louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00560664: Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty: a Randomized Trial
Official title: Phase 3 Study Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Chondral or Osteochondral Defect
Keywords: knee
chondral defect
osteochondral defect
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2007-11-20
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Numerous surgical techniques have been developped for the treatment of chondral and osteochondral defects of the knee. Among those techniques autologous chondrocyte transplantation (ACT) was promising but have potential drawbacks. A novel development by TBF is available. The aim of this randomized trial is to compared this new ACT technique to mosaicoplasty. Final outcomes were measured at 2 years using clinical evaluation scoring system (International Knee Documentation Committee), MRI and arthroscopy with biopsy. 64 patients are needed to detect a mean IKDC difference of at least 15 points with 90% power at a 5% alpha level. Twelve surgical centers in France are involved.


Eligibility criteria: Inclusion Criteria:

* isolated femoral osteochondral lesion
* aged 18 to 50
* grade 3 or 4 lesion (ICRS) sized 2,5 cm2 to 7,5 cm2.
* IKDC score below 55

Exclusion Criteria:

* pregnancy
* allergy
* arthrosis
* varus or valgus angle greater than 10°
* ACL laxity
* Severe chronic disease
* BMI \> 30 Kg/m2
* HIV, B or C Hepatitis

Primary outcomes:
measure: Clinical evaluation scoring system
timeFrame: IKDC
Secondary outcomes:
measure: MRI
timeFrame: at 2 years
measure: Arthroscopy with biopsy
timeFrame: at 2 years
Other outcomes:
Locations:
city: Brest
country: France
facility: Orthopaedic surgery Departement Brest University Hospital
city: Caen
country: France
facility: CHU de Caen
city: Dracy-Le-Fort
country: France
facility: Centre médico chirurgical de Dracy-Le-Fort
city: Grenoble
country: France
facility: CHU de Grenoble
city: Le Chesnay
country: France
facility: Ch Versailles
city: Limoges
country: France
facility: Clinique Chenieux
city: Lyon
country: France
facility: CHU de Lyon
city: Mayenne
country: France
facility: CH Nord Mayenne
city: Nancy
country: France
facility: CHU de Nancy
city: Saint Mandé
country: France
facility: HIA Bégin
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: Clinique du cours Dillon
Study officials:
affiliation: University Hospital, Brest
name: F DUBRANA, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04097964: Examining the Effectiveness of the FaCES Adolescent SBIRT Intervention
Official title: Examining the Effectiveness of the FaCES Adolescent SBIRT Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Health Services
Adolescent Behavior
Keywords: SBIRT
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Conrad N. Hilton Foundation
First posted: 2019-09-20
Enrollment: 1226
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will utilize a stepped wedge cluster randomized design to examine the effectiveness of the full FaCES (Facilitating Change for Excellence in SBIRT) adolescent SBIRT change package. Primary care providers will be randomized as to when they receive training and begin delivery of FaCES with their 12 to 17 year old patients, which includes targeted feedback based on the patient's endorsed substance use level on the S2BI screening instrument.

Detailed description: The study will utilize a stepped wedge cluster randomized design to examine the effectiveness of the full FaCES (Facilitating Change for Excellence in SBIRT) adolescent change package for 12 to 17 year old primary care patients. Primary care providers at two rural federally qualified health centers in New Mexico and Tennessee will be randomized as to when they receive training and begin delivering FaCES to their adolescent patients. FaCES includes targeted feedback based on the patient's endorsed substance use level on the S2BI screening instrument. Study participants will complete a baseline and follow-up assessment 3-months post study recruitment.

Eligibility criteria: Inclusion Criteria:

* Ages 12 to 17 years, inclusive
* Registered patient at one of the participating FQHCs
* Able and willing to provide informed consent

Exclusion Criteria:

* Inability to comprehend the assent form
* Parent/guardian declines consent

Primary outcomes:
measure: S2BI
timeFrame: 3 months
Secondary outcomes:
measure: ASSIST
timeFrame: 3 months
measure: BSTAD
timeFrame: 3 months
Other outcomes:
Locations:
city: Lordsburg
country: United States
facility: Hidalgo Medical Services
state: New Mexico
city: Silver City
country: United States
facility: Hidalgo Medical Services
state: New Mexico
city: Adamsville
country: United States
facility: Lifespan Health
state: Tennessee
city: Savannah
country: United States
facility: Lifespan Health
state: Tennessee
Study officials:
affiliation: Friends Research Institute, Inc.
name: Shannon G Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04230564: Acute Myeloid Leukemia Real World Treatment Patterns
Official title: Characteristics, Treatment Patterns, and Clinical Outcomes in Non-intensive Chemotherapy Acute Myeloid Leukemia (AML) Patients - a US Real-World Study Using Electronic Medical Record Data
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Leukemia, Myeloid, Acute
Keywords: Acute Myeloid Leukemia (AML)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 0
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: This study will include adult patients diagnosed with AML who, at any point during first line therapy, received non-intensive therapy

Brief summary: Among patients with a diagnosis of AML who received non-intensive chemotherapy:

* Describe patient demographic and clinical characteristics
* Describe treatment patterns
* Describe effectiveness outcomes
* Evaluate tumor response


Eligibility criteria: Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Confirmed diagnosis of AML on or after 01 January 2012 through Clinical Research Nurse (CRN) review of provider documentation of AML diagnosis in the medical record.
2. Receipt of non-intensive therapy at any point during first line therapy following initial AML diagnosis. For this study, non-intensive therapy will be defined as 1 of the following agents, alone or in combination with any other agent:

   1. AZA
   2. GLAS
   3. VEN
3. Age ≥18 years at initial diagnosis of AML.

Exclusion Criteria:

Patients meeting any of the following criteria will not be included in the study:

1. Record of 1 or more of the following confounding diagnoses at any point before or after AML diagnosis: Acute lymphoblastic leukemia; acute promyelocytic leukemia, aggressive systemic mastocytosis; hypereosinophilic syndrome and/or chronic eosinophilic leukemia; dermatofibrosarcoma protuberans; gastrointestinal stromal tumors.

Primary outcomes:
measure: Overall Survival
timeFrame: January 1, 2012 to January 10, 2020
measure: Event Free Survival
timeFrame: January 1, 2012 to January 10, 2020
measure: Relapse Free Survival
timeFrame: January 1, 2012 to January 10, 2020
measure: Best response
timeFrame: January 1, 2012 to January 10, 2020
measure: Time to best response
timeFrame: January 1, 2012 to January 10, 2020
measure: Duration of best response
timeFrame: January 1, 2012 to January 10, 2020
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02466464: Microporous Polysaccharide Hemospheres Epistaxis
Official title: Use of Microporous Polysaccharide Hemospheres (MPH) in Management of Acute Epistaxis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Epistaxis
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 0
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 compare a new treatment for nosebleeds to the treatment that has been used for many years.

Detailed description: Nosebleeds are a common condition which affect many Americans every day.The standard treatment in this hospital for nosebleeds that do not resolve with squeezing the nose or nasal spray is to place a nasal packing (aka nasal tampon) into the nose. This is an effective treatment in most cases, but patients may find it to be uncomfortable. The investigators will be comparing the standard nasal packing with a new type of powder which may also stop nosebleeds.

Eligibility criteria: Inclusion Criteria:

* acute epistaxis who have failed conservative measures (including application of pressure and application of oxymetazoline spray) and for which the Otolaryngology service has been consulted
* must be alert and oriented
* hemodynamically stable with a hemoglobin greater than 9 g/dL
* cooperative

Exclusion Criteria:

* unable to consent or cooperate
* history of hereditary hemorrhagic telengectasias
* hemophilia
* clotting factor deficiencies
* history of prior surgery for epistaxis control
* nasal trauma
* recent sinonasal surgery
* hemodynamic instability
* posterior bleed (as determined by Ear, Nose, Throat physician)
* visibly bleeding vessel
* allergy to product
* current diabetic ketoacidosis

Primary outcomes:
measure: Number of subjects with resolution of bleed
timeFrame: 15 minutes (average time to resolve bleeding)
Secondary outcomes:
measure: Time until resolution of bleeding
timeFrame: 15 minutes (average time to resolve bleeding)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Department of Otolaryngology Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Oswaldo Henriquez Ajami, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04003064: Heavy Metals' Influence on Early Pregnancy Through Oxidative Stress
Official title: Heavy Metals' Influence on Early Pregnancy Through Oxidative Stress
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spontaneous Abortion
Oxidative Stress
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Exclusion Criteria:

not long-term residents in Peking; Inconvenient for following up; Long-term of drug use; Cesarean section scar pregnancy and other high-risk pregnancy; Diagnosis of pregnancy beyond 12 weeks.

Brief summary: Patients with diagnosis of spontaneous abortion are enrolled in the cohort, in the cohort of patients who met the criteria, 3ml of whole blood intravenous and 5ml of urine were taken for heavy metal level examnation. Part of the villi tissue was sent for genetic testing, and the results were traced. In addition, about 10g of villi tissue was frozen for testing. Patients with normal genetic results of villi tissue will have villus samples go through oxidative stress level detection.

Detailed description: From May 1, 2019, patients with diagnosis of spontaneous abortion are enrolled in the cohort, exclusion criteria were: not long-term residents in Peking; Inconvenient for following up; Long-term of drug use; Cesarean section scar pregnancy and other high-risk pregnancy; Diagnosis of pregnancy beyond 12 weeks.

In the cohort of patients who met the criteria, 3ml of whole blood intravenous and 5ml of urine were taken on the day of admission for curettage and suction, and the levels of heavy metals were tested. Part of the villi tissue was sent for genetic testing, and the results were traced. In addition, about 10g of villi tissue was frozen for testing. Patients with normal genetic results of villi tissue will have villus samples go through oxidative stress level detection.

Eligibility criteria: Inclusion Criteria:

1) the length of fetal bud is equal to or greater than 7 mm and there is no cardiac activity; 2) the maximum zh diameter of the pregnancy sac is equal to or greater than 25mm, and there is no fetal heart beat; 3) an embryo with no heartbeat at 2 weeks or more after ultrasound examination showing a pregnancy sac without yolk sac; 4) embryos without heartbeat for 11 days or longer after ultrasonography showed the yolk sac as a type pregnancy sac.

Primary outcomes:
measure: oxident stress level
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xinyan U Liu
role: STUDY_CHAIR
References:
Clinical trial NCT03844464: Safety and Efficacy of Lorbrena
Official title: Special Investigation for LORBRENA Tablets
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-02-18
Enrollment: 683
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 683 patients

Brief summary: To investigate the following matters under post-marketing use of Lorbrena in patients who received this drug

1. Factors affecting the onset of central nervous system disorder
2. Effect of Lorbrena in combination with CYP3A inducers on the onset of hepatic dysfunction


Eligibility criteria: Inclusion Criteria:

* All administered patients

Exclusion Criteria:

* Nothing

Primary outcomes:
measure: Incidence of adverse drug reactions of central nervous system disorder and hepatic dysfunction
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: 3-22-7, Yoyogi, Shibuya-ku
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03250364: Compression Bandages in Upper Limb Lymphedema
Official title: Compression Bandages in Upper Limb Lymphedema After Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 5 goups: Multilayer bandage group; Double compression bandage group; Cohesive bandage group; Adhesive compression bandage group; Kinesiotaping bandage group
Primary purpose: TREATMENT

Brief summary: Despite different types of bandages are using in the lymphedema treatment, numerous of them have not been directly compared. The aim of this study is to compare the efficacy of five different kinds of bandages on limb volume and lymphedema-related symptoms. It was also measured as secondary variables the comfort of the bandage related by the participants and the directly cost of each kind of bandage during the treatment.


Eligibility criteria: Inclusion Criteria:

* Women after breast cancer surgery undergoing upper limb lymphedema not previously treated
* Having more than two centimeters between two adjacent measurements between the lymphedematous and the contralateral upper limb
* The presence of heaviness, tension or fovea in the affected limb
* More than six months post-surgery or radiation to eliminate the possibility of being a post-chirurgical oedema

Exclusion criteria will be:

* Bilateral breast cancer surgery
* Only hand lymphedema
* Active cutaneous infection
* A loco-regional cancer recurrence
* The impossibility of complete all the physical therapy sessions
* A primary lymphedema
* Women with lymphedema symptoms like thickness and heaviness in the upper limb but without a difference of two centimeters in two adjacent points
* Any contraindication to physiotherapy

Primary outcomes:
measure: Change in arm volume
timeFrame: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention
measure: Change in heath related quality of life lymphedema
timeFrame: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention
Secondary outcomes:
measure: Change in comfort of the bandage
timeFrame: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention
Other outcomes:
Locations:
city: Alcalà de Henares
country: Spain
facility: Physiotherapy in women´s health research group. University of Alcalà
state: Madrid
city: Alcalá de Henares
country: Spain
facility: University of Alcalá. FPSM research group. HUPA
state: Madrid
Study officials:
References:
Clinical trial NCT05048264: Effect of Corticosteroid Injections on Blood Glucose
Official title: Corticosteroid Injections Administered Under Ultrasound Guidance to Diabetic Patients and the Effect on Blood Glucose
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes Mellitus
Steroid Diabetes
Shoulder Osteoarthritis
Knee Osteoarthritis
Adhesive Capsulitis
Hip Osteoarthritis
Keywords: Diabetes
Corticosteroids
Injection
Shoulder
Pain
Osteoarthritis
Knee
Hip
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who has been clinically diagnosed with diabetes and receiving a corticosteroid injection in their shoulder, knee or hip joints.

Brief summary: The purpose of this study is to measure the effect of various corticosteroids administered to the shoulder, knee and hip joints in diabetic patients on resultant blood glucose readings.

Detailed description: The purpose of this study is to measure the effect of various corticosteroids administered to the shoulder, knee, and hip joints in diabetic patients on resultant blood glucose readings.

Corticosteroid injections (CSI) are frequently used in orthopedic settings in order to treat a wide array of orthopedic issues, including osteoarthritis, bursitis, tendinitis, and many others. The effect of diabetes on the musculoskeletal system and its role in orthopedic disease has been well-documented. Current evidence demonstrates that corticosteroids, even when administered through a local musculoskeletal injection, can lead to temporary increases in blood glucose. Ultrasound guidance was not explicitly used in any of the studies examining the impact of steroids on blood glucose. The utilization of ultrasound guidance has been shown to increase accuracy when performing injections into the subacromial space as well as the glenohumeral joint when compared to palpation/landmark-guided injections.

Eligibility criteria: Inclusion Criteria:

* Known diabetic patients ages 40-75 undergoing clinically indicated standard of care corticosteroid shoulder, knee and hip joint injection
* Ability to perform daily blood glucose testing
* Can receive and send text messages

Exclusion Criteria:

* Previous joint arthroplasty
* Corticosteroid injection at other sites in the body within the past month
* Systemic corticosteroid within the last month other than asthma inhaler
* Anyone who are unable to read and/or understand English
* Pregnant women (self-report)

Primary outcomes:
measure: Change in blood glucose measures
timeFrame: Baseline & 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Sports Science Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Anthony Ceraulo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05225064: Increasing COVID-19 Vaccine Uptake in Developing Countries (Bihar)
Official title: Increasing COVID-19 Vaccine Uptake in Developing Countries (Bihar)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination Refusal
Keywords: COVID-19
vaccination
masks
incentives
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: University of Connecticut
name: Lahore University of Management Sciences
name: University of California, Berkeley
name: Innovations for Poverty Action
First posted: 2022-02-04
Enrollment: 114512
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are five arms. Arm 1: Control; Arm 2: Village-level vaccine clinics with monetary, non-monetary, or no incentive; Arm 3: Household-level vaccination with monetary, non-monetary, or no incentive; Arm 4: Mask promotion; Arm 5: Village-level vaccine clinics and mask promotion
Primary purpose: PREVENTION

Brief summary: Working with governments in Bihar, India, we will evaluate a number of mechanisms to increase vaccine uptake. These include household vaccination visits instead of community vaccination clinic.monetary and non-monetary incentives, and concurrent mask promotion. This ClinicalTrials entry contains results only for the study in Bihar.

Detailed description: The goal of the study is to identify strategies that best promote and support COVID vaccine uptake in developing countries, we propose to test a range of scalable social and behavioural interventions. This could help policy makers design and employ interventions that are effective. This is especially valuable in resource constrained contexts where funds and institutional resources can be diverted towards interventions that have proven to work.

In Bihar the intervention will be village-level social mobilization involving community promotion, including in-person vaccine reinforcement, and household-level social mobilization. Some treatment villages will receive household- level interventions with varying intensity (different proportion of households will be visited). There will also an accompanying mask distribution campaign during household visits where the importance of mask-wearing as a complement to vaccine use will be explained.

This ClinicalTrials entry contains results only for the study in Bihar.

Eligibility criteria: Inclusion Criteria:

* Lives in study village

Exclusion Criteria:

* Does not live in study village

Primary outcomes:
measure: Percent of individuals who receive the first, second, or third dose of covid vaccine
timeFrame: up to 4 weeks (endline may vary depending on estimated uptake rates)
Secondary outcomes:
Other outcomes:
Locations:
city: Patna
country: India
facility: Project Concern International
state: Bihar
Study officials:
References: