louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00686348: Somatuline® Depot (Lanreotide) for Acromegaly Post-Marketing Observational Study
Official title: Somatuline® Depot (Lanreotide) Injection for Acromegaly (SODA): A Post-marketing Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Keywords: acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2008-05-29
Enrollment: 260
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a clinical diagnosis of acromegaly

Brief summary: To assess the safety and effectiveness of Somatuline® Depot (lanreotide) Injection when administered by a health care professional (HCP), the patient, the patient's partner or parent/guardian as part of their routine acromegaly care.

Detailed description: The objectives of this post-marketing observational study are to assess the safety and effectiveness, as measured by insulin-like growth factor-1 (IGF-1) and growth hormone (GH) levels, of Somatuline® Depot (lanreotide) Injection when administered by a health care professional (HCP), the patient, the patient's partner or parent/guardian as part of their routine acromegaly care. Treatment convenience and acromegaly symptom relief will also be assessed through questionnaires, and demographic and medical history information will be collected.

Eligibility criteria: Inclusion Criteria:

* The patient must have a clinical diagnosis of acromegaly
* The patient must be treated with Somatuline® Depot (including patients newly prescribed Somatuline® Depot)
* The patient or legally authorized representative must be able to understand the protocol and give signed informed consent. Assent from the patient should also be obtained, where appropriate. Signed informed consent and assent must be obtained before any study-related activities are conducted.

Exclusion Criteria:

* Symptomatic, untreated biliary lithiasis
* Known hypersensitivity to somatostatin analogs or related compounds (e.g., octreotide)

Primary outcomes:
measure: Assess the safety & effectiveness, as measured by IGF-1 & GH levels, of Somatuline® Depot Injection when administered by a health care professional, the patient, the patient's partner or parent/guardian as part of their routine acromegaly care.
timeFrame: 2 - 4 years/patient
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Ipsen
state: New Jersey
Study officials:
affiliation: Ipsen (formerly Tercica, Inc.)
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Salvatori R, Gordon MB, Woodmansee WW, Ioachimescu AG, Carver DW, Mirakhur B, Cox D, Molitch ME. A multicenter, observational study of lanreotide depot/autogel (LAN) in patients with acromegaly in the United States: 2-year experience from the SODA registry. Pituitary. 2017 Dec;20(6):605-618. doi: 10.1007/s11102-017-0821-y.
Clinical trial NCT01123148: A P300 Brain Computer Interface to Operate Power Wheelchair Tilt
Official title: A P300 Brain Computer Interface to Operate Power Wheelchair Tilt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Amyotrophic Lateral Sclerosis
Keywords: Brain computer interface
wheelchair control
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-05-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators want to develop a brain-computer interface (BCI) that will eventually allow people who are completely paralyzed to independently control the tilt feature on their power wheelchairs. This study will allow healthy volunteers to test the feasibility and accuracy of controlling a BCI using only their brain signals while seated in a tilting wheelchair.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older.
* Able to read text on a computer screen
* Able to understand and remember instructions concerning participation.

Exclusion Criteria:

* Unable give informed consent.
* Unable to understand and follow instructions.
* Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings.
* Known to have photosensitive epilepsy.
* Open head lesions or sores.

Primary outcomes:
measure: The Accuracy of BCI Typing While Tilting in a Power Wheelchair and While Sitting Still in a Power Wheelchair.
timeFrame: 3 1-2 hour sessions over 2-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan
name: Jane Huggins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05713448: Prevalence of Overweight and Obesity in Adult Patients Suffering From Type 1 Diabetes
Official title: Prevalence of Overweight and Obesity in Adult Patients Suffering From Type 1 Diabetes and Its Effect on Treatment and Associated Co-morbidities
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Obesity
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with type 1 diabetes

Brief summary: A registry of individuals with type 1 diabetes that visited the Department of Endocrinology of the University Hospitals of Leuven is established. The objective of this registry is to phenotype patients with type 1 diabetes and obesity and their response to treatment with regard to their outcomes

Detailed description: A registry/database is constructed with data of the individuals with type 1 diabetes that visited the Department of Endocrinology of the University Hospitals of Leuven. Data will be obtained from all visits in terms of sociodemographics, disease origin and disease impact including but not limited to glycemic control, medical history, comorbidities, complications, clinical parameters, anthropometric parameters, biochemical blood values, medical therapy, lifestyle, ...

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Type 1 Diabetes

Primary outcomes:
measure: Prevalence of patients with type 1 diabetes and obesity
timeFrame: Up to 100 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Departement Endocrinology, University Hospitals Leuven
Study officials:
References:
Clinical trial NCT00185848: Assessing the Suitability of an Imaging Probe for Use in Clinical Cell and Gene Therapy Trials in Cancer and Rheumatoid Arthritis
Official title: Imaging the Biodistribution of the Positron Emission Tomography Reporter Probe, [18F]FHBG, in Humans.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Brain Cancer
Arthritis, Rheumatoid
Central Nervous System Neoplasms
Glioma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether \[18F\]FHBG is suitable for use as an imaging probe in cancer or rheumatoid arthritis patients enrolled in cell or gene therapy trials. In this phase 1 study we will assess the safety and biodistribution of \[18F\]FHBG in patients.

Detailed description: The success of cell and gene therapy depends on specific targeting of the therapeutic gene or cell that is administered to the patient. Our goal is to develop an imaging method to non-invasively monitor the location of the therapeutic gene or cell. Imaging should help in the design of better protocols and potentially reduce side-effects of cell and gene therapy.

Eligibility criteria: Inclusion Criteria:

- Clinical diagnosis of brain tumor or rheumatoid arthritis

Exclusion Criteria:

- Below 18 years of age

Primary outcomes:
measure: The primary endpoint of the study for each patient is acquisition of PET/CT image.
timeFrame: Time of scan
Secondary outcomes:
measure: Collection of vital signs, EKG, blood chemistry and CBC data
timeFrame: day 1, 2 and 8.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Sanjiv Sam Gambhir M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yaghoubi S, Barrio JR, Dahlbom M, Iyer M, Namavari M, Satyamurthy N, Goldman R, Herschman HR, Phelps ME, Gambhir SS. Human pharmacokinetic and dosimetry studies of [(18)F]FHBG: a reporter probe for imaging herpes simplex virus type-1 thymidine kinase reporter gene expression. J Nucl Med. 2001 Aug;42(8):1225-34.
Clinical trial NCT01244048: Intervention With n3 LC-PUFA-supplemented Yogurt
Official title: Intervention With n3 LC-PUFA-supplemented Yogurt: Effects on Cardiovascular Risk Factors and Inflammatory Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate Hypertriacylglycerolemic Subjects
Keywords: n3 LC-PUFA, yoghurt, inflammatory markers
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2010-11-19
Enrollment: 53
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effective dosage of a n3-LC-PUFA intervention (with n3 LC-PUFA-enriched yoghurt) on the modulation of cardiovascular risk factors and inflammatory biomarkers were determined.

Detailed description: Fifty three mildly hypertriacylglycerolemic subjects (TAG ≥ 150 mg/dL (1.7 mmol/L)) participated on the placebo-controlled, double-blind, parallel designed study.

The subjects consumed placebo yoghurt (1), or n3 LC-PUFA-enriched yoghurt (0.8 g n3 LC-PUFA/d (2), 3 g n3 LC-PUFA/d (3)) for 10 weeks.

Blood samples were taken at the beginning and at the end of the period.

Parameters:

* Blood lipids (total cholesterol, HDL, LDL, triacylglycerols)
* Fatty acid distribution of plasma lipids (PL) and erythrocyte membranes (EM)
* Concentrations of eicosanoids (PGs, HETEs)
* Production of ex vivo stimulated cytokines by T cells
* SNPs in the CD36 genotype

Eligibility criteria: Inclusion Criteria:

* hypertriacylglycerolemic subjects (TAG: ≥ 150 mg/dl (1.7 mmol/l))

Exclusion Criteria:

* patients receiving blood-diluting and lipid-lowering medications or glucocorticoids
* patients suffering from gastrointestinal or metabolic diseases (e.g., diabetes mellitus, hyper- and hypothyroidism) and hypercholesteremic patients with familial previous impacts
* patients taking dietary supplements (e.g., fish oil capsules, vitamin E) or having either known allergies or foodstuff indigestibility
* further exclusion criteria: smoking, high sportive activity or daily alcohol intake

Primary outcomes:
measure: Blood lipids (total cholesterol, HDL, LDL, triacylglycerols)
timeFrame: change from baseline after 10 weeks
Secondary outcomes:
measure: fatty acid distribution in plasma lipids and erythrocyte membranes, eicosanoids in plasma, production of ex vivo stimulated cytokines by T cells, SNPs on CD36 genotype
timeFrame: change from baseline after 10 weeks
Other outcomes:
Locations:
city: Jena
country: Germany
facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology
Study officials:
affiliation: Department of Nutrition, University Jena
name: Gerhard Jahreis, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dawczynski C, Massey KA, Ness C, Kiehntopf M, Stepanow S, Platzer M, Grun M, Nicolaou A, Jahreis G. Randomized placebo-controlled intervention with n-3 LC-PUFA-supplemented yoghurt: effects on circulating eicosanoids and cardiovascular risk factors. Clin Nutr. 2013 Oct;32(5):686-96. doi: 10.1016/j.clnu.2012.12.010. Epub 2012 Dec 28.
Clinical trial NCT00539448: Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study
Official title: Phase IV, Open Label, Non-comparative, Multi-center, Study of the Effects of Both Insulin Glargine & Insulin Glulisine in Type I Diabetes Mellitus Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-04
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary objective :

To evaluate the efficacy (in terms of change in HbA1c readings starting from baseline then after 13 weeks \& at the end of the study which will be after 26 weeks) in subjects with type I diabetes mellitus.

Secondary objective :

* Recording the average daily dose of both insulin Glulisine \& insulin Glargine in type I DM.
* Recording adverse events.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed type I diabetic patients
* Type I diabetes treated with basal-bolus regimen including 3 or more injections of Regular Human Insulin per day
* BMI, 26-40 kg/m2
* HbA1c, 7.5%-10%
* Median 2Hrs post -prandial more than or equal to 140 mg/dl (more than or equal to 7.8 mmol/L)
* FPG more than or equal to 120 mg/dl (more than or equal to 6.7 mmol/L)
* Willingness to accept, and ability to inject insulin Glargine therapy

Exclusion Criteria:

* Pregnancy : The use of LANTUS \& APIDRA during pregnancy is not contraindicated. However, in the absence of supportive data, Sanofi- Aventis Pharmaceuticals cannot specifically recommend the use of Lantus in this patient population

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Primary outcomes:
measure: Evaluating the Glycemic control of the regimen : Change in A1C levels
timeFrame: from baseline to study end
Secondary outcomes:
measure: Average daily dose : - For both insulin Glulisine & insulin Glargine. - FBG and PPBG if possible ?
timeFrame: from baseline to study end
Other outcomes:
Locations:
city: Manama
country: Bahrain
facility: Sanofi-aventis administrative office
city: Kuwait City
country: Kuwait
facility: Sanofi-aventis administrative office
city: Doha
country: Qatar
facility: Sanofi-Aventis Administrative Office
city: Dubai
country: United Arab Emirates
facility: Sanofi-aventis administrative office
Study officials:
affiliation: Sanofi
name: Hisham - MAHMOUD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01519648: A Russian Prospective Observational Study of Invasive Fungal Infections in Patients With Acute Leukemia and Hematopoietic Stem Cell Transplantation
Official title: A Russian Prospective Observational Study of Invasive Fungal Infections in Patients With Acute Leukemia and Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Fungal Infections
Keywords: Invasive fungal infection
Acute leukemia (AL)
Hematopoietic stem cell transplantation
Antifungal stewardship
Neutropenia
Hematological malignancies
Lead sponsor: National Hematological Society, Russia
Sponsor class: OTHER
First posted: 2012-01-27
Enrollment: 808
Sex: ALL
Minimum age (years): 1
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This observational study will be implemented in the hematology departments or hematology centers with or without HSCT located throughout Russia.

Brief summary: Estimate the rate of occurrence of Invasive Fungal Infections (IFIs) in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.

Detailed description: This multi-center observational study of IFI in high risk hematological patients, the study will investigate the epidemiology of IFI, describe antifungal strategy, proportion of antifungal prophylaxis, empiric therapy, pre-emptive therapy and targeted therapy in at-risk patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with de novo or relapsed AL (AML, ALL)started chemotherapy
* All newly allogeneic or autologous transplant recipients during the study period

Primary outcomes:
measure: The Rate of Invasive Fungal Infections
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Hematological Society
Study officials:
affiliation: National Research Center for Hematology
name: Galina A Klyasova
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00854048: The Performance of Pulse Oximeters in Pediatric Patients With Low Oxygen Saturation Levels
Official title: The Performance of Nellcor OxiMax N-560 and Masimo SET Radical Pulse Oximeters in Pediatric Patients With Low Oxygen Saturation Levels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiopulmonary Bypass
Keywords: Pediatric
Oxygen Saturation
Cardiopulmonary bypass
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
Collaborators: name: Medtronic - MITG
First posted: 2009-03-02
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients after cardiopulmonary by-pass in the PICU.

Brief summary: Evaluate pulse oximeters with children after cardiopulmonary by-pass under low Oxygen conditions.


Eligibility criteria: Inclusion Criteria:

* Include pediatric patients with a baseline Sa02 \< 90% and no contraindications to using an adhesive sensor.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing University of Medical Sciences
country: China
facility: Chidren's Hospital
state: Chongqing
Study officials:
affiliation: Children's Hospital Congqing Medical University
name: Xu Feng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01686048: The Significance of Ambrosia in Allergic Rhinitis and Asthma in Israel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Asthma
Allergic Conjunctivitis
Atopic Dermatitis
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-09-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients refered for allergic evaluation

Brief summary: Ambrosia is known for its allergenicity in the USA causing hay fever and asthma. Israel has always been considered "clean" of Ambrosia but over the past years growth of Ambrosia plants has been detected in several locations in Israel.

In the proposed study, patients referred for routine allergic evaluation will also be skin tested with Ambrosia allergens, in addition to their regular prick skin tests with all other airborne allergens.


Eligibility criteria: Inclusion Criteria:

* Patients with allergic rhinitis, asthma, allergic conjunctivitis or atopic dermatitis who undergo prick skin tests with airborne allergens

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Arnon Goldberg, M.D., Allergy and Clinical Immunology Unit, Meir Medical Center
Study officials:
References:
Clinical trial NCT00493948: Evaluation of a Portable Device for Assessing Sleep Disordered Breathing in Congestive Heart Failure
Official title: Evaluation of a Portable Device for Assessing Sleep Disordered Breathing in Congestive Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Congestive
Sleep Apnea Syndromes
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2007-06-29
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population under investigation are those people with moderate to severe heart failure who are currently admitted to the Coronary Care Unit of a major Sydney hospital.

Brief summary: The purpose of this study is to evaluate an approved, portable device for assessing Sleep Disordered Breathing in Congestive Heart Failure.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe heart failure (as determined via Echocardiogram or treating physician)

Exclusion Criteria:

* Clinically significant asthma requiring therapy
* Significant (parenchymal) lung disease
* Severe pulmonary hypertension
* Hypercapnia (PCO2 \> 60mmHg)
* Cardiogenic Shock
* Severe chronic renal failure
* Narcotic abuse/intravenous drug use (including heart failure due to alcohol abuse or chemotherapy, HIV+ and Hepatitis C)
* Methicillin- resistant Staphylococcus aureus infection
* Tracheotomy
* Enrolled in any concurrent study that may confound the results of this study
* Nocturnal positive airway pressure or oxygen
* Inability or refusal to sign patient consent form
* Inability or refusal to adhere to protocol requirements

Primary outcomes:
measure: Apnea- Hypopnea Index
timeFrame: Overnight
Secondary outcomes:
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
Study officials:
affiliation: ResMed/The University of New South Wales
name: Rachel A Coxon, BE/MBiomedE
role: STUDY_DIRECTOR
affiliation: ResMed/The University of New South Wales
name: Klaus Schindhelm, PhD
role: STUDY_DIRECTOR
affiliation: Royal Prince Alfred Hospital, Sydney, Australia
name: Jodie Lattimore, PhD
role: STUDY_DIRECTOR
affiliation: Royal Prince Alfred Hospital/The University of Sydney
name: Ian Wilcox, PhD
role: PRINCIPAL_INVESTIGATOR
References: