louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00833716: Effect of Renal Impairment on the Pharmacokinetics of NN9535
Official title: An Open-label Trial Investigating the Pharmacokinetics and the Tolerability of NN9535 in Subjects With Normal Renal Function and Various Degrees of Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Renal Impairment
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-02-02
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate how different degrees of renal impairment (mild, moderate, severe and end-stage renal disease) affect the pharmacokinetics of NN9535.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
* Subjects meeting the pre-defined GFR (glomerular filtration rate) criteria (estimated by the Cockcroft \& Gault formula) for any of the renal function groups
* Body Mass Index (BMI) equal to or less than 40kg/m2

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Renal transplanted patients
* Certain cardiac problems (heart failure, unstable angina, MI (myocardial infarction) within the last 3 months)
* Known current hepatic dysfunction or severe hepatic disease during the last 12 months
* Female of childbearing potential/breast feeding
* History of alcoholism or drug abuse
* Blood donation during the last 8 weeks prior to the study
* Past or current history of pancreatitis

Primary outcomes:
measure: AUC of NN9535
timeFrame: at 21 days
Secondary outcomes:
measure: Laboratory safety, adverse events
timeFrame: at 21 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Orlando
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Knoxville
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Marbury T, Flint A, Segel S, Lindegaard M, Lasseter K. Pharmacokinetics and tolerability of semaglutide, a once-weekly human GLP-1 analog, in subjects with and without renal impairment. Diabetes 2014; 63 (Suppl 1): A260 (abstract 1010-P)
citation: Marbury TC, Flint A, Jacobsen JB, Derving Karsbol J, Lasseter K. Pharmacokinetics and Tolerability of a Single Dose of Semaglutide, a Human Glucagon-Like Peptide-1 Analog, in Subjects With and Without Renal Impairment. Clin Pharmacokinet. 2017 Nov;56(11):1381-1390. doi: 10.1007/s40262-017-0528-2.
Clinical trial NCT01339416: HIV Cohort Study At Johns Hopkins University, University of North Carolina at Chapel Hill and Vanderbilt University
Official title: Clinical Adverse Events In HIV-Infected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
AIDS
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Johns Hopkins University
name: University of North Carolina, Chapel Hill
name: Vanderbilt University
name: Pfizer
First posted: 2011-04-20
Enrollment: 8202
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV infected patients seeking treatment at Johns Hopkins University, Vanderbilt University and University of North Carolina at Chapel Hill

Brief summary: Human Immunodeficiency Virus (HIV) infected patients in the HIV registries of Johns Hopkins University, University of North Carolina and Vanderbilt University will be followed in the routine clinical care to estimate the rates of prespecified clinical events in this population.

Detailed description: All patients identified in the HIV registries will be included without any sampling

Eligibility criteria: Inclusion Criteria:

* HIV infection.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Incidence Rate of Malignancies
timeFrame: Up to Week 626
measure: Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
timeFrame: Up to Week 626
measure: Incidence Rate of Myocardial Infarction
timeFrame: Up to Week 626
measure: Incidence Rate of Liver Failure
timeFrame: Up to Week 626
measure: Incidence Rate of Viral Encephalitis
timeFrame: Up to Week 626
Secondary outcomes:
measure: Incidence Rate of Rhabdomyolysis
timeFrame: Up to Week 626
measure: Incidence Rate of Death
timeFrame: Up to Week 626
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01626716: Collaborative Care for Depressed Elderly in Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Elderly
Korean
Collaborative Care
Lead sponsor: National Clinical Research Coordination Center, Seoul, Korea
Sponsor class: OTHER_GOV
First posted: 2012-06-25
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Late-life depression is associated with physical limitations, greater functional impairment, increased utilization and cost of health care, and suicide. Collaborative care, linking primary and mental health specialty care, has been shown to be effective for the treatment of late-life depression in primary care settings in Western countries. The primary aim of this project is to implement a depression care management intervention, and examine its effectiveness on the depressive symptoms of older patients in Korean primary care settings. Based on chronic disease management theory and previous Collaborative care management studies in western countries, we propose to test a Depression Care Management intervention,which includes care manager to support a primary care physician of depression in their old patients. Care manager'd role are monitoring the progress of treatment, supporting patient's adherence, educating patients/ family and facilitate communication between providers. Also psychiatrists provide consultation and supervision of care managers. Using a randomized controlled design, we will examine whether the Depression care management is an effective treatment for patients with late life depression in rural Korea. The primary outcome would be the improvement of depressive symptoms of patients in primary care setting.


Eligibility criteria: Inclusion Criteria:

* 60 year or older
* diagnosed depression based on DSM-IV criteria

Exclusion Criteria:

* impairment of hearing
* dementia
* other psychiatric disorders

Primary outcomes:
measure: Reduced depression symptoms
timeFrame: 3 months
Secondary outcomes:
measure: Depression response and remissionhealth related quality of life
timeFrame: 3months and 6months
measure: Reduced suicide ideation
timeFrame: 3 months and 6 months
measure: Improvement of Quality of life
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Chungju
country: Korea, Republic of
facility: Chungju community health care center
state: ChoongBuk
Study officials:
References:
Clinical trial NCT02972216: Post-marketing Surveillance Study of Docetaxel-Based Chemotherapy
Official title: A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of Docetaxel-Based Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonsmall Cell Lung Cancer
Squamous Cell Carcinoma of the Head and Neck
Lead sponsor: Yung Shin Pharm. Ind. Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Taichung Veterans General Hospital
name: National Cheng-Kung University Hospital
name: Tri-Service General Hospital
First posted: 2016-11-23
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 40 evaluable patients with locally advanced or metastatic NSCLC, SCCHN or esophageal cancer will be equally randomized to either Nolbaxol or Taxotere.

Brief summary: A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of Docetaxel-Based Chemotherapy


Eligibility criteria: Inclusion Criteria:

-Histologically or cytologically confirmed unresectable locally advanced NSCLC with progressed or recurred after no more than four previous docetaxel-free chemotherapy regimens, or unresectable locally advanced or metastatic SCCHN or recurred after previous docetaxel-free chemotherapy regimens

Exclusion Criteria:

1. Women who are nursing or pregnant during the study period;
2. Patients with carcinoid tumors, small-cell carcinoma of the lung;
3. A history of another malignancy within the last five years (except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the uterine cervix);
4. Any other morbidity or situation with contraindications for chemotherapy (e.g. active infection, myocardial infarction in the preceding 6 months);
5. Neutrophil counts \< 1,500 cells/mm3;
6. A history of hypersensitivity to docetaxel or cisplatin;
7. Symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias;
8. Subjects have active hepatitis;
9. Subjects are known positive for Human Immunodeficiency Virus (HIV);
10. Any condition judged by investigator, participates the study will jeopardize patient's wellbeing

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months.
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months.
measure: Adverse Events as a measure on safety
timeFrame: Adverse event will be evaluated during the study regimens treatment period and up to 8 weeks after the last dose of study regimen visit.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02175316: Enhanced External Counterpulsation on Delayed Onset Muscle Soreness
Official title: Effects of Enhanced External Counterpulsation on Delayed Onset Muscle Soreness, a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Tightness
Lead sponsor: David Grant U.S. Air Force Medical Center
Sponsor class: FED
First posted: 2014-06-26
Enrollment: 18
Sex: ALL
Minimum age (years): 25
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will evaluate the effects of Enhanced External Counterpulsation on delayed onset muscle soreness. The primary outcomes will be duration of delayed onset muscle soreness, WBC count, CRP count, CPK count, and pain tolerance.


Eligibility criteria: Inclusion Criteria:

* Healthy active Duty or DoD beneficiaries between 25 and 59 years old

Exclusion Criteria:

* Not on a physical profile
* Not taking any OTC or prescription pain medications or workout supplements

Primary outcomes:
measure: Change in delayed onset muscle soreness over time.
timeFrame: At 3, 6, 9, 12, 15, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 Hours
Secondary outcomes:
measure: Pain tolerance
timeFrame: Baseline, 24 hours, 2 days 3 days 4 days 33 days
measure: Bio-markers for muscle inflammation
timeFrame: Baseline, 24 hours, 2 days 3 days 4 days 33 days
Other outcomes:
Locations:
city: Travis Air Force Base
country: United States
facility: David Grant USAF Medical Center
state: California
Study officials:
affiliation: United States Air Force
name: Sachin Shah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02097316: Feasibility Study of the JewelPump Version 3
Official title: Feasibility Study of the JewelPump Version 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes
Keywords: Glycemic control
JewelPump accuracy
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
First posted: 2014-03-27
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will be conducted, in cross-over with a time interval of at least 2 days between 2 treatment periods. Patients will be randomized into 2 groups According to the order of the randomization, patients will bear the JewelPump for 5 days, followed by a period of 5 days of treatment with their usual pumps.

Detailed description: The JewelPump (Debiotech) will be compared to the conventional pumps. Patients will treated with the JewelPump during 5 days, and with their usual pump during 5 other days.

The study will be conduct with 15 patients at the following investigation centers : Corbeil Hospital, CHU of Strasbourg, and CHRU of Marseille.

Eligibility criteria: Inclusion Criteria:

* Patients type 1 diabetics treated by external insulin pump;
* Patients with HbA1c \< 8.5%
* Patients who signed consent

Exclusion Criteria:

* Patients type 2 diabetics
* Patients who have all serious diseases that could interfere with the study

Primary outcomes:
measure: Time spent in glycemic area 70-180 mg / dl, measured continuously for 5 days with a continuous glucose monitoring (CGM) DEXCOM G4
timeFrame: up to 5 days of each treatment period
Secondary outcomes:
measure: Time spent in the strict glycemic area 80-140 mg / dl
timeFrame: up to 5 days of each treatment period
Other outcomes:
measure: Time spent below 70 mg / dl
timeFrame: up to 5 days in each treatment period
measure: Time spent above 180mg/dl;
timeFrame: up to 5 days in each treatment period
Locations:
city: Evry
country: France
facility: Centre Hospitalier Sud Francilien
city: Marseille
country: France
facility: CHU Marseille-Hôpital Nord
city: Strasbourg
country: France
facility: CHU Strasbourg
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Sylvia FRANC, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Strasbourg, France
name: Nathalie JEANDIDIER, Pr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Marseille
name: Denis RACCAH, Pr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
name: Guillaume CHARPENTIER, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03689816: the Related Factors of Bariatric Surgery on Bone Mineral Density
Official title: The Impact of Bariatric Surgery on Estimated Bone Mineral Density in Chinese Obesity Patients: a Retrospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Mineral
Bariatric Surgery
Lead sponsor: First Affiliated Hospital of Jinan University
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Obesity and related metabolic diseases have become a chronic disease that is a threat to human health. Bariatric surgery can effectively and long-term reduce excess body weight and relieve related metabolic diseases, including type 2 diabetes. Laparoscopic gastric bypass surgery and laparoscopic sleeve gastrectomy are commonly used in bariatric surgery. Laparoscopic sleeve gastrectomy due to simple operation, good weight loss, and metabolic disease control effect, which is more widely used. However, there are several studies that show an increased chance of gastroesophageal reflux disease after laparoscopic sleeve gastrectomy. Long-term gastroesophageal reflux may lead to Barrett's esophagus or esophageal cancer. Nowadays, the cause of gastroesophageal reflux disease after sleeve gastrectomy is not clear and precautionary measures are not precise.

In this study, prospective randomized controlled trials were conducted to explore the possible causes of bone mineral after bariatric surgery and to explore ways to prevent bone mineral after bariatric surgery.


Eligibility criteria: Inclusion Criteria:

-For the choice of surgical approach, numerous studies have shown that BMI ≧ 45, the general choice of gastric bypass surgery, BMI \<45, you can choose sleeve gastrectomy. The remission rate for T2DM, sleeve gastrectomy has a good result for young patients with shorter duration. In our country, the BMI less than 45 is majorities.

Exclusion Criteria:

-BMI\<27.

Primary outcomes:
measure: Preoperative of bone density
timeFrame: Preoperative
measure: Postoperative of bone density at 3 months
timeFrame: 3 months
measure: Postoperative of bone density at 6 months
timeFrame: 6 months
measure: Postoperative of bone density at 1 year
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The frist affiliated hospital of Jinan University
state: Guangdong
Study officials:
References:
Clinical trial NCT03425916: Changes in Abdominal Muscles Performance in Postpartum Women.
Official title: Changes in Abdominal Muscles Performance and Inter-rectus Distance in Postpartum Women: an Ultrasonography and Electromyographic Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recti Diastasis
Pregnancy Related
Keywords: Hypopressive exercises
Ultrasonography
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 196
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primiparous women after normal, not operative, vaginal one-child delivery, recruited 6-7 weeks after delivery from Hospital Universitario Principe de Asturias (Alcala de Henares, Madrid)

Brief summary: To describe and compare abdominal muscles and inter-rectus distance conditions in postpartum period in comparison with nulliparous women. Also to describe the activation changes during different abdominal exercises.

Detailed description: Pregnancy and childbirth cause corporal changes in women, altering the structure and function of the abdominal and pelvic floor muscles. The distension of the muscular tissue and the possible diastasis recti can alter the performance of the abdominal musculature in the control of intra-abdominal pressure and the lumbo-pelvic stabilization in postpartum term. Abdominal exercise is highly recommended to restore these changes but there is not enough evidence about the effects of exercise modalities.

Eligibility criteria: Inclusion Criteria:

* Primiparous women
* Normal not operative delivery
* One child delivery

Exclusion Criteria:

* Two or more previous gestation
* Previous abdominal surgery
* Systemic disease, neurologic or metabolic disease

Primary outcomes:
measure: Inter-rectus distance (mm)
timeFrame: 1 day
Secondary outcomes:
measure: Cross-sectional area (mm)
timeFrame: 1 day
measure: Neuromuscular activity (mV)
timeFrame: 1 day
measure: Inter-rectus distance (mm) during an hypopressive exercise
timeFrame: 1 day
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: Beatriz Arranz Martin
state: Madrid
Study officials:
affiliation: University of Alcala
name: Maria Torres, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04361916: Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino)
Official title: Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
oximetry
active monitoring
home care
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm, open label trial on active home monitoring strategy
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Starting an early home management and monitoring of patients with suspected or confirmed COVID-19 to ensure a rapid and adequate transfer to hospital care.

Assess the feasibility of home monitoring in a pilot study to possibly extend it to a larger scale.

Detailed description: The study will include adult patients with suspected or confirmed COVID-19 for whom home care is considered appropriate.

Trained health workers will conduct home care monitoring of pulmonary performance using oximetry, Quick Walk Test and Single Breath Count.

Monitoring will be done daily until disappearance of symptoms or hospitalization which will be requested by health workers or study coordination board on the basis of the monitoring results (blood oxygen level SpO2\< 90% OR SpO2\> 90% with desaturation index of at least 5% at Quick Walk Test)

Eligibility criteria: Inclusion criteria:

adult patients with suspected or confirmed COVID-19 for whom home care is considered appropriate.

Exclusion criteria: physical, mental or temporary impairments that preclude the conduction of the test

Primary outcomes:
measure: SpO2 at hospital entry
timeFrame: 24 hours
Secondary outcomes:
measure: in-hospital mortality
timeFrame: 30 days
measure: need of intubation
timeFrame: 30 days
measure: Percentage of hospitalized patients among those with recommendation of hospitalization
timeFrame: 30 days
Other outcomes:
Locations:
city: Casale Monferrato
country: Italy
facility: Asl Alessandria
state: Alessandria
Study officials:
affiliation: Mario Negri Institute for Pharmacological Research
name: Guido Bertolini, MD
role: PRINCIPAL_INVESTIGATOR
References: