louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01138826: Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets
Official title: Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 6-Sequence, 3-Period Crossover Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablets, Manufactured By Aurobindo Pharma Ltd., India To Amlodipine Besylate 10 Mg Tablets Manufactured by Pfizer Illertissen, Germany Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: biological availability
bioavailability
amlodipine
orally disintegrating tablet
ODT
tablets
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Aurobindo Pharma Ltd
name: Trident Life Sciences Ltd.
First posted: 2010-06-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine besylate (non-ODT) tablet.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 18 to 26 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
timeFrame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose
measure: AUC From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose
Secondary outcomes:
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose
Other outcomes:
Locations:
city: Hydrabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06654726: A Multi-center Evaluation of Aldafermin in a Randomized, Double-blind, Placebo-controlled Study in Subjects With Primary Sclerosing Cholangitis.
Official title: A Phase 2b/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of Aldafermin in Subjects With Primary Sclerosing Cholangitis (ALPINE-PSC).
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Primary Sclerosing Cholangitis
Keywords: PSC
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2024-10-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with Primary Sclerosing Cholangitis.

Detailed description: Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects with Primary Sclerosing Cholangitis (ALPINE-PSC)

Eligibility criteria: Inclusion Criteria:

1. Able and willing to give informed consent
2. Confirmed diagnosis of PSC based on either:

   1. Abnormal cholangiography consistent with PSC as measured by MRCP with contrast
   2. Liver biopsy consistent with PSC
3. LSM by VCTE, indicative of at least F2 liver fibrosis stage
4. Laboratory parameters:

   1. TBL ≤2.5 mg/dL unless known for Gilbert's Syndrome
   2. ALT and ALT \<5x ULN
   3. MELD score ≤12

Exclusion Criteria:

1. Clinically significant acute or chronic liver disease of an etiology other than PSC
2. Alternate causes of sclerosing cholangitis including IgG4 related sclerosing cholangitis
3. Subjects with moderate to severe hepatic impairment
4. Subjects with moderate to severe renal impairment
5. Placement of bile duct stent or percutaneous bile duct drain within 12 weeks of Screening

Primary outcomes:
measure: Change From Baseline in Enhanced Liver Fibrosis Score at Week 96
timeFrame: 96 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04022226: EEG Characteristics in ECT
Official title: A Randomized Pilot Study Examining DCEEG Characteristics in Ketamine Versus Methohexital Induction in Depressed Patients Receiving Electroconvulsive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Electroconvulsive Therapy
Direct Current Electroencephalogram
Ketamine
Spreadind Depression
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators will be examining slow-wave characteristics in depressed patients receiving electroconvulsive therapy (ECT) using direct current electroencephalogram (dcEEG) by anesthesia induction agent.

Detailed description: This is a pilot project using dcEEG to look at infra-slow waves in depressed patients receiving ECT randomized to ketamine or methohexital where ketamine suppresses infra-slow waves. The rationale for this project is to identify biomarkers of treatment adequacy in ECT, which could lead to decreased morbidity and mortality with the procedure and lessen the burden of depression in our patient population.

Eligibility criteria: Inclusion Criteria:

* Structured Clinical Interview for DSM-5 will confirm diagnosis of MDD or BPD-depressed (with or without psychotic features
* The clinical indications for ECT including treatment resistance or a need for a rapid and definitive response;
* Hamilton Depression Rating Scale 24-item (HDRS-24) \> 21; and
* Age range between 18 and 65 years of age.

Exclusion Criteria:

* Defined neurological or neurodegenerative disorder (e.g., history of head injury with loss of consciousness \> 5 minutes, epilepsy, Alzheimer's disease);
* Other psychiatric conditions (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)
* Current drug or alcohol use disorder, except for nicotine and marijuana
* Adults unable to consent, pregnant women, prisoner
* Non-English speakers
* Patients that cannot tolerate Methohexital and Ketamine.

Primary outcomes:
measure: Number of Participants Assessed for Clinical Efficacy of ECT
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Mental Health Center
state: New Mexico
Study officials:
References:
Clinical trial NCT06958926: A Translational Study for Locoregional Recurrence of T4 Colon Cancer
Official title: A Translational Study for Locoregional Recurrence of T4 Colon Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: T4 Colorectal Cancer
Colorectal Cancer Stage III
Colorectal Cancer Stage II
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 60
Sex: ALL
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: Patients with suspected cT4 or pT4 colorectal cancer

Brief summary: The outcome of T4 locally advanced colon cancer is poor when locoregional recurrence occurred. Previous studies had showed that the aggravation of T4 colon cancer is higher than N-positive colon cancer, contributing to staging paradox that outcomes of stage IIB/C are poorer than stage IIIA colon cancer and higher locoregional recurrence of stage IIB/C colon cancer. The phenomenon cannot be explained by radicality, lymph node harvested and adjuvant chemotherapy administration. To elucidate the cancerous aggravation of T4 colon cancer, the investigators should dive into the clinicopathology, metastatic mechanism and cancer biology.

The investigators hypothesize that peritoneal spreading can be one of the metastatic routes of T4 colon cancer; however, few studies have addressed the finding and deserved investigation. Previous research have found that serum epigenetic alterations and cell-free DNA can serve as a prognostic marker for stage II/III colon cancer.

Therefore, the aim of this study is (1) to explore the role of ascites cfDNA as a potential biomolecular marker for locoregional recurrence; (2) to identify the risk factors of locoregional recurrence for T4 colon cancer by correlating biomolecular markers between clinicopathology, epigenomic alterations in blood and ascites.


Eligibility criteria: * Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Diagnosed as colorectal cancer
  3. Undergo radical colectomy or palliative colectomy, not limited to minimally invasive surgery or open surgery
* Exclusion Criteria:

  1. Age\<18 years old
  2. Pregnancy
  3. Patients with peritoneal dialysis
  4. Patients who are unwilling to undergo colorectal surgery

Primary outcomes:
measure: The correlation the cell-free DNA level and sequencing between ascites and serum
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu branch
Study officials:
affiliation: National Taiwan University Hospital Hsin-Chu Branch
name: Yu-Tso Liao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital Hsin-Chu Branch
name: Yu-Tso Liao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04843826: Modified Pedicle Subepithelial Connective Tissue Graft for Interdental Papillary Reconstruction Around Delayed Implants in the Esthetic Zone: A Case Series Trail
Official title: تعديل النسيج الضام عنيق تحت الظهارة من أجل إعادة بناء حليمي بين الأسنان حول الزراعه المتأخره في المنطقة الجمالية
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Papilla Reconstruction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case Series trial
Primary purpose: TREATMENT

Brief summary: This case series trial aims to evaluate the effect of a modified pedicle subepithelial connective tissue graft in creating anatomical papilla around one-stage delayed implant in the esthetic zone to establish better esthetics.

Detailed description: * Preparation of the implant site will be prepared by a crestal incision on the ridge bisecting the existing keratinized mucosa and vertical releasing incisions extending to the vestibule. The papillae of the adjacent teeth are not included in the flap design.
* A full thickness flap will be raised buccally exposing the underlined ridge of the implant site. A surgical drill guide will be used for the precise placement of the pilot drill. After pilot drill application, the osteotomy will be prepared with the corresponding size of parallel drill.
* The implant will be placed in the recipient site by means of an insertion device. The implant neck will be positioned flushing with the crestal bone level.
* The healing abutment extension of the implant will be placed in such a way that the head of the implant protruded about 2 to 3 mm from the bone crest.
* Reassessment of the case to assure absence of any signs of inflammation and presence of normal tissues before the surgical procedure

Eligibility criteria: Exclusion Criteria:

1. Pregnant females.
2. Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, et al., 2009)
3. Handicapped and mentally retarded patients.
4. Patients undergoing radiotherapy.
5. Presence of systemic disease that would affect wound healing

Primary outcomes:
measure: papilla height
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Faculty of Dentistry
state: Manial
Study officials:
References:
Clinical trial NCT01000766: Identifying Changes in Blood (Potential Biomarkers) in Individuals With Drug-Induced Liver Injury
Official title: Identification of New Biomarkers of Drug Induced Liver Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Induced Liver Injury
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2009-10-23
Enrollment: 25
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 will be identified in emergency rooms or inpatients at the University of North Carolina Memorial Hospital.

Brief summary: The purpose of this study is to try to develop new blood tests that may help doctors identify if a drug is hurting a person's liver.

Detailed description: Our hypothesis is that there are liver-specific particles, called mRNA, that are identifiable in a person's blood sample during liver injury caused by some drugs. The purpose of this study is to try to develop new blood tests that may help doctors identify if a drug is hurting a person's liver, perhaps early in the process before significant injury or illness have occurred.

Eligibility criteria: Inclusion Criteria:

* ALT \> 200 IU/L at presentation to UNC Hospitals
* Drug induced liver injury considered likely by admitting medical staff

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Paul B Watkins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05507866: Evaluation of a Comprehensive School Nutrition Enrichment Intervention (CSNEI) in Rural School Districts
Official title: Evaluation of a Comprehensive School Nutrition Enrichment Intervention (CSNEI) in Rural School Districts
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Nutrition, Healthy
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 11536
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Matched-pairs cluster-randomized trial
Primary purpose: PREVENTION

Brief summary: Obesity is a significant cause of cancer and cardiovascular disease incidence and mortality, and diabetes incidence among rural communities. Arkansas has the sixth-highest proportion of rural population (\~41%),and has the third-highest obesity prevalence (37.4%) in the nation. Arkansas has the third-highest prevalence of obesity for high school students (22.1%) and the fifth-highest prevalence for children ages 10-17 (20.2%). In Arkansas, children in rural areas have very high rates of both food insecurity (26%) and free and reduced lunch eligibility (72.9%). In the study's 6 participating school districts, free and reduced lunch eligibility ranges from 51.4% to 79.3%. School meals are an important opportunity to influence students' nutritional intake and long-term food preferences, which can reduce obesity. A multidisciplinary team has partnered with 6 rural Arkansas school districts which have agreed to participate in a study to evaluate the effects of an evidence-based population-level policy intervention designed to improve the nutritional quality of food served in schools.

The study team will conduct a matched-pairs cluster-randomized trial with pre-test and repeated post-tests in 6 rural Arkansas school districts, 3 implementing CSNEI, and 3 matched comparison school districts following their existing nutritional practices. Baseline data collection will take place prior to implementation (Year 1), and follow-up data will be collected annually thereafter (Years 2-5). The study will compare individual-level change in relative body mass index (adjusted for age and sex) and district-level changes in the nutritional quality of food served, amount of food consumed per diner, and fruit and vegetable intake in school districts implementing the intervention compared to matched comparison districts.


Eligibility criteria: Inclusion Criteria:

- Student currently enrolled at one of the 6 rural public school districts

Exclusion Criteria:

- N/A

Primary outcomes:
measure: Change in student body mass index (BMI) z-score
timeFrame: Baseline; 3 years post-intervention; 5 years post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Springdale
country: United States
facility: University of Arkansas for Medical Sciences Northwest
state: Arkansas
Study officials:
affiliation: UAMS
name: Christopher R Long, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05224466: Characteristics and Clinical Outcomes of Peritoneal Dialysis Patients
Official title: Characteristics and Clinical Outcomes of Peritoneal Dialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peritoneal Dialysis Complication
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ESRD patients who start the PD at the first time

Brief summary: Peritoneal dialysis patients worldwide account for about 11% of the global dialysis population. The global annual growth rate of peritoneal dialysis is estimated to be 8%, which is listed as the preferred method of renal replacement therapy in most countries. Although peritoneal dialysis has been widely used, due to complications such as peritoneal dialysis related infection, peritoneal ultrafiltration failure and EPS, the failure rate of peritoneal dialysis technology is high, and the 3-year technical survival rate is only 64%. Therefore, this study intends to explore clinical strategies for maintaining the long-term peritoneal dialysis by analyzing the clinical characteristics of patients , as well as the differences of risk factors affecting the survival rate of peritoneal dialysis technology at different time stages of peritoneal dialysis treatment.


Eligibility criteria: Inclusion Criteria:

* ESRD patients
* The first time of peritoneal dialysis

Exclusion Criteria:

* Age \<18 years at start of PD
* Transfer or follow-up loss
* Previous transplantation or HD history
* Incomplete clinical data

Primary outcomes:
measure: baseline clinical characteristics before PD
timeFrame: within one month before the start of PD
Secondary outcomes:
measure: the factors that may lead to the termination of PD
timeFrame: up to 20 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Wei Fang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06354166: Study Human Digital Support Transitional Care
Official title: Contribution of a Digital Tool Combined With Supportive Human Coordination for Transitional Care of Patients in Unscheduled Hospitalisation in Geriatric Short-stay Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aging
Lead sponsor: Divoluci
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 150
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional, randomised (1:1 ratio), single-centre study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to compare the effectiveness of Divomed in organising complex hospital discharges with a conventional organisation. Effectiveness will be assessed by reducing the length of stay of patients in geriatric short-stay care.

Detailed description: This is an interventional, randomised (ratio 1:1), single-centre, open-label study evaluating Divomed, a digital tool combined with human coordination, to speed up the discharge of people aged over 75 from unscheduled short-stay geriatric hospital admissions to their homes.

The study population will be patients aged 75 or over, admitted for short term unscheduled geriatric hospitalisation and eligible for discharge home.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 75 years ;
* Unplanned hospitalisation from emergency, transfers from other inpatient departments or outpatient medicine;
* Patient eligible for short-stay geriatric hospitalisation estimated to last at least 10 days;
* Patient eligible for a return home;
* Patients who have been informed and have signed an informed consent form. If necessary (for cognitive or other reasons), the information must be given to a third party, i.e. the patient's legal representative or trusted person (independent of the investigator and the sponsor), who may be asked to sign or co-sign the informed consent form (depending on the patient's vulnerability).

Exclusion Criteria:

* Patients scheduled for transfusion, iron infusion or colonoscopy;
* Patients in palliative care;
* Geographical area other than department 37;
* Planned discharge from hospital to a residential establishment for dependent elderly people or to follow-up and rehabilitation care or long-term care units;
* Patient or deprived of liberty by judicial or administrative decision ;
* Patient participating in or being excluded from another clinical trial;
* Patients not covered by a social security scheme.

Primary outcomes:
measure: length of stay
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: CHRU de Tours - Hôpital Bretonneau
Study officials:
References: