louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004396: Studies in Porphyria III: Heme and Tin Mesoporphyrin in Acute Porphyrias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Porphyria
Keywords: inborn errors of metabolism
porphyria
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 1999-10-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Compare the efficacy of heme arginate, singly or in combination with tin mesoporphyrin, in lowering porphyrin precursors in patients with asymptomatic acute intermittent porphyria.

II. Evaluate and compare the safety and tolerability of these treatment regimens in this patient population.

Detailed description: PROTOCOL OUTLINE: This is an unblinded, dose ranging study. Patients receive heme arginate alone or in combination with tin mesoporphyrin.

Patients receive tin mesoporphyrin IV as a single dose. Heme arginate is administered as a single intravenous infusion.

Patients are entered in cohorts of 4. Subsequent cohorts of 4 patients each receive escalating doses of tin mesoporphyrin in combination with 1 of 2 different dosages of heme arginate. Subjects must maintain a constant diet.

Patients experiencing adverse reactions are followed as clinically indicated.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Documented acute intermittent porphyria in remission for at least 1 month
* Increased excretion of porphyrin precursors
* Absence of neurovisceral symptoms due to porphyria for at least 1 month

--Prior/Concurrent Therapy--

* At least 1 month since prior heme preparation therapy
* Concurrent medication for coexisting condition is allowed, as long as dose and pattern of administration is held constant during study

--Patient Characteristics--

* Renal: Urinary porphobilinogen excretion of at least 20 mg every 24 hours
* Other: Not pregnant Fertile female patients must use effective contraception during and at least 6 months before study At least 1 month since any symptoms of disease No concurrent acute hemorrhagic disorder such as: Gastrointestinal bleeding Intracerebral hemorrhage No known hypersensitivity to heme arginate, tin mesoporphyrin, another heme preparation, or related heme analogue No other condition that may increase risk to patient

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Rockefeller University Hospital
state: New York
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Karl Elmo Anderson
role: STUDY_CHAIR
References:
Clinical trial NCT01171196: Questionnaires to Identify Chinese Patients at Risk for Obstructive Sleep Apnea
Official title: Validation of Questionnaires to Identify Chinese Patients at Risk for Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: Sleep Apnea
Questionnaire
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2010-07-28
Enrollment: 378
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: Subjects who are referred to have a diagnostic polysomnography (PSG) will be recruited from the Sleep Disorders Centre, Department of Medicine, Queen Mary Hospital.

Brief summary: The purpose of this study is to validate the Berlin questionnaire and STOP-BANG (snore, tired, obstruction, pressure, body mass index (BMI), age, neck, gender) as effective screening tools for Chinese subjects who are suspected to have obstructive sleep apnea (OSA).

Detailed description: Obstructive sleep apnea (OSA) is a common sleep related breathing disorder associated with excessive daytime sleepiness and cardiovascular disease. It is prevalent in both western (4-26%) and eastern countries (4-19%). In recent studies, it has been estimated that at least 70-80% of middle aged individuals with sleep apnea are undiagnosed and untreated. The prevalence of undiagnosed OSA subjects within the community suggests the need for a greater awareness and a high index of suspicion of this disease entity as well as its associated short- and long-term comorbidities.

A reliable and easy-to-use screening questionnaire is required for efficient prediction of OSA and treatment arrangement. It would be helpful to prioritize patients who require sleep study according to the probability of suffering from sleep apnea. It reduces the use of sleep study for those with low probability of having OSA, but giving treatment to those who are with more severe OSA first. Meanwhile, it enhances the cost effective management of disease especially with limited resources in our society.

Eligibility criteria: Inclusion Criteria:

a. No known history of any sleep disorder

Exclusion Criteria:

1. History of heavy alcoholism ( ≥ 3 times / week)
2. Underlying pulmonary diseases
3. Recent upper respiratory tract infection in the past one week
4. Unstable medical conditions
5. Pregnancy
6. History of psychiatric illness

Primary outcomes:
measure: To validate the Berlin questionnaire and STOP-BANG as effective screening tools
timeFrame: at the time of completing the questionnaire
Secondary outcomes:
measure: the predictive performance on OSA of Berlin questionnaire and STOP-BANG
timeFrame: at the time of completing questionnaire
Other outcomes:
Locations:
city: Hong Kong Island
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Agnes YK Lai, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00931996: Oculomotor and Spatial Cognition Deficits in Schizophrenia
Official title: Clinical and Computational Studies of Dopamine Function in Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
antipsychotic
risperidone
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-07-02
Enrollment: 12
Sex: ALL
Minimum age (years): 15
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: DESCRIPTION: (Verbatim from the Applicant's Abstract) Abnormalities of eye movement control and spatial cognition are well-established deficits in schizophrenia. However, the regional disturbances in brain function causing these deficits are not yet known. This application proposes a series of integrated behavioral studies designed to identify causes of deficits in schizophrenia.

Detailed description: We will be assessing clinical symptoms and cognition before and after treatment.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria: Inclusion criteria for this study are (1) able and willing to give written informed consent; (2) no contraindications to MRI (cardiac pacemaker, aneurysm clip, cochlear implants, IUD, shrapnel, history of metal fragments in eyes, neurostimulators or other metal devices, weight of 250lbs or more, claustrophobia) and (3) medically stable. Sedation will not be used for MRI studies because cooperation is essential.

Exclusion Criteria:

* Any subject is excluded from the imaging studies if they have any contraindications to MRI such as cardiac pacemaker, aneurysm clip, cochlear implants, pregnancy in the later stages (because of body size and limited comfort for MRI studies), IUD, shrapnel, history of metal fragments in eyes, neurostimulators, weight of 250 lbs. or more, or claustrophobia. Individuals with mental retardation, neurologic disease or significant medical illness that might effect neuronal or vascular physiology will not be recruited.

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS) Score Change From Baseline.
timeFrame: Baseline and 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: UIC Center for Cognitive Medicine
state: Illinois
Study officials:
affiliation: UIC/UTSW
name: John A Sweeney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00245596: Evaluation of the Index of Sexual Life Questionnaire
Official title: An Open Label, Multicenter Study to Measure Treatment Responsiveness of Quality of Sexual Life Questionnaire in the Female Partner of Men With Erectile Dysfunction Treated With Viagra (Sildenafil Citrate)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impotence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-28
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the sensibility of the ISL questionnaire.


Eligibility criteria: Inclusion Criteria:

ED patient must:

* Be male, 18 years of age with no upper age limit;
* Have a documented clinical diagnosis of erectile dysfunction confirmed by an Erectile Function (IIEF) score 25. Erectile dysfunction is defined as "the inability to achieve and/or maintain an erection of the penis sufficient to permit satisfactory sexual performance" (Impotence-NIH Consensus Conference, JAMA 1993, 270: 83-90);
* Have a stable female partner for at least 6 months prior to screening.

Exclusion Criteria:

* Have a known hypersensitivity to sildenafil or any component of the study medication; medical history of treatment-related intolerable side effects to sildenafil
* Be currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or intermittent basis.

Primary outcomes:
measure: Treatment responsiveness of a new quality of sexual life questionnaire for female partners of men with erectile dysfunction.
Secondary outcomes:
measure: The correlation between ED patients' partner quality of sexual life changes and patient's efficacy measures and these changes and patient reported outcomes of self-esteem
Other outcomes:
Locations:
city: Amphion-Les-Bains
country: France
facility: Pfizer Investigational Site
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: La Rochelle
country: France
facility: Pfizer Investigational Site
city: Lille
country: France
facility: Pfizer Investigational Site
city: Lyon Cedex 03
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: PARIS Cedex 13
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Saint-Emilion
country: France
facility: Pfizer Investigational Site
city: Thionville
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06112496: Effect of Smartphone Addiction on Myoelectrical Activity of Sternocleidomastoid Muscle in Adult
Official title: Effect of Smartphone Addiction on the Myoelectrical Activity of the Sternocleidomastoid Muscle in Adult
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heavy Smart Phone Users
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: smart phone users

Brief summary: This study will be conducted to identify the effect of smartphone addiction myoelectrical activity on sternocleidomastoid in adults by measuring The amplitude of EMG signals of the sternocleidomastoid muscle in adults and Root mean square of EMG signals of the sternocleidomastoid muscle in adults


Eligibility criteria: Inclusion Criteria:

* Subject's age range from 18-30 years old
* All participants use the same smartphone with a touch screen of 6,7 inches.

Exclusion Criteria:

* Neck pain ( spondylosis, spondylolysis)
* Systemic diseases.
* Spinal deviation

Primary outcomes:
measure: Changes in surface electromyographic (EMG) amplitude of sternocleidomastoid muscle
timeFrame: day 1
measure: change in RMS
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Huda Adel
Study officials:
References:
Clinical trial NCT03143296: Reverberation Effects on MED-EL Recipients
Official title: The Effects of Reverberation on Speech Understanding in MED-EL Cochlear Implant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Med-El Corporation
First posted: 2017-05-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate speech understanding in simulated reverberant environments with MED-EL cochlear implant recipients.

Detailed description: The study will determine if electrode length and coding strategy effect performance. The investigator will also study performance over time with new recipients.

Eligibility criteria: Inclusion Criteria:

* MED-EL current cochlear implant recipients of the Flex 24 or 28 will be included
* Minimum of 6 months experience with their cochlear implant
* Minimum of 10 new adult Med-El recipients of the Flex 24 or Flex 28 electrodes
* Patient at the University of Miami

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)

Primary outcomes:
measure: Speech Performance
timeFrame: Up to six months
measure: Coding strategy
timeFrame: Two hours
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Department of Otolaryngology
state: Florida
Study officials:
affiliation: University of Miami
name: Sandra Prentiss, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03130296: Genotyping FcɣRs Genes of HIV-1 Patients "Progressor": Correlation With the Changing Profile of the Infection
Official title: Genotyping FcɣRs Genes of HIV-1 Patients "Progressor": Correlation With the Changing Profile of the Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infection
Keywords: HIV infection
Fc receptor polymorphism (FcR)
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 230
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 infected with HIV-1 having progressed in clinical (stage C) or biologically (CD4 nadir \<350 / mm3 and viral load\> 10,000 copies / ml)

Brief summary: This non-interventional study aims to determine whether there is a correlation between the Fc receptor polymorphism (FcR) and the course of the disease following HIV infection.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 or older,
* Patient affiliated to a social security scheme,
* Informed consent dated and signed by the investigating physician the patient,
* Patients infected with HIV-1 having progressed in clinical (stage C) or biologically (CD4 nadir \<350 / mm3 and viral load\> 10,000 copies / ml)

Exclusion Criteria:

* Impossibility of giving the subject informed information (subject in an emergency situation, difficulty in understanding the subject, ...)
* Subject under safeguard of justice,
* Subject under tutelage or under curatorship,

Primary outcomes:
measure: Correlation research between Fc receptor polymorphism (FcR) and the course of disease following HIV infection.
timeFrame: After infection, up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Le Trait d'Union - Centre de soins de l'infection par le VIH au NHC
Study officials:
affiliation: University Hospital, Strasbourg, France
name: David REY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04904796: Effects of Constraint-induced Movement Therapy With Home-based Hand-arm Bimanual Intensive Therapy in Children With Unilateral Cerebral Palsy
Official title: Effects of Constraint-induced Movement Therapy With Home-based Hand-arm Bimanual Intensive Therapy in Real-world Bimanual Hand Use in Children With Unilateral Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy, Spastic Hemiplegic
Keywords: Constraint-Induced Movement Therapy
Home-based Hand-arm Bimanual Intensive Therapy
Unilateral Cerebral Palsy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 22
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the therapeutic effects of constraint-induced movement therapy (CIMT) with home-based hand-arm bimanual intensive therapy (H-HABIT) with unilateral cerebral palsy. Half of the participants will receive CIMT and H-HABIT and others will only receive CIMT.


Eligibility criteria: Inclusion Criteria:

* Age 4 to 12 years
* MACS level 1-3
* Diagnosed with unilateral CP due to central nervous system lesions

Exclusion Criteria:

* Severe cognitive dysfunction that rendered them unable to perform simple tasks (e.g., reaching, grasping
* Untreated seizures
* Visual or auditory problems interfering with treatment
* Prior history of musculoskeletal disorders.
* MACS level 4-5

Primary outcomes:
measure: Change from Assisting Hand Assessment (AHA) score at 2-month follow-up test
timeFrame: baseline and 2 months
Secondary outcomes:
measure: Change from Baseline Pediatric Motor Activity Log (PMAL) score at 2-month follow-up test
timeFrame: baseline and 2 months
measure: Change from Baseline Melbourne Assessment 2 (MA2) score at 2-month follow-up test
timeFrame: baseline and 2 months
measure: Change from Canadian Occupational Performance Measure (COPM) score at 2-month follow-up test
timeFrame: baseline and 2 months
measure: Change from Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score at 2-month follow-up test
timeFrame: baseline and 2 months
measure: Change from baseline Use ratio(Accelerometer) at 2-month follow-up test
timeFrame: baseline and 2 months
measure: Change from baseline Magnitude ratio(Accelerometer) at 2-month follow-up test
timeFrame: baseline and 2 months
measure: Change from baseline Bilateral magnitude(Accelerometer) at 2-month follow-up test
timeFrame: baseline and 2 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT03271216: Surveillance Monitoring on General Wards
Official title: Surveillance Monitoring on General Wards
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Masimo Corporation
First posted: 2017-09-05
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-surgical patients on a general hospital ward

Brief summary: This is a study to determine if surveillance monitoring of general ward patients can reduce cardio-pulmonary arrest while maintaining an acceptable false alarms rate for nursing workload.

Detailed description: The investigators placed a wired monitoring system (pulse oximetry, heart rate and respiratory rate) on every patient who arrived on a subject general post surgical ward who assented to wear the system. this was the Masimo PSNET system using the Radical 87 monitor and an acoustic respiratory sensor along with a Masimo pulse oximetry probe. Patients were monitored for a minimum of 48 hrs. Heart Rate (HR) parameters were set between 45-130, Respiratory rate was set between 6-20 and pulse oximetrry was 85-100%. Nurses documented in the Electronic Medical Record (EMR) any alarms they responded to as to whether they were false (vital sign not out of range when rechecked) or true and what the response was. Responses ranged from nurse managed to notification of primary service to Rapid Response Activation to Code team activation as well as transfer to a higher level of care (operating room or Intensive Care Unit (ICU)/IMC. Patient and Nursing satisfaction surveys were collected.

Eligibility criteria: Inclusion Criteria:

* all post-surgical patients admitted to a post-operative general hospital ward

Exclusion Criteria:

* inability to understand English or provide verbal consent for data analysis

Primary outcomes:
measure: positive predictive value (PPV)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02941016: Vascular Inflammation and Cholesterol Lowering Therapy
Official title: Vascular Inflammation and Cholesterol Lowering Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Lipid Lowering, Vascular Inflammation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-10-21
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: OTHER

Brief summary: This study aim to detect change in vascular inflammation following intense lipid lowering therapy


Eligibility criteria: Inclusion Criteria:

* treatment with PCSK-9 inhibitors

Exclusion Criteria:

* Infection Pregnancy Severe claustrophobia Weight \>140 kg

Primary outcomes:
measure: Change in vascular inflammation
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Rasmus S Ripa, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: