cyrilzakka/clinical-trials huggingface dataset:
Incision and Loop Drainage Utilizing a Novel Technique for Management of Cutaneous Abscess in an Adult Population

When using the rolled ring of a sterile glove as a loop drain in incision and loop drainage, is it superior to incision and drainage for treatment of a cutaneous abscess in 18 to 65 year-old patients presenting to the Emergency Department, Family Health Clinic, Family Medicine Residency Clinic, or Internal Medicine Clinic?

Hypothesis: When treating a cutaneous abscess, incision and loop drainage utilizing the rolled ring of a sterile glove as a loop drain is superior to the standard (incision and drainage) yielding a treatment failure rate of 1% at seven to ten days.

Practicing medicine in an austere environment is fraught with challenges. One primary challenge is that clinicians will frequently be practicing without the supplies needed for specific indicated purpose. For treatment of a cutaneous abscess, sterile gloves are readily available whether at home or when deployed. It can be much more difficult to come across a penrose or vessel loop. In addition, follow up for wound repacking and reassessment is a struggle. Patients may have to move from location to location or have work hours that make it difficult to return to the clinic. The loop technique utilizing the rolled ring of a sterile glove solves both of these problems. Sterile gloves are always available and the Loop technique requires little to no follow up. Additional benefits include: subjects may experience less pain, improved cosmesis, faster healing, and decreased complication rates with incision and loop drainage utilizing the rolled ring of a sterile glove compared to traditional incision and drainage.

Eligibility Criteria:
\*\*Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study\*\*

Inclusion Criteria:

* Active Duty and DoD beneficiaries aged 18 to 65 years old.
* Abscess that requires drainage.

Exclusion Criteria:

* Abscess of the hand, foot, or face, immunocompromised by disease or medications.
* Temperature greater than 100.4 degrees Fahrenheit.
* Systolic blood pressure less than 90 mmHG.
* Abscess is too small to treat with incision and drainage (as seen on ultrasound).
* Patient is too ill to be included in the study determined by clinical judgement of the treating provider.
A French Non Interventional Multicentric Cohort Study in Patients With Colorectal Dysplasia

The main purpose is to describe clinical practices nowadays prospectively about patients with a dysplasia diagnosis or another histological lesions.

It will be identified colic situation during the initial colonoscopy after dysplasia diagnosis or atypical lesion.

Also the frequency and the type of monitoring conducted about these patients(surgical and endoscopic treatments).

The main criterion evaluation will be the surgical and endoscopic rates during the time.

The treatments offered such as surgical, endoscopic ones or none of them will be followed.

Finally, the outcome of these patients: stability, lesion disappearance, surgery or development of cancer with frequencies for each of them and relationships with histological abnormal colorectal lesion will be measured.

A replay centralized pathological lesion slides corresponding to the different lesion will be done

Eligibility Criteria:
Inclusion Criteria:

* intestinal chronic inflammatory disease with at least one lesion such as hyperplasia or no dysplastic scalloped lesion, dysplastic scalloped lesion or low grade dysplasia or high grade dysplasia
* compliant patient
* endoscopic follow possible
* no settler cancer
* no serious pathology such as cancer

Exclusion Criteria:

* settler cancer
* serious pathology such as cancer
* no compliant patient
* endoscopic follow not possible
Lestaurtinib With or Without Chemotherapy Agents in Samples From Young Patients With Leukemia

This research study is studying lestaurtinib with or with chemotherapy in samples from young patients with leukemia. Studying the effects of lestaurtinib with or without chemotherapy in cell samples from patients with cancer in the laboratory may help doctors learn more about the effects of this treatment on cancer cells. It may also help doctors identify biomarkers related to cancer.

PRIMARY OBJECTIVES:

I. Determine the potential of lestaurtinib with or without chemotherapy agents in treating samples from infants with leukemia.

II. Determine whether FLT3 protein expression level and/or activation and sensitivity to lestaurtinib differ between subgroups of infants with leukemia.

III. Determine whether lestaurtinib activates STAT5, AKT, and RAS-MAPK and other pathways.

IV. Determine whether lestaurtinib can synergize with other chemotherapy agents kill infant leukemia cells.

OUTLINE: This is a multicenter study.

Cryopreserved specimens are studied in vitro with lestaurtinib with or without chemotherapy agents. Samples are analyzed for FLT3 protein expression and/or activation; sensitivity to lestaurtinib with or without chemotherapy agents; and activation of STAT, AKT, and RAS-MAPK and other pathways by western blot. The most effective treatment from this study is then validated in vivo in a NOD/SCID xenograft model.

Eligibility Criteria:
Inclusion Criteria:

* Cryopreserved samples from infants with leukemia available
Correlation Study Between Clinical Phenotype and Pathology of Type 2 Diabetic Nephropathy

With the rapid increase of diabetic nephropathy worldwide, type 2 diabetes mellitus(DM) is the leading cause of end-stage renal disease(ESRD). Pathological types of diabetic kidney disease(DKD) could be mainly divided into diabetic nephropathy（DN）and non-diabetic renal diseases（NDRD）. There are no accurate renal biopsy indications and standardized operation procedures for type 2 diabetic nephropathy. The clinical stages of type 2 diabetic nephropathy still referred to the Mogensen stage of type 1 diabetic nephropathy. Thus, our study aim to clarify the differences in clinical phenotype between type 2 DN and type 2 NDRD, analysis the correlation between clinical and pathological features, and offer the criteria for clinical staging and prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Age≥18, male or female
* Clinical diagnosed as type 2 diabetes mellitus
* The presence of renal impairment including: microalbuminuria or overt proteinuria or renal insufficiency
* The renal biopsy was performed with complete renal pathological diagnosis
* Obtaining the signed informed consent from patients

Exclusion Criteria:

* The history of the disease was not complete
* Clinical diagnosed as other secondary renal diseases
* Patients with hereditary kidney disease
* Autoimmune diseases
* Patients with malignant tumor were expected to survive less than 6 months
* Pregnancy and lactation
Characterizing Ankle Function During Sloped Locomotion for Prosthesis Development

The proposed study aims to characterize biological ankle joint function during walking and running on slopes in order to further develop advanced powered ankle-foot prostheses. Ankle joint torque and angle data will be collected from non-amputees while walking and running at multiple speeds and slopes. This data will be used to develop control parameters for a powered ankle-foot prosthesis. Then, these parameters will be implemented and tested in a powered prosthesis worn by people with below the knee amputations.


Eligibility Criteria:
Inclusion Criteria:

Study 1:

- Between 18-60 years old.

Study 2 and 3:

* Between 18-60 years old.
* At least 1 year post-amputation
* no current problems with prosthesis or residual limb
* At least a K3 level of ambulation

Study 4:

- Between 18-45 years old

Study 5:

* Between 18-45 years old
* At least 1 year post-amputation
* no current problems with prosthesis or residual limb
* Experience running with a passive prosthesis
* At least a K4 level of ambulation

Exclusion Criteria:

Studies 1-5

* Cardiovascular, pulmonary, or neurological disease or disorder
* Musculoskeletal injury
Ambulatory Blood Pressure Monitoring in Hypertension

The primary objective of this proposal is to demonstrate that ABPM can be used to improve study design for interventional trials in children with hypertension.

ABPM is a standard technique in adult antihypertensive trials to study the magnitude and duration of effect of investigational drugs. These methods are needed for pediatric studies. Before such methods can be developed, preliminary information must be collected to demonstrate that the device can be used for antihypertensive studies in children (i.e, to determine the dropout rate following the first ABP study, to determine the frequency of white coat hypertension in a selected population, to compare casual (office) blood pressures commonly used to diagnose hypertension in children with those obtained by ABPM, and to assess the placebo effect in children with borderline and mild hypertension).

All participants will be asked to complete 24 hour ABPM on two occasions within one week. During the ABPM parents and children will be asked to keep a diary recording the times that the child slept. A crossover design will be used, where subjects are initially randomized to either drug or placebo and then will be crossed over to the other intervention at a set time during the study.

Eligibility Criteria:
Inclusion Criteria:

* Male and female children 5-16 years of age.
* Borderline or mild systolic and or diastolic hypertension as defined by 1996 Task Force criteria.
* No current drug therapy for hypertension being taken.
* Must be ambulatory and willing to wear an ABP monitor for 24 hours
* Agree to refrain from swimming, showering and other activities that might result in damage to ABP monitor during the two 24 hour intervals that the monitor is worn.
* Standing height between 45 inches and 73 inches
* Informed parental consent and patient assent.

Exclusion Criteria:

* Severe or life threatening hypertension.
* Any drug therapy that may raise or lower the blood pressure.
* Any severe bleeding disorder or concurrent treatment with anticoagulant medications
* Non-ambulatory
* Significant arrhythmia
* Previous history of significant non-compliance with prescribed medical care.
* Any other disease that, in the opinion of the investigator, might interfere with the accurate measurement of the blood pressure or place the subject at risk unnecessarily.
measurINg forceS durInG cHiropractic Treatment

The INSIGHT pilot study will measure forces applied by a doctor of chiropractic (DC) during the delivery of a specific, manually based chiropractic treatment for participants with low back pain.

Low back pain (LBP) is a well-recognized health problem. One common manual therapy available for the treatment of LBP is spinal manipulation (SM), which can be separated into 2 categories: High-Velocity Low-Amplitude (thrust) and Low-Velocity (non-thrust) SM according to their force-delivery profiles. One commonly utilized non-thrust SM technique is the Flexion-Distraction procedure. Several studies have reported manually applied forces during thrust SM; however, the forces used during non-thrust SM, specifically those used with Flexion-Distraction treatment are still unknown. The results of this pilot study will provide preliminary information on treatment forces and sample size justification for future full-scale trials, while also ascertaining the feasibility of the study protocol and patient recruitment methods for such trials.

Eligibility Criteria:
Inclusion Criteria:

* Able to demonstrate the necessary abilities (English language, literacy) needed to provide informed consent without the assistance of another person (e.g., a proxy, spouse, family member or other support person)
* Self-reported low back pain (acute, subacute or chronic) at the time of examination and enrollment

Exclusion Criteria:

* Weight \> 300lbs
* Spinal Pathology or conditions contraindicating study procedures or compromising participant safety
* Inflammatory arthropathy involving the spine (e.g. Ankylosing spondylitis, Rheumatoid arthritis)
* Spinal fracture in the past 6 months
* Other conditions requiring referral (e.g. self-reporting alcohol/substance dependence or abuse, unstable spinal segments, and cauda equina syndrome)
* Pregnant or planning to become pregnant within the next 5 weeks
* Unable to tolerate study procedures safely
* Altered Mental Capacity
* Sensitivity to adhesives used in the study
* Uncontrolled hypertension
* Co-morbidity requiring simultaneous clinical management that compromises ability to deliver study procedures or assess the participant's heath status or poses as a scheduling burden
* Retention of legal advice or seeking a health-related insurance claim
* Compliance concerns (e.g. scheduling conflicts, moving from the quad city area, unwilling to undergo required study procedures or receive treatment from study doctor(s))
* Quebec Task Force Classification of 10 or 11: (chronic pain syndrome, visceral/infectious source of LBP)
PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims

This is a randomized, double-blind, placebo-controlled study to determine whether administration of sertraline to patients who exhibit acute stress disorder secondary to severe burns can contribute to the prevention of post-traumatic stress disorder (PTSD).


Eligibility Criteria:
Inclusion Criteria:

* Victim of a traumatic event leading to personal injury
* Patient experienced a feeling of intense fear, hopelessness, or horror during the course of the event or immediately afterward
* Positive screen on the ASDS (for inclusion in the randomization phase); a total ASDS score of ≥ 37 (including a dissociative score of ≥ 9) will be counted as a positive screen.

Exclusion Criteria:

* Age \< 18
* Pregnant women, lactating women, or women not using acceptable form of birth control
* Epilepsy or head trauma resulting in seizures
* Current or historical schizophrenia, bipolar disorder, mental retardation, OCD, eating disorders, dementia, delirium, or self-injurious behavior
* Current/previously diagnosed PTSD
* History of hypersensitivity to sertraline
* Trauma occurring \> 7 days prior to likely first treatment in the randomization phase of the trial.
* Unable to provide informed consent for participation in the study protocol.
* Patient at high risk of recurrent bleeding despite surgical stabilization
* Patient with a history of serotonin syndrome
* Patient non-fluent in English
* Patient currently prescribed an antidepressant (any SSRI, SNRI, TCA, MAOI, mirtazapine, or trazodone in excess of 100mg per day)
Quantifying Drug Adherence and Drug Exposure to Antiretroviral Therapy

The purpose of this study is to evaluate cumulative exposure to tenofovir diphosphate (TFV-DP) using dried blood spots (DBS) in treated HIV-infected patients who are receiving a TFV-based regimen. Using DBS will allow the investigators to assess this simple method to measure drug exposure in the clinical setting. The investigators hypothesize that TFV-DP levels will be lowest in individuals with a detectable viral load and highest in those with viral suppression.

Antiretroviral drug exposure is directly linked to individual host factors which include age, weight, diet, and genetics. However, the main factor impacting long-term drug exposure is drug adherence. Adherence is a strong predictor of HIV treatment outcomes, but measuring adherence is difficult due to the inaccuracy of self-reporting and other commonly used monitoring methods. To date, no gold standard measure to monitor antiretroviral exposure and adherence has been applied in clinical practice. Tenofovir (TFV) and its active metabolite, tenofovir diphosphate (TFV-DP), have distinctive pharmacological characteristics that make them ideal candidates for drug adherence and exposure monitoring. The long half life (\~14-17 days) of TFV-DP in red blood cells (RBC) are properties well suited for monitoring average dose exposure over time. Based on these, the investigators propose that RBC levels of TFV-DP are an accurate and precise measure of long-term drug exposure in HIV-infected individuals. In addition, the investigators aim to quantify TFV-DP in dried blood spots (DBS) as a simple method to measure drug exposure.

This is an observational, 48-week prospective study of HIV-infected individuals treated with TFV in which the investigators will compare DBS TFV-DP levels in virologically suppressed vs. non-suppressed individuals and evaluate the utility of TFV-DP in DBS to predict virologic failure and also drug toxicity. To accomplish this, the investigators will approach HIV-infected patients currently taking TFV (which is being prescribed by a primary care physician) and who present to the clinic for regular HIV care. After informed consent is obtained, the investigators will collect extra blood samples for DBS TFV-DP and obtain information on drug adherence. The investigators will also collect extra blood samples for DBS TFV-DP at each subject's subsequent visit for approximately 3 visits in a 48 week period of time.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected individual.
* 18 years and older.
* Taking tenofovir.
* Blood drawn during regular clinic visit.

Exclusion Criteria:

* Refusal to participate.
* Pregnancy.
* Inability to provide informed consent.
Subcutaneous Immunoglobulin (Hizentra) in Patients With Dermatomyositis: A Proof of Concept Study

The purpose of the study is to evaluate the effectiveness and safety of human immunoglobulin SCIg in the form of Hizentra (Immune globulin Subcutaneous) in patients with Dermatomyositis. Hizentra provides effective protection against infection by maintaining a steady and normal level of immunoglobulin in the body) in patients with primary immunodeficiency. At present, patients with steroid resistant dermatomyositis can only be treated with IVIg (The healthy antibodies in IVIG can block the damaging antibodies that attack muscle and skin in dermatomyositis) treatment. An evaluation can then be made to see if SCIg is a suitable replacement and exerts immunomodulatory effect on complement antibodies.


Eligibility Criteria:
Inclusion Criteria:

1. Men or woman aged \>18 years
2. Diagnosis of DM based on standard criteria
3. Receiving the equivalent of at least 0.4 g/kg IVIg every 4 weeks (IVIg group only)
4. Established response to IVIg or dependence on IVIg to maintain status established either by symptomatic worsening of condition at the end of the inter-dose interval for both groups or by worsening after reduction of the dose within the previous 12 months (IVIg group only)
5. IVIg regimen stable for 12 weeks while on IVIg (minor changes are permitted provided that the dose change is 15% or less) (IVIg group only)
6. Stable dosing with steroids and/or other immunosuppressives for 12 weeks with no changes schedule or intended.

Exclusion Criteria:

1. Pregnancy, planned pregnancy, breast feeding or unwillingness to practice contraception
2. Severe concurrent medical conditions which would prevent treatment or assessment, including significant hematological, renal or liver dysfunction or malignancies
3. Initiation or immunomodulatory treatment other than IVIg in the past 24 weeks or modification of immunomodulatory treatment other than IVIg in the past 12 weeks.
4. Participation in trial of an investigational medicinal product in the past 12 weeks
5. Presence of skin infection unrelated to dermatomyositis, severe skin involvement

Presence of any other medical condition, which in the opinion of the investigator might interfere with performance or interpretation of this study.
Open-label Multicenter Phase 1 Study of TBI 302 as Second-Line Therapy in Patients With Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is one of the most common cancers worldwide. TBI 302 is being developed for the treatment of inoperable HCC by intravenous infusion. The objective is to determine the safety and tolerability of TBI 3002.

This is an open-label, Phase 1 study to evaluate the safety, tolerability, PK, and MTD of TBI 302 in patients with non-resectable, non-transplantable HCC. Tumor response will be assessed at Week 9 (5 weeks following cessation of treatment) according to RECIST (ver 1.1) and AASLD criteria.

Eligibility Criteria:
Inclusion Criteria:

* Patients histologically or cytologically confirmed, unresectable, or metastatic HCC
* Child-Pugh Category A or B (score 6-7); stable, well-compensated, mild cirrhosis with minimal or no ascites
* Male or female patients 18 years of age or older
* Patients must be willing and able to read, understand and sign a written informed consent form
* Male, or female of childbearing potential, must agree to use double barrier contraception, oral contraceptives or other ways to avoid pregnancy during the study and for 90 days after the last day of treatment
* Life expectancy of greater than 3 months
* Plasma haptoglobin ≥ LLN (lower limit of normal)

Exclusion Criteria:

* Patients confirmed with hemolysis confirmed by serum lactate dehydrogenase, serum haptoglobin or indirect bilirubin levels
* Patients who have received a blood transfusion within 4 weeks of enrolment
* Patients with infiltrating diffuse hepatocellular carcinoma, Type 1 or 2 diabetes mellitus, Hepatitis B or Hepatitis C infection
* Systemic chemotherapy-naive patients
* Patients with significant cardiovascular impairment, including history of congestive heart failure, unstable angina, myocardial infarction, or serious cardiac arrhythmia within the last 6 months
* Patient with a history of tumor rupture
* Patients with serious non-healing wound , ulcer or bone fracture
* Known positive human immunodeficiency virus (HIV) test
Effectiveness of Ecoguided Percutaneous Neuromodulation of the Multipurpose Musculature of L-3 in Non-specific Chronic Lumbar Pain.

The study evaluates the effectiveness of Ultrasound-guided Percutaneous Neuromodulation in the lumbar multifidus of L3 in non-specific chronic low back pain.

The effectiveness of neuromoduation in analgesic therapies has been more than contrasted. Considering that multifidus muscles, composed of the spinous transverse rotators muscles and spinous transverse multifidus muscles, are fundamental both for the static and for the dynamics of the lumbar spine, particularly for the region of L-3, the treatment of this musculature with ultrasound-guided percutaneous neuromodulation in patients with nonspecific chronic low back pain must have an analgesic repercussion in this nociceptive process.

Therefore, given that neuromodulation has been considered as a more than effective treatment in painful symptomatology and that diverse scientific literature has proven the activity of the multifida musculature directly affects the stability and mobility of the lumbar spine, it is more than likely interventions with neuromodulative treatments in the multifidus musculature at the level of the third lumbar vertebrae have positive results in Non-specific Chronic Low Back Pain.

Eligibility Criteria:
Inclusion Criteria:

* Score ≥4 on the Roland Morris Disability Questionnaire.
* Low back pain for ≥3 months
* Age between 18 and 65 years
* Not undergoing another physical therapy treatment

Exclusion Criteria:

* Presence of lumbar stenosis
* Diagnosis of spondylolisthesis
* Diagnosis of fibromyalgia
* Treatment with corticosteroid or oral medication within the past two weeks
* A history of spinal surgery
* Contraindication of analgesic electrical therapy
* Having previously received a treatment of electrical analgesia.