louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02085551: Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
Official title: The Prism Trial: A Retrospective Case Review of Technical Success Using the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Occlusion or Emboli
Keywords: peripheral arterial occlusion
visceral emboli
limb ischemia
adverse events
Indigo System
aspiration
mechanical thrombectomy
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-13
Enrollment: 85
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this retrospective case review study is to determine the safety and effectiveness of the Penumbra and Indigo Systems for mechanical thrombectomy in a cohort of patients with confirmed peripheral or visceral arterial occlusion or embolus. This is a retrospective, single arm, multi-center trial. Up to 100 patients at up to 10 centers will be enrolled. Angiographic assessment of vessel patency at immediate post-procedure as measured by TIMI scores and procedural serious adverse events are assessed and recorded.


Eligibility criteria: Inclusion Criteria:

* Evidence of a peripheral or visceral arterial occlusion or embolus (TIMI 0-1) prior to treatment.
* Treatment with components of the Penumbra and/or Indigo System.

Exclusion Criteria:

* Participation in another clinical investigation that may confound the results of the study.

Primary outcomes:
measure: Angiographic Assessment of Vessel Patency at Immediate Post-procedure as Measured by TIMI Scores
timeFrame: Immediate post-procedure
measure: Procedural Serious Adverse Events
timeFrame: During the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Tri-City Medical Center
state: California
city: Miami
country: United States
facility: Baptist Health South Florida
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Fargo
country: United States
facility: Sanford Medical Center
state: North Dakota
Study officials:
affiliation: Tri-City Medical Center, San Diego, CA
name: Richard Saxon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sanford Medical Center Fargo, ND
name: Corey Teigen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05059951: Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer
Official title: Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Small Cell Lung Cancer
Keywords: Chemotherapy, Immune Checkpoint Inhibitors
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer

Brief summary: Although several clinical trials provide evidence for efficacy benefit for Checkpoint Inhibitors plus chemotherapy for lung cancer. However, there was rare evidence for clinical evidence in Hunan province.

Detailed description: This prospective study aimed to assess its efficacy and adverse event for Checkpoint Inhibitors with or without chemotherapy in clincial practice. Several cohorts were devided including pathological type, treatment line, treatment regiems, combination strategies. Tissue samples were collected with permission of patients for TME evaluation.

Eligibility criteria: Inclusion Criteria:

1. ≥18，Lung Cancer Confirmed by Histopathology
2. Treated with Chemotherapy with or Without Checkpoint Inhibitors.
3. ECOG 0 - 1.
4. Predicted survival ≥ 12 weeks.
5. Adequate bone marrow hematopoiesis and organ function
6. Presence of measurable lesions according to RECIST 1.1.
7. Subjects with stable brain metastases may be included in the study.

Exclusion Criteria:

Patients did not match for the Inclusion Criteria.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Time from first subject dose to study completion, or up to 36 month
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Time from first subject dose to study completion, or up to 36 months.
measure: Objective Response Rate (ORR)
timeFrame: Time from first subject dose to study completion, or up to 36 months.
measure: Duration of Response (DOR)
timeFrame: Time from first subject dose to study completion, or up to 36 month
measure: Adverse events (AEs) according to CTCAE 5.0
timeFrame: From first dose until 28 days after the last dose, up to 24 month
measure: Patient reported outcome
timeFrame: Time from first subject dose to study completion, or up to 36 months.
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Yongchang Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01560351: Repeated Low-frequency Transcranial Magnetic Stimulation Reduces Cue-induced Craving: a Randomized, Prospective, Double-blind, Sham-controlled, Cross-over Study
Official title: Repeated Low-frequency Transcranial Magnetic Stimulation Reduces Cue-induced Craving: a Randomized, Prospective, Double-blind, Sham-controlled, Cross-over Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pathological Gambling
Keywords: Pathological gambling
craving
repeated Transcranial Magnetic Stimulation
craving cues
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of repeated low-frequency Transcranial Magnetic Stimulation (rTMS) of the right dorsolateral prefrontal cortex, combined with gambling cues, on gambling craving. Participants are pathological gamblers. A single real stimulation and a single shame stimulation are administered in a random order for each participant (cross-over study).


Eligibility criteria: Inclusion criteria:

* Pathological gambler (DSM-IV criteria)
* Seeking treatment at the University Hospital of Nantes
* Right-handed
* 18-65 years old
* Increase in the intensity (at least 50%) of the gambling craving with gambling cues

Non-inclusion criteria:

* pregnant woman
* no effective contraception
* Substance use disorders (excluding nicotine)
* Benzodiazepine use
* Chronic neurological disease
* History of head injury
* History of neurosurgery
* Cochlear implant or other metal objects in the head
* History of Transcranial Magnetic Stimulation or repeated Transcranial
* Magnetic Stimulation
* Difficult to read or write French

Exclusion criteria:

* Occurrence of side effects (like seizures)
* Psychoactive substance use 12 hours before the rTMS (excluding nicotine)

Primary outcomes:
measure: Visual Analogue Scale (VAS)
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
measure: Gambling Craving Scale (GACS)
measure: blood pressure
measure: heart rate
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes
Study officials:
affiliation: Nantes UH
name: Anne SAUVAGET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04547751: Hospitalisations of Teenagers and Young Adulthoods in Mayotte After Consumption of an Illegal Drug Called " Chimique ", Which Substances Are Incriminated ? : HOMACHI
Official title: Hospitalisations of Teenagers and Young Adulthoods in Mayotte After Consumption of an Illegal Drug Called " Chimique ", Which Substances Are Incriminated ? : HOMACHI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Abuse
Keywords: drug abuse
chimique
High resolution mass spectrometry
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: ARS (Agence Régionale de Santé) Mayotte
First posted: 2020-09-14
Enrollment: 13
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in the Emergency Department of the Mayotte Hospital Center after taking a chemical or other psychoactive substance

Brief summary: The study aims (i) to identify which substances leading to hospitalizations at Mayotte are also called "chimique" and (ii) to correlate these substances with clinical pictures in order to favor a better approach of the treatments.

Detailed description: The CEIP-A of Bordeaux (in charge of French overseas departments) has been commissioned by the MILD\&CA in 2015 to reinforce the links between local caregivers and the addictoviligance's inquieries. In particular, the CEIP-A has been alerted about a drug called " chimique " in Mayotte, leading to many hospitalizations. Most of the patients are less than 18 year old or are young adulthoods. For all patients who have agreed to participate in this study, the remainder of the blood sample will be reused for a drop of blood on blotting paper; the remainder of the remainder will be stored in the heparinized tube. Medical data collected in the emergency department will also be collected. All the data will be analyzed by the pharmacology and toxicology laboratory of the Bordeaux University Hospital

Eligibility criteria: Inclusion Criteria:

* Patients hospitalized in the Emergency Department of the Mayotte Hospital Center after taking a chemical or other psychoactive substance and for whom a blood test is required;
* Age ≥ 14 years.

Exclusion Criteria:

* Patient without parental authority for minor patients aged 14yrs; Patient not included in the exception article 59 of the law of January 6th, 1978 modified for patient aged 15yrs and older

Primary outcomes:
measure: number of new substances identified
timeFrame: Baseline
Secondary outcomes:
measure: Active ingredients found
timeFrame: Baseline
Other outcomes:
Locations:
city: Mayotte
country: France
facility: CH Mayotte
Study officials:
References:
Clinical trial NCT01607177: Do Text Message Reminders Increase Preoperative Exercise in Obesity Surgery Candidates?
Official title: Text Messaging to Improve Adherence to Prehabilitation in Patients Undergoing Bariatric Surgery: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perioperative Care
Bariatric Surgery
Obesity
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
Collaborators: name: Health Research Council, New Zealand
First posted: 2012-05-28
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preoperative exercise has been shown to improve physiological and functional capacity in patients undergoing abdominal surgery to prepare them for the stress of surgery. Patients undergoing bariatric surgery are advised to partake in regular preoperative exercise. In the setting of bariatric surgery, as well as preparing patients for the stress of surgery, it is also thought to increase the likelihood that they will exercise postoperatively. However, compliance to this advice is extremely low. Text-message interventions have been shown to improve compliance to other lifestyle interventions. The investigators will compare the rate of compliance to preoperative exercise prior to bariatric surgery in patients who receive a daily text message to those who do not. The investigators will also compare weight loss.


Eligibility criteria: Inclusion Criteria:

* Patients having laparoscopic sleeve gastrectomy at Manukau Surgery Centre
* Operation used primarily for the treatment of morbid obesity

Exclusion Criteria:

* Operation not performed at Manukau Surgery Centre
* Patient does not have a mobile phone which can receive text messages

Primary outcomes:
measure: Proportion of patients partaking in the minimum recommended amount of weekly physical activity
timeFrame: 6 weeks post recruitment
Secondary outcomes:
measure: Postoperative Physical Activity
timeFrame: 6 weeks postoperatively
measure: Functional capacity
timeFrame: Baseline and 6 weeks post recuitment (preoperatively)
measure: Length of Hospital Stay
timeFrame: As assessed at day of discharge
measure: Short term weight loss
timeFrame: Out to 6 months postoperatively
measure: Perioperative complications
timeFrame: Out to 30 days postoperatively
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Manukau Surgery Centre
state: Manukau City
Study officials:
affiliation: South Auckland Clinical School, University of Auckland
name: Andrew G Hill, MBChB, MD, EdD, FRACS, FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00259077: Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population
Official title: A Double-blind, Randomised, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy of Omeprazole 20mg and 10mg od for the Four-week Treatment of Non-erosive Reflux Disease (NERD) With That of Placebo od and to Investigate Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-erosive Reflux Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Mitsubishi Tanabe Pharma Corporation
First posted: 2005-11-29
Enrollment: 270
Sex: ALL
Minimum age (years): 20
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 study safety and efficacy of omeprazole standard treatment in a Japanese non-erosive reflux disease population.


Eligibility criteria: Inclusion Criteria:

* Patients who identified their predominant symptom as heartburn and were classifiend as Grande M or N according to Hoshihara's modofied version of Los Angeles Classification at esophagogastroduodenoscopy.

Exclusion Criteria:

* Patients with any ongoing gastrointestinal bleeding at the time of esopgahogastroduodenoscopy, patients with any history of erosive esophagitis or any other major diseases or concommittant drugs likely to interfere with the evaluation of this study

Primary outcomes:
measure: To determine the efficacy of omeoprazole 20mg and omeprazole 10mg by assessment of complete resolution rate of heartburn during the fourth week of treatment.
Secondary outcomes:
measure: Complete resolution of heartburn during the first and second week of treatment, assessment of sufficient relief rates of heartburn, assessment of nocturnal heartburn, assessment of other GERD symptoms.
Other outcomes:
Locations:
city: Asa
country: Japan
city: Beppu
country: Japan
city: Chiyoda
country: Japan
city: Fujieda
country: Japan
city: Fukuoka
country: Japan
city: Kanagawa
country: Japan
city: Kawagucki
country: Japan
city: Kitakyushu
country: Japan
city: Kita
country: Japan
city: Kyota
country: Japan
city: Meguro
country: Japan
city: Minato
country: Japan
city: Mitsukaido
country: Japan
city: Mizumaki
country: Japan
city: Nagoya
country: Japan
city: Nanao
country: Japan
city: Onoda
country: Japan
city: Osaka
country: Japan
city: Ota
country: Japan
city: Otsu
country: Japan
city: Sapporo
country: Japan
city: Shinagawa
country: Japan
city: Shinjuku
country: Japan
city: Tokyo
country: Japan
city: Ube
country: Japan
city: Yukuhashi
country: Japan
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Medical Science Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04296877: Evaluation of Wear Experience With a Daily Disposable Contact Lens
Official title: Evaluation of Wear Experience With PRECISION1® Contact Lenses in Previous Acuvue® Oasys® Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens
Keywords: Daily Disposable Contact Lens
Soft Contact Lens
Spherical Contact Lens
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2020-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single arm, non-comparative study.
Primary purpose: TREATMENT

Brief summary: To evaluate the wear experience of current two-week contact lens wearers after they have been fit into a daily disposable contact lens. This is a single arm, non-comparative study.

Detailed description: This is a single arm, non-comparative study. All participants were habitual lens wearers of the same brand of lenses, and were re-fit with the study lenses.

Eligibility criteria: Inclusion Criteria:

* Must be current Acuvue® Oasys® spherical contact lens wearers.
* Distance visual acuity of 20/25 or better with current contact lenses.
* Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI).
* Ability to give informed consent.
* Willing to spend time for the study, which includes attending two study visits and wearing contact lenses on days between study visits.
* Either gender.
* Any racial or ethnic origin.

Exclusion Criteria:

* No current ocular inflammation or infection.
* Not currently pregnant or lactating.

Primary outcomes:
measure: Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
Study officials:
affiliation: The Ohio State University College of Optometry
name: Jennifer Fogt, OD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04679077: Preoperative Microcirculation and Postoperative Outcome After Major Vascular Surgery
Official title: Preoperative Microcirculation and Postoperative Outcome After Major Vascular Surgery: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Surgery--Complications
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will be split into two groups after data collection. They will receive the same treatment during the clinical trial.
Primary purpose: OTHER

Brief summary: The aim of the study is to determine whether there is a correlation between the microcirculation measured preoperatively in patients undergoing major vascular surgery and the postoperative mortality during hospitalization period. The microcirculation will be measured sublingually with the Cytocam-IDF imaging technique.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years

  * Males and females
  * ASA III classification
  * Written informed consent obtained by the patient
  * Elective hospital admission for major vascular surgery, both open and endovascular

Exclusion Criteria:

* Emergency surgery

  * Minor vascular procedures (e.g. varicose vein stripping; thromboembolectomy; vascular access formation)
  * Pregnancy
  * Refusal or inability to provide written informed consent (language barrier, mental retardation)

Primary outcomes:
measure: Postoperative high-sensitive troponin T (hsTnT)
timeFrame: 30 days
Secondary outcomes:
measure: Cause of death
timeFrame: 30 days
measure: Non-cardiovascular adverse events and serious adverse events
timeFrame: 30 days
measure: Cardiovascular adverse events and serious adverse events
timeFrame: 30 days
measure: Correlation between preoperative microcirculation and postoperative outcome during the hospitalization period.
timeFrame: 30
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussel
Study officials:
References:
Clinical trial NCT00279877: Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial
Official title: Cost Effectiveness and Efficacy of Kypho and Vertebro Plasty Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporotic Vertebral Compression Fractures
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Cardinal Health
name: ArthroCare Corporation
name: Cook Group Incorporated
First posted: 2006-01-20
Enrollment: 112
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures.


Eligibility criteria: * \> or = 50 years of age
* Compression fracture (T4-L5)within previous 12 mo.
* Pain from compression fracture
* No malignant tumor
* No back surgery

Primary outcomes:
measure: Back specific functional status(Roland)
timeFrame: 12 mo
measure: Pain
timeFrame: 12 mo
Secondary outcomes:
measure: Health status outcome measure(SF-36)
timeFrame: 12 mo
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Avery Evans, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evans AJ, Kip KE, Brinjikji W, Layton KF, Jensen ML, Gaughen JR, Kallmes DF. Randomized controlled trial of vertebroplasty versus kyphoplasty in the treatment of vertebral compression fractures. J Neurointerv Surg. 2016 Jul;8(7):756-63. doi: 10.1136/neurintsurg-2015-011811. Epub 2015 Jun 24.