cyrilzakka/clinical-trials huggingface dataset:
Interrupting Sedentary Time to Improve Cardiometabolic Health and Toxicity in Patients With Lymphoma Receiving Chemotherapy: The iSTAND Trial

This study aims to see if a 12-week exercise program designed to reduce long periods of inactivity is feasible in newly diagnosed lymphoma participants receiving R-CHOP or POLA-R-CHP chemotherapy treatments, and whether it can improve heart health and reduce chemotherapy drug side effects.

The purpose of this study is to see if a 12-week exercise program designed to reduce long periods of inactivity is feasible in newly diagnosed lymphoma participants receiving R-CHOP or POLA-R-CHP chemotherapy treatments, and whether it can improve heart health and reduce chemotherapy drug side effects.

Participants will be randomized into one of two groups: Group A: Interrupted Sedentary Time Intervention vs. Group B: Usual Care Control Group. Randomized means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, assessments of fitness and physical health, blood tests, and questionnaires.

Participation in this research study is expected to last about 3 months.

It is expected that about 24 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and the willingness to sign informed consent prior to any study- related procedures.
* Patients diagnosed with lymphoma.
* Will receive first line R-CHOP or POLA-R-CHP chemotherapy regimens, patients do not need to be within a certain timeframe from diagnosis.
* Aged ≥18 years; due to the rarity of the disease in those \<18 years, this age bracket will not be included.
* Engaging in ≤60-minutes of structured moderate or vigorous intensity exercise.
* Have physician clearance to participate in exercise.
* Speak English.
* Willing to travel to Dana-Farber Cancer Institute for necessary data collection and exercise sessions.
* Access to a phone that can receive text messages.

Exclusion Criteria:

* Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities likely require supervised exercise for safety, and part of this study involves unsupervised exercise; therefore, for safety reasons, these persons are excluded.
* Participate in more than 60 minutes of structured moderate-to-vigorous exercise per week over the last month. Excess additional exercise is a confounding factor in assessing the effect of the current interrupted sedentary time intervention.
* Patients receiving treatment for other active malignancies (except basal cell carcinoma). This study is exclusively targeting lymphoma chemotherapy-related effects.
* Subjects who in the opinion of the investigators may not be able to comply with the safety monitoring requirements of the study.
* Unable to travel to DFCI Longwood campus for necessary data collection and chemotherapy infusions.
A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC

This is an open-label, single arm, multicenter, Phase 2a study evaluating the efficacy, safety, and tolerability of MORF-057 in adult patients with Moderately to Severely Active Ulcerative Colitis (UC)

The main part of this Phase 2a study will consist of 3 study periods: a Screening Period, a Treatment Period and a Safety Follow-up Period. All participants who complete the open-label Treatment Period will have the opportunity to continue their treatment in an optional 26-week Long-term Extension study after completing the Week 52 assessments.

Eligibility Criteria:
Inclusion Criteria:

* Has signs/symptoms of moderately to severely active UC for at least 3 months prior to Screening
* Has evidence of UC extending at least 15 cm from the anal verge
* Is bio-naïve or had an inadequate response, loss of response, or intolerance to other UC drugs
* Agrees to abide by the study guidelines and requirements
* Capable of giving signed informed consent

Exclusion Criteria:

* Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn's disease
* Has positive findings on a subjective neurological screening questionnaire
* Has a concurrent, clinically significant, serious, unstable comorbidity
* Primary non-responder to vedolizumab or other integrin inhibitors
* Participation in any other interventional study or received any investigational therapy within 30 days
* Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057
* Unable to attend study visits or comply with study procedures
Prenatal Exposure to Emerging Contaminants and Children's Atopic Dermatitis

This prospective cohort study aims to investigate the association between prenatal blood levels of Emerging Contaminants and the five-year incidence of atopic dermatitis (AD) in offspring.

This prospective birth cohort study, conducted within the Shanghai prenatal population, involves the collection of maternal blood samples during gestation to directly measure the biological exposure levels of Emerging Contaminants, including Per- and Polyfluoroalkyl Substances (PFAS), Organophosphate Flame Retardants (OPFRs), and Microplastics. Serum and whole blood levels of these contaminants are evaluated during pregnancy at 12-14, 22-26, and 31-34 gestational weeks. Subsequently, the study assesses skin barrier function in infants at 24-48 hours, 42 days, and 6 months of age. During a five-year period, the occurrence of atopic dermatitis (AD) in offspring is assessed. The objectives of this cohort study are twofold: (1) to elucidate the relationship between maternal exposure to Emerging Contaminants and the development of AD in offspring, and (2) to evaluate the impact of such exposure on the skin barrier function of infants. This research aims to provide substantial evidence for the prevention of AD, offering a unique and meaningful approach to mitigating the incidence of AD.

Eligibility Criteria:
Inclusion Criteria:

* Mother plans to proceed prenatal care and delivery in Minhang Maternal and Children Health Care Hospital
* 12-14 weeks of singleton pregnancy, non-stillborn or miscarrying, offspring without familial hereditary skin diseases
* Offspring plans to stay in Shanghai until 5 years and proceed follow-up at the Dermatology Department of Children's Hospital affiliated with Fudan University
* signed informed consent.

Exclusion Criteria:

* Multiple pregnancies
* perinatal death
* a fetus with congenital skin or appendages disorders
Does Early Weight Loss Following Laparoscopic Sleeve Gastrectomy Affect Long-term Outcomes

A study to explore the relationship between early weight loss in the 4 weeks following laparoscopic sleeve gastrectomy and outcomes, in terms of weight loss and comorbidity improvement, 7 years following the surgery.

Patients who underwent laparoscopic sleeve gastrectomy in the 6 month period between 01/04/2012 and 01/10/2019 were identified. For those meeting the inclusion criteria, demographic and medical data was extracted from hospital notes. This included initial BMI and the presence of, or treatment for, diabetes or hypertension.

Using the contact details available in the medical records, a scripted telephone interview was performed. The current weight of the patient as well as a current medical and drug history were elicited. This data was compared with data attained during initial patient interaction with the service.

Early weight loss, defined as weight lost in the 4 weeks following surgery, was subsequently correlated with outcomes in terms of weight loss and improvement/resolution of either hypertension or diabetes at a 7 year follow up interval.

Eligibility Criteria:
Inclusion Criteria:

* LSG performed must have been the first surgical procedure performed for that the patient had undergone to treat their obesity
* Have not undergone any further bariatric surgical procedures since the index operation
* Still be alive at the time of the study
* Have correct be contactable with the contact details present available in the electronic database

Exclusion Criteria:

* Missing data
* Uncontactable
* Unwilling to participate
Place of Glycation in Diabetic Retinopathy

1. Definition: Diabetic retinopathy is a microangiopathic complication of diabetes diabetes mellitus. Its pathophysiology includes glycation and intracellular hypoxia. Diabetic retinopathy (DR) is a microvascular complication of diabetes. It is the leading cause of It is the leading cause of blindness and visual impairment in people under the age of 60 in industrialized countries.

   Chronic hyperglycemia during diabetes plays a major role in the occurrence of diabetic diabetic retinopathy by promoting protein glycation and the accumulation of glycation end products (GTPs). GTPs are a heterogeneous group of compounds resulting from non-enzymatic and irreversible reactions between reducing sugars and amine groups of biological molecules such as proteins, lipids or nucleic acids.
2. Interest: The aim of our work is to describe the mechanisms by which glycation participates in the pathophysiology of diabetic retinopathy and to discuss the use of AGEs as biomarkers in this biomarkers in this pathological context and the therapeutic means that limit the toxicity of of AGEs.

The study is designed through a retrospective and prospective observational study to establish the of glycation in the occurrence of diabetic retinopathy. It will describe the demographic demographic profiles, glycemic control, clinical and paraclinical status of patients with diabetic diabetic retinopathy and will evaluate the relationship between glycation and diabetic retinopathy as well as the factors that influence this glycation in these patients, and induce the occurrence and / or of diabetic retinopathy. The data collected will allow to improve the knowledge, the diagnosis and the treatment of diabetic diabetic retinopathy, as well as a good management of the patients who should benefit from a more individualized and individualized and adequate treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients type 1 and type 2, of both sexes, and of all ages. Regular follow-up

Exclusion Criteria:

* Other types of diabetes. Irregular follow-up.
Human Composite Facial Allotransplantation

Allotransplantation of maxillofacial of subject with severe facial deformities due to traumatic events.

A facial transplantation is a highly dynamic, prolonged operation requiring teams communicating seamlessly through its duration. This is similar to complex solid organ transplant teams at Methodist Transplant Institute. The Institute's clinical experience in management of complex facial defects and deformities along with the personnel and infrastructure at Methodist Dallas transplant institute would help develop a center for Facial Allotransplantation. The team experience, true collaboration, creativity and a unique approach to each patient would help provide the optimal care and reconstruction for the face allotransplant patient both before and after surgery.

The purpose of this study is centered on the advancement of a safe and effective procedure for Facial Allotransplantation at Methodist Hospital Medical Center at Dallas. Composite tissue allotransplantation for facial reconstruction is in its infancy as liver transplantation was 30 years ago when the first liver transplant was completed in Texas. This study will establish Methodist Hospital System as a center for Facial Allotransplantation for reconstruction of extensive facial defects resulting in functional loss and poor quality of life.

Patient participation post transplantation will either be for life, or failure of the composite tissue allograft. Patient enrollment will be initiated immediately after the IRB approval. The enrollment period will be completed after the patient receives the final transplant, and the study will be completed at 24 months after the final transplant. However, all patients enrolled into the study will have lifelong follow up with immunosuppressive management, psychological support, and evaluation of functional recovery per protocol.

Eligibility Criteria:
Inclusion Criteria:

* Between ages 18-70 years
* Must be willing to undergo major facial reconstruction
* Be able to understand the pre and post-transplantation evaluation, physical therapy, and follow up procedures
* Conventional reconstruction deemed unsatisfactory

Exclusion Criteria:

* Medically unable to provide consent
* Active infections such as Human Immunodeficiency Virus, mycobacteria, hepatitis B, and hepatitis C
* Recent history of alcohol or IV drug or chemical dependency
* Psychiatric evaluation that indicate mental instability or non-compliance
* Cognitively impaired and Terminally ill
* Women of child bearing age with intent to conceive, pregnant or lactating
* Unable to receive immunosuppression after transplantation because of either geographic or financial limitations
* End stage organ disease (renal failure, Congestive Heart Failure (CHF), Chronic Obstructive Pulmonary Disease (COPD), etc.)
* Chronic infections such as osteomyelitis
Safe Discharge in Lower Gastrointestinal Bleeding

The increasing incidence in lower gastrointestinal bleeding (LGIB) leads to a rise in hospital admission. Many LGBI are self-limiting thus the several scores to identify low risk patients suited to outpatient care have been described. We aim to compare two of this scores (Oakland score and SHA2PE score) in terms of performace to predict "safe discharge" from the emergency department.

The growing incidence of lower gastrointestinal bleeding (LGIB) is leading to a rise in hospital admissions even though most LGIB episodes are self-limiting. The Oakland and SHA2PE scores were designed to identify patients best suited to outpatient care. Our aim is to validate the SHA2PE score and compare both of these scores in terms of predictiveness of safe discharge.

We conducted a retrospective observational study of LGIB patients admitted to our hospital between June 2014-June 2019. During this period, data from all LGIB episodes admitted from the ED were collected in an electronic anonymized database created specifically for this study. If any of the principal variables or critical information was missing, the patient was excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* All \> 18 year old patients, male and women, admitted to our hospital between June 2014 and June 2019 because of LGIB (lower gastrointestinal bleeding).

Exclusion Criteria:

* Patients in whom LGIB occurred while already admitted for an other cause.
* Patients with LGIB transferred from another hospital due to comorbidities or severity of the gastrointestinal bleeding episode.
* Patients with post-polypectomy LGIB (endoscopic polypectomy \<14 days before admission).
* Patients with gastrointestinal bleeding of unknown origin after a complete study.
* Patients who had undergone digestive tract surgery in the previous month.
* Patients with an ostomy.
* Patients with known colorectal cancer who had not undergone surgery.
Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process

This trial is conducted in Europe. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Caucasian
* Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
* Fasting blood glucose below or equal to 6 mmol/L
* Body mass index (BMI) 22.0-27.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Participated in another clinical study with an investigational drug within the last 4 weeks
* Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable
* Known or suspected allergy to the trial product or related products
* Family history of type 2 diabetes
Adding Atomoxetine To Standard Medication Treatment In Patients With Alzheimer's Disease

This study will compare atomoxetine to placebo when taken with current standard Alzheimer's Disease medications. The treatment will take approximately 6 months and it is hypothesized atomoxetine will significantly improve cognitive performance as compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patient presents with Alzheimer's Disease based on clinical history.
* Patient must have a Mini Mental Status Score between 10 and 26.
* Patient must have a reliable caregiver in frequent or daily contact with the patient.
* Patient must be currently treated with and on a stable dose of a standard Alzheimer's drug treatment for at least 3 months.

Exclusion Criteria:

* Patients who are receiving pharmacologic treatments (other than a cholinesterase inhibitor or memantine) for Alzheimer's Disease.
* Patients who have a history in the past 5 years or any current evidence of major psychiatric illness.
* Patients who have narrow angle glaucoma.
* Patients who are experiencing clinically significant urinary hesitancy or retention as assessed by a physician.
Clinical Study of the Solo Tympanostomy Tube Device

The objective of this study is post-approval evaluation of the safety and performance of the Solo Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure

The study will be a multi-site, prospective, treatment-only study of the Solo Tympanostomy Tube Device. Patients will already have a scheduled tympanostomy procedure.

Eligibility Criteria:
Inclusion Criteria:

* Listed for bilateral tympanostomy tube insertion

Exclusion Criteria:

* Anatomy that precludes sufficient visualisation of both the left and right eardrum
* Narrow ear canals
* Anatomy that precludes safe access to both the left and right eardrum
* Membrane \>25% sclerosis
* Congenital or craniofacial abnormalities
* No available baseline audiometry and tympanometry
The Severity of Newly Diagnosed Asthma Patients and the Result of Initial 12 Weeks Treatment in China

The primary objective of the NIS is to evaluate the severity of newly diagnosed asthma patients based on Global Initiative for Asthma (GINA) severity category (GINA 2006 update).

This is a multi-centre, prospective non-interventional study planned to be conducted in China. The study aims to recruit about 5000 newly diagnosed patients from about 50 tier 3 hospitals with respiratory department. Each site recruits about 50-150 patients.

The primary variable will be distribution of severity based on GINA definition (GINA 2006 update) at baseline in the total population.

There will be 4 visits for this study, Informed consent and following study procedures (ACQ-5(asthma control questionnaire), severity assessment) will be done at visit 1. After that, according to clinical practice in China patients usually go to the clinic every 4 weeks. Asthma control status, ACQ-5 and sever exacerbation will be assessed at each clinic visit till 12 weeks (visit 2, 3, 4).

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed asthma patients who are not on inhaled gluococorticosteroid within 3 months.
2. Out-patient with an age of 18 years and above
3. Signed and dated informed consent The prescription of the medicinal product is clearly separated from the decision to include the subject in the NIS. Generally, asthma medication refers to those recommended in GINA guideline (GINA2012 update) and decided by investigator.

Exclusion Criteria:

1. Participating in any clinical trial during the last 90 days
2. Have COPD
3. With asthma exacerbation
Myocet, Docetaxel & Trastuzumab as 1st Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer

To study the pharmacokinetic profile of the therapeutic schedule in order to demonstrate absence of negative interactions among the 3 drugs administered

1. To assess the maximum tolerated dose (MTD) of Myocet at different dosages in combination with Taxotere at the fixed dose of 35 mg/m2 on day 2 and 9 every 21 days and weekly Herceptin as first line therapy in patients affected by HER-2/neu positive metastatic breast cancer
2. To enhance the proportion of complete remission
3. To allow the feasibility of the combination of Herceptin with both Myocet and Taxotere without an enhanced risk of cardiotoxicity

Eligibility Criteria:
Inclusion Criteria:

* HER-2/neu overexpression assessed by FISH test or with immunohistochemical methods: Dako(the result must be 3+ with dakotest); if the immunohistochemical test results 2+ it is needed a positive FISH test
* Female \< 70yrs
* Histologically or cytologically proven breast cancer.
* Metastatic or locally advanced breast cancer (clinical stage: III-IV)
* Adequate hematological, hepatic, renal and cardiac function, the latter confirmed by echocardiography with FEVS ≥50%
* Prior adjuvant chemotherapy if doxorubicin total dose ≤300 mg/m2, epirubicin total dose ≤450 mg/m2

Exclusion Criteria:

* History of cardiopathy
* Severe hepatic and renal diseases
* Brain metastases as the only parameter of disease
* Contraindication to the use of corticosteroids as premedication
* Acute infectious diseases
* Insulin-dependent diabetes
* History of other cancers except for adequately treated basal cell skin cancer or in situ carcinoma of the cervix
* Concurrent treatment with any other cancer therapy
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids

This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated written informed consent prior to any study-specific procedures.
2. Adults aged 18-75, inclusive when signing the informed consent.
3. Documented physician-diagnosis of asthma for at least 12 months.
4. Treated with medium or high dose ICS in combination with LABA.
5. Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 .
6. Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal.
7. Documented exacerbation history in the last 12 months and biomarker requirements of:

   1. 2 severe exacerbations OR
   2. 1 severe exacerbation and:

   (i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb
8. Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.
9. Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test.
10. Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

1. Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1.
2. Clinically significant pulmonary disease other than asthma .
3. Current smokers, former smokers with \>10 pack-years history.
4. Clinically significant aortic stenosis or pulmonary arterial hypertension.
5. Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease.
6. Unstable cardiovascular disorders.