louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01926171: Icotinib With Whole Brain Radiation Therapy in NSCLC Patients With Brain Metastases
Official title: A Single Center, Open Label, Multicenter Study to Determine the Safety and Efficacy of Icotinib in Combination With Whole Brain Radiation Therapy For NSCLC Patients With Brain Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-small-cell Lung Cancer
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of icotinib in combination with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is objective response rate of intracranial lesions.

Detailed description: Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases. Patients with multiple brain metastasis showed poor prognosis and displayed an untreated median survival of only 3-6 months, and most patients died due to the progression of brain metastases. This study is designed to evaluate the safety and efficacy of icotinib combined with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is intracranial objective response rate .

Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmation of non-small-cell lung cancer (NSCLC).
* Diagnosis of non-systematic brain metastases on a Gadolinium-enhanced MRI. More than 2 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm.
* No other metastases except for brain metastases.

Exclusion Criteria:

* Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
* CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.

Primary outcomes:
measure: Objective response rate of intracranial lesions
timeFrame: 8 weeks
Secondary outcomes:
measure: Objective response rate of extracranial lesions
timeFrame: 8 weeks
measure: Progression-free survival of intracranial lesions
timeFrame: 3-6 months
measure: Safety and tolerability
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongolia
Study officials:
affiliation: Baotou Central Hospital
name: Wei Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01456871: Finger Muscle Reaction After Electrical Stimuli to the Human Finger Pulley System; a Pilot Study
Official title: Finger Muscle Reaction After Electrical Stimuli to the Human Finger Pulley System; a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Mechanoreceptors
PIP joint
Ligamento-muscular reflexes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-10-21
Enrollment: 6
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The purpose of the study is to gain a better understanding of mechanoreceptors in the PIP joint ligamento-muscular reflexes and their role is.

Detailed description: Encapsulated nerve endings called mechanoreceptors are end components of afferent nerves and have specialized end organs surrounding the nerve terminal. Those receptors are concentrated in various human periarticular tissues. It is believed that these mechanoreceptors in the periarticular tissues are related to muscle reflexes. However, it is still unknown which type of mechanoreceptors contribute to the muscle reflexes and whether the mechanoreceptors excite and/or inhibit muscle activation. In the investigators previous studies, mechanoreceptors in the human proximal interphalangeal (PIP) joint and surrounding structures have been extensively examined. The investigators have identified that Pacini-like nerve endings in the PIP joint were found in substantial numbers in the junction of the C1 pulley and accessory collateral ligaments. The investigators hypothesize that the Pacini-like nerve endings in the junction of the C1 pulley generate activity in the associated flexor muscle/tendon in the finger.

Eligibility criteria: Inclusion criteria:

- Females aged 20-30

Exclusion criteria:

* A history of any upper extremity injury or disorder in the non-dominant arm
* A history of any neurologic or bleeding disorder, or taking blood-thinning medication.
* Presence of Linbug-Comstock syndrome

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Richard Berger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05403671: Fit for Everyday Life - Increasing Exercise and Physical Activity in Those Rehablilitating From Cancer
Official title: Fit for Everyday Life - Increasing Exercise and Physical Activity in Those Rehablilitating From Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Survivor
Keywords: exercise
cancer survivor
rehabilitation
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Lounais-Suomen Syöpäyhdistys
First posted: 2022-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to increase the physical activity and exercise of those recovering from cancer (after treatments) and to promote a functional return to everyday life and coping in everyday life. The aim of the study is to evaluate the effects of a exercise intervention on the quality of life, functional fitness (functional muscle strength and endurance tests) and the amount of physical activity of the participants in the study.

Detailed description: Design: This is a quantitative study, whose data includes structured surveys (questionnaires) and measurements. Data are collected before and after the group exercise intervention. This 8 week tailored, progressive program will consist muscle strength training, endurance training, flexibility training, relaxation and home-exercises.

Eligibility criteria: Inclusion Criteria:

* Active cancer treatments have ended under 12 months
* Age 18-70 years
* Finnish speaking
* moving without aids
* z=1-0
* able to come Meri-Karina
* normal or low physical activity
* able to use digital equipments to participate remote exercise sessions

Exclusion Criteria:

* Exercise contraindications
* Memory and mental health problems
* Exercise every day over two hours

Primary outcomes:
measure: The change of Quality of life
timeFrame: change from baseline at 8 weeks
measure: The change of Functional muscle strength
timeFrame: change from baseline at 8 weeks
measure: The change of Endurance
timeFrame: change from baseline at 8 weeks
measure: The change of Subjective physical activity
timeFrame: change from baseline at 8 weeks
measure: The change of Subjective physical capability
timeFrame: change from baseline at 8 weeks
Secondary outcomes:
measure: Experiences and feedback
timeFrame: only at 8 weeks
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Maijastiina Rekunen
Study officials:
affiliation: Turku University Hospital
name: Pia Vihinen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02044471: The IMPULSE Study: Pilot
Official title: The IMPULSE Pilot Study-- Investigating a Novel Synergy: Applying Ischemic Conditioning to Modulate the Altered Physiology From Contemporary continUous Flow Left Ventricular Assist Devices, to Reduce Stroke and Other Adverse Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: left ventricular assist device
continuous flow
remote ischemic conditioning
hypertension
sympathetic tone
endothelial dysfunction
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Thoratec Corporation
First posted: 2014-01-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Continuous-flow (CF) left ventricular assist devices (LVADs) are an important tool in the treatment of end-stage heart failure, affording patients significantly improved quantity and quality of life. In recent years, tens of thousands of LVADs have been implanted worldwide, with nearly 1,000 at the Texas Heart Institute (THI). Despite the benefits from LVAD therapy, one major weakness is the high frequency of late strokes, reported up to 19%. CF LVADs minimize or remove the pulsatility within the blood system, introducing a new and incompletely understood physiology.

Increased sympathetic ("fight or flight" nervous system) tone secondary to lack of pulse in the blood system can cause high blood pressure, with subsequent hemorrhaging strokes (bleeding into the brain) are one possible explanation for this high adverse event rate in CF LVAD patients. A simple intervention to decrease the increased sympathetic tone is called "ischemic conditioning"; a sphygmomanometer (blood pressure cuff) is placed on the patient's arm to compress a major artery (ischemia) with subsequent release of the cuff (reperfusion) for set periods of time. This has been shown to reduce blood pressure and major adverse cardiovascular events in other patient populations.

We plan to conduct a trial to evaluate this intervention, ischemic conditioning, in patients with CF LVADs. We hypothesize that IC will cause a reduction in blood pressure and strokes in this patient population.


Eligibility criteria: Inclusion Criteria:

* continuous flow LVAD and able to provide informed consent and comply with follow-up

Exclusion Criteria:

* \< 18 years of age

Primary outcomes:
measure: Change in mean doppler blood pressure
timeFrame: 6 weeks
Secondary outcomes:
measure: change in mean levels of inflammatory markers (TNFa, IL6, IL8, IL10) and endothelial function (adenosine, acetylcholine, bradykinin, nitric oxide, angiotensin, aldosternone)
timeFrame: 6 weeks
measure: change in sympathetic neuronal activity
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Gilberto Defreitas, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01005771: Study to Assess the Efficacy and Safety of GF-001001-00 Cream in Secondarily-Infected Traumatic Lesions
Official title: GF-001001-00 Cream.A Multicentre, Randomised, Double-blind, Parallel, Placebo-controlled Phase II Study to Assess the Efficacy and Safety of 3 Different Doses of GF-001001-00 Cream Versus Placebo Cream Applied 2 Times Daily for 7 Days in the Treatment of Adult Patients With Secondarily-infected Traumatic Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Secondarily Infected Traumatic Lesions
Keywords: Secondarily infected traumatic lesions
Lead sponsor: Ferrer Internacional S.A.
Sponsor class: INDUSTRY
First posted: 2009-11-01
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: This is a double-blind, randomized, placebo-controlled, parallel-group, dose-finding study.

Detailed description: 200 eligible patients will be included in the double-blind phase (50 in each group, randomised 1:1:1:1 to GF-001001-00 at a concentration of 0.25%, 1% or 2% or placebo).

Randomised patients will apply the study medication as follows depending on their assigned treatment group.

* GF-001001-00 2%, 2 times daily, for 7 days
* GF-001001-00 1%, 2 times daily, for 7 days
* GF-001001-00 0.25%, 2 times daily, for 7 days
* Placebo, 2 times daily, for 7 days

The first application will be done after randomisation at Visit 1 under the guidance of the investigator. Patients will return for control visits: Visit 2 (Day 5) and Visit 3 (Day 7), after randomisation. Patients will return for the Final Visit (Visit 4, Day 14 after initiation of treatment).

Primary objective:

To determine the most effective dose of GF-001001-00 cream for treatment of adult patients with secondarily infected traumatic lesions.

Primary efficacy endpoint:

Clinical response (success or failure) at the Final Visit (Day 14) in the ITTC population.

Eligibility criteria: Inclusion Criteria:

* Males and females ≥ 18 years of age.
* Presence of small laceration, sutured wound, abrasion or burn, which has a secondary bacterial infection.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Clinical cure
timeFrame: Day 14
Secondary outcomes:
measure: Microbiological cure
timeFrame: Day 14
measure: Adverse events Clinical laboratory parameters Vital signs
timeFrame: Day 14
Other outcomes:
Locations:
city: Mahlow
country: Germany
facility: Dermatologische Praxis
Study officials:
References:
Clinical trial NCT06262971: Left Main Percutaneous Coronary Intervention Registry in Istanbul Medipol University Hospital
Official title: Comprehensive Registry of Left Main Coronary Artery Percutaneous Coronary Intervention Outcomes at Istanbul Medipol University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Left Main Coronary Artery Disease
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 3620
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients performing any PCI procedure(s) in given timeframe will be included in this registry

Brief summary: This hospital-based registry study at Istanbul Medipol University Hospital focuses on documenting and analyzing the clinical and demographic characteristics, procedural-related aspects, and both short and long-term outcomes of patients undergoing left main coronary artery percutaneous coronary intervention (PCI). The study aims to identify predictors for adverse clinical outcomes in patients treated for left main coronary artery disease.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing any PCI procedure(s) in given timeframe will be included in this registry

Exclusion Criteria:

* Patients with no informed consent

Primary outcomes:
measure: Incidence of Major Adverse Cardiac Events (MACE) within One Year Following Left Main Coronary Artery PCI
timeFrame: up to 1 month, 3 months, 1 year
Secondary outcomes:
measure: Ischemia-Driven Target Vessel Revascularization (ID-TVR) Ischemia-Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 1 year
measure: Procedure-Related Complications Within 30 Days of PCI
timeFrame: 1 month
measure: Health-Related Quality of Life (HRQoL) Scores One Year After PCI
timeFrame: 1 year
measure: Rate of stent thrombosis
timeFrame: 1 month, 3 months, 1 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
References:
Clinical trial NCT02307071: Occipital Transcutaneous Stimulation in Chronic Migraine
Official title: Transcutaneous Suboccipital Neurostimulation for the Treatment of Chronic Migraine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Migraine
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect in chronic migraine patients of daily 20 minute-transcutaneous sub occipital neurostimulation using the occipital Cefaly° device.

Detailed description: Chronic migraine is a disabling neurological condition affecting 0.5-2% of the population.

CM is difficult to treat and preventive treatment options are limited. Due to the inefficiency of available and the lack of new preventive anti-migraine drug, neurostimulation methods have raised great interest in recent years.

The ONSTIM study showed a reduction in headache frequency in 39% of patients treated with active ONS during 12 weeks, compared to no improvement in the "non-effectively" stimulated or medically treated groups.

Eligibility criteria: Inclusion Criteria:

* diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse

Exclusion Criteria:

* other diseases

Primary outcomes:
measure: Monthly frequency of migraine days
timeFrame: 2 months treatment
Secondary outcomes:
measure: Monthly frequency of headache days
timeFrame: 2 months
measure: Monthly frequency of total headache days
timeFrame: 2 months
measure: Cumulative monthly headache hours
timeFrame: 2 months
measure: Monthly acute drug intake
timeFrame: 2 months
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: CHR Citadelle
Study officials:
affiliation: University of Liege
name: Jean Schoenen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Liege
name: Delphine Magis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06472271: Colistin Dosage Prsonalization Approach
Official title: Colistin in Neonatal ICU Patients With Gram Negative Resistant Infection: Dosage Personalization Approach
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colistin Adverse Reaction
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm, critically-ill, neonates diagnosed with resistant gram-negative infections

Brief summary: A few studies have evaluated higher doses or the administration or a loading dose, which is routine in adults, in pediatric patients, and reported improved colistin exposure without an increased risk of nephrotoxicity The main questions it aims to answer are What is the optimal dosing strategies of intravenous colistin for the treatment of multidrug-resistant gram-negative bacterial infections in preterm neonates? What is the incidence of AKI? What is the factors increasing AKI incidence? A single center retrospective and comparative study, cohort study compare low dose 5 mg/kg/day versus 7.5mg/kg/day

Detailed description: Retrospective study to measure safety and efficacy of colistin conventional dose versus high dose then prospective design to measure pharmacokinetics parameter of both doses to design optimal dose

Eligibility criteria: Inclusion Criteria:

* Neonates aged between (0-30 days) born before 37 weeks
* Critically ill patients with nosocomial infection with proven culture-resistant gram-negative bacteria.
* Neonates who are indicated for colistin and started colistin therapy for at least 48 hr.

Exclusion Criteria:

* Serum creatinine ≥1.5 baseline before colistin
* Received colistin before NICU stay
* Administration of concurrent nephrotoxic drugs including amphotericin, gentamicin, or amikacin.
* Major congenital anomalies or with previous renal impairment.

Primary outcomes:
measure: Clinical response
timeFrame: 21 days
Secondary outcomes:
measure: Microbiological clearance
timeFrame: 21 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo univrsity Hospitals
Study officials:
References:
Clinical trial NCT04238078: Taste Function and Eating Habits in Polycystic Ovary Syndrome
Official title: Investigation of Taste Function and Eating Habits in Women With Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient clinic

Brief summary: This study evaluates taste function and eating habits in patients with PCOS compared to healthy women and before and after oral contraceptive use.

Detailed description: The objective of this study is to investigate the taste function and eating habits in patients with PCOS in comparison with healthy women at baseline and after routine use of an oral contraceptive (2mg ethinylestradiol and 0.03mg dienogest) along with general lifestyle advice for three months.

Patients with diagnosis of PCOS (Rotterdam criteria) will be recruited from Hacettepe University outpatient clinics. Along with clinical, hormonal and biochemical evaluation, taste function and eating habit tests will be performed at baseline both in patients and healthy volunteers. These tests will be repeated in women with PCOS after 3 months of oral contraceptive use.

Eligibility criteria: Inclusion Criteria:

* Women diagnosed with PCOS (Rotterdam criteria) who will receive oral contraceptive pill for long-term management

Exclusion Criteria:

* Any systemic illness
* Any other medication use
* Age\<18 or \>35 years
* Pregnant or nursing
* Untreated hypothyroidism or hyperthyroidism
* Known rhinoplasty or nasal surgery
* Known defect in smell or taste function
* Being active smoker.

Primary outcomes:
measure: Taste function
timeFrame: Three months
Secondary outcomes:
measure: Eating habits
timeFrame: Three months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University School of Medicine
Study officials:
affiliation: Hacettepe University
name: Bulent Yildiz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simchen U, Koebnick C, Hoyer S, Issanchou S, Zunft HJ. Odour and taste sensitivity is associated with body weight and extent of misreporting of body weight. Eur J Clin Nutr. 2006 Jun;60(6):698-705. doi: 10.1038/sj.ejcn.1602371. Epub 2006 Jan 25.
citation: Wolf A, Varga L, Wittibschlager L, Renner B, Mueller CA. A self-administered test of taste function using "Taste Strips". Int Forum Allergy Rhinol. 2016 Apr;6(4):362-6. doi: 10.1002/alr.21681. Epub 2015 Dec 3.