louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00696163: Observational Study to Assess the Quality of Life and Clinical Outcomes in Subjects Using NovoMix® 30 for the Treatment of Diabetes
Official title: A Multicentre, Open Label, Nonrandomised, Non- Interventional, A Multicentre, Open Label, Nonrandomised, Non- Interventional, Observational Study to Evaluate the Quality of Life and Clinical Outcomes in Subjects Using Biphasic Insulin Aspart 30 (NovoMix® 30) for the Treatment of Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-06-12
Enrollment: 24975
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 diabetes

Brief summary: This study is conducted in Asia. The aim of this observational study is to evaluate the quality of life and clinical outcomes in subjects using NovoMix® 30 (biphasic insulin aspart 30) for the treatment of diabetes mellitus under normal clinical practice conditions in India.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes, including newly-diagnosed who have never received insulin or an insulin analogue before, at the discretion of the physician.

Exclusion Criteria:

* Currently treated with NovoMix® 30
* Subjects who are unlikely to comply with protocol requirements
* Previously enrolled in this study
* Hypersensitivity to biphasic insulin aspart or to any of the excipients
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months

Primary outcomes:
measure: Change in Quality of Life from baseline (using QoLD questionnaire)
timeFrame: From baseline to 26 weeks of treatment
Secondary outcomes:
measure: Safety
timeFrame: After 26 weeks
measure: Efficacy
timeFrame: After 26 weeks
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06212063: Aim High: Readiness & Meeting the Standards in Military Pre-Recruits
Official title: Aim High: Readiness & Meeting the Standards in Military Pre-Recruits
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Behavior
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary objective of the proposed study is to complete a comprehensive needs assessment of the Louisiana National Guard (LANG) Youth Challenge Program (YCP) in the YCP leadership and junior cadet population related to nutrition, fitness, sleep, and mental health and resilience. Results of this needs assessment will further inform the development of the intervention skills training program.

The secondary objective of this work is to provide a scalable, integrated physical and mental optimization training program that would be integrated into relevant systems and maintained over time as a core tool for young individuals readying themselves to join the Army. The program would include an environmental intervention approach as well as nutrition, physical activity, sleep, and stress reduction/positive coping guidance.


Eligibility criteria: Inclusion Criteria:

* Must be either staff, cadre, or cadets in the YCP program.

Exclusion Criteria:

* Not staff, cadre, or cadets in the YCP program.

Primary outcomes:
measure: Height
timeFrame: 16 Months
measure: Weight
timeFrame: 16 Months
measure: Body Fat
timeFrame: 16 Months
measure: Depression
timeFrame: 16 Months
measure: Anxiety
timeFrame: 16 Months
measure: Body Esteem
timeFrame: 16 Months
measure: Coping
timeFrame: 16 Months
measure: Perceived Stress
timeFrame: 16 Months
measure: Eating Competence
timeFrame: 16 Months
Secondary outcomes:
measure: Knowledge & Attitudes
timeFrame: 16 Months
measure: Program Satisfaction
timeFrame: 16 Months
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
Clinical trial NCT01903863: The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity
Official title: Prospective, Randomized Pilot Study of Prophylactic Fresh Frozen Plasma Administration During Neonatal-Pediatric Extracorporeal Membrane Oxygenation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extracorporeal Membrane Oxygenation
Keywords: FFP
fresh frozen plasma
ECMO
extracorporeal membrane oxygenation
anticoagulation
transfusion
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 31
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the impact of scheduled fresh frozen plasma (FFP) administration on extracorporeal membrane oxygenation (ECMO) pump longevity in critically ill pediatric and neonatal patients. Almost all ECMO patients receive multiple FFP transfusions during their ECMO course. The investigator proposes that scheduled FFP may maintain pro and anticoagulation balance thus mitigating the need for expensive and dangerous ECMO pump changes. In addition, this may lead to less overall transfusion with all products (red blood cells, platelets, and FFP) if coagulation homeostasis is maintained. The subjects will be neonatal and pediatric patients requiring ECMO support for any reason in the pediatric and pediatric cardiac critical care units. Subjects will be randomized to receive every other day FFP infusions or FFP administration per current standard of care. ECMO pump longevity (hours) and FFP use will be compared between the two groups There is a small risk that study subjects may receive more FFP transfusions and therefore have the increased associated risks however it is also possible that these subjects may benefit from less ECMO circuit changes and/or fewer transfusions of all blood products.


Eligibility criteria: Inclusion Criteria:

* All patients \< 18 years receiving ECMO

Exclusion Criteria:

1. Planned withdrawal of life sustaining therapy in the next 48 hours
2. Previous enrollment in the study
3. Patients who cannot be consented within 48 hours
4. Pregnant patients

Primary outcomes:
measure: ECMO Pump Longevity
timeFrame: ECMO course (median 198 hours)
Secondary outcomes:
measure: Hemorrhagic and Thrombotic Complications
timeFrame: ECMO course (median 198 hours)
measure: Antithrombin Levels
timeFrame: ECMO course (median 198 hours)
measure: Plasma Free Hemoglobin
timeFrame: ECMO course (median 198 hours)
measure: Red Blood Cell Transfusion
timeFrame: ECMO course (median 198 hours)
measure: Time to Therapeutic aPTT
timeFrame: ECMO course (median 198 hours)
measure: Platelets Transfusion Requirement
timeFrame: ECMO course (median 198 hours)
measure: Fresh Frozen Plasma Transfusion Requirements
timeFrame: ECMO course (median 198 hours)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center PICU and PCICU
state: North Carolina
Study officials:
References:
Clinical trial NCT03606863: Peripheral Parenteral Nutrition vs Conventional Fluid in Colorectal Resection in ERAS
Official title: A RANDOMIZED, CONTROLLED, CLINICAL TRIAL TO COMPARE PERIPHERAL PARENTERAL NUTRITION (PeriOlimel N4-E) VERSUS CONVENTIONAL FLUID THERAPY IN ENHANCED RECOVERY AFTER SURGERY (ERAS) PROTOCOL IN COLORECTAL CANCER SURGERY.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colon Cancer
Parenteral Nutrition
Fast-track
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 200
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: Assess if administration of early nutrition support with Perioperative Peripheral Nutrition (PeriOliclimonel) N4-E) in patients undergoing colon cancer resection in an Enhanced Recovery After Surgery (ERAS) Protocol improve the results of morbi-mortality and hospitalization versus standard intravenous fluid therapy.

Detailed description: The main objective is to determine if perioperative nutritional support with PeriOlimel N4-E, that reaches nutritional requirements of ERAS protocol for colorectal cancer surgery patients, can improve nutritional status so it decreases postoperative complications, hospital length of stay and costs, compared to conventional fluid therapy administration since patients receive oral nutrition at day 3-5.

Eligibility criteria: Inclusion Criteria:

* scheduled colorectal cancer surgery
* ASA I-IV

Exclusion Criteria:

* Emergency surgery
* Distant metastasis
* Patient´s refusal to participate
* Allergy or hypersensitivity to egg or soy protein
* Advanced kidney or hepatic impairment
* Severe bleeding disorders
* Congenital abnormalities of amino acid metabolism
* Hyperlipidemia and severe or difficult to control hyperglycemia

Primary outcomes:
measure: morbi-mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
Study officials:
affiliation: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana
name: Antonio Arroyo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00333463: Compliance With Once Daily Glaucoma Medication
Official title: Compliance With Once Daily Glaucoma Medication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Compliance
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: Johns Hopkins University
name: University of Pennsylvania
First posted: 2006-06-05
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary open angle glaucoma or ocular hypertension patients

Brief summary: A study to examine patient compliance with once daily glaucoma medication


Eligibility criteria: Inclusion Criteria:

* Primary open angle glaucoma or ocular hypertension patients

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ft. Worth
country: United States
facility: Ft. Worth
state: Texas
Study officials:
affiliation: Study Director
name: David Friedman, MD
role: STUDY_DIRECTOR
References:
citation: Okeke CO, Quigley HA, Jampel HD, Ying GS, Plyler RJ, Jiang Y, Friedman DS. Adherence with topical glaucoma medication monitored electronically the Travatan Dosing Aid study. Ophthalmology. 2009 Feb;116(2):191-9. doi: 10.1016/j.ophtha.2008.09.004. Epub 2008 Dec 12.
Clinical trial NCT05240963: Patient Specific PEEK Implants for Immediate Restoration of Temporal Fossa After Maxillary Reconstruction With Temporalis Muscle Flap
Official title: Patient Specific PEEK Implants for Immediate Restoration of Temporal Fossa After Maxillary Reconstruction With Temporalis Muscle Flap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporal Hollowing
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study conducted on patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap.

For each patient, a patient specific PEEK implant was fabricated, the temporalis muscle was exposed, elevated, and transferred to the maxilla, finally PEEK implants were fixed in place to prevent temporal hollowing.

Detailed description: Study conducted on patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap.

For each patient, a patient specific PEEK implant was fabricated, the temporalis muscle was exposed, elevated, and transferred to the maxilla, finally PEEK implants were fixed in place to prevent temporal hollowing.

Eligibility criteria: Inclusion Criteria:

* Patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap.

Exclusion Criteria:

-

Primary outcomes:
measure: patient's satisfaction
timeFrame: 3 weeks postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry, Cairo university
Study officials:
References:
citation: Ali S, Abdel Aziz O, Ahmed M. Patient-specific PEEK implants for immediate restoration of temporal fossa after maxillary reconstruction with temporalis muscle flap. Maxillofac Plast Reconstr Surg. 2022 May 7;44(1):20. doi: 10.1186/s40902-022-00348-4.
Clinical trial NCT00006063: Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: cardiovascular and respiratory diseases
cystic fibrosis
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Indiana University School of Medicine
First posted: 2000-07-06
Enrollment: 24
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Compare the efficacy of enteric coated pancrelipase with bicarbonate (PANCRECARB) capsules versus the patient's usual enteric coated pancreatic enzyme without bicarbonate in decreasing fecal fat and nitrogen losses in patients with cystic fibrosis.

Detailed description: PROTOCOL OUTLINE: This is a randomized, multicenter study. In the first treatment period, patients are randomized to one of two treatment arms.

Arm I: Patients receive enteric coated pancrelipase with bicarbonate (PANCRECARB) capsules before meals and snacks for 7 consecutive days.

Arm II: Patients receive their usual enteric coated pancreatic enzyme without bicarbonate capsule before meals and snacks for 7 consecutive days.

Patients receive approximately 50% of their usual lipase dose during treatment. Food intake is recorded on days 1-3, food intake is weighed and recorded on days 4-7, and stools are collected over 72 hours on days 5-7 to determine fecal fat and nitrogen excretion. Anthropometric measurements including height, weight, and skinfolds are assessed.

In the second treatment period, patients are switched to the alternate treatment arm after a 3 day washout period. Patients receive the opposing treatment as per protocol.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Clinical diagnosis of cystic fibrosis Duplicate sweat chloride measurements greater than 60 mEq/L on samples collected after pilocarpine iontophoresis
* Patients with a history of malabsorption who consume at least 1,000 to 2,500 lipase units/kg/meal

--Prior/Concurrent Therapy--

* No concurrent oral antibiotics, antacids, H2 receptor antagonists, or any drugs known to interfere with digestion

--Patient Characteristics--

* Weight for height greater than the 5th percentile
* No prior meconium ileus with intestinal resection
* No known hypersensitivity to pancrelipase or pork protein

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Indiana University School of Medicine
name: Mary Sue Brady
role: STUDY_CHAIR
References:
Clinical trial NCT01837563: Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer
Official title: Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Locally Advanced Breast Cancer
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 36
Sex: FEMALE
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: Women with locally-advanced breast cancer, with or without metastatic disease, meeting inclusion criteria (and giving informed consent for participation) receiving systemic therapy at DHMC will be enrolled. Breast size and epithelial integrity of the skin surface can limit the ability to deliver effective imaging exams, adn these individual characteristics need be determined in each individual patient. Women with pacemakers or other implanted electronic devices will not be allowed into the study because of potential for electrical interference with proper operation during an imaging session.

Brief summary: The purpose of this study is to determine whether four new alternative imaging methods can be used to follow the response of breast cancer to the treatment patients are being given. These methods produce an image of the inside of the breast so that doctors can better decide whether breast cancer is responding to therapy. An important part of the study is to examine the same person with all methods in order to directly compare results. The four methods are: MRI Elasticity Imaging (abbreviated MRE), Electrical Impedance Spectroscopy (abbreviated EIS), Microwave Imaging and Spectroscopy (abbreviated MIS), Near Infrared Spectroscopy (abbreviated NIR). In addition to the experimental imaging methods, patients may also undergo a contrast-enhanced MRI, and/or additional mammography, which will help researchers compare the experimental methods. These additional examinations are accepted diagnostic procedures; they are not experimental. Some participants will have one or both of these additional examinations if clinically indicated.


Eligibility criteria: Inclusion Criteria:

1. Locally advanced breast cancer, with or without metastatic disease
2. Patient to receive systemic therapy
3. Breast size and epithelial integrity adequate to allow alternate imaging exams.
4. Patient able to provide written informed consent.
5. No serious associated psychiatric illness
6. Age ≥ 18 years old

Exclusion Criteria:

1. Cardiac pacemaker
2. Any implanted electronic device
3. Severe claustrophobia
4. Allergy to the MRI contrast agent gadolinium

Primary outcomes:
measure: Objective Response
timeFrame: at baseline, at conclusion of treatment (up to 6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
Clinical trial NCT06908863: Correlations Between Fine Manual Motor Skills and Speech Articulation
Official title: Cortical Correlations Between Fine Manual Motor Skills and Speech Articulation : Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Correlations Between Cerebral Motor Control During a Manual Task and During an Articulatory Task
Keywords: Motor skills, speech, cortical
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Category 2 pilot study involving healthy subjects.
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to examine the relationship between cerebral motor control during a manual task and during an articulary task, using functional MRI in a cohort or young adults aged between 18 and 35.

The literature reveals a well-established relationship between manual motor skills and speech from an anatomical and functional point of view. Some studies indicate a proximity between the motor cortical regions corresponding to the hand and the mouth, with a mutual interaction of the two functions from the earliest stages of life (for example, the Babkin reflex). Experimental data shows that hand movements can be influenced by mouth movements. Neurophysiological studies have demonstrated the existence of a link between these two systems in humans and monkeys.

To date, no study has identified the common cortical networks that are active during these two limb movements in a given sample of subjects. The aim of this study is to determine whether such networks exist. The results could be therapeutically relevant, particularly for stroke patients, by enabling more effective restoration of articulatory abilities through complementary limb movements.


Eligibility criteria: Inclusion Criteria:

1. Male or female between the ages of 18 and 35
2. Right-handed
3. Member of beneficiary of a social security insurance
4. Signature of an informed consent

Exclusion Criteria:

1. Disorders of fine manual motor skills and/or articulatory disorders
2. A neurological history that has affected the subject's cerebral function (stroke, head injury)
3. Contraindication to MRI (presence of ferromagnetic material in the body, claustrophobia)
4. Pregnant women
5. Taking medication that may alter the cerebral haemodynamic signal

Primary outcomes:
measure: Recording of brain activity during manual motor skills and speech articulation
timeFrame: 2 weeks after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Paca
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Guillaume SACCO
role: PRINCIPAL_INVESTIGATOR
References: