louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03380819: The VetSeq Study: a Pilot Study of Genome Sequencing in Veteran Care
Official title: Clinical Safety and Efficacy of Pharmacogenetics in Veteran Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rare Diseases
Genetic Disease
Lead sponsor: VA Boston Healthcare System
Sponsor class: FED
First posted: 2017-12-21
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The VetSeq Study is a pilot intervention study exploring the feasibility of integrating genome sequencing into clinical care at the VA Boston Healthcare System.

Detailed description: The VetSeq Study is a pilot intervention study exploring the feasibility of integrating genome sequencing into clinical care at the VA Boston Healthcare System. Healthcare providers may refer any patients who they think might benefit from diagnostic whole genome or exome sequencing. Providers will briefly discuss genome sequencing and the pilot study with potentially eligible patients. If a patient is interested, the provider will refer him/her to the study by contacting the study staff and providing the reason (clinical question) why the provider thinks genome sequencing might be beneficial for the patient. The study staff will meet with the patient to conduct a baseline interview and survey, obtain informed consent for sequencing, and obtain a blood specimen for sequencing. A clinical laboratory will perform exome or whole-genome sequencing and issue an interpreted genome report including any variant possibly explaining the patient's condition, in addition to secondary monogenic, carrier, and pharmacogenomic results. This report will be sent to the referring provider, who will document the results and associated decision-making in the medical record. Approximately 3 months later, study staff will conduct a follow-up interview and survey with the participating patient.

Eligibility criteria: Inclusion criteria:

* Patient referred by provider to study for genome sequencing
* Life expectancy of at least 12 months in the judgment of the referring provider

Exclusion criteria:

* Life expectancy of \<12 months
* Inability to give informed consent

Primary outcomes:
measure: Primary molecular diagnosis
timeFrame: Baseline
Secondary outcomes:
measure: Secondary genomic results
timeFrame: Baseline
Other outcomes:
measure: Change in clinical management
timeFrame: 3 months
measure: Self-reported health and quality of life
timeFrame: 3 months
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System
name: Jason L Vassy, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06990919: Evaluation of the Stress Levels of Children and Their Parents
Official title: Evaluation Of The Impact Of Dental Rehabilitation Under General Anesthesia On The Stress Levels Of Children And Their Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Biomarkers
Anxiety
Keywords: Alpha-amylase
Cortisol
Dental anxiety
general anesthesia
dental treatments
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 72
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The stress levels of the participating child and their parents were evaluated using saliva to measure the stress biomarkers.

Detailed description: All of the dental treatments of the enrolled children were performed under general anesthesia. The stress biomarkers, such as alpha-amylase and cortisol levels, were measured from the participating child's saliva samples at pre-operative and post-operative. Additionally, the stress levels of the mothers were evaluated by questionnaires at the beginning of the study.

Eligibility criteria: Inclusion Criteria: The children

* who did not allow their dental treatments to be completed using behavioral guidance techniques in the clinical environment.
* who had no physical or psychosocial diseases were recruited Exclusion Criteria: The children
* who were unable to give a saliva sample due to increased anxiety or inadequate saliva.

Primary outcomes:
measure: alpha-amylase
timeFrame: 1-month
measure: cortisol
timeFrame: 1-month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Başkent University
state: Cankaya
Study officials:
References:
Clinical trial NCT00500019: Uterine Flora During Elective and Urgent Cesarean Sections
Official title: Uterine Flora During Elective and Urgent Cesarean Sections and Its Relationship to Postpartum Complications.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometritis
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2007-07-12
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing cesarean sections in Western galilee Hospital

Brief summary: Hypothesis: The bacterial flora of the uterus during elective Cesarean sections differs from the uterine flora during non-elective Cesarean sections. We want to study whether the uterine flora can predict post-cesarean febrile morbidity and endometritis.

Detailed description: Objective: To evaluate the uterine flora at the time of elective and non-elective cesarean sections and to study the relationship to the development of postpartum fever and/or endometritis.

Methods: Eight-hundred women who will be delivered by cesarean section will be enrolled in this study. Cultures will be obtained during the surgery from the open uterine cavity after removal of the placenta. Data regarding postpartum morbidity would be collected.

Eligibility criteria: Inclusion Criteria:

* Cesarean delivery

Exclusion Criteria:

* Vaginal delivery

Primary outcomes:
measure: To compare bacteriological growth between elective and non-elective cesarean section
timeFrame: 5 years
Secondary outcomes:
measure: To study the various bacteria growth in the uteri, and to compare type of bacteria to post-op morbidity
timeFrame: 5 years
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Western Galilee Hospital
Study officials:
affiliation: Western Galilee Hospital
name: Ido Solt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05339919: Relationship Between Liver Cancer and Sarcopenia
Official title: The Effect of Sarcopenia on Hepatocellular Carcinoma After Hepatectomy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Liver Cancer
Sarcopenia
Keywords: Sarcopenia
Liver cancer
Hepatectomy
Short-term outcomes
Long-term outcomes
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: Qilu Hospital of Shandong University
name: The Second Hospital of Shandong University
First posted: 2022-04-21
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with preoperative clinical diagnosis of liver cancer admitted to the hepatobiliary surgery department and received standard tests and questionnaires.

Brief summary: By tracking the short-term and long-term results of patients after hepatectomy, the difference of short-term results between patients with sarcopenia and patients without sarcopenia was analyzed, and the correlation between sarcopenia and short-term and long-term results of patients after hepatectomy was explored, so as to improve people's awareness of sarcopenia and pay attention to its prevention and treatment.

Detailed description: All implementation details are based on the newest EWGSOP definition. The investigators consecutively admitted patients the questionnaire and evaluated the assessment of muscle strength (grip strength test and chair stand test), muscle quantity (L3 plane total skeletal muscle area) and physical performance (gait test) following the F-A-C-S approach, to confirm patients with sarcopenia accurately. And by tracking the short-term and long-term outcomes of patients after hepatectomy, the differences were analyzed and the relationship between sarcopenia and liver cancer was explored.

Eligibility criteria: Inclusion Criteria:

* Patients with preoperative clinical diagnosis of liver cancer
* No cancer other than liver cancer has been diagnosed
* Age ≥18 years

Exclusion Criteria:

* Patients who could not complete the standard tests and questionnaires
* Patients who did not accept liver resection after evaluation of treatment plan
* Patients who had other concomitant preoperative causes of muscle weakness (injury, fracture, stroke, etc.)
* Patients who missing CT data or CT scan did not reach the level of the third lumbar vertebra (L3)

Primary outcomes:
measure: Short-term postoperative results
timeFrame: 3 months
measure: Long-term results after operation
timeFrame: 10 years
Secondary outcomes:
measure: Postoperative hospitalization time
timeFrame: 2 months
measure: Hospitalization expenses
timeFrame: 2 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Gang Chen
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Wenzhou Medical University
name: Gang Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005619: Analysis of Blood and Bone Marrow to Detect Residual Disease in Patients With Previously Treated Hairy Cell Leukemia
Official title: Detection of Hairy Cell Leukemia Minimal Residual Disease: Detection by Flow Cytometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: progressive hairy cell leukemia, initial treatment
refractory hairy cell leukemia
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-07-19
Enrollment: 16
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 a documented diagnosis of hairy cell leukemia who are undergoing routine bone marrow boipsy/aspiration and peripheral blood collection.

Brief summary: RATIONALE: Diagnostic procedures that detect residual disease may predict disease relapse in patients who have hairy cell leukemia.

PURPOSE: Diagnostic trial to determine the effectiveness of analyzing blood and bone marrow to detect residual disease in patients who have previously treated hairy cell leukemia.

Detailed description: OBJECTIVES: I. Compare the sensitivity of flow cytometry, immunohistochemistry, and polymerase chain reaction in detecting minimal residual disease following therapy with cladribine in patients with hairy cell leukemia.

OUTLINE: Blood and bone marrow samples are obtained from patients at time of bone marrow biopsies to assess minimal residual disease using flow cytometry, immunohistochemistry, and polymerase chain reaction. Patients are followed for 2 years or until disease relapse.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study over 12-24 months.

Eligibility criteria: DISEASE CHARACTERISTICS: Clinically documented hairy cell leukemia Active or in remission Must have received prior cladribine and be undergoing bone marrow biopsies as follow up

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior chemotherapy following prior cladribine Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center, Northwestern University
state: Illinois
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Loann C. Peterson, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04895319: Adherence to Computer-assisted Maxillofacial Reconstructions
Official title: Adherence to Computer-assisted Surgical Planning in 136 Maxillofacial Reconstructions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maxillofacial Abnormalities
Computer-assisted Surgery
Virtual Surgical Planning
Keywords: Computer-Assisted Surgery
Treatment Adherence and Compliance
Patient-Specific Modelling
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 136 patients who undergone computer-assisted maxillofacial reconstructive surgeries that conducted from June 2014 to June 2020.

Brief summary: The study was approved by the Local Ethics Committee and was conducted in compliance with the World Medical Association Declaration of Helsinki on medical research. A total of 335 patients who underwent oral and maxillofacial reconstruction were recorded from Jan 2014 to Jun 2020. Reconstruction with computer-assisted surgery ( CAS), which included, virtual surgical planning, computer-aided design-computer-aided manufacturing (CAD-CAM) surgical guides/templates and pre-bent plates on 3D printed models. Reasons for tissue defect were oncologic, osteoradionecrosis, trauma and osteoporosis. Patients undergoing dental implant placement and orthognathic surgery were excluded. Finally, 136 patients were selected and the reasons for partial or abandon surgical plan performance were described and analyzed.

Detailed description: computer-aided design

Eligibility criteria: Inclusion Criteria:

1. Maxillofacial reconstruction with CAS, including virtual surgical planning, CAD-CAM surgical guides/templates and pre-bent plates on 3D printed models.
2. Reasons for reconstruction were oncologic, osteoradionecrosis, trauma and osteoporosis.

Exclusion Criteria:

1. Patients undergoing computer-assisted implant surgery were excluded.
2. Patients undergoing computer-assisted orthognathic surgery were excluded.

Primary outcomes:
measure: The adherence of computer-assisted surgery
timeFrame: The outcome were recorded preoperatively or intraoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00631319: A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic Osteoarthritis (OA) Pain
Official title: A Phase III, Flexible Dose Titration Followed by a Randomized Double-Blind Study of Controlled Release OROS Hydromorphone HCL Compared to Placebo in Patients With OA Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Pain
Keywords: OA
Chronic Pain
Osteoarthritis
OA Pain
Osteoarthritis Pain
Pain
Hip Pain
Knee Pain
Joint Pain
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 343
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) Pain


Eligibility criteria: Inclusion Criteria

* Primary clinic diagnosis of osteoarthritis pain of the hip or of the knee for at least 6 months
* Patients required daily opioid medication to treat their chronic osteoarthritis pain

Exclusion Criteria

* Joint replacement of the hip or of the knee that is the primary source of osteoarthritis Pain
* History drug or alcohol abuse
* Fibromyalgia
* Patients who have major depression or anxiety
* Women who are pregnant or breast feeding

Primary outcomes:
measure: Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase
timeFrame: Baseline, Week 12
Secondary outcomes:
Other outcomes:
measure: Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity and Change From Baseline by Visit in the Double-blind Phase
timeFrame: Baseline to Week 12
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score and Change From Baseline by Visit in the Double-blind Phase
timeFrame: Baseline to Week 12
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score and Change From Baseline by Visit in the Double-blind Phase
timeFrame: Baseline to Week 12
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score and Change From Baseline by Visit in the Double-blind Phase
timeFrame: Baseline to Week 12
measure: Patient Global Assessment and Change From Baseline by Visit in the Double-blind Phase
timeFrame: Baseline to Week 12
measure: Time to Treatment Failure From Baseline
timeFrame: within 12 weeks from Baseline
Locations:
Study officials:
References:
Clinical trial NCT01969019: A Prospective, Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy
Official title: A Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Graves' Ophthalmopathy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 70
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: TREATMENT

Brief summary: This study was designed to compare the efficacy and safety of 4.5g iv MP administered in 12 weeks and 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Patients should meet the criteria of either a or b and together with c, d and e to include into the study.

  a. Lid retraction with any one of the following: i) Thyroid dysfunction ii) Proptosis iii) Optic nerve involvement iv) Extraocular muscle involvement b. Thyroid dysfunction with any one of the following: i) Proptosis ii) Optic nerve involvement iii) Extraocular muscle involvement c. Exclude cases with such ophthalmological signs caused by other diseases. d. Moderate to severe patients defined by EUGOGO. e. Clinical activity score (CAS)≥3/7 f. Normal function of heart, liver and kidney.

Exclusion Criteria:

* Orbital decompression surgery needed immediately
* History of chronic recurrent or active infection
* History of peptic ulcer
* Patients with a history of chronic liver disease or liver disorders； ALT or AST above 2.5 times upper limit of normal
* History of HIV, hepatitis C or hepatitis B Positive
* Cardiovascular or cerebrovascular disease clinically significant
* Uncontrolled diabetes mellitus
* Use of corticosteroids during 12 weeks before to inclusion period
* Pregnant patient or patient who is planning to become pregnant during the study

Primary outcomes:
measure: response rate
timeFrame: 3 months
Secondary outcomes:
measure: change of CAS, adverse effects and retreat
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Institute of Endocrine and Metabolic Diseases Department of Endocrine and Metabolic Diseases, Ruijin Hospital
state: Shanghai
Study officials:
References:
citation: Zhu W, Ye L, Shen L, Jiao Q, Huang F, Han R, Zhang X, Wang S, Wang W, Ning G. A prospective, randomized trial of intravenous glucocorticoids therapy with different protocols for patients with graves' ophthalmopathy. J Clin Endocrinol Metab. 2014 Jun;99(6):1999-2007. doi: 10.1210/jc.2013-3919. Epub 2014 Feb 28.
Clinical trial NCT02754219: Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction
Official title: A Study to Evaluate Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction and Control Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Dysfunction
Keywords: Diabetes Mellitus, Type II
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-04-28
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to compare the pharmacokinetics profiles and safety of Evogliptin in patients wit hepatic dysfunction versus healthy volunteers after single oral dose of Evogliptin

Detailed description: When the future evogliptin be administered to liver dysfunction patients, to investgate whether dose adjustment is necessary.

Eligibility criteria: Inclusion Criteria:

\<Hepatic Dysfunction\>

* At least 6 months with chronic liver disease (Regardless of cause hepatic dysfunction)
* Child-Pugh A or B

\<Healthy Control\>

* Subject has the following conditions: age ± 5 years, BMI ± 20%, same sex of each matched hepatic dysfunction subject

Exclusion Criteria:

\<Hepatic Dysfunction\>

* Child-Pugh C
* History of Liver transplant

\<Healthy Control\>

* History of chronic liver disorders
* Pregnant or lactating women

Primary outcomes:
measure: Pharmacokinetic(Cmax of Evogliptin)
timeFrame: Day1, Day2, Day3, Day4, Day5, Day6
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Clinical Trial Center
Study officials:
References: