louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05764005: Optimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study
Official title: Optimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: low-risk
active surveillance
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-03-10
Enrollment: 40
Sex: MALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a pilot evaluation of a patient-centered intervention that enables providers to support men on active surveillance to maximize adherence. Conducted in urology practices, this pilot will measure key patient-reported, provider-reported, and implementation outcomes. Successful completion of this work will inform a subsequent multi-center effectiveness-implementation hybrid design trial and ultimately will improve low-risk cancer management by effectively engaging Primary Care Physicians (PCPs) in care delivery.


Eligibility criteria: Patient Inclusion Criteria:

* 55 years old or older
* Men diagnosed with low-risk prostate cancer currently on active surveillance
* Men who identify having a primary care provider
* Access and ability to use the Internet

Patient Exclusion Criteria:

* Men who are unable to read and/or speak English
* Men with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss)

PCP Inclusion Criteria:

* Identified by patient on baseline survey as their PCP

Urologist and Clinic Staff Inclusion Criteria:

* Clinicians or staff at a participating urology clinic, including but not limited to MDs, APPs, and nurses

Primary outcomes:
measure: Feasibility - recruitment
timeFrame: up to 9 months post last patient recruitment
measure: Feasibility - Uptake
timeFrame: up to 6 months post last patient recruitment
measure: Acceptability - Mean Satisfaction Scores
timeFrame: up to 4 months post last patient completing intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Archana Radhakrishnan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04144205: Effect of Arterial Oxygen Partial Pressure on Mixed Venous Oxygen Saturation
Official title: Effect of Arterial Oxygen Partial Pressure on Mixed Venous Oxygen Saturation and Regional Cerebral Oxygen Saturation During Cardiopulmonary Bypass in Patients Undergoing Cardiac Surgery: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Mixed venous oxygen saturation is known to reflect oxygen delivery and, thus, is frequently monitored in patients undergoing cardiac surgery. Factors that affect mixed venous oxygen saturation include hemoglobin level, arterial oxygen saturation and arterial oxygen partial pressure. Among them, arterial oxygen partial pressure is known to have minimal effect on oxygen delivery compared to hemoglobin and arterial oxygen saturation. However, some argues that in certain clinical setting, such as anemia which is very common in cardiac surgery patients, the contribution of plasma (arterial oxygen partial pressure in this case) to oxygen delivery becomes more significant. Therefore, we planned to perform a pilot clinical trial to observe the change of oxygen delivery, which would be reflected in mixed venous oxygen saturation and cerebral regional oxygen saturation, according to hemoglobin level.


Eligibility criteria: Inclusion Criteria:

* Patients that scheduled to undergo cardiac surgery using cardiopulmonary bypass.

Exclusion Criteria:

* Emergent surgery
* Symptomatic carotid artery stenosis or carotid artery stenosis of ≥50%
* Preoperative oxygen therapy that is equivalent to the inspired oxygen fraction of 0.5.

Primary outcomes:
measure: Mixed venous oxygen saturation
timeFrame: From the beginning and the stabilization of cardiopulmonary bypass to 15 minutes thereafter.
Secondary outcomes:
measure: Cerebral regional oxygen saturation
timeFrame: From the beginning and the stabilization of cardiopulmonary bypass to 15 minutes thereafter.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03374605: Modulating Context Generalization Through Transcranial Direct Current Stimulation
Official title: Modulating Context Generalization Through Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anxiety and Fear
Lead sponsor: Butler Hospital
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Behavioral adaptation is particularly relevant to anxiety and related disorders, where exposure-based therapies rely on such adaptation as part of behavior therapy.. However, while initial fear reactions generalize easily across contexts, subsequent adaption of behavior through learning is context-specific. The primary goal of this study is to investigate whether transcranial direct current stimulation (tDCS) can be used to acutely impact generalization of subsequent learning across contexts in an experimental paradigm. As part of this study, participants will complete a clinical interview and questionnaires, as well as a computer task asking them to make choices between stimuli on the screen and during which they may or may not receive tDCS.


Eligibility criteria: Inclusion Criteria:

1. Primary diagnosis of an anxiety or related disorder, (defined as panic disorder, social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, and/or post-traumatic stress disorder);
2. aged 18-55;
3. ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent;
4. Stable psychiatric medication use for at least 6 weeks.

Exclusion Criteria:

1. Lifetime history of psychotic symptoms or bipolar disorder,
2. Current substance use disorder;
3. Acute suicidality or homicidality,
4. Significant neurological disorder,
5. Any problems that would interfere with study participation, significant or unstable medical disorders and tDCS-related contraindications (e.g., implanted metallic substances, pregnancy, holes in the skull, skin abnormalities under stimulation sites).

Primary outcomes:
measure: Relative frequency of selection of task-specific stimuli
timeFrame: 1 hour (measurement occurs 1 time only)
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Sarah Garnaat, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06156605: Looking Beyond the Immediate Effects of Lumbar Spinal Manipulation Using Pain Pressure Threshold in Asymptomatic Individuals
Official title: Looking Beyond the Immediate Effects of Lumbar Spinal Manipulation Using Pain Pressure Threshold in Asymptomatic Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spine Injury
Pain
Lead sponsor: University of Mary
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test in the effects of pain pressure threshold (PPT) looking out to 30 minutes in the lumbar spine. The main question\[s\] it aims to answer are:

• Is there a difference between PPT from baseline, immediately after, or 30 minutes after compared to sham ultrasound control group? Participants will be exposed to sham ultrasound or sidelying lumbar manipulation with between groups and within group comparisons of PPT at the posterior superior iliac spine up to 30 minutes following the intervention.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic individuals between the ages of 18-50

Exclusion Criteria:

* Current low back pain (LBP)
* A history of low back pain LBP within the last three months
* Previous spinal surgery
* Rheumatological condition or neurological symptoms or conditions
* Recent ingestion of pain-relieving medications within the last 24 hours
* A lumbar manipulation within three days prior to the exam
* Exhibited any contraindications to manipulation
* Positive findings during screening precautions

Primary outcomes:
measure: Pain pressure threshold
timeFrame: Baseline, Immediately after, 30 minutes after
Secondary outcomes:
Other outcomes:
Locations:
city: Bismarck
country: United States
facility: University of Mary
state: North Dakota
Study officials:
References:
Clinical trial NCT02618005: Probiotics on Immune Function and Intestinal Microbiota in Astronauts Under Closed Microgravity Environment
Official title: Study for Evaluating the Impact of Continuous Consumption of Probiotics on Immune Function and Intestinal Microbiota in Astronauts Under Closed Microgravity Environment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Immune Function and Intestinal Microbiota
Keywords: Astronauts
Probiotics
Immune function
Intestinal microbiota
Lead sponsor: Yakult Honsha Co., LTD
Sponsor class: INDUSTRY
Collaborators: name: Japan Aerospace Exploration Agency
First posted: 2015-12-01
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Human immune function and intestinal microbiota are suggested to be altered within long-duration stay in space. Accumulated evidences on earth support that Lactobacillus casei strain Shirota (LcS) is a promising probiotic strain on improvement of immune function and intestinal microbiota. This study aims to investigate the impact of long-duration spaceflight as well as intake of LcS on the international space station (ISS), on immune system and intestinal microbiota in astronauts.


Eligibility criteria: Inclusion Criteria:

* Individuals who are scheduled to stay on the ISS for at least 3 months
* Individuals who fully understand the study protocol and provide written informed consent for the study participation

Exclusion Criteria:

* Individuals who routinely use antibiotic, laxative, and/or bowel regulating medicine
* Individuals who participate in other research that competes with this study in terms of the purpose and field, e.g., study with dietary management or intake of bifidobacteria/lactic acid bacteria, oligosaccharides, antibiotic, laxative, and/or bowel regulating medicine

Primary outcomes:
measure: Longitudinal changes in the number of LcS in feces
timeFrame: 9-18 months
measure: Longitudinal changes in the level of immune markers
timeFrame: 9-18 months
measure: Longitudinal changes in numbers and composition of intestinal microbiota
timeFrame: 9-18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ibaraki
country: Japan
facility: Japan Aerospace Exploration Agency
Study officials:
References:
Clinical trial NCT05070897: Health Literacy and Digital Health in Cancer Patients.
Official title: Health Literacy and Digital Health in Cancer Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Health literacy
Digital health
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2021-10-07
Enrollment: 1518
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients seen in an oncology, or oncogeriatric consultation or treated in an oncology or geriatric outpatient clinic (not including full hospitalisation lasting ≥ 24h).

Brief summary: This is a multicentric, prospective, observational, transversal study, aiming to evaluate the health literacy of cancer patients using the approved French version of the Functional, Communicative and Critical Health Literacy (FCCHL) scale in 2 populations:

* Population A: patients age 65 and over treated in an oncology or oncogeriatric outpatient clinic, or seen in an oncology or oncogeriatric consultation.
* Population B: young patients age 18 to 64 treated in an oncology or outpatient clinic, or seen in an oncology consultation.

The following questionnaires:

* Approved French version of the FCCHL scale
* Questionnaire on the use of digital tools adapted from the questionnaire on digital tools,

will be completed once only. It will be completed by the participant during the oncology or oncogeriatric consultation or outpatient clinic appointment, in self-questionnaire mode or face to face, assisted if necessary by a family member or member of the medical team.


Eligibility criteria: Inclusion Criteria:

1. Man or woman.
2. Age ≥ 18 years.
3. Patient treated for cancer.
4. Patient who can read and understand French.
5. Patient seen in an oncology or oncogeriatric consultation or treated in an outpatient clinic.
6. Patient in treatment or about to start treatment that has been offered to them, from the announcement consultation to 2 years after the start of treatment

Exclusion Criteria:

1. Patient hospitalised for longer than 24 hours.
2. Patient with know cognitive impairment preventing them from answering the questionnaire.

Primary outcomes:
measure: Percentage of Participants With an Overall Score of ≤ 4 on the FCCHL Scale.
timeFrame: 1 month
Secondary outcomes:
measure: Number et Percentage of Participants by Items of the Questionnaire on the Use of Digital Tools.
timeFrame: 1 month
Other outcomes:
Locations:
city: Paris
country: France
facility: Pr Elene Paillaud
Study officials:
References:
Clinical trial NCT02444897: The Comparison Between Epidural and Intravenous Patient-controlled Analgesia for Laparoscopic Gastrectomy
Official title: The Comparison Between Epidural and Intravenous Patient-controlled Analgesia for Laparoscopic Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Gastric cancer
epidural
PCA
laparoscopy
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was designed to assess the effectiveness of epidural patient-controlled analgesia compared to intravenous patient-controlled analgesia in patients undergoing laparoscopic gastrectomy. The investigators hypothesized that epidural PCA would be more effective in pain control than IV PCA even for laparoscopic gastrectomy.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed adenocarcinoma in stomach
* Males or Females, aged≥19 years and ≤80 years
* Scheduled as laparoscopic gastrectomy
* Patient has given their written informed consent to participate in the study

Exclusion Criteria:

* History of hypersensitivity for analgesics
* Recent history of narcotic analgesics
* Disability of central nerve system
* Uncontrolled co-morbidity

Primary outcomes:
measure: VAS score
timeFrame: 24 hours after operation
Secondary outcomes:
measure: number of participants with complication
timeFrame: for 5days after operation
measure: Bowel motility
timeFrame: for 5days after operation
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
Study officials:
affiliation: Director of gastrointestinal surgery devision, associate proffessor
name: Seung Wan Ryu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00359697: Comparison of Two Different Medications Used to Treat Elevated Intracranial Pressure
Official title: Prospective, Randomized Clinical Trialto Compare Mannitol and Hypertonic Saline for Treatment of Increased Intracranial Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Increased Intracranial Pressure
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2006-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall purpose of this study is to compare the effects of mannitol and hypertonic saline on patients with increased intracranial pressure. The hypothesis being tested is that hypertonic saline is more effective in controlling increased intracranial pressure than mannitol.


Eligibility criteria: Inclusion Criteria:

* Documented SAH (by computed tomography or lumbar puncture), ICH, TBI or brain tumor
* Patient greater than or equal to 18 years of age
* ICP monitor in place
* ICP greater than 20mmHg, not related to a transient noxious stimulus and not responding to standard measures for controlling ICP (ventricular drainage, elevation of head of the bed and optimizing PaCO2)
* Patient or patient's legally authorized representative has provided written informed consent

Exclusion Criteria:

* Patient less than 18 years of age
* Lack of ICP monitoring
* Patient received Mannitol prior to placement of ICP monitor
* Baseline serum osmolarity of greater than 310 mOsm/L
* Patient is currently enrolled in another investigational drug or device study
* Congestive heart failure at time of enrollment
* Chronic renal failure on hemodialysis
* Pregnancy

Primary outcomes:
measure: Reduction of ICP below treatment threshold (less than 20 mmHg)
Secondary outcomes:
measure: Compare effects of each treatment on MAP, CPP, serum and urine sodium and osmolality
Other outcomes:
Locations:
Study officials:
affiliation: Thomas Jefferson University
name: Robert H Rosenwasser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02383797: Immunodeficiency in Cartilage-hair Hypoplasia: Sub-project on Safety of Vaccination Against Chickenpox
Official title: Immunodeficiency in Cartilage-hair Hypoplasia: Correlation With Pulmonary Disease, Infections and Malignancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cartilage-hair Hypoplasia
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 5
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigatoris will carefully select cartilage-hair hypoplasia patients unexposed to varicella (VZV) and immunize patients in a controlled manner with VZV vaccine. Patients will be selected on the basis of disease severity and the degree of immunodeficiency (including CD4+ T-cell counts). Any potential complication of VZV immunization, such as rash, will be discussed with the patients/caregivers beforehand and acyclovir will be used to treat any VZV related symptoms, consistent with the current practices. The investigators will verify the development of immune response to vaccination by testing for VZV antibodies and cell-mediated immunity.


Eligibility criteria: Inclusion Criteria:

* genetically confirmed cartilage-hair hypoplasia diagnosis
* age \>12 months
* no history of chickenpox
* informed concent of the patient/caregiver.

Exclusion Criteria:

* positive serum IgG for varicella zoster virus
* low CD4+ cell counts (\<15% or \<200 cells/mm3)
* clinical or laboratory signs of severe immunodeficiency
* ongoing intravenous or subcutaneous immunoglobulin treatment

Primary outcomes:
measure: Humoral response to vaccination
timeFrame: 4-6 weeks post-vaccination
measure: Cell-mediated response to vaccination
timeFrame: 4-6 wks post-vaccination
measure: Number and severity of adverse events to vaccination
timeFrame: 0-60 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Central Hospital and University of Helsinki, Folkhälsan Research Centre, Helsinki Finland
name: Outi Mäkitie, PhD
role: STUDY_DIRECTOR
References:
citation: Vakkilainen S, Kleino I, Honkanen J, Salo H, Kainulainen L, Grasbeck M, Kekalainen E, Makitie O, Klemetti P. The Safety and Efficacy of Live Viral Vaccines in Patients With Cartilage-Hair Hypoplasia. Front Immunol. 2020 Aug 11;11:2020. doi: 10.3389/fimmu.2020.02020. eCollection 2020.
Clinical trial NCT01725997: Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation
Official title: Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation Rockwood Grade III and V - a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acromioclavicular Joint Dislocation
Keywords: acromioclavicular joint dislocation
ac joint dislocation
acromioclavicular joint separation
hook plate
Rockwood
Lead sponsor: St Goran's Hospital
Sponsor class: OTHER
First posted: 2012-11-14
Enrollment: 124
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: The study aims to answer if surgery with hook plate for acute dislocation of the acromioclavicular joint (AC joint) grade III and V according to Rockwood is superior to conservative treatment.


Eligibility criteria: Inclusion Criteria:

* AC joint dislocation grade III according to Rockwood with at least half a clavicular bone width above the acromion or grade V according to Rockwood
* men and women 18-65 years and able to work
* understand spoken and/or written Swedish or English language
* be able to start treatment within 3 weeks from trauma
* consent form signed

Exclusion Criteria:

* earlier injury to, or surgery of either of the shoulders
* simultaneous fracture of the clavicle or acromion
* associates neurovascular injury
* severe osteoporosis
* open dislocation
* open growth plate of the acromion
* local skin damage

Primary outcomes:
measure: Constant Score
timeFrame: change from Baseline in Constant Score at 24 months
Secondary outcomes:
measure: Disabilities of Arm, Shoulder and Hand function (QuickDASH)
timeFrame: change from Baseline in QuickDASH at 24 months
Other outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Change from baseline in SPADI at 24 months
measure: Radiographs with and without weight
timeFrame: Change in the position of the AC-joint from baseline to at 24 months
measure: European Quality of Life - 5 dimensions (EQ5D)
timeFrame: Change from baseline in EQ-5D at 24 months
measure: Pain rated with Visual Analogue Scale (VAS)
timeFrame: Change from baseline in VAS at 24 months
measure: Computed Tomography
timeFrame: Change in the position of the AC-joint from baseline to at 24 months
Locations:
city: Stockholm
country: Sweden
facility: Capio St Gorans Hospital AB
Study officials:
affiliation: Capio St Gorans hospital
name: Helena Boström Windhamre
role: PRINCIPAL_INVESTIGATOR
References: