louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00930072: Safety Study of Cervical Sympathetic Block for Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage
Official title: Safety and Efficacy of Cervical Sympathetic Block in Patients With Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage - Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Vasospasm
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2009-06-30
Enrollment: 7
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: To evaluate the feasibility of performing a cervical sympathetic block in patients with severe cerebral vasospasm involving the anterior cerebral circulation following aneurysmal SAH.


Eligibility criteria: Inclusion Criteria:

1. High grade spontaneous SAH (Fisher Grade III and IV)
2. Secured aneurysm (clipped/coiled)
3. Evidence of severe vasospasm - MCA mean flow velocity \>200 cm/sec and Lindegaard ratio \>6 OR Symptomatic vasospasm with either angiographic evidence (no angioplasty), or at least moderate severity according to TCD criteria (MCA mean flow velocity \>150 cm/sec and Lindegaard ratio \>3, or ACA vasospasm)
4. Age ≥18

Exclusion Criteria:

1. Allergy to local anesthetic or contrast
2. Coagulation disorders with PT \<70%, or INR \>1.4, or PTT \>1.5 times control and/or platelets \<70,000x106/L
3. Use of enoxaparin within 12 hours
4. Use of clopidogrel within 7 days
5. Use of coumadin within 5 days
6. Use of ticlopidine within 14 days
7. Use of intravenous thrombolytics within 10 days
8. Any use of hirudin derivatives during ICU stay

Primary outcomes:
measure: To evaluate the feasibility of performing a cervical sympathetic block in patients with severe cerebral vasospasm involving the anterior cerebral circulation following aneurysmal SAH.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Miriam Treggiari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04208672: Validation of a Handy Sleep Monitoring Device: UMindSleep in Patients With Obstructive Sleep Apnea
Official title: Validation of a Handy Sleep Monitoring Device: UMindSleep in Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Validation
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a validation study recruiting subjects with and without obstructive sleep apnea. All subjects will undergo a nocturnal standard polysomnography and UMindSleep assessment. Sleep parameters, such as sleep stages and apnea UMindSleep software. Correlation in each parameter between PSG and events in polysomnography (PSG) will be scored according to the AASM criteria while the sleep parameters will be automatically scored by the UMindSleep will be analyzed to determine the magnitude of agreement between UMindSleep and PSG.

Detailed description: Obstructive sleep apnea (OSA) is a common sleep disorder in the general population with a prevalence ranging from 4-30%. OSA has been shown to be a significant risk factor of many cardiovascular diseases and mental disorders. However, OSA is a neglected problem in the general population. In addition, there is a significant unmet need for the treatment of OSA. One of the major reason for the under-diagnosis and under-treatment of OSA in the general population is a lack of reliable screening tool in detecting OSA. In this regard, several devices, such as ApneaLink, have been developed for the screening of OSA. However, as this kind of device only employs time in bed rather than actual sleep time to calculate the apnea index or desaturation index, they tend to underestimate the severity of sleep apnea. In this regard, it is timely need to develop and validate new device that can integrate the actual sleep time and apnea or desaturation events for the precise calculation of sleep apnea index or desaturation index.

The UMindSleep is a handy and wearable device to acquire EEG, heart rate, saturation, snoring and temperature. The signal will be uploaded to a smartphone through Bluetooth. By integrating these signals, the system can automatically analyze several key parameters by the algorithms, such as sleep stages and desaturation events.

Eligibility criteria: Inclusion Criteria:

* complain of habitual snoring;
* AHI as measured by standard PSG \> 5/hour

Exclusion Criteria:

* Aged 17 years old or below
* patients with narcolepsy and REM sleep behavior disorder

Primary outcomes:
measure: sleep apnea
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT02873572: Vulnerability Markers in Pathological Gambling
Official title: Marqueurs de vulnérabilité Aux Jeux Pathologiques
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gaming
Gambling
Keywords: Online poker
Casino
Massively Multiplayer Online Role-Playing Game (MMORPG)
Iowa Gambling Task (IGT)
High Resolution Electroencephalography (HR-EEG)
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Saint Anne's Hospital
First posted: 2016-08-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Addictions without substances are an emergent problem giving rise to a recent and increasing request of care. Among these new addictions, pathological gambling and pathological online video gaming which are up. The purpose of this study is to identify vulnerability factors (personality traits, decision making strategies...), which are common or specific to each type of game (on line poker, casino, MMORPG, and no-gamers).


Eligibility criteria: Inclusion Criteria:

* arm 1: online poker gamblers who don't play another type of gamble/game
* arm 2: casino gamblers who don't play another type of gamble/game
* arm 3: MMORPG gamers who don't play another type of gamble/game
* arm 4: no-gamblers/gamers subjects
* step 2 : only right-handled subjects (due to registration of brain activity)

Exclusion Criteria:

-

Primary outcomes:
measure: Compare the average activation differences in each arm regarding the dependance level and between the 4 arms.
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Besancon
Study officials:
affiliation: Saint Anne's Hospital
name: Philip Gorwood, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giustiniani J, Gabriel D, Nicolier M, Monnin J, Haffen E. Neural Correlates of Successful and Unsuccessful Strategical Mechanisms Involved in Uncertain Decision-Making. PLoS One. 2015 Jun 18;10(6):e0130871. doi: 10.1371/journal.pone.0130871. eCollection 2015.
Clinical trial NCT06685172: Comparison of the Acute Effects of Focused and Radial ESWT on Pain and Balance Performance in Individuals With Plantar Fasciitis: A Randomized Clinical Trial
Official title: Comparison of the Acute Effects of Focused and Radial ESWT on Pain and Balance Performance in Individuals With Plantar Fasciitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fascitis
Pain
Keywords: Balance
pain
plantar fasciitis
stability
Lead sponsor: Gulhane Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-11-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 63
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 40 patients with plantar fasciitis were randomly assigned to focal-ESWT treatment (n= 20) or radial-ESWT treatment (n= 20).
Primary purpose: TREATMENT

Brief summary: This study aimed to compare the acute effects of focused and radial ESWT on pain and balance performance in individuals with plantar fasciitis.

Detailed description: This study aimed to compare the acute effects of focused and radial ESWT on pain and balance performance in individuals with plantar fasciitis. The study included 40 individuals (27 females and 13 males) aged between 18 and 63 years, presenting with plantar fasciitis (PF). Extracorporeal shockwave therapy (ESWT) was administered once a week for four weeks. The participants were randomly assigned to two groups (f-ESWT and r-ESWT). Pain levels were assessed using the Visual Analogue Scale, while Static and Dynamic Balance were evaluated using the Biodex Balance System.

Eligibility criteria: Inclusion Criteria:

unilateral or bilateral tenderness in the medial tubercle of calcaneus and heel pain in the first few steps in the morning, which gets worse with increased activity, absence of any known systemic disease, absence of any surgical procedure to lower extremity, absence of any treatment for PF in the last 6 months, 18-65 years, and consent to participate in the study.

Exclusion Criteria:

pregnancy, pacemaker, receiving anticoagulant therapy, uncontrolled cardiovascular disease, tumor, acute infection, nerve root compression, local dermatological or neurological problems, diabetes mellitus, taking anti-inflammatory drugs during treatment, or incomplete follow-up.

Primary outcomes:
measure: Visual Analog Scale (VAS) was used to determine the intensity of pain in patients with PF, and Biodex Balance System device (Biodex Balance System SD, 2009 USA) was used to assess balance performance.
timeFrame: Baseline and 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences, Gulhane Faculty of Medicine
Study officials:
affiliation: Health Sciences University, Gulhane Training and Research Hospital
name: Aydan Örsçelik, Associate Professor MD
role: STUDY_CHAIR
References:
Clinical trial NCT03223272: Mechanisms of Refractory Hypertension (Reserpine)
Official title: Mechanisms of Refractory Hypertension (Reserpine)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Refractory Hypertension
Keywords: hypertension
sympathetic tone
resperpine
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 7
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, dose titration study
Primary purpose: TREATMENT

Brief summary: The study is deigned to determine if refractory hypertension is attributable to heightened sympathetic tone by quantifying the antihypertensive benefit of reserpine, a sympatholytic agent, in patients failing other classes of antihypertensive agents.

Detailed description: Patients with refractory hypertension, defined as uncontrolled office blood pressure despite use of 5 or more antihypertensive agents, including a thiazide diuretic and spironolactone. After withdrawal from other centrally-acting agents if needed, enrolled patients will be randomized to open-label reserpine 0.1 mg daily for 4 weeks. Twenty-four hour ambulatory blood pressure monitoring will be done at baseline, after the initial 4-week treatment period. All other antihypertensive medications will remain unchanged during the 4-week treatment period. The primary endpoint will be change in 24-hr ambulatory systolic blood pressure.

Eligibility criteria: Inclusion Criteria:

- adult with refractory hypertension defined as uncontrolled office blood pressure with use of 5 or more hypertensive agents, including a thiazide diuretic and spironolactone

Exclusion Criteria:

* congestive heart failure (EF 40%)
* chronic kidney disease (GFR \<40 ml/min/1.73 mm)
* stroke and/or myocardial infarction or acute CHF exacerbation within last 3 months
* ongoing depression
* active peptic ulcer disease
* bradycardia \<50 beats per minute
* 2nd or 3rd degree heart block
* known intolerance of reserpine
* use of digoxin or tricycle antidepressants

Primary outcomes:
measure: Change Ambulatory Systolic Blood Pressure
timeFrame: Baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: David A Calhoun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02105272: Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-04-07
Enrollment: 237
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
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 the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with latanoprost ophthalmic solution in subjects who are insufficiently responsive to latanoprost ophthalmic solution.


Eligibility criteria: Inclusion Criteria:

* Subjects with diagnosis of bilateral primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* Subjects with ocular conditions as defined by the protocol

Primary outcomes:
measure: Decrease From Baseline in Intraocular Pressure
timeFrame: Baseline, week 8 predose
Secondary outcomes:
measure: Intraocular Pressure at Week 8 Predose
timeFrame: Week 8 Predose
measure: Intraocular Pressure at Week 8 at 2 Hours After IMP Administration
timeFrame: Week 8 at 2 hours after IMP administration
measure: Intraocular Pressure at Week 8 at 8 Hours After IMP Administration
timeFrame: Week 8 at 8 hours after IMP administration
measure: Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration
timeFrame: Baseline, Week 8 at 2 hours after IMP administration
measure: Decrease From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration
timeFrame: Baseline, Week 8 at 8 hours after IMP administration
Other outcomes:
Locations:
city: Kansai Region
country: Japan
Study officials:
References:
Clinical trial NCT03112772: Socket Preservation for Dental Implant Site Development.
Official title: Socket Preservation for Dental Implant Site Development.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Loss
Lead sponsor: Imam Abdulrahman Al Faisal Hospital
Sponsor class: OTHER_GOV
First posted: 2017-04-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Changes in alveolar bone following teeth extraction can compromise implant placement. Socket preservation (alveolar ridge preservation) is considered as a surgical procedure employed to preserve the ridge volume within the envelope existing at the time of extraction.The ultimate aim of such procedure is to compensate the expected amount of horizontal and vertical alveolar bone resorption. In order to better understand which socket preservation materials might be more effective for ridge preservation and to strengthen the evidence that is relevant to the clinicians' choice of socket preservation materials, two different materials were compared in a randomized controlled approach. (1) Demineralized Bone Matrix (DBM) Putty and Putty with Chips allograft covered by collagen membrane, and (2) Deprotonated bovine bone xenograft covered by collagen membrane. The independent variable is the grafting material while the dependent variables are the change in socket height, and width; the ability of implant placement without the need for grafting and the success rate of implants at the time of loading.


Eligibility criteria: Inclusion Criteria:

1. Adult patient \> 18 years old.
2. Single and or multi-rooted teeth that are non-restorable.
3. Patients are keen to have implant placement at the extraction sites after 4 months of extraction.
4. Intact buccal bone after extraction, which was confirmed by visual inspection and clinical examination using a periodontal probe.
5. Patients are medically fit with no underlying systemic diseases.

Exclusion Criteria:

1. Pregnant females.
2. Smokers.
3. Presence of any acute infection at the time of teeth extraction.

Primary outcomes:
measure: Width of alveolar ridge
timeFrame: 4 months
measure: height of the alveolar ridge
timeFrame: 4 months
measure: Need of further grafting at the time of implant placement
timeFrame: 4 months
Secondary outcomes:
measure: Osseintegration of implants
timeFrame: 4 months
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Immam Abdulrahman Bin Faisal University
state: Eastern
Study officials:
References:
Clinical trial NCT01574872: Efficacy of Aerosal® in the Treatment of Inverse Psoriasis and Sebopsoriasis
Official title: Double-blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of Aerosal® in the Treatment of Inverse Psoriasis and Sebopsoriasis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Inverse Psoriasis
Sebopsoriasis
Keywords: psoriasis
salt
sodium chloride
Lead sponsor: Tecno Sun SRL
Sponsor class: INDUSTRY
Collaborators: name: Centro Studi Gised
First posted: 2012-04-10
Enrollment: 0
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 evaluate the efficacy of Aerosal® compared to placebo in the prognosis of inverse psoriasis or sebopsoriasis present for at least one year


Eligibility criteria: Inclusion Criteria:

* Inverse Psoriasis or Sebopsoriasis lasting from at one year
* At least 1% of total body surface area involvement Suspension for more than 3 months from start of the study of any systemic drugs for psoriasis, immunosuppressive treatments (cyclosporin, systemic steroids), psoralen plus ultraviolet A irradiation (PUVA) or ultraviolet B phototherapy (UVB)

Exclusion Criteria:

* Patients with acute bronchopulmonary disease, tuberculosis, severe hypertension, hyperthyroidism, cancer (chemotherapy), intoxication, heart failure
* Iodine allergy
* Women who are pregnant or planning to become pregnant during the study

Primary outcomes:
measure: Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +)
timeFrame: 3 weeks (15 sessions), 15 weeks
Secondary outcomes:
measure: Any change from baseline of physician's clinical judgment
timeFrame: 3 weeks (15 sessions), 15 weeks
measure: Overall patient satisfaction
timeFrame: 3 weeks (15 sessions), 15 weeks
measure: Any change from baseline of PASI index
timeFrame: 3 weeks (15 sessions), 15 weeks
measure: Number of reported adverse events
timeFrame: 3 weeks (15 sessions), 15 weeks
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione S.Raffaele del Monte Tabor
Study officials:
affiliation: Centro Studi Gised
name: Luigi Naldi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00502372: Effect of an Oral Supplement Enriched in Amino Acids and the Leucine Metabolite B-hydroxy B-methylbutyrate (HMB)
Official title: Nutritional Effect of an Oral Supplement Enriched in Arginine, Glutamine and Leucine Metabolite B-Hydroxy B-Methylbutyrate
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pressure Ulcers
Lead sponsor: Central Arkansas Veterans Healthcare System
Sponsor class: FED
Collaborators: name: Abbott
First posted: 2007-07-17
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The focus of this study is to look at the role of nutrition in the healing of pressure ulcers. The purpose of this study is to test whether the rate of healing of pressure ulcers is increased in those patients receiving a nutritional supplement of amino acids and the leucine metabolite, B-hydroxy-B-methylbutyrate is enhanced when compared to control patients receiving a supplement containing only one of the proteins in the experimental supplement

Detailed description: Patients who have pressure ulcers Stage II or greater will be randomized to receiving one of two nutritional supplements. One supplement contains arginine and the other contains both arginine,glutamine and leucine metabolites. Pressure ulcers will be measured at study entry and measured biweekly using a standardized tool (PUSH) until the trial is completed or the pressure ulcer has healed.

Inclusion criteria include:

* Stage II or greater pressure ulcer
* Patient consent
* Patients who can drink supplement or receive it by tube
* Patients who are 21 years old or greater

Exclusion criteria include:

* Patients with infected wounds
* Patients with cellulitis, sepsis or osteomyelitis
* Patients with end-organ failure
* Patients with poorly controlled diabetes mellitus (HbA1C\>10)
* Patients who cannot tolerate oral or tube feeding

Eligibility criteria: Inclusion Criteria:

1. Patients with Stage II pressure ulcer or greater
2. Patients who consent to participate
3. Patients who can ingest the supplement either orally or per feeding tube
4. Patients who are 21 years of age or older

Exclusion Criteria:

1. Patients with infected wounds
2. Patients with cellulitis, sepsis or osteomyelitis
3. Patients with end-organ failure
4. Patients with poorly controlled diabetes mellitus (HbA1C\>10)
5. Patients who cannot tolerate oral or bolus tube feedings

Primary outcomes:
measure: PUSH tool score
timeFrame: 8 weeks or healing completed
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System
state: Arkansas
Study officials:
affiliation: Central Arkansas VA/UAMS College of Medicine
name: Cathey Powers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Arkansas VA/UAMS College of Medicine
name: Ronni Chernoff, PhD
role: PRINCIPAL_INVESTIGATOR
References: