cyrilzakka/clinical-trials huggingface dataset:
Evaluation and Implementation of Mobile Tracking Devices to Increase Safety in Hospitalized Patients (MONITOR)

The study investigates the technical feasibility of using mobile health trackers for monitoring of hospitalized patients. Therefore the measurement accuracy of several vital parameters in postoperative hospitalized patients will be compared to clinical gold standard. Factors that could have an influence on the measurement accuracy of the mobile sensors will be investigated.Furthermore patient compliance in continous use of mobile health trackers and technical feasibility of needed data flow will be analyzed. In addition, patients' activity levels are recorded and correlated with various clinical parameters.


Eligibility Criteria:
Inclusion Criteria:

* Patients with elective surgery (≥ 18 years).
* Written informed consent to participate in the study
* Planned invasive arterial blood pressure measurement

Exclusion Criteria:

* Postoperative invasive ventilation
* American Society of Anaesthesiologists (ASA) Class V
* Outpatient surgical procedure
* Previous participation in this study
* Patients unable to give consent or patients who do not have adequate German language skills
* Suspected lack of compliance
* Skin lesions of the forearms or inability to wear a tracking device
* Known allergy to latex/silicone/nickel
MRE Predictors of Disease Relapse After Stopping Biologics

This study aims to investigate if MR Enterography (MRE) improves the ability to predict which Crohn's disease patients will relapse quickly (disease comes back) after stopping biologic medication. MRE is a safe MRI scan of the bowel, widely used in Crohn's disease patients.

This study aims to investigate if MR Enterography (MRE) improves the ability to predict which Crohn's disease patients will relapse (disease comes back) after stopping biologic medication when clinically well. MRE is a safe MRI scan of the bowel, widely used in Crohn's disease patients.

Using a network of British Society of Gastrointestinal and Abdominal Radiology (BSGAR) affiliated NHS hospitals, up to 200 patients who have stopped biologic treatment and recently underwent MRE as part of usual care will be identified. Detailed analysis will be performed on these MRI scans using scores measuring residual bowel inflammation, and retrospectively collect standard clinical data such as blood, stool and colonoscopy results. Using hospital records (accessed by each local care team before being pseudoanonymised) the study will see what happened to patients after one year, specifically if they relapsed or remained well off the biologics.

Based on a literature review, the most promising predictors of early relapse will be identified, such as blood/stool tests, to build a statistical model that provides the risk of a patient relapsing within one year. MRE scores will be added to this model to see if it improves the ability to predict relapse.

The results of the study could form part of a clinical decision support tool to help risk stratify patients and improved joint management decision making.

Eligibility Criteria:
Inclusion Criteria:

* Luminal small bowel or colonic Crohn's disease in clinical remission
* 16 years or older
* MRE as part of routine care performed within three months prior, or one month after the decision to stop biologic therapy Anti-TNF (Adalimumab, infliximab, Certolizumab) IL-23 or IL-12 antagonists (Ustekinumab) Anti-integrin biologics (Natalizumab, Vedolizumab)
* Biologic therapy stopped due to clinical remission only

Definition of clinical remission: There is no agreed consensus on how clinical remission is defined and practice differs between hospitals and patients. To mirror current clinical practice, no strict definition of clinical remission will therefore be used. Detailed clinical parameters the time of stopping biologic agents will be collected.

Exclusion Criteria:

\<16 years of age

Non-biological therapy, unless part of combination therapy with biologic agents

Biological therapy stopped for other reasons e.g. loss of effect, side effects

Resection of diseased segment(s) after MRE but before stopping biologic agent.

No MRE with the time window defined by eligibility criteria
The Effect of Skill Centered Intervention Based on IMB Model on Promoting Teachers' Professional Competence in Teaching Sexuality Health.

Study aim is determining the impact of a skill based intervention based on IMB model on Promoting School Teachers' Professional Competence in Teaching Sexual Health.

This research is a randomized control field trial with two groups; intervention and control. Sampling will be conducted by block design (with block size of 4) random allocation.

Intervention group: Intervention group will be received sexuality teaching skills for promotion of professional competence based on information, motivation and behavioral skills model for adolescent sexuality after signing informed consent form and being informed about the goals and details of intervention for 6 sessions (one two hour session per week).

The control group will not receive any intervention until the end of the research. Then, based on the ethics of the research and their willingness can use the content of program.

Eligibility Criteria:
Inclusion Criteria:

* Having instructors' consent to enter the study, instructor approval for teaching in terms of education system
* Having at least 5 years of teaching experience.

Exclusion Criteria:

* Not participating in at least a third of the sessions
* Not willing to continue cooperation.
Tranilast Plus Allopurinol in Patients With Moderate to Severe Gout (TAnGO)

This Phase 2 study will be a multicenter, double-blind, randomized, active-comparator study to evaluate the safety and efficacy of tranilast in combination with allopurinol in patients with hyperuricemia and moderate to severe gout.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 to 80
* Severe gout, demonstrated by 3 or more gout flares in the previous 12 months, or the presence of at least one gout tophus or gouty arthritis
* Hyperuricemia with a sUA ≥8.0 mg/dL

Exclusion Criteria:

* Pregnant or nursing
* Known hypersensitivity to any of the components of tranilast or allopurinol
* Known history of xanthinuria or kidney stones
* Use of an investigational drug within 30 days
* Presence of, or history of, cancer with the exception of completely excised, non-metastatic squamous cell and basal cell carcinomas of the skin
* Subject is planning or likely to require a surgical procedure during the study
A Prospective Cohort Study of Myasthenia Gravis in China

The goal of this prospective cohort study is to investigate long-term therapeutic strategies for myasthenia gravis (MG) and identify potential biomarkers. The main questions it aims to answer are:

1. Whether low-dose oral steroids may lead to a reduction in the recurrence rate among patients with MG.
2. To identify potential biomarkers that can predict disease progression and prognosis.

This study recruits well-controlled patients with MG. Based on patient preferences and considerations such as coexisting conditions (e.g., uncontrolled hypertension, diabetes, severe osteoporosis, obesity), the participants will be non-randomly divided into two groups: a maintenance steroid therapy group and a withdrawal group (withdraw all immunosuppresants). Subsequently, these groups of patients will undergo long-term follow-up assessments.


Eligibility Criteria:
Inclusion Criteria:

* 1: Attended the outpatient department of neurology of PUMCH from 9/30/2022 to 9/30/2024.
* 2: Diagnosed as myasthenia gravis.
* 3: Follow-up time at PUMCH\>6 months.
* 4: The patient understood and signed the informed consent form.

Exclusion Criteria:

* 1: Comorbidities with other conditions that cause skeletal muscle weakness make the clinical symptoms difficult to assess
* 2: Records related to comorbidities and medications were not available at baseline and during follow-up.
The Relationship Between Drainage Fluid and Anastomotic Leakage After Colorectal Cancer Surgery

A prospective and analytical study on the detection of early anastomotic leakage by abdominal drainage fluid after colorectal cancer surgery. pay attention to indicators including bilirubin


Eligibility Criteria:
Inclusion Criteria:

1) Preoperative pathologically confirmed colorectal adenocarcinoma; 2) Patients undergoing minimally invasive (robot or laparoscopic) tumor resection + bowel anastomosis; 3) Age: 18 to 80 years old; 4) Preoperative TNM staging (whole abdomen) Enhanced CT or MRI, laparoscopic exploration): cT1-3bN0-2M0; 5) Preoperative ASA score: ≤Ⅲ; 6) No history of malignant tumors and no other malignant tumors by preoperative examination; 7) Not accepted before surgery Deterministic treatment, such as radiotherapy, chemotherapy or immunotherapy; 8) No pre-existing ascites was found before and during the operation; 9) Informed consent signed by the patient or his agent

Performance status (ECOG) 0\~1

Exclusion Criteria:

1) Patients with obstructive jaundice or other congenital disorders of bile acid synthesis and metabolism; 2) Severe abdominal cavity infection and other infections; 3) A large amount of abdominal effusion was found before and during the operation; 4) Tumor was confirmed during the operation For T4b or intraoperative detection of other tumors, joint resection or distant metastasis is required; 5) Intraoperative conversion to laparotomy; 6) Intraoperative change of surgical method to perform Miles or Hartmann surgery; 7) Intraoperative and postoperative abdominal cavity Hyperthermic perfusion chemotherapy.
A Study in Adult Subjects With Select Advanced Solid Tumors

To evaluate the safety and tolerability of MEDI1873 in adult subjects with selected advanced solid tumors.

This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm dose-escalation study of MEDI1873 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and anti-tumor activity in adult subjects with advanced solid tumor malignancies

Eligibility Criteria:
Inclusion Criteria:

* All subjects must consent to provide archived tumor specimen
* Subjects must have histologically or cytologically confirmed advanced solid tumor for recurrent or metastatic disease.
* At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must have been treated and must be asymptomatic
* Willingness to provide pretreatment and on-treatment biopsies.
* Adequate organ function
* Females of childbearing potential and nonsterilized males who are sexually active must use effective methods of contraception

Exclusion Criteria:

* Known allergic reaction to any component of MEDI1873
* Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
* Receipt of any anticancer therapy within 4 weeks prior to the first dose of MEDI1873; in the case of mAbs, 6 weeks prior to the first dose of MEDI1873
* Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
* Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational product
* Unresolved toxicities from prior anticancer therapy
* Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.
Supermicrosurgical LVA for Lymphedema Treatment

LVA orientations such as lymphaticovenous end-to-end (LVEEA), end-to-side (LVESA), and side-to-end (LVSEA) are commonly performed. Each orientation has its own advantages and disadvantages. The key factors affecting the type of anastomotic orientation are the sizes of the LVs and the RVs, and the relative distance between them. Most published literatures have focused on LVSEA2-9, which is considered to be the most efficient. With one anastomosis in LVSEA, the RV is able to drain both the antegrade and retrograde lymphatic flow. Nevertheless, how to determine the anastomotic orientation has remained ambiguous. In this study, we aimed to establish the basis of selecting the proper anastomotic orientation, based on the size and comparative size discrepancy between LV and RV. To the best of our knowledge, this is the first report to focus on this subject.


Eligibility Criteria:
Inclusion Criteria:

* lymphedematous lower limbs (International Society of Lymphology stage I-III) between March 2016 to October 2018 were included

Exclusion Criteria:

* Patients whose data were missing will be excluded.
Digital Behavioral Interventions in Inflammatory Bowel Disease

Given the bidirectionality between psychological distress and disease activity in inflammatory bowel disease (IBD), whereby increased psychological distress exacerbates disease activity and vice versa, psychosocial aspects of IBD care are receiving increased attention. However, proposed interventions are generally resource-intensive and have been tested in majority white populations. While people of color are an increasing segment of the IBD population, they are currently underrepresented in research studies. The purpose of this study is to evaluate the efficacy and implementation of internet-based cognitive behavioral therapy (iCBT) among IBD patients of color with elevated psychological distress.

The investigators propose a 1:1 randomized trial design to evaluate the efficacy of iCBT among a population of Black and Latinx IBD patients and to assess factors influencing its implementation. Patients within the integrated health system at Montefiore Medical Center will be actively recruited and screened to identify those with elevated psychological distress.

Eligible patients will be randomized to receive 8 weeks of iCBT or digital mood tracking to evaluate the effect of iCBT on levels of psychological distress, HRQoL and disease activity post-intervention. The investigators will also evaluate individual process level barriers and facilitators to iCBT implementation via surveys and semi-structured interviews.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* race/ethnicity self-identified as Black/African American or Hispanic/Latino
* established diagnosis of Crohn's disease or ulcerative colitis
* elevated psychological distress: at least one T-score within two standard deviations above the mean in the domains of anxiety or depression on the National Institutes of Health Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) with or without a T-score within two standard deviations above the mean for perceived stress on the National Institute of Health Toolbox Perceived Stress Scale (Perceived Stress Scale)
* internet access (smartphone/mobile device with data plan, computer with internet)
* ability to provide informed consent in English or Spanish

Exclusion Criteria:

* PROMIS-29 anxiety or depression T-scores in the severe range (above 2 standard deviations)
* Current suicidal ideation, past suicidal attempt or hospitalization
Establish Quantitative Measurements of Laryngeal Sensorimotor Functions and Evaluating the Grade of Phonation and Swallowing Impairment

Laryngeal motor and sensory nerve dysfunction may cause phonation and swallowing disturbance, which often happens after the treatment for laryngopharyngeal and esophageal cancer and may induce fatal complications such as aspiration pneumonia. By the conventional examinations, the tiny sensory or motor changes are hard to be detected before complete vocal paralysis. It is utmost important to establish a comprehensive quantitative method which is sensitive enough to evaluate the neuromuscular functions. The present project will evaluate the laryngeal nerve function by quantitative laryngeal electromyography, which was developed by the research team, and another novel examination technique, mucosal membrane sensation test. The comprehensive method is expected to grade the laryngeal nerve injuries quantitatively before the significant symptoms or complications and can also help to evaluate the treatment effect from medicine, rehabilitation or surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with laryngopharyngeal or esophageal cancer who have taken active therapy and are not neck tissue damage.
* Patients with clear conscious and stable mental status

Exclusion Criteria:

* Patients who cannot sit for longer than 30 minutes or received other vocal cord treatments before the selection
* Pregnant and breastfeeding women
* Patients with communication disorder
Integrative Approaches For Cancer Survivorship 2: Project 1

The purpose of this study is to develop and test a 12-month Integrative Medicine intervention based on Ayurvedic medicine in recent breast cancer survivors.

Cancer associated symptoms and impaired quality of life remain significant problems for patients despite advances in cancer treatment. Few effective treatment options exist for these symptoms. Integrative medicine is rising in popularity in the United States; however, few integrative medicine modalities have been rigorously studied. Ayurveda, a whole system of medicine that originated in the Indian subcontinent, has its own system of diagnostics and therapeutics, and among its strengths are wellness and prevention. The investigators aim to perform a prospective single arm clinical study of a manualized Ayurvedic approach in breast cancer survivors with impaired quality of life. Specifically, the investigators aim to refine the manualized Ayurvedic intervention; to assess feasibility; and to determine whether clinically meaningful effects can be achieved with the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Female breast cancer survivor who is over 1 month and less than 24 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy)
* Having received chemotherapy as part of their primary therapy for breast cancer
* Be in complete remission
* Aged 18 years or older
* Able to read, write, and understand English
* Karnofsky Performance Status (KPS) greater than or equal to 60
* Have impaired quality of life
* Ability to give informed consent

Exclusion Criteria:

* Having received Ayurvedic treatment within 6 months of study enrollment
* Receiving chemotherapy or radiotherapy at the time of study enrollment. Anti-her2 directed therapy is not exclusionary.
* Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary.
* Patients on adjuvant hormone therapy for less than 2 months
* Have surgery for breast cancer or breast reconstructive surgery planned during the initial 6 month study period. Smaller surgical procedures such as implant exchange are not exclusionary.
Interleukin-4 in Pityriasis Lichenoides Chronica

assessment of the level of interleukin 4 (IL-4) in the lesional skin and serum of PLC patients and compare its level with healthy controls.

measuring the level of Interleukin 4 in lesional skin and it's serum level using ELIZA in patients with Pityriasis lichenoides chronica and comparing the levels with healthy controls levels

Eligibility Criteria:
Inclusion Criteria:

* Patients with pityriasis lichenoides Chronica (PLC): either with the classical presentation papular or hypo-pigmented macules and patches that proved histopathologically to be PLC.
* Both genders
* Age group ≥ 8 years

Exclusion Criteria:

* Patients with other skin diseases
* Patient received treatment for PLC within period less than three months
* Pregnant patients
* Lactating patients
Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)

A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18 to 55 years, inclusive
* Good general health status
* Screening laboratory results within institutional normal range or Grade 1 abnormality if the Investigator documents clinical insignificance. Grade 2 laboratories may be permissible if considered not clinically significant by the investigator.
* For women who have not been surgically sterilized or who do not have laboratory confirmation of postmenopausal status, negative pregnancy test
* Willingness to practice a highly effective method of contraception
* Ability and willingness to comply with all aspects of the study, including nasopharyngeal swabs and blood and urine samples, through the entire study period

Exclusion Criteria:

* Subjects at increased risk of exposure to SARS-CoV-2, including healthcare workers, emergency response personnel, and those with known contact with COVID-19 patients
* Pregnant or lactating women or planning to conceive a child during the next 3 months
* Body mass index (BMI) \> 30.0 kg/m2
* Acute COVID-19, a positive test result for SARS-CoV2 infection, a positive SARS-CoV-2 serology for prior SARS-CoV-2 infection at screening, or exposure within 14 days to an individual with acute COVID-19
* An acute respiratory illness
* Positive result for HIV, hepatitis B virus, or hepatitis C virus at screening
* Chronic or current cigarette smoking
* Any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or a subject's ability to give informed consent
Iodine Status in Pregnant Women and Their Newborns: is Congenital Hypothyroidism Related to Iodine Deficiency in Pregnancy?

Iodine is an essential component of thyroid hormone, which is necessary for many metabolic processes as well as the maturation of the CNS. Deficiencies of iodine have deleterious effects on both pregnant women and infants. The iodine status of the population after implementation of the universal salt iodization program in Zhejiang province has not been known. This study was to determine whether pregnant women show evidence of iodine deficiency, and to examine the correlation between maternal urine iodine concentration and newborn thyroid function.

Iodine is an essential component of thyroid hormone, which is necessary for many metabolic processes as well as the maturation of the CNS. Deficiencies of iodine have deleterious effects on both pregnant women and infants. The iodine status of the population after implementation of the universal salt iodization program in Zhejiang province has not been known. This study was to determine whether pregnant women show evidence of iodine deficiency, and to examine the correlation between maternal urine iodine concentration and newborn thyroid function.

Healthy women at 12 weeks' gestation and over from four different areas in Zhejiang province were enrolled to participate this program from May 2007 to May 2010. Women consented to provide urine samples and salt samples during pregnancy (12, 16, 24 weeks' gestation and before delivery), and give permission to access their newborn's TSH value. Urinary iodine concentration (UIC) was determined by ammonium persulfate digestion microplate method, and TSH was determined by a time resolved fluoro-immunoassay (TRFIA). The diagnostic standard for congenital hypothyroidism was: TSH ≥ 20 mU/L and declined FT4 levels. Compare the correlation to effects with different level of iodine content in salt, maternal UIC and neonatal TSH. Investigate the optimal level of iodine content in salt in different areas in ZheJiang province.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in Zhejiang province (and their newborns)

Exclusion Criteria:

* Endocrine disease