cyrilzakka/clinical-trials huggingface dataset:
Resistance Exercise to Improve Flu Vaccine for Older Adults

This study evaluates whether resistance exercise will improve immune responses to the seasonal influenza vaccine in older adults. One third of the participants will perform exercise in the arm that receives the vaccine, one third of the participants will perform the same exercise in the arm that does not receive the vaccine, and one third will only receive the vaccine.

Resistance exercise, particularly novel eccentric exercise, recruits immune cells to the targeted muscle. The exercises selected here targets the deltoid and biceps brachii muscles-those same muscles that the flu vaccine is delivered to during typical vaccination.

Eligibility Criteria:
Inclusion Criteria:

* non-frail older adult (≥65 years old) of any sex and race/ethnicity
* non-smokers (\>10 yrs)
* meets American College of Sports Medicine criteria for participation in exercise
* US resident

Exclusion Criteria:

* underlying medical problems that contraindicate supervised resistance exercise
* past or present history of autoimmune disease, HIV, hepatitis, stroke, or cardiovascular disease
* current debilitating arthritis of the shoulder
* central or peripheral nervous disorders
* bedridden in the past three months
* history of vaccine-related allergies, or severe egg allergy;
* physician-confirmed influenza infection in the prior year
* regular user of corticosteroids
* functional or cognitive impairment that would limit exercise performance or prohibit informed consent
* blood pressure greater than 160/90
* participation in resistance arm exercises in the prior 6 months
Lung Function Testing in Patients With Locally Advanced or Metastatic Solid Tumors

RATIONALE: Measuring how well the lungs work in patients with cancer may help doctors predict how patients will respond to treatment and help plan the best treatment.

PURPOSE: This clinical trial is studying lung function testing in patients with locally advanced or metastatic solid tumors.

OBJECTIVES:

Primary

* To obtain the distribution of DLCO, FVC, and FEV_1 by pulmonary function testing (PFT) in patients with heavily pretreated locally advanced or metastatic solid tumors referred to the Karmanos Cancer Institute (KCI) Phase I Clinical Trials Program.
* To estimate the mean DLCO to within 4 units (% of predicted) of the true mean with 95% confidence.

Secondary

* To estimate the percentage of patients who meet the defined eligibility criteria (including PFT levels, especially DLCO) from the entire population enrolled in the KCI Phase I Clinical Trials Program.

OUTLINE: Patients undergo pulmonary function testing comprising spirometry test, lung volumes, and DLCO measurement utilizing the single-breath breath-holding technique. Patients then proceed to treatment on a phase I clinical trial.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed solid tumor

  * Locally advanced or metastatic disease
* Disease progressed on or after standard therapy OR there is no standard therapy for the malignancy

  * Standard therapy is defined as first- or second-line therapy that has been shown to provide clinical benefit
* Life-long non-smoker
* No lung metastasis and/or pleural effusion causing signs or symptoms that impact patient performance status

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* Body mass index ≤ 35
* No concurrent uncontrolled illness including, but not limited to, the following:

  * Ongoing or active infection
  * Symptomatic congestive heart failure
  * Unstable angina pectoris
  * Ventricular arrhythmia
  * Psychiatric illness or social situation that would limit compliance with study requirements
* No uncontrolled chest or abdominal pain
* No oral or facial pain exacerbated by an oral device
* No stress incontinence
* No COPD, interstitial lung disease, pulmonary embolism, or hemorrhage within the past 6 months
* No history of pulmonary fibrosis or pulmonary hypertension
* No oxygen requirement at baseline
* No asthma
* No occupational lung disease, including, but not limited to, asbestos exposure
* No polycythemia
* No history of connective tissue disease

PRIOR CONCURRENT THERAPY:

* No prior radiotherapy to the lung
* At least 6 months since prior lung surgery
* No prior amiodarone hydrochloride
* No prior high-dose chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation
* No concurrent combination antiretroviral therapy for HIV-positive patients
INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs

This was a randomized, double blind, placebo controlled, dose ranging, parallel group study. Participants who had active rheumatoid arthritis (RA) who had inadequate response to any disease modifying anti-rheumatic drug (DMARD) therapy including biologics were enrolled. Screening evaluations were performed within approximately 28 days of randomization. The duration of the study was 6 months with the primary endpoint assessed at 3 months. Eligible participants were randomly assigned to one of three doses (4, 7 or 10 mg QD) of INCB028050 (Baricitinib) or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Must have rheumatoid arthritis which has been inadequately controlled with at least one DMARD
* For subjects receiving antimalarials, they must be treated with antimalarials for at least 6 months and receiving a stable daily dose
* For subjects receiving sulfasalazine, they must be treated with Sulfasalazine (SSZ) for at least 6 months and receiving a stable daily dose of no more than 3 grams per day
* For subjects on methotrexate, they must be treated with methotrexate for at least 6 months, and receiving a stable weekly dose of methotrexate between 7.5 and 25 mg
* For subjects on leflunomide, they must be treated with leflunomide for at least 6 months, and receiving a stable dose of leflunomide between 10 to 20 mg
* For subjects receiving corticosteroids, they must be on a dose not to exceed 10 mg of prednisone daily
* Active rheumatoid arthritis at the time of screening defined by the following: 6 or more joints tender or painful on motion and 4 or more swollen joints and at least one of the following two: Erythrocyte sedimentation rate (ESR) greater than or equal to 28 mm/hr or C-reactive protein (CRP) greater than or equal to 7 mg/liter
* Have evidence of lack of risk for tuberculosis

Exclusion Criteria:

* Current or recent viral, bacterial, fungal, parasitic or mycobacterial infection requiring systemic therapy
* History of infected joint prosthesis
* Subjects who have a current or recent history of severe, progressive, uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease
* Subjects who have received treatment with the following drugs or drug classes within the specified timeframe: prior treatment with rituximab within 12 months, prior treatment with an oral Janus kinase (JAK) inhibitor, DMARDs or other anti-rheumatic therapies not specified and allowed according to protocol, treatment with any investigational medication within 12 weeks or 5 half-lives (whichever is longer), and treatment with a biologic agent within 12 weeks prior to the first dose of study medication
* Subjects with a past history of neutropenia, thrombocytopenia or anemia requiring transfusion other than at the time of trauma or surgery, and subjects that meet protocol specified laboratory measures
Expanding NGS Data with Optical Genome Mapping (OGM)

Over 50% of pediatric neurological and neurodevelopmental disorders lack a molecular diagnosis after standard DNA sequencing and molecular karyotyping. This is due to technical limitations, incomplete variant interpretation, and inadequate genotype-phenotype correlations. New sequencing technologies are crucial for clinical decision-making, offering complete profiles of variants in a patient's DNA to personalize treatment. Optical Genome Mapping (OGM) can detect nearly all structural variants in one experiment. This project aims to use OGM alongside NGS to improve diagnostic yield in 60 children with severe disorders who tested negative for NGS/CMA.


Eligibility Criteria:
Inclusion Criteria:

* individuals without a molecular diagnosis (negative to ES/CMA analyses);
* individuals with genetic diagnoses that explain only one component of their primary phenotype;
* individuals carrying one or more variants of uncertain clinical significance
* individuals with a phenotype highly reminiscent of clinically and molecularly well-defined syndromes (i.e., Marfan Syndrome) but negative to routine molecular analysis.

Exclusion Criteria:

* individuals who have not undergone initial diagnostic genetic tests (ES/CMA)
Prognosis of Posterior Lamellar Keratoplasty, an Observational Cohort Study

Over the past decade, the management of Fuchs' endothelial corneal dystrophy (FECD) and pseudophakic bullous keratopathy (PBK) has been revolutionized by the development of posterior lamellar keratoplasty techniques: DSAEK and DMEK.

DSAEK (Descemet Stripping Automated Endothelial Keratoplasty) involves replacing the patient's endothelium and pathological descemetum with a descemetic endothelial graft combined with a thin stromal lamella. The endothelial density of the grafts is generally greater than 2,400 cells/mm². Depending on the grafting center and tissue bank, grafts may be either pre-cut in the tissue bank or cut on the operating table by the surgeon himself.

The donor graft is placed on an artificial anterior chamber, and automated microkeratome cutting produces grafts with an average thickness of 100 to 200µm, sometimes less than 100um (known as UT-DSAEK or ultra-thin DSAEK).

DMEK (Descemet Membrane Endothelial Keratoplasty) is a strictly endothelium and Descemet's membrane graft, as close as possible to the original anatomy of the cornea. The graft is dissected manually either in a tissue bank (pre-cut grafts) or on the operating table by the surgeon. The thickness of the graft is between 15 and 18 microns.

The primary objective of this observational cohort is to compare the evolution of visual acuity after DMEK, DSAEK or UT-DSAEK transplantation.

Secondary objectives are to compare the evolution of endothelial cell density, corneal thickness and early and late post-operative complications, and to identify factors predictive of these different endpoints.


Eligibility Criteria:
Inclusion Criteria:

* patients who received a posterior lamellar keratoplasty in Metz-Thionville Regional Hospital between 2012 and 2030

Exclusion Criteria:

* patients refusing to take part in the study
Mouth Dissolving Mosapride Tables Enhance Post Cesarean Gut Recovery

Giving women one day before and immediately after cesarean section a mouthly dissolving mosapride tablets 2every every 8 hours for maximum of 5 days ,or getting recovered gastrointestinal functions And assess preoperative gastrointestinal functions

Uncomplicated post cesarean women one day before and immediately after elective cesarean receive 2 mouthly dissolving mosapride tablets every 8 hours maximum for 5 days and clinical care giver follow the woman's gastrointestinal functions, including intraoperative and postoperative nausea vomiting, passing flatus, hearing intestinal sounds, passing stools, occurring of paralytic ileus, length of the hospital stay

Eligibility Criteria:
Inclusion Criteria:

* all women undergoing elective cesarean section

Exclusion Criteria:

* prior abdominal surgery, abdominal adhesion, chronic constipation, allergy to mosapride
Fetal Intrapartum Heart Rate FHR/ECG Study

The objective of the study is to evaluate the association between certain markers in the blood of neonatal brain injury and specific Fetal Heart Rate monitoring findings using the device under study.

The purpose of the study is to:

1. evaluate the association between serologic markers of neonatal brain injury and the specific FHR monitoring findings using the investigational device;
2. investigate the relationship between selective serotonin reuptake inhibitor (SSRI) antidepressants and the QT interval of the fetal heart. Specifically, examine the potential association between maternal SSRI use and the fetal QT interval,and;
3. develop the capacity to measure uterine contractions during labor using non-invasive electrodes that measure the electrical signal from the uterine muscle.

For this study, the investigational device will not be used to diagnose or treat as it will be used in concert with the current standard of care monitors.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in their third trimester and Women in labor (the progressive effacement and dilatation of the cervix) who are having their fetus' heart rate monitored continuously will form the eligible population for recruitment into our study
* 18 years old or older
* Women with the diagnosis of fetal intrauterine growth restriction may be included.

Exclusion Criteria:

* Speakers of languages other than English
* Gestational age less than 24 weeks 0 days
Optical Spectroscopy for Skin Carcinomas' Surgical Management

Actinic keratosis are of utmost medical and economical interest because of their high prevalence (20 % of 60 year-old people and older in the Northern hemisphere) and their important cosmetic impact as such actinic keratosis mostly appear on photo-exposed skin sites. The surgeon in charge of such lesions' removal (i) some actinic keratosis adjoining carcinoma to be resected therefore causing the problem of functional areas damaging (eyelids, lips, etc.) or (ii) numerous actinic keratosis localized away from carcinoma (photo-carcinogenesis field) faces the issue of clinical evaluation of such lesions: which ones will spontaneously regress (it is supposed to be the case for 20 % of such lesions);which ones will remain and which ones will develop into invasive carcinomas ?

A non-invasive, non-traumatic, automated and real-time help for the clinical diagnosis orientation of such skin lesions could help improving diagnosis accuracy of the medical practitioner's visual inspection:

* In terms of sensitivity in order to potentially decrease the number of actinic keratosis evolving towards invasive carcinoma,
* In terms of specificity in order to potentially decrease useless resections and reduce resection margins and therefore reduce scars surface.


Eligibility Criteria:
Inclusion Criteria:

* Adults, and
* Autonomous: enjoying full citizenship rights and full mental abilities, and
* Affiliated to a social security system, and
* Suffering from carcinomatous or polymorphous skin lesions that can be fully managed in an outpatient (ambulatory) surgery procedure.

Exclusion Criteria:

* Carcinomatous or polymorphous skin lesions that require day admission, or
* Carcinomatous or polymorphous skin lesions for which resection margins are uncertain, or
* Naevomatous skin lesions and related skin pathologies.
Study of Dasatinib (BMS-354825) in Patients With Advanced Estrogen/Progesterone Receptor-positive (ER+/PR+) or Her2/Neu-positive (Her2/Neu+)Breast Cancer

This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer


Eligibility Criteria:
Inclusion Criteria:

* females, 18 or older
* recurrent, locally advanced, or metastatic breast cancer with expression of ER/PR receptor and/or overexpression of Her2/neu
* paraffin-embedded tissue block must be available
* measurable disease
* prior chemotherapy with an anthracycline and/or a taxane (neoadjuvant, adjuvant, or metastatic setting)
* 0, 1 or 2 chemotherapies in the metastatic setting
* adequate organ function

Exclusion Criteria:

* Metastatic disease confined to bone only
* Symptomatic central nervous system (CNS) metastasis
* Concurrent medical condition which may increase the risk of toxicity
* Unable to take oral medication
A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis

This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of etanercept with that of placebo in adult subjects with axial Spondyloarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 18 years and over at the time of consent to the study.
* Diagnosis of SpA, as defined by the ASAS criteria for axial SpA
* Axial involvement refractory to previous or current intake of NSAIDs, defined as at least 2 NSAIDs at maximum tolerated dose determined from past medical history taken for a duration of \> 1 month (for both NSAIDs combined) before the Screening visit.
* Active axial involvement defined by mini BASDAI

Exclusion Criteria:

* Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
* Subjects who have received any previous treatment with etanercept or other TNFα inhibitors or biologic agents.
* Subjects with a known or expected allergy, contraindication, or hypersensitivity to etanercept or its excipients.
Evaluation of the Effectiveness of the Video Prepared to Raise Cervical Cancer Awareness in Women Between the Ages of 18 and 65 Via Social Media.

This research, a quasi-experimental study based on the comparison of the pre-test and post-test results of individuals in a single group is conducted to raise awareness about cervical cancer in women aged 18-65 years. The questionnaire includes 32 questions about the individual's socio-demographic characteristics, pregnancy, and sexual life information, cervical cancer, pap-smear test, and HPV vaccine information, as well as a 27-item 3-point likert type to measure cervical cancer risk factors, symptoms, and prevention. A survey form consisting of 61 questions, consisting of 2 questions and 2 guestions for evaluating the animated training video, and an informative animated training video of 4 minutes and 33 seconds constituted the data collection tools. During the Covid-19 pandemic, the study has completed with 433 people who participated voluntarily by directing the participants via online platforms (WhatsApp / Instagram / E-mail) using the snowball sampling method of survey applications. The women who participated in the research completed the first part by watching the informative animated training video at the end of the questionnaire form.


Eligibility Criteria:
Inclusion Criteria:

* be 18-65 years old
* Being literate
* Using Whatsapp / Instagram / Email
* Will volunteer to participate in the research.

Exclusion Criteria:

* Attending the pre-test but not participating in the post-test
* Filling the survey form incompletely.
MT1013 Injection for the Treatment of Patients With Secondary Hyperparathyroidism (SHPT) Undergoing Maintenance Dialysis

This is a phase II study comprising 3 parts, which Part A/Part B a double-blind, randomized, placebo-controlled SAD/MAD study, and Part C a single arm study to investigate long-term efficacy and safety of MT1013 after 52 week treatment.The treatment duration for Part B MAD study is 2-4 weeks and the duration for Part C study is 52 weeks.


Eligibility Criteria:
1. Receiving hemodialysis 3 times weekly for at least 3 months, and have adequate hemodialysis with a delivered Kt/V≥1.2 or urea reduction ratio (URR)≥65% within 4 weeks prior to screening;
2. Dialysis prescription dialysate calcium concentration must be ≥2.25 mEq/L, and stable for at least 4 weeks prior to screening, remain stable for the duration of the study;
3. Diagnosed of Secondary Hyperparathyroidism (SHPT), with averaged iPTH ≥300 pg/ml (42.4pmol/L) 14 days prior to screening;
4. Receiving active vitamin D sterols must have had no more than a maximum dose change of 50% within the 1 month prior to screening, remain stable;
5. Subject receiving calcium supplements, or phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening, remain stable.
The Efficacy of B6 and Metoclopramide Combination in Comparison With the Other Antiemetics

This study investigates the effectiveness of combining vitamin B6 (pyridoxine) and metoclopramide compared to standard antiemetic treatments for managing nausea and vomiting. Through a prospective, randomized controlled trial involving adult patients with diverse causes of nausea and vomiting, we aim to evaluate the frequency, severity, and tolerability of the B6 and metoclopramide combination. By elucidating its comparative efficacy against established antiemetics, this research seeks to provide evidence-based guidance for clinicians in selecting optimal treatment regimens tailored to individual patient needs, ultimately enhancing the management of nausea and vomiting across various medical conditions.

Title: Investigating the Efficacy of B6 and Metoclopramide Combination Versus Alternative Antiemetics: A Clinical Trial Proposal

Introduction:

Nausea and vomiting are common symptoms across various medical conditions and can significantly impact patients' quality of life and treatment outcomes. While several antiemetic medications exist, finding the most effective regimen remains a clinical challenge. This proposal aims to investigate the efficacy of a combination therapy comprising vitamin B6 (pyridoxine) and metoclopramide compared to other antiemetics in managing nausea and vomiting.

Rationale:

Both vitamin B6 and metoclopramide have shown antiemetic properties through different mechanisms of action. However, the comparative efficacy of this combination therapy against other standard antiemetics remains largely unexplored. Understanding the relative effectiveness of this combination could provide valuable insights into optimizing antiemetic strategies, particularly in patients with chemotherapy-induced nausea and vomiting (CINV), postoperative nausea and vomiting (PONV), and other related conditions.

Objectives:

This prospective, randomized controlled trial aims to evaluate the efficacy of B6 and metoclopramide combination therapy compared to alternative antiemetic regimens in reducing the frequency and severity of nausea and vomiting episodes in adult patients. Additionally, the study seeks to assess the safety profile and tolerability of the combination therapy.

Conclusion:

By elucidating the comparative efficacy of B6 and metoclopramide combination therapy, this study endeavors to contribute to evidence-based decision-making in the management of nausea and vomiting. The findings could potentially guide clinicians in selecting the most appropriate antiemetic regimen tailored to individual patient needs, ultimately improving patient outcomes and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Any patients with vomiting

Exclusion Criteria:

* Patients vitally unstable
The Relationship Between Time Perspective, Fear of Cancer Recurrence, Rumination, and Catastrophizing in Gastric Cancer Survivors

The temporal perspective provides a theory oriented to temporal insights that can shed light on the role of cognitive coping styles in the formation of fear of cancer recurrence. The self-regulatory executive function model elucidates the central role of rumination thinking, catastrophizing cognitive coping styles in the formation of cancer recurrence fear. Therefore, this study will rely on both theoretical models to construct a cognitive appraisal coping model to explore the formation pathway of cancer recurrence fear


Eligibility Criteria:
Inclusion Criteria:

* Preoperative gastroscopy and pathological diagnosis of gastric cancer;
* Aged 18 years or older
* There is no history of recurrent disease or new primary cancer
* Received surgical resection of cancerous tissues or radiotherapy treatment
* Conscious, with normal communication and comprehension ability
* The patients were aware of their own condition and diagnosis, and informedly agreed to participate in this study

Exclusion Criteria:

● History of mental or cognitive impairment prior to cancer diagnosis