louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02108483: Phototoxicity Test of Dapsone Gel in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
Collaborators: name: Allergan
First posted: 2014-04-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the potential of dapsone gel and its vehicle to cause a phototoxic reaction following irradiation of the skin under controlled conditions.


Eligibility criteria: Inclusion Criteria:

-Healthy adults.

Exclusion Criteria:

* Skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application
* Sensitivity to adhesive bandages or tape.

Primary outcomes:
measure: Phototoxicity Irritation Potential Using a Visual Scale
timeFrame: 4 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Fair Lawn
country: United States
state: New Jersey
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04129983: Treatment of Sudden Deafness With Prednisone+Hyperbaric Oxygen and Prednisone+Somatosensory Stimulation
Official title: Prospective Study of Sudden Deafness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Loss, Sudden
Prednisone Acetate
Hyperbaric Oxygen
Somatic Stimulus
Keywords: Hearing Loss, Sudden
Prednisone acetate
Hyperbaric oxygen
Somatic stimulus
Lead sponsor: The First Affiliated Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effective treatment of sudden deafness by giving prednisone, hyperbaric oxygen and somatosensory stimulation to sudden deafness patients.

Detailed description: 60 cases of sudden deafness within 2 months of 14-80 years old were randomly divided into two groups. They underwent hearing tests, magnetic resonance imaging of the head, and routine hospital admissions. One group was given prednisone for 1 mg / kg body weight × 7 days + somatosensory stimulation × 30 days, the other group was given prednisone for 1 mg / kg body weight × 7 days + hyperbaric oxygen × 15 days, and repeated electrical audiometry every week. One month and three months after the experiment, repeated audiometry.

Eligibility criteria: Inclusion Criteria:

* Sudden deafness
* History within 2 months
* Age 14-80

Exclusion Criteria:

* Neurological diseases (such as brain tumors)
* Patients with mental / mental illness undergoing treatment
* Pregnant women and patients with other untreatable diseases
* Finding the cause of sensorineural deafness
* Patients Not Suitable for Hyperbaric Oxygen
* A patient with dermatosis

Primary outcomes:
measure: Audiometry
timeFrame: Three months from the patient's selection to the end of treatment
measure: Cranial magnetic resonance imaging
timeFrame: When patients are enrolled
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: E.N.T. department of the First Affiliated hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: E.N.T. department of the First Affiliated hospital of Anhui Medical University
name: Busheng Tong, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04360083: Long-term Assessment of Rhône RéPPOP Care for Overweight and Obese Children.
Official title: Long-term Assessment of Rhône RéPPOP Care for Overweight and Obese Children.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight, Childhood
Pediatric Obesity
Keywords: Pediatric Obesity
Overweight, Childhood
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 106
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight and obese children included in RéPPOP care programs between 2007 and 2010

Brief summary: Childhood obesity is a major public health issue since it is a risk factor of adulthood obesity, cardiovascular disease, psychological disorders, and other chronic conditions.

RéPPOP is a two year personalized pathway for multidisciplinary care for overweight and obese children, close to patients' homes.

Short and medium-term assessments of Rhône RéPPOP care for overweight and obese children show encouraging results. Long-term assessment is needed to confirm these results.

The present study aims to assess the long-term efficiency of Rhône RéPPOP care for overweight and obese children by comparing BMI Z-scores at the start and the end of RéPPOP care to the current BMI. This data will be collected through a telephonic questionnaire by the scientific manager.

The study's secondary objectives are to evaluate patients and their families' lifestyle changes and to improve RéPPOP practices.


Eligibility criteria: Inclusion Criteria:

- All overweight and obese children included in RéPPOP care programs from 01/01/07 to 31/12/10

Exclusion Criteria:

* Refusal to respond to the telephonic questionnaire
* Subjects who withdraw their consent to participate in the study
* Subjects aged under 12 years

Primary outcomes:
measure: Comparison of BMI Z-scores at the start and the end of RéPPOP care programs to the current BMI Z score.
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices civils de Lyon, Endocrino-pediatric service
Study officials:
affiliation: Hospices Civils de Lyon, Endocrino-pediatric service, HFME
name: Marc NICOLINO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03680183: Clinical Pharmacokinetics of TKIs in Chinese Patients of Hepatitis B (HBV)
Official title: Clinical Pharmacokinetics of Tyrosine Kinase Inhibitors in Chinese Patients of Hepatitis B
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
Hepatitis B
Keywords: Tyrosine kinase inhibitors
pharmacokinetics
Hepatitis B
Lead sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese patients diagnosed of non-small-cell lung cancer. Controlled group are HBV negative and HBV group are diagnosed of chronic hepatitis B. All subjects should be able to make their own decision and sign informed concerned.

Brief summary: The study will explore the characteristics in clinical pharmacokinetics of gefitinib, erlotinib,afatinib,osimertinib, crizotinib, apatinib, icotinib in Chinese patients of Non-small-cell lung cancer and hepatitis B. The study is self-controlled. The plasma concentration of tyrosine kinase inhibitors will be analyzed before and after system treatment of HBV.

Detailed description: Tyrosine kinase inhibitors (TKIs) are first line treatment for non-small-cell lung cancer patients with mutations in targeted genes. TKIs are metabolized in liver into inactive metabolites before eliminating from body. Liver function might plays a significant role in inter-individual differences of pharmacokinetics of TKIs. Hepatitis B is a disease of high prevalence in south China. The liver function will be compromised if the infection of hepatitis B virus has not been controlled. This study aims to compare the pharmacokinetics of TKIs before and after controlling HBV with standard treatment in Chinese patients of non-small-cell lung cancer.

Eligibility criteria: Inclusion Criteria:

* pathological confirmed non-small-cell lung cancer
* with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genetic mutation required by different TKIs
* liver function, ALT and/or AST \<= 2\*upper limit of normal (ULN)
* diagnosed of chronic hepatitis B
* Hepatitis B negative as controlled group
* receiving one type of TKIs
* Age between 18-70

Exclusion Criteria:

* diagnosed of acute/ active hepatitis B
* diagnosed of AIDS
* unable to make decision because of metastasis to central nervous system

Primary outcomes:
measure: Average plasma concentration of the drugs (TKIs)
timeFrame: one year after recruit
Secondary outcomes:
measure: Incidence of adverse reaction caused by TKIs
timeFrame: one year after recruit
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Shuzhong Cui, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01080183: Functional Assessment Screening Tablets - Patient Reported Measures
Official title: Functional Assessment Screening Tablets - Patient Reported Measures Translating Research Into Practice Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Health-related quality of life
physical activity
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: RAND
First posted: 2010-03-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The team's ultimate goal is to improve health care quality and effectiveness and support patient-centered care. In this project, we, the investigators, will test whether providing patients with guideline based-recommendations regarding tobacco use, physical activity and mental and physical health-related quality of life (patient reported measures: PRMs) using health information technology increases doctor-patient discussions regarding these topics and results in improvements in PRMs. We will randomize physicians in a single general internal medicine practice. Patients seeing intervention physicians will receive guideline-based recommendations regarding PRMs, those seeing control physicians will not. We will compare differences in doctor-patient discussions regarding PRMs between the intervention and control groups. The successful completion of this project will provide evidence the effectiveness of involving patients in their care through the use guideline-based feedback.


Eligibility criteria: Inclusion Criteria:

* physicians who see patients in the University of Pittsburgh General Internal Medicine Practice.
* patients of physician's who have consented to participate.

Exclusion Criteria:

* age less than 18.

Primary outcomes:
measure: Doctor Patient Communication
timeFrame: The doctor and patient pair will complete a one time survey within two weeks of the doctor patient encounter. Audiotaping of the encounter will occur once at the time of encounter.
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: General Internal Medicine Oakland
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Rachel Hess, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05916183: Dehydration Cognition
Official title: Impact of Dehydration and Rapid Rehydration on Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators want to understand the impact of the body losing and gaining water on brain function. Participants will restrict fluids consumed and exercise to lose 5% of body mass. Participants will then be provided fluid equal to the volume lost to consume over 2 hours (recovery). A series of brain function tests will be performed at baseline, following weight loss, and following recovery.

Detailed description: A baseline series of brain function tests will be performed. Following this, participants will complete a 24 hour fluid and water rich food restriction on the day proceeding testing. Participants will then complete moderate to high intensity exercise in a hot/humid room to achieve 5% body mass loss. Once baseline core body temperature returns to baseline levels, the series of brain function tests will be performed. Participants will then consume a sports drink equal to the volume of sweat lost over the course of a 2 hour recover period. Following this, he series of brain function tests will be performed.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Recreationally active
* 18-26 years old

Exclusion Criteria:

* History of cardiovascular, metabolic, respiratory, neural, or renal disease
* Hypertensive (systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg) or tachycardic (resting heart rate ≥ 100 bpm) during the screening visit
* Taking medication or supplements with a known side effect of affecting physiological responses to exercise (e.g., aspirin, acetaminophen, beta blockers, statins, stimulants, depressants, SSRIs)
* Tobacco or nicotine use in the past six months
* Current or past musculoskeletal injury impacting physical activity
* Study physician discretion based on any other medical condition or medication

Primary outcomes:
measure: Multitasking test
timeFrame: Upon completion of 5% body mass loss protocol, approximately 2 hours into the trial
measure: Multitasking test
timeFrame: 2 hours following the dehydration cognitive function test, approximately 4.5 hours into the trial
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Riana R Pryor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00116883: A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics
Official title: A Randomized, Double-blind, Parallel Group, Placebo Controlled, 6-week Study of the Effect of GW685698X Aqueous Nasal Spray 100mcg QD on the Hypothalamic Pituitary Adrenocortical (HPA) Axis in Children 2 to 11 Years of Age With Perennial Allergic Rhinitis (PAR).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Keywords: GW685698X
perennial allergic rhinitis
pediatric
intranasal corticosteroid
HPA axis function
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-07-01
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound GW685698X compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in children 2 to 11 years of age with perennial allergic rhinitis.


Eligibility criteria: Inclusion criteria:

* Diagnosis and history of perennial allergic rhinitis.
* Must be willing to stay overnight in the clinic at the beginning and end of the study for the collection of urine and blood samples over 24 hours.
* Must comply with all study procedures and be literate.

Exclusion criteria:

* Significant concurrent medical conditions.
* Certain medications such as corticosteroids and allergy medications.

Primary outcomes:
measure: HPA axis function at baseline and after 6 weeks of treatment as measured by 24 hour urine and serial serum cortisol assessments in domiciled subjects
Secondary outcomes:
measure: Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Lafayette
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Rolla
country: United States
facility: GSK Investigational Site
state: Missouri
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Orangeburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04841083: Narrow Band Green Light and Migraine
Official title: A Real World Evaluation of the Allay Lamp in Reducing Headache Symptoms and Frequency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Headache
Lead sponsor: Vedanta Research
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 182
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: Study volunteers are asked to use the Allay Lamp routinely during the 6-week study period. A web based survey is provided when the Lamp is purchased for study volunteers to complete. A daily usage paper diary is sent with the lamp so that volunteers can keep track of the frequency and duration of lamp usage and any noticeable benefits. At the end of six weeks a second survey is sent to study volunteers to capture their perceptions of potential lamp benefits with respect to headache frequency and their experience of migraine specific symptoms.


Eligibility criteria: Inclusion Criteria:

* Adults with headaches or migraines.

Exclusion Criteria:

* Not having headaches or migraines

Primary outcomes:
measure: Change in number of headache days per week
timeFrame: Change from baseline at 6 weeks
measure: Change in number of headache days per month
timeFrame: Changes from baseline at weeks 3-6 of using the Allay lamp
measure: Change in frequency of experiencing photophobia
timeFrame: Changes from baseline at 6 weeks of using the Allay Lamp.
measure: Change in headache severity
timeFrame: Changes from baseline at 6 weeks of using the Allay lamp
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Vendata Research
state: North Carolina
Study officials:
References:
Clinical trial NCT06044883: Radiological Evaluation of the Penis Before and After a Botox Injection
Official title: Role of Shear Wave Elastography in Assessment of Penile Cavernosal Elasticity and Response to Treatment by Botox Injection in Patients With Erectile Dysfunction.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Erectile Dysfunction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to find out if injecting Botox into men with erectile dysfunction makes their penis less stiff and gives them better erections. This will be done using a new ultrasound method. The main questions it tries to answer are: Is Botox injection safe and effective for men suffering from erectile dysfunction who failed other treatment methods? Does this new method have any radiological criteria for penile tissues? • If Botox is injected into the penis, is there a cut-off number for this technique that shows how much better things are before and after? Before and after treatment, participants will rate how much their erections have improved, and investigators will connect their answers to the findings


Eligibility criteria: Inclusion Criteria:

* Men with ED not responding to oral PDE5Is.

Exclusion Criteria:

* Patients with penile prostheses.
* Patients diagnosed with Peyronie's disease.
* Non-vascular erectile dysfunction.
* Medical comorbidities that would limit the benefit of ICI such as uncontrolled diabetes mellitus, significant cardiovascular disease interfering with sexual activity, unstable psychiatric conditions, and the presence of anatomical, hormonal, or neurological abnormalities that would significantly impair erectile function.
* Patients with a history of radical pelvic surgery.
* Pelvic or spinal trauma

Primary outcomes:
measure: The International Index of Erectile Function Questionnaire (IIEF-5) score in patients with erectile dysfunction correlated with penile elasticity.
timeFrame: 1 months
measure: Change from baseline in penile hardness using Shear wave elastosonography (SWE) after Intracavernosal injection by Botox at 6 weeks.
timeFrame: 6 weeks
measure: Change from baseline in the IIEF-5 score after Intracavernosal injection by Botox at 6 weeks.
timeFrame: 6 weeks
Secondary outcomes:
measure: A cut-off SWE value for determining significant pathological degree of elasticity of the cavernous tissue that would possibly benefit from ICI treatment by Botox
timeFrame: 1 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University
Study officials:
References:
Clinical trial NCT04383483: CoV-ICU Score, Intensive Care Unit, SARS-CoV-2
Official title: CoV-ICU Score: Who Will Need Intensive Care in the Course of Corona Virus Disease?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus as the Cause of Diseases Classified Elsewhere
Keywords: SARS-CoV-2, intensive care
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-05-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted to the intensive care unit with the diagnosis of COVID

Brief summary: In the course of COVID disease, some patients need intensive care treatment. We aim to find an answer to the question of whether the patient's CRP, ferritin, D-dimer, Oxygen Saturation, lymphocyte count, and body mass index can be used as a criterion for admitting patients with COVID to the intensive see unit.

Detailed description: It is aimed to determine the patients who are above the threshold value to be determined according to this scoring result. Identifying patients who may need intensive care and following them closely will positively affect patient prognosis.

Eligibility criteria: Inclusion Criteria:

Patients admitted to the intensive care unit with the diagnosis of COVID

Exclusion Criteria:

\<18 years patients

Primary outcomes:
measure: COVICU score
timeFrame: 1 week
measure: Values
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yüksek Ihtisas Training and Research Hospital
state: Yildirim
Study officials:
affiliation: Bursa Yuksek Ihtisas Training and Research Hospital
name: Ali Asan, MD
role: PRINCIPAL_INVESTIGATOR
References: