cyrilzakka/clinical-trials huggingface dataset:
Effect of a Modified 5:2 Intermittent Fasting Diet on Population With Overweight or Obesity in China

This study aimed to investigate the effects of the modified 5:2 IF dietary intervention on the Chinese population with overweight or obesity based on a self-controlled clinical trial.

There are fewer studies on the influence of dietary interventions on the Chinese populations with obesity, and the degree of obesity, body fat distribution, dietary pattern and structure, and metabolic status of populations with obesity are different between the Chinese and European populations. The effects of a 5:2 IF dietary intervention on the Chinese population with overweight or obesity are unclear. Therefore, this study aimed to investigate the effects of the modified 5:2 IF dietary intervention on the Chinese population with overweight or obesity based on a self-controlled clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. participants aged 18 to 60 years
2. participants with a body mass index (BMI) ≥ 24 kg/m2
3. participants engaged in light physical labor and their weight was relatively stable.

Exclusion Criteria:

1. participants taking any medication with an effect on body weight in the three months prior to enrollment;
2. participants with liver or kidney dysfunction (liver enzymes ≥ 2 times normal; blood creatinine \> the upper limit of normal);
3. participants with a history of cardiovascular disease (e.g., coronary heart disease, stroke);
4. participants with malignant tumors;
5. women during pregnancy or breastfeeding;
6. participants deemed unsuitable by the investigator to participate in this trial.
Multiple Dose Ethnobridging PK Study in Healthy Subjects

A Phase 1, double blind, placebo controlled, 4 cohort, multiple dose study in healthy adult Japanese and Caucasian subjects.


Eligibility Criteria:
Inclusion Criteria:

For All subjects:

* Male or female between 18 to 55 years old
* Female subjects must have documentation of a negative serum pregnancy test,
* Female subjects must be either of non-childbearing potential or if of childbearing potential use a highly efficient birth control method
* Male subjects must be vasectomized with documented medical assessment of the surgical success, or use acceptable contraception
* All male subjects must agree to refrain from sperm donation during the study and for at least 7 days after the last dose of study drug.
* Body Mass Index (BMI) 18 to 32 kg/m2, inclusive, and weighs at least 50 kg and less than 90 kg
* Willing and able to give informed consent
* Additional inclusion criteria apply

For Japanese subjects only:

* Subject must have been born in Japan, with 2 Japanese biological parents and 4 Japanese grandparents as confirmed by interview.
* Subject has lived no longer than 10 years outside of Japan.
* Subject had no significant change in lifestyle, including diet, since leaving Japan.

For Caucasian subjects only:

* Subject has 2 Caucasian biological parents and 4 Caucasian grandparents as confirmed by interview.
* Subject has lived no longer than 10 years outside of Europe and/or North America.

Exclusion Criteria:

For all subjects:

* Subject is a female who is pregnant, lactating, breastfeeding, or planning to become pregnant during the study or within 7 days after the last dose of study drug.
* Subject is a male who is planning to father a child during the study or within 7 days after the last dose of study drug.
* Is positive for hepatitis A, B or C, and/or HIV
* Has clinically significant abnormalities in baseline laboratory evaluations
* Subject has a clinically significant abnormal electrocardiogram (ECG)
* Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening or is currently participating in another trial of an investigational drug (or medical device) Additional exclusion criteria apply
Rebeccamycin Analog in Treating Patients With Advanced Kidney Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analog in treating patients who have advanced kidney cancer.

OBJECTIVES:

* Determine the response rate of patients with advanced renal cell carcinoma when treated with rebeccamycin analogue.
* Assess the quantitative and qualitative toxicities associated with this drug in this patient population.

OUTLINE: Patients receive rebeccamycin analogue IV over 30-60 minutes daily for 5 days. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 23-44 patients will be accrued for this study within 9-18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed locally advanced unresectable, locally recurrent, or metastatic renal cell carcinoma not eligible for a higher priority trial
* Measurable disease

  * Longest diameter at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan
* No nonmeasurable disease only including:

  * Bone lesions
  * Leptomeningeal disease
  * Ascites
  * Pleural/pericardial effusion
  * Lymphangitis cutis/pulmonis
  * Abdominal masses not confirmed and followed by imaging techniques
  * Cystic lesions
* No known brain metastases

  * History of brain metastases that have been resected and/or irradiated with subsequent normal brain CT scan allowed

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2 OR
* Karnofsky 60-100%

Life expectancy:

* Greater than 12 weeks

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* AST/ALT no greater than 2.5 times upper limit of normal

Renal:

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other prior malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of any site
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to rebeccamycin analogue
* No other concurrent uncontrolled illness (e.g., ongoing or active infection)
* No concurrent psychiatric illness or social situation that would preclude study compliance
* HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior biologic therapy allowed
* Recovered from toxic effects

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* At least 4 weeks since prior radiotherapy and recovered

Surgery:

* See Disease Characteristics

Other:

* No other concurrent investigational or commercial agents or therapies for renal cell cancer
Treatment of Patients With Nephrogenic Systemic Fibrosis With Glivec

The investigators will study the effect of imatinib mesylate (Glivec) in treatment of moderate to severe nephrogenic systemic fibrosis (NSF).

So far there is no evidence of adequately effective treatment options of NSF. Various treatments have been tried to stop the progressing disease. Corticosteroids, which suppress the early inflammatory stage of the disease, fail to halt disease progression.

Other immunosuppressive agents, photopheresis, and kidney transplantations are reported to be partly beneficial to the patients.

It has not been possible to confirm these findings in further studies because in photopheresis, and kidney transplantation, such effects are generally unreproducible.

NSF is a relatively newly defined fibrosing disease not described before 1997 where the Gadolinium-based contrast agents (GBCAs) were introduced in patients with kidney disease. The association between NSF and GBCA has in many studies shown to be very strong. Until recently, radiologists believed that commercially available GBCAs were safe to use whether the renal function was normal or not. Since the 1980s, \>200 million patients have been given these agents. Lately, the occurrence of NSF, a relatively new chronic disorder, has given serious speculations about the safety of these drugs and has questioned their future use. First identified in 1997, but not described until 2000, NSF has been reported only in patients with acute or chronic severe renal insufficiency (with a glomerular filtration rate \<30 ml/min/1.73 m2).

Fibrosis in the subcutis means that the skin hardens and loses flexibility. Hard dermal plaque changes often appear on legs, arms and abdomen together with dyspigmentation. As the lesions involve the deep part of the subcutis the muscles are often affected. Involvement of the joints leads to contractures and narrowing of movement. Patients with massive affection of the joints often end up with a zimmer frame or in a wheelchair. The connecting tissue in the inner vital organs may also be affected and NSF can accelerate the death of the patient. The retained gadolinium in lesions of NSF can be found years after administration.

Interestingly, a case report suggests beneficial effects of imatinib mesylate in two patients. Two other independent case reports also show promising results.

Imatinib mesylate inhibits several tyrosine kinases involved in the fibrotic reaction, which is one of the main pathogenetic components of NSF.

Eligibility Criteria:
Inclusion criteria:

1. Age \> 18 years
2. Diagnosed with NSF
3. mRodnan skin score =\> 20 or
4. Rapid progression of the disease defined as a 50% increase in mRodnan skin score in less than 7 weeks or
5. Progression of the fibrosis in the inner organs ex. the heart or the lungs, AND
6. No absolute contraindications to the treatment

Exclusion Criteria:

1. Known sensitivity to Imatinib mesylate or to any of its components
2. Pregnant or lactating woman
3. ALAT \> 3 x upper limit of normal
4. Severe congestive heart failure (NYHA Class III or IV)
The REST Study for CGM Use in Older Adults With Insulin-treated Diabetes

To assess the efficacy of the REST model in facilitating adoption and sustained use of CGM, in older adults with Type 1 diabetes (T1D) or Type 2 Diabetes (T2D) on complex insulin regimens. To examine barriers and enablers for the implementation feasibility of the REST intervention model using a mixed-methods approach. To assess the impact of REST model on economic factors and quality of life measures. The goal of this study is to facilitate the adoption of continuous glucose monitoring (CGM) in older adults (≥65 years) with diabetes mellitus (DM) on complex insulin regimens, and additionally, to build a framework for sustained CGM use over time using a novel patient-centered model - the REST model.

Older adults with diabetes on multiple insulin injections are at greater risk of hypoglycemia and its poor outcomes. Use of continuous glucose monitoring (CGM) has shown to improve glycemic control and reduce hypoglycemia in this age group. Despite Medicare coverage for CGM, uptake in this age group is still low. The goal of this study is to facilitate the adoption of continuous glucose monitoring (CGM) in older adults (≥65 years) with diabetes mellitus (DM) on complex insulin regimens, and additionally, to build a framework for sustained CGM use over time using a novel patient-centered model - the REST model. This model will assess Readiness and barriers to CGM initiation and utilization, provide remote Education, and implement a framework for Sustainability of CGM Technology adoption. The study will assess the impact of the REST model and its ability to increase CGM uptake and use in this age group, as well as its effectiveness on improving glycemic metrics. The study will also evaluate the impact of the REST model on economic and health-related quality-of-life measures.

Eligibility Criteria:
Inclusion Criteria:

* Older adults age ≥65 years
* T1D or T2D with duration longer than 1 year
* Insulin treatment includes: ≥3 insulin injections/day or on insulin pump therapy
* CGM naïve and/or CGM users (Dexcom G6) who are not meeting glycemic goals (per

CGM metrics):

* ≥4% hypoglycemia (sensor glucose ≤70 mg/dL) or
* time in range (70-180 mg/dL) TIR ≤40 %
* Willing to wear CGM Dexcom at all times while in the study
* Willing to use/carry personal or loaned smart phone device to use as Dexcom receiver for continual data upload to cloud

Exclusion Criteria:

* Life expectancy \<1 year
* End-stage renal disease (eGFR\< 30ml/min)
* On acetaminophen \>4 gr/day due to interference with Dexcom G6 sensor readings
* On hydroxyurea therapy due to interference with Dexcom G6 sensor readings
* Impaired vision and hearing which would interfere with participation in remote video visits
* Use of hybrid closed-loop systems (this may require different and additional focused education and will not be addressed in this study).
Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis (AS) Patients

This was a prospective mono-country, multi-center study of the frequency of extra-axial manifestations (EAMs) in Ankylosing Spondylitis (AS) participants treated with adalimumab in routine clinical practice.

A baseline assessment was performed prior to the first dose of adalimumab. Participants received 40 mg of adalimumab every other week for one year. Study visits were conducted at 12, 28, 36 and 52 weeks. All participants were to have one follow-up approximately 70 days after the last dose of adalimumab.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be ≥19 years of age
* Participant has been diagnosed with ankylosing spondylitis (AS) according to the 1984 modified New York criteria for at least 3 months
* Participant has active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥4, despite treatment with at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) or with disease-modifying antirheumatic drugs (DMARDs) for more than 3 months based on Korea AS reimbursement guideline
* Participant is eligible for adalimumab in daily rheumatologic practice
* Participant must provide written authorization form to use personal and/or health data prior to the entry into the study

Exclusion Criteria:

* Female participants who are pregnant or breastfeeding
* Participants who are contraindicated to any anti-tumor necrosis factor (TNF) agent
* Participant is enrolled in other clinical trials
Remotely Monitored and Coached Cardiac Rehabilitation Northern Sweden

Supervised exercise is an essential component of contemporary center-based cardiac rehabilitation (CR) programs. Despite the proven effectiveness, uptake and adherence to supervised exercise-based CR (exCR) remains suboptimal (approximately 50%), especially in rural and remote areas of Sweden. The main reasons for low participation rate in centre-based exCR are different accessibility barriers i.e. long distances, transportation problems or employment commitments. In this randomised clinical trial, the overall aim is to evaluate the effectiveness of, home-based, remotely monitored and coached exCR using the REMOTE-CR system compared to home-based exCR based on individualized information regarding current exercise recommendations but without monitoring and coaching (usual care) to improve exercise capacity. Our hypothesis is that remotely monitored and coached exCR will improve exercise capacity to a greater extent than home-based exCR without monitoring and coaching (usual care).


Eligibility Criteria:
Inclusion Criteria:

* Scheduled appointment with physiotherapist for follow-up after cardiac event: ----Myocardial Infarction (MI)
* Per cutaneous coronary intervention (PCI) due to MI or angina pectoris
* Open heart surgery due to coronary artery disease or valvar disease
* Living in the catchment area of Heart centre, University Hospital of Umeå.

Exclusion Criteria:

* Clinically unstable
* Postoperative infection
* Comorbidity affecting ability to participate in exCR
A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

This study is to verify the efficacy of 3.0 g/day of SA-001 in patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by pancreatectomy as compared with placebo under a double-blind design using the change in a coefficient of fat absorption as a primary endpoint.


Eligibility Criteria:
Inclusion Criteria

* Subjects with chronic pancreatitis in the non-compensatory stage or pancreatectomy
* Subjects whose CFA is 80% or less
* Subjects who are able to be hospitalized

Exclusion Criteria

* Subjects who are judged to be difficult to have at least 40 g/day of fat intake during course of the study
* Subjects who have a known allergy to porcine protein and/or any component of digestive enzyme preparations
* Subjects who are in the acute phase of chronic pancreatitis
* Subjects with non-pancreatic malabsorption syndrome
* Subjects with acute pancreatitis or ileus
Prevalence and Clinical Significance of Anti-annexin A2 Antibodies in COVID-19 Infection

In January 2020, researchers isolated and sequenced in China from patients with severe atypical pneumonia a novel coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 has rapidly spread throughout the world. SARS-CoV-2 may trigger hyperstimulation of immune system with an autoinflammatory response but also the development of an autoimmune process. These autoimmune responses may also develop through the molecular mimicry between virus and human-self components. Multiple autoantibodies have been described in COVID-19 patients.

Annexin A2 (ANXA2), an endothelial cell receptor for plasminogen and tissue plasminogen activator has been identified as a new autoantigen in antiphospholipid syndrome. ANXA2 has been identified as candidate autoantigen recognized by SARS patient sera. ANXA2 contributes also to pulmonary microvascular integrity. These data lead to identify anti-ANXA2 antibodies in COVID-19 patient sera and to know if the presence of these antibodies is associated with pulmonary injury or thrombosis in COVID-19 and represents a marker of severity.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* All patients hospitalized in Amiens University Hospital with COVID-19 infection

Exclusion Criteria:

* Autoimmune diseases
* Chronic viral infection by hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV)
* Immunosuppressive treatment
* Solid tumors
* Hematological malignancies
D-dimer to Establish Duration of Anticoagulation After Venous Thromboembolism

The optimal duration of oral anticoagulant treatment in patients with idiopathic venous thromboembolism is still uncertain. The present study addresses the possible role of the D-dimer test in assessing the need for continuation of anticoagulation.The study aims at assessing whether D-dimer assay may have a role in guiding the duration of anticoagulation in these patients

This is a multicenter prospective follow-up study in patients with a first episode of symptomatic idiopathic venous thromboembolism (proximal deep vein thrombosis and/or pulmonary embolism) who are treated with vitamin K antagonists (either warfarin or acenocoumarol) for a minimum of 3 months. Eligible patients who give informed consent are instructed to immediately stop oral anticoagulation and refrain from taking any other antithrombotic drugs until the next visit, scheduled after 30 days. At that visit, venous blood is sampled to perform D-dimer assay and thrombophilia tests. D-dimers are assessed using the Clearview Simplify D-dimer assay (Agen Biomedical Limited, Brisbane, Australia). Patients with normal D-dimer results do not continue anticoagulation, whereas those with elevated D-dimer results are randomized using a computer program to either stop or resume anticoagulation with vitamin K antagonists (INR 2.0-3.0). All patients are followed-up for 18 months. The study outcome are the composite of confirmed recurrent venous thromboembolism and major bleeding events. All suspected outcome events and all deaths are evaluated by a central adjudication committee whose members are unaware of the D-dimer and thrombophilia results and of the group assignments.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* After a first documented idiopathic proximal deep vein thrombosis and/or pulmonary embolism
* After at least 3 months of oral anticoagulation
* After written informed consent

Exclusion Criteria:

* If the Venous thromboembolism occurred:
* during pregnancy or puerperium
* after recent (i.e. within three months) fracture or plaster casting of a leg,
* after immobilization with confinement to bed for three consecutive days
* after surgery with general anesthesia lasting longer than 30 minutes
* Patients with:
* active cancer
* antiphospholipid antibody syndrome
* antithrombin deficiency
* serious liver disease or renal insufficiency (creatininemia \> 2 mg/dL),
* other indications for anticoagulation or contraindications for this treatment
* limited life expectation
* Patients who live too far from the clinical center
Treatment Use of Generex Oral-lyn™ in Patients With Diabetes

The objective of this Treatment IND protocol is to provide Generex Oral-lyn™ to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for treatment of diabetes, and who are not eligible to participate in the ongoing pivotal clinical trial (Protocol GEN-084-OL). This protocol is intended as a substitute for the Single Patient IND mechanism to obtain Generex Oral-lyn™.


Eligibility Criteria:
Study is closed
Feeding and Wellness Among Late Preterm Infants

1. The first aim of this proposal is to pilot the feasibility of weekly phone monitoring of infant feeding and illness patterns in a socio-economically and racially diverse population. Specifically, the investigators aim to estimate the rate of group loss to follow up from birth to 13 weeks (3 months) of age with weekly phone interview of mothers of late preterm (LPT, gestational age 34 0/7- 36 6/7 weeks gestation) infants.
2. The second aim is to describe breastfeeding and formula feeding practices, and rates of illness and post-discharge hospital care utilization, through age 13 weeks (3 months) among late preterm infants born at MacDonald Women's Hospital. The investigators estimate that the rate of exclusive breastfeeding among LPT infants at 3 months of age is less than the documented rate of 37% for all infants in Cuyahoga County.

Late preterm infants (LPT, gestational age 34 0/7 - 36 6/7 weeks) are the largest proportion of all preterm (less than 37 weeks gestation) infants. Recent evidence finds an increased risk of early post-discharge morbidity and re-hospitalization among LPT as compared to full term infants, which is linked to breastfeeding, specifically to early lactation failure and decreased breast milk intake. Accurate and inexpensive methods to collect data on rates of breastfeeding and early morbidity among LPT infants are critical to design, implementation and monitoring of effective interventions. This pilot study evaluates the feasibility of weekly phone calling in a racially and socioeconomically diverse population of mothers of LPT infants.

Eligibility Criteria:
Inclusion Criteria:

* Mothers of singleton LPT (late preterm, gestational age 34 0/7- 36 6/7 completed weeks) infants

Exclusion Criteria:

* Exclusion criteria for mothers include positive maternal drug screen for drug of abuse
* Age \< 18 years, or per caregiver discretion mother is not appropriate for study.
* Exclusion criteria for infants include custody under contention, positive screen for maternal drugs of abuse, or major congenital anomaly or congenital infection.