louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04317404: Knee Steroid Injection and Blood Sugar Signatur
Official title: Identifying Variables Associated With Steroid-Induced Hyperglycemia Following Intra-articular Knee Injections Among Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Knee Osteoarthritis
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Foundation for Physical Medicine and Rehabilitation
First posted: 2020-03-23
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Knee joint osteoarthritis requiring knee joint steroid injection

Brief summary: A prospective, observational study assessing the relationship between HbA1c level and the post-injection blood glucose signature. Participants will be non-diabetic, pre-diabetic, non-insulin dependent and insulin dependent type 2 diabetic patients who will be receiving a knee steroid injection. All of them will be consented a week prior to the injection, when the CGM sensor will be applied to the back of the upper arm. This will be removed a week after the injection. KOOS survey as well as VAS will be administered. Adverse events (e.g., change in medication or hospitalization) will be monitored throughout the study.


Eligibility criteria: Inclusion Criteria:

* Patients at the Parkland Outpatient Clinic
* Indication for unilateral knee joint steroid injection for the treatment of knee joint osteoarthritis

Exclusion Criteria:

* Less than 18 years old
* HbA1c \> 12.0%
* steroid exposure in the 3 months prior to Visit 1
* 3 or more steroid injections in the preceding 12 months
* known contraindication to steroid injection (adverse reaction or allergy, active infection, INR \> 3.0)
* lack of improvement with prior knee steroid injection
* change in diabetic medication regimen in the last 1 month
* significant change in diet within the last 1 month
* current use of aspirin
* allergy to adhesive
* planned MRI, XR, or CT during the 2-week study period

Primary outcomes:
measure: Post-injection glucose levels
timeFrame: 1 week
Secondary outcomes:
measure: Post-injection adverse events
timeFrame: 1 week
measure: KOOS Knee survey
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Hospital
state: Texas
Study officials:
References:
Clinical trial NCT01967004: Enhancing Upper Limb Prostheses With Radio Frequency Identification
Official title: Validation of a Control Method for Upper Limb Myoelectric Prostheses Using Radio Frequency Identification (RFID)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Below Elbow Amputation
Lead sponsor: Infinite Biomedical Technologies
Sponsor class: INDUSTRY
First posted: 2013-10-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if Radio Frequency Identification (RFID) can lead to greater prosthesis function and control. Subjects are asked to perform specific tasks and actions using the traditional control method, as well as RFID control.


Eligibility criteria: Inclusion Criteria:

1. Age 18 or greater.
2. Below elbow amputation, unilateral or bilateral.
3. Chronic stable amputation: \> 6 months from amputation.
4. Stable prosthesis prescription: \> 3 months since last major prosthesis modification.
5. Cognitively intact, as determined by Mini-Mental Status Examination score \> 24.
6. Able to provide informed consent and available to participate in study activities.
7. No severe residual limb motor/sensory impairment or pain likely to interfere with treatment.
8. Expected to be medically and psychiatrically stable for study duration.

Exclusion Criteria:

1. Patients with diseases which weaken and/or adversely affect the control of skeletal muscle.
2. Patients with poor skin integrity.

Primary outcomes:
measure: Time required to perform different functional tasks
timeFrame: 12 weeks
Secondary outcomes:
measure: Questionnaires on prosthesis function and satisfaction
timeFrame: 20 minutes per questionnaire, total of 3 different questionnaires administered twice each
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Eastern Campus
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Eastern Campus
state: Maryland
Study officials:
References:
Clinical trial NCT04479904: A Trial of Famitinib in Patients With Failure of First-Line Treatment For Intrahepatic Cholangiocarcinoma
Official title: A Single-Arm, Open-Label, Multi-Center, Phase II Study of Famitinib Malate to Treat Intrahepatic Cholangiocarcinoma Patients With FGFR2(Fibroblast Growth Factor Receptor2) Genetic Aberrations Who Failed First-Line Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Intrahepatic Cholangiocarcinoma
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm, open-label, multi-center Phase II clinical trial intended to observe and evaluate the efficacy and safety of famitinib malate in treating iCCA(Intrahepatic Cholangiocarcinoma ) patients with FGFR2 genetic aberrations who failed first-line therapy.


Eligibility criteria: Inclusion Criteria:

1. Voluntary participation and written informed consent;
2. Aged 18-75 years (inclusive), males and females;
3. Those with histopathologically diagnosed iCCA, who had previously undergone but failed first-line systematic chemotherapy;
4. FGFR2 fusion/rearrangement confirmed by tests conducted in designated central laboratory;
5. At least one measurable lesion that has not been treated locally;
6. ECOG score of 0-1;
7. Expected survival ≥ 12 weeks;

Exclusion Criteria:

1. Presence of multiple factors affecting oral medications;
2. Wounds unhealed over a long period of time, or fractures not completely healed;
3. Known or suspected allergy to investigational drug or any drug related to this trial.
4. Known cases of CNS(Central Nervous System) metastasis;
5. Uncontrolled cardiac diseases or symptoms;
6. Patients with congenital or acquired immunodeficiency (such as HIV positive), or a history of organ transplants;
7. Patients previously treated with FGFR inhibitors (such as erdafitinib)

Primary outcomes:
measure: Objective response rate per RECIST 1.1
timeFrame: up to 24 months
Secondary outcomes:
measure: DOR
timeFrame: At pre-defined intervals from initial dose up to 24 months
measure: DCR
timeFrame: At pre-defined intervals from initial dose up to 24 months
measure: PFS
timeFrame: At pre-defined intervals from initial dose up to 24 months
measure: OS
timeFrame: At pre-defined intervals from initial dose up to 24 months
measure: Adverse events (AE) and serious adverse event (SAE)
timeFrame: At pre-defined intervals from initial dose up to 24 months
measure: Plasma concentrations of famitinib and its N-desethyl metabolite
timeFrame: At pre-defined intervals from initial dose up to 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00225004: Osteoporosis and Colles Fracture
Official title: Low-energy Fracture of the Wrist (Colles Fracture) and Osteoporosis. A Ten Year Follow-up and a Prospective Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Previous or Actual Colles Fracture
Keywords: Colles Fracture
Osteoporosis
BMD
Quality assurance
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2005-09-23
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: years

Brief summary: The primary purpose of the retrospective study is to determine the incidence of osteoporosis in women with previous Colles Fracture. Secondly, to determine to which extent Colles Fracture has led to a diagnosis and/or treatment of osteoporosis.

The primary purpose of the prospective study is to determine the incidence of osteoporosis in women with an actual Colles Fracture. Secondly, to investigate the consistency between prospective and retrospective data.

Detailed description: Colles Fracture is known to be connected to decreased bone mineral density (BMD). Thus, it can be an early sign of osteoporosis and therefore an increased risk of new fractures.

The results of earlier studies have not been unambiguous in the respect of what extent decreased BMD in the wrist of women with Colles Fracture is synonymous of osteoporosis in the spine and the hip.

An earlier enquiry to the Danish Orthopedic Departments in 1995 showed that only 18 % of the departments diagnosed or referred patients with possible osteoporosis.

The two study designs enhance the possibilities of evaluating the relevance of Low Energy Fractures in the wrist to avoid new fractures and their relation to bone mineral density.

The results could also be a useful tool in quality assurance of the osteoporosis diagnostics.

Eligibility criteria: Inclusion Criteria:

Colles Fracture Women over 40 years Informed consent-

Exclusion Criteria:

High Energy Fracture Deceases or conditions that makes the participant unable to contribute to the investigation-

Primary outcomes:
measure: The incidence of Osteoporosis ten years after a Colles Fracture
timeFrame: years
measure: The incidence of Osteoporosis in women with an actual Colles Fracture
timeFrame: years
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg,
country: Denmark
facility: The department of Orthopedic surgery Northern Jutland Counties, Denmark
state: Jutland
city: Aalborg
country: Denmark
facility: Northern Orthopaedic Division, Klinik Aalborg
state: Northern Jutland
Study officials:
affiliation: Dept. of Orthopedic Northern Jutland Counties, Denmark
name: Klaus K Pedersen, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopedic surgery, Northern Jutland Counties, Denmark
name: Klaus K Pedersen, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02002104: Endothelialized ePTFE Graft by Nanobiotechnology
Official title: Endothelialized ePTFE Graft by Nanobiotechnology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Apparatus for Processing the Tubular Graft Modification Will be Designed and Evaluated.
The On-site Capturing of the Endothelial (Progenitor) Cells by Peptide-mediated Selective Adhesion in Vitro and in Vivo Will Also be Elucidated.
The Patency Rate of ITRI-made Artificial Blood Vessels Will be Evaluated by the Porcine Animal Model.
Keywords: Expanded polytetrafluoroethylene( ePTFE)
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Native arteriovenous fistulas are not available in up to 40 percent of patients with renal dialysis. Therefore, the replacement of autologous blood vessels by artificial grafts is urgently needed. Expanded polytetrafluoroethylene( ePTFE) grafts are the most clinically used artificial blood vessels.

Brief summary: The replacement of autologous blood vessels by artificial grafts is urgently needed in clinical applications. Expanded polytetrafluoroethylene (ePTFE) grafts are the most clinically used artificial blood vessels because of its chemical and mechanical stability. But, when used as arteriovenous (AV) grafts for haemodialysis, small diameter ePTFE grafts have a high failure rate of 40% in three years in vivo because of the functional lack of an intact endothelial cell layer. Here we developed a two-step modification including chemical etching and plasma activation to enhance the hydrophilicity of ePTFE. Peptide motifs (eg. cyclic RRE, RGD) known to bind integrins on the endothelial cells were immobilized on ePTFE grafts. Functional peptide immobilization significantly increased the adherence and growth of HUVEC cells on ePTFEs. Patch ePTFE implantation in the pig's descending aorta was used to evaluate the in vivo endothelialization of these modified ePTFE grafts. At 28 days implantation, newly formed endothelial layers on peptide-immobilized ePTFE grafts were demonstrated by SEM and histological analysis. These preliminary data showed the potential to grow an intact endothelial layer to improve the patency rate of the modified ePTFE grafts.


Eligibility criteria: Obtained from the peripheral blood leukocyte thick liquid (Hsinchu Blood Center, Taiwan Blood Services Fundation) Times - sampled 20 \~ 40ml / time, 2 to 3 times / month

Primary outcomes:
measure: Isolate and expand EPCs from peripheral blood
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipai
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Cardiac Surgical Division, Surgical Department, National Taiwan University Hospital
name: I Hui Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05971004: Effectiveness of Hydrolyzed Collagen Peptide Injection for the Treatment of Collateral Ligament Pain
Official title: Effectiveness of Hydrolyzed Collagen Peptide Injection for the Treatment of Collateral Ligament Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Collateral Ligament Injury of Stifle Joint
Keywords: Collateral Ligament Pain
Knee Pain
Knee Instability
Sports Trauma
Collagen Peptide Injections
Ligament Healing
Lead sponsor: Tiss'You srl
Sponsor class: INDUSTRY
First posted: 2023-08-02
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Conducted by Binh Luu Thi, Lan Tran Thi, and Minh Hang Hoang Thi at Thai Nguyen National Hospital, the study investigates a new approach to treating persistent collateral ligament pain, common among athletes. The research examines the therapeutic use of hydrolyzed collagen peptide injections, a treatment that addresses pain and inflammation in ways previous methods have not.

The study involves a randomized controlled trial with 62 patients, all diagnosed with inflammation in the collateral ligament site. The patients are split into two groups: one receiving collagen injections alongside oral painkillers and the other receiving depo-medrol injections with oral painkillers.


Eligibility criteria: Inclusion Criteria:

* age above 18 years,
* lateral knee pain with a duration of 3 months or longer,
* ultrasound evidence of inflammation of the femoral condyle attachment point,
* agreement to participate in the study

Exclusion Criteria:

* trauma,
* infection,
* dermatitis at the site of the inflammation,
* damage to surrounding knee structures,
* history of chronic inflammatory arthritis (such as gout or rheumatoid arthritis),
* local corticosteroid injection within 3 months before participating in the study.

Primary outcomes:
measure: WOMAC
timeFrame: 6 months
Secondary outcomes:
measure: VAS (Visual Analogue Pain)
timeFrame: Baseline, 3 months, 6 months
measure: Ultrasound
timeFrame: Baseline, 3 months, 6 months
measure: Likert
timeFrame: Baseline, 6 months
measure: WOMAC
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Domagnano
country: San Marino
facility: Tiss'You
state: RSM
Study officials:
References:
Clinical trial NCT01797601: Insulin Sensitivity of the Human CNS System: fMRI Study With Intranasal Insulin Application
Official title: Insulinsensitivität Des Menschlichen Zentralnervensystems: Kernspintomographische Untersuchung Mit Intranasaler Gabe Von Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to investigate whether insulin sensitivity and insulin resistance of the human brain is comparable in all insulin sensitive parts of the brain and whether correlates to other phenotypic information (i.e. whole body insulin sensitivity, BMI, age) of the study participants.


Eligibility criteria: Inclusion Criteria:

* Normal routine blood works
* for women: negative pregnancy test
* healthy

Exclusion Criteria:

* Type 2 diabetes
* pregnancy
* acute or chronic diseases
* Pacemakers
* Artificial heart valves
* Metal prostheses
* Implanted magnetic metal parts (screws, ...)
* Metal fragments
* Braces
* insulin pumps
* Tattoos
* claustrophobia
* reduced temperature sensation and / or increased sensitivity to warming of the body
* Ear disease or an increased sensitivity to loud noises

Primary outcomes:
measure: Insulin effect on regional brain activity assessed by fMRI
timeFrame: Change from Baseline to 15 minutes and 60 minutes post spray application
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University of Tuebingen
Study officials:
affiliation: Universität Tübingen
name: Andreas Fritsche, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kullmann S, Heni M, Veit R, Scheffler K, Machann J, Haring HU, Fritsche A, Preissl H. Selective insulin resistance in homeostatic and cognitive control brain areas in overweight and obese adults. Diabetes Care. 2015 Jun;38(6):1044-50. doi: 10.2337/dc14-2319. Epub 2015 Mar 20.
Clinical trial NCT00929201: Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)
Official title: An Open-Label, Randomized, Two-Period Crossover Definitive Bioequivalence Study With the Final Marketed Image (FMI) Sitagliptin/Metformin Fixed-Dose Combination (FDC) Tablet and Co-Administration of the Sitagliptin and Metformin Individual Tablets After Consumption of a High-Fat Meal in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-06-26
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual tablets after consumption of a high-fat meal.


Eligibility criteria: Inclusion Criteria:

* is in good health
* is a nonsmoker
* is willing to follow all study guidelines

Exclusion Criteria:

* has or has a history of any illness or condition that might confound the results of the study or make participation unsafe for the participant
* is a nursing mother
* is unwilling to consume the required high-fat breakfast

Primary outcomes:
measure: Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin
timeFrame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax) of Metformin
timeFrame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02815501: Thyroid Dysfunction and Obstetric Complications
Official title: Thyroid Dysfunction and Obstetric Complications
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pregnancy
Keywords: Thyroid dysfunction
obstetric complications
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 0
Sex: FEMALE
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: women attending the emergency room and/or hospitalised or followed for:

* Spontaneous and/or repeated miscarriage
* Foetal death
* Pre-eclampsia
* Retroplacental haematoma
* Post-partum haemorrhage
* Premature delivery

Brief summary: Obstetric complications are common and can be responsible for maternal and foetal morbidity and mortality. Thyroid dysfunction has been identified as a possible cause of obstetric complications.

Many studies have been conducted to estimate the prevalence and define the nature of obstetric complications observed in patients with thyroid dysfunction. However, women with obstetric complications are not systematically screened for thyroid dysfunction and no published study has evaluated the prevalence of thyroid dysfunction in women with an obstetric complication. As no consensus has been reached concerning systematic screening for thyroid dysfunction in pregnant women, the identification of new high-risk populations could possibly result in a change of clinical practice.


Eligibility criteria: Inclusion Criteria:

women attending the emergency room and/or hospitalised or followed for:

* Spontaneous and/or repeated miscarriage
* Foetal death
* Pre-eclampsia
* Retroplacental haematoma
* Post-partum haemorrhage
* Premature delivery
* who consent to participate in the study.
* Assessment of these women will include blood samples for a laboratory work-up and anti-thyroid antibodies.

Exclusion Criteria:

* normal pregnancy

Primary outcomes:
measure: Prevalence of thyroid dysfunction
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Rachel DESAILLOUD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: