louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02879175: Patients' Follow-up After Subarachnoid Haemorrhage Caused by Ruptured Intracranial Aneurysms
Official title: Patients' Follow-up After Subarachnoid Haemorrhage Caused by Ruptured Intracranial
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intracranial Aneurysms
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-08-25
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing endovascular treatment for a subarachnoid haemorrhage caused by ruptured intracranial aneurysms.

Brief summary: After endovascular treatment of the intracranial aneurysm, recanalization may occur, with a risk of recurrent subarachnoid haemorrhage or long-term angiographic recurrences of aneurysms.

Few data exist on patients' long-term follow-up after subarachnoid haemorrhage caused by ruptured intracranial aneurysms.


Eligibility criteria: Inclusion Criteria:

* Subarachnoid haemorrhage caused by ruptured intracranial aneurysms
* endovascular embolization of the aneurysm

Exclusion Criteria:

* none

Primary outcomes:
measure: early neurological clinical recovery
timeFrame: 1 year after Subarachnoid Haemorrhage
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Opthalmologique A de Rothschild
Study officials:
affiliation: Fondation ophtalmologique de Rothschild
name: Raphaël BLANC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00205075: Impact of Moderate Alcohol Use on Hepatitis C Virus (HCV) Progression
Official title: The Use of Validated Measures of Alcohol Intake to Measure the Impact of Moderate Alcohol Consumption on Hepatic Fibrogenesis in Individuals Infected With Hepatitis C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatic Fibrogenesis
Hepatitis C
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 47
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: outpatient with HCV not receiving or planning treatment but is receiving standard of care monitoring every 3 months, abstinent or drinking

Brief summary: The purpose of this study is to determine the effect of moderate alcohol intake on liver disease caused by HCV in terms of speed of progression as compared to those not drinking alcohol.


Eligibility criteria: Inclusion Criteria:

* Outpatient with HCV who is not receiving or planning treatment but is receiving standard of care monitoring every 3 months and is either abstinent from alcohol or drinking only moderately

Exclusion Criteria:

* HIV co-infection
* Treated within the past 6 months
* History (hx) of other liver disease
* Alcohol use greater than 30 g/day or history of binge drinking in the last year
* Decompensated liver disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Adnan Said, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01991275: Intrathecal Morphine in Robot-assisted Prostatectomy
Official title: The Efficacy of Intrathecal Morphine in Patients Undergoing Robot-assisted Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Keywords: Prostatic Neoplasms
Laparoscopy
Injections, Spinal
Morphine
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the efficacy and safety of intrathecal morphine for the patients undergoing robot-assisted prostatectomy

Detailed description: Prostatectomy is the treatment of choice for prostate cancer. The robot-assisted prostatectomy is becoming the most popular surgical method for prostate cancer. The small incision after robot-assisted prostatectomy is thought to reduce the postoperative pain. There is few investigations for the strategy to reduce the postoperative pain of robot-assisted prostatectomy.

The intrathecal morphine injection is known to reduce postoperative pain for surgeries like hepatectomy, myomectomy and open prostatectomy. This method, however, is not yet studied for the robot-assisted prostatectomy. This study will investigate the efficacy and safety of intrathecal morphine for the patients undergoing robot-assisted prostatectomy.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for the open nephrectomy

Exclusion Criteria:

* Patients with renal insufficiency
* Patients with coagulopathy
* History of any neurologic disorder
* History of recent infection in 2 weeks
* History of drug abuse
* Patients who cannot understand the usage of th intravenous patient-controlled analgesia
* Patients using opioids due to the chronic pain

Primary outcomes:
measure: The evaluation of pain at 24 hours after surgery
timeFrame: at postoperatively 24 hours
Secondary outcomes:
measure: The consumption of analgesics
timeFrame: at postoperatively 24 hours
measure: The consumption of intraoperative opioids
timeFrame: From the induction of anesthesia till the emergence of anesthesia, an expected average of 4 hours
measure: The side effects of opioids after surgery
timeFrame: During 72 hours after the end of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University of Hospital
Study officials:
affiliation: Seoul National University of Hospital
name: Deok-Man Hong, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02898675: Advantages of Autologous Platelet-Rich Fibrin Membrane on Growth Factor Levels and Periodontal Healing
Official title: Investigation of the Contributions of Platelet Rich Fibrin Combined With Open Flap Debridement on Periodontal Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Platelet rich fibrin is a second generation platelet concentration which contains various growth factors. The aim of this study is to evaluate the clinical and biochemical efficacy of PRF in subjects of chronic periodontitis in the operation of conventional periodontal flap.

Detailed description: PRF was developed in 2001 by Choukroun in France, it was the second generation fibrin adhesive, and was used to accelerate the soft and hard tissue healing. Many studies have shown beneficial effects of PRF on osteoconductive filler material in sinus lift operations, treatment of periodontal sulcus defect and treatment of furcation defects. Also PRF contains many growth factors. PRF accelerates periodontal regeneration through the gradually excreted growth factors and contributes to the bone regeneration. In this study, the investigators evaluated the effect of PRF on growth factors and its contribution to periodontal regeneration in subjects with chronic periodontitis.

Eligibility criteria: Inclusion Criteria:

* Patients with CP who had pocket depth ≤ 5 mm and at least two area (grouped as Control and PRF) with horizontal bone loss after initial treatment

Exclusion Criteria:

* The subjects excluded in the study had history of systemic disease, were smokers, had allergy to any drug, had need for prophylaxis of antibiotic and had taken antibiotics at least 6 months

Primary outcomes:
measure: Level of Growth Factor
timeFrame: 6 weeks
Secondary outcomes:
measure: Alteration of Clinical Attachment Level
timeFrame: 9 month
measure: Alteration of Periodontal Pocket Depth
timeFrame: 9 month
Other outcomes:
Locations:
Study officials:
affiliation: Adiyaman University
name: Yasin ÇİÇEK
role: STUDY_CHAIR
References:
citation: Pradeep AR, Shetty SK, Garg G, Pai S. Clinical effectiveness of autologous platelet-rich plasma and Peptide-enhanced bone graft in the treatment of intrabony defects. J Periodontol. 2009 Jan;80(1):62-71. doi: 10.1902/jop.2009.080214.
citation: Arabaci T, Kose O, Albayrak M, Cicek Y, Kizildag A. Advantages of Autologous Platelet-Rich Fibrin Membrane on Gingival Crevicular Fluid Growth Factor Levels and Periodontal Healing: A Randomized Split-Mouth Clinical Study. J Periodontol. 2017 Aug;88(8):771-777. doi: 10.1902/jop.2017.160485. Epub 2017 Apr 28.
Clinical trial NCT02850575: Bone Fixation of Mpact Double Mobility Cup
Official title: Etude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte Pour l'évaluation de la Fixation Osseuse d'Une Cupule hémisphérique, le Mpact® Double Mobilité
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Total Hip Replacement
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2016-08-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients eligible for a total hip replacement at the investigational sites will be invited in the study

Brief summary: This study aims to evaluate long term fixation of the Mpact Double Mobility cup trough IMAGIKA technology.


Eligibility criteria: Inclusion Criteria:

* primary hip replacement
* patients 18 to 80 years old
* patients who accept the follow-up schedule

Exclusion Criteria:

* femoral neck fracture
* patients requiring grafts
* progressive local or systemic infections
* patients presenting muscular deficiency, neuromuscular disease or vascular insufficiency of the involved limb
* patients suffering from diseases that can compromize the recovery to independent mobility
* patients with BMI \> 40
* patients with cognitive diseases that can compromize their participation in the study
* patients living in geographical area not allowing the clinical follow-up to be performed
* patients participating in other biomedical research
* patients \<18 years old
* patients \> 80 years old
* pregnant or breast feeding women

Primary outcomes:
measure: implant fixation trough IMAGIKA
timeFrame: 10 years
Secondary outcomes:
measure: Harris Hip Score
timeFrame: preop, 3 months, 1, 2, 5, 10 years
measure: complications
timeFrame: intraop, immediate postop, 3 months, 1, 2, 5, 10 years
measure: penetration of femoral head in the polyethylene insert trough IMAGIKA
timeFrame: 3 months, 5 and 10 years
measure: implant stability trough standard x-ray
timeFrame: 3 months, 1, 2, 5, 10 years
measure: implant survival trough Kaplan-Meier curve
timeFrame: 3 months, 1, 2, 5, 10 years
measure: implant fixation trough IMAGIKA
timeFrame: 3 months and 5 years
Other outcomes:
Locations:
city: Annecy
country: France
facility: Clinique Générale
city: Saint Etienne
country: France
facility: Orthéo - Espace Fauriel
Study officials:
References:
Clinical trial NCT06575075: Pilot Study of RR-HNK in OCD
Official title: A Double-blind, Placebo-controlled Study to Determine the Safety and Feasibility of Two Doses of Intravenous (2R, 6R)-Hydroxynorketamine (RR-HNK) in Adults With Obsessive-Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
AMPA receptor antagonist
hydroxynorketamine
ketamine metabolite
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-08-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized with a 1:1:1 allocation to either 0.25 mg/kg RR-HNK or 0.5 mg/kg IV RR-HNK + IV placebo (sterile saline)
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to understand how RR-HNK works in the brain to bring about a reduction in OCD symptoms.

Detailed description: This protocol examines the safety and efficacy of 2 dosage levels of intravenous RR-HNK administration in individuals with OCD.

Eligibility criteria: Inclusion Criteria:

* Ages 18-65
* Meet the criteria for OCD diagnosis
* Failed at least 1 prior trial of standard first-line OCD treatment (e.g. SRI/CBT) or or had refused these treatments for individual reasons
* Agree to the following lifestyle modifications: comply with requirements for fasting prior to --the infusion session, not enroll in any other interventional clinical trials during the duration of the study, and commit to medication study procedures.
* Able to provide informed consent

Exclusion Criteria:

* Allergy or hypersensitivity to ketamine
* Any current or past medical/psychiatric condition that makes participation unsafe in the opinion of the investigator or study physician
* Pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control
* Lifetime history of deep brain stimulation

Primary outcomes:
measure: Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: Baseline (Visit 3) to Week 1 (Visit 8), up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Carolyn Rodriguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02282475: Role of Liver and Visceral Fat in Glucose and Lipid Metabolism During Pregnancy
Official title: Role of Liver and Visceral Fat in Glucose and Lipid Metabolism During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Gestational Diabetes
Obesity
Liver Fat
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2014-11-04
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women ages 18-40 years and actively enrolled in Kaiser Permanente Northwest (KPNW).

Brief summary: Obesity, increased abdominal fat, fat stored in the liver, and insulin resistance may all be associated with adverse maternal and fetal pregnancy outcomes. This study will examine how fat storage changes during pregnancy; and if how the body stores fat impacts one's ability to metabolize glucose (sugar) during pregnancy.

Detailed description: This study aims to serially evaluate liver and visceral fat stores during pregnancy and their relationship with glucose and lipid metabolism, placental function, and newborn size. To do this we will conduct both a prospective cohort study of pregnant women without pre-gestational or early gestational diabetes assessed at both 12-16 weeks gestation and at 32-36 weeks gestation and a case-control study of women with normal and impaired glucose tolerance in the early third trimester. Physical assessments will be performed by the Oregon Health and Science University bio-nutrition unit and will include the use of magnetic resonance imaging, ultrasound, and blood draws.

Eligibility criteria: Inclusion Criteria:

* Pregnant and enrolled members of Kaiser

Exclusion Criteria:

* Women with multiples pregnancy; history of: cardiovascular disease, bariatric surgery, anemia, chronic hypertension or renal disease.
* Non-English speaker

Primary outcomes:
measure: Assess visceral adipose fat and intrahepatic lipid stores change during pregnancy
timeFrame: 12-16 weeks and 32-36 weeks gestation
Secondary outcomes:
measure: Compare glucose tolerance in pregnant women with gestational diabetes to those with normal glucose tolerance
timeFrame: 34 weeks gestation
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Permanente
name: Kim Vesco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03258775: Water Consumption, Hydration and Resting Energy Expenditure
Official title: Water Consumption, Hydration and Resting Energy Expenditure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydration and Resting Metabolism
Keywords: RMR
hydration
substrate oxidation
Lead sponsor: George Mason University
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: A randomized, cross over study will assess the effects of ingestion of high and low volumes of water on REE over 90 minutes. The high volume of water 500ml and the low volume of water 250ml. Participants will be computer randomized to determine which volume of water to receive first. Participants will arrive at the Nutrition Assessment Laboratory between 7:00 and 7:30am following a 9 hour overnight fast. Participants will be instructed not to consume any food or drink after 10pm the night before the assessment. Participants will also be asked to abstain from alcohol and caffeine for 3 days before the assessment. After verification of eligibility, baseline REE will be measured for 30 minutes followed by administration of first assigned dose of water. REE will be monitored for the next 90 minutes. Blood pressure and heart rate will also be monitored, simultaneously to REE. After a 7-10 day washout period, participants will return for their second test day where the second dose of water will be administered. A 7-10 day washout period was selected to allow participants time to resume normal diet and hydration between visits.


Eligibility criteria: Inclusion Criteria:

* 18-39 years of age
* Generally Healthy men and women
* BMI 18.5-28
* Willing to abstain from caffeine for 3 days prior to testing
* Able to provide written consent in English
* Ability to communicate in English (oral and written

Exclusion Criteria:

* \<18 or \>39 years
* BMI \< 18.5 or \>28
* Pregnant or Nursing
* Taking prescribed or over the counter medication affecting fluid balance or metabolism
* Suffers from hepatic, renal, pulmonary, endocrine or hematological disease
* Performs more than 3 hours a week of strenuous exercise
* Consumes, on average, more than 2 alcoholic beverages per day
* More than 5kg of weight change over the past 6 months
* Claustrophobic

Primary outcomes:
measure: Resting Metabolic Rate (RMR)
timeFrame: 90 minutes
measure: Substrate oxidation
timeFrame: 90 minutes
Secondary outcomes:
measure: blood pressure
timeFrame: 90 minutes
measure: heart rate
timeFrame: 90 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05845359: Intraoperative Methadone for Postoperative Pain Control
Official title: Randomized Control Study on the Effectiveness of Intraoperative Methadone on Postoperative Pain Control
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Bariatric Surgery Candidate
Keywords: methadone
bariatric surgery
pain management
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare patient pain perception and satisfaction as well as opioid-related side effects during inpatient and outpatient care when undergoing bariatric enhanced recovery after surgery protocols with and without methadone.


Eligibility criteria: Inclusion Criteria:

• All patients undergoing initial gastric sleeve resection

Exclusion Criteria:

* Age \<18 years or \>60 years
* Patients with BMI \>60
* AHI \> 30 (AHI = Apnea-Hypopnea Index), indicative of severe Obstructive Sleep Apnea (OSA)
* ASA IV or V (American Society of Anesthesiology physical status classification system)
* Patients taking opioids for chronic conditions in the last 10 days preceding the surgery
* Patients currently being treated for chronic opioid addiction
* Patients with severe psychiatric diagnoses
* Allergies to medications used in protocol

Primary outcomes:
measure: Postoperative opioid use
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Total Postoperative opioid use
timeFrame: 48 hours postoperatively and approximately at 2 weeks (follow up visit upon discharge)
measure: Respiratory interventions
timeFrame: Up to 4 hours postoperatively
measure: Duration of hospital stay
timeFrame: Approximately 5 days postoperatively
measure: Patients Perception of Pain Management
timeFrame: 24 hours postoperatively
measure: Patients Perception of Pain Management
timeFrame: 2 days postoperatively
measure: Sedation Score (POSS)
timeFrame: 2 days postoperatively
measure: Agitation and Sedation Severity (RASS)
timeFrame: 2 days postoperatively
measure: Opioid-related side effects
timeFrame: Up to 2 days postoperatively
measure: Early Mobilization
timeFrame: Up to 2 days postoperatively
measure: GI recovery time
timeFrame: Up to 2 days postoperatively
measure: Adverse events due to procedure or anesthesia
timeFrame: Up to 2 days postoperatively
measure: Pain Scores
timeFrame: After 30 minutes in the PACU; upon discharge from PACU (variable timepoint); at 6, 12, 18, and 24 hours after being on the in-patient floor; and at hospital discharge
Other outcomes:
Locations:
Study officials:
affiliation: Montefiore Medical Center
name: Jennifer Choi, MD
role: PRINCIPAL_INVESTIGATOR
References: