louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00987727: Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
Official title: Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-10-01
Enrollment: 82
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: This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.


Eligibility criteria: Inclusion Criteria:

* Have been using artificial tears for at least 3 months prior to study inclusion
* Have been using preservative free artificial tears at least three times daily (TIB) for at least 2 weeks immediately prior to study inclusion
* Having moderate to severe symptoms suggestive of dry eye

Exclusion Criteria:

* Current enrollment in an investigational drug or device study or participation in such a study within 3 months prior to entry into this study
* Moderate to severe blepharitis
* History or active signs of ocular trauma, ocular infection, or ocular inflammation within the last 3 months
* History or active signs of ocular allergic disease or ocular herpes within the last year
* History or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time.

Primary outcomes:
measure: Change From Baseline in Global Ocular Staining Score at Day 35
timeFrame: Baseline, Day 35
Secondary outcomes:
measure: Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35
timeFrame: Baseline, Day 35
Other outcomes:
Locations:
city: Paris
country: France
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01863927: The Effect of Ventilated Vest on Thermoregulation During Exercise in Hot Environment
Official title: The Effect of Ventilated Vest on Thermoregulation During Exercise in Hot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Body Temperature Changes
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-05-29
Enrollment: 10
Sex: MALE
Minimum age (years): 21
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this preliminary experiment is to measure the effect of a novel ventilation system on the physiological strain during exercise in high heat load while wearing ballistic protective vest. Ten young and healthy participants will participate in the study. They will all go through a six days heat acclimation period in a heat chamber according to a valid protocol. Afterwards they will be randomly exposed to 4 conditions during four separate consecutive days.

Detailed description: Ten young and healthy civilian participants will participate in the study. They will all go through a six days heat acclimation period in a heat chamber according to a valid protocol. After heat acclimation the participant will be randomly exposed to 4 conditions during four separate consecutive days: 1) walking on a treadmill for two hours in hot-wet conditions (30OC, 70% RH) while wearing military uniforms and a vest (control group); 2) walking on a treadmill for two hours in hot-dry conditions (40OC, 30% RH) while wearing military uniforms and a vest (control group); 3) walking on a treadmill for two hours in hot-wet conditions (30OC, 70% RH) while wearing military uniforms and a vest with a ventilator (experimental group); 4) walking on a treadmill for two hours in hot-dry conditions (40OC, 30% RH) while wearing military uniforms and a vest with a ventilator (experimental group). During the heat exposures, rectal temperature, skin temperature and heart rate will be continuously monitored. Subjective comfort measures, heat strain indices, sweat rate and sweat evaporation will be also measured/calculated. The differences in the above measures, during exposure to exercise in the heat between ventilator and no ventilator will be then analyzed.

Eligibility criteria: Inclusion Criteria:

* age 21-28
* healthy
* after medical checkup
* after signing concent form

Exclusion Criteria:

* heart disease
* respiratory disease
* baseline bp above 140/90 mmHg
* sleep disorders
* diabetes
* anhydrosis
* skin disease
* acute illness in last 3 days prior to the examination

Primary outcomes:
measure: Heat tolerance test
timeFrame: 1 year
measure: Maximal oxygen consumption test
timeFrame: 1 year
Secondary outcomes:
measure: Skin temperature
timeFrame: 1 year
measure: Rectal temperature
timeFrame: 1 year
measure: Heart rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Tel-Hashomer, Ramat- Gan
country: Israel
facility: Sheba medical center
Study officials:
affiliation: Sheba Medical Center
name: Barliz Adato, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04412473: COVID-19 Respiratory Distress and Antithrombotic Drugs in Subject's Habits
Official title: COVID-19 Respiratory Distress and Antithrombotic Drugs inSubject's Habits
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sars-CoV2
Keywords: Sars-CoV2
Covid-19
Antithrombotic treatments
ARDS
Hypoxemia
Thrombosis
Pulmonary arteries
Endothelial
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Partients hospitalised in HUS or GHRMSA for COVID-19 with diagnosis COVID-19 confirmed by smear or evoked by CT scan or chest X-ray without a differential diagnosis retained in the medical record

Brief summary: Current management of VID-19 consists of oxygen support without specific treatment. Hospitalization may suddenly require delayed resuscitation. This evolution corresponds to an atypical acute respiratory distress syndrome (ARDS), the mechanism of which is poorly understood and difficult to predict. The general pathophysiology of ARDS, the vascular tropism of SARS-Cov2, the description of coagulopathy and numerous pulmonary artery thromboses in resuscitation and the encouraging investigation of antithrombotics in general ARDS


Eligibility criteria: Inclusion Criteria:

* Major Subject (≥18 years)
* Subject hospitalised in HUS or GHRMSA for COVID-19
* The diagnosis COVID-19 confirmed by smear or evoked by CT scan or chest X-ray without a differential diagnosis retained in the medical record
* Subjects who, after being informed, do not wish to have their data reused for the purposes of this research

Exclusion Criteria:

* Subject who expressed opposition to participating in the study
* Subject under guardianship or trusteeship
* Subject under safeguard of justice
* Patient hospitalized in a geriatric service or in a ward not labeled COVID (surgery, oncology,...) or in a short-term hospitalization unit without transfer to another service.
* Serious patient on admission to the emergency room and recused from resuscitation.

Primary outcomes:
measure: Analysis of Respiratory Distress and Antithrombolytic Therapy in Patients with covid19
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Médecine Intensive et Réanimation
Study officials:
References:
Clinical trial NCT00411073: Study Of The Effects Of SB 480848 (Darapladib) On The Electrical Conduction Of The Heart
Official title: A Study to Evaluate the Effect of Repeat Oral Doses of Darapladib on Cardiac Conduction as Compared to Placebo and a Single Oral Dose of Moxifloxacin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atherosclerosis
Keywords: darapladib
moxifloxacin
QT study
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-12-13
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a study to assess the effects of darapladib on the cardiac conduction of the heart as compared to placebo and moxifloxacin. This a four period crossover design with each period lasting about 10 days. There will be a 7 to 10 day wash out in between each period.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Body weight greater than 50 kg (110 lbs) and a body mass index between 19 and 30
* Signed and dated written informed consent prior to admission to the study
* Subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions

Exclusion Criteria:

* cardiac abnormalities
* history of asthma or severe allergic reactions
* history of alcohol or drug abuse
* use of prescription or non-prescription drugs or vitamins or herbal supplements
* history of cholecystectomy or biliary tract disease
* pregnant or nursing women
* history of allergy to the study drugs

Primary outcomes:
measure: Change in QTc interval as compared to placebo and moxifloxacin
timeFrame: throughout the study
Secondary outcomes:
measure: Change in ECG parameters as compared to placebo and moxifloxacin
timeFrame: throughout the study
Other outcomes:
Locations:
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03498573: Evaluation of Alveolar Augmentation Using Tunneling Surgical Technique
Official title: Evaluation of Minimally Invasive Alveolar Augmentation Procedure of Anterior Maxillary Ridge Using Tunneling Surgical Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Atrophy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: patients suffering from anterior maxillary horizontal bone defect the alveolar ridge will be augmented by minimally invasive tunneling technique utilizing MPM as bone graft and patients followed up for 14 weeks .


Eligibility criteria: Inclusion Criteria:

* Patients' age range from 18-60 years.
* Patients with horizontal bone defect in anterior maxillary area.
* Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome.

Exclusion Criteria:

• Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders and autoimmune diseases (may affect normal healing).

Primary outcomes:
measure: bone formation
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Nevins ML, Camelo M, Nevins M, Schupbach P, Friedland B, Camelo JM, Kim DM. Minimally invasive alveolar ridge augmentation procedure (tunneling technique) using rhPDGF-BB in combination with three matrices: a case series. Int J Periodontics Restorative Dent. 2009 Aug;29(4):371-83.
Clinical trial NCT00206973: Bronchial Response to Mannitol and Inflammation in Steroid Naive Asthmatics.
Official title: Bronchial Response to Mannitol and Inflammation in Steroid Naive Asthmatics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: Study on the relationship between the response of the airways to a bronchial provocation test with mannitol and the degree of airway inflammation in asthma patients.

Detailed description: Study on the relationship between the response of the airways to a bronchial provocation test with mannitol and the degree of airway inflammation in asthma patients.

Eligibility criteria: Inclusion Criteria:

* Steroid naive asthma.
* Non-smoker

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Respiratory Research Unit, Med. Clinic I, Bispebjerg Hospital, Bispebjerg Bakke 23
state: NV
Study officials:
affiliation: unaffilliated
name: Celeste porsbjerg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01051973: Cognitive Behavior Therapy (CBT) Compared to Stress Management for Irritable Bowel Syndrome
Official title: Internet-delivered Cognitive Behavior Therapy Compared to Stress Management in the Treatment of Irritable Bowel Syndrome - A Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Cognitive behavior therapy
exposure
stress management
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2010-01-20
Enrollment: 200
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: The study aims to compare two manualized treatments. They are based on cognitive behavior therapy or stress management. Both treatments are delivered via an internet application and the patients' work with the treatments is supported through online contact with a therapist. The treatments last for 10 weeks.

Approximately 200 patients will be included in the study and randomized to either condition.

The study hypothesis is that CBT will be superior to stress management on the main outcome measure, which is IBS symptom severity measured over 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of IBS given by physician
* At screening fulfilling Rome III-criteria for IBS

Exclusion Criteria:

* Severe depression
* Suicidal ideation
* Presence of unexplained IBS alarm symptoms

Primary outcomes:
measure: Level of IBS symptoms
timeFrame: During 4 consecutive weeks before randomization
measure: Level of IBS symptoms
timeFrame: During 4 consecutive weeks after treatment completion (10 weeks after randomization)
measure: Level of IBS symptoms
timeFrame: During 4 consecutive weeks 6 months after treatment completion
Secondary outcomes:
measure: Quality of life
timeFrame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
measure: Use of health care resources and societal production loss because of illness
timeFrame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
measure: Level of IBS-symptoms
timeFrame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
measure: Anxiety related to gastrointestinal symptoms
timeFrame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
measure: Level of daily stress
timeFrame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
measure: Subjective relief of IBS-symptoms
timeFrame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Internetpsykatrienheten, M57, Psykiatri sydväst
Study officials:
affiliation: Karolinska Institutet
name: Nils Lindefors, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05165173: Almond Milk With Vitamin D: Impact on Vitamin D Status
Official title: Almond Milk With Vitamin D: Impact on Vitamin D Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency, Chronic
Kidney Failure, Chronic
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized comparator-controlled trial
Primary purpose: BASIC_SCIENCE

Brief summary: The overall goal is to enhance vitamin D status in a safe and effective manner. A 3-week randomized comparator-controlled trial among a cohort of adults with CKD (stages 3-5) (n=24) will test the main objective: Evaluate the bioefficacy of D3 in micro- and nanoparticles (4000IUs) in almond milk with the sub-objective of: Explore the effect of D3 in micro- and nanoparticles (4000IUs) in almond milk on inflammation markers CRP, TNF-α and IL-6.


Eligibility criteria: Inclusion Criteria:

* adults who have been diagnosed with CKD
* have no GI disorders or GI disturbances
* age 18 years or older
* no food allergies or dietary restrictions
* all with no contraindications to consuming anything by mouth as per their physician

Exclusion Criteria:

* no diagnosis of CKD
* GI disorders
* gastrointestinal disturbances
* under 18 years old
* food allergies to almonds
* Dietary restrictions as medically indicated
* trouble chewing/swallowing as confirmed by physician

Primary outcomes:
measure: Vitamin D
timeFrame: 21 days
Secondary outcomes:
measure: Calcium
timeFrame: 21 days
measure: PTH
timeFrame: 21 days
measure: parent vitamin D
timeFrame: 21 days
measure: IL-6
timeFrame: 21 days
measure: C-reactive protein
timeFrame: 21 days
measure: TNF-alpha
timeFrame: 21 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Jeanette Andrade, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01557660: Inhaled Treprostinil for PAH: Open-label Extension
Official title: Inhaled Treprostinil in Subjects With Pulmonary Arterial Hypertension: An Open-Label, Phase III, International, Multi-Center Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-03-19
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: TREATMENT

Brief summary: Open-label extension of RIN-PH-302.


Eligibility criteria: Participation and completion of all required visits for study RIN-PH-302.

Primary outcomes:
measure: Long term safety of inhaled treprostinil
timeFrame: up to 5 years
Secondary outcomes:
measure: Six-minute walk distance
timeFrame: up to 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02561260: Multicenter and Prospective Clinical Registry Study of Autoimmune Encephalitis in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autoimmune Encephlitis in China
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Xuanwu Hospital, Beijing
name: Peking Union Medical College Hospital
name: Beijing Children's Hospital
First posted: 2015-09-28
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The unidentified encephalitis patients who meeting the inclusion criteria and exclusion criteria and signed a written informed consent.

Brief summary: In recent years, more and more previously thought to be unknown encephalitis was found to be a specific antigen associated encephalitis，but because of the lack of recognition in the clinic, usually been misdiagnosed as other causes of encephalitis. Therefore, it is urgent to establish a database of autoimmune encephalitis in Chinese population. The prospective clinical trial of atutoimmune encephalitis in China, by screening the autoimmune encephalitis associated antibody and summarizing the cases analysis, in order to provide evidence for clinical diagnosis and treatment of autoimmune encephalitis.


Eligibility criteria: Inclusion Criteria:

1. Older than 6 months.
2. Encephalopathy symptoms (change of mental state and consciousness level) persist for more than 24 hours;
3. At least one or more clinical features of the followings: fever, epilepsy, focal neurological deficiency symptoms, changes in CSF(cerebrospinal fluid inflammatory), changes in EEG (electroencephalogram), radiographic abnormalities;
4. Clinical suspected encephalitis, but conventional detected methods cannot make etiology clear.
5. Signed the informed consent.

Exclusion Criteria:

1. Infants less than 6 months;
2. The metabolic encephalopathy;
3. Infectious encephalitis with clear pathogen clinically, referring the specific pathogenic microorganisms, including: bacteria, virus, fungus, parasite, spirochete and so on;
4. Non-infectious encephalitis with clear diagnosis clinically, including: multiple sclerosis, neuromyelitis optic, acute disseminated encephalomyelitis and so on.

Primary outcomes:
measure: death
timeFrame: 30days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: