cyrilzakka/clinical-trials huggingface dataset:
Internet-based System for Cancer Patients to Self-report Toxicity

Cancer patients may develop side effects during treatment, such as nausea, pain, fatigue, diarrhea, constipation, or shortness of breath. These symptoms may be due to the cancer itself, or due to treatments like chemotherapy drugs or radiation therapy. Doctors and nurses often ask patients about their symptoms, because an important part of cancer treatment is to make patients feel as well as possible. If patients do not feel well, the investigators may need to change the way the investigators are treating you or prescribe therapies that will decrease your symptoms. The best way to find out how you are feeling is to ask you directly.

However, during your time between appointments the investigators may not be able to ask you how you are feeling on a regular basis. In addition, even at an appointment, there may be symptoms that the investigators do not have a chance to discuss.

The investigators are interested in developing new ways to ask patients about how they are feeling, using the Internet. A special new website called STAR ("Symptom Tracking and Reporting for Patients") has been developed to help patients record this information, so that their doctors and nurses can review it during clinic appointments. This study is designed to help us see if STAR is a helpful way for us to keep track of information about patients' symptoms and quality of life.

This pilot study will assess patient use of STAR (Symptom Tracking and Reporting for Patients), an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events v3.0, performance status by ECOG criteria, global quality of life by the EuroQOL 5-D assessment tool, emergency room visits, and survival. Secondary outcomes will include patient assessment of the usefulness of STAR, clinician perceptions of the potential value of STAR in routine clinical practice, and an evaluation of whether STAR improves the patient experience of care as assessed by satisfaction measures.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Diagnosis of gynecologic (ovarian; cervical; uterine; primary peritoneal), lung (non-small cell; small cell), gastrointestinal (colorectal, rectal, gastric, esophageal, GI neuroendocrine, small intestine malignancy, pancreatic, hepatocellular), breast, bladder cancer or prostate malignancy
* Receiving primary medical oncology care at MSKCC medical oncology outpatient clinics
* Receiving cytotoxic chemotherapy not on a clinical trial (or a new hormonal therapy in the case of prostate cancer patients only), with treatment expected to continue for at least four weeks from the time of enrollment
* Signed informed consent and Research Authorization

Exclusion Criteria:

* ECOG performance status greater than 2
* Unable to read and comprehend English language text
Psychometric Evaluation of the Arabic Activity-specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire (PMQ)

The primary aim of this study is to perform perform a psychometric analysis of Arabic Activity-specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire (A-PMQ) through a modern psychometric approach involving Rasch analysis (RA) to enable its use among Arabic speaking population and to enhance confidence in its use patients with lower limb amputation.


Eligibility Criteria:
Inclusion Criteria:

* current users of lower limb prosthesis of minum 6 month,
* to be able to fully understand and appropriately complete the questionnaire,
* to be unilater amputee.

Exclusion Criteria:

* inability to understand and complete the questionnair (e.g. cognitive or language impairment; not native-Arabic speaker),
* less the 6 month of using the prosthesis,
* bilateral and partial lower limb amputees
Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

This is an open-label, single institution study evaluating the efficacy of intravenous iron sucrose monotherapy in patients with thoracic, breast, GU and GI malignancies undergoing neoadjuvant chemotherapy with the goal of undergoing surgical resection.

This is an open-label, single institution study evaluating the efficacy of intravenous iron sucrose monotherapy in patients with thoracic, breast, GU and GI malignancies undergoing neoadjuvant chemotherapy with the goal of undergoing surgical resection. The concomitant use of radiation and immunotherapy as part of the neoadjuvant protocol is allowed in this protocol. The study is designed to evaluate the efficacy of iron infusions in reducing blood transfusion frequency and improving hemoglobin levels prior to surgical intervention.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \> 18 years
* Patients undergoing neoadjuvant chemotherapy, including radiation and/or immunotherapy, with intent for curative surgical resection for breast, thoracic, gastrointestinal (GI) or genitourinary (GU) malignancies.
* Anemia defined as Hgb \<10.5 g/dL during chemotherapy.
* Iron storage levels of ferritin \<500 ng/mL and iron saturation \<35%
* Ability to understand and willingness to sign a written informed consent and HIPAA consent document

Exclusion Criteria:

* Diagnosis of anemia at the time of cycle 1 day 1 of neoadjuvant chemotherapy, Hgb \< 11.0 g/dL, uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic new/exacerbated congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Prior parenteral iron infusion in the past 4 weeks
* The use of erythropoietin stimulating agents within 4 weeks unless chronic needs due to CKD
* Concurrent systemic infection at the time of enrollment.
* Known hypersensitivity to Iron sucrose
* Pregnant or breast feeding. Refer to section 4.4 for further detail.
* Anemia from another established etiology (i.e MDS, Myeloma)
Repeated Insult Patch Test of Personal Lubricants

Determine the ability of the study material (personal lubricant) to cause sensitization by repeated topical application to the skin of humans under controlled patch test conditions.


Eligibility Criteria:
Inclusion Criteria:

* In general good health
* Free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, will interfere with the study results or increase the risk of adverse events
* Are of any skin type or race, providing the skin pigmentation will allow discernment of erythema
* Complete a medical screening procedure
* Read, understand, and sign an informed consent agreement

Exclusion Criteria:

* Have any visible skin disease at the study site which, in the opinion of the investigative personnel, will interfere with the evaluation
* Are receiving systemic or topical drugs or medication which, in the opinion of the investigative personnel, will interfere with the study results
* Have psoriasis and/or active atopic dermatitis/eczema.
* Are females who are pregnant, planning on getting pregnant during the study, or breast-feeding
* Have a known sensitivity for cosmetics, skin care products, topical drugs, or any other type of the products, as related to the material being evaluated
Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®

BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and safety of single-injection of Leucostim® to healthy volunteers compared to Neupogen®


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Male gender.
* Age between 18 and 45 years.
* Normal body mass index.
* Verified diagnosis "healthy", established according to the anamnesis, physical examination and laboratory findings.
* Absence of alcohol or drug abuse.

Exclusion Criteria:

* History of use of filgrastim.
* Allergy to any components of study drugs.
* Acute hemorrhage, donation of blood / plasma or blood transfusions during last 2 months prior to enrollment in the study, history of chronic bleeding.
* Surgical interventions during last 30 days prior to screening or planed surgical intervention during the study.
* Any diseases that could interfere with pharmacokinetics of filgrastim, including chronic liver, liver or blood diseases, diseases of cardiovascular, lung and neuroendocrine systems.
* Fever with body temperature higher than 40°С.
Waking Hypnosis in the Treatment of MS-related Fatigue

The proposed study is a single-center, single-blind three-group randomized (1:1:1) controlled trial (RCT) comparing two hypnosis interventions to waitlist control efficacy for MS-related fatigue.

This project will test the efficacy of two different hypnosis approaches for improving MS-related fatigue that have shown to be beneficial for individuals with cancer and other medical conditions in the management of their symptoms. One of these methods, the active-alert hypnosis has helped people to manage fatigue and may have important advantages over the more traditional relaxation hypnotic approaches in the treatment of fatigue, since the hypnotic inductions and the self-hypnosis methods use activation instead of relaxation. Therefore, the goals of this study are to determine if a comparison study of these two hypnotic conditions is feasible, and, if so, to determine which treatment may be more effective for helping individuals with MS gain more control over fatigue. Additionally, it will explore the mechanisms of these two approaches to hypnosis treatment to determine which might be most helpful to individuals with MS and fatigue.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS;
* Adults 18 years of age or older;
* Bothersome fatigue (defined as the presence of chronic, problematic fatigue that, in the opinion of the patient, has interfered with their daily activities for ≥ 3 months and average Fatigue Severity Scale score \> to 4 at screening);
* Ability to read, speak, and understand English and/or Spanish.

Exclusion Criteria:

* Exclusion criteria will be evidence for significant psychopathology that would interfere with study participation, including current suicidal ideation with intent, active psychosis or hallucinations, or severe cognitive impairment.
Teaching Simple Skin Sutures to Medical Students

Learning the simple skin suture is part of the surgical basics required for all medical students, including future general practitioners.

However, there is no data in the educational literature to help choose the best learning technique.

Several teams have offered video learning showing the correct technique. Level n+1 peer learning was also proposed, without and with supervision by an expert.

The investigators propose to carry out a prospective study comparing the quality of sutures and knowledge according to the chosen learning method.

Send to medical student a teaching package two weeks before simulation session to practice skin suture. There are 4 teaching packages related to 4 interventional groups The skin suture performed by medical students are recorded on video. 1 video per medical student.

The skin sutures recorded in these video are rated by two blinded expert with evaluation grid.

After the simulation session, the students complete knowledge, self-confidence, satisfaction and mental load questionnaires

Eligibility Criteria:
Inclusion Criteria:

* Medical student of the faculty of Clermont-Ferrand

Exclusion Criteria:

* Refusal to participate
Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD

The goals of this study are:

To assess the impact of genetic testing based on how it alters behaviors, to assess the utility of serum biomarker measurement in combination with genetic testing, to assess the utility of genetic counseling in personal analysis of risk for age-related macular degeneration (AMD), and to assess the impact of presymptomatic genetic testing for choroidal neovascularization (CNV).


Eligibility Criteria:
Inclusion Criteria:

* Caucasian (this particular genetic test is only validated in Caucasians) Participants can have a positive family history of AMD but this is not necessary.

Exclusion Criteria:

* Individuals with a personal history of AMD are not eligible. Non-caucasian individuals are not eligible. Employees of the Moran Eye Center are not eligible.
* Individuals with a personal history of previous AMD genetic risk testing are not eligible.
* Individuals with a major psychiatric disorder
Selenium Supplementation Versus Placebo in Patients with Graves' Hyperthyroidism

The purpose of this study is to investigate if selenium supplementation to the standard treatment with anti-thyroid drugs in patients with Graves' hyperthyroidism, will lead to a fewer people with anti-thyroid treatment failure and faster remission, in terms of better quality of life during the first year of treatment and more patients staying in remission.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Active Graves' hyperthyroidism (suppressed TSH (\< 0.1) and positive TRAb) measured within the last two months prior to the inclusion date.
* Written informed consent

Exclusion Criteria:

* Major co-morbidity, making the participants unlikely to continuously receive trial intervention in the intervention period.
* Previous treatment with radioactive iodine.
* Current ATD treatment having been received for more than two months.
* Treatment with immunomodulatory drugs, such as cyclosporine A, methotrexate, cyclophosphamide.
* Allergy towards the components in the selenium and placebo pills.
* Pregnant or breast-feeding women.
* Intake of selenium supplementation above 70 µg per day (70 µg corresponds to the amount in a multivitamin tablet).
* Unable to read and understand Danish.
* Lack of informed consent
Eealy Improvement Predicts Antidepressants Response in Adults With Major Depression Disorder

Early improvemrnt, decreased 20% in the 17 items of Hamilton Depression Rating Scale (HAMD-17) at the second week of the treatment of major depression disorder (MDD), can arguably predict the remission at the 12th week. Our observation study including 80 MDD patients will access resting-state function MRI to finding factors which infuencing early improvemrnt, respone and remission of antidepressants.


Eligibility Criteria:
Inclusion Criteria:

* right-handed; HAMD-17 more than 17; diagnosed with MDD by the Structured Clinical Interview for DSM-IV

Exclusion Criteria:

* patients diagnosed with other condition in DSM-IV Axis I; pregnency; Thyroid disease; Heart Disease
Clinical Evaluation of Polymethyl Methacrylate CAD/CAM Crowns Versus Prefabricated Zirconia Crowns in Primary Molars

, in this studythe investigator will compare between ready-made zirconia crowns and Computer-aided design and Computer-aided manufacturing (CAD/CAM) polymethyl methacrylate (PMMA) crowns to overcome the disadvantages of ready-made zirconia crowns.


Eligibility Criteria:
A- Inclusion Criteria:

1. Primary molars indicated for crown restoration (pulp treated molars indicated for crown
2. Co-operative child (Frankel scale +ve and ++ve)
3. The age ranged from 4 to 8 years regardless of sex or socioeconomic background.

B- Exclusion Criteria:-

1. Badly decayed non-restorable tooth indicated for extraction.
2. Patients with parafunctional habits like bruxism.
3. Systemic diseases with oral manifestation or blood diseases.
Clinical Evaluation of NeoPlex4 Assay and NeoPlex System

The purpose of this study is to assess the agreement of clinical performance between the proposed NeoPlex 4 assay and NeoPlex System and the comparator devices in clinical use in newborn screening programs for detection of T4, TSH, 17-OHP and IRT.

The proposed (investigational) NeoPlex4 assay measures levels of thyroxine (T4), thyrotropin (hTSH), 17-alpha-OH-progesterone (17-OHP) and immunoreactive trypsinogen (IRT) from dried blood specimens (DBS) collected from neonates to screen for congenital hypothyroidism (CH), congenital adrenal hyperplasia (CAH) and cystic fibrosis (CF). The Clinical Evaluation of the xMAP® NeoPlex4™ Assay (NeoPlex4) for Detection of T4, TSH, 17-OHP and IRT using the NeoPlex System is a multi-center method concordance study on a combination of prospectively collected neonatal dried blood spots and pre-selected archived frozen dried blood spots that have been demonstrated to be positive for 17-OHP (CAH), IRT (CF), and T4 or TSH (CH). The study will be conducted at selected sites that routinely perform newborn screening testing in the United States.

Eligibility Criteria:
Inclusion Criteria:

* The dried blood spot specimen was collected on an FDA-cleared collection paper that has not yet passed its expiration dating.
* Prospective specimens used in this study should only be those collected for the first time from a subject, or initial collection specimens.

Exclusion Criteria:

* Collected within 24 hours of birth.
* Specimens stored at ambient temperature for greater than 14 days prior to testing.
* The specimen DBS appears diluted.
* The specimen DBS shows evidence of clotting, caking, layering or serum rings.
* The DBS punched disks were punched too close to the edge of the blood spot or show printed markings.
* The specimen or collection card was contaminated with fecal material.
* Non-eluting blood spot due to deterioration of sample caused by exposure to heat and humidity.
Proposed Meal Changes for CACFP: Impact on Child Food Intake and Costs

Child and Adult Care Food Program (CACFP) meals are an important influence on diets of children from low-income families enrolled in the CACFP and should meet children's nutrient needs while fostering healthy eating habits that enable them to maintain energy balance. Recent national data revealed that children consumed low intakes of foods that support healthy dietary patterns (whole grains, fruit and vegetables other than potatoes), but high intakes of low nutrient, energy dense foods. The 2011 USDA-commissioned Institute of Medicine (IOM) report for CACFP meals provided new recommendations that include new meal pattern requirements for the meals programs, aligning them with the U.S. Dietary Guidelines to ensure that the meals promote health and reduce inadequate and excessive intakes. The report recommended inclusion of more whole grains, fruit, vegetables, and meat/meat alternatives which will likely increase meal costs. Two of the IOM report recommendations call for research to better understand how the new meal requirements would change children's CACFP meal dietary intakes and food service costs. These are important questions, and answers are needed to inform policy and future technical and educational assistance needs. The overall objective of this project is to implement the IOM meal pattern requirements for CACFP meals in day homes and centers in Texas. The multidisciplinary team will focus on nutrition, economics, and provider outcomes. The specific aims are to assess the impact of the new meal pattern requirements on 1) Meal participation rates; 2) Provider food service costs (food, labor, total meals); and 3) Child dietary intake at CACFP homes and centers. It is hypothesized that, compared with control sites, intervention site children will select and consume healthier diets (more fruit, vegetables and whole grains) at school. A total of 32 day care sites will be recruited for the study. It is hypothesized that, compared with control sites, children at the intervention sites will select and consume healthier diets (more fruit, vegetable and whole grains) at the center. It is also hypothesized that the increase in food costs will be less than that projected in the IOM report. The results on the costs associated with creating the desired meals will be very important as these data have not been systematically collected in previous studies. This significant study targets underserved minority populations with health promoting intervention to reduce health disparities, and in addition, will inform policy on the influence of a healthy food environment on children's diet, as well as provide critical information on costs.


Eligibility Criteria:
Inclusion Criteria:

* Must be day care sites
* Must be parents of children attending the day care sites

Exclusion:

* Parents of children not attending one of the 32 day care sites
Cephalic Femoral Heads Follow Up

Study design: monocentric, retrospective, observational and post-market clinical study.

Purpose: To demonstrate the safety and performance of cephalic femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with cephalic femoral heads from 1st January 2023 onwards at the site in accordance with the indication for use of the product.

The study is aiming to demoranstrate safety and performance of cephalic femoral heads and will do it by considering the rate of revision of any prosthesis component and dislocation, by x-ray evaluation, by patient reported outcomes and walking/residential status. Patients are followed for 2 years after hemiarthroplasty and data are collected at 6 timepoints (pre-operative, intra-operative, at discharge, 4-months follow up, 12 months follow up and 24 months follow up).

Eligibility Criteria:
Inclusion Criteria:

* Displaced intracapsular hip fracture (Garden III-IV).
* Subjects underwent a Unipolar Hemiarthroplasty with a Cephalic femoral head as per their Indication For Use from January 1st, 2023, onwards.
* No concurrent joint disease at the time of the surgery.
* Absence of severe cognitive dysfunction demonstrated by 3 or more correct answers on the Pfeiffer test.
* Ability to ambulate independently with or without walking aids before surgery.
* Subject willingness to participate.

Exclusion Criteria:

* Undisplaced or minimally displaced intracapsular hip fracture (Garden I-II).
* Any Cephalic femoral head contraindication for use as reported in the current Instruction For Use.
* Pathological fracture secondary to malignant disease.
* Subjects with rheumatoid arthritis or symptomatic osteoarthritis.
* Previous treatment to the same hip for a fracture at the time of the surgery.
* Subjects who were deemed unsuitable for the surgical procedures by the anesthesiologist.
* Severe cognitive dysfunction or cognitive impairment demonstrated by 2 or less correct answers on the Pfeiffer test.
* Unable to walk before surgery (e.g., wheelchair or bed-ridden subjects).
Validating a New Point-of-care Device for Estimation of Blood Count in Pregnant Women

Postpartum hemorrhage is a well-known complication of delivery and the leading cause of maternal mortality worldwide. In developed nations, a complete blood count (CBC) is commonly collected as a means to assess or base treatment for blood loss. The Hemi device is a point-of-care device designed to provide hematocrit, followed by the stage of hemorrhagic shock using artificial intelligence algorithms. The ultimate goal of the product is to provide an accurate hematocrit from easily attainable samples such as vaginal blood during hemorrhage to remove yet another barrier to access for actively bleeding women. The purpose of this study is to compare the hematocrit of vaginal blood using the Hemi device with standard venipuncture.

This will be a prospective cohort study. The investigators will recruit 41 pregnant women admitted for delivery. Following delivery, a sample of vaginal blood will be collected and the Hemi device will be used to obtain hematocrit. These results will be masked to the clinical team until the time of data collection. A CBC will also be collected via venipuncture at this time. This study will be comparing hematocrit levels by standard clinical laboratory versus results from the device.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between the ages of 18-50
* Admission for vaginal delivery
* Singleton pregnancy
* Term gestation (\>=37 weeks)

Exclusion Criteria:

* Pregnant women \< 18 years or \> 50 years
* Incarcerated patients
* Patient unwilling or unable to provide consent
* Enrolled in another trial that may affect outcome