louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04377139: Management of Cytomegalovirus (CMV) Infection in Lung Transplant Recipients (LTR)
Official title: Observational, Epidemiological, Retrospective Study of the Management of CMV Infection in a Cohort of Patients Receiving Lung Transplantation in Spain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Transplant; Complications
Keywords: cytomegalovirus
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All those LTR performed in Spain during the study period

Brief summary: Background: Lung transplant recipients (LTR) have the highest risk of CMV infection. CMV pneumonitis, lymphocytic bronchitis, and detection of CMV DNA in bronchoalveolar lavage fluid are independent risk factors for the development of chronic lung allograft dysfunction (CLAD). However, to demonstrate the clinical impact of the indirect effects of CMV, it is necessary to conduct studies with a very large sample size.

Hypothesis: The different current preventive strategies for CMV infection in LTR and their clinical application on a daily basis impact on the development of direct and indirect effects of CMV in this population.

Objectives: To study the effect of CMV infection on LTR in relation to current preventive strategies in terms of:

* The incidence of acute and chronic rejection
* The incidence of other opportunistic infections
* The incidence of neoplastic disease, especially, post-transplant lymphoproliferative disease
* Patient and graft survival Methods: Multicenter, retrospective, cohort study. Consecutive inclusion of all adult lung transplant recipients from 2013 to 2017 with 2 years of follow-up. The investigators will collect and analyze the main clinical and microbiological variables in order to respond to the objectives of the study.

Relevance: Knowing in detail the current epidemiology of CMV infection in LTR and its subsequent influence on both mortality and the presence of different complications, could allow improving the management of these patients in the future.


Eligibility criteria: Inclusion Criteria:

· Survival \> 1 month post-transplant

• High to moderate risk patients to develop CMV disease by means of pre-transplant CMV serology:

* Donor positive to recipient negative
* Recipient positive independently of donor serology

Exclusion Criteria:

* Survival \< 1 month after procedure
* Low risk serology to develop CMV disease: both donor and recipient seronegative

Primary outcomes:
measure: CMV infection and/or disease
timeFrame: Two-year follow-up
Secondary outcomes:
measure: Graft rejection both acute or CLAD
timeFrame: Two-year follow-up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02919839: Measuring and Predicting Glycemic Response to Food in Patients With Type 1 Diabetes
Official title: Measuring and Predicting Glycemic Response to Food in Patients With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Personalized Medicine in Type 1 Diabetes
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Weizmann Institute of Science
First posted: 2016-09-29
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 diabetes

Brief summary: Personalized medicine methods in the management of type 1 diabetes

Detailed description: This proposal joins together clinical practitioners, biologists, and computer scientists to set up the infrastructure for research that will facilitate, for the first time, the use of big-data, machine-learning approaches in the application of personalized medicine methods in the management of type 1 diabetes mellitus. We will model the clinical, microbial, and nutritional factors underlying the variability in glycemic response to food in this population; develop algorithms for prediction of this response and for the accurate administration of insulin, assisting the clinical management of the disease and discover intervention targets in the gut microbiome aimed at improving glycemic control.

Eligibility criteria: Inclusion Criteria:

over one year of diagnostic with T1DM.

Exclusion Criteria:

Drug related diabetes. genetical diabetes.

Primary outcomes:
measure: blood glucose
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Orit Hamiel, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Weizmann Institute of Science
name: Eran Segal, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shilo S, Godneva A, Rachmiel M, Korem T, Bussi Y, Kolobkov D, Karady T, Bar N, Wolf BC, Glantz-Gashai Y, Cohen M, Zuckerman-Levin N, Shehadeh N, Gruber N, Levran N, Koren S, Weinberger A, Pinhas-Hamiel O, Segal E. The Gut Microbiome of Adults With Type 1 Diabetes and Its Association With the Host Glycemic Control. Diabetes Care. 2022 Mar 1;45(3):555-563. doi: 10.2337/dc21-1656.
citation: Shilo S, Godneva A, Rachmiel M, Korem T, Kolobkov D, Karady T, Bar N, Wolf BC, Glantz-Gashai Y, Cohen M, Zuckerman Levin N, Shehadeh N, Gruber N, Levran N, Koren S, Weinberger A, Pinhas-Hamiel O, Segal E. Prediction of Personal Glycemic Responses to Food for Individuals With Type 1 Diabetes Through Integration of Clinical and Microbial Data. Diabetes Care. 2022 Mar 1;45(3):502-511. doi: 10.2337/dc21-1048.
Clinical trial NCT02977039: Effect of a Plant Rich Diet on in People With Type 2 Diabetes and Obesity
Official title: Effect of a Nutrient Dense Plant Rich Diet on Glycemic Control in People With Type 2 Diabetes and Obesity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus in Obese
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of a nutrient dense plant rich (NDPR) diet compared to a standard USDA diet on glycemic control, inflammation, and cardiovascular risk in individuals with type 2 diabetes and overweight/obesity.


Eligibility criteria: Inclusion Criteria:

1. Men and women ages 18-75
2. Type 2 diabetes mellitus diagnosed \> 6 months prior to screening visit according to American Diabetes Association criteria
3. HBA1c \>7.5% but \< 10%
4. BMI \>25 kg/m2 ; \>23 kg/m2 for Asian subjects but \< 45 kg/m2
5. Stable weight (variation \< 5 kg within 6 months of screening visit)
6. Ability to give informed consent
7. Ability to follow verbal and written instructions in English

Exclusion Criteria:

1. Active cardiac issues: history of myocardial infarction within 3 months of screening visit, unstable angina pectoris, or Class III or Class IV congestive heart failure
2. Persistent uncontrolled hypertension (BP \> 160/100 mmHg on or off antihypertensive medication)
3. Active marijuana or intravenous drug use
4. Recent weight loss (\> 5 kg within 6 months of the screening visit)
5. Inflammatory or irritable bowel disease (Crohn's Disease, Ulcerative Colitis, or IBS)
6. Celiac disease
7. Malignancy treated with chemotherapy within the past 1 year
8. Depression or psychosis requiring hospitalization within 1 year, or use of major antipsychotic or tranquilizer drugs (i.e. benzodiazepines)
9. Renal insufficiency (creatinine clearance \< 30 ml/min)
10. Transaminases \> 2x above the normal range
11. Pregnancy within 6 months of the screening visit
12. Lactation
13. History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling
14. History of alcohol abuse within the past 5 years
15. Vegetarian/Vegan diet
16. Dairy Allergy/Intolerance
17. Anemia, including iron deficient and megaloblastic
18. Vitamin B12 deficiency
19. Leber's disease

Primary outcomes:
measure: Glycemic control
timeFrame: change at 1, 3, 6, 9, 12 months
Secondary outcomes:
measure: body weight
timeFrame: change at 1, 3, 6, 9, 12 months
measure: body composition
timeFrame: change at 1,3,6,9, 12 months
measure: hepatic steatosis
timeFrame: baseline, 1, 3, 6, 9, 12 months
measure: inflammatory markers
timeFrame: change at, 1, 3, 6, 9, 12 months
measure: quality of life
timeFrame: change at, 1, 3, 6, 9, 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT01149239: The Effect of Preoperative Anxiety Level on the Induction Dose of Propofol and Minimum Alveolar Concentration (MAC) Hour of Sevoflurane During Thyroidectomy
Official title: The Effect of Preoperative Anxiety Level on the Induction Dose of Propofol and MAC-hour of Sevoflurane During Thyroidectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroidectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-06-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: female patients aged between 20-65 years and scheduled elective thyroidectomy

Brief summary: This study is to evaluate the level of anxiety, and to check the correlation of induction dose and the amount of sevoflurane to keep anesthetic depth in in female patients undergoing thyroidectomy.


Eligibility criteria: Inclusion Criteria:

* female patients (ASA physical status I and II) aged between 20-65 years and scheduled elective thyroidectomy

Exclusion Criteria:

* cardiovascular, renal, liver disease, or psychiatric disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
Study officials:
affiliation: Anesthesiology & Pain Medicine, Severance Hospital
name: Jeong-Yeon Hong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02815839: Single Dose Study of SHR4640 in Healthy Subjects
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of Single Doses of SHR4640 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout; Hyperuricemia
Keywords: urate transporter 1
SHR4640
single ascending dose
pharmacokinetics
pharmacodynamics
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess the safety, tolerance, food effect, pharmacokinetic and pharmacodynamic properties of single dose adminstration of SHR4640 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Body weight≥50, BMI:19-24kg/m2;
* Screening serum urate level ≤ 4.5 mg/dL for male and ≤ 3.5 mg/dL for female;
* Medically stable based on physical examination, medical history, laboratory results, vital sign measurements, and 12-lead electrocardiogram (ECG) at screening;

Exclusion Criteria:

* History of hyperuricemia or gout.
* Pregnancy or breastfeeding;
* History or suspicion of kidney stones;
* serum creatinine\>1.5mg/dl for male, \>1.2mg/dl for female;
* alanine aminotransferase and/or aspartate aminotransferase\>2 upper limit of normal, or total bilirubin\>2.5 upper limit of normal.

Primary outcomes:
measure: Adverse events
timeFrame: Clinical significant changes from baseline up to to Day 15; from baseline up to Day 19 for 7.5mg dose group
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: up to day 4; up to day 11 for 7.5mg dose group
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: up to day 4; up to day 11 for 7.5mg dose group
measure: Half-time (T1/2)
timeFrame: up to day 4; up to day 11 for 7.5mg dose group
measure: Time to the peak plasma concentration (Tmax)
timeFrame: up to day 4; up to day 11 for 7.5mg dose group
measure: Cmax of SHR4640 dosed after high-fat meal in 7.5mg dose group
timeFrame: up to day 11
measure: AUC of SHR4640 dosed after high-fat meal in 7.5mg dose group
timeFrame: up to day 11
measure: T1/2 of SHR4640 dosed after high-fat meal in 7.5mg dose group
timeFrame: up to day 11
measure: Tmax of SHR4640 dosed after high-fat meal in 7.5mg dose group
timeFrame: up to day 11
measure: Changes in serum uric acid concentration from baseline
timeFrame: up to day 4; up to day 11 for 7.5mg dose group
measure: Changes in urinary uric acid excretion from baseline
timeFrame: up to day 4; up to day 11 for 7.5mg dose group
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT02098239: Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.
Official title: An Open, Multiple Dose, Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Jaundice
Pancreatic Cancer
Lead sponsor: Cancer Advances Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-27
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The study was designed to assess the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advances pancreatic cancer.

Detailed description: Jaundiced patients with advanced pancreatic cancer (either locally, advanced or metastatic) were treated with G17DT either immediately (Group A), or following biliary stenting when jaundice had resolved (Group B). Patients not jaundiced at time of presentation were to enter Group B. Patients received 3 Intramuscular injections of G17DT at weeks 0, 1, and 3. A booster injection was offered to patients who had measurable anit-G17Dt antibodies but had anti-G17DT antibodies that fell below a pre-specified threshold after week 23. Patients were evaluated until study closure ort until patient death.

Eligibility criteria: Inclusion Criteria:

* Patients with a pancreatic adenocarcinoma (cytologically or histologically proven), not suitable for a potentially curative resection.
* If patients were jaundiced, bilirubin had to be \>80 μmol/L.
* Male or female patients over 18 years of age.
* World Health Organization (WHO) performance status of 0 to 2.
* Patients with a life expectancy of at least 8 weeks.
* Patients must have given written informed consent.

Exclusion Criteria:

* Patients undergoing a potentially curative resection.
* Jaundiced patients with a bilirubin value \<80 μmol/L.
* Patients not considered fit for endoscopic or percutaneous biliary stenting.
* Patients receiving any other anti-cancer therapy.
* History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the cervix.
* Females who were pregnant, planning to become pregnant, or who were lactating.
* Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study.
* Previous G17DT treatment.
* Haematological indicators:

Haemoglobin (Hb) \<10.0 g/dL. White cell count (WCC) \<4.0×109/L. Platelets \<100×109/L.

Primary outcomes:
measure: Pharmacodynamic
timeFrame: Weeks 0, 1,3,4,6,8,12, 16+
measure: Patient Survival
timeFrame: Up to week 139
Secondary outcomes:
measure: Injection Tolerability
timeFrame: Up to Week 16
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01996839: Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Official title: Loteprednol Etabonate Ophthalmic Gel, 0.38% (BID and TID) Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammation
Pain
Cataract
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2013-11-27
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel

Detailed description: The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel, 0.38% (BID and TID) for the treatment of postoperative inflammation and pain following cataract surgery.

Eligibility criteria: Inclusion Criteria:

Visit 1 (Screening Visit)

* Be willing and able to comply with all treatment and follow-up/study procedures.
* Be a candidate for routine, uncomplicated cataract surgery

Visit 3 (Postoperative Day 1)

* Have undergone routine, uncomplicated cataract surgery (phaco- emulsification with posterior chamber IOL implantation, not combined with any other surgery) in the study eye.
* Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.

Exclusion Criteria:

* Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
* Have known hypersensitivity or contraindication to the study drug(s) or their components.

Primary outcomes:
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells
timeFrame: 8 days
measure: Percentage of Participants With Grade 0 Pain in the Study Eye.
timeFrame: 8 days
Secondary outcomes:
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit
timeFrame: 18 days
measure: Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.
timeFrame: 18 days
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.
timeFrame: 18 days
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.
timeFrame: 18 days
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Bausch & Lomb Incorporated
state: New Jersey
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Jon I Williams, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02152839: The Implementation of Novel 'Heavy' Water Techniques for Determining Modulation of Muscle Protein, DNA and Lipid Synthesis Due to Ageing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Physiological Society
First posted: 2014-06-02
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Maintenance of body's skeletal muscle is key to a healthy older age. However, as we age we lose on average 1-2% of our muscle each year. In order to slow this loss we need to understand fully the mechanisms regulating muscle mass with ageing. In this project we aim to determine these mechanisms using a new novel technique of 'heavy' water ingestion, which will allow us to measure multiple aspects of skeletal muscle mass control during normal everyday activities in young and old individuals over a period of 6 weeks. We will also determine the influence of resistance exercise training during this period in offsetting declines in muscle with ageing using this method


Eligibility criteria: Inclusion Criteria:

* Young (18-30y) and old men (65-75y) who are generally healthy and recreationally active

Exclusion Criteria:

* Active cardiovascular disease
* Cerebrovascular disease including previous stroke, aneurysm (large vessel or intracranial)
* Respiratory disease including pulmonary hypertension or COPD
* Hyper/ hypo parathyroidism, hyper/ hypothyroidism, Cushing's disease, diabetes
* Active inflammatory bowel disease
* Renal disease
* Malignancy
* Recent steroid treatment (within 6 mo), or hormone replacement therapy
* Clotting dysfunction
* Musculoskeletal or neurological disorders
* Any disease requiring long-term drug prescriptions, including statins

Primary outcomes:
measure: Muscle Protein Synthesis
timeFrame: 0-6 Weeks
Secondary outcomes:
measure: Muscle Sub fractions
timeFrame: 0-6 week
Other outcomes:
measure: Muscle Functions
timeFrame: 0-6 Weeks
Locations:
city: Derby
country: United Kingdom
facility: Royal Derby Hospital Medical School
Study officials:
affiliation: University of Nottingham
name: Philip Atherton, PhD, AFHEA
role: PRINCIPAL_INVESTIGATOR
References: