louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03389685: Can PRP Reduce Pro-Inflammatory Biomarkers Following ACL Injury
Official title: Can Platelet Rich Plasma Reduce the Level of Pro-Inflammatory Synovial Fluid Biomarkers Following an Anterior Cruciate Ligament Tear
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: ACL - Anterior Cruciate Ligament Rupture
ACL Injury
Keywords: Platelet Rich Plasma
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 0
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: The purpose of this single-center, double-blinded randomized control trial with prospective data collection is to assess the ability of platelet rich plasma (PRP) treatment to reduce the level of pro-inflammatory synovial fluid biomarkers following an acute anterior cruciate ligament (ACL) tear. The study will collect and analyze synovial fluid of patients presenting with an acute anterior cruciate ligament (ACL) tear with a second synovial fluid sampling at the time of surgery. It will compare synovial fluid biomarker levels between those receiving an intra-articular Platelet Rich Plasma (PRP) injection versus an intra-articular saline injection serving as a control. Post-operative clinical outcomes will also be assessed, including post-operative pain levels, incidence of post-operative knee stiffness and patient reported outcome scores.


Eligibility criteria: Inclusion Criteria:

* Patients have suffered an acute ACL tear (initial presentation within 7 days of injury) with or without an associated meniscus injury
* Patient must undergo ACL reconstruction surgery

Exclusion Criteria:

* Mentally impaired (e.g, Alzheimer's subjects, dementia, etc.)
* Younger than 18 years of age
* Patients who have a multiligamentous injury
* Patients with underlying inflammatory arthropathies
* Previous ACL injury and/or reconstruction

Primary outcomes:
measure: synovial fluid biomarker levels
timeFrame: 2 Days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Eric Strauss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04846985: Nutritional Problems in Pallative Cancer
Official title: Observational Study of Nutritional Problems in Lung and Pancreas Cancer Patients in Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Pancreatic Cancer
Keywords: Malnutrition
cancer
weight loss
lean body mass
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Hillerod Hospital, Denmark
First posted: 2021-04-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lung and pancreas cancer patients in chemotherapy.

Brief summary: The aim of this study is to investigate those nutritional problems contributing to loss of lean body mass in lung and pancreas cancer patients in chemotherapy. Furthermore to investigate alterations in taste and how they correlates with changes in following factors: nutritional intake, physical activity, appetite, food preferences, side effects, fatique and meal perception.

Detailed description: This study will include a recruitment of 50 lung and pancreas cancer patients currently in chemotherapy. They will be observed during a period of 9-12 week, including at least 2 chemotherapy treatments. The presence and severity of the nutritional problems will be examined by observing as many different factors as possible. This includes taste alterations, weight changes, nutritional intake, physical activity, interviews and weekly questionnaires. In relation to this our primary outcome is to investigate the correlation between changes in taste and changes in nutritional intake. Secondarily the investigators want to investigate nutritional intake, physical activity, appetite, food preferences, side effects, fatique and meal perception.

Eligibility criteria: Inclusion Criteria:

* Lung or pancreas cancer patient
* In chemoterapy regardless of line treatment with/without combined treatment
* Legal age
* Able to speak and read in danish
* Ambulant

Exclusion Criteria:

* Inability to give consent and complete questionnaires
* Participating in clinical interventions during the periode of observation
* Allergic to milk or for any reason don't consume diary products

Primary outcomes:
measure: To investigate the correlation between changes in taste and changes in nutritional intake
timeFrame: 9-12 weeks (3 treatment cycles)
Secondary outcomes:
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Hillerod hospital, Denmark
state: Sjælland
Study officials:
affiliation: Hillerod Hospital, Denmark
name: Maria Elisabeth Lendorf, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01944085: Percutaneous Pin Removal in Children - is Analgesia Necessary?
Official title: Percutaneous Pin Removal in the Outpatient Clinic - do Children Require Analgesia? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elbow Fracture
Keywords: children
supracondylar fracture
pin removal
analgesia
pain score
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2013-09-17
Enrollment: 240
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a simple randomised clinical trial to study if non-narcotic analgesia reduces the pain score and pulse rate of children who undergo removal of percutaneous pins in the outpatient clinic.

Inclusion criteria:

* 5-12 years of age
* 2 or 3 percutaneous pins in either elbow

Exclusion criteria:

- documented or suspected allergies to acetaminophen, ibuprofen

Patients enrolled in the study are instructed not take additional analgesia prior to the clinic visit (risk of overdosage explained). This is verified by clinic nurses conducting the trial.

At the clinic visit, they are randomized into one of three groups

1. acetaminophen; 2. ibuprofen; or 3. Vitamin C (Placebo).

They are served the 'medication' (weight-appropriate dose) and the pins are removed in the clinic an hour later.

Pain score (Wong-Baker scale) and pulse rate are measured before pin removal, immediately following pin removal, and 10 minutes after pin removal.

The study hypothesis is that non-narcotic analgesia (such as acetaminophen and ibuprofen) do not decrease pain score and pulse rate associated with the pin removal procedure.

Detailed description: See Brief Summary

Eligibility criteria: Inclusion Criteria:

* age: 5-12 inclusive
* 2 or 3 percutaneous pins in either elbow

Exclusion Criteria:

* documented or suspected allergies to acetaminophen or ibuprofen

Primary outcomes:
measure: Pain Score (0 -10)
timeFrame: 10 minutes after pin removal
Secondary outcomes:
measure: Pulse rate
timeFrame: 10 minutes after pin removal
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's & Children's Hospital
Study officials:
affiliation: KK Women's & Children's Hospital, SINGAPORE
name: Kevin Lim, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tay GT, Lokino ES, Ong LL, Abdullah SN, Wong ML, Lim KB. Pain during percutaneous pin removal in children with elbow fractures. J Orthop Surg (Hong Kong). 2012 Dec;20(3):369-70. doi: 10.1177/230949901202000322.
citation: Lim KB, Tan SS, Abdullah SN, Ong LL, Wong ML, Allen JC. Percutaneous pin removal in the outpatient clinic--do children require analgesia?: a randomized controlled trial. J Bone Joint Surg Am. 2014 Apr 2;96(7):597-602. doi: 10.2106/JBJS.M.00806.
Clinical trial NCT01295385: Contribution Of Nuclear Magnetic Resonance Imaging In The Study Of Diabetic Cardiomyopathy
Official title: Contribution Of Nuclear Magnetic Resonance Imaging In The Study Of Diabetic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic
Cardiomyopathy
Keywords: type 2 diabetes
Cardiovascular diseases
coronary syndrome have abnormalities of glucidic metabolism
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2011-02-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Diagnosis of diabetic cardiomyopathy is then retained, supposing a change in the coronary microcirculation linked to an endothelial dysfunction. Abnormalities of the myocardial metabolism is frequently associated. It is regrettably about a hypothesis difficult to verify with current medical techniques.This deficiency being not only harmful to the diagnosis, but also to the assessment of the efficiency of the medical treatment on the myocardial metabolism and the endothelial function. Techniques of nuclear magnetic resonance offer interesting perspectives.

Detailed description: These techniques allow in this context:

1. to quantify the myocardial blood flow at rest and after "cold pressor test" in a population of healthy volunteers. The myocardial blood flow will be obtained by estimating myocardial blood flow at the venous coronary sinus site. This allows us to quantify a possible endothelial dysfunction in a reproducible way. No MRI study in diabetic patients has ever been led until now with this technique.
2. to estimate the metabolic and structural abnormalities in this population, with particularly:

   * Quantification of the myocardial metabolism in vivo by spectrometry of phosphorus 31.
   * Structural abnormalities: become integrated into the description of diabetic cardiomyopathy.

Eligibility criteria: Inclusion Criteria:

* more than 18 years old
* patient type 2 diabetes affects taken care more than 5 years to Timone Hospital
* patient with a diabetic cardiomyopathy
* informed and consented

Exclusion Criteria:

* less than 18 years
* Pregnant woman
* patient type 1 diabetes affects
* patient presents a cardiomyopathy mixed (no diabetic)
* patients presents an arrhythmia ventriculaire or above - ventriculaire
* Unstable hémodynamique patients

Primary outcomes:
measure: To quantify the myocardial blood flow at rest and after "cold pressor test" in a population of healthy volunteers
timeFrame: 12 months
Secondary outcomes:
measure: To estimate the metabolic and structural abnormalities in this population
timeFrame: 12 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique - Hopitaux de Marseille
Study officials:
affiliation: APHM
name: Jacques Quilici, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04755985: A Study to Compare PK, PD and Safety of the AD-213-B and AD-2132
Official title: A Randomized, Open Label, Multi Dose, Cross Over Design Clinical Study to Evaluate the Pharmacokinetic Pharmacodynamic Characteristics and Safety of AD-213-B and AD-2132 After Oral Administration in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastroesophagus Reflux Disease
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-16
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study to compare safety, pharmacokinetics and pharmacodynamics of AD-213-B to AD-2132 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy adults over 19 years of age.
* Weight is more than 50kg and BMI is more than 18.0 kg/m\^2 , no more than 27.0 kg/m\^2.
* Subject who has been judged to be eligible for clinical laboratory tests and electrocardiogram tests such as serum tests, hematology tests, blood chemistry tests, and urinary tests conducted within four weeks prior to the administration of clinical trials.
* Subjects who has heard and fully understood the detailed description of this clinical trial and have willingness to sign of informed consent in writing.

Exclusion Criteria:

* A subject who has a history that can affect the absorption, distribution, metabolism, or excretion of a drug.
* As a result of laboratory tests, the following figures: ALT or AST or total bilirubin \> 1.5 times upper limit of normal range.
* As a result of laboratory tests, the following figures: Creatinine clearance \< 80mL/min.
* Subjects who judged ineligible by the investigator.

Primary outcomes:
measure: AUCtau
timeFrame: From Day 1 up to Day 17
measure: The change of Integrated gastric acidity(%) from baseline
timeFrame: 4 times from Day -1 to Day 17
Secondary outcomes:
measure: Cmax
timeFrame: Day 1
measure: AUClast
timeFrame: Day 1
measure: AUCinf
timeFrame: Day 1
measure: Tmax
timeFrame: Day 1
measure: t1/2
timeFrame: Day 1
measure: CL/F
timeFrame: Day 1
measure: Vd/F
timeFrame: Day 1
measure: Cmax,ss
timeFrame: Day 1 up to Day 17
measure: Cmin,ss
timeFrame: Day 1 up to Day 17
measure: AUCinf
timeFrame: Day 1 up to Day 17
measure: Tmax,ss
timeFrame: Day 1 up to Day 17
measure: t1/2
timeFrame: Day 1 up to Day 17
measure: CLss/F
timeFrame: Day 1 up to Day 17
measure: Vdss/F
timeFrame: Day 1 up to Day 17
measure: The change of Integrated gastric acidity(mmol∙hr/L) from baseline
timeFrame: 4 times from Day -1 to Day 17
measure: Percentage of time to maintain gastric pH 4.0 or higher
timeFrame: 4 times from Day -1 to Day 17
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Young-Ran Yoon
Study officials:
References:
Clinical trial NCT01288885: First in Men Study of Single Oral Doses of ASP1941 in Healthy Subjects
Official title: A Double-blind, Placebo-controlled, Dose Escalating Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food-effect of Single Oral Doses of ASP1941 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ASP1941
Diabetes Mellitus
First in Men
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-02-03
Enrollment: 76
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study determined the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of ASP1941 after a single oral dose (Part A). In addition, it was investigated whether the intake of food had an effect on the PK of ASP1941 (Part B).

Detailed description: This study consists of two parts. Part A is a double-blind, placebo controlled single dose escalation study to evaluate the safety and tolerability of single ascending doses of ASP1941. Part B is an open label, crossover design food-effect study to evaluate the effect of fed conditions on the PK of ASP1941.

Eligibility criteria: Inclusion Criteria:

* Body weight between 60-100 kg, body mass index (BMI) between 20-30 kg/m2, inclusive

Exclusion Criteria:

* Fasting Plasma Glucose (FPG) \> 6.4 mmol/l
* HbA1c \> 6.2%
* Pulse \<40 or \>90 beats per minute; Systolic Blood Pressure (SBP) \<90 or \>140 mmHg; Diastolic Blood Pressure (DBP) \<40 or \>95mmHg

Primary outcomes:
measure: Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests
timeFrame: Up to 2 weeks after each administration
Secondary outcomes:
measure: Pharmacokinetics calculated by ASP1941 plasma concentration change
timeFrame: Up to 72 hours
measure: Pharmacodynamics assessed by ASP1941 glucose concentration changes in blood and urine
timeFrame: Up to 72 hours
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT01626885: A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia
Official title: A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Antipsychotic Agents
Mental Disorder
Psychotropic Drugs
Dopamine Agents
Central Nervous System Agents
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-06-25
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with receiving multiple drugs schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained from the patient before the initiation of any study-specific procedures
* Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
* Patients who receive 1 or more antipsychotic drugs
* Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria:

* Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 60 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kurayoshi
country: Japan
state: Tottori
Study officials:
References:
Clinical trial NCT05554185: Probiotic Supplementation During Pregnancy in Preeclampsia High-risk Groups
Official title: Effects of Probiotic Supplementation During Pregnancy on Maternal and Infant Outcomes in Preeclampsia High-risk Groups Based on Abnormal Intestinal Flora: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PE (Pre-eclampsia) High-risk Population With Gut Microbiota Dysbiosis During Their Pregnancy
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 338
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this randomized controlled study, preventive intervention of aspirin combined with probiotics or aspirin combined with placebo would given to PE (pre-eclampsia) high-risk population with gut microbiota dysbiosis during their pregnancy, and finally assess the efficacy and safety of aspirin combined with probiotics to prevent PE.


Eligibility criteria: Inclusion Criteria:

* PE high-risk population aged 18-50 years with gut microbiota dysbiosis
* No severe cardiopulmonary diseases
* No severe hepatic and renal insufficiency
* No severe active infection
* Pregnant women did not take antibiotics or antifungal drugs 30 days before fecal sample collection; No probiotic preparation was taken 2 weeks before sample collection; Never take drugs that may interfere with glucose and lipid metabolism
* No diseases affecting intestinal microecology
* No history of smoking and drinking
* The researchers evaluated those pregnant women expected to deliver more than 20 weeks
* Voluntarily participate in this clinical study and sign the informed consent form

Exclusion Criteria:

* With severe cardiopulmonary, hepatic and renal insufficiency
* With uncontrolled active infections 2 weeks before enrollment
* Subjects took antibiotics or antifungal drugs 30 days before sample collection; Take probiotics 2 weeks before sample collection; Have taken drugs that may interfere with glucose and lipid metabolism
* with diseases affecting intestinal microecology
* Smoking and drinking history
* With acute gastrointestinal ulcer
* Hemorrhagic constitution
* Other discomfort assessed by the investigato

Primary outcomes:
measure: The incidence of preeclampsia
timeFrame: From being recruited to 6 weeks after delivery
Secondary outcomes:
measure: The incidence of fetal growth restriction
timeFrame: From being recruited to 6 weeks after delivery
Other outcomes:
Locations:
Study officials:
References:
citation: Chen X, Li P, Liu M, Zheng H, He Y, Chen MX, Tang W, Yue X, Huang Y, Zhuang L, Wang Z, Zhong M, Ke G, Hu H, Feng Y, Chen Y, Yu Y, Zhou H, Huang L. Gut dysbiosis induces the development of pre-eclampsia through bacterial translocation. Gut. 2020 Mar;69(3):513-522. doi: 10.1136/gutjnl-2019-319101. Epub 2020 Jan 3.
Clinical trial NCT04408885: Rehabilitation Treatment of Anterior Cruciate Ligament Rupture
Official title: Rehabilitation Treatment of Anterior Cruciate Ligament Rupture
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ACL Injury
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Horsens Hospital
name: Central Jutland Regional Hospital
name: Regionshospitalet Silkeborg
name: Herning Hospital
First posted: 2020-05-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will include 400 patients with Anterior cruciate ligament injury. Patients will be included at different orthopaedic Clinics at 5 hospitals in Region Midtjylland.

Brief summary: The purpose with this present study is to investigate the effect og a non-surgical regime in patients with an Anterior Cruciate ligament injury.

The effect will be measured by patient reported outcome scores, level of function and how many of the patients are converting to operative treatment.


Eligibility criteria: Inclusion Criteria:

* Anterior cruciate ligament injury where rehabilitation regime is selected as treatment.

Exclusion Criteria:

* Other knee ligament instability
* Rheumatoid arthritis
* Morbus Bechterews Disease

Primary outcomes:
measure: Changes in patient reported outcome score (IKDC)
timeFrame: Baseline - 2 Years
Secondary outcomes:
measure: Changes in patient reported outcome score (KOOS)
timeFrame: Baseline - 2 Years
measure: Changes in patient reported outcome score (KNEES-ACL)
timeFrame: Baseline - 2 Years
measure: Changes in patient reported outcome score (TEGNER)
timeFrame: Baseline - 2 Years
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Division of Sports Trauma, Palle Juul-Jensens Boulevard 99
Study officials:
References: