louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03320044: Early Diagnosis of Small Pulmonary Nodules by Multi-omics Sequencing
Official title: Genetic Variations,Immuno-sequencing and Circulating Tumor DNA(ctDNA) for Early Diagnosis of Small Pulmonary Nodules
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma
Non-small-cell Lung Cancer
Lung Neoplasm
Keywords: Circulating Tumor DNA
Lung cancer Surgery
early diagnosis
immuno-sequencing
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patient are found small nodules in pulmonary and prepare for surgery

Brief summary: Analyse immune repertoire and genetic mutations of benign and malignant pulmonary nodule，and evaluate peripheral blood detection for identifying nature of pulmonary nodule.

Detailed description: Early diagnosis of lung cancer is of vital importance in lung cancer treatment. This research will first analyse the features of immune repertoire and genetic mutations from tissue of benign and malignant pulmonary nodule，then explore the feasibility of detecting these features from peripheral blood sample, and finally evaluate peripheral blood detection of lung cancer related immune repertoire and genetic mutations for identifying nature of pulmonary nodule.

Eligibility criteria: Inclusion Criteria:

1. Sign informed consent and consent to participate in this study;
2. Found small nodules in pulmonary by CT and prepare for surgery;

Exclusion Criteria:

1. Malignant tumor history within the past 5 years;
2. Receiving chemotherapy, radiotherapy or targeted therapy before surgery;
3. Histology confirmed not non-small cell lung cancer
4. No matching tissue or blood samplesUnqualified blood samples

Primary outcomes:
measure: The sensitivity and specificity of combining peripheral plasma circulating tumor DNA and white cell immuno-sequencing in diagnosis of early stage non-small cell lung cancer
timeFrame: 6 months
Secondary outcomes:
measure: The sensitivity and specificity of tissue immune repertoire in diagnosis of early stage non-small cell lung cancer
timeFrame: 6 months
measure: The concordance of peripheral plasma circulating tumor DNA and tumor tissue DNA in diagnosis of early stage non-small cell lung cancer
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Jun Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen K, Bai J, Reuben A, Zhao H, Kang G, Zhang C, Qi Q, Xu Y, Hubert S, Chang L, Guan Y, Feng L, Zhang K, Zhang K, Yi X, Xia X, Cheng S, Yang F, Zhang J, Wang J. Multiomics Analysis Reveals Distinct Immunogenomic Features of Lung Cancer with Ground-Glass Opacity. Am J Respir Crit Care Med. 2021 Nov 15;204(10):1180-1192. doi: 10.1164/rccm.202101-0119OC.
Clinical trial NCT05138744: Behavioral Activation for Depression Through Virtual Reality
Official title: Behavioral Activation for Depression Through Virtual Reality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single case design (multiple baselines)
Primary purpose: TREATMENT

Brief summary: Evaluate the effectiveness of a brief, virtual reality intervention for depressed mood


Eligibility criteria: Inclusion Criteria:

* Patient Health Questionnaire - 9 (measure of depression) over 9
* Positive and Negative Affect Schedule (measure of positive and negative affect): positive affect score below 24
* Age over 18 years
* Signs informed consent

Exclusion Criteria:

* Completes more than 20% of evaluations retrospectively (not the day they are assigned)
* Has a severe mental health disorder as evaluated with the MINI International Neuropsychiatric Interview
* Does not sign the informed consent

Primary outcomes:
measure: Change in Behavioral activation
timeFrame: Change through study completion, an average of 31 days. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline vs posttreatment)
Secondary outcomes:
measure: Change in Mood
timeFrame: Change through study completion, an average of 31 days. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline to posttreatment)
measure: Change in Depression
timeFrame: Change through study completion, an average of 31 days.. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline to posttreatment)
measure: Change in Positive affect
timeFrame: Change through study completion, an average of 31 days.. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline to posttreatment)
measure: Change in Negative affect
timeFrame: Change through study completion, an average of 31 days.. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline to posttreatment)
measure: Change in Activity level
timeFrame: Change through study completion, an average of 31 days.. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline to posttreatment)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03509844: The Modum Bad Complex Posttraumatic Stress Disorder Study
Official title: Comparison of Treatments for Complex Posttraumatic Stress Disorder -a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Lead sponsor: Modum Bad
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 96
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 compares three established, manual based psychotherapies for Complex Post-traumatic Stress disorder (CPTSD) in patients with childhood trauma (e.g. sexual abuse, violence). The primary aim of the study is to compare phase-oriented treatment (Stabilization + Exposure) with two non-phased treatments, Exposure and Stabilization.

Detailed description: Available treatment procedures for PTSD are largely developed within the context of adult trauma (e.g. accidents, natural disasters, rape or combat). The need for additional treatment options targeting dysfunctional affect regulation and interpersonal problems in patients suffering after childhood trauma is debated in research and clinical settings.

96 patients will be recruited from referrals to an in-patient clinic in Norway called Modum Bad. After assessment, patients will be randomly assigned to one of three treatment arms. One-third will receive 10 weeks of Prolonged Exposure, one-third 10 weeks of Skills Training in Affect and Interpersonal Regulation (STAIR), and the last third a phase-based treatment lasting 16 weeks (STAIR + Narrative Therapy).

Eligibility criteria: Inclusion Criteria:

* childhood trauma (e.g. sexual abuse, violence prior to age 18),
* a diagnosis of Posttraumatic Stress Disorder PTSD according to DSM-5
* a diagnosis of Complex PTSD according to the suggested additional criteria for complex PTSD in International Classification of Diseases (ICD-11)

Exclusion Criteria:

* severe psychotic disorder
* dissociative identity disorder (DID)
* active phase substance dependence
* acute suicidality
* major current life crisis
* severely disturbed group functioning
* mental disability

Primary outcomes:
measure: Clinician-Administered PTSD Scale (CAPS-5) for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
timeFrame: approximately 15 months
Secondary outcomes:
measure: The PTSD Checklist for DSM-5 (PCL-5)
timeFrame: approximately 15 months
measure: Inventory of Interpersonal Problems (IIP-64)
timeFrame: approximately 15 months
measure: Beck Depression Inventory-Second Edition (BDI-II)
timeFrame: approximately 15 months
Other outcomes:
Locations:
city: Vikersund
country: Norway
facility: Modum Bad
state: Buskerud
Study officials:
References:
Clinical trial NCT04479644: Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-198
Official title: A Phase 1 Randomized, Single-blind, Placebo-controlled, Single Ascending Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Human Monoclonal Antibody, BRII-198 Administered Intravenously to Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Keywords: COVID-19 phase I
monoclonal antibody
Lead sponsor: Brii Biosciences Limited
Sponsor class: INDUSTRY
Collaborators: name: TSB Therapeutics (Beijing) CO.LTD
First posted: 2020-07-21
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 1 study in which healthy adult volunteers will receive BRII-198 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.


Eligibility criteria: Inclusion Criteria:

* Subject must be 18 to 49 years of age inclusive;
* Body weight ≤100 kg and body mass index (BMI) within the range of 19.0-24.0kg/m2 (inclusive);
* Male or female;

Exclusion Criteria:

* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
* A history of significant hypersensitivity, intolerance, or allergy to any drug compound;
* History of alcohol or other substance abuse;

Primary outcomes:
measure: Incidence of adverse events (AEs) by CTCAE v5.0
timeFrame: up to 24 weeks
measure: Proportion of subjects with SAEs
timeFrame: up to 24 weeks
measure: Proportion of subjects with infusion-related reactions
timeFrame: up to 24 weeks
measure: Proportion of subjects with hypersensitivity reactions
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Serum Concentration of BRII-198
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigative Site
state: Beijing
Study officials:
affiliation: TSB Therapeutics (Beijing) CO.LTD
name: Yao Zhang
role: STUDY_DIRECTOR
References:
citation: Hao X, Zhang Z, Ma J, Cheng L, Ji Y, Liu Y, Zhao D, Zhang W, Li C, Yan L, Margolis D, Zhu Q, Zhang Y, Zhang F. Randomized, placebo-controlled, single-blind phase 1 studies of the safety, tolerability, and pharmacokinetics of BRII-196 and BRII-198, SARS-CoV-2 spike-targeting monoclonal antibodies with an extended half-life in healthy adults. Front Pharmacol. 2022 Sep 6;13:983505. doi: 10.3389/fphar.2022.983505. eCollection 2022.
citation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Clinical trial NCT00579644: Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate Alone
Official title: Treatment of Early Rheumatoid Arthritis: Minocycline in Combination With Methotrexate Versus Methotrexate Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 91
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a combination of methotrexate and minocycline works better than methotrexate alone in early Rheumatoid Arthritis

Detailed description: The purpose of this study is to determine if a combination of methotrexate and minocycline works better than methotrexate alone in early Rheumatoid Arthritis (RA). Specific aims of this study are:

A. To demonstrate that the combination of minocycline and methotrexate is well tolerated when used in the first year of RA.

B. To compare the efficacy of the combination of minocycline and methotrexate with methotrexate and placebo therapy in early sero-positive RA patients.

Eligibility criteria: Inclusion Criteria:

* Age over or equal to 19 years old and less than or equal to 75 years old
* Diagnosis of RA as determined by fulfilling 4 of 7 ACR criteria
* Positive rheumatoid factor
* Duration of disease: greater than six weeks and less than one year

Exclusion Criteria:

* Allergy to tetracycline or methotrexate
* Previous DMARD treatment
* Doses of oral steroids greater than 7.5 mg/day
* Intra-articular injections within the last four weeks
* Significant liver or renal disease or active peptic ulcer disease
* Patients who are not willing to abstain from alcohol consumption
* Women of childbearing potential who are not practicing a successful method of contraception

Primary outcomes:
measure: Remission evaluated by American College of Rheumatology (ACR) outcome variables
timeFrame: 48 weeks
Secondary outcomes:
measure: Comparison of combination therapy versus methotrexate alone, Composite Index
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Unversity of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: James R O'Dell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03789344: Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated With PCI
Official title: Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated With PCI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Percutaneous Coronary Intervention
Keywords: acupuncture, PCI
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2018-12-28
Enrollment: 240
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: Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated with PCI


Eligibility criteria: Inclusion Criteria:

* The main inclusion criteria were patients who underwent coronary angiography. Patients suffer from Generalized anxiety disorder(GOD).

Exclusion Criteria:

* The exclusion criteria were as follows: patients with chronic renal failure, chronic liver disease, bone disorders, and/or thyroid disorders.

Primary outcomes:
measure: Change from Baseline Heart Rate Variability at 7 days
timeFrame: at 1day before and 7 days after percutaneous coronary intervention
Secondary outcomes:
measure: Scores of HAM-A
timeFrame: 1day before, 7，14 days after the intervene
measure: Scores of AIS
timeFrame: 1day before, 7，14 days after the intervene
measure: Scores of HRSD
timeFrame: 1day before, 7，14 days after the intervene
Other outcomes:
measure: inflammation mediators level in blood
timeFrame: 1day before, 7days after the intervene
Locations:
city: Beijing
country: China
facility: PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01628744: Autoantibodies Against Specific Cytokines in Adults With Severe Mycobacterial Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mycobacterium Infection
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pateitns with Mycobacterium, Particular to the non Tuberculosis mycobacterium infection, in Taiwan

Brief summary: In adult, the prevalence of mycobacterial infections is increased with age is largely unknown. IFN-gamma-IL-12/23 axis or NF-kappaB pathways might also plays crucial roles in adult against mycobacteria. Based on this hypothesis, the investigators had applied a functional assay to these pathways in patients with mycobacterial infection.


Eligibility criteria: Inclusion Criteria:

* Patients with mycobacterial infection

Exclusion Criteria:

* Malignancy
* Severe autoimmune
* HIV infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Graduate Institute of Clinical Medical Science, China Medical University
Study officials:
affiliation: Graduate Institute of clinical Medical Science, China Medical Univerity, Taiwan
name: Cheng-Lung KU, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00538044: Simvatstatin Used to Treat Pulmonary Hypertension
Official title: the Clinical Research Using Simvastatin as a Medication to Treat Advanced Secondary Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hypertension, Pulmonary
Keywords: pulmonary hypertension
simvastatin
advanced pulmonary hypertension secondary to congenital heart disease
advanced pulmonary hypertension secondary to chronic pulmonary embolism
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2007-10-02
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: we try to use simvastatin in the treatment of advanced pulmoary hypertension secondary to congenital heart disease or chronic pulmonary embolism before and after the operation.

Detailed description: advanced pulmonary hypertension is refractory to the medication in use nowaday, especially pulmonary hypertension secondary to congenital heart disease or chronic pulmonary embolism.It is revealed that statins may intefere the pathogenisis of the pulmonary hypertension in many key poing, such as improving apotosis or inhiting the proliferation of pulmonary vascular smooth muscle cell. so we try to use simvastatin in the treatment of advanced pulmoary hypertension secondary to congenital heart disease or chronic pulmonary embolism before and after the operation.

Eligibility criteria: Inclusion Criteria:

* pasp\>50mmHg

Exclusion Criteria:

* pasp\<50mmhg

Primary outcomes:
measure: the simvastatin can alleviate pulmonary hypertension
measure: pulmonary pressure
Secondary outcomes:
measure: simvastatin can highten the perioperative and long term survaval rate and the living quality
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
Study officials:
affiliation: Beijing Anzehn Hospital
name: Huili Gan, MD,Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00484744: Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement
Official title: Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Orthodontic Pain
Keywords: pain
orthodontic
acetaminophen
ibuprofen
separator
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
First posted: 2007-06-11
Enrollment: 35
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to compare pain control effectiveness of two medicines and a placebo (a dummy pill that does not contain any pain relieving medication) to see which one works better at preventing pain when taken both 1 hour before and 6 hours after orthodontic separators are placed. The research hypothesis is that there will be a significant difference in pain as measured by Visual Analogue Scales (VAS) over time and that this effect will differ for acetaminophen versus ibuprofen.


Eligibility criteria: Inclusion Criteria:

* Orthodontic treatment requires banding of posterior teeth
* Orthodontic treatment requires the placement of two or more separators
* Able to swallow analgesic pills
* English speaking
* Age 9-17
* Minimum weight requirement of 88 pounds

Exclusion Criteria:

* Orthodontic appliances are present in the mouth
* Use of acetaminophen or ibuprofen is contraindicated (allergy, GI problems)
* Antibiotics or analgesics are currently in use
* History of systemic disease exists (arthritis, diabetes, cystic fibrosis)
* Significant cognitive impairment

Primary outcomes:
measure: Pain/discomfort levels reported on Visual Analogue Scales
timeFrame: Assessments conducted at six intervals during a 24 hour period
Secondary outcomes:
Other outcomes:
Locations:
city: Lee's Summit
country: United States
facility: Orthodontic office of Drs. Dan Blackwell, Beth Blackwell-Nill, Scott Francois
state: Missouri
city: Lee's Summit
country: United States
facility: Orthodontic office of Dr. James Osborne
state: Missouri
Study officials:
affiliation: University of Missouri-Kansas City School of Dentistry Department of Orthodontics and Dentofacial Orthopedics
name: Shelliann A Kawamoto, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Missouri-Kansas City School of Dentistry
name: Karen Williams, RDH, MS, PhD
role: STUDY_CHAIR
References: