louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00821873: Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee.
Official title: Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR Plug) for Repair of Defects Created at the Harvest Site During the Osteochondral Autograft Transfer System(OATS)Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Injury
Keywords: Cartilage injury
OATS
Knee injury
allograft
autograft
Lead sponsor: RTI Surgical
Sponsor class: INDUSTRY
First posted: 2009-01-14
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to test the ability of an allograft plug to provide a successful repair of an osteochondral defect left at the harvest site during OATS procedure.

Detailed description: The objective of this study is to determine how effective a plug made out of human bone (called "CR-Plug") will be in the treatment at the site that your tissue was removed, thereby filling the hole created during the OATS procedure.At the present, OATS is used for knee articular cartilage defects or injuries smaller than the size of a dime (or 2.5 cm2) in the areas that bear weight have been commonly treated by using a tiny cylinder of the subjects' own tissue called an osteochondral autograft (OATS).

Eligibility criteria: Inclusion Criteria:

* Are male or female at least 18 years of age and up to 55 years of age
* Must be skeletally mature
* Have a grade III or IV lesion in femoral condyle

Exclusion Criteria:

* Skeletally immature
* Osteoarthritic knees, osteonecrotic knees, osteophyte formation
* Use of any investigational therapy within thirty (30) days prior to the first visit

Primary outcomes:
measure: MRI to Evaluate Success of Outcome.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: American Sports Medicine Institute
state: Alabama
city: Phoenix
country: United States
facility: The Orthopedic Clinic Assoc
state: Arizona
city: Englewood
country: United States
facility: Colorado Orthopedic Consultants
state: Colorado
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: The Orthopedic Clinic, Assoc
name: Thomas Carter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Ohio State Univesity
name: David Flanigan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Colorado Orthopedic Consultants
name: Phillip Stull, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: American Sports Medicine Institute
name: Jeffrey Dugas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03004573: Role of Deep Brain Stimulation on Social Cognition in Parkinsonian Patients
Official title: Functioning of the Mirror Neurons System in Parkinson's Disease and Its Impact on the Social Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
emotional recognition
Deep Brain Stimulation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Parkinson's disease (PD) is usually responsible of cognitive and behavioral non-motor signs with a major impact on the quality of life. Social cognition is a complex system relying on emotion recognition (neurons mirror system, NMS), the theory of mind (with its two parts: emotional and cognitive), but also on the social and cultural environment and the personal history. The first step in this model is represented by the NMS, which seems to be altered in PD patients for both positive and negative emotions as shown in our preliminary study. The investigator purpose is to investigate the role of the treatment (levodopa and deep brain stimulation) on the functioning of the NMS.


Eligibility criteria: Inclusion Criteria:

* Parkinson's disease with motor fluctuations and dyskinesias receiving deep-brain stimulation
* Social insurance

Exclusion Criteria:

* No affiliation to the social insurance
* Patients under guardianship

Primary outcomes:
measure: variation of the emotional recognition score (point lights test) before deep brain surgery
timeFrame: Baseline
measure: variation of the emotional recognition score (point lights test) after deep brain surgery
timeFrame: 1 year
Secondary outcomes:
measure: PDQ39 score (Parkinson's Disease Questionnaire)
timeFrame: 1 year
measure: MATTIS (dementia rating scale) score
timeFrame: 1 year
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Neurologie C Hôpital " Pierre Wertheimer "
Study officials:
affiliation: Hospices Civils de Lyon
name: Teodor Danaila, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04052373: Peri-implantitis Implantoplasty Treatment
Official title: Surgical Peri-implantitis Treatment With and Without Implantoplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peri-Implantitis
Peri-implant Mucositis
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This double arm, split-mouth, single centre, controlled, randomised clinical study is designed to examine the effect of implantoplasty in treatment of peri-implantitis.

Peri-implantitis will be treated with open flap debridement, with or without implantoplasty.


Eligibility criteria: Inclusion Criteria:

* Peri-implantitis (according to 2018 criteria) on minimum 2 implants of similar surface and defect type
* Competent to give consent
* Exposed, modified implant surface with loss \>2mm

Exclusion Criteria:

* Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
* Present or past use of bisphosphonate treatment • Pregnant or nursing subjects
* Patients classified as \> class II according to ASA classification
* Implant unavailable for implantoplasty treatment
* Inhability to comprehend and respond to the quality of life questionnaire
* Examiners/operators deem original placement of implant (angle, position) suboptimal and considered to play a major role in development of peri-implantitis
* History of peri-implantitis surgery prior to 6 months of screening

Primary outcomes:
measure: Bleeding on probing
timeFrame: 12 months after treatment
measure: Bleeding on probing
timeFrame: 24 months after treatment
Secondary outcomes:
measure: Suppuration
timeFrame: 12 months after treatment
measure: Suppuration
timeFrame: 24 months after treatment
measure: Pocket probing depth
timeFrame: 12 months after treatment
measure: Pocket probing depth
timeFrame: 24 months after treatment
measure: Changes in patient-reported quality of life (QoL)
timeFrame: Preoperatively compared to 24 months after treatment
measure: Clinical attachment loss measurements
timeFrame: 12 months after treatment
measure: Clinical attachment loss measurements
timeFrame: 24 months after treatment
measure: Radiographic bone loss
timeFrame: 12 months after treatment
measure: Radiographic bone loss
timeFrame: 24 months after treatment
measure: Implant fracture
timeFrame: 24 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo
city: Oslo
country: Norway
facility: Institute of Clinical Dentistry, University of Oslo, Norway
Study officials:
References:
Clinical trial NCT02106273: The Use of LMA-Proseal and Endobronchial Blocker for One Lung Anesthesia, Case Series
Official title: The Use of LMA-Proseal and Endobronchial Blocker for One Lung Anesthesia, Case Series.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthetic Technique
One-lung Ventilation
Keywords: LMA
Bronchial blocker
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ASA class I-III patients age 18-75 years scheduled for thoracic surgery that required one-lung ventilation

Brief summary: An observational pilot study to determine the success rate of using LMA Proseal in conjuction with endobronchial blocker to provide one-lung anesthesia for thoracic surgery.

Detailed description: The use of LMA has gained popularity secondary to benefits confirmed by many literatures. However, LMA is rarely used in thoracic surgery. To enable one-lung ventilation, the LMA need to be used with bronchial blocker. The use of this combination has been reported as a rescue technique in special clinical scenarios, i.e. patient with difficult airway. When used in patient with difficult airway, the LMA will be inserted until proper ventilation achieved, then endobronchial blocker will be subsequently placed through the LMA into the selected main bronchus. The success rate of the the bronchial blocker placement via properly placed LMA has never been studied. This pilot study was designed to evaluate the success rate, the quality of lung collapsed, the dislodgement or other associated problems including some minor complications i.e. postoperative dysphagia, sore throat hoarseness of voice.

Eligibility criteria: Inclusion Criteria:

* thoracic surgery that needed one-lung ventilation Exclusion Criteria:patient with
* Restrictive lung disease that needed positive pressure ventilation \> 30 cm.H2O
* Mass or hematoma in the mouth which obstruct LMA insertion
* Emergency surgery
* Pregnancy
* Severe infection or active pulmaonary tuberculosis
* Hemoptysis
* Pulmonary nodule \> 20 cm. or bronchilal pathology
* Pneumonectomy or sleeve resection

Primary outcomes:
measure: success rate
timeFrame: 15 mintues
Secondary outcomes:
measure: Time consuming in achieving one-lung anesthesia
timeFrame: 15 mintues
measure: Sorethroat
timeFrame: 1 day
measure: Hoarseness of voice
timeFrame: 1 day
measure: Difficulty swallowing
timeFrame: 1 day
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Prasert Sawasdiwipachai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06482073: Molecular Analysis of Suspected or High-Risk Lung Cancer to Drive Individualized Care (Interception for Suspected Lung Cancer)
Official title: Molecular Analysis of Suspected or High-Risk Lung Cancer to Drive Individualized Care (Interception for Suspected Lung Cancer)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Carcinoma
Metastatic Malignant Neoplasm in the Lung
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 100
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: Patients scheduled for a bronchoscopy recruited through Mayo Clinic

Brief summary: This study evaluates the effectiveness of robotic biopsies in providing information about hereditary or cancer specific genetic variants that may have a role in diagnosis of cancer and to develop genetic results and medical record databank for future studies.

Detailed description: PRIMARY OBJECTIVES:

I. Assessing whether the percentage of samples adequate for WES (Whole Exome Sequencing)/WT (Wild-Type) sequencing is at least 80%.

II. Development of a data bank of WES/WT and germline sequencing data for future analyses.

OUTLINE: This is an observational study.

Patients receive genomic counseling and genomic testing education, undergo blood or saliva collection, provide previously collected tissue sample and have medical records reviewed on study. Patients and healthcare providers receive results of any genetic variants found on testing.

Eligibility criteria: Inclusion Criteria:

* \* Subject age 18 years and older

  * Subject is scheduled for a bronchoscopy as part of standard of care
  * Subject with a moderate to high risk of lung cancer based on clinical demographic and radiologic information or with suspected metastatic disease
  * Ability to provide blood or saliva sample
  * Enrolled in study IRB#16-009655
  * Ability to provide archived tissue
  * Subject is able to understand and adhere to study requirements and able to provide informed consent

Exclusion Criteria:

* \* Individuals who have situations that would limit compliance with the study requirements

  * Institutionalized (i.e. federal medical prison)
  * Pregnant
  * Prior germline genetic testing with a 40+ multi-gene panel within the last 1 year of enrollment
  * Prior somatic tissue (250+ gene) testing within the prior 3 months of enrollment

Primary outcomes:
measure: Percent of samples adequate for sequencing
timeFrame: Up to 2 years
Secondary outcomes:
measure: Data bank of genomic data
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Janani S. Reisenauer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02532673: Impact of Hyperbilirubinemia Among HIV Patients Treated With Atazanavir
Official title: Impact of Hyperbilirubinemia Among HIV Patients Treated With Atazanavir
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-08-26
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Commercially insured population (single large health plan)

Brief summary: The purpose of this study is to determine whether HIV patients on Atazanavir who have Hyperbilirubinemia have different outcomes from those without Hyperbilirubinemia.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Human immunodeficiency virus
* Treatment with Atazanavir
* 18 yrs and older

Primary outcomes:
measure: Atazanavir persistence among treated patients who develop hyperbilirubinemia compared with Atazanavir-treated patients without evidence of hyperbilirubinemia
timeFrame: One year after starting Atazanavir
measure: Atazanavir compliance among treated patients who develop hyperbilirubinemia compared with Atazanavir-treated patients without evidence of hyperbilirubinemia
timeFrame: One year after starting Atazanavir
Secondary outcomes:
measure: Healthcare costs for HBR vs non-HBR patients
timeFrame: 1 year
measure: Health care resource utilization for HBR vs non-HBR patients
timeFrame: 1 year
measure: Changes (increase, decrease, no change) in the grade of bilirubin laboratory test results during follow-up among Atazanavir-treated patients who develop hyperbilirubinemia
timeFrame: 1 year
measure: Rate of Human immunodeficiency virus viral suppression among patients treated with Atazanavir who develop hyperbilirubinemia compared with patients without evidence of hyperbilirubinemia
timeFrame: 1 year
measure: Liver function based on Alanine aminotransferase and Aspartate aminotransferase test results among patients treated with Atazanavir who develop hyperbilirubinemia compared with patients without evidence of hyperbilirubinemia
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00490373: Trial of Pemetrexed for Patients With Pancreatic Cancer Which Cannot be Treated With Surgery or is Metastatic
Official title: A Phase 2 Trial of ALIMTA in Pretreated Patients With Unresectable or Metastatic Cancer of the Pancreas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-06-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study with pemetrexed is for patients with metastatic or unresectable pancreatic cancer who progressed after first line chemotherapy with gemcitabine.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological diagnosis of adenocarcinoma of the pancreas that is locally advanced (Stage II, III) or metastatic (Stage IV), as staged by the American Joint Committee on Cancer (AJCC; Protocol Attachment S041.2; Fleming et al. 1997), and not amenable to resection with curative intent.
* Prior systemic first line chemotherapy with gemcitabine single agent or a combination regimen including gemcitabine (not more than one prior systemic chemotherapy allowed).
* Uni-dimensionally measurable disease according to the RECIST criteria (Therasse et al. 2000), defined as: At least one lesion that can be accurately measured in at least one dimension, with the longest diameter greater than or equal to 2 cm with conventional techniques or greater than or equal to 1.0 cm with spiral CT scans. Ultrasound and X-ray are NOT allowed to measure or follow lesions.

Exclusion Criteria:

* Prior radiation of equal to or greater than 25% of the bone marrow (Cristy and Eckerman 1987)
* Prior immunotherapy, biological therapy, and/or hormonal therapy for pancreas cancer.
* Prior systemic chemotherapy with 5-FU.
* Patient not yet recovered from the acute toxic effects of the treatment prior to study enrollment.
* Radiotherapy within the last 4 weeks before study entry

Primary outcomes:
measure: To evaluate the efficacy.
Secondary outcomes:
measure: To assess tumor response.
measure: To assess time to event efficacy variables including time to progressive disease and overall survival.
measure: To characterize the quantitative and qualitative toxicities of pemetrexed in this population of pancreatic cancer patients.
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04820673: Patient-reported Outcomes for Sarecycline Effectiveness and Safety (PROSES)
Official title: A Real-world Prospective Cohort Study of Patients With Moderate to Severe Acne Vulgaris Treated With Sarecycline (Seysara®) In Community Practice Settings in the U.S
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne Vulgaris
Keywords: Prospective
Non-nodular Acne Vulgaris
Perceptions
Health-Related Quality of Life (HRQoL)
Patient-Reported Outcomes (PROs)
Signs & Symptoms
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2021-03-29
Enrollment: 300
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate to severe non-nodular acne vulgaris who are on prescribed sarecycline will be enrolled. Caregivers of eligible pediatric patients will also be enrolled.

Brief summary: The purpose of this study is to evaluate the patient-reported outcomes (PROs) in terms of health-related quality of life (HRQoL) and signs of Acne Vulgaris (AV) among patients with moderate to severe non-nodular AV who are administered sarecycline (Seysara®) in real-world community practice settings in the United States (U.S). Investigator's Global Assessment (IGA) of AV and safety measures associated with use of sarecycline (Seysara®) will be assessed over the study observation period of 12 weeks. Clinicians will prescribe sarecycline (Seyara®) as per their own clinical judgment and standard practice.


Eligibility criteria: Inclusion Criteria:

Patient Inclusion Criteria:

* Male or female, aged 9 years and above
* Has facial non-nodular AV with IGA score of moderate or severe
* Considered as a potential candidate for sarecycline (Seysara®) treatment, per clinician judgment

Caregiver Inclusion Criteria:

* Primary caregiver of the study-eligible patient
* Male or female, aged 18 years and above

Exclusion Criteria:

* Patients with any known resistance to other tetracyclines
* Patients with any dermatological or physical condition of the face that could interfere with the AV clinical evaluations.
* Patients with any history of allergy to tetracycline-class antibiotics, pseudomembranous colitis or antibiotic-associated colitis.
* Unable to comply with the requirements of the study or patients who in the opinion of the Site Investigator should not participate in the study

Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percentage of Participants With Facial Investigator Global Assesment (IGA) Success at Week 12
timeFrame: At Week 12
Other outcomes:
Locations:
city: Boston
country: United States
facility: Almirall Site#2
state: Massachusetts
city: Brooklyn
country: United States
facility: Almirall Site #1
state: New York
Study officials:
affiliation: Almirall, S.A.
name: Study Director
role: STUDY_DIRECTOR
References: