louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03405727: Improvement of Sarcopenia in Patients Following Two Different Diets
Official title: Improvement of Sarcopenia in Sarcopenia Patients Following Two Different Diets
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sarcopenia is defined as a decrease in muscular strength and muscle mass, accompanied by a decrease in physical performance. Seniors might develop sarcopenia because of a decreased physical activity and a decreased protein intake. Many patients also develop sarcopenia after a long stay in an intensive care unit.

Protein intake is very important when treating sarcopenia. However, meeting the protein requirements at home proves difficult. Oral dietary supplements, given in addition to the other known recommendations, might provide a solution.

This study will assess the efficacy of the oral dietary supplements for the treatment of sarcopenia.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized within the CHU Brugmann, Brussels
* Patients diagnosed with sarcopenia (by means of a dynamometer)
* Patients having stayed in an intensive care unit for longer than 5 weeks

Exclusion Criteria:

* Oncology patients
* Anorexic patients
* Patients having a life expectancy of less than 6 months
* Demented patients
* BPCO patients
* Patients with neuropathies

Primary outcomes:
measure: Prehension force
timeFrame: 3 months after first consultation
measure: Prehension force
timeFrame: 6 months after first consultation
measure: Fat mass evaluation
timeFrame: 3 months after first consultation
measure: Fat mass evaluation
timeFrame: 6 months after first consultation
measure: Muscle mass evaluation
timeFrame: 3 months after first consultation
measure: Muscle mass evaluation
timeFrame: 6 months after first consultation
measure: Walking speed
timeFrame: 3 months after first consultation
measure: Walking speed
timeFrame: 6 months after first consultation
measure: "Time Up and Go" test
timeFrame: 3 months after first consultation
measure: "Time Up and Go" test
timeFrame: 6 months after first consultation
measure: Sedentary lifestyle questionnaire
timeFrame: 3 months after first consultation
measure: Sedentary lifestyle questionnaire
timeFrame: 6 months after first consultation
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: Haute Ecole Lucia De Brouckère
name: Turkan Dalgic
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00898027: Effect of Epidermal Growth Factor Receptor Inhibitors on Magnesium Homeostasis in Patients With Cancer
Official title: Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on Magnesium Homeostasis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Solid Tumor
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2009-05-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with the diagnosis of a malignancy for which they are considering therapy with an inhibitor of the EGFR pathway, have received an inhibitor of the EGFR pathway prior to study start, have no severe underlying renal dysfunction as defined as estimated GFR\<60 by MDRD equation and must be ≥ 18 years of age.

Brief summary: RATIONALE: Studying samples of blood and urine in the laboratory from patients with cancer receiving epidermal growth factor receptor inhibitors may help doctors understand the effect of epidermal growth factor receptor inhibitors on magnesium levels in the body.

PURPOSE: This laboratory study is looking at the effect of epidermal growth factor receptor inhibitors on magnesium homeostasis in patients with cancer.

Detailed description: OBJECTIVES:

* Determine the effects of EGFR inhibitors on magnesium homeostasis in patients with cancer.

OUTLINE: This is a pilot study.

Patients undergo blood and urine sample collection at baseline and at 2, 4, and 8 weeks during treatment.

After finishing treatment, patients are followed periodically for up to 10 weeks.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of malignancy

  * Planning to receive therapy with an inhibitor of the EGFR pathway (either on or off a clinical trial and may be monotherapy or combined with other therapies)
* Normal serum magnesium level

Exclusion Criteria:

* Glomerular filtration rate ≥ 60 mL/min
* No severe underlying renal dysfunction
* Normal serum potassium and calcium level
* No history of primary or secondary hyperparathyroidism

PRIOR CONCURRENT THERAPY:

* No prior EGFR pathway inhibitor

Primary outcomes:
measure: Effects of EGFR inhibitors on magnesium homeostasis
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Laura Goff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02084927: Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery
Official title: Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery -Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Intracranial Meningioma
Neurologic Deficits
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-03-12
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to evaluate, in a prospective cross-over, randomized study, the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic neurological deficits and cognitive impairment after anterior skull base meningioma tumor removal.


Eligibility criteria: Inclusion Criteria:

* Post intracranial meningioma removal surgery 3-12 months prior to the inclusion in the study.
* All patients have to have persistent cognitive or neurological complaints regarding without noticeable improvement during the last month prior to their enrolment.
* Age 18 years or older.

Exclusion Criteria:

* Dynamic neurologic/cognitive improvement or worsening during the past month;

  * Evidence of dynamic cognitive/neurological improvement in the last month.
  * Previous brain radiotherapy and/or radiosurgery.
  * Steroids dependence
  * Seizures 1 month previous to inclusion
  * Had been treated with HBOT for any other reason 1 month prior to inclusion;
  * Have any other indication for HBOT;
  * Chest pathology incompatible with pressure changes;
  * Inner ear disease;
  * Patients suffering from claustrophobia;
  * Inability to sign written informed consent;
  * Smoking patients will not be allowed to smoke during the study and if they would not comply with this demand they will be excluded.

Primary outcomes:
measure: Neurocognitive functions
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 6 months
Other outcomes:
Locations:
city: Zerifin,
country: Israel
facility: Assaf-Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Shai Efrati, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03534427: The Effects of a Jump Rope Exercise Program on Vascular Health, Inflammatory Markers in Prehypertensive Adolescent Girls
Official title: The Effects of a 12-Week Jump Rope Exercise Training Program on Arterial Stiffness, Vasodilating and Vasoconstricting Factors, Inflammatory Markers, and Body Composition in Prehypertensive Adolescent Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prehypertension
Blood Pressure
Abdominal Obesity
Adiposity
Keywords: arterial stiffness
endothelin-1
c-reactive protein
adiposity
exercise
jump rope
Lead sponsor: Pusan National University
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: exercise intervention group, control group
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study was to examine the impact of a 12-week jump rope exercise program on blood pressure, arterial stiffness, vasodilating and vasoconstricting factors, inflammatory markers, and body composition in prehypertensive adolescent girls. Forty prehypertensive adolescent girls participated in this study. The girls were randomly divided into the jump rope exercise intervention group (EX, n=20) and control group (CON, n=20). The EX group performed a jump rope training program at 40-70% of their heart rate reserve (HRR) 5 days/week for 12 weeks (sessions 50 minutes in duration). The CON group did not participate in any structured or unstructured exercise protocol. Blood pressure, arterial stiffness, plasma nitrate/nitrite levels, endothelin-1, C-reactive protein, and body composition were measured before and after the 12-weeks study.


Eligibility criteria: Inclusion Criteria:

* prehypertensive
* sedentary (no regular exercise training or physical activity within the last year)
* no weight loss diet during the last six months

Exclusion Criteria:

* pregnancy
* chronic disease
* daily medication use (including antioxidants and weight loss supplements)

Primary outcomes:
measure: Arterial Stiffness
timeFrame: 12 weeks
measure: Endothelin-1
timeFrame: 12 weeks
measure: Body Mass
timeFrame: 12 weeks
measure: Height
timeFrame: 12 weeks
measure: Waist Circumference
timeFrame: 12 weeks
measure: Body Fat
timeFrame: 12 weeks
measure: Lean Body Mass
timeFrame: 12 weeks
measure: Nitrate/Nitrite Levels
timeFrame: 12 weeks
measure: C-reactive Protein
timeFrame: 12 weeks
measure: Systolic Blood Pressure
timeFrame: 12 weeks
measure: Diastolic Blood Pressure
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05765227: Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens
Official title: Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Ametropia
Keywords: Presbyopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-03-13
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.

Detailed description: Subjects will be expected to attend 3 scheduled visits. Eligible subjects will wear each study lens type in a cross-over fashion for approximately 2 days.

Eligibility criteria: Key Inclusion Criteria:

* Able to understand and sign an consent form (ICF) that has been approved by an Institutional Review Board (IRB);
* Willing to stop wearing habitual contact lenses for the duration of study participation;
* Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator;
* History of refractive surgery, or plan to have refractive surgery during the study;
* Current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator;
* Monovision contact lens wear;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)
timeFrame: Day 2, each study lens type worn during the corresponding crossover period
Secondary outcomes:
Other outcomes:
Locations:
city: Johns Creek
country: United States
facility: Johns Creek Research Clinic
state: Georgia
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT00133627: Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis
Official title: Safety and Efficacy Comparison Ketotifen Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Allergic Conjunctivitis
Keywords: Allergic
Conjunctivitis
Ketotifen
Histamine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Alcon Research
First posted: 2005-08-23
Enrollment: 229
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Medications available for the treatment of seasonal allergic conjunctivitis include antihistamines. These medicines block the release of histamine, a substance in the body that is released when an allergic reaction occurs. Novartis (NVS) has developed an eye drop formulation of a well tried antihistamine called ketotifen. This study will compare the efficacy and the tolerability of ketotifen eye drops with emedastine, which is a popular treatment for seasonal allergic conjunctivitis in China.


Eligibility criteria: Inclusion Criteria:

* Age 3 years or older.
* History of seasonal allergic conjunctivitis
* Presence of bilateral ocular itching/conjunctival hyperaemia (redness) at baseline:

  1. at least intensity degree 2 for itching, and
  2. at least intensity degree 4 for composite score of itching and conjunctival hyperaemia

Exclusion Criteria:

Other systemic/ophthalmic conditions

* Presence of any form of allergic conjunctivitis other than seasonal allergic conjunctivitis (e.g. perennial allergic conjunctivitis, vernal keratoconjunctivitis, atopic keratoconjunctivitis, giant papillary conjunctivitis).
* Active bacterial or viral conjunctivitis or history of ocular herpes.
* Presence or history of severe dry eye.

Previous treatments

* Any systemic or ocular corticosteroids within two (2) weeks prior to randomization.
* Any systemic or ocular mast cell stabilizers within two (2) weeks prior to randomization.
* Any other ophthalmic medication within three (3) days prior to randomization.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Hospital of Shanghai Medical University
Study officials:
affiliation: Hospital of Shanghai Medical University
name: Sun Xinghuai
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03513627: Microvascular Reactivity of the Gingiva Around Implant Born Crown
Official title: Comparison of Microvascular Reactivity Assessed by Post-occlusive Reactive Hyperaemia Test in Gingiva at Natural Tooth and at Implant Borne Crown
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Implants
Keywords: periimplant soft tissue
gingiva
human
microcirculation
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy patients who are not taking medication, with healthy gingiva

Brief summary: Apply LSCI method for follow-up changes in regional blood flow after compression of the gingiva in order to compare the vascular reactivity of the attached gingiva at implant versus at tooth.

Detailed description: This study will examine the effects of implantation and peri-implant soft tissue shaping on the circulation and the regeneration processes of the human gingiva.

The primary aim is to determine the effect of a short term disruption of the blood flow in the gingiva next to an implant and the contralateral tooth, in order to compare the functionally active collateral circulation in the attached gingiva at these respective regions. Using Laser Speckle Contrast Imaging technique (LSCI), which provides blood perfusion data, the investigators will have the possibility to detect functional alterations in gingival microcirculation during and after a short term compression of the gingiva. The secondary aim is to assess and compare the time course of the restoration of the circulation on the affected areas. Further aims are to observe if the compensation capability of the circulation is influenced by gingival thickness (biotype) and patient's gender.

Eligibility criteria: Inclusion Criteria:

Patient with single dental implant installed in the front region of the jaw at least 6 months ago. On the contralateral side a natural tooth is located.

Exclusion Criteria:

* systemic disease
* smoking
* alcohol abuse
* pregnancy
* gingivitis
* periodontitis

Primary outcomes:
measure: Magnitude of the hyperemia after PORH test
timeFrame: 5min
Secondary outcomes:
measure: Longevity of the hyperemia after PORH test
timeFrame: 20min
measure: Size of the hyperemia after PORH test
timeFrame: 20 min
measure: Difference in the magnitude and longevity of hyperemia induced by PORH test next to an implant born crown between women and men.
timeFrame: 20 min
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Janos Vag
Study officials:
References:
Clinical trial NCT00214227: ATM Variants in Radiotherapy Patients
Official title: ATM Variants in Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiotherapy
Keywords: patient who will undergo definitive radiotherapy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 60
Sex: MALE
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: Patients who have been enrolled on RO02803.

Brief summary: The purpose of this study is to compare the baseline incidence of variant alleles in the ATM and/or other DNA repair genes present in the Native American population versus the non-Native American population. It is thought that a higher baseline incidence of the variant alleles in the ATM gene may correlate to higher rates and higher grades of radiation toxicities noted in the Native American population.


Eligibility criteria: Inclusion Criteria:

* Indication for radiotherapy.
* Ability or desire to donate a blood sample and be followed closely for radiation toxicities

Primary outcomes:
measure: to determine baseline incidence of variant alleles in ATM
timeFrame: one blood draw
Secondary outcomes:
measure: to compare the baseline incidence of variant alleles in ATM
timeFrame: one blood draw
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Mark Ritter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01637727: Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women
Official title: Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Diabetes Mellitus
Keywords: Long term effects of gestational diabetes mellitus in a population of parous women
Gestational diabetes mellitus- GDM is defined as glucose intolerance diagnosed during pregnancy and not present shortly after birth
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 324
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The proposed research format is: a case control study using a historical cohort of women diagnosed with GDM. The study group will include women who gave birth in Shaare Zedek Medical Center between the years 2000 and 2010. Women with a GDM history will be identified based on the gestational diabetes clinic files. Women without a history of GDM who will be the control group will be identified from the Shaare Zedek Medical Center birth registration records

Brief summary: The primary goal of this proposed research deals with estimating the risk of developing type 2 diabetes and metabolic syndrome in women with a history of GDM compared to women without a history of GDM. In addition, this study will attempt to evaluate the effect of parity on the late appearance of type 2 diabetes and metabolic syndrome in this unique population.


Eligibility criteria: Inclusion Criteria:

* The study group will include women who gave birth in Shaare Zedek Medical Center between the years 2000 and 2010.
* Women with a GDM history will be identified based on the gestational diabetes clinic files.
* Women without a history of GDM who will be the control group will be identified from the Shaare Zedek Medical Center birth registration records

Exclusion Criteria:

* We established the following exclusion criteria:

  * women who are diagnosed with metabolic syndrome before pregnancy or have type 1 or type 2 diabetes, and
  * women with severe chronic diseases.

Primary outcomes:
measure: Long term effects of gestational diabetes mellitus in a population of parous women
timeFrame: 24-32 months
Secondary outcomes:
measure: Long term effects of gestational diabetes mellitus in a population of parous women
timeFrame: 24-32 months.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center
name: Arnon Samueloff, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaare Zedek Medical Center
name: Sorina Grissaro Granovsky, Dr
role: STUDY_CHAIR
References: