cyrilzakka/clinical-trials huggingface dataset:
The Effect of Barefoot Walking Plantar Chronic Heel Pain

Many patients suffer from chronic heel pain, and studies have not yet found the most appropriate treatment. There are some researchers who claim that the pain is caused by weakness in the muscles of the foot, which causes increased pressure in the heel. In walking, the muscles of the foot are activated and strengthened. No research has yet been done on whether walking (barefoot or with shoes) on a treadmill reduces pain in the heel and improves function.

A bare foot functions differently than a foot in a shoe while walking, as there are differences in movement, muscle tone, pressure and sensation. Wearing shoes over the years can cause changes in walking and pain. In the examination of the feet of patients suffering from chronic pain in the heel was found a smaller volume of muscle, and calcification in the heel area that could be caused by increased pressure. Although the trend of physiotherapy treatments has changed in recent years from passive to active treatments, the overwhelming majority of studies are testing passive therapies only as a treatment option for chronic heel pain. Barefoot walking has not been tested as an option for treating chronic pain in the heel, although there are studies indicating that bare feet lead to reduced heel pressure, increased muscle work, and better proprioception.The purpose of this study is to examine the effect of barefoot walking on the level of pain, function and pain threshold for stress in patients with chronic heel pain.

Eligibility Criteria:
Inclusion Criteria:

* Local pain in the heel that lasts more than 12 weeks,
* pain in the first steps in the morning
* Pain that disappears in situations of weightlessness
* Ability to walk on a moving track.

Exclusion Criteria:

* Pain in proximal areas along the leg or lower back pain that can radiate to the heel
* Sensory disorders for various reasons
* Tumors, fractures, previous operations in the lower extremities
* Irritable cardiovascular problems
* Balance problems and dizziness.
A Study of Paclitaxel and Carboplatin in Combination With Bexarotene Oral Capsules in Patients With Advanced Lung Cancer

The primary aim is to evaluate the safety (Phase I components) of administering bexarotene (Targretin®, LGD1069) oral capsules in combination with two Taxol® and carboplatin (Paraplatin®) schedules to patients with stage IIIB and IV non-small cell lung cancer. This study will also evaluate the preliminary efficacy (Phase II component) of bexarotene oral capsules in combination with the weekly Taxol® schedule and carboplatin in these patients.

The phase I portion of the study will evaluate the safety of administering bexarotene oral capsules daily at two dose levels (300 mg/m2 and 400 mg/m2) in combination with carboplatin and Taxol®. At least 6 patients will be entered onto each dose level. Doses will not be escalated over the course of treatment of an individual patient. The recommended Phase II dose is defined as the highest dose of bexarotene oral capsules (300 mg/m2 or 400 mg/m2) in combination with carboplatin and Taxol® that induces DLT in fewer than or equal to 33% of patients.

The sequential phase II portion of the study will evaluate the efficacy of bexarotene oral capsules in combination with carboplatin and weekly Taxol® in patients with advanced non-small cell lung cancer. The efficacy will be gauged according to the rate of major response where, by definition, a major response occurs if a patient achieves either complete remission (CR) or partial remission (PR). For these patients a true response rate of 20% or greater is sufficiently large to warrant further investigation. A true response rate of 10% or less indicates that the combination is less active.

Eligibility Criteria:
Inclusion Criteria:

* unresectable stage IIIB or IV NSCLC
* adequate bone marrow, hepatic, thyroid and renal function

Exclusion Criteria:

* peripheral neuropathy \>= grade 2
* gastrointestinal abnormalities
* known hypersensitivity to retinoids
Chinese American Family Caregiver Writing Study

The Chinese American Family Caregiver Writing Study is a Randomized Controlled Trial (RCT) testing the efficacy of the Expressive Helping (EH) intervention among Chinese Americans who are providing care for family members undergoing cancer treatment.

Because the psychosocial health of Chinese cancer patients and their caregivers are linked, there is a need to improve health outcomes for not just the patients, but also for the caregivers. While many caregiving interventions have focused on the caregiver-patient dyad as the "the unit of care", interventions that solely target caregivers are crucial given the emotional, social, financial, and physical toll of caregiving. To address this need, investigators are testing a writing intervention, Expressive Helping (EH), with Chinese family members who are providing care for their family members diagnosed with cancer. Over four brief structured writing sessions, participants write about their cancer caregiving experiences, disclosing their emotions and providing encouragement and guidance, with the knowledge that their narratives will be shared with and used as a resource for other Chinese cancer caregivers. Participants will be adult cancer caregivers of Chinese descent. After screening and consent, eligible participants will be enrolled in a 1:1 randomized controlled trial. Assessments of psychological symptoms will occur at baseline (prior to randomization), 1-month post-intervention, and 3-month post-intervention. Investigators will also assess potential mediators and moderators of the potential intervention effects. Investigators interacting with the participants will be blind to condition assignment.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Of Chinese descent
* Informal (i.e., uncompensated) caregiver of individual diagnosed with cancer

Exclusion Criteria:

* Inability to read or write English or Traditional/Simplified Chinese
Clinical Pattern of Stroke and Transient Ischemic Attack Mimics

wide range of diagnoses may present like stroke, called stroke mimics as well as transient ischemic attacks .


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* aged above 18 years
* Accept all requirements of the study

Exclusion Criteria:

.Refuse participation in the study
A Pharmacokinetics Study to Investigate the Effect of Ketoconazole on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma

This open-label, multi-center, three-period, one sequence study will investigate the effect of ketoconazole on the pharmacokinetics of vemurafenib in patients with unresectable BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a V600-activating mutation of BRAF without acceptable standard treatment options. Patients will receive a single dose of vemurafenib in Periods A and C and multiple doses of ketoconazole in Periods B and C. Eligible patients will have the option to continue treatment with vemurafenib as part of an extension study (NCT01739764). The anticipated time on study treatment is approximately 19 days.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \>= 18 years old
* Patients with either unresectable Stage IIIc or Stage IV metastatic melanoma positive for the BRAFV600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, as determined by results of cobas® 4800 BRAF V600 mutation test or a DNA sequencing method, and who have no acceptable standard treatment options
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Life expectancy \>= 12 weeks
* Full recovery from the effects of any major surgery or significant traumatic injury within 14 days prior to the first dose of study treatment
* Adequate hematologic and end organ function
* Female patients of childbearing potential and male patients with partners of childbearing potential must agree to always use two effective methods of contraception
* Negative serum pregnancy test within 7 days prior to commencement of dosing in women of childbearing potential

Exclusion Criteria:

* Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of first dose of study drug
* Requirement for immediate or urgent treatment with daily vemurafenib and for whom the intermittent schedule of vemurafenib employed during the 19-day period for this trial is not clinically acceptable
* Allergy or hypersensitivity to components of the vemurafenib formulation
* Experimental therapy within 4 weeks prior to first dose of study drug
* Major surgical procedure or significant traumatic injury within 14 days prior to first dose of study drug or anticipation of the need for major surgery during study treatment
* Prior anti-cancer therapy within 28 days before the first dose of study drug
* History of clinically significant cardiac or pulmonary dysfunction
* History of symptomatic congestive heart failure of any New York Heart Association class or serious cardiac arrhythmia requiring treatment
* History of myocardial infarction within 6 months prior to first dose of study drug
* Current dyspnea at rest, owing to complications of advanced malignancy or any requirement for supplemental oxygen to perform activities of daily living
* History of congenital long QT syndrome or QTc \> 450 ms
* Active central nervous system lesions
* Uncontrolled or poorly controlled diabetes
* Current severe, uncontrolled systemic disease
AV Node Isolation in Atrial Fibrillation vs. Modulation by "Pace and Ablate" Strategy

AV-node ablation (AVNA) is a common therapy option for rate control strategy of permanent atrial fibrillation with numerous side effects. The investigators hypothesised that an isolation of the AV node is concomitant with less occurrence of new bundle brunch blocks, more frequent preservation and higher rate of escape rhythm compared to AVNA. This retrospective study includes 20 patients being treated with AV-node isolation (AVNI) and 40 historical AVNA-controls. Among others these two methods were compared regarding escape rhythm, delta QRS, procedure time, ablation points, fluoroscopy time and total dose area product (DAP).


Eligibility Criteria:
Inclusion Criteria:

* paroxysmal, persistend or permanent atrial fibrillation; indication for AVNA

Exclusion Criteria:

* other indications for AVNA than atrial fibrillation as AVNRT, atrial flutter, atrial tachycardia
Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age

Evaluate the safety and efficacy of Smoflipid compared to standard of care lipid emulsion Intralipid 20% administered via a central vein in pediatric patients 3 months to 16 years of age who require parenteral nutrition for at least 90 days and up to 1 year.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients 3 months to 16 years of age.
2. Patients who require PN for at least 5 days/week.
3. Patients who receive 60% or more of their total energy requirements as PN at enrollment and who are expected to receive 60% or more of their total energy requirements as PN for at least 90 days.
4. Written informed consent from parent(s) or legal representative(s). If possible, patient assent must also be obtained (according to local law).

Exclusion Criteria:

1. Known hypersensitivity to fish, egg, soybean, or peanut proteins, or to any of the active ingredients or excipients of Smoflipid or Intralipid 20%.
2. Hyperlipidemia or disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentration \> 250 mg/dL).
3. Inborn errors of amino acid metabolism.
4. Cardiopulmonary instability (including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis and hemodynamic instability requiring significant vasopressor support).
5. Hemophagocytic syndrome.
6. Liver enzymes (either AST, or ALT, or GGT) exceeding 5 x upper limit of normal range
7. Direct bilirubin ≥ 2.0 mg/dl
8. INR \> 2.
9. Any known hepatic condition outside of Intestinal Failure-Associated Liver Disease (IFALD) that will increase direct bilirubin ≥ 2.0 mg/dl.
10. Clinically significant abnormal levels of any serum electrolyte (sodium, potassium, magnesium, calcium, chloride, phosphate).
11. Active bloodstream infection demonstrated by positive blood culture at screening.
12. Severe renal failure including patients on renal replacement therapy.
13. Abnormal blood pH, oxygen saturation, or carbon dioxide.
14. Pregnancy or lactation.
15. Participation in another clinical study.
16. Unlikely to survive longer than 90 days.
A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients

To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant patients with stage 5 chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria: A subject will only be included if all the following entry criteria are met:

* Patients ≥ 18 years of age
* Stage 5 chronic kidney disease (CKD) patients receiving hemodialysis and with moderate to severe secondary hyperparathyroidism (SHPT)
* Patients with anemia due to renal insufficiency but who are iron replete:; Transferrin saturation (TSAT) \> 20% and Ferritin levels \> 200 ng/mL and requiring treatment with erythropoietin (EPO)
* Patients with vitamin B levels \> lower limit of normal (LLN) and folic acid levels \> LLN
* Patients treated only with intravenous calcitriol for at least 6 months
* Patients with serum intact parathyroid hormone (iPTH) level \> 500 pg/mL
* Patients with calcium phosphate product (Ca × PO4) \< 65 mg²/dL²
* Patients willing to sign "written informed consents" before participating in any the study related activity.
* Patients with phosphorus levels \< 6.5 mg/dL and calcium levels \< 11.2 mg/dL

Exclusion Criteria:

A subject will be excluded from the study if he/she meets any of the following criteria:

* Patients who have known hypersensitivity and/or toxicity to vitamin D metabolites and/or to paricalcitol and/or to other product ingredients.
* Patients who have participated in a clinical study within the last month.
* Patients whose previous concomitant medication and laboratory data for 6 months prior to the baseline visit are not available.
* Patients with known contraindication to selective Vitamin D receptor activators (VDRAs) according to the Summary of Product Characteristics (SmPC).
* Pregnancy, breast-feeding or planning a pregnancy within next 6 months after enrollment. Sexually active female patients not accepting appropriate contraceptive methods during the course of the study will also be excluded.
* Hypertensive and diabetic patients who are not on an optimal and steady medication regimen for more than 30 days.
* Patients with microcytic (mean corpuscular volume \[MCV\] \< 80 fL) and macrocytic (MCV \> 100 fL) anemia at screening that may be caused by diseases such as for microcytic anemias - Iron Deficiency, Thalassemias, Anemia of Chronic Disease, Copper Deficiency, Zinc poisoning, Sideroblastic Anemia, macrocytic anemias -ethanol abuse, myelodysplastic syndromes, acute myeloid leukemias, reticulocytosis, drug induced anemia, liver disease.
A Novel Score to Predict Risk of Symptomatic Intracerebral Hemorrhage

This study sought to develop and validate a new risk stratification score (Henan predicting the risk of intracerebral hemorrhage score, Henan-PRIHS) based on intra-arterial contrast enhanced Flat Detector CT (IA-CEFDCT) to predict symptomatic intra-cerebral hemorrhage (sICH) after stroke thrombectomy.

The Henan-PRIHS was developed from 95 patients who underwent IA-CEFDCT and MT for acute anterior stroke. Patients were classified as having one of three grades according to the presence of contrast filling within the occluded vascular territory. Grade 0 was normal or less contrast filling in affected hemisphere, grade 1 and 2 were small and medium-large area without contrast filling, respectively. The Youden index was used to determine the optimum no contrast filling area cutoff for defining grade 1 and 2. The score was subsequently validated in a different population of 208 patients and compared with three established scores.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥18 years,
2. occlusion of internal carotid artery and/or middle cerebral artery (MCA) M1 or M2 segments confirmed by CTA or MRA or DSA,
3. baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 4 points,
4. MT was performed within 16 hours from stroke onset,
5. baseline CT scan and IA-CEFDCT scan must be performed; 24 hours post-treatment CT scan was done and when the patient's neurological state had deteriorated.

Exclusion Criteria:

1. bilateral infarcts,
2. history of hemorrhagic stroke,
3. post-procedure ICH (including SAH) due to iatrogenic complications,
4. missing clinical and demographic data,
5. poor-quality IA-CEFDCT scans (i.e., motion artifact) that limited accurate identification of the region of interest. Bridge treatment (combined intravenous thrombolysis with MT) was not excluded from this study.
My Baby Biome: Infant Stool Samples for Microbiome Health (MBB)

My Baby Biome is an observational study that will use 600 infant stool samples to determine the biomarkers associated with a healthy infant gut. Biomarkers identified in this study will be used to develop precision probiotics and LBPs for improving infant gut health outcomes to the benefit of all infants. Parents will be asked to submit follow-up questionnaires regarding infant immune health to improve insights obtained from the data.


Eligibility Criteria:
Exclusion Criteria:

* Infants under 2 weeks or over 2 months old
* Infants given any antibiotic or probiotic treatments
* Infants delivered prematurely or admitted to the NICU outside of establishment of normal feeding
* Infants with mothers under the age of 18
* Infants with mothers known to have HIV, Hepatitis A, Hepatitis B, Hepatitis C, or SARS-CoV2
Front-of-package Label Effects in Latine and Limited English Proficiency Populations

The goal of this experiment is to examine the effects of 4 types of front-of-package food labels among a sample of Latino adults. The main questions this experiment aims to answer are:

What front-of-package label design is most effective in helping Latino and low English proficiency consumers identify healthier and less healthy food products?

What front-of-package label design is most effective in helping Latino and low English proficiency consumers choose healthier food products?

Additionally, this experiment also aims to answer the following question:

Do the benefits of front-of-package label designs differ by English proficiency and parental status?

Participants will be randomly assigned to 1 of 4 types of front-of-package label designs and view their assigned label design on 3 sets of products. Each set will display 3 similar products, each high in either 1, 2, or 3 nutrients of concern. For each set, participants will select the product that they believe to be the healthiest, least healthy, and the product that they would most want to consume. Researchers will compare results across label designs.

This study aims to determine which front-of-package label design is most effective at helping Latino consumers identify and choose healthier products, as well as explore whether the benefits of different front-of-package label designs differ by English proficiency. A Latino-focused panel company will recruit 4,000 US Latino adults of parental age (18-55 years), approximately 50% of whom will have limited English proficiency.

In a between-subjects experiment, researchers will randomize participants to 1 of 4 types of front-of-package label designs: a numerical label, an interpretive text-only label, an interpretive label with a magnifying glass icon, or separated interpretive labels with a magnifying glass icon. Participants will view their assigned label design on 3 similar products (each product high in either 1, 2, or 3 nutrients of concern) and complete selection tasks. These tasks will be repeated 3 times, each time with a different type of product (i.e., frozen meals, frozen pizzas, and frozen desserts), with the products displayed in random order.

Eligibility Criteria:
Inclusion Criteria:

* Identifying as Latino or Hispanic
* Ages 18-55 years old
* Residing in US

Exclusion Criteria:

* Not identifying as Latino or Hispanic
* Less than 18 or greater than 55 years old
* Not residing in the United States
Metabolomic Phenotyping After Surgery for Colon Cancer: Study of Novel Predictive Biomarkers

Predictive biomarkers are needed to identify those patients with higher risk of recurrence after surgery for colon cancer with curative intent. Our main objective is to determine a metabolite profile in blood plasma from patients operated from colorectal cancer that can be associated with the oncologic outcome and be validated as predictive biomarkers in future studies. A secondary objective is to study the glycolytic metabolism of colon cancer cell lines treated with plasma samples from the same patients. In particular, to validate the increased utilization of lactate by tumor cells as a metabolic substrate using postoperative human samples.

Patients with colorectal cancer that have undergone surgical resection will be included. Plasma samples will be obtained before surgery and the 4th day and the 3rd, 6th, 12th, and 18th months after surgery. Metabolic profiles in plasma samples will be determined using a kit that allows the quantification of 180 metabolites by mass spectrometry.

A clinical follow up will be maintained for at least 2 years to identify tumor recurrences.

Up to 30-40% of patients operated from colorectal cancer display tumor recurrence. Predictive biomarkers are needed to identify those patients with higher risk of recurrence. Our main objective is to determine a metabolite profile in blood plasma from patients operated from colorectal cancer that can be associated with the oncologic outcome and be validated as prognostic biomarkers in future studies. A secondary objective is to study the glycolytic metabolism of colon cancer cell lines treated with plasma samples from the same patients. In particular, to validate the increased utilization of lactate by tumor cells as a metabolic substrate using postoperative human samples, as it was previously observed by us in vitro using an inflammatory environment in conditions of hypoxia and lack of glucose. Patients with colorectal cancer that have undergone surgical resection will be included. Plasma samples will be obtained before surgery and the 4th day and the 3rd, 6th, 12th, and 18th months after surgery. Metabolic profiles in plasma samples will be determined using a kit that allows the quantification of 180 metabolites by mass spectrometry. Cellular assays will be performed on the SW620 and HT-29 colon cancer cell lines. Cells will be treated with plasma samples and the concentration of lactate and other metabolites will be analyzed in the medium supernatants. A clinical follow up will be maintained for at least 2 years to identify tumor recurrences.

Eligibility Criteria:
Inclusion Criteria:

* Non-metastatic colon and rectal cancer undergoing surgery with curative intent
* Patients signed informed consent

Exclusion Criteria:

* Patients undergoing preoperative chemotherapy and/or radiotherapy
* Emergency surgery
* Surgical resection R1 or R2
* Patients presenting with other known malignancies for which they are receiving treatment