louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06802926: Pilot Trial of Colchicine for Graft Failure in CABG
Official title: A Single Center Pilot Trial of Preliminary Effect of Colchicine on Graft Failure in Patients Underwent CABG
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: CABG
Graft Failure
Colchicine
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 100
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: The goal of this pilot trial is to to evaluate the preliminary effect of oral colchicine therapy on graft outcomes in patients underwent primary isolated CABG.

The main questions it aims to answer is:

1. Whether the oral colchicine therapy may reduce the failure outcome of grafts after CABG.
2. Whether it is feasible to construct a muticenter powered trial to test the superiority hypothesis.

Researchers will compare colchicine to none to see if colchicine works.

Participants will

1. Take oral colchicine (0.5mg daily) therapy for 12 months after CABG.
2. Clinical follow-up at Month 1, 6, and 12 after CABG.
3. Protocol-driven CCTA at Week 1 and Month 12 after CABG.


Eligibility criteria: Inclusion Criteria:

* Age≥18 years old，
* Any sex，
* Signed informed consent，
* Within 3 days after a successful isolated CABG

Exclusion Criteria:

* Allergy,
* Hematopoietic dysfunction,
* Moderate to severe hepatic dysfunction,
* Moderate to severe renal dysfunction.

Primary outcomes:
measure: The Graft Failure Rate at 1 year
timeFrame: at 1 year post-CABG
Secondary outcomes:
measure: The time to first 5-point Major Adverse Cardiovascular Event (MACE-5)
timeFrame: within 1 year post-CABG
measure: The rate of new perioperative atrial fibrillationat (PAF) within 1 week after CABG
timeFrame: within 7 days post-CABG
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China
name: Qiang Zhao, MD
role: STUDY_CHAIR
affiliation: Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China
name: Yunpeng Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01088126: Linear Ablation Versus Focal Ablation of Complex Fractionated Atrial Electrograms in Persistent Atrial Fibrillation
Official title: Comparison of Linear Ablation Versus Focal Ablation of Complex Fractionated Atrial Electrograms After Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation: A Prospective & Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Persistent Atrial Fibrillation
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2010-03-17
Enrollment: 0
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: The end point of catheter ablation at complex fractionated atrial electrograms (CFAE) was not established yet. Furthermore, incomplete CFAE ablation may have a potential to develop atrial tachyarrhythmias (AT). The investigators hypothesized that linear ablation extending the clusters of CFAE would be a better strategy than focal ablation at the individual CFAE sites.


Eligibility criteria: Inclusion Criteria:

* patients age 18 or greater
* persistent atrial fibrillation
* candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication
* at least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial
* continuous anticoagulation with warfarin (INR 2-3) for \>4 weeks prior to the ablation
* patients must be able and willing to provide written informed consent to participate in the clinical trial

Exclusion Criteria:

* paroxysmal or permanent atrial fibrillation
* patients with AF felt to be secondary to an obvious reversible cause
* inadequate anticoagulation as defined in the inclusion criteria
* left atrial thrombus on TEE prior to procedure
* contraindications to systemic anticoagulation with heparin or coumadin
* previously undergone atrial fibrillation ablation
* patients who are or may potentially be pregnant

Primary outcomes:
measure: freedom from AF/AT more than 3 months after first ablation
timeFrame: 12 months
Secondary outcomes:
measure: freedom from AF/AT within 3 months following first ablation
timeFrame: 3 months
measure: acute intra-procedure termination of AF
timeFrame: 12 months
measure: organization of AF/conversion to AT during the ablation
timeFrame: 12 months
measure: procedure time
timeFrame: 12 months
measure: ablation time
timeFrame: 12 months
measure: procedure-related complication
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Medical Center
Study officials:
affiliation: Korea University
name: Young-Hoon Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06169826: Histidine Oral Supplementation as a Therapeutic Modality for Alzheimer's Disease
Official title: Histidine Oral Supplementation as a Therapeutic Modality for Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Alzheimer Disease
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oral supplementation of histidine in patients with cognitive dysfunction should increase brain anserine, carnosine and histamine levels which will result in improved cognition via numerous proven in vivo mechanisms including increasing blood flow, neurogenesis, angiogenesis, activation of histaminergic neural pathways and autophagy of beta-amyloid protein, which is pathognomonic for Alzheimer's disease.

Randomized into one of 2 arms to receive Histidine or placebo to take for up to 3 months. Baseline evaluation and followup evaluation at 3 months postop.

Detailed description: The patients will be offered enrollment by sequential measures with odd numbers placed into the Control Group and even numbers in the Treatment Arm. One hundred patients will be enrolled in each arm. Study medications will be initiated in the outpatient setting following informed consent, enrollment and baseline lab evaluation. Scheduled clinic visits at 3 months and 1 year from date of enrollment will be used to re-assess performance via repeat cognitive testing. Lab evaluation of CBC, CMP, histidine and histamine levels will occur at baseline and the 3 month clinic visit for the treatment arm subjects.

Group I: Control Arm- No intervention. Subjects will receive cognitive and lab testing and continue with current management of their cognitive impairment.

Group II: Treatment Arm- In the outpatient setting, one chewable tablet multivitamin (Zn and folic acid containing) plus a titrated dosing of L-histidine powder or capsules starting at 2g consumed before noon escalating every 2 weeks up to 4, 6, then 8 g per day as tolerated.

Eligibility criteria: Inclusion Criteria:

* \>49 years
* Live at home currently
* Clinical Dementia Score of 3.0 or higher

Exclusion Criteria:

* psychiatric

Primary outcomes:
measure: Clinical Dementia Rating
timeFrame: 12 months
Secondary outcomes:
measure: Histidine blood levels
timeFrame: 3 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Wells Reynolds, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03134326: Rainbow R2-25 vs. R1-25 SpHb Sub-Range Performance Equivalence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter sensors and compared against the hemoglobin measurement from the subject's blood sample under controlled conditions. Data collected in the study was in the sub-range of 12-17 g/dL in the device's 8-17 g/dL specification range.

The purpose of the study was to evaluate a change in the sensor component and to assess performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not uniform across the accuracy range.


Eligibility criteria: Inclusion Criteria:

* Greater than 18 years old
* Healthy

Exclusion criteria:

* Do not understand the study and the risks involved
* Deemed ineligible by study test personnel

Primary outcomes:
measure: Sub-Range Performance Equivalence of R2-25 and R1-25 Sensors by ARMS Calculation
timeFrame: 1-5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Clinical Lab
state: California
Study officials:
References:
Clinical trial NCT06718426: Evaluation of Fertitonex Effects on Semen Parameters in Clinical Varicocele Patient.
Official title: Evaluation of Fertitonex Effects on Semen Parameters in Clinical Varicocele Patient, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Varicocele
Keywords: varicocele
Fertitonex
infertility
semen analysis
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 110
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the Fertitonex effects on semen parameters in clinical varicocele patients.

Detailed description: Infertility is defined as the inability of a couple to conceive after one year of unprotected, frequent and regular sexual intercourse. Almost 15% of all couples trying to conceive are affected by infertility, and in almost half of these cases male infertility is the sole or a contributing factor. The most common cause is idiopathic oligoasthenoteratozoospermia (OAT) that is defined as follows sperm concentration, the proportion of morphologically normal sperm and the proportion of motile sperm are all lower than the World Health Organization (WHO) reference values.

Despite extensive research, a successful treatment for OAT had not yet been developed. Small amounts of reactive oxygen species (ROS) are produced by spermatozoa in physiological conditions, and various scavengers act to reduce the concentration of these ROS in the seminal plasma. ROS are needed for capacitation, acrosome reaction and ultimately fertilization.

Antioxidants might help maintain the balance between ROS production and clearance and thus could improve sperm quality Additionally, observational studies had found a lower frequency of sperm aneuploidy in men with a higher dietary intake of antioxidants than in those with a lower intake. In semen, antioxidants decrease OS, potentially improving sperm motility and reducing DNA fragmentation.

We aim to evaluate the Fertitonex effects on semen parameters in clinical varicocele patients.

Eligibility criteria: Inclusion Criteria:

* Primary infertility.
* Abnormal semen analysis parameters.
* Clinically evident varicocele confirmed by scrotal duplex.

Exclusion Criteria:

* 2ry infertility.
* Normal semen analysis parameters.
* Clinically non-evident varicocele.
* Past history of varicocelectomy.

Primary outcomes:
measure: Total sperm count
timeFrame: 3 months
measure: Sperm motility
timeFrame: 3 months
measure: Sperm Morphology
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shebin El-Kom
country: Egypt
facility: Menoufia Faculty of Medicine
state: Menoufia
Study officials:
References:
Clinical trial NCT05866926: Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
Official title: A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Ferrer Internacional S.A.
Sponsor class: INDUSTRY
First posted: 2023-05-19
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: For ADOREXT study, arms from parent study ADORE have been analyzed.

Data presented for the FAB122 study group correspond to subjects receiving FAB122 in the ADORE study as well as the ADOREXT study (FAB122-FAB122). Data presented for the placebo study group correspond to subjects receiving placebo in the ADORE study and FAB122 in the ADOREXT study (placebo-FAB122).
Primary purpose: TREATMENT

Brief summary: A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis


Eligibility criteria: Inclusion Criteria:

1. who completed the full study period in the main ADORE study (FAB122-CT-2001);
2. whom the investigator has no concern and judges tolerable for initiating or continuing treatment with FAB122 from a risk and benefit point of view;
3. a female subject should not be able to become pregnant up to 30 days after the last dose of FAB122 and needs to meet at least one of the following criteria:

   * female who is of reproductive potential and has a negative pregnancy test at baseline and is non-lactating.
   * female subject who is not of reproductive potential is eligible without requiring the use of contraception
4. a male patient must:

   * agree he will not donate sperm during the period he will be using FAB122, AND use a condom during sexual intercourse with pregnant or non-pregnant women of childbearing potential

Exclusion Criteria:

1. Patient who has a medical condition or personal circumstances which, in the opinion of the investigator, will make initiation or continuation of treatment with FAB122 not tolerable for them from a risk and benefit point of view.
2. Patient who discontinued study drug prematurely in the double-blind phase of the study (ADORE Study) for safety reasons.
3. Patient who has received any other investigational drug within the period between last visit of the main study and first visit of the extension study

Primary outcomes:
measure: Number of Participants Experiencing Treatment Emergent Adverse Events
timeFrame: approximately 44 weeks
Secondary outcomes:
measure: The Secondary Efficacy Objective to Evaluate the Effect of Treatment With FAB122 Based on Change From Baseline in ALSFRS-R Until End of Study
timeFrame: 45 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
Study officials:
References:
Clinical trial NCT06167226: Understanding Ayurveda Disease Conditions and Treatment Responses
Official title: Prediction of Ayurveda Prakriti and Vikriti Using Automatic Questionnaire and Digital Sensors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2diabetes
Rheumatoid Arthritis
Osteo Arthritis Knee
Skin Diseases
Gastric Ulcer
Neurodegenerative Diseases
Lead sponsor: Ayurai Private Limited
Sponsor class: INDUSTRY
Collaborators: name: SRM Medical College Hospital & Research Centre
First posted: 2023-12-12
Enrollment: 497
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of various diseases visiting the OPD

Brief summary: The goal of this observational study is to assess Prakriti \& Vikriti in patients visiting OPD of IIISM department, SRM hospital.

The main question\[s\] it aims to answer are:

* To evaluate Prakriti \& Vikriti of patients using Prakriti \& Vikriti questionnaire and with digital devices
* To correlate the determined Prakriti and Vikriti with the doctor's assessment along with clinical and biochemical parameters Participants will be advised to follow the treating physician's advice on medicines

Detailed description: The Ayurveda is an ancient documented medical system originated in India. The Ayurveda stratified humans into 7 broad categories based on the phenotype features viz. Vata, Pitta, Kapha, Vatapitta, Vatakapha, Kaphapitta and Vatapittakapha Prakriti types. Also, the features of the disease conditions are clearly described based on the predominance of Vata, Pitta and Kapha or its combinations. Presently, the identification of Prakriti type and Vikriti status are basically subjective assessment. This study proposes to integrate the subjective assessment with objective digital signal parameters. This digital signatures would be useful in ML / AI based assessment and prediction of Prakriti type and Vikriti status of the patients.

Eligibility criteria: Inclusion Criteria:

* Patients of various diseases visiting the OPD

Exclusion Criteria:

* Pregnancy and lactating females

Primary outcomes:
measure: Change from baseline in Complete blood count at 12 week
timeFrame: 12 weeks
measure: Serum Urea
timeFrame: 12 weeks
measure: Serum creatinine
timeFrame: 12 weeks
measure: Lipid Profile
timeFrame: 12 weeks
measure: Cytokines (TNF- alpha, IFN-gamma, IL-1, IL-4, IL-6, IL-10)
timeFrame: 12 weeks
Secondary outcomes:
measure: Pulse Plethysmography signals (PPG) - Finger PPG sensor
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chennai
country: India
facility: SRM Medical College Hospital & Research Centre
state: Tamil Nadu
Study officials:
affiliation: SRM Medical College Hospital & Research Centre
name: RC Sathish kumar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05872126: Video Assisted Thoracoscopic Surgery (VATS) - Surgical Pleurodesis vs Tube Drainage in Management of Malignant Pleural Effusion (MPE)
Official title: Video Assisted Thoracoscopic Surgery (VATS) - Surgical Pleurodesis vs Tube Drainage in Management of Malignant Pleural Effusion (MPE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Pleural Effusion
Thoracic Cancer
Keywords: Malignant pleural effusion
VATS
PleurX
Abrasion
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Clinical Trial with 2 groups; Case group for VATS mechanical abrasion and Control group for tube drainage
Primary purpose: TREATMENT

Brief summary: Malignant Pleural Effusion (MPE) is considered to be a common presentation at malignant tumors representing 15% of all cancer cases. It carries a burden on our patients with dyspnea being the most common symptom in most of cases.

Management of symptomatic malignant pleural effusion remains to be a point of debate. Data available from literature shows conflicting results lacking high quality evidence which necsscitates further research work. Options differs to include chemical pleurodesis using medical or surgical talc poudrage or slurry. Surgical intervention with abrasion pleurodesis or pleurectomy using VATS approach has been used in many studies. Using indwelling pleural catheters (IPCs) has also proved comparable efficacy at many clinical trials. In this study we want to help answering this question so that we can add to the current knowledge aiming to offer the best care for those patients


Eligibility criteria: Inclusion Criteria:

* 1-patients with symptomatic malignant pleural effusion. 2- symptomatic patients with shortness of breath. 3-Lung can be fully expanded.

Exclusion Criteria:

1. Patients with non symptomatic malignant pleural effusion
2. Pleural symphysis with no potentiality for re-expansion
3. Patients managed surgically through open thoracotomy.
4. Pleural effusion due to causes other than malignancy
5. Loculated malignant effusion judged by chest ultrasound
6. Trapped lung due to malignant pleural effusion assessed by multislice CT chest.,
7. .Refusal to share the research project and not to sign the consent.

Primary outcomes:
measure: Total hospital stay
timeFrame: 3 months postoperative
measure: duration of airleak
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Status of performance
timeFrame: 3 months
measure: mortality
timeFrame: '3 months
measure: Failure of management
timeFrame: 3 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university heart hospital
Study officials:
References:
Clinical trial NCT04383626: Fear Among Dentists During COVID-19 Pandemic
Official title: Fear and Practice Modification Among Dentists During COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Keywords: fear
practice modification
COVID-19
epidemic
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 216
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Dentist having bachelor of dentistry or equivalent degree

Brief summary: This study aimed to evaluate the anxiety and fear of infection between dentists working during the present corona virus disease 2019 (COVID-19) pandemic and to explore dentist's knowledge about various practice modifications and guidelines to fight the novel corona virus

Detailed description: The spread of corona virus (COVID-19) has posed significant challenges for dentistry and medicine, and dental and medical schools, in all affected countries.

The speed of reaction and type of response to this disease around the world have been very variable according to differing healthcare systems, economies and political ideologies

Eligibility criteria: Inclusion Criteria:

* Dentist having bachelor of dentistry or equivalent degree

Exclusion Criteria:

* paramedical staff and dental students

Primary outcomes:
measure: fear among dentist during COVID 19 epidemic
timeFrame: 1 week
Secondary outcomes:
measure: practice modification among dentist during COVID 19 epidemic
timeFrame: 1 week
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: