louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02494804: Effect of Cytokine-induced Killer Cells for Stage I-II Malignant Gliomas
Official title: A Study of CIK in Combination With Temozolomide With and Without Radiation in Adults With Stage I-II Malignant Gliomas
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cytokine-Induced Killer Cells
Milignant Gliomas
Keywords: Cytokine-Induced Killer Cells
Milignant Gliomas
Temozolomide
Lead sponsor: The First People's Hospital of Changzhou
Sponsor class: OTHER
First posted: 2015-07-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether combining of Temozolomide and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of Malignant Glioma is also evaluated.


Eligibility criteria: Inclusion Criteria:

Histologically confirmed intracranial Grade 1 or 2 anaplastic glioma or glioblastoma (astrocytic tumor, anaplastic oligodendroglioma, or oligoastrocytoma).

Received prior standard radiation for a Grade 3 or 4 astrocytic tumor with a minimum cumulative dose of 40 Gy administered.

Completed at least one full cycle of temozolomide of 200 mg/m2/day administered on Days 1-5 of a 28-day cycle, without unacceptable toxicity or progression.

Karnofsky performance status of 60 or more. Adequate organ and bone marrow function as defined by hematological and serum chemistry limits.

At least 18 years old. Both men and women must practice adequate contraception. Informed consent.

Exclusion Criteria:

Progressed while on temozolomide. Evidence of acute intracranial or intratumoral hemorrhage \> Grade 1. Not recovered from the toxic effects of prior therapy. Pregnant or breast feeding. History of diabetes mellitus. Uncontrolled intercurrent illness. Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.

HIV positive. Diagnosis of another malignancy may exclude subject from study.

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03975504: China Lung Cancer Screening (CLUS) Study Version 2.0
Official title: Community-based Lung Cancer Screening With Low-dose CT in China (CLUS Study) Version 2.0
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Neoplasms
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 6000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Our previous study, china lung cancer screening study version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). The present one arm study is performed to evaluate the efficacy of new techniques in improving the implementation of lung cancer screening and validate our previous findings. 6000 high-risk subjects (age 45-75) were recruited to take LDCT screening. (Baseline + 2 biennial repeated LDCT screening). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.


Eligibility criteria: Inclusion Criteria:

* Eligible participants were those aged 45-75 years, and with either of the following risk factors:

  1. history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;
  2. malignant tumors history in immediate family members;
  3. personal cancer history;
  4. professional exposure to carcinogens;
  5. long term exposure to second-hand smoke;
  6. long term exposure to cooking oil fumes.

Exclusion Criteria:

1. Had a CT scan of chest within last 12 months
2. History of any cancer within 5 years

Primary outcomes:
measure: The mortality rate of lung cancer
timeFrame: 5 years
measure: The attendance rate of high-risk individuals
timeFrame: 5 year
measure: Diagnostic accuracy rate of lung cancer
timeFrame: 5 year
Secondary outcomes:
measure: The mortality of all-cause
timeFrame: 5 years
measure: The detection rate of lung nodules
timeFrame: 5 year
measure: The incidence rate lung cancer
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT04313504: Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC
Official title: An Open-label, Phase II Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2020-03-18
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the best overall response of the combination of dostarlimab and niraparib in patients with recurrent and/or metastatic HNSCC patients.

Detailed description: Recurrent and/or metastatic HNSCC patients will be treated with combination of the PD-1 inhibitor (dostarlimab) and PARPi (niraparib) concurrently and ORR, PFS and OS will be determined.

Eligibility criteria: Inclusion Criteria:

* Histologically, cytologically, or radiographically confirmed recurrent or metastatic non cutaneous HNSCC for which there are no surgical or radiation curative options.
* ECOG performance status ≤2
* Patients must be able to swallow pills

Exclusion Criteria:

* Nasopharyngeal and salivary gland tumors
* Patients who have not recovered from adverse events due to prior anti-cancer therapy with the exception of alopecia
* Prior exposure to both immunotherapy drugs (PD-1, PDL-1, CTLA-4 inhibitors) and PARP inhibitors. Single exposure to either immunotherapy or PARP inhibitors is allowable.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to niraparib or dostarlimab.
* Patients with uncontrolled intercurrent illness.
* Requirement of any use of steroids greater than the equivalent of 10mg prednisone daily is not allowed.

Primary outcomes:
measure: Overall Response
timeFrame: 8 weeks
Secondary outcomes:
measure: Rate of all Adverse Events
timeFrame: 30 days after completion of treatment
measure: Progression Free Survival
timeFrame: 1 and 3 years
measure: Overall Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Trisha Wise-Draper, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02695004: Safety, Tolerability and Pharmacokinetics of DKF-310 ( (Donepezil).
Official title: Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of DKF-310 Intramuscular Injection in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Dongkook Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-03-01
Enrollment: 44
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a study to evaluate safety, tolerability and PK of DKF-310 IM injection in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Men aged 19 to 50 years
* Body weight 55 to 90 kg and BMI 18.0 to 27.0
* Voluntarily signed the informed consent form
* Eligible according to the screening test results
* Available to follow up after drop-out

Exclusion Criteria:

* Clinically significant disorders or a medical history of hepatic, renal, neurological, respiratory, endocrine, hemato-oncologic, cardiovascular, urological and psychiatric diseases
* Hypersensitivity to donepezil, piperidine derivatives and other drugs
* SBP \<100 mmHg or \>150 mmHg, or DBP \<60 mmHg or \>100 mmHg
* Skin and muscle disorders or history of surgery at the injection site
* AST or ALT \>1.5xULN; QT/QTcB interval \>450 ms
* History or positive result of drug abuse
* Prescribed drugs or herbal medicines within 2 weeks, over-the-counter drugs or vitamins within 1 week
* Participated in other clinical trials within 3 months
* Donated whole blood within 2 months or apheresis within 1 month, or transfusion within 1 month
* Alcohol consumption \>21 units/week
* Smoked \>10 cigarettes/day within 3 months
* Caffeine-containing foods
* Not eligible due to other reasons at the investigator's discretion

Primary outcomes:
measure: AUC
timeFrame: 1056h
measure: Cmax
timeFrame: 1056h
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hospital
Study officials:
References:
Clinical trial NCT06449404: 7.0T Magnetic Resonance Imaging Study of Parkinson's Disease
Official title: 7.0T Magnetic Resonance Imaging Study of Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson's Diseases
MRI
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease

Brief summary: This clinical trial study is conducted to detect the imaging characteristics of the patients with Parkinson's diseases (PD) by 7-Tesla (7T) magnetic resonance imaging (MRI).

Detailed description: In this study,we explored the imaging characteristics of PD. First, with the advantage of 7T, we detect the slight changes of PD with short diseases history compared with the healthy. Second, we investigate the different imaging characteristics in subtypes of PD, finding the effective neuroimaging biomarkers to distinguish different subtypes of PD. Finally, we take long time follow-up to evaluate the correlation between the imaging changes and clinical score alteration in PD.

Eligibility criteria: Inclusion Criteria:

* the patients with PD who was diagnosed by the experienced neurologist specializing in movement disorders

Exclusion Criteria:

* the patients with brain disorders such as cerebrovascular disease, brain tumors, epilepsy, other neurodegenerative disease;
* psychiatric disorders with impaired cognitive function;
* contraindications to MRI.

Primary outcomes:
measure: The change in motor symptoms in PD patients.
timeFrame: 5 year after the conduction of clinical trial
Secondary outcomes:
measure: Functional connectivity alterations between individuals with different subtypes of PD and healthy subjects.
timeFrame: 5 year after the conduction of clinical trial
measure: Structural connectivity alterations between individuals with different subtypes of PD and healthy subjects.
timeFrame: 5 year after the conduction of clinical trial
measure: Clinical variables spectrum features linking to the motor symptoms and imaging spectrum features.
timeFrame: 5 year after the conduction of clinical trial
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing, China
Study officials:
References:
Clinical trial NCT05945004: ChatGPT v.s. Human in Writing a Preoperative Visit Sheet
Official title: Using Natural Language Processing Models for Writing Preoperative Visit Sheets: a Preliminary Study Comparing ChatGPT and Clinicians
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Preoperative Care
Lead sponsor: Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Tsinghua University
First posted: 2023-07-14
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: No restictions are applied to population.

Brief summary: The goal of this study is to evaluate the performance of large language models i.e. ChatGPT, in making preoperative visit sheets using clinical records. The main questions it aims to answer are:

* Can large language models read clinical records and make preoperative visit sheets same as physicians?
* Can physicians distinguish preoperative visit sheets made by physicians and models?

Participants' records will be generated using ChatGPT-4, and read by both ChatGPT-4 and physicians to make 2 separate preoperative visit sheets, and form 2 groups, GPT group and physician group respectively.

A group of professionals will compare result of above mentioned 2 groups to see if ChatGPT can afford to write preoperative visit sheets.


Eligibility criteria: Inclusion Criteria:

* Any as records are generated using ChatGPT-4.

Exclusion Criteria:

* Any as records are generated using ChatGPT-4.

Primary outcomes:
measure: Familiarity to human writing
timeFrame: Each record will be screened for 6 minutes at most and results will be given in 8 minutes after receiving a record.
measure: Satisfaction for clinical use
timeFrame: Each record will be screened for 6 minutes at most and results will be given in 8 minutes after receiving a record.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04104204: The Efficacy of Pain Control After Total Hip Replacement Between Ultrasound Guided Supra-inguinal Fascia Iliaca Block and Intrathecal Morphine
Official title: The Efficacy of Pain Control After Total Hip Replacement Between Ultrasound Guide Supra-inguinal Fascia Iliaca Block and Intrathecal Morphine: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Hip Replacement
Ultrasound Guided Supra-inguinal Fascia Iliaca Block
Intrathecal Morphine
Postoperative Pain
Keywords: Total hip replacement
Ultrasound guided supra-inguinal fascia iliaca block
Intrathecal morphine
postoperative pain
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Total hip replacement is one of major orthopedic surgery which result in severe postoperative pain especially at first 24 hours. Ultrasound guided regional anesthesia has become a part of multimodal analgesia.Ultrasound guided supra-inguinal fascia iliaca block is a new technique which can consistently cover femoral and lateral femoral cutaneous nerve. And with large volume (40ml), it may cover obturator nerve. This technique already proved to be useful for acute pain control in hip fracture or postoperative control in dynamic hip screw or nail insertion operation. However, it has not been compared with intrathecal morphine for total hip replacement yet.

Detailed description: By using combine ultrasound guided supra-inguinal fascia iliaca block with periarticular infiltration with mutimodal analgesic drugs will have longer duration time to first rescue analgesic drug compared with combine intrathecal morphine with periarticular infiltration with multimodal analgesic drugs.

Eligibility criteria: Inclusion Criteria:

* elective surgery of primary total hip replacement, body weight ≥40kg and BMI ≤35 kg/m2, competence to consent

Exclusion Criteria:

* contraindication to regional anesthesia, allergy to study drugs, skin infection at supra-inguinal fascia iliaca injection point, neurological deficit affecting the lower extremities, inability to use patient-controlled analgesia, GFR \<50 mL/min

Primary outcomes:
measure: Time to first analgesic request (PCA fentanyl)
timeFrame: 48 hours
Secondary outcomes:
measure: Pain score
timeFrame: 48 hours
measure: Amount of rescue analgesic drugs
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj hospital
Study officials:
affiliation: Siriraj Hospital
name: Pawinee Pangthipampai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01027104: Evaluation of a Resident Curriculum in Firearm Injury Prevention
Official title: Evaluation of a Firearm Injury Prevention Web-based Curriculum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury
Training
Keywords: injury prevention
firearms
training
counseling
medical education
safety
anticipatory guidance
Firearm injury prevention anticipatory guidance
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: Children's Mercy Hospital Kansas City
First posted: 2009-12-07
Enrollment: 92
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL

Brief summary: The purpose of this project is to evaluate the efficacy of a web-based curriculum designed to teach pediatric practitioners how to provide injury prevention anticipatory guidance, emphasizing firearm injury prevention in a clinic setting. Data will be collected regarding the curriculum's effectiveness using a web-based questionnaire which will be administered to pediatric residents prior to, immediately post, and six months following completion of the curriculum. Pre- and post-test questionnaires will be compared. Residents will also be asked to evaluate the curriculum by completing a survey. We hypothesize that the curriculum will improve residents' knowledge, attitudes and beliefs, and self-efficacy regarding firearm injury prevention anticipatory guidance.


Eligibility criteria: Inclusion Criteria:

* Pediatric resident at Children's Memorial Hospital

Exclusion Criteria:

* None

Primary outcomes:
measure: Likert-scale based testing
timeFrame: pre-test, post-test, and 6-months post-test
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Leslie M Dingeldein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Karen Sheehan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02929004: Chronic Effects of Local Vibration on Neuromuscular Reconditioning After Anterior Cruciate Ligament Reconstruction
Official title: Chronic Effects of Local Vibration on Neuromuscular Reconditioning After Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: Anterior Cruciate Ligament Reconstruction
Local vibration training
Ligamentoplasty
Anterior cruciate ligament
Corticospinal excitability
Elastography
Knee extensor muscles
Readaptation
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-10-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: These last years, it has been proven that the solicitation of a muscle using vibration may lead to positive effects on the neuromuscular function. Thus, the aim of the current study is to assess if the addition of local vibration training sessions on the quadriceps muscle to the classic readaptation program (i.e. physiotherapist sessions) may allow a better recuperation 2 months after the surgery and the reconstruction of the anterior cruciate ligament.

The aim of the vibration training proposed in the current study is to allow a better recuperation 2 months after the anterior cruciate ligament reconstruction when compared with conventional physiotherapy alone.


Eligibility criteria: Inclusion Criteria:

* Undergoing to surgery (i.e. ligamentoplasty) of the anterior cruciate ligament

Exclusion Criteria:

* Taking neuro-active substances which can lead to alteration of the corticospinal excitability
* Contra indications for using magnetic stimulation
* Participating in another study in the same time

Primary outcomes:
measure: Maximal voluntary force
timeFrame: 60 days
Secondary outcomes:
measure: 6 minutes walking test
timeFrame: 60 days
measure: Get up and Go test
timeFrame: 60 days
measure: The cortical level of activation (%)
timeFrame: 60 days
Other outcomes:
Locations:
city: Challes-les-Eaux
country: France
facility: CEPART
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Pascal EDOUARD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jean Monnet University
name: Thomas LAPOLE, PhD
role: STUDY_CHAIR
References:
citation: Coulondre C, Souron R, Rambaud A, Dalmais E, Espeit L, Neri T, Pinaroli A, Estour G, Millet GY, Rupp T, Feasson L, Edouard P, Lapole T. Local vibration training improves the recovery of quadriceps strength in early rehabilitation after anterior cruciate ligament reconstruction: A feasibility randomised controlled trial. Ann Phys Rehabil Med. 2022 Jun;65(4):101441. doi: 10.1016/j.rehab.2020.08.005. Epub 2021 Nov 13.