louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03988062: Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study
Official title: Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ruptured or Unruptured Cerebral Aneurysms
Lead sponsor: Shape Memory Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: APEX-FIH is a first-in-human, open-label prospective multicenter study of the TrelliX Embolic Coil System for use in embolization of the medium to large, ruptured or unruptured cerebral aneurysms


Eligibility criteria: Inclusion Criteria:

* Subject age ≥18 and ≤80 years with a diagnosis of a ruptured or unruptured intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion during single procedure
* Aneurysm size \[largest measurement from the cross sectional images to determine overall aneurysm size, not just the lumen) ≥5 mm and ≤16mm
* If ruptured aneurysm: either WFNS grade 1 or 2, or Hunt and Hess 1 or 2
* If unruptured aneurysm: Subject grade Modified Rankin Scale mRS 0 - 2
* Investigator plans to use ≥70% in volume TrelliX coils to fill target aneurysm

Exclusion Criteria:

* Prior treatment (surgical or endovascular) of the target aneurysm
* Planned treatment of multiple aneurysms in index procedure
* Planned use of other modified coils (Matrix, HydroCoil or fibered coils)
* Planned use of liquid embolic material
* Life expectancy less than 12 months
* Presence of arteriovenous malformation
* Fusiform, mycotic, traumatic, or tumoral aneurysms
* Intended or planned aneurysm treatment by parent vessel occlusion
* Clipping or endovascular treatment of another intracranial aneurysm performed within 30 days before or planned within 30 days following the index procedure

Primary outcomes:
measure: Safety - Serious adverse events
timeFrame: 30 days
measure: Efficacy - Angiographic occlusion
timeFrame: Immediate
measure: Efficacy - Angiographic occlusion
timeFrame: 6 months and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Concepción
country: Chile
facility: Hospital Clínico Regional Guillermo Grant Benavente
city: Santiago
country: Chile
facility: Instituto de Neurocirugía
Study officials:
References:
Clinical trial NCT00375362: The Analgesic Effect of Nitroglycerin Patch for Postoperative Pain After Total Knee Replacement
Official title: The Analgesic Efficacy of Nitroglycerin Patches for Postoperative Pain in Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: nitroglycerin
morphine
patient controlled analgesia
total knee arthroplasty
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2006-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients who undergo general anestheesia for total knee arthroplasty pften have sever postoperative pain which hinders their rehabilitation. Nitroglycerin patches have been found to cause alleviation of pain especially when used in conjuction with morphine. Therefore we propose placement of a nitroglycerin patch after total kneee arthroplasty surgery and see how it affects pain scores or causes less nedd for morphine after surgery.

Detailed description: Patients undergoing total knee arthroplasty will be randomized into two groups: control and placebo.

Eache patient will undergo total knee arthroplasty under general anesthesia. Both groups will get the same anesthetic protocal. At the end of surgery, before awakening patients will recieve either a nitroglycerin or placebo patch on their back. Both the participant and the investigator will be blinded to the group assisignment. At the end of surgery both groups will recieve morphine for postoperative pain. In the recovery room they will be given patient controlled analgesia with morphine. An investigator blinded to study assisignment will record pain scores, sedation scores, nauseau and vomiting. Patients will be given patient controlled analgesia for 24 hours and they will be followed for pain levels, morphine use, sedation and nauseau levels. The nitroderm or placebo patch will be removed after 24 hours.

Eligibility criteria: Inclusion Criteria:

* Healthy patients undergoing total knee arthroplasty

Exclusion Criteria:

* Pshychiatric disorder
* Allergy to nitroglycerin or morphine
* Chronic renal failure
* Migraine headaches
* Hypotension

Primary outcomes:
measure: pain scores
measure: morphine use
measure: sedation score
measure: nausea and vomiting
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikvah
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Leonid A Eidelman, MD
role: STUDY_DIRECTOR
affiliation: Rabin Medical Center
name: Sharon Orbach-Zinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05640362: Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial
Official title: Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia
Dry Mouth
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical is to assess the efficacy of natural enzymes mouthwash in the treatment of xerostomia (dry mouth). The main questions it aims to answer are: (1) the efficacy of natural enzymes mouthwash in the symptomatic treatment of xerostomia; and (2) the response of xerostomia patients towards natural enzymes mouthwash. Participants were given a mouthwash to be used. Intervention group received natural enzymes moisturising mouthwash, while control group received benzydamine mouthwash. Mouthwashes were repacked, labelled with specific code and were given to participants by third-party. Subjects were instructed to rinse with the mouthwash 4 times per day at a specific period, for 2 weeks. Data were compared within each arm before and after using the mouthwashes; and between both arms after using the mouthwashes.


Eligibility criteria: Inclusion Criteria:

* 18 years old and above,
* complained of dry mouth (xerostomia), and
* taking nutrition orally

Exclusion Criteria:

* patients who had been using mouthwash for xerostomia in the past 1 week,
* unable to provide saliva samples,
* unable to chew paraffin wax for stimulated saliva,
* patients with oral motor function deficits, and
* those with severe cognitive deterioration.

Primary outcomes:
measure: Changes in symptoms
timeFrame: At Day 0 and Day 14 of intervention
Secondary outcomes:
measure: Changes in clinical signs
timeFrame: At Day 0 and Day 14 of intervention
measure: Salivary flow rate
timeFrame: At Day 0 and Day 14 of intervention
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Faculty of Dentistry, Universiti Kebangsaan Malaysia
Study officials:
affiliation: National University of Malaysia
name: Rifqah Nordin, MClinDent
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06169462: Comparison of Pericapsular Nerve Group Block With Suprainguinal Fascia Compartment Block in Hip Fractures
Official title: Comparison of Pericapsular Nerve Group (PENG) Block Alone Versus Combined With Suprainguinal Fascia Compartment Block (SIFCB) for Postoperative Analgesia and Quality of Recovery in Older Adult Patients With Hip Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Keywords: Anesthesia
Lower extremity
pericapsular nerve group block
suprainguinal fascia compartment block
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 38
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data of patients underwent hip surgery under spinal anesthesia between 31.01.2023 and 01.10.2023.

Brief summary: Ultrasound-guided Supra-inguinal Fascia Iliaca compartment Block (SIFCB) and Pericapsular Nerve Group Block (PENG) are increasingly being used for postoperative analgesia for hip surgery. The postoperative analgesic efficacy of SIFCB added to PENG block in elderly hip fracture patients will be evaluated. Postoperative opioid consumption and quality of recovery will also be evaluated.

Detailed description: The study was conducted as a retrospective cohort feasibility design within a tertiary hospital. Patient records and electronic data systems were used to gather the required data for analysis. Before surgery, a carefully selected cohort of patients who underwent PENG block and PENG block added SIFCB were included in the study.

Eligibility criteria: Inclusion Criteria:

* Physical status according to American Society of Anesthesiologists (ASA ) I-III

Exclusion Criteria:

* Previous operation on the same hip
* Hepatic or renal insufficiency
* Patients undergoing general anesthesia
* Allergy or intolerance to one of the study medications
* BMI \>40
* ASA IV

Primary outcomes:
measure: Opioid consumption
timeFrame: Postoperative 48th hour
Secondary outcomes:
measure: Numerical Rating Scale (NRS) scores
timeFrame: Postoperative 48th hour
measure: Quality of Recovery 15 Score
timeFrame: Postoperative day 1 and 1 month
measure: Postoperative complications
timeFrame: 24 hours
measure: Mobilization time
timeFrame: 24 hours
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
state: Karaman/Merkez
Study officials:
References:
Clinical trial NCT01463462: Electronic Catheter Stethoscope
Official title: Use of the Electronic Catheter Stethoscope for the Detection of Urinary Tract Injury During Gynecologic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Gynecologic Cancers
Uterine Leiomyomata
Adenomyosis
Endometrial Hyperplasia
Other Abnormal Uterine and Vaginal Bleeding
Pelvic Mass
Pelvic Pain
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2011-11-02
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current patients having gynecological surgery

Brief summary: This is an observational, exploratory study designed to collect (record) and analyze normal and abnormal sound data from the human bladder during surgery using a novel sensor-based catheter system (Electronic Catheter Stethoscope) and to develop algorithms to detect changes of baseline bladder and ureteral function. The Electronic Catheter Stethoscope device will measure acoustic and pressure data within the bladder. The measurements will be used to detect any leakage from the bladder and/or changes in baseline ureteral flow by correlation of sound data with surgical data reported by the surgeon. These data will be used to develop algorithms to detect changes of baseline bladder and ureteral function. The algorithms will be tested in future clinical trials.


Eligibility criteria: Inclusion Criteria

* age 18 or older
* plan to have one of the following types of surgery:

  * laparoscopic or abdominal gynecological surgery
  * vaginal surgery
* able to provide written informed consent

Exclusion Criteria

* under 18 years of age
* bilateral tubal ligation as the single reason for surgery
* current pregnancy
* unable to provide written informed consent

Primary outcomes:
measure: bladder and ureter sounds during pelvic surgery.
timeFrame: from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours)
Secondary outcomes:
measure: changes from baseline bladder and ureteral function sounds
timeFrame: from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours)
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Women's Center Operating Rooms at the Tampa General Hospital
state: Florida
Study officials:
affiliation: University of South Florida
name: Stuart Hart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03319862: Post-massive Weight Loss Chest Contouring: Inferior Pedicle Technique in Pseudo-gynecomastia Correction
Official title: Post-massive Weight Loss Chest Contouring: Inferior Pedicle Technique in Pseudo-gynecomastia Correction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecomastia
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 28
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: every patient hospitalized for gynaecomastia but only whose have a inferior pedicle gynaecomastia are selected for the project.

Brief summary: The massive weight loss leads an important excess of skin on thoracic level giving the aspect of a feminine breast with a relatively important ptose. Several techniques were described in the literature about gynaecomastia , but the post-bariatric pseudo-gynaecomastia was not handled yet enough. Moreover, there is no single consensual technique on this subject. The technique used in this service was described for the first time in 2008 ( 1 ) on a serie of 8 patients with an average follow-up of 13 months. Although the results are promising, no other publication was done, and the procedure remains badly represented in the world literature.


Eligibility criteria: Inclusion Criteria:

* inferior pedicle gynaecomastia surgery
* Age \> 16

Exclusion Criteria:

* Age \< 16

Primary outcomes:
measure: aesthetic result score
timeFrame: Average of 6 months post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: GHPSJ
name: Philippe LEVAN, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00185562: A Pilot Trial of Adalimumab for the Treatment of Osteoarthritis
Official title: A Pilot Trial of Adalimumab for the Treatment of Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 12
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A 12 week trial of Adalimumab in subjects with active erosive inflammatory OA who have ahd an inadequate response to NSAID therapy


Eligibility criteria: Inclusion Criteria:

* Age 45 or older, \>/=2 tender and 2 swollen joints, inadequate response to NSAID therapy, hand radiographs with evidence of erosive changes, acceptable form of birth control

Exclusion Criteria:

* Autoimmune arthropathy, History of psoriasis, Previous TNF therapy, current use of any DMARD, evidence of TB, history of Hep C, B, or HIV

Primary outcomes:
measure: Safety
Secondary outcomes:
measure: 20% ACR response
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Mark C Genovese, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03279562: Patient Driven Recovery With Nalmefene and Coaching
Official title: Patient Driven Recovery With Nalmefene and Coaching
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid-use Disorder
Harmful; Use, Alcohol
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: First Pavlov State Medical University in St. Petersburg, Russia
First posted: 2017-09-12
Enrollment: 10
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
Intervention model description: Pilot, open label, non-randomized clinical trial
Primary purpose: TREATMENT

Brief summary: In collaboration with the First Pavlov State Medical University in St. Petersburg, Russia, we are proposing a pilot, open label, non-randomized clinical trial to evaluate the safety, feasibility, acceptability, and preliminary efficacy of treatment for alcohol and opioid use disorders combining Nalmefene and recovery coaching (educational and behaviorally oriented drug counseling). The proposed pilot study will also be used to further develop and refine the recovery coaching/counseling intervention and to train additional cadre of clinicians and researchers in St. Petersburg, Russia.

Detailed description: The specific aims and hypotheses of the proposed study are as follows:

Specific Aim 1: To evaluate the safety, feasibility, acceptability, and preliminary efficacy of treatment of alcohol and opioid use disorders combining Nalmefene and recovery coaching for rehabilitation of detoxified opioid dependent individuals in Russia.

Specific Aim 2: To further develop and refine the recovery coaching/counseling intervention and to train additional cadre of clinicians and researchers in St. Petersburg, Russia.

Eligibility criteria: Inclusion Criteria:

* individuals who meet DSM IV criteria for opioid dependence, who use street methadone (the main, most frequently used street opioid in Saint Petersburg, Russia) by intravenous injections, who have a history of alcohol use disorder or high risk alcohol use, who successfully completed inpatient, medically supervised detoxification, who are seeking a rehabilitation treatment following detoxification, and who pass a naloxone challenge (indicating the current lack of physiological dependence on opioids)

Exclusion Criteria:

* current suicide or homicide risk; current psychotic disorder or major depression; inability to understand the consent form or assessments; pregnancy; acute medical conditions requiring medical treatment, co-occurring dependence/abuse of other drugs including alcohol, benzodiazepines, or amphetamine type stimulants (ATS)

Primary outcomes:
measure: Duration of abstinence from illicit opioids
timeFrame: Past 30 days
Secondary outcomes:
measure: Treatment retention
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University, Department
state: Connecticut
Study officials:
References:
Clinical trial NCT01193062: Study In Healthy Subjects To Evaluate The Changes In The Protein sAPP-Alpha In Cerebrospinal Fluid Following A Single Oral Dose Of PF-04995274
Official title: A Phase 1 Investigator And Subject-Blind Study In Healthy Subjects To Evaluate The Pharmacodynamic Effects Of Single Doses Of PF-04995274 On Sapp-Alpha Concentrations In Cerebrospinal Fluid Using Serial Sampling Methodology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy volunteers
pharmacokinetics-pharmacodynamics
cerebrospinal fluid
serial sampling
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary purpose of the study is to evaluate the effect of PF-04995274 on cerebrospinal fluid levels of soluble Amyloid precursor protein fragments and Amyloid beta fragments following single oral dose in healthy volunteers. Safety and tolerability of PF-04995274 single dose administration in healthy volunteers will also be assessed as part of the objectives.

Detailed description: The purpose of the study is to evaluate the effect of PF-04995274 on CSF levels of s-APP and Abeta fragments following single oral dose in healthy volunteers

Eligibility criteria: Inclusion Criteria:

* For all cohorts, healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Pregnant or nursing women; women of childbearing potential.

Primary outcomes:
measure: Safety Endpoints (AE's, Vital signs, ECG, Clinical safety laboratory endpoints, Clinical examinations)
timeFrame: duration of study
measure: Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 04995274 and PF-05082547 in plasma, as the data permit
timeFrame: upto 5 days post dose
measure: Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 04995274 and PF-05082547 in cerebrospinal fluid, as the data permit
timeFrame: upto 8 hrs post dose
measure: Cmax, Tmax, AUClast, AUCinf, and t1/2 of s-APP alpha and Abeta fragments in cerebrospinal fluid, as the data permit
timeFrame: 8 hours post dose
Secondary outcomes:
measure: PK/PD model
timeFrame: 8 hours post dose
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: