louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03164434: Influence of Drainage on EVD ICP-signal
Official title: Influence of Drainage of Cerebrospinal Fluid on ICP Signals Obtained Through an External Ventricular Drain.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head Injury
Subarachnoid Hemorrhage
Keywords: intracranial pressure
cerebrospinal fluid drainage
waveform analysis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe traumatic brain injury or subarachnoid hemorrhage in whom monitoring of ICP is warranted.

Brief summary: This observational study investigates ICP signals obtained through an external ventricular drain in the brain connected with an external transducer. In particular, the study investigates how drainage influences the monitored signal: influence of flow rate, reservoir height and initial ICP before draining.


Eligibility criteria: Inclusion Criteria:

* TBI/SAH patients with need for ICP monitoring

Exclusion Criteria:

-

Primary outcomes:
measure: ICP signal changes
timeFrame: immediate during drainage
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Bart Depreitere, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05100134: Managed Access Programs for LDK378, Ceritinib
Official title: Managed Access Programs for LDK378, Ceritinib
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Anaplastic Lymphoma Kinase (ALK)- Positive Tumors
Non-small Cell Lung Cancer (NSCLC)
Keywords: MAP
Manage access program
ceritinib
ALK positive tumors
Non-small cell lung cancer (NSCLC)
Anaplastic large cell lymphoma (ALCL)
Inflammatory myofibroblastic tumour (IMT),
LDK378
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-10-29
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this registration is to list Managed Access Programs (MAPs) related to LDK378, Ceritinib.

Detailed description: CLDK378A2401 - No longer available - Managed Access Program (MAP) to provide access to Ceritinib, for ALK Positive Tumors.

CLDK378A2402 - No longer available - An open-label, multi-center, Expanded Treatment Protocol (ETP) of oral LDK378 in adult patients with non-small cell lung cancer (NSCLC) characterized by ALK positivity.

CLDK378A2003M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLDK378A2003M to provide access to LDK378 (ceritinib), for ALK-Positive Tumor Pediatric Patients.

Eligibility criteria: Inclusion Criteria:

1. An independent request was received from a licensed physician.
2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
3. The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial.
4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
7. Managed Access provision is allowed per local laws/regulations.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03284034: Cryolipolysis Versus ATX-101 (Deoxycholic Acid) for Upper Back Fat
Official title: Comparison of the Efficacy Between Cryolipolysis Versus ATX-101 (Deoxycholic Acid) for the Treatment of Upper Back Fat: a Prospective Randomized Controlled Pilot Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Upper Back Fat
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized controlled study comparing the efficacy of cryolipolysis versus ATX-101 (deoxycholic acid) for the treatment of upper back fat. Participants currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment. The treatment sites are the right and left upper back fat areas. The right and left sides of the upper back fat will be randomly assigned (1:1) to receive cryolipolysis, while the contralateral side will receive ATX-101.

This study was a pilot study designed to determine feasibility of this procedure.


Eligibility criteria: Inclusion Criteria:

1. Males or females ≥ 18 years old
2. Subjects are in good health as judged by the investigator.
3. Subjects with mild to moderate upper back fat.
4. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.

Exclusion Criteria:

1. History of hypertrophic scars or keloids
2. Subjects currently under treatment with an antiplatelet or anticoagulant for any medical problem or patients who have coagulation disorder
3. Subjects who have a known history of cold-induced disease such as cryoglobulinemia, paroxysmal cold hemoglobulinuria, cold urticaria.
4. Pregnant or breast feeding
5. Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
6. Subjects who are unable to understand the protocol or give informed consent.

Primary outcomes:
measure: Change in fat measurements from baseline to Day 90.
timeFrame: Baseline and Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06683534: Palmitic Acid and Human Microvascular Function
Official title: Use of Quercetin to Increase Resiliency to Palmitic Acid in the Human Microvasculature
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Microvascular Dysfunction
Microvasculature
Cardiovascular Diseases
Cardiovascular Diseases (CVD)
Microvascular Health
Obesity and Overweight
Keywords: Obesity
Supplement
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to receive the supplement quercetin or placebo for 30 days to determine its effect on microvascular function.
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to learn how a supplement Quercetin can affect microvascular function.

Participants will:

* give two blood draws of 5 mL each
* have a camera placed under the tongue to take pictures of blood vessels
* have 2 laser Doppler microdialysis catheters placed on the forearm to monitor blood vessels before and after local drug infusion

Researchers will compare blood vessel function of those who take estrogen supplements to those who do not.


Eligibility criteria: Inclusion Criteria:

* Obesity (BMI\>30)
* Aged 18-60 years
* English Speaking

Exclusion Criteria:

* BMI\>60
* Resting SBP ≥180 mmHg or DBP ≥ 110mmHg
* Pregnancy or breastfeeding.
* Prior history of myocardial infarction
* Diagnosis of more than 1 risk factor for coronary artery disease (active smoker, diabetes mellitus- type 1 or 2, congestive heart failure, hyperlipidemia, hypertension)
* Active mouth sores that affect the buccal mucosa.

Primary outcomes:
measure: Change in blood vessel dilation
timeFrame: 2 hours
Secondary outcomes:
measure: Change in Perfused Vessel Density
timeFrame: 0.5 hours
Other outcomes:
Locations:
city: Wauwatosa
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
References:
Clinical trial NCT02050334: CC100: Safety and Tolerability of Single Doses
Official title: Protocol CC100A CC100: Safety and Tolerability of Single Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
Healthy Volunteer
Safety
Healthy Volunteer Safety Study
Lead sponsor: Chemigen, LLC
Sponsor class: INDUSTRY
First posted: 2014-01-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to see if CC100, given by mouth, is safe and is tolerated in increasing doses. How long the drug remains in the body will also be calculated.

Detailed description: Approximately 18 healthy subjects will be randomized to receive by mouth either 3 single increasing doses of CC100 or 1 dose of placebo and 2 increasing doses of CC100. Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. Subjects are required to stay in the Clinic for approximately 24 hours following each dose. Subjects may choose to have an optional lumbar puncture following the 3rd dose of study drug.

Eligibility criteria: Inclusion Criteria:

* Men must practice a reliable method of birth control during study and for 2 weeks following study. Women must be non-fertile or post-menopausal.

Exclusion Criteria:

* Have serious or unstable illnesses as determined by the investigator.
* Have current or a history of asthma, or severe drug allergies or pollen allergy.
* Have used medications (except for calcium supplements or externally applied eye drops or antibiotics) within 30 days prior to dosing or are expected to use other medications during the study.
* Have had serious infectious disease affecting the brain within the preceding 5 years; or have known or existing evidence of serious infection.
* Have laboratory test values that are considered clinically significant as determined by the investigator.
* Have ECG abnormalities that are clinically significant.
* Have donated blood (a pint or more) or received an experimental drug within 30 days prior to dosing.
* Have a history of chronic alcohol or drug abuse within the past 2 years.

Primary outcomes:
measure: Unsolicited Adverse Event Reports
timeFrame: Minimum of 24 hours after each dose.
Secondary outcomes:
measure: Pharmacokinetics (PK)
timeFrame: 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100
measure: Half-Life (t1/2)
timeFrame: 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health Neuroscience Center
state: Indiana
Study officials:
affiliation: IU Health Physicians - Neurology
name: Robert M Pascuzzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02747134: Combining Emotion Regulation and Mindfulness Skills for Preventing Depression Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 75
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: In the present study researchers aim to investigate the effectiveness of an intervention combining emotion regulation and mindfulness skills in a single 10-week program. A total of 75 individuals with major depressive disorder (MDD) diagnosis in complete or partial remission participated in this randomized controlled trial (RCT) comparing an intervention including emotion regulation and mindfulness skills (ER+M) with a psychoeducative program. After treatment, participants were followed for a 1-year period. Researchers results indicate that ER+M was not more effective than the treatment used with the control group in preventing depression relapse. Participants allocated to the ER+M group showed a significant decrease on global psychiatric symptoms, whereas those in the control group did not. Further studies are needed in order to better determine the combined effects of mindfulness and behavioral activation.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 75 years
* having a former MDD diagnosis in complete or partial remission at the time of the study as indicated by the major depressive section of the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) and scores below 17 on the Hamilton Depression Rating Scale (HSRD)
* having the last major depressive episode between 18 and 2 months prior to the study
* having at least two previous depressive episodes
* patients could continue pharmacological treatment on condition that it remained stable for at least the last two months before entering the study.

Exclusion Criteria:

* DSM-IV-TR criteria for current MDD or any other affective disorder
* DSM-IV-TR criteria for alcohol or drug dependence, schizophrenia or psychotic disorders
* DSM-IV-TR criteria for personality disorders; severe physical conditions such as organic brain syndrome or neurological disease; mental retardation or cognitive impairments
* having received any psychotherapy including cognitive-behavioral therapy in the past
* changes in the pharmacological treatment during the study.

Primary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Elices M, Soler J, Feliu-Soler A, Carmona C, Tiana T, Pascual JC, Garcia-Palacios A, Alvarez E. Combining emotion regulation and mindfulness skills for preventing depression relapse: a randomized-controlled study. Borderline Personal Disord Emot Dysregul. 2017 Jul 5;4:13. doi: 10.1186/s40479-017-0064-6. eCollection 2017.
Clinical trial NCT01544517: 5 Day Concomitant Versus 10 Day Sequential Therapy for Eradication of H. Pylori Infection
Official title: Five-day Concomitant Versus 10-day Sequential Therapy for Eradication of Helicobacter Pylori Infection: a Randomized Trial of Levofloxacin-based Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Concomitant therapy
Sequential therapy
levofloxacin
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2012-03-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A five day quadruple concomitant therapy is as effective and safe as a 10 day sequential therapy for eradication of H. pylori infection.

Detailed description: The investigators studied 180 consecutive patients with H. pylori infection who were randomized to 5-day concomitant therapy (90 patients) and to 10-day sequential therapy (90 patients). 6 and 10 weeks after the end of therapy, patients were evaluated for their H. pylori status by 13C Urea Breath Test. Side effects and costs of either regimen were evaluated. In patients whose H pylori status at entry was assessed by endoscopy, culture was performed and antimicrobial resistance was determined

Eligibility criteria: Inclusion Criteria:

* H. pylori-infected patients who were at least 18 years of age and who had never received H. pylori eradication treatment were included in the study.

Exclusion Criteria:

* previous treatment for H. pylori infection,
* use of inhibitors of acid secretion and/or antibiotics during the 6 weeks before the study,
* gastrointestinal malignancy,
* previous gastro-oesophageal surgery,
* severe concomitant cardiovascular,
* respiratory or endocrine diseases,
* clinically significant renal or hepatic disease,
* hematologic disorders,
* any other clinically significant medical condition that could increase risk,
* history of allergy to any of the drug used in the study,
* pregnancy or lactation,
* alcohol abuse,
* drug addiction,
* severe neurologic or psychiatric disorders, and
* long-term use of corticosteroids or anti-inflammatory drugs.

Primary outcomes:
measure: Eradication Rate
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events
timeFrame: 1 year
measure: Costs of either regimen
timeFrame: 1 year
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Dipartimento di Internistica Clinica e Sperimentale, SUN
state: Napoli
Study officials:
affiliation: Second University of Naples Medical School
name: Marco Romano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01990417: Evaluation of Passive Stretching in the Hamstrings Flexibility
Official title: Evaluation of Passive Stretching in the Hamstrings Flexibility of Who Practice Exercises
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Students
Healthy Volunteers
Keywords: Muscle Stretching Exercises
Joint range of motion
Resistance Training
Physical Therapy
Lead sponsor: Fortaleza University
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The present study aimed to analyze the influence of passive stretching before and after strength training on flexibility of the hamstrings in people who work out

Detailed description: Question: Does passive stretching before and after strength training effect the flexibility of the hamstrings in people who work out?

Design: Intervention study in humans

Participants: 40 healthy student volunteers, ranging in age from 18 to 35 years old, who work out.

Intervention: The Wells bench was used to assess the flexibility of the hamstring muscle. In this test, a person sits on a mat, with the soles of both feet maintaining contact with a box. The top of the box has an indicator marked in centimeters that is used to measure flexibility by how far the person can push the indicator without bending the legs. The knees of the seated person are extended while the hips are flexed. The subject is then asked to take a deep breath, and during exhalation, flex the trunk forward with the upper limbs extended.

The upper limbs are supported by a bench of 23 cm long aligned with a tape measure over the bench. During flexion of the trunk, the right hand is placed over the left and the tips of the fingers touch the indicator on top, and move it forward as far as possible.

Eligibility criteria: Inclusion Criteria:

* The healthy students volunteers who worked out at the gym between 1-15 months of activities and ranging in age from 18 to 35 years

Exclusion Criteria:

* Volunteers who had history of chronic disease diagnosed and /or musculoskeletal injury.

Primary outcomes:
measure: hamstrings flexibility
timeFrame: 30 seconds of maintenance
Secondary outcomes:
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Núcleo de Atenção Médica Integrada (NAMI), in the evaluation room of the academy school at the University of Fortaleza (UNIFOR)
state: Ceará
Study officials:
affiliation: University of Fortaleza - UNIFOR
name: Ana Paula V Abdon, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01224717: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women
Official title: A Phase I, Partially Blinded, Randomized, Placebo Controlled, Active Comparator Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Post-menopausal Women After Daily Oral Doses of PTH134
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Post-menopausal Osteoporosis
Keywords: Osteoporosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-10-20
Enrollment: 104
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to provide information about the bone-anabolic response of PTH134 when administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide, the active ingredient in PTH134.


Eligibility criteria: Inclusion Criteria:

* Post-menopausal women osteoporotic/osteopenic with an additional risk factor 45 to 80 years old

Exclusion Criteria:

* Use of estrogen or hormone replacement therapy
* Use of parathormone or parathormone fragments, calcitonin, aluminum supplements, within 12 months prior to first dose.
* Use of bisphosphonates and strontium ranelate
* Cancer or history of malignancy of any organ system
* Any radiation therapy to the skeleton.
* Any known clinically significant disease affecting calcium metabolism. Any history of metabolic disorders including Paget's disease, osteogenesis imperfecta, or osteomalacia.
* History or clinical evidence of any impairment of thyroid function
* Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Measure: Effects of treatment on bone biomarkers. Measure levels of PINP, CTX-1, and serum calcium levels, serum phosphate, P1CP, bone-specific alkaline phosphatase, osteocalcin.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in serum calcium levels after 12 weeks of treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Novartis Investigative Site
city: Ballerup
country: Denmark
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Munich
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00170417: Clinical Benefit of CBT for Insomnia in Primary Care
Official title: Clinical and Health Economic Benefit of Non-Pharmacological Treatment of Chronic Insomnia in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: NHS Greater Clyde and Glasgow
Sponsor class: OTHER
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate using an RCT the potential benefits of CBT for insomnia in the community


Eligibility criteria: Inclusion Criteria:

* Adult years (18+), living at home
* Meets clinical/RDC criteria for chronic insomnia

Exclusion Criteria:

* Deteriorating health
* Untreated major mental disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow and Edinburgh
country: United Kingdom
facility: Primary Care NHS
Study officials:
affiliation: University of Glasgow
name: Colin A Espie, PhD
role: PRINCIPAL_INVESTIGATOR
References: