual
* Tumor size of 10 cm or less
* No history of other malignant tumors
* ECOG score is 0-1
* ASA score is Ⅰ-Ⅲ
* Informed consent

Exclusion Criteria:

* Body mass index (BMI) \>35 kg/m2
* Familial adenomatous polyposis (FAP)
* Inflammatory bowel disease (IBD)
* Multiple malignant colorectal tumors
* Pregnant woman or lactating woman
* Severe mental disease
* Previous gastrointestinal surgery (except appendectomy ）
* Combination of intestinal obstruction, bleeding, perforation requiring emergency surgery
* Requirement of simultaneous surgery for other disease
* Serious disorders of liver and kidney function, coagulation function, or severe underlying diseases that cannot tolerate the surgery.
* Patients or family members who cannot understand the study program.
Determine the Utility of Liquid Biopsies and Tumor Molecular Profiling in Predicting Recurrence in Endometrial Cancers

This study is to find out how well liquid biopsies work as a non-invasive alternative to other methods of finding cancer cells (such as a tissue biopsy) in patients with endometrial cancer. A liquid biopsy is a blood test that may be able to find cancer cells. Collecting and storing samples of blood and tissue from patients with endometrial cancer to study in the laboratory may help doctors learn how the cells in the blood may change during treatment for uterine cancer.

PRIMARY OBJECTIVES:

I. Compare TP53, FBXW7, and other mutated gene variant allele frequencies (VAF) in serial circulating cell free deoxyribonucleic acid (ccfDNA) samples obtained from patients with endometrial cancer subtypes during the primary treatment course, which may include pretreatment, post-surgical removal, post adjuvant treatment, and at time of recurrence.

II. Compare the findings from the liquid biopsy mutational analysis to next generation sequencing from the primary tumor.

EXPLORATORY OBJECTIVES:

I. To estimate the presence of malignant cells in the vagina before and after minimally invasive hysterectomy among patients with endometrial cancer.

II. Characterize the immune profile and single cell ribonucleic acid (RNA) sequencing (scRNAseq) profile of endometrial cancer subtypes.

III. Estimate time to progression (TTP), and investigate potential correlations between mutated gene variant allele frequency (VAF) ccfDNA samples and progression.

IV. Compare the efficacy of experimental ccfDNA assays to approved ccfDNA assay using the same samples.

OUTLINE:

Patients undergo collection of blood samples for liquid biopsy during pre-treatment consultation before hysterectomy, after hysterectomy but before starting any chemotherapy, and at the end of last chemotherapy cycle. Patients also undergo collection of tissue samples during hysterectomy. Patients may also undergo Pap smears before and after hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* Women age 18 years and older
* Histologic diagnosis of endometrial cancer
* Candidate for primary surgical treatment or has recently had prior primary surgery
* Willing and able to provide informed consent

Exclusion Criteria:

Patients who have received prior treatment including chemotherapy or radiation therapy for endometrial cancer. Patients with prior primary surgery will be allowed to enroll in this trial if the patient has not received any chemotherapy or radiation at the time of enrollment. Note: patients with a history of other cancers may be enrolled after discussion with the PI if it is determined that they are at low risk for recurrence or metastasis.
A Study to Assess the Pharmacokinetics and the Ability for Pediatric Participants With Type 2 Diabetes to Swallow MK-0431A XR Tablets (MK-0431A-296)

The purpose of this study is to assess:

1. the safety and tolerability of two sitagliptin 50 mg/metformin 1000 mg XR tablets in pediatric participants with type 2 diabetes mellitus (T2DM), aged 10 to 17 years
2. the ability of pediatric participants with T2DM, aged 10 to 17 years, to swallow two sitagliptin 50 mg/metformin 1000 mg XR tablets or two matching placebo tablets (excluding marking)
3. the pharmacokinetics of sitagliptin and metformin following the administration of two sitagliptin 50 mg/metformin 1000 mg XR tablets to pediatric participants with T2DM, aged 10 to 17 years.


Eligibility Criteria:
Inclusion Criteria:

* Female participant of reproductive potential must not be pregnant and agrees to use (and/or have their partner use) two acceptable methods of birth control
* T2DM diagnosed by American Diabetes Association criteria
* No clinically significant abnormality on electrocardiogram
* No clinical or laboratory evidence to indicate a diagnosis of type 1 diabetes
* Nonsmoker

Exclusion Criteria:

* Mental or legal incapacitation
* Estimated creatinine clearance of 80 mL/min or lower
* History of stroke, chronic seizures, or major neurological disorder
* History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* History of neoplastic disease
* Unable to refrain from or anticipates the use of any medication (with the exception of metformin and thyroid hormone) from approximately 2 weeks before the first dose of study drug through the poststudy visit
* Consumes alcohol or consumes excessive amounts of coffee, tea, cola, or other caffeinated beverages
* Had surgery, donated or lost 1 unit of blood, or participated in another investigational study within the past 4 weeks
* History of multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
* Currently a regular user (including illicit drugs) or has a history of drug (including alcohol) abuse
* Lactose intolerant
Prediction of Functional Outcomes From Chronic Critical Illness

The purpose of the study is to establish clinical determinants of poor cognitive and physical functional outcome of CCI patients so that the investigators may develop and validate a multi-dimensional clinical prediction model to more effectively inform decision making earlier in the course of the ICU care. The investigators hypothesize that multiple premorbid and acute factors measured early in the course of CCI will have strong independent associations with functional recovery. The investigators further hypothesize that social and economic factors are associated with long-term functional outcomes independent of the acute clinical problems.

A substantial number of critically ill patients experience persistent organ failure leading to chronic critical illness (CCI). The majority of these patients die within a year, and many survivors must cope with long-term physical and cognitive limitations that are often severe. Survival with severe physical and cognitive dysfunction is a significant clinical, emotional, and economic burden in this population, but little is known about which patients are at highest risk for physical and cognitive dysfunction. Moreover, although long-term mortality in CCI can be reliably estimated with a validated mortality prediction model, there is currently no validated method to predict long-term functional disability for purposes of shared decision-making and resource planning. In order to address these gaps in knowledge, the investigators will conduct a multi-center prospective cohort study that measures clinical and premorbid risk factors for long-term physical and cognitive dysfunction in CCI. Using these risk factors, the investigators will construct a multi-outcome prognostic model for survival with severe physical or cognitive dysfunction to facilitate shared decision-making and resource planning. Additionally, the investigators will identify independent social and economic variables that are risk factors for long-term survival and functional disability.

Eligibility Criteria:
Inclusion Criteria

1. Patients in enrolling ICU
2. Expected to require 7 days of mechanical ventilation uninterrupted for 72 hours for acute illness.
3. Adults \>/= 18yo of age.

Exclusion Criteria

1. Patients with respiratory failure due to neuromuscular disease
2. Patients with respiratory failure due to severe burn
3. Patients requiring chronic mechanical ventilation at home
4. Patients receiving mechanical ventilation at an outside hospital \>7 days
5. Expected death prior to day 8 of mechanical ventilation therapies in 24 hrs.
6. Prisoners
7. No family member or surrogate available
8. Patient not proficient in English (or Spanish at select sites)
9. Unwilling or unable to provide written informed consent (patient or when indicated, by surrogate)
10. Co-enrollment in another study not approved
Effects of Cytotoxic Chemotherapy and PARP Inhibition on the Genomic Contexture of Ovarian Cancer

EFFECTS OF CYTOTOXIC CHEMOTHERAPY AND PARP INHIBITION ON THE GENOMIC CONTEXTURE OF OVARIAN CANCER: TR_NACT_OV/17 In order to approach the above open questions, ultimately aiming in understanding the effects of cancer drugs on tumor biology and hence in selecting the proper drugs for the patients in the context of Precision Medicine, the objective of this study is to study the genomic characteristics of ovarian tumors before and after treatment with classic neoadjuvant chemotherapy (NACT) and with the more recently approved PARP inhibitor olaparib.


Eligibility Criteria:
Inclusion Criteria:

* ovarian cancer eligible for neoadjuvant chemotherapy

Exclusion Criteria:

-
A Retrospective Chart Review of OZURDEX® in Patients With Macular Edema

This retrospective chart review study will describe the history of patients with retinal disease with macular edema to whom OZURDEX® (dexamethasone intravitreal implant) is administered, and assess treatment patterns and visual outcomes. OZURDEX® was previously administered according to general clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Retinal disease involving macular edema
* Received at least one OZURDEX® injection

Exclusion Criteria:

* None
Is There Increased Polyethylene Wear and Increased Periprosthetic Bone Loss in Femur in Reverse Hybrid Technique Compared With Conventional Cemented Technique in Total Hip Replacement?

Total hip replacement is a very cost effective procedure to enhance life quality in a group of patients. In the period 2000-2004 7-8000 procedures were preformed, 13% were revisions (1). Historically, many different principles have been used from the first resurfacings to cemented and uncemented total hip replacements as we know them today. In 2000, 28 different femoral stems and 26 different acetabular components were in regular use in Norway. There are several well-documented cemented acetabular components, but no such uncemented cup. On the femoral side there are several well-documented stems both cemented and uncemented. (2).

From the late 1990's a reverse hybrid (uncemented stem and cemented cup) is being more frequently used. In 2004 a total of 276 reverse hybrid hips were done and the trend is increasing. (1). This technique is solely based on experience and the fact that one combines the better of two principles (cemented and uncemented). There is no scientific evidence that this technique is as good or better than a cemented THR.

One of the potential problems with hydroxyapatite coated components is that it is suspected that it may increase wear due to the particle theory. (3,4). There are no prospective randomised controlled RSA and DXA studies that conclude on this matter. This is such a study and our hypothesis is that there is no difference in wear or osteolysis between the methods.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis
* Indication for THR

Exclusion Criteria:

* Significant anatomical abnormalities
* Rheumatoid artheritis, dysplasia, fracture sequela
Oocyte Vitrification Aided With Latrunculin A

Using cytoskeleton Stabilizer the Latrunculin A would improve the outcome of oocyte vitrification


Eligibility Criteria:
Inclusion Criteria:

* indication for oocyte cryopreservation

Exclusion Criteria:

-
Optimizing the Treatment of Toenail Onychomycosis Using a New Transdermal Patch Combined With Terbinafine/Ketoconazole

This study is to explore the optimization of anti-onychomycosis patch with various formulation contents (three patch groups: 3%, 6% and 8% of terbinafine (contains 3-mg, 6-mg and 8-mg/patch terbinafine, respectively) combined with fixed 2% ketoconazole (contains 2-mg ketoconazole/patch) and its safety profile.

This study is to explore the optimization of anti-onychomycosis patch with various formulation contents (three patch groups: 3%, 6% and 8% of terbinafine (contains 3-mg, 6-mg and 8-mg/patch terbinafine, respectively) combined with fixed 2% ketoconazole (contains 2-mg ketoconazole/patch) and its safety profile. At least 18 patients (age: 20 to 75 years old) with one or two feet toenails infected simultaneously need to complete the whole study. Patients will be assigned to one of patch groups. The patients with only one infected toenail will also apply one patch on other foot with uninfected toenail. The patch will be applied on the foot on the dorsal site and leave it there for two consecutive days. Totally six patches will be used for each week. The duration of therapy will be 24 weeks. The patients' blood sample and toenail clippings will be collected every 8 weeks and will be analyzed as well as the safety profiles. The most appropriate patch formulation will be selected on the drug content residues in toenail. The safety profile will be also presented and discussed with various anti-onychomycosis patch formulations.

Eligibility Criteria:
Inclusion Criteria:

* Male and females 20-75 years of age
* Fungal infection of one or both toenails will be confirmed using the method of histopathological examination with periodic acid-Schiff (PAS) staining (Yang JH, et al., 2007)
* The toenail infection can be due to a dermatophyte, yeast or mixed infections (dermatophyte and non-dermatophyte)
* The target toenail area must have at least 25% to no more than 75% disease involvement without spikes
* Patients agree to sign the informed consent form

Exclusion Criteria:

* Using any kind of systemic or topical nail lacquer solution antifungal drugs within 6 months before at screening visit; or using any other topical antifungal agents, such as ointment, cream, gel, solution, suspension, oil or lotion forms, within two weeks before at screening visits
* Patients with the target toenail involving the matrix (lunula) or having less than 2 mm clear (unaffected) nail plate length beyond the proximal fold
* Presence of dermatophytoma on the target nail
* Using professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit
* Patients who are unwilling to provide nail clippings
* Patients who have been previously reported to be allergic to topical or systemic terbinafine or ketoconazole therapy or both
* Known pregnancy or plan to get pregnant within study duration or lactation at time of enrollment
* Unconsciousness or inability to understand this form or this study project.