louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06320106: Assessment of Navigation Abilities in Children With Cerebral Palsy and Their Peers
Official title: Evaluation of Spatial Navigation Skills in Typically Developing Children and in Children With Cerebral Palsy Using a Head Mounted Display
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Healthy Volunteers
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 26
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Spatial navigation skills are very important in everyday activities and quality of life but spatial navigation abilities are not part of the standard process of assessment and rehabilitation of patients. Furthermore, it is known that children with cerebral palsy have impaired visuo-spatial competences. The main objective of this study is to evaluate and compare the spatial navigation abilities of typically developing children and of children with cerebral palsy using the "StarMaze" application delivered by means of a Head Mounted Display (HMD). The second aim is to investigate the user experience during the session. A similar application was already developed and tested in a virtual reality large scale platform whose size and cost limit the accessibility. Therefore, the assessment (and future training) of navigation abilities with affordable and easy-to-use technology such as HMD open new perspectives.


Eligibility criteria: Inclusion Criteria:

* IQ higher than 70

Exclusion Criteria:

* Subjects with epileptic issues
* Subjects with poor head control
* Visual acuity not correctable with eyeglasses

Primary outcomes:
measure: Navigation strategy
timeFrame: One day
Secondary outcomes:
measure: Learning rate
timeFrame: One day
measure: Simulator Sickness Questionnaire
timeFrame: One day
measure: System Usability Scale
timeFrame: One day
measure: Independent Television Commission-Sense of Presence Inventory
timeFrame: One day
measure: Suitability Evaluation Questionnaire - simplified version
timeFrame: One day
measure: Short-form of PANAS-Positive Affect and Negative Affect Scales
timeFrame: One day
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: Scientific Institute, IRCCS E. Medea
state: Lecco
Study officials:
References:
Clinical trial NCT01434706: Implementation of Nucleic Acid Amplification Testing Screening to Identify Acute and Early HIV Infection
Official title: NAT: The Early Test Program: Implementation of NAT Screening to Identify Acute and Early HIV Infection at San Diego Public HIV Counseling and Testing Sites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute HIV Infection
Keywords: HIV
acute infection
primary infection
seroconverters
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Centers for Disease Control and Prevention
First posted: 2011-09-15
Enrollment: 22607
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators propose to study the impact of nucleic acid amplification testing (NAT) screening for acute Human Immunodeficiency Virus (HIV) and Hepatitis C (HCV) infections and Less-Sensitive Enzyme linked Immunoassay (LS-EIA) or 'detuned' testing Vironostika, Trinity Biotech BED, or Ortho-Clinical Diagnostic Vistros ECi for early HIV infection in conjunction with routine rapid HIV testing at HIV counseling and testing sites and venues in the San Diego county. The overarching goal of this study is to develop and implement a system to identify, notify and engage into care those individuals with recent HIV infection in order to better define the HIV and Hepatitis C Virus (HCV) epidemics in the San Diego county and to evaluate and characterize HIV transmission dynamics within the San Diego population.


Eligibility criteria: Inclusion Criteria:

* Persons presenting for HIV testing to Public Health Department HIV testing site.
* Men and women \>13 years of age.
* Those who are 13 or older and younger than 18 should be an emancipated minor or have consent given by their legal representative.
* Participants 18 and over must be able to provide written consent.
* Participants should be available for follow up for a period of at least 2 weeks after enrollment

Exclusion Criteria:

* Refusal to participate.
* Unable to provide informed consent.

Primary outcomes:
measure: Nucleic Acid Amplification Testing
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Christie's Place
state: California
city: San Diego
country: United States
facility: San Diego LGBT Community Center
state: California
city: San Diego
country: United States
facility: UC San Diego Antiviral Research Center
state: California
city: San Diego
country: United States
facility: UCSD Lead the Way Storefront
state: California
city: San Diego
country: United States
facility: Family Health Centers of San Diego
state: California
Study officials:
References:
Clinical trial NCT06131606: Effect of Stress Ball in Angiography
Official title: Effect of Stress Ball in Angiography: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Keywords: Pain
Angiography
Anxiety
Nursing
Stress ball
Lead sponsor: Firat University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 120
Sex: ALL
Minimum age (years): 47
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This controlled randomized study
Primary purpose: PREVENTION

Brief summary: The target of this study was to determine the influence of stress ball application on pain and anxiety levels experienced by patients during angiography procedures.

Detailed description: The purpose of this research was to investigate the effect of stress ball application, which is a non-pharmacologic method, on the pain and anxiety levels of patients during the angiography procedure. The present randomized controlled trial was conducted on all adult patients undergoing angiography between January 2023 and June 2023 in the Cardiovascular Surgery Clinic of a state hospital in eastern Turkey. The sample population was composed of 120 randomized patients who underwent stress ball application and received routine care. Numerical Rating Scale (NRS), Patient Information Form, and State-Trait Anxiety Inventory (STAI) were employed for data collection. The mean NRS posttest score of the experimental group patients increased significantly less than the control group (p\<0.001), while the mean STAI posttest score decreased significantly (p= 0.019). A positive significant correlation was determined between the mean NRS and STAI post-test scores of the patients in the experimental group (p\<0.05). It was found that the level of state-trait anxiety decreased as the pain decreased. The stress ball applied during angiography decreased the anxiety and pain levels of the patients. Stress ball application may be recommended as a complementary method to support pharmacologic treatment.

Eligibility criteria: Inclusion Criteria:

* no communication problems,
* being older than 18 years of age,
* having good mental health,
* undergoing wrist angiography (Radial Angiography),
* being willing to take part in the study.

Exclusion Criteria:

* Any complication during angiography.

Primary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: two weeks
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: two weeks
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Firat Universty
Study officials:
References:
Clinical trial NCT02690506: The Effect of Pregabalin on the Spinal Anesthesia
Official title: The Effect of Pregabalin on the Spinal Anesthesia: Randomized Controlled Placebo Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Block
Keywords: pregabalin
spinal anesthesia
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Pregabalin, an anticonvulsant is widely used for treatment of neuropathic pain. Recently, it was reported that premedication of pregabalin before general anesthesia is effective to reduce postoperative pain. Up to date, there is no study about the effect of premedication of pregabalin on the spinal anesthesia. Therefore, in this study, investigators investigate the effect of premedication of pregabalin on the spinal anesthesia.

Detailed description: In this study, investigators investigate the effect of premedication of pregabaline 150 mg on the spinal anesthesia. Two hours before spinal anesthesia, placebo pill was administered to patients in the group C and pregabalin 150 mg was administered to patients in the group P, respectively. Time for the onset of blockade, cephalad level of analgesia and duration of analgesia were measured.

Eligibility criteria: Inclusion Criteria:

* Patients of American Society of Anaesthesiologists Grades I and II

Exclusion Criteria:

* Patients with infection at the puncture site, coagulopathy, having true hypersensitivity to drugs used, diabetes and hypertension, psychiatric and neurological diseases

Primary outcomes:
measure: Duration of spinal anesthesia
timeFrame: 24 hours after spinal anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Younghoon Jeon, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01501006: Social and Behavioral Influence (SBI)
Official title: Social and Behavioral Influences on Clinical Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Communication
Keywords: Physicians
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2011-12-29
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and Female physicians of all races and ethnicities

Brief summary: The purpose of the study is to improve patient-physician communication and clinical decisions in the context of serious illness that may affect important clinical outcomes. The investigators will examine how variations in communication patterns and clinical decisions are affected by patient demographics (e.g age, sex), patient interactional style (e.g. communication behaviors) and physician characteristics (e.g. attitudes, background, training).

Detailed description: This will be a randomized field experiment. Physicians will receive two unannounced covert standardized patient (SP) visits during the 12-24 months after enrollment. SPs are trained actors who will pose as patients to assess physician behavior and communication. Each SP will present just like a real patient, and will have a standardized fabricated scenario and identity. The SP visit will be unannounced; the physician will not be informed at the time of the visit that they are seeing an SP. The visits will be covertly audio-recorded. This is being conducted at 3 sites: University of Rochester, Rochester, NY; Purdue, IN; and University of Michigan.

Eligibility criteria: Inclusion Criteria:

* Currently in clinical practice
* Do not plan on moving during the next year

Exclusion Criteria:

* Non-physicians

Primary outcomes:
measure: Physicians Communication Style
timeFrame: 2 years
Secondary outcomes:
measure: Physician Communication Moderators (Sex,Class)
timeFrame: 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University Of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Ronald Epstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shields CG, Griggs JJ, Fiscella K, Elias CM, Christ SL, Colbert J, Henry SG, Hoh BG, Hunte HER, Marshall M, Mohile SG, Plumb S, Tejani MA, Venuti A, Epstein RM. The Influence of Patient Race and Activation on Pain Management in Advanced Lung Cancer: a Randomized Field Experiment. J Gen Intern Med. 2019 Mar;34(3):435-442. doi: 10.1007/s11606-018-4785-z. Epub 2019 Jan 10.
citation: Elias CM, Shields CG, Griggs JJ, Fiscella K, Christ SL, Colbert J, Henry SG, Hoh BG, Hunte HER, Marshall M, Mohile SG, Plumb S, Tejani MA, Venuti A, Epstein RM. The social and behavioral influences (SBI) study: study design and rationale for studying the effects of race and activation on cancer pain management. BMC Cancer. 2017 Aug 25;17(1):575. doi: 10.1186/s12885-017-3564-2.
Clinical trial NCT05814406: To Evaluate the Efficacy and Safety of JW0201 Added on in Patients With T2DM
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of JW0201 Added on in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With C2202 and C2204
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2023-04-14
Enrollment: 180
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized, double blind, placebo controlled, parallel, phase Ⅲ study to evaluate the efficacy and safety of JW0201 added on in patients with type 2 diabetes mellitus who have inadequate glycemic control with C2202 and C2204

Detailed description: A multicenter, randomized, double blind, placebo controlled, parallel, phase Ⅲ study

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* The subject not meet the specified HbA1c and FPG

Primary outcomes:
measure: HbA1C (24 Weeks) lowering effect
timeFrame: 24 Weeks
Secondary outcomes:
measure: HbA1c lowering effect
timeFrame: 6, 12, 18 Weeks
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
Study officials:
affiliation: Chosun University Hospital
name: Sangyong Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06000306: MRD Monitoring by Digital Droplet PCR in the Early Period After Allo-HSCT to Predict Patients at High Risk of Relapse
Official title: Measurable Residual Disease Monitoring by Digital Droplet PCR in the Early Period After Allogeneic Hematopoietic Stem Cell Transplantation to Predict Patients at High Risk of Relapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Measurable Residual Disease
Keywords: droplet digital PCR
allogeneic hematopoietic stem cell transplantation
relapse
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 192
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with hematological malignancies who underwent allo-HSCT were enrolled for MRD mornitoring in the early period of allo-HSCT

Brief summary: A study on the Effectiveness of digital droplet PCR in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse

Detailed description: This is a retrospective and multicenter clinical study.This study is indicated for patients with hematological malignancies who underwent allo-HSCT. It aims to evaluate the effectiveness of digital droplet PCR in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse. 192 patients will be enrolled. The clinical end points include cumulative incidence of relapse, relapse-free survival, non-relapse mortality, and overall survival.

Eligibility criteria: Inclusion Criteria:

1. The presence of at least one haematological tumour-associated mutation or fusion gene detected at diagnosis by NGS or real-time qPCR provided for posttransplant MRD monitoring;
2. Successful stem cell engraftment
3. Received at least one bone marrow MRD detection by ddPCR in +30 days to +120 days after HSCT;
4. Age 12-70

Exclusion Criteria:

1. Patients who relapsed or died before the first ddPCR monitoring;
2. Patients with only germline mutations.

Primary outcomes:
measure: Cumulative incidence of relapse (CIR)
timeFrame: At Year 2
Secondary outcomes:
measure: Relapse-free survival (RFS)
timeFrame: At Year 2
measure: Non-relapse mortality (NRM)
timeFrame: At Year 2
measure: Overall survival (OS)
timeFrame: At Year 2
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Hospital of Zhejiang Medical Colleage Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT02827006: CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects
Official title: CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects: A 2 Year Prospective Randomised Study on Distal Radius Osteotomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dorsal Malunion of the Distal Radius
Keywords: Bone graft
Calcium phosphate bone cement
RCT
Xray
CT
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the standard treatment is a corrective osteotomy with bone graft. The intervention in parallel group is a corrective osteotomy and use of CaP bone cement
Primary purpose: TREATMENT

Brief summary: CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects

Detailed description: Background: A bone graft from the iliac crest has long been the gold standard for filling voids in opening wedge osteotomies. CaP bone cement has been considered the possible alternative to bone graft.

Methods: 20 adult patients with distal radius malunions and dorsal deformities were randomised intra-operatively to bone graft (10) or CaP bone cement (10). Dorsal titanium locking plates were used and the wrist was stabilised in a cast for 8 weeks. Follow-ups for 24 months included VAS on wrist and iliac crest, grip strength, ROM bilaterally, Quick-DASH and Gartland \& Werley's functional scoring system. X-rays and CT scans were taken at 8 wks, 3-6-12-24 mths.

Eligibility criteria: Inclusion Criteria:

* distal radius malunion with dorsal deformity, disability and pain.

Exclusion Criteria:

* age under 18 years, bad health, inflammatory arthritis and radio-carpal osteoarthritis.

Primary outcomes:
measure: volar angulation distal radius, x-ray
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: OUS RH
name: Magne Røkkum, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05826106: The Benefits of R Anastomotic Technique for Billroth-Ⅱ Reconstruction With Braun Anastomosis After Totally Laparoscopic Distal Gastrectomy
Official title: R Anastomosis for B-Ⅱ-B Anastomosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Time for R Anastomosis; Complication Related to Anastomosis
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 85
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All cases were confirmed to have malignant tumors in the gastric antrum or body through endoscopic and pathological examinations, and multi-slice spiral CT scans revealed no distant metastasis.

Brief summary: This study proposes a novel, straightforward, and viable technique for performing posterior gastrojejunostomy anastomosis during totally laparoscopic Billroth-II reconstruction with Braun anastomosis (named R anastomosis). This study prospectively evaluated clinical and pathological data from patients who underwent totally laparoscopic distal gastrectomy with R anastomosis at Northern Jiangsu People's Hospital, China, in order to investigate the feasibility and functional outcomes of R anastomosis for B-II-B anastomosis.

Detailed description: Paients were recruited who were confirmed to have malignant tumors in the gastric antrum or body through endoscopic and pathological examinations, and multi-slice spiral CT scans revealed no distant metastasis. All case underwent totally laparoscopic distal gastrectomy with R anastomosis. Prospectively examined the intraoperative data, including operation time, time for R anastomosis, blood loss; Postoperative data including pathological data, duration of gastric tube placement, time to initiate liquid diet, the length of hospital stay; other functional outcomes and short-term postoperative complication data, graded according to the Clavien-Dindo complication classification system

Eligibility criteria: Inclusion Criteria:

(1) Elective surgery, indications for surgery: Cases diagnosed with malignant tumors of the gastric antrum or body by endoscopy and pathology, confirmed by multi-slice spiral CT to have no distant metastasis. (2) Patients who underwent laparoscopic distal gastrectomy with Billroth II + Braun anastomosis for gastric cancer, and can be followed up after surgery.

Exclusion Criteria:

(1) Patients who received neoadjuvant chemotherapy before surgery; (2) Emergency surgery patients; (3) Patients with concurrent malignant tumors; (4) Patients lost to follow-up due to non-tumor reasons after surgery.

Primary outcomes:
measure: Complication
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
Study officials:
References: