louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01143766: Gabapentin to Improve Patient Tolerance in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official title: Premedication With Single Dose Gabapentin to Improve Patient Tolerance in ERCP: A Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conscious Sedation
Keywords: Sedation
Gabapentin
ERCP
Endoscopy
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2010-06-14
Enrollment: 56
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 standard approach to sedation in endoscopic retrograde cholangiopancreatography (ERCP) involves the use of benzodiazepines and opiates to achieve a moderate depth of sedation. There is data to suggest supplementing this regimen with gabapentin may lead to reduced pain, higher patient satisfaction and lower opiate requirements. The investigators are conducting a clinical trial to study this hypothesis.


Eligibility criteria: Inclusion Criteria:

* Male or female patients \>18 years of age referred to IUMC for first-time ERCP procedure.

Exclusion Criteria:

1. Pregnant women
2. age \<18 years
3. Incarcerated individuals
4. Patients currently taking or having taken gabapentin or pregabalin within the last 3 months
5. Patients unable to give informed consent
6. Patients not able to fill out visual analog scales for pain, nausea and anxiety or unable to fill out survey regarding procedural satisfaction.
7. High risk patients for anesthesia: home oxygen, class III or IV heart failure, sleep apnea (on CPAP/BiPAP at home), or ASA class \> 3.
8. Patients undergoing general anesthesia for their ERCP procedure
9. Patients receiving propofol sedation for their ERCP procedure

Primary outcomes:
measure: Dosing Requirements
timeFrame: At time of discharge post-procedure
Secondary outcomes:
measure: Number of Participants With Sedation-Related Adverse Events
timeFrame: At time of discharge post-procedure
measure: Median Pain Score at Time of Discharge
timeFrame: At time of discharge post-procedure
measure: Median Anxiety Score at Time of Discharge
timeFrame: At time of discharge post-procedure
measure: Median Nausea Score at Time of Discharge
timeFrame: At time of discharge post-procedure
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: University Hospital, Indiana University Purdue University Indianapolis
state: Indiana
Study officials:
affiliation: Indiana University
name: Gregory A Cote, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00103766: Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion
Official title: Randomized Comparison of Two Dose and Frequency Regimens of Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Empyema
Pleural Effusion
Keywords: Alteplase
Empyema
Complicated Parapneumonic Effusion
Lead sponsor: O'Brien, Jeana D., MD, FACP, FCCP
Sponsor class: INDIV
Collaborators: name: Genentech, Inc.
name: Scott and White Hospital & Clinic
name: Scott, Sherwood and Brindley Foundation
name: Texas A&M University
First posted: 2005-02-15
Enrollment: 75
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 purpose of this study is to assess the benefit to patients with empyema or complicated parapneumonic effusion (CPE) using a daily versus twice daily Alteplase regimen of two different dose strategies compared with saline placebo.

Detailed description: This is a randomized, double-blind, placebo-controlled pilot study. Patients with empyema and complicated parapneumonic effusion who are felt to require fibrinolytic therapy will be considered for study enrollment. Enrolled patients will be randomized to one of five potential treatment arms (saline placebo, 4 mg once daily, 4 mg twice daily, 10 mg once daily, or 10 mg twice daily) in a double-blinded manner.

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent
* Age greater or equal to 18 yrs
* Presence of empyema or CPE

Exclusion Criteria:

* Active internal bleeding
* Pregnancy
* Prior enrollment in this study
* Platelet count less than 100,000/mm3
* Use of warfarin sodium if INR is greater than 1.7
* Use of heparin unless the PTT is less than 1.5 times baseline normal
* Known neurological disorders
* Current or pre-existing bleeding dyscrasia
* Known allergy to Alteplase

Primary outcomes:
measure: Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy.
Secondary outcomes:
measure: Mortality
measure: Hospital length of stay
measure: Daily chest tube drainage
measure: Radiographic improvement
Other outcomes:
Locations:
city: Temple
country: United States
facility: Scott and White Memorial Hospital & Clinic
state: Texas
Study officials:
affiliation: Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation
name: Jeana D O'Brien, MD, FACP, FCCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03654066: Botox or Botox With Esophageal Dilation in Patients With Achalasia
Official title: Prospective Single-Blinded Randomized Controlled Trial Comparing Botox or Botox With Esophageal Dilation in Patients With Achalasia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Achalasia
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 50
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: Achalasia is a rare esophageal motility disorder. Treatment of achalasia is aimed toward palliation of symptoms. These include botox injections to the lower esophageal sphincter (LES), pneumatic dilation, surgical myotomy, and per-oral endoscopic myotomy (POEM). Botox injections are frequently used for patients that have significant comorbidities. The primary aim of this study is to assess symptomatic response of patient with achalasia to esophageal dilation and botox injection to the LES compared to standard therapy of only botox injection.


Eligibility criteria: Inclusion Criteria:

* Adults with known diagnosis of achalasia who are NOT candidates for definitive therapy with pneumatic dilation, surgical myotomy, or POEM
* Patient undergoing routine care upper endoscopy for achalasia

Exclusion Criteria:

* Less than 18 years old
* Previous surgery for reflux or peptic ulcer disease
* Significant medical conditions possibly placing subjects at risk to undergo endoscopy

Primary outcomes:
measure: dysphagia score
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center Endoscopy Laboratory
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Dhyanesh Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02204566: OFDI Capsule Imaging in Patients With Atrial Fibrillation Undergone Radio Frequency (RF) Ablation
Official title: Pilot Study of OFDI Capsule Imaging of the Esophagus of Patients With Atrial Fibrillation Following RF Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: OFDI
RF Ablation
Atrial Fibrillation
Imaging
Esophagus
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2014-07-30
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 12 patients with Atrial Fibrillation, a kind of irregular heart beat who have undergone Radio frequency (RF) ablation will be asked to swallow the capsule.

As they swallow the capsule, images of the esophagus will be taken to see if the RF ablation caused any form of damage to the esophagus considering it being so close to the heart.

After the capsule has been removed from the mouth, they will be asked about the tolerability of the capsule.

Detailed description: A total of 12 patients with a known diagnosis of Atrial Fibrillation who have previously undergone Atrial RF ablation will be enrolled in the study. Patients will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.

As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.

Eligibility criteria: Inclusion Criteria:

* Subjects must be over 18 years of age
* Subjects must be able to give informed consent.
* Subjects must be referred to Massachusetts General Hospital (MGH) endoscopy for RF Ablation treatment of their Atrial Fibrillation.

Exclusion Criteria:

* Subjects with current esophageal strictures and dysphagia
* OR subjects with a prior history of intestinal strictures, prior GI surgery or intestinal Crohn's disease.
* OR subjects with a known history of chronic aspiration.
* OR women who are currently pregnant.

Primary outcomes:
measure: Feasibility of a Tethered OFDI Capsule in Patients With Atrial Fibrillation Following RF Ablation That Swallow the OFDI Capsule
timeFrame: After the completed imaging session
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03522766: Evaluation of Urine Samples and Their Relation to Urinary Tract Infection
Official title: Evaluation of Urine Samples and Their Relation to Urinary Tract Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2018-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of danish subjects and will consist of healthy volunteers as well as users of intermittent catheter (neurogenic bladder or enlarged prostate) with and without reoccurring urine tract infections.

Brief summary: The aim is to explore the human urine composition and its relation to urine tract infections


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. For the 2 patient populations: Use intermittent catheter on a daily basis due to neurogenic bladder or enlarged prostate and have used IC for at least 2 months
4. For healthy volunteers without UTIs: No diag-nosed UTIs within the last year
5. For healthy volunteers with recurrent UTIs: 3 or more UTIs within the last year or 2 UTIs within the last 6 months (treated with antibiotics)

Exclusion Criteria:

1. Be treated for urinary tract infection at time of enrolment
2. May not take prophylactic treatment for urinary tract infections (antibiotics only)

Primary outcomes:
measure: Type of bacteria present in the urine
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Coloplast A/S
name: Lene F Nielsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01733966: A Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults
Official title: A Third Phase, Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diverticular Sigmoïditis
Lead sponsor: Quanta Medical
Sponsor class: INDUSTRY
Collaborators: name: Laboratoires Iprad-Vegebom
First posted: 2012-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary outcome measure is to compare efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults in clinical and biological cure.

The cure rate will be evaluated at the second visit (14 days after the inclusion visit)


Eligibility criteria: Inclusion Criteria:

* Adult
* Recovering of written and dated informed consent form
* Social Security medical cover
* Left Iliac Fossa (LIF) pain
* Moderate fever (\>37.8°C)
* Sensitivity/defence during LIF palpation

Biological results :

* CRP \> 10mg/L
* NFS \> 10G/L
* Neutrophil Granulocytosis \> 75%
* Radiological results - presence to the scan :diverticul \& pericolic infiltration

Exclusion Criteria:

* Patients treated by antibiotherapy in the last 15 days prior inclusion
* Patients treated by morphinic drug
* Patients treated by anticoagulant drug
* Pregnant or breast-feeding women
* Patients presenting allergy to active principal, to galactose
* Patients having taking part in another study in the last 3 months prior inclusion
* Patients unable to comply with the study requirements
* Patients presenting Chronic affection inconsistent with the study
* Patients presenting high fever
* Patients presenting abdominal contracture
* Patients presenting immunosuppression
* Radiological sign of complication (abscess\>3cm)
* Patients presenting Pathology inconsistent with efficacy evaluatio

Primary outcomes:
measure: comparaison of the efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for clinical and biological cure
timeFrame: the cure rate will be evaluated at the second visit (14 days after the inclusion visit)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05624866: Dexmedetomidine Versus Triamcinolone Treatment in Carpal Tunnel Syndrome
Official title: Dexmedetomidine Versus Triamcinolone Local Injection for Pain Alleviation in Patients With Carpal Tunnel Syndrome; A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Investigate if, and to what extent,carapl tunnel hydro-dissection using DEX or triamcinolone (TM) along with saline, under ultrasound guidance, can improve the clinical condition, change in nerve conduction parameters of patients with CTS and delay or avoid the surgical intervention.
Primary purpose: TREATMENT

Brief summary: Carpal tunnel syndrome (CTS) is a common mononeuropathy due to entrapment of the median nerve in the carpal tunnel. a lot of modalities are available for treatment of mild to moderate CTS.

Detailed description: Carpal tunnel syndrome (CTS) is a common mononeuropathy due to entrapment of the median nerve in the carpal tunnel. a lot of modaleties are available for treatment of mild to moderate CTS.

In case of failed conservative oral therapey, local hydro-dessction of the median nerve can be done with saline alone. local anethetics, steroids, hyalase,and ozone have been utilized to augment the symptoms reliefe.

Dexmeditomidine (DEX) has been studied as adjuvant for nerve block to aumnet the pain reliefe. Recently, it has been discovered that DEX can offer some antinflammatory effects when injected in the perineural area. Upon such discovery, the goal of this study has been built.

Eligibility criteria: Inclusion Criteria:

* adult patients
* complaining of carpal tunnel syndrome of 3 month duration or more
* diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study

Exclusion Criteria:

* patient refusal
* infection at the site of intervention
* allergy to utilized drugs
* diabetic
* previous surgery in the site of injection
* previous injection in the targeted site within the last year

Primary outcomes:
measure: pain visual analoge scale visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain
timeFrame: 6 months
Secondary outcomes:
measure: change of cross sectional area of the median nerve
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Universit Hospital
Study officials:
References:
Clinical trial NCT01390766: Drug Use Investigation for IMURAN (Azathioprine) Tablet (Hepatic Transplantation)
Official title: Drug Use Investigation for IMURAN (Azathioprine) Tablet (Hepatic Transplantation)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Diseases
Keywords: Antirejection
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-07-11
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The following subjects to whom azathioprine tablet is administered for "the suppression of liver transplant rejection";

* Subjects on whom liver transplantation is performed and to whom azathioprine tablet is administered within 1 year after transplant surgery from the approval date of the additional indication of azathioprine tablet for liver transplantation (20 June 2001) to May 2010.
* Subjects on whom liver transplantation is performed before the approval date of the additional indication of azathioprine tablet for liver transplantation (20 June 2001) and to whom azathioprine tablet is administered within 1 year after transplant surgery.

Brief summary: This post-marketing surveillance (PMS) study is designed to investigate the efficacy and safety of azathioprine tablets in Japanese subjects whom liver transplantation is performed.


Eligibility criteria: Inclusion Criteria:

* Subjects who undergo liver transplantation and azathioprine tablet was administered

Exclusion Criteria:

As this is PMS study, there are no exclusion criteria but contraindications are as follows.

* Subjects with hypersensitivity to the ingredients of azathioprine tablet
* Subjects who is pregnant or might be pregnant
* Subjects whose white count is lower than 3000/cubic millimeter

Primary outcomes:
measure: The number of incidence of adverse events related to azathioprine tablets and serious adverse events
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06701266: Accuracy of PoCT to ELISA by Detecting Human IL-6 in Teeth with Apical Periodontitis
Official title: Diagnostic Agreement of Human Interleukin-6 Chairside Point-of-Care Test (PoCT) to Enzyme-Linked Immunosorbent Assay (ELISA) in Teeth with Apical Periodontitis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Apical Periodontitis
Lead sponsor: Manipal University College Malaysia
Sponsor class: OTHER
Collaborators: name: Melaka Manipal Medical College
First posted: 2024-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who is having apical periodontitis and undergo RCT in MUCM

Brief summary: To compare the diagnostic agreement of human IL-6 chairside PoCT to ELISA in apical periodontitis undergoing endodontic therapy which could be clinically helpful to monitor the healing of periapical tissues enabling the clinician to complete the endodontic procedure, leading to a better patient care.

This study will be conducted at the Conservative and Endodontics Department in Polyclinic B, Faculty of Dentistry, Manipal University College Malaysia (MUCM). It involves 30 selected patients who have single rooted tooth with apical periodontitis that undergo RCT. The collection of the exudate from the canal will be on pre and post-instrumentation. The exudated will collect twice in each instrumentation for PoCT and ELISA.


Eligibility criteria: Inclusion Criteria:

* Patient having single root tooth with AP that is negative to the pulp sensitivity test
* Presence of periapical lesion

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Detect the IL-6 in the exudate of the tooth with apical periodontitis
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Malacca
country: Malaysia
facility: Manipal University College Malaysia
state: Melaka
Study officials:
References: