louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00697281: OC000459 Dose Finding Study in Hay Fever Sufferers.
Official title: A Dose Finding Study Of The Effects Of OC000459 On Responses To Allergen Challenge In The Vienna Chamber In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Keywords: allergic rhinitis
human
clinical trial
efficacy
safety
challenge test
Lead sponsor: Oxagen Ltd
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate a range of dose levels for efficacy in the control of symptoms of allergic rhinitis

Detailed description: This will be a randomised, double blind, placebo controlled, parallel group evaluation of OC000459 given orally for eight days. Four dose levels will be studied and compared to placebo. They will be studied in treatment groups of 18 to 21 subjects. The placebo group will also consist of 18 to 21 subjects. There will be a screening period of up to six weeks. There will be a follow up one to three weeks after the last dose of study drug.

Eligibility criteria: Inclusion Criteria:

* Males and females aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.
* Females of childbearing potential (i.e. having had a menstrual period within two years prior to the date of screening) must practise two forms of contraception and must have a negative pregnancy test (blood or urine) at screening.
* Acceptable contraception includes the use of TWO of the following:

  * oral contraception (i.e. the Pill);
  * intrauterine device (an IUD or 'Coil');
  * barrier contraception (i.e. condoms or diaphragm/cap);
  * transdermal patch

Exclusion Criteria:

* Medical conditions likely to affect the outcome of the study.
* Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases as determined by the principal investigator or designee.
* Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (defined as FEV1 ≥ 90% predicted for height and age).
* Immunotherapy treatment course in the past 28 days
* Use of inhaled or local corticosteroids in the past 28 days.

Primary outcomes:
measure: Total nasal symptom score (TNSS)
timeFrame: After 8 days of treatment
Secondary outcomes:
measure: Other symptom scores of allergic rhinitis
timeFrame: After 8 days of treatment
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Allergie Zentrum Wien West, Vienna Challenge Chamber
Study officials:
affiliation: Allergie Zentrum Wien West
name: Univ Prof. Dr. Friedrich Horak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01699581: Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant
Official title: Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hodgkin's Lymphoma
Multiple Myeloma
Non-Hodgkin's Lymphoma
Keywords: Hodgkin's Lymphoma
Multiple Myeloma
Non-Hodgkin's Lymphoma
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Nestle Impact has shown efficacy in multiple surgical trials in relation to improving hospital length of stay and infection rate. 1 dose of Nestle Impact Advanced Recovery will be taken orally three times a day beginning on the morning following stem cell transplant and will continue until the day of hospital discharge.


Eligibility criteria: Inclusion Criteria:

* Patients receiving an autologous stem cell transplant using the preparative regimens of BEAM (Carmustine, Etoposide, Cytarabine, Melphalan), Melphalan 140mg/m2, or Melphalan 200mg/m2
* Any prior diet or supplement will be allowed.
* Age \>18 years.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nestle Impact including fish oil.

Primary outcomes:
measure: Hospital length of stay
timeFrame: Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge
measure: Days to engraftment
timeFrame: Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky, Markey Cancer Center
state: Kentucky
Study officials:
affiliation: Lucille P. Markey Cancer Center at University of Kentucky
name: Greg Monohan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00745381: A Collection of Clinical and Epidemiologic Data Combined With Tissue and Blood From Patients With a Diagnosis of Neuroendocrine Tumors
Official title: Gastroenteropancreatic and Unknown Primary Neuroendocrine Registry A Collection of Clinical and Epidemiologic Data Combined With Tissue and Blood From Patients With a Diagnosis of Neuroendocrine Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Pancreatic Cancer
Keywords: PANCREAS
STOMACH
Questionnaire
08-105
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with GEPNET or NET of unknown primary

Brief summary: The purpose of this study is to establish a neuroendocrine tumor registry. A registry is a collection of information. To create this registry, the investigators would like to get information, blood and tumor samples from people with neuroendocrine tumors. By collecting this information and material, the investigators are hoping to learn more about the genetic causes of neuroendocrine tumors. All of this will help us to better understand neuroendocrine cancer, so the investigators can find better ways to treat and diagnose this disease. DNA will be taken from the blood samples and will be used in future studies. This will be an important resource from which the investigators can study genes that may be related to a higher risk of neuroendocrine tumors.

The information collected will include medical information, family history of cancer and your answers to questions about how the cancer affects quality of life.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of gastroenteropancreatic neuroendocrine tumors or neuroendocrine tumors of unknown primary
* Willing to donate blood samples
* \>= 18years old
* Patients may have received prior hormonal therapy, cytotoxic therapy, irradiation, immunotherapy or surgical therapy

Exclusion Criteria:

* Have any condition, which in the opinion of the primary MSKCC clinician or investigators precludes their ability to provide informed consent

Primary outcomes:
measure: To develop a tissue, serum, plasma and DNA bank from individuals with NET. This bank will be combined with epidemiologic and clinical information to create a NET database.
timeFrame: conclusion of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan-Kettering Cancer Center at Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan-Kettering Cancer Center at Commack
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Diane Reidy-Lagunes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02215681: Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study
Official title: Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Otitis Media With Effusion
Keywords: otitis media with effusion
acupuncture
inflammatory markers
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2014-08-13
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective: to evaluate acupunctures effect on inflammatory markers in pediatric Otitis Media with Effusion Methods: 100 Children with otitis media with effusion (OME) diagnosis, who are in watchful waiting for 3 month, will be randomized in two groups: acupuncture and control. 50 Children in the acupuncture group will receive standard treatment combined with acupuncture for 3 months. 50 Children in the control group will receive standard treatment only, for the same time period. After 3 months, both groups will be reassessed for OME. Children with no improvement from both groups will be assigned for tympanostomy.

Data collection: in children undergoing tympanostomy, middle ear effusion (MEE) will be collected, analyzed and evaluated for group differences.


Eligibility criteria: Inclusion Criteria:

* otherwise healthy children ages 2-8 years
* autoscopic OME diagnosis
* tympanometry type B
* conductive hearing impairment of 30 decibel or more
* who are at watchful waiting treatment for 3 months
* signed parental consent.

Exclusion Criteria:

* lack of parental consent
* known coagulopathy
* past tympanostomy
* regular intake of steroids or cytotoxic drugs

Primary outcomes:
measure: presence of inflammatory markers in middle ear effusion
timeFrame: 3 months
Secondary outcomes:
measure: acupuncture effect on OME
timeFrame: 3 months
Other outcomes:
measure: acupuncture acceptance
timeFrame: 3 months
Locations:
city: Zefat
country: Israel
facility: Ziv Medical Center
Study officials:
affiliation: Ziv Medical Center
name: peter Gilbey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05149781: Standardized Diagnosis and Treatment of Endocrine Hypertension
Official title: Standardized Diagnosis and Treatment of Endocrine Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endocrine Hypertension
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with endocrine hypertension or primary hypertension treated at Affiliated Hospital of Nantong University between 2021 and 2024

Brief summary: Cases of endocrine hypertension or primary hypertension who have signed informed consent will be collected. Patients with endocrine hypertension will be divided into surgical treatment group and drug treatment group according to actual treatment situation. A database will be established for all patients. The investigators will comprehensively evaluate the general conditions, past medical history, metabolic and biochemical indicators, psychological status, cardiovascular risk factors. All the patients will be followed up for 12 months at baseline, 6 months and 12 months. Clinical data and specimen will be collected.

Detailed description: The investigators will collect 100 patients with secretory hypertension and 100 patients with essential hypertension. Patients with endocrine hypertension will be divided into surgical treatment group and drug treatment group according to actual treatment situation. Resected specimens from surgical patients will be used for immunohistochemistry and western blot. A database will be established for all patients to assess their general situation, past medical history, metabolic and biochemical indicators, psychological status, cardiovascular risk factors, etc. The investigators expect to find more accurate screening indicators from blood and urine specimens. All the patients will be followed up for 12 months at baseline, 6 months and 12 months. Blood pressure, degree of atherosclerosis, biochemical markers, hormone levels and cardiac function indicators will be measured at three time points.

Eligibility criteria: Inclusion Criteria:

age≥18 years

Exclusion Criteria:

1. myocardial infarction
2. congestive heart failure
3. stroke

Primary outcomes:
measure: The control rate of blood pressure
timeFrame: 12 months
Secondary outcomes:
measure: Changes of carotid imima-media thickness
timeFrame: 12 months
Other outcomes:
Locations:
city: Nantong
country: China
facility: Gu Yunjuan
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Gu Yunjuan, M.D/Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03952481: Effect of Lifitegrast 5% on Tear Film Markers
Official title: Improvement in Markers of Tear Film Instability After Initiation of Lifitegrast 5% Ophthalmic Solution: A Prospective Interventional Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Dry Eye
Dry Eye Syndromes
Dry Eyes Chronic
Keywords: Dry Eye
Lifitegrast
Xiidra
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2019-05-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the duration of time (in weeks) for improvement in objective dry eye markers for people who are placed on lifitegrast 0.5% (Xiidra®), an FDA-approved therapy for dry eyes.


Eligibility criteria: Inclusion Criteria:

* Signs or symptoms of Dry Eye Disease
* 18 years or older
* Abnormal MMP9 (positive as read by 2 blinded investigators with both in agreement) and/or Abnormal tear osmolarity (greater than or equal to 308 or an inter-eye difference \>=8 mOsm/mL)

Exclusion Criteria:

* Active eye infection. Patients with blepharitis may be enrolled.
* Any eye drop that was instilled within 2 hours of the Baseline eye exam
* Current contact lens wearer. Subjects who have not worn contact lenses 30 days prior to baseline and have no intention to wear CLs during the study duration may enroll.
* History of ocular herpes simplex
* Active episcleritis, scleritis, iritis or uveitis
* Active keratitis secondary to any etiology other than dry eyes
* History of refractive surgery (LASIK or PRK) or penetrating corneal transplant (PK)
* Uses eye drops (ex. glaucoma or allergy drops) for indications other than dry eyes
* Active allergic conjunctivitis
* Current use of punctal plugs or anticipation of use during the study
* Use of topical ophthalmic steroids within 14 days of the Baseline Visit or anticipated use during the study
* Use of lifitegrast 5% or Restasis within 30 Days of the Baseline Visit.
* Allergy to lifitegrast 5%

Primary outcomes:
measure: The change in proportion of subjects demonstrating improved tear film osmolarity
timeFrame: Baseline, Weeks 1, 2, 3 and 4
Secondary outcomes:
measure: The proportion of subjects demonstrating normal Matrix Metallopeptidase 9 (MMP9).
timeFrame: Week 4
measure: The proportion of subjects demonstrating normal Tear Break-Up Time (TBUT).
timeFrame: Week 4
measure: The proportion of subjects demonstrating normal corneal fluorescein staining.
timeFrame: Week 4
measure: The proportion of subjects demonstrating improvement in their symptoms as measured by the modified SANDE Questionnaire.
timeFrame: Week 4
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Ophthalmology
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Christopher Starr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03212781: Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women
Official title: Total Dose Infusion of Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Iron deficiency is the most prevalent nutritional deficiency and the most common cause of anemia .It is characterized by a defect in hemoglobin synthesis, resulting in red blood cells that are abnormally small (microcytic) and contain a decreased amount of hemoglobin (hypochromic).


Eligibility criteria: Inclusion Criteria:

* Hemoglobin \< 10 g/dL
* Gestational age between 14-28 weeks.
* Willingness to participate and signing the informed consent form.

Exclusion Criteria:

* Iron overload or disturbances in utilization of iron
* Decompensated liver cirrhosis and active hepatitis
* Active acute or chronic infections
* History of multiple allergies
* Known hypersensitivity to parenteral iron or any recipients in the investigation drug products
* Erythropoietin treatment within 8 weeks prior to the screening visit
* Other iron treatment or blood transfusion within 4 weeks prior to the screening visit
* Planned elective surgery during the study.

Primary outcomes:
measure: The change in Hemoglobin concentration from baseline to 8 weeks therapy
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT02805881: Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
Official title: Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Neurolief Ltd.
Sponsor class: INDUSTRY
First posted: 2016-06-20
Enrollment: 28
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: Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)


Eligibility criteria: Inclusion Criteria:

* The subject is capable of understanding the study and to sign an informed consent.
* Subject is between the ages of 18 to 65 years old.
* Unipolar major depressive disorder
* Score on the Hamilton Depression Rating Scale (HDRS21) \> 22
* Current MDD episode \>3 months
* Nonresponse with \>6 week use of one to six antidepressant in current episode

Exclusion Criteria:

* History of neurosurgical interventions.
* Subjects with metal implants or shrapnel in their head, except for dental implants.
* Skin lesion or inflammation at the region of the stimulating electrodes.
* Pregnancy or Lactation.
* Women of reproductive age not using efficient contraceptive method.
* History of cerebrovascular event.
* Psychotic or bipolar depression
* History of schizophrenia, schizoaffective disorder or other non-mood disorder psychosis
* Current delirium, dementia, amnestic disorder or other cognitive disorders
* Clinically significant current suicidal intent as assessed by the investigator team.
* Obsessive-compulsive disorder or post-traumatic stress disorder
* Alcohol and non-alcohol psychoactive substance abuse or dependence
* Significant cardiac, medical, or progressive neurological or medical illness
* An implantable electrical device such as a pacemaker.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 6 weeks
measure: Hamilton Depression Rating Scale (HDRS21)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ness Ziona
country: Israel
facility: Beer- Yakov Nees-Ziona Mental Health Center
Study officials:
affiliation: Deputy Director, Beer- Yakov Nees-Ziona Mental Health Center
name: Hilik Levkovitz, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02210481: The Role of Intravitreal Glucose in Macular Thinning Following Surgery for Retinal Detachment or Epimacular Membrane
Official title: Impact of Intravitreal Glucose Rate in Macular Thinning Following Retinal Detachment or Epimacular Membrane Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitrectomy
Macular Thinning
Keywords: vitrectomy,
macular thinning,
retinal detachment,
epimacular membrane,
intravitreal glucose,
OCT
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2014-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cohort composed of patients undergoing vitrectomy for retinal detachment or epimacular membrane at Reims University Hospital

Brief summary: Comparison between intravitreous glucose rate and macular thinning measured by Ocular Coherence Tomography (OCT) at 3 months post vitrectomy for retinal detachment or epimacular membrane. Hypothesis : Association between post-operative macular thickness and intravitreous glucose rate

Detailed description: Comparison between intravitreous glucose rate and macular thinning measured by OCT at 3 months post vitrectomy for retinal detachment or epimacular membrane. The cohort is divided in 2 groups, one with the thinnest macular measurement under 190µm, and the others above 190µm. We are looking for a correlation between increasing glucose rates and decreased macular thickness.

Eligibility criteria: Inclusion Criteria:

* patient who underwent vitrectomy for retinal detachment or epimacular membrane

Exclusion Criteria:

* patient suffering of diabetes,
* recurrence of retinal detachment,
* age-related macular degeneration,
* post surgical macular oedema

Primary outcomes:
measure: macular thickness measured by OCT
timeFrame: 3 months post-operatively
Secondary outcomes:
measure: visual acuity
timeFrame: 3 months post-operatively
Other outcomes:
Locations:
city: Reims
country: France
facility: Centre Hospitalier Universitaire de Reims
Study officials:
References: