cyrilzakka/clinical-trials huggingface dataset:
Monogenic Kidney Stone - Genetic Testing

This study will attempt to identify the specific gene (coded in the DNA) and changes (mutations) within that gene that are the cause of monogenic kidney stone disease. This study will help researchers determine the characteristics of the stone disease associated with specific genes and mutations. This information may help develop more effective treatments for monogenic kidney stone diseases.

Have a blood test (about 2 teaspoons; ½ to 1 teaspoons for children) or buccal cell collection for DNA or RNA isolation • Complete a kidney stone history questionnaire

In addition to the above testing, family members may be asked to participate in the following:

• Complete a 24 hr. urine collection Your samples will undergo genetic testing. We will share the results with your local doctor. All family members, of a patient whose genetic testing showed no known mutations, will not be tested. These samples will be stored for future research.

Eligibility Criteria:
Inclusion Criteria:

Participants meet at least one of the following criteria:

1. Patients \<18yrs with a history of kidney stones, and/or nephrocalcinosis, OR
2. Patients \>18yrs with a history of kidney stones, and/or nephrocalcinosis and at least one of the following:

   1. Family history of stones or nephrocalcinosis or unexplained kidney failure
   2. Growth retardation
   3. Metabolic bone disease
   4. Unusual stone composition or pathologic or urinary crystals
   5. Proteinuria
   6. Reduced glomerular filtration rate (GFR)
   7. Hypomagnesemia or hypophosphatemia or hypercalcemia
   8. Increased oxalate
   9. Renal cysts, OR
3. Patients with a high clinical suspicion for a monogenic kidney stone disease or a disorder of calcium metabolism OR
4. Patients previously enrolled in the Rare Kidney Stone Consortium 6406 protocol (identified as legacy samples), "Genetic Characterization and Genotype/Phenotype Correlations in Primary Hyperoxaluria." These patients have already consented for their samples to be used in genetic research and that consent will serve to enroll them in this study, OR
5. Patients previously enrolled in the Rare Kidney Stone Consortium 6403 protocol (identified as legacy samples), "Screening for Dent Disease Mutations in Patients with Proteinuria or Hypercalciuria and Calcium Urolithiasis." These patients have already consented for their samples to be used in genetic research and that consent will serve to enroll them in this study, OR
6. Family member of a patient that meets at least one of the above criteria

Exclusion Criteria:

1. Stone formers who do not meet the inclusion criteria for clinical suspicion of one of the monogenic kidney stone diseases
2. Unwilling or unable to provide consent/assent
Smart Nutrition, Healthier Communities

The project investigates the effect of the health app Lifeness as a digital therapeutic (DTx) and follow-up tool in a municipal setting at a regional Healthy Lives Center in central Norway (Frisklivssentralen Værnesregionen), targeting early intervention for overweight and obesity.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≤27kg/m2 or obesity measured by waist circumference, current weight stability, motivated to lifestyle change using mobile apps, access to smartphone with 5G. Living in the municipallies covered by the Værnes region of central Norway.

Exclusion Criteria:

* previous bariatric surgery, use of anti-obesity drugs, pregnancy, current or present cancer diagnosis,substance abuse or psychiatric diagnosis (such as eating disorders), or other conditions that can hinder physical activity.
Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache

Objective: To determine if lower paracervical intramuscular ropivacaine injection is an effective treatment for pediatric headache in an emergency department setting.

Methods: The study will be a double-blind randomized control trial. Patients will be randomly assigned to receive either intramuscular injection of the lower cervical paraspinous muscles with 1 mL of 0.5% ropivacaine on each side, placebo injections with 1 mL normal saline on each side, or no intervention at all. If randomized to an injection, the investigator and the patient will both be blinded as to the nature of the injection.

The location of the child's pain as well as severity will be assessed immediately prior to intervention and every 10 minutes for 30 minutes. If after 30 minutes relief is insufficient for discharge to home, intravenous treatment will be instituted according to current protocol. Pain will be reassessed at the time of ultimate disposition. The scale used to assess severity will vary based on the child's age.

Eligibility Criteria:
Inclusion Criteria:

* Chief complaint of headache
* Age 7-17 years

Exclusion Criteria:

* Presence of fever
* meningismus
* headache that wakes the child at night
* known organic brain disease, mass, or tumor
* history of stroke
* history of allergy to ropivacaine or other aminoacyl local anesthetics
* history of liver disease
* history of impaired cardiac function
* abnormal neurologic signs
* a focal neurologic abnormality on exam that is not a known component of the child's headache syndrome
* cognitive inability to communicate the intensity of pain.
* history of shunt or other intracranial hardware
Clinical Feasibility of Disease Managing Mobile App for Hyperthyroidism

This randomized controlled study aims to investigate the effects of using a mobile app that integrates with wearable devices to monitor heart rate, check self-reported symptoms, provide disease-related information, and set medication reminders for patients with thyrotoxicosis. The study intends to evaluate how the use of the app affects disease progression, quality of life, and health-related behaviors associated with the disease.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have been newly diagnosed or are currently undergoing treatment for thyrotoxicosis at Bundang Seoul National University Hospital.
* Subjects must be able to use the smartphone app required for the use of wearable devices and their integration.

Exclusion Criteria:

* Subjects who have constraints on normal activity due to diseases other than thyroid dysfunction.
* Subjects who are currently taking medication that affects heart rate.
* Subjects with heart conditions such as arrhythmia that affect heart rate.
* Subjects who cannot undergo antithyroid drug treatment and require surgery or radioactive iodine therapy.
Nudge to Gynecologic Oncology

Ovarian cancer lacks an effective screening test, and prompt treatment at diagnosis is the only way to improve outcomes. Referral to gynecologic oncology at diagnosis of adnexal mass is recommend by guidelines from every major medical organization. Yet, 1 in 4 patients with ovarian cancer nationwide and at Penn Medicine never see a gynecologic oncologist. Even when referred to gynecologic oncology, patients from historically-marginalized groups have twice as long duration from diagnosis to seeing gynecologic oncology. In this project, the investigators will pilot a clinician nudge to gynecologic oncology referral and compare the impact to historical controls.

The study consists of one intervention, a clinician nudge to gynecologic oncology referral. Referral to gynecologic oncology is recommended when patients are diagnosed with a complex adnexal mass on imaging (i.e., Ovarian-Adnexal Reporting and Data System \[O-RADS\] 4 or 5 on ultrasound or Magnetic Resonance Imaging \[MRI\]). When patients are identified as having a complex adnexal mass, the order will be pended by the clinical research coordinator and sent to the ordering provider with a message to sign. The message will include content about national guidelines on referral to gynecologic oncology with opt-out framed language.

Eligibility Criteria:
Inclusion Criteria:

* Women ages 18 years or older
* Adnexal mass identified on imaging (i.e., O-RADS 4 or 5 on ultrasound or MRI, Codex 4 or 5 on CT scan) ordered by Penn Medicine clinician

Exclusion Criteria:

* Known diagnosis of ovarian cancer
* Patient already established in gynecologic oncology
Foot and Ankle Post-operative Oedema Management Using Geko™

The multicentre randomised geko™ Foot and Ankle Trial will prospectively and systematically collect clinical data on patients randomised, on a 1:1 basis, to either standard care or standard care plus geko™ therapy to assess oedema management and patient outcomes during a follow-up period of up to three months post-surgery.

The geko™ device has a wide range of clinical applications including the post-operative management of oedema.

Although many short-term acute studies have been completed using the device, little clinical data has been collected on the effect of geko™ use in current standard care pathways for oedema management on patient outcomes during long term follow-up after surgery.

This study is an open label, multi-centre prospective randomised study. The study patient population will be randomised on a 1:1 basis into two groups of 61 patients each. These groups are defined as Group A patients who receive geko™ therapy and SC i.e. the intervention group and Group B patients who receive Standard Care (SC) only i.e. no intervention. The participants will be assessed pre-surgery and up to 90 days post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Intact healthy skin at the site of geko™ device application.
* Patients that have been listed for forefoot and / or hindfoot surgery
* Patient understands and is willing to participate in the study and can comply with study procedures
* Patient is willing and able to give written informed consent

Exclusion Criteria:

* Pregnant
* Use of any other neuro-modulation device.
* Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
* No response to geko™ therapy i.e. no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting
* Participation in any other clinical study that may interfere with the outcome of either study
Late Incomplete Stent Apposition Evaluation II: Comparison Between Polimer-based and No-polimer Stent System. IVUS Based Study

Vascular effects evaluation after non-polimeric and polimeric paclitaxel stent implantation.In particular the investigators will use Taxus )as a polimeric stent)and Axxion (as a non-polimeirc)stent system. The investigators will look at late stent malapposition by means of intracoronary ultrasound imaging technique (IVUS) at baseline and 9 months follow-up. The investigators sought to compare the two stent types with the same drug to verify the polimer role. The polimer itself seems to provoke inflammation and hypersensibility if the arterial wall and it seems to be the base of a process of positive remodeling found at drug eluting stent implantation site.

This positive remodeling is the mechanism producing late stent malapposition which on its turn can determine stent thrombosis, as demonstrated by pathological studies. At the same time the investigators will study the incidence of clinical events like myocardial infarction, stent thrombosis, TLR and death along with the incidence of angiographic restenosis at 2 years follow up.


Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary artery stenosis in one, two or three vessels, and with objective evidence of isquemia.
* The stenosis must allow IVUS analisis, must be treatable with angioplasty with stent
* Target Vessel diameter must be between 2.25- 4 mm with QCA.
* Patients must sign informed consent
* Patients and their physician must accept the angiographic follow-up

Exclusion Criteria:

* 18 years old patients
* SCA within the last 72 hours, or patients with CK twice over the upper normal limit
* Pregnancy
* Target vessel diameter \< 2.25 or \> 4 mm by QCA
* Previous brakitherapy or DES in the target lesion
* Restenotic lesion
* -Allergy to aspirin, clopidogrel or ticlopidin
* Patients enrolled in other studies or trials
* By-pass graft lesions
* Real bifurcationa lesions
* Severe Renal insufficiency (creatinin clearance \< 30 ml/min).
* Severe Liver failure(GOT y GPT \> 3 times the upper normal limit)
* Life expectancy \< 1 year because of other pathologies
Evaluating the Effects of a Computerized Training Program Coupled With Cognitive Behavioral Therapy (CBT) for OCD.

This study will evaluate the effects of a computerized training program coupled with cognitive behavioral therapy (CBT) for OCD.

This study will evaluate the effectiveness of a computerized training program (called Personalized Computerized Inhibitory Training, or PCIT) coupled with cognitive behavioral therapies (CBT) consisting of Exposures and Response Prevention in treating obsessive compulsive disorder (OCD) in patients who previously underwent CBT, but still have residual symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Principal diagnosis of OCD (assessed by SCID).
* Clinically significant OCD symptoms (Y-BOCS score of at least 14).
* Allowed to be on medications if they have been on a stable dose for at least 12 weeks prior to the study and will remain on a stable dose during this study.
* Have access to a computer or laptop.

Exclusion Criteria:

* Individuals with the following disorders will excluded: bipolar, psychosis, current major depressive disorder (assessed by SCID).
* Patients with head injury and loss of consciousness of more than five minutes or a neurological condition affecting the central nervous system.
* Patients taking a psychiatric medication will be asked to maintain a stable dose for 6 weeks prior to study entry.
* Patients with a history of more than 8 hours of therapist-assisted ERP for OCD in the past 6 months,
* Vision or hearing loss (although individuals with vision corrected by glasses or contacts will not be excluded).
* Active suicidality warranting immediate clinical care.
Albumin-bound Paclitaxel Plus S-1 Versus SOX as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma

It is a trial to compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus S-1 (SOX) as first-line treatment in advanced or recurrent gastric adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Age of 18-75 years;
2. Cytological or histological diagnosis of recurrent or metastatic gastric adenocarcinoma;
3. At least one measurable lesion as defined by RECIST 1.1 criteria;
4. ECOG performance status of 0-1;
5. Estimated life expectancy of at least 3 months;
6. Left ventricular ejection fraction (LVEF) ≥ 50%;
7. Bone marrow function: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥90×109 /L, hemoglobin(HB) ≥90 g/L;
8. Liver and kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), or ≤5 x upper limit of normal range (ULN)when with hepatic metastases，total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN), or≤2.5 x upper limit of normal range (ULN) when with Gilbert's syndrome;
9. Not be breast-feeding; men and women of reproductive age are willing to take reliable contraceptive measures during the study;
10. Able and willing to comply with the study plans in this protocol and sign the informed consent;

Exclusion Criteria:

1. Have received chemotherapy before；patients that received neoadjuvant or adjuvant chemotherapy are eligible provided the treatment is completed\>6 months prior to first recurrence or metastasis;
2. HER-2 positive;
3. Patients with symptomatic brain metastases;
4. II-IV peripheral neuropathy \[NCI-CTCAE 4.03\];
5. Anti-HCV antibody positive and HCV-RNA positive; anti-HBV antibody positive with active hepatitis ; anti-HIV antibody positive;
6. Patients with serious systemic infection or other diseases;
7. Allergic to the chemotherapy drugs or the materials in this study;
8. Patients with gastrointestinal bleeding that need clinical intervention;
9. Patients with digestive tract obstruction or oral nutrition difficulty;
10. Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer;
11. Have participated in other clinical trials within 28 days prior to the first dose of this study;
12. Contraindications to chemotherapy;
13. Patients that researcher consider cannot sign informed consent or complete the study plan due to medical science factor, social factor or psychological reasons.
Risk Factor Involved in Knee Osteoarthritis (KOA)

Clinical study regarding the incidence and severity of knee osteoarthritis (KOA) in a certain area from South-Eastern Europe. Aim of the clinical study: to determine the KOA grade through X-Ray studies, to perform nuclear magnetic resonance (NMR) analysis to assess the KOA severity and to determine the level of significant parameters in the synovial liquid extracted from the patients presenting KOA.

Clinical study regarding the incidence and severity of KOA in a certain area from South-Eastern Europe. Clinical study on 85 patients out 373 participants that were screened, chosen based on inclusion/exclusion criteria.

Aim of the clinical study: to determine the KOA grade through X-Ray studies, to perform nuclear magnetic resonance (NRM) analysis to assess the KOA severity. Data corroboration of the KOA degree with the results of the blood samples analysis, looking for the influence of the metabolic syndrome (MetS) parameters - high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, triglycerides, glycemia, and then the body mass index (BMI). In the meantime, there is intended to associate the environment of origin of the patients from the trial group with the KOA incidence and severity. To determine the level of significant parameters in the synovial liquid extracted from the patients presenting KOA, analysis of the degradation products present in the synovial fluid of patients with KOA, such as free radicals, like reactive oxygen species (ROS) and reactive nitrogen species (RNS) and their influence on the severity of the pathology.

Eligibility Criteria:
Inclusion Criteria:

* male and female with knee pain (complaints); presented symptoms and clinical signs corresponding to KOA and had knee X-rays in the anteroposterior view and nuclear magnetic resonance (NMR) performed for setting the diagnosis with unilateral or bilateral knee pain; patients with clinically determined and recorded values of total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides and the glycemia in the clinical observation sheet.

Exclusion Criteria:

* patients presenting lower limb arthroplasties; history of lower limb or pelvis fractures and previous knee surgery: ligamentoplasty, meniscectomy; inflammatory rheumatic diseases such as rheumatoid polyarthritis; other major conditions like malignant illness.
Asthma Action at Erie Trial

The Asthma Action at Erie Trial compares the current best practice in asthma self-management education (certified asthma educator services) to an integrated community health worker (CHW) home intervention in which the real-life challenges of patients and the health care system are taken fully into account. This trial will provide clarity as to the expected effect size, cost savings, and resources needed to integrate asthma CHWs into clinical practice.

The Asthma Action at Erie Trial will test the ability of a community health worker (CHW) intervention with three important modifications to achieve asthma control in high-risk children. These modifications are: 1) CHWs will be integrated into both the clinical and the home setting, 2) A system for directly addressing mental health and psychosocial barriers will be provided, and 3) Participants will be provided only materials and equipment for trigger remediation that are supported by the current medical reimbursement system. To test this intervention, a two-arm behavioral randomized controlled trial (N=220) will be conducted in partnership with a federally-qualified health center (FQHC) serving a low income, minority population that is at high-risk for significant asthma morbidity. The intervention arm will receive an integrated CHW home intervention for pediatric asthma education. The comparison arm will received clinic-based certified asthma educator (AE-C) services. Primary Aim 1 is to assess the efficacy of the integrated CHW home asthma intervention, relative to clinic-based AE-C education over 12-months, as demonstrated by asthma control. Specific Aim 2 is to assess maintenance of intervention efficacy, as demonstrated by asthma control at 18 and 24 months after randomization. Specific Aim 3 is to determine the cost-effectiveness at 12-months of CHW and AE-C intervention delivery, and additional costs or savings related to asthma exacerbations at 12- and 24-months. Specific Aim 4 is to assess the efficacy of the integrated CHW home asthma intervention relative to clinic-based AE-C education, as demonstrated by asthma control, among those experiencing depression, stress, and/or a post-traumatic stress disorder.

Eligibility Criteria:
Inclusion Criteria:

* Child is a patient at Erie Family Health Center
* Child is age 5-16 at the start of the study
* Child lives with the index caregiver at least 5 days out of the week
* Child has uncontrolled asthma. This is defined as a score of 1.25 or greater on the Asthma Control Questionnaire, or report of oral corticosteroid use in the past year
* Family has a working telephone

Exclusion Criteria:

* Exclusion criteria include family not fluent in English or Spanish, family lives in temporary housing such as a shelter, caregiver does not have permanent custody of child, or child has significant developmental delays or co-morbidities that would limit their ability to participate in the program.
YouTube-Delivered Physical Activity Intervention

This study will be an 8-week randomized controlled trial examining the effects of a YouTube-delivered aerobic and muscle strengthening physical activity intervention on university students' physical activity, fitness, sleep quality, and psychosocial health outcomes. Participants will be randomized into 1 of 2 groups: (1) intervention group (receive twice-weekly YouTube videos \[1 aerobic workout video; 1 muscle-strengthening workout video\] for 8 weeks); or (2) control group (receive twice-weekly YouTube videos with general health information \[no physical activity-related information or workouts\] for 8 weeks). Baseline (0 weeks), mid-point (4 weeks), and post-test (8 weeks) testing will take place and the following outcome measures will be assessed at these time points: participants' free-living (7-day) objectively-measured physical activity and sleep quality data will be collected; anthropometric measures (height, weight, percent body fat); cardiorespiratory and muscular fitness; and psychosocial assessments (perceived physical activity barriers and social support).


Eligibility Criteria:
Inclusion Criteria:

* 18-35 years of age; able to participate in aerobic and muscle-strengthening exercise; healthy (i.e., no diseases or clinical/mental health conditions which will prevent physical activity participation); does not meet minimum physical activity guidelines criteria for aerobic (≥ 150 minutes per week of moderate-to-vigorous intensity physical activity) and muscle-strengthening (≥ 2 days per week; 8-10 exercises for all major muscle groups) physical activity at time of enrollment; willing to be randomized to the intervention or control group.

Exclusion Criteria:

* less than 18 years old or greater than 35 years old; physical or mental health contradictions which do not allow participants to participate in physical activity; exceed minimum aerobic or muscle-strengthening physical activity guideline recommendations; unwilling to be randomized to either intervention or control group.