louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00876720: Effectiveness Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus
Official title: Effectiveness of Combined Frontal and Temporal Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: Tinnitus
chronic subjective tinnitus
transcranial magnetic stimulation
sensation disorders
hearing disorders
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2009-04-07
Enrollment: 100
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: Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by hearing loss and leading to the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus.

Detailed description: Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Treatment is difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Low-frequency rTMS has been investigated for the treatment of hyperexcitability disorders such as auditory hallucinations and tinnitus. Pilot data indicate that the beneficial effect of low-frequency rTMS can be enhanced by high frequency rTMS of the left dorsolateral prefrontal cortex (DLPFC). In the proposed study we investigate whether high frequency rTMS of the DLPFC improves therapeutic efficacy of low-frequency rTMS on tinnitus in a controlled trial.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of subjective chronic tinnitus
* Duration of tinnitus more than 3 months

Exclusion Criteria:

* Objective tinnitus
* Treatable cause of the tinnitus
* Involvement in other treatments for tinnitus at the same time
* Clinically relevant psychiatric comorbidity
* Clinically relevant unstable internal or neurological comorbidity
* History of or evidence of significant brain malformation or neoplasm, head injury
* Cerebral vascular events
* Neurodegenerative disorder affecting the brain or prior brain surgery;
* Metal objects in and around body that can not be removed
* Pregnancy
* Alcohol or drug abuse
* Prior treatment with TMS

Primary outcomes:
measure: tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller
timeFrame: Baseline, Day 12
Secondary outcomes:
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University of Regensburg - Dept of Psychiatry
state: Bavaria
Study officials:
affiliation: University of Regensburg-Dept of Psychiatry
name: Berthold Langguth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01122420: Online Resources to Manage Obesity and Health Risks in an Employee Wellness Program
Official title: Online Resources to Manage Obesity and Health Risks in an Employee Wellness Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2010-05-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether different types of online health tools can aid overweight individuals in reducing their weight and managing their cardiovascular risk factors in the context of an employee wellness program.


Eligibility criteria: Inclusion Criteria:

* Vanderbilt University employee
* Completion of the 2009 Go For the Gold Health Risk Assessment (HRA)
* Obesity defined by BMI \> 30
* Identification of an additional risk factor on the HRA by either (a) a personal history of diabetes, high blood pressure, or high cholesterol or (b) a reported cholesterol \>= 240 mg/dl, blood glucose \>= 126 mg/dl, a systolic blood pressure \>= 140 mm Hg, or a diastolic blood pressure \>= 90 mm Hg
* Permission to be contacted regarding health on the HRA

Exclusion Criteria:

* Pregnant females and those who become pregnant prior to completion of the study
* Age younger than 18 years or older than 65 years
* Non English speaking individuals

Primary outcomes:
measure: Change in body mass index
timeFrame: At enrollment and at 6 months
measure: Change in excess body weight
timeFrame: At enrollment and at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Gretchen P Jackson, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06644820: Clinical Characteristics and Outcome of Patients Xith Spontaneous Pneumothorax
Official title: Clinical Characteristics and Outcome of Patients Xith Spontaneous Pneumothorax
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spontaneous Pneumothorax
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 100
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: The study will include patients ≥18 years old with spontaneous pneumothorax admitted at Sohag University Hospital

Brief summary: Pneumothorax occurs when air accumulates between the visceral and parietal pleura, and canbe defined as spontaneous, iatrogenic or traumatic. Spontaneous pneumothorax further classified as primary or secondary. Primary spontaneous pneumothorax (PSP) occur in the absence of underlying lung disease. Primary spontaneous pneumothorax is more common in men and in younger patients and associated with smoking. Secondary spontaneous pneumothorax (SSP) occur in the presence of underlying lung disease, most commonly chronic obstructive pulmonary disease, cystic fibrosis, pneumocystis pneumonia, lung cancer,and interstitial lung diseases (ILDs) in older adults.


Eligibility criteria: Inclusion Criteria:

* The study will include patients ≥18 years old with spontaneous pneumothorax admitted at Sohag University Hospital

Exclusion Criteria:

* Patients with traumatic or iatrogenic pneumothorax.

Primary outcomes:
measure: Duration of hospital stay
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.
citation: Hilliard NJ, Marciniak SJ, Babar JL, Balan A. Evaluation of secondary spontaneous pneumothorax with multidetector CT. Clin Radiol. 2013 May;68(5):521-8. doi: 10.1016/j.crad.2012.10.008. Epub 2012 Dec 5.
citation: Khusial RJ, Honkoop PJ, van der Meer V, Snoeck-Stroband JB, Sont JK. Validation of online Asthma Control Questionnaire and Asthma Quality of Life Questionnaire. ERJ Open Res. 2020 Jan 27;6(1):00289-2019. doi: 10.1183/23120541.00289-2019. eCollection 2020 Jan.
citation: Noh TJ, Lee CH, Kang YA, Kwon SY, Yoon HI, Kim TJ, Lee KW, Lee JH, Lee CT. Chest computed tomography (CT) immediately after CT-guided transthoracic needle aspiration biopsy as a predictor of overt pneumothorax. Korean J Intern Med. 2009 Dec;24(4):343-9. doi: 10.3904/kjim.2009.24.4.343. Epub 2009 Nov 27.
Clinical trial NCT03848520: Survey of Running Following a TKA
Official title: Do People Run Following a TKA? A Cross-sectional Survey Study Addressed to Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty
Knee Replacement
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Human adults that underwent a TKA at the investigator's Hospital and with data available on the Institution's Implants Registry

Brief summary: The hypothesis of this study is that there are people running following a total knee arthroplasty (TKA).

The objective is (1) to determine if there are people that ran/run following their TKA and (2), in case (1) is true, to identify some general running parameters such as duration, frequency, perceived barriers for running.

Patients with a TKA and a score equal or higher than 9 on the UCLA activity scale at any time between 2 years prior to surgery and at present will be invited to participate in the trial by phone. All these patients will receive the study's information form and questionnaire by post with a pre-stamped envelope to return the documents.The survey was created and piloted internally for this study. There are 21 questions, most of them are "yes or no" and some others open questions to assess parameters such as duration of difficulties faced. The questionnaire is composed of three parts. The first part is interested in the preoperative activity (during the 2 years before surgery), the second part in the postoperative activity (during the 2 years after surgery) and the third part refers to the current practice. For each part, people are asked about specific practice parameters and modalities. Furthermore, we seek to determine whether there was/is a willingness to run following TKA, if patients receive any education/information about it and their personal attitudes towards running with a TKA. The anonymized data will be collected by the main author for subsequent analysis.


Eligibility criteria: Inclusion Criteria:

* TKA and UCLA score = or \> 9

Exclusion Criteria:

* Inability to read/write in french language
* Cognitive or neurological impairment

Primary outcomes:
measure: Changes in number of runners following a TKA
timeFrame: From preoperatively to up to 20 years following TKA. From date of the preoperative assessment until the last clinical assessment available following TKA
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University Hospital of Lausanne
Study officials:
References:
Clinical trial NCT01985620: The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate.
Official title: The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate and Morbidity in Infants Born Premature.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prematurity
RSV
Influenza
Upper Respiratory Tract Infection
Lower Respiratory Tract Infection
Keywords: Vaccination
RSV
Influenza
Prematurity
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-11-15
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Premature infants (born before 34 wk) are routinely vaccinated against RSV but vaccination rate against influenza are low in spite of national programs. Study goal is to evaluate the effectiveness of short intervention during RSV prophylaxis visit, planned to educate parents about the importance of influenza vaccination.


Eligibility criteria: Inclusion Criteria:

* Infants coming for RSV prophylaxis

Exclusion Criteria:

* Already vaccinated against influenza
* Contraindication for influenza vaccination

Primary outcomes:
measure: Influenza vaccination rate
timeFrame: 5 months
Secondary outcomes:
measure: respiratory morbidity
timeFrame: 5 months
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
References:
Clinical trial NCT03111420: Study of AggreGuide A-100 (ADP) Assay
Official title: Pivotal Study of the AggreGuide A-100 Adenosine Diphosphate (ADP) Assay to Evaluate the Detection of Platelet Dysfunction Due to P2Y12 Antiplatelet Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Factor, Cardiovascular
Platelet Dysfunction Due to Drugs
Lead sponsor: Aggredyne, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-12
Enrollment: 280
Sex: ALL
Minimum age (years): 22
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Study to evaluate the performance of the AggreGuide A-100 ADP assay for detection of platelet dysfunction caused by P2Y12 inhibitor antiplatelet therapy.

Detailed description: Study subjects will have A-100 ADP measurements performed at baseline and after initiation of P2Y12 inhibitor antiplatelet therapy, following loading and maintenance doses.

Eligibility criteria: Inclusion Criteria:

* Subject has a history of cardiovascular disease OR
* Subject has 2 or more cardiac risk factors:

  * Smoking
  * Hypertension
  * Hyperlipidemia
  * Family History of Heart Disease
  * Post-menopausal female
  * Diabetes
  * Obesity (BMI \> 30)
  * Sedentary lifestyle

Exclusion Criteria:

Taken nonsteroidal anti-inflammatory drugs (NSAIDs) drugs, anti-platelet drugs or anticoagulant drugs within the past seven (7) days, over age 75, under 60 kg body weight, in the last trimester of pregnancy or breastfeeding, with a diagnosed history of: stroke or transient ischemic attacks, or other thromboembolic disease, anemia, thrombocytopenia, uncontrolled hypertension,platelet disorders,hemophilia or other bleeding disorder, gastrointestinal disease, severe renal disease, expect to engage in contact sports, scheduled for elective surgery, have a medical history as determined by the Investigator that would pose safety concerns, or possess contraindications for any of the study medications.

Primary outcomes:
measure: Change in Platelet Activity Index (PAI)
timeFrame: Baseline, day 1, day 7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Aggredyne, Inc.
name: Phil Speros
role: STUDY_DIRECTOR
References:
citation: Gurbel PA, Tantry US, Bliden KP, Fisher R, Sukavaneshvar S, Dahlen J, Speros PC. Clinical validation of AggreGuide A-100 ADP, a novel assay for assessing the antiplatelet effect of oral P2Y12 antagonists. J Thromb Thrombolysis. 2021 Jul;52(1):272-280. doi: 10.1007/s11239-021-02498-0. Epub 2021 Jun 18.
Clinical trial NCT01000220: Evaluation of Omeprazole Effect on Glaucoma
Official title: Evaluation of Omeprazole Effect on Glaucoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Glaucoma
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Ophthalmic Research Center
First posted: 2009-10-22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Omeprazole is a safe drug listed in OTC drug due to its safety. It acts by irreversible inhibition of K/H ATP ase pump and also Na/K ATP ase, Na/H ATP ase.Considering these actions the effect of omeprazole on decreasing intra ocular pressure is an issue of debate.In this Randomized Clinical Trial conducted in labafinejad hospital, patients with glaucoma who need to take omeprazole due to GI problem are evaluated in two groups including placebo and drug users. The effect will be finally assessed.

Detailed description: Omeprazole is a safe drug listed in OTC drug due to its safety. It acts by irreversible inhibition of K/H ATP ase pump and also Na/K ATP ase, Na/H ATP ase.Considering these actions the effect of omeprazole on decreasing intra ocular pressure is an issue of debate.In this Randomized Clinical Trial conducted in labafinejad hospital, patients with glaucoma who need to take omeprazole due to GI problem are evaluated in two groups including placebo and drug users. The effect will be finally assessed.

Eligibility criteria: Inclusion Criteria:

* patients with glaucoma
* 18 to 70 years
* POAG patients, Pseudoexfoliation
* no history of other systemic disease
* no history of intraocular intervention
* no history of H2 blocker or PPI consumption during the past month consuming 2 or less topical anti-glaucoma medication
* no present immune deficiency
* no addiction habit

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT00048620: Study of Recombinant Human N-Acetylgalactosamine 4-Sulfatase in Patients With MPS VI
Official title: Double-Blind,2 Dose Group Study of Recombinant Human N-Acetylgalactosamine 4-Sulfatase in Patients With MPS VI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mucopolysaccharidosis VI
Lead sponsor: BioMarin Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2002-11-06
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety, efficacy and pharmacokinetics of two dose levels of weekly intravenous infusions of recombinant human N-acetylgalactosamine 4-sulfatase (rhASB) for a minimum of 24 weeks in patients diagnosed with MPS VI.


Eligibility criteria: Inclusion Criteria:

* Patient consent
* Patient must be five years of age or older
* Patient must have documented diagnosis of MPS VI, confirmed at screening by measurable clinical signs and symptoms of MPS VI
* Leukocyte ASB enzyme activity level less than 20% of the normal range
* Clinical evidence of significant MPS VI disease that provides adequate opportunity to achieve quantitative, short-term therapeutic benefit in three or more of the following parameters: endurance (as measured by a six-minute walk test), forced vital capacity (as measured by spirometry), joint range of motion, urinary glycosaminoglycans, and hepatomegaly.
* Ability to perform all protocol tests
* Ability to stand independently for six minutes
* Sexually active subjects must agree to use an adequate form of contraception

Exclusion Criteria:

* History of bone marrow transplantation
* Pregnant or lactating patient
* Use of an investigational drug or device within 30 days prior to study participation.
* A medical condition, serious intercurrent illness, or other extenuating circumstances that may significantly decrease study compliance including prescribed follow-up
* Known hypersensitivity to rhASB or to components of the study drug
* History of cancer (except low grade and fully resolved skin malignancy)

Primary outcomes:
measure: Lysosomal storage disease
Secondary outcomes:
Other outcomes:
Locations:
city: Novato
country: United States
facility: BioMarin Pharmaceutical Inc.
state: California
Study officials:
affiliation: BioMarin Pharmaceutical
name: Stuart J Swiedler, MD, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01093820: Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction
Official title: Documentation of Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction (BEAT-STEMI Pilot)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myocardial Infarction
Keywords: acute myocardial infarction
continuous erythropoetin receptor activator
Mircera
hemoglobin kinetics
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2010-03-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypothesis:

Based on available pharmacokinetic data from healthy volunteers we hypothesize that the administration of a cumulative dose of 210μg of the continuous erythropoietin receptor activator, Mircera® (Roche), during 3 months post percutaneous coronary intervention (PCI) does not result in hemoglobin (Hb) levels \>15 g/dl in patients with ST-segment elevation myocardial infarction (STEMI)

Design:

Prospective, open label single center pilot study

Detailed description: This pilot trial will include 8 patients. The inclusion of 8 patients will allow to perform representative statistics of expected Hb kinetics in response to Mircera®.

Eligibility criteria: Inclusion Criteria:

* Patients (age 18 - 80 years) with acute STEMI undergoing PCI

Main Exclusion Criteria:

* Hemoglobin levels \>15g/dL
* history of a myeloproliferative syndrome
* thrombolysis for index infarction
* anticipated additional revascularization within 3 months
* cardiogenic shock

Primary outcomes:
measure: Proportion of patients exceeding Hemoglobin (Hb) of 15 g/L within 3 months
timeFrame: three months
Secondary outcomes:
measure: Maximal change in Hb within 3 months relative to baseline
timeFrame: three months
measure: Relative change in Hb from baseline to 1 months
timeFrame: first month
measure: Maximal change in Hematocrit (Hk) within 3 months relative to baseline
timeFrame: three months
measure: change in platelet count within 3 months relative to baseline
timeFrame: three months
measure: Safety endpoints including all cause mortality,myocardial infarction,stroke,hospitalization,life threatening arrhythmias,thromboembolic events,stent thrombosis,poorly controlled hypertension despite therapy,seizures
timeFrame: three months
measure: Relative change in Hb from 1 to 2 months
timeFrame: second month
measure: Relative change in Hb from 2 to 3 months
timeFrame: third month
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Matthias Pfisterer, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06702020: VIS Opti-K Vision Improvement for Presbyopes
Official title: VIS Opti-K Vision Improvement for Presbyopes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Presbyopia Correction
Lead sponsor: VIS, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-22
Enrollment: 135
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients had documented presbyopia and a need for near vision improvement

Brief summary: The VIS Opti-K device and procedure were used to provide vision improvement to patients with presbyopia.

Detailed description: The VIS Opti-K device was used to irradiate the cornea with light that changed corneal shape.

Eligibility criteria: Inclusion Criteria:

Female or male Any race 40 years of age or older Presbyopia

Exclusion Criteria:

None

-

Primary outcomes:
measure: Uncorrected distance and near visual acuities
timeFrame: Up to 24 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: VIS, Inc.
name: Michael J Berry, PhD
role: PRINCIPAL_INVESTIGATOR
References: