louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01709682: A Comparison of the Drug Therapy Versus Re-Ablation
Official title: Progression of Atrial Fibrillation After a Failed Initial Ablation Procedure in Patients With Paroxysmal Atrial Fibrillation: A Randomized Comparison of the Drug Therapy Versus Re-Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Paroxysmal Atrial Fibrillation
Failed First Radiofrequency Ablation Procedure
Keywords: atrial fibrillation
arrhythmias
anti-arrhythmic agents
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2012-10-18
Enrollment: 154
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 hypothesis of this study was that early re-ablation (test) was superior to AAD therapy (control) in patients with previous failed PVI ablation for paroxysmal AF.


Eligibility criteria: Inclusion Criteria:

* history of symptomatic PAF

Exclusion Criteria:

* congestive heart failure
* LV ejection fraction \< 35%
* left atrial diameter \> 60 mm

Primary outcomes:
measure: progression of AF (AF burden progression and persistent AF)
timeFrame: 3 year
Secondary outcomes:
measure: recurrence of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia
timeFrame: 3 years
measure: number of further ablation
timeFrame: 3 years
measure: predictors of AF progression
timeFrame: 3 years
measure: complications
timeFrame: 3 years
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
affiliation: State Research Institute of Circulation Pathology
name: Evgeny Pokushalov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pokushalov E, Romanov A, De Melis M, Artyomenko S, Baranova V, Losik D, Bairamova S, Karaskov A, Mittal S, Steinberg JS. Progression of atrial fibrillation after a failed initial ablation procedure in patients with paroxysmal atrial fibrillation: a randomized comparison of drug therapy versus reablation. Circ Arrhythm Electrophysiol. 2013 Aug;6(4):754-60. doi: 10.1161/CIRCEP.113.000495. Epub 2013 Jun 7.
Clinical trial NCT01315782: Alveolar Dead Space as Predictor of Organ Failure in Severe Sepsis
Official title: Alveolar Dead Space as Predictor of Multi-organ Failure and Mortality in Medical Intensive Care Patients With Sepsis Requiring Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sepsis
Severe Sepsis
Septic Shock
Multi-organ Failure
Keywords: Sepsis
Severe sepsis
Septic shock
Alveolar dead space
Multi-organ failure
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 30
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: Adult patients admitted to medical intensive care unit with severe sepsis or septic shock requiring mechanical ventilation.

Brief summary: This is an observational study to understand the changes in alveolar dead space in medical critically ill patients with severe infection (severe sepsis) requiring mechanical ventilation and the possibility to predict multi-organ failure.

The measurement of alveolar dead space used to require sophisticated equipment and time. New ventilators have microprocessors that allow rapid mathematical calculation with minimal intervention.

Detailed description: The patient will be followed during their ICU stay up to two weeks while on mechanical ventilation.

Patient will be followed daily for the initial 48 hours and then once per week for 2 weeks while mechanically ventilated.

Eligibility criteria: Inclusion Criteria:

* Adults with severe sepsis or septic shock on mechanical ventilation
* Enrolled in the initial six hours of ICU admission

Exclusion Criteria:

* Patients with withdrawal or hospice order.
* Patients with terminal, irreversible disease, expect to decease in 48 hours from ICU admission.
* Patients with COPD.
* Patients transferred from outside ICU with ongoing sepsis management for more than six hours.

Primary outcomes:
measure: Multi-organ failure
timeFrame: daily for 48 hours then weekly for 2 weeks.
Secondary outcomes:
measure: Mortality
timeFrame: ICU mortality
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Rosa M Estrada-Y-Martin, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05096182: Long-term Follow-up of Patients With Chronic Kidney Disease Who Had Administered Cellgram-CKD in PMC-P-12 Study
Official title: Long-term Follow-up of Patients With Chronic Kidney Disease Who Had Administered Cellgram-CKD in PMC-P-12 Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Renal Insufficiency, Chronic
Lead sponsor: Pharmicell Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-27
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic kidney disease who participated in the PMC-P-12 clinical trial, among those who received Cellgram-CKD, those who agreed to participate in this long-term follow-up study

Brief summary: This long-term follow-up study is a 5-year long-term follow-up study to evaluate long-term safety in Cellgram-CKD subjects. (refer to ClinicalTrials.gov.Identifier: NCT05042206).

Detailed description: This long-term follow-up study is a 5-year long-term follow-up study to evaluate long-term safety in Cellgram-CKD subjects. (refer to ClinicalTrials.gov.Identifier: NCT05042206).

The long-term safety of Cellgram-CKD is evaluated by monitoring whether or not an adverse event of special interest (AESI) occurs for 5 years from the date of administration in Cellgram-CKD subjects who voluntarily consented in writing to participate in the long-term follow-up study.

Eligibility criteria: Inclusion Criteria:

* Those who participated in the PMC-P-12 clinical trial and received Cellgram-CKD
* Subjects who consented in writing to this long-term follow-up study

Exclusion Criteria:

* Not Applicable

Primary outcomes:
measure: Observe the occurrence of Adverse Event of Special Interest (AESI).
timeFrame: 5 years from the date of administration of Cellgram-CKD
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center Hospital
Study officials:
affiliation: Asan Medical Center Hospital
name: Hyosang Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02747082: Antibacterial Effectiveness of Two Root Canal Irrigants
Official title: Antibacterial Effectiveness of Two Root Canal Irrigants in Root-filled Teeth With Infection: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periapical Periodontitis
Keywords: endodontic retreatment
sodium hypochlorite
chlorhexidine
calcium hydroxide
Retreatment
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Universidade Estácio de Sá
First posted: 2016-04-21
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized clinical trial is to compare the antibacterial effects of 1% sodium hypochlorite (NaOCl) and 2% chlorhexidine gluconate (CHX) during retreatment of teeth with apical periodontitis (AP).

Detailed description: Root canal-treated teeth with AP were randomly distributed in two groups according to the irrigant used. After removal of the previous filling material, bacteriological samples were taken from the canals before (S1) and after chemomechanical preparation using either NaOCl or CHX (S2), and after calcium hydroxide medication for 2-3 weeks (S3). 16S rRNA gene-based real-time qPCR was performed to detect and quantify total bacteria, Streptococcus species and Enterococcus faecalis.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of apical periodontitis in a root-filled tooth assessed by radiography.

Exclusion Criteria:

* Presence of gross carious lesions in the diagnosed tooth,
* Presence of fractures involving the periodontium of the diagnosed tooth,
* Presence of periodontal pockets more than 4 mm deep in the diagnosed tooth,
* Diagnosis of diabetes,
* Diagnosis of HIV infection,
* Other immunocompromising disease,
* Antibiotic therapy within the previous 3 months.

Primary outcomes:
measure: Periapical radiolucency (PAI- and Friedman-scores)
timeFrame: 12 months
Secondary outcomes:
measure: Bacterial load assessed by qPCR
timeFrame: 21 days
measure: Pyrosequencing of species found before and after the intervention
timeFrame: 21 days
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: Chair of the endodontic department, University of Oslo
name: Dag MR Ørstavik, DDS, PhD
role: STUDY_CHAIR
References:
citation: Rocas IN, Siqueira JF Jr. Comparison of the in vivo antimicrobial effectiveness of sodium hypochlorite and chlorhexidine used as root canal irrigants: a molecular microbiology study. J Endod. 2011 Feb;37(2):143-50. doi: 10.1016/j.joen.2010.11.006.
Clinical trial NCT03285282: Evaluation of Thoracolumbar Interfascial Plane Block for Postoperative Analgesia After Herniated Lumbar Disc Surgery
Official title: Evaluation of Thoracolumbar Interfascial Plane Block for Postoperative Analgesia After Herniated Lumbar Disc Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Postoperative Analgesia After Disc Surgery
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several regional anesthesia have been shown to improve postoperative outcomes in many studies. The transversus abdominis plane (TAP) block provides anesthesia to the abdominal wall by introducing local anesthetic to the anterior rami of the spinal nerve roots. This work evaluates the analgesic effects gained after performing thoracolumbar interfacial plane block (analogous to the TAP block but intended for the back) which targets the sensory component of the dorsal rami of the thoracolumbar nerves in patients undergoing back surgeries.


Eligibility criteria: Inclusion Criteria:

* patients with ASA 1 or 2 aged between 21years old up to 60 years old of both sex scheduled of back surgery

Exclusion Criteria:

* Exclusion criteria will be patients refusal or inability to give an informed consent , history of relevant allergy to any of the drugs used in the procedure , previous lumbar spine surgery or back surgery with planed spinal fixation.

Primary outcomes:
measure: Visual Analogue Score
timeFrame: 24 hrs postoperative
Secondary outcomes:
measure: Total morphine consumption
timeFrame: 24 hrs postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine
Study officials:
References:
Clinical trial NCT03372382: Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section
Official title: Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section: A Prospective, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Use
Pain, Postoperative
Keywords: postpartum
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two parallel groups included, randomized to control analgesic regimen versus alternative analgesic regimen and followed prospectively.
Primary purpose: TREATMENT

Brief summary: Postpartum patients delivered by cesarean section will be randomized to NSAIDS Vs NSAIDS plus opioid

Detailed description: Women will be approached priors to discharge from the hospital, if they meet inclusion criteria and consent for the study, they will be randomized to one of two possible analgesic regimens. They will be followed at 1-2 weeks and 4-6 weeks after discharge to assess pain level.

Eligibility criteria: Inclusion Criteria:

* English or Spanish speaker women who had a cesarean section

Exclusion Criteria:

* Inability or refusal to provide informed consent.
* Reported current or prior opioid or benzodiazepine use disorder, including urine drug screen positive for a non prescribed opioid or benzodiazepine upon admission or during prenatal care.
* Current treatment with methadone, buprenorphine or buprenorphine plus naloxone.
* Known alcoholism disorder.
* Severe renal or hepatic impairment.
* Known creatinine \> 1.5 at the time of delivery or severe proteinuria leading to diagnosis of renal disease prior to delivery.
* Severe peptic ulcer disease
* Severe asthma (if patient has asthma but has previously tolerated NSAIDS, she will be allowed to participate)
* Known CYP450/CY92D6 mutation conferring opioid ultra-rapid metabolizer status.
* Allergy to any of the study drugs (anaphylaxis).
* Incarcerated or institutionalized patients.
* Inability to follow up as outpatient in our outpatient clinic.
* wound dehiscence or infection diagnosed prior to discharge from the hospital
* wound vac placed prior to discharge from the hospital

Primary outcomes:
measure: Pain Level
timeFrame: 2-4 weeks postpartum
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 2-4 weeks postpartum
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: UT Houston, McGovern Medical School
name: Jenifer Dinis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01210482: Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Official title: SAFETY AND EFFECTIVENESS OF TEMSIROLIMUS IN JAPANESE PATIENTS WITH UNRESECTABLE OR METASTATIC RENAL CELL CARCINOMA: A POST-MARKETING, ALL-CASE SURVEILLANCE STUDY INCLUDING B1771016 STUDY - SURVEY ON LONG-TERM USE -
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: Torisel
Regulatory Post Marketing Commitment Plan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-28
Enrollment: 1050
Sex: ALL
Minimum age (years): 15
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma).

Brief summary: The objective of this investigation is to determine the following items in all patients receiving Torisel for a certain period after marketing:

1. Confirmation of efficacy and safety for medical practice use.
2. Investigation of factors that may influence the incidence of adverse events (Particularly priority investigation items).
3. Investigation of the incidence status and the risk factors for interstitial lung diseases.

Detailed description: Implemented as a Drug Use Investigation by Central Registration System

Eligibility criteria: Inclusion Criteria:

* Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma).

Exclusion Criteria:

* Patients not administered Torisel.
* Patients with a history of severe hypersensitivity to temsirolimus, sirolimus derivative, or any of their components and/or derivatives.

Primary outcomes:
measure: Number of Participants With Adverse Drug Reactions
timeFrame: 96 weeks at maximum
measure: Number of Participants With Adverse Drug Reactions of Major Investigation Items
timeFrame: 96 weeks at maximum
Secondary outcomes:
measure: Overall Response Rate
timeFrame: 96 weeks maximum
measure: Response Rate Excluding Participants Evaluated as "Unassessable"
timeFrame: 96 weeks maximum
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Kyusyu University Hospital
state: Fukuoka PREF
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Sugiyama S, Sato K, Shibasaki Y, Endo Y, Uryu T, Toyoshima Y, Oya M, Miyanaga N, Saijo N, Gemma A, Akaza H. Real-world use of temsirolimus in Japanese patients with unresectable or metastatic renal cell carcinoma: recent consideration based on the results of a post-marketing, all-case surveillance study. Jpn J Clin Oncol. 2020 Aug 4;50(8):940-947. doi: 10.1093/jjco/hyaa062.
Clinical trial NCT00371982: Effect of Fish Oil on Adiposity and Atherogenic Factors in Type 2 Diabetic Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Fish oil
Type 2 diabetic women
adiposity
adipose tissue inflammation
PAI-1
Insulin sensitivity
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2006-09-04
Enrollment: 24
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. whether the intake of n-3 PUFA has additional effects on insulin sensitivity and adiposity (total fat mass and adipocyte morphology and function) in T2D women.
2. n-3 PUFA supplementation might influence inflammatory genes expression in the adipose tissue of T2D patients.

Detailed description: Thus, the present study was designed to evaluate the effects of n-3 PUFAs dietary supplementation on lipid and glucose homeostasis and to address the impact of this treatment on adiposity and adipose tissue gene expression in T2D women.A total of 27 T2D women (BMI 27-35kg/m², age 40-60 y) were randomly allocated to two months of 3 g/day of either fish oil (1.8 g n-3 PUFA) or placebo (paraffin oil), in a double-blind parallel design.

Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetic postmenopausal women
2. glycaemia of 7.87-14.0 mmol/l, HbA1c of 7 to 10.5%
3. plasma triglycerides between 1.72-4.6 mmol/l,
4. aged between 40 -60,
5. BMI: 27-40 kg/m2
6. able to swallow tablets

Exclusion Criteria:

1. patients with abnormal renal, hepatic and thyroid functions as determined by physical examination, blood cell count and standard blood biochemical profile
2. patients with gastrointestinal disorders
3. patients treated with thiazolidinediones or insulin

Primary outcomes:
measure: The effect of 2 month treatment on:
measure: adiposity (total fat mass, adipocyte morphology), atherogenic markers and insulin sensitivity
Secondary outcomes:
measure: the underlying mechanisms of the observed results and tried to define new targets of fish oil metabolic effects
measure: and the impact of fish oil on systemic inflammatory markers and adipose tissue inflammatory genes.
Other outcomes:
Locations:
city: Paris
country: France
facility: Department of Diabetes-Hotel Dieu Hospital
Study officials:
affiliation: INSERM (National institution of Health and Medical Research)
name: Salwa W Rizkalla, MD,PhD
role: STUDY_DIRECTOR
affiliation: Public Assistance-Paris Hospitals (AP-HP), University Paris 6
name: Gerard Slama, MD, professor
role: STUDY_CHAIR
References:
Clinical trial NCT04789382: Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations
Official title: Clinical Biocompatibility of Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: contact lens
contact lens solution
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2021-03-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate corneal staining observed after 2 hours of wear with an investigational contact lens against both PureVision contact lenses pre-cycled with Biotrue and Biofinity contact lenses pre-cycled with RepleniSH.

Detailed description: Subjects will be randomized in a 1:1:1:1 manner to receive one of 4 regimen sequences with lens and multipurpose disinfection solution (MPDS) combinations. The expected duration of subject participation in the study is approximately 1 week with 2 study visit days.

Eligibility criteria: Key Inclusion Criteria:

* Understand and sign an Informed Consent;
* Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
* Manifest cylinder of less than or equal to 1.50 diopter (D) in each eye;
* Best corrected visual acuity (BCVA) better than or equal to 20/25 Snellen in each eye;
* Willing to stop wearing habitual contact lenses for the duration of study lens exposure and during the washout period.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any eye condition or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
* Eye surgery, as specified in the protocol;
* Dry eye; use of artificial tears, as specified in the protocol;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Average Percent Area of Corneal Staining
timeFrame: Hour 2 (each wear period)
Secondary outcomes:
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Alcon Investigator 6565
state: Florida
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References: