louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03898765: Dry Blood Spot Screening Test for Biliary Atresia（DBS-SCReBA）
Official title: Dry Blood Spot Screening Test for Biliary Atresia and Other Cholestasis Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatobiliary Disease
Biliary Atresia
Neonatal Cholestasis
Keywords: Dry blood spot test
Biliary Atresia
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Our study aims to develop a screening test for biliary atresia (BA) using dry blood spot to improve patient survival by early diagnosis. Newborn screening dry blood spot will be examined for the direct bilirubin (DB), γ-GT or matrix metalloproteinase-7 (MMP-7) levels. These findings will promote early diagnosis for BA and hence improve the survival.

Detailed description: BA accounts for approximately 60% of the liver transplantations in infants younger than 1 year of age. The diagnosis of BA remains a clinical challenge because affected neonates have signs, symptoms, and serum liver biochemistry that are also seen in those with other causes of neonatal cholestasis.

The success of the Kasai procedure is varied, but a good outcome is correlated with an early diagnosis. Unfortunately, most BA are usually identified later and the average age at surgery is about 60 days. To address this problem, some research groups screen infants for the pale stools or measure bilirubin level in the serum. However, these screening programs have not yet to be implemented because of several reasons. Recently, the relative abundance of serum MMP-7 was suggested to have discriminatory features for infants with BA. Nevertheless, whether the level of MMP-7 elevates in newborn dry blood spot of BA is still undefined. In this study, we will explore a screening strategy based on DB, γ-GT or MMP-7 measurement in newborn screening blood spot, and identify whether DB , γ-GT or MMP-7 measurement in the newborn period could be sensitive and specific for BA.

Eligibility criteria: Inclusion Criteria:

* Neonates born in Shanghai

Exclusion Criteria:

* Subjects who do not agree with study protocol
* Subjects who join other clinical trials

Primary outcomes:
measure: Suspected BA
timeFrame: Three to Seven days after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Wei Cai, Pro
role: STUDY_DIRECTOR
References:
Clinical trial NCT06592365: Clinical Study to Evaluate the Effects and Safety of Green Tea Extract on Blood Glucose Regulation
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effects and Safety of Green Tea Extract(GTE) Consumption on Blood Glucose Regulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Sugar
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 84
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study was conducted to investigate the effects of green tea extracts on reducing blood glucose level

Detailed description: This study was conducted over 12 weeks with a randomized, double-blind, placebo-controlled, parellel design

Eligibility criteria: Inclusion Criteria:

* Males and females aged between 19 to 64 years
* BMI between 18.5 and 29.9kg/m²
* fasting blood glucose between 100 and 139 mg/dL (Note: if some subjects with blood glucose range of 126 - 139 mg/dL, those who are taking or requre medication must be excluded to meet ethical standards.)
* subjects who voluntarily decide to participate in this study and sign the informed consent form.

Exclusion Criteria:

* Individuals taking to obesity, dyslipidemia, or uncontrolled hypertension at the screening
* Individuals diagnosed with diabetes and who have taken medications related to blood glucose
* Individuals congenital enzyme deficiencies related to sugar metabolism.
* with hypersensitivity to the test food or ingredients(e.g., green tea, caffeine).
* Individuals ongoing treatment diseases significantly related glucose metabolism.
* Individuals with a history of surgery significantly related to glucose metabolism within the last 6 months
* diagnosed with gastrointestinal diseases, cardiovascular diseases, uncontrolled chronic medical conditions, thyroid disorders, or active malignant tumors requiring medication
* Individuals with liver function impairment or acute or chronic hepatitis or liver cirrhosis
* Individuals with renal disorder
* Individuals with a weight change of 5 kg or more within the last 3 months.

Primary outcomes:
measure: Change in fasting glucose level
timeFrame: Baseline, week 12
Secondary outcomes:
measure: changes of indicator of lipid metabolism
timeFrame: Baseline, week 12
measure: OGTT
timeFrame: Baseline, week 12
measure: blood biomarkers
timeFrame: Baseline, week 12
measure: change in waist circumference(cm)
timeFrame: Baseline, week 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk samsung hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National Universtiy Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent's Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Jae-Heon Kang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04880265: Assessing the Burden of Perioperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Official title: Assessing the Burden of Perioperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Cardiac Surgery
Keywords: Wearable Device
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing cardiac surgery

Brief summary: Background and Significance:

In the United States approximately 220,000 patients undergo cardiac surgery per annum. Among potential complications, the incidence of atrial fibrillation (AF) is estimated at 30 - 60 %, and therefore presents the most common adverse event after cardiac surgery. Multiple complications may be associated with AF: Patients are usually subject to an increased length-of-stay in the intensive care unit and in the hospital. Furthermore, the risk for stroke and development of long-term AF is elevated, while further anticoagulation is required putting the patient at risk for bleeding. On average, an additional $10,000 - $20,000 is spent for each patient with AF. However, the exact burden of postoperative AF still remains unknown.

Specific Aims of Research Project:

1. To collect data from an electrocardiogram (EKG) monitoring patch, we aim to accurately determine the prevalence of atrial fibrillation in patients undergoing cardiac surgery at our center.
2. To collect data on epidemiological characteristics to investigate risk factors for developing perioperative atrial fibrillation in patients undergoing cardiac surgery. This will allow us to create robust risk prediction models.


Eligibility criteria: Inclusion Criteria:

* Elective open heart surgery
* Age \> 20 years

Exclusion Criteria:

* Refusal to participate (patient or health care proxy)
* Participation in other pharmacological trials
* Lack of data or poor data quality which cannot be analyzed for any heart rhythm in 80% of the postoperative study period.

Primary outcomes:
measure: Atrial Fibrillation
timeFrame: Up to 30 days after discharge from the hospital
Secondary outcomes:
measure: Other arrhythmias
timeFrame: Up to 30 days after discharge from the hospital
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT04287465: Comparison of Outcomes in Asleep and Awake DBS With a Directional Electrode
Official title: Comparison of Outcomes in Asleep and Awake DBS With a Directional Electrode
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Parkinson Disease
Deep Brain Stimulation
Lead sponsor: Hospital District of Helsinki and Uusimaa
Sponsor class: OTHER
Collaborators: name: University of Turku
First posted: 2020-02-27
Enrollment: 30
Sex: ALL
Maximum age (years): 80
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 advanced Parkinson's disease and their willingness to undergo DBS operation and treatment.

Brief summary: To compare the clinical outcome of patients with Parkinson's disease (PD) treated with directional deep brain (dDBS) stimulation undergoing subthalamic deep brain stimulation operation (STN-DBS) under general anesthesia versus local anesthesia.

Detailed description: To compare the clinical outcome of patients with Parkinson's disease (PD) treated with directional deep brain (dDBS) stimulation undergoing subthalamic deep brain stimulation operation (STN-DBS) under general anesthesia versus local anesthesia.

In awake group, 10 patients with Parkinson's disease were treated with St Jude Medical/Abbott Infinity DBS system, and the electrode implantation and testing were performed while the patients were awake. In asleep group, 14 patients with Parkinson's disease were treated with St Jude Medical/Abbott Infinity DBS system, and the electrode implantation were performed while the patients were under general anesthesia. The clinical outcome of the DBS treatment, possible adverse effects and the electrode placement will be compared within these two groups.

Eligibility criteria: Inclusion Criteria:

Advanced Parkinson's disease

* The clinical decision of DBS treatment
* The clinical inclusion criteria of DBS treatment:
* drug-resistant tremor
* severe daily motor fluctuations or dyskinesia in despite of the optimal oral medication
* an improvement of UPDRS III scores over 30 % in levodopa challenge test.

Exclusion Criteria:

* The general exclusion criteria for DBS treatment:
* a major depression
* on-going psychosis
* a significant brain atrophy observed in a brain MRI
* a suspicion of atypical parkinsonism
* marked cognitive decline.

Primary outcomes:
measure: The change of UPDRS III score
timeFrame: 6 months
Secondary outcomes:
measure: The change of levodopa equivalent dose, LED
timeFrame: 6 months
measure: Electrode trajectory
timeFrame: 6 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: HUH Meilahti Hospital, department of neurology
Study officials:
affiliation: HUH
name: Eero Pekkonen, M.D-, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03879265: Validation of a NICS Method Using the Culture Medium
Official title: Validation of a Noninvasive Chromosome Screening (NICS) Method Using the Culture Medium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chromosome Abnormality
Abnormality
Keywords: Diagnosis
Reproduction
Chromosomal Endowment
Lead sponsor: Instituto Bernabeu
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 50
Sex: MALE
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Couples who come to the study center to carry out a PGT-A cycle. Only couples that perform treatment using their own gametes will be selected and where the indication of PGT-A will be able to be advanced maternal age, failure of implantation, repeat abortion, male factor or structural chromosomal alterations.

Brief summary: This study aims to validate a non-invasive method of chromosomal screening (NICS), based on the Multiple Annealing and Looping Based Amplification Cycles- Next-generation Sequencing (MALBAC-NGS) technology, in order to determine the chromosomal endowment of a blastocyst from the DNA of the embryonic culture medium.

The chromosomal status of the embryo from an embryo biopsy of trophoectoderm will be established (usual clinical practice), the chromosomal endowment from the DNA of the embryonic culture medium will be determined, and the results using the NICS and the conventional invasive method (Preimplantation Genetic Testing for Aneuploidy \[PGT-A\]) will be compared.


Eligibility criteria: Inclusion Criteria:

* Treatment by oocyte donation or own oocyte nd preimplantation genetic screening of aneuploidies (PGT-A).
* Embryonic cryopreservation.
* Informed consent signature

Exclusion Criteria:

* Embryo transfer without embryo freezing
* Embryonic block.
* Bad embryo quality.

Primary outcomes:
measure: Presence of Mosaicism
timeFrame: At Day 5-6 after FIV
measure: Quality value of NICS DLRS
timeFrame: At Day 5-6 after FIV
Secondary outcomes:
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Instituto Bernabeu
Study officials:
affiliation: Instituto Bernabeu
name: Belén Lledo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00319865: PAD Combination Therapy Followed by Thal/Dex for Relapsed or Refractory Multiple Myeloma
Official title: PS-341 (Bortezomib, Velcade®), Adriamycin and Dexamethasone (PAD) Combination Therapy Followed by Thalidomide With Dexamethasone (Thal/Dex) for Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma Relapsed
Lead sponsor: Korean Multiple Myeloma Working Party
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2006-04-27
Enrollment: 47
Sex: ALL
Minimum age (years): 0
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective multicenter phase 2 study using PAD and Thal/Dex combination sequentially.

Detailed description: Although the overall survival was improved with the introduction of high dose therapy with autologous hematopoetic stem cell transplantation,it remains as a incurable disease. Most patients ultimately relapse. Recenlty, targeted therapy using novel agents, such as bortezomib and thalidomide, shows the possibility of improved in this situation. Among them, PAD (Velcade, Adriamycin,Dexamethasone) showed highest response rate. PAD does not show any cross resiatance with another effective combination, thalidomide plus dexamethasone.

We desined prospective multicenter phase 2 study using these combination sequentially.

Eligibility criteria: Inclusion Criteria:

* Patients with multiple myeloma who relapsed after at least 1 lines of therapy including high dose thearapy with autologous stem cell transplantation and chemotherapy.
* Presence of measureble disease : serum M-protein \> 1g/dL or urine M-protein \> 400mg/day
* Age \< 75
* Performance status \</= ECOG 2
* Expected survival \> 6 months
* who signs the informed consent

Exclusion Criteria:

* known hypersensitivity to thalidomide or dexamethasone
* known refractoriness to thalidomide + dexamethasone
* Previous Velcade therapy
* Sepsis
* Woman in reproductive age
* Serum creatinine \> 2 mg/dL ; 24 hour creatinine clearance \< 30 ml/min; past medical history of kidney transplatation
* Peripheral neuropathy \>/= grade 2
* Recurrent DVT or pulmonary embolism
* Cardiac ejection fraction \<0.5 : Severe conduction disorder
* Hepatic dysfunction (AST or ALT ≥ x 5 upper normal) or active hepatitis
* Active ulcers in gastrofiberscope

Primary outcomes:
measure: Response rate of PAD induction Therapy
Secondary outcomes:
measure: Response rate of PAD followed by Thal/Dex maintenance
measure: Progression free survival and Overall survival of PAD/Thal-Dex.
measure: To evaluate toxicities of PAD/Thal-Dex
Other outcomes:
Locations:
city: Inchon
country: Korea, Republic of
facility: Gachon University Gil Hospital
Study officials:
affiliation: Korean Multiple Myeloma Working Party
name: Jae Hoon Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01548365: Impact of an Infusion Therapy Nursing Expert Service on Length of Stay and Clinical Results of Venous Access Devices
Official title: Impact of an Infusion Therapy Nursing Expert Service on Length of Stay, Clinical Results of Venous Access Devices and Satisfaction on Patients With Long Intravenous Therapy Prescription.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Prolonged Intravenous Therapy
Keywords: Nursing Services
Catheterization, Central Venous
Catheters Indwelling
Catheterization, Peripheral
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
Collaborators: name: KRONIKGUNE Cronicity Research Centre
First posted: 2012-03-08
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether an infusion therapy nursing expert service is effective in decreasing hospital length of stay, improving the clinical results of venous access devices and increasing patient satisfaction with venous access.


Eligibility criteria: Inclusion Criteria:

* Require an estimated long prescription of intravenous treatment. These treatments may be of fluid therapy, pharmacological, nutritional or hemotherapy.

  * Estimation of 7 days or more of continuous intravenous therapy.
  * Estimation of an intermittent intravenous therapy of less than a week, but on a monthly basis or less and a total estimated duration superior to 3 months.
* Be patient at Araba University Hospital

Exclusion Criteria:

* To have a central venous catheter indwelled
* MRSA (Methicillin Resistant Staphylococcus Aureus)
* Younger than 18 years old

Primary outcomes:
measure: Hospital Length of Stay
timeFrame: 3 months
Secondary outcomes:
measure: Venous Access Devices reaching end of treatment
timeFrame: 3 months
measure: Incidence of complications derived from VAD
timeFrame: 3 months
measure: Patients receiving intravenous therapy at home
timeFrame: 3 months
measure: Patient satisfaction with VAD
timeFrame: 3 months
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Araba University Hospital
state: Araba
Study officials:
affiliation: Basque Health Service
name: Lucia Garate, MsC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04947865: Reflex Excitability in Post-stroke Stiff-Knee Gait
Official title: Characterization of Abnormal Reflex Couplings Via H-reflex Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Chronic Stroke
Gait, Hemiplegic
Gait, Spastic
Gait Disorder, Sensorimotor
Gait Disorders, Neurologic
Walking, Difficulty
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-07-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the reflex excitability of the rectus femoris in individuals with and without post-stroke Stiff-Knee gait. We use electrical stimulation of the peripheral nerve innervating the rectus femoris for a well-controlled reflex stimulus. We are investigating whether reflex excitability of the rectus femoris correlates with gait kinematics.

Detailed description: The purpose of this study is to investigate the role of hyperreflexia in post-stroke Stiff-Knee gait function. In one aim,

Eligibility criteria: Inclusion criteria:

* Aged at least 18
* Premorbidly independent
* If post-stroke, mild to moderate impairment determined by standard practices per the physical therapist
* Able to continuously walk for 30 minutes
* If post-stroke, reduced knee flexion during walking relative to unimpaired side
* If post-stroke, hemiparesis
* Ability to provide informed consent

Exclusion criteria:

* No history of serious lower limb musculoskeletal injury
* No functionally relevant osteoarthritis and weight-bearing restrictions
* No functionally relevant polyneuropathy
* No functionally relevant cognitive impairment
* No functionally relevant vision impairment

Primary outcomes:
measure: Surface electromyographic recording of leg muscles during different conditions
timeFrame: 1 hour
Secondary outcomes:
measure: Circumduction measure
timeFrame: 1 hour
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: James S Sulzer
role: PRINCIPAL_INVESTIGATOR
References: