louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00416156: Effect of Weight Reduction on Inflammatory Markers and Genes Expression in Obese Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Inflammation
Keywords: Obesity
Inflammation
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2006-12-27
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To investigate whether weight reduction by life style modification for 12 weeks will improve circulating inflammatory markers, adipocytokines as well as gene expression of proinflammatory protein obtained from circulating monocytes from obese individuals.


Eligibility criteria: Inclusion Criteria:

* Nondiabetes obese individuals with BMI greater than 27 kgs/m2

Exclusion Criteria:

* Diabetes
* Abnormal hepatic, renal and cardiac function

Primary outcomes:
measure: Inflammatory responses after weight reduction
Secondary outcomes:
measure: BMI
measure: Circulating inflammatory markers
measure: Adipocytokines
measure: Gene Expression from mononuclear cells
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Wayne H Sheu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01341756: Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial
Official title: Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Gastric Cancer
Radiotherapy
palliation
bleeding
pain
obstruction
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: Tan Tock Seng Hospital
First posted: 2011-04-26
Enrollment: 63
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to historical controls.

Detailed description: The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to historical controls. (Tey et al.) With this dose fractionation is used for bleeding, there is an increase in response rates from 55%(historical) to 75%for pain, there is an increase in response rates from 25% (historical) to 45% for obstruction, there is an increase in response rates from 25% (historical) to 45%

Eligibility criteria: Inclusion Criteria:

* Biopsy proven adenocarcinoma of the stomach
* Treated with palliative intent
* At least one index symptom such as bleeding, obstruction or pain
* No prior abdominal radiotherapy
* Not on chemotherapy

Exclusion Criteria:

* Patients treated with radical intent
* Previous abdominal radiotherapy
* Patients on chemotherapy

Primary outcomes:
measure: Response of bleeding to radiotherapy
timeFrame: At the 12th fraction of radiotherapy and at one month post radiotherapy
Secondary outcomes:
measure: Number of patients who develop anorexia, nausea, vomiting as per common toxicity criteria v3.0
timeFrame: within the first 14 days from start of radiotherapy
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Jeremy Tey, FRANZCR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tey J, Zheng H, Soon YY, Leong CN, Koh WY, Lim K, So JBY, Shabbir A, Tham IWK, Lu J. Palliative radiotherapy in symptomatic locally advanced gastric cancer: A phase II trial. Cancer Med. 2019 Apr;8(4):1447-1458. doi: 10.1002/cam4.2021. Epub 2019 Feb 20.
Clinical trial NCT02731456: Effect of High Altitude Exposure, Acclimatization and Re-exposure on Psychomotor Performance in Lowlanders
Official title: Effect of High Altitude Exposure, Acclimatization and Re-exposure on Psychomotor Performance and Sleep Quality in Lowlanders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of High Altitude
Keywords: high altitude
cognition
sleep
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2016-04-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure to high altitude on psychomotor vigilance to measure sustained attention.

Detailed description: Baseline measurements will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (2 h flight) and by bus (2 h ride) to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 7 nights and they will spend the days (6 total; 6-8 h daily) at the telescope station at 5050 m while undergoing testing as described above at the first and the last day at 5050m. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 7 day altitude sojourn participants will return to the Santiago area (520 m) for a 7 day recovery period. A second altitude sojourn with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.

Eligibility criteria: Inclusion Criteria:

* born, raised and currently living \<1300m
* No overnight stays at altitudes \>1500m 4 weeks before the study

Exclusion Criteria:

* previous altitude intolerance \<3000m
* pregnancy
* health impairment, which requires regular treatment

Primary outcomes:
measure: Sustained attention measured by a visual pychomotor vigilance test (PVT)
timeFrame: Low altitude dojourn at 520m; forst sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7
Secondary outcomes:
measure: Indices of sleep quality measured by actigraphy (total sleep time, sleep efficiency, sleep latency
timeFrame: Low altitude dojourn at 520m; forst sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Marc J Poulin, PhD, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03112356: The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials
Official title: The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Endocarditis
Keywords: infectious endocarditis
prosthetic valve infection
implantable cardiac device infection
99mTc-Leukoscan® scintigraphy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Infectious endocarditis is a serious pathology with difficult diagnosis especially on prosthetic valves or cardiac device because of the plurality of clinical presentations and the low sensitivity value of echocardiography in these patients. Despite a well validated indication for the detection of septic emboli, the value of FDG-PET for the detection of prosthetic valves or cardiac implantable device is still unclear especially because of frequent non-septic inflammatory processes.

To improve the specificity value, the use of radio-labeled leukocytes scintigraphy is conventionally proposed. An alternative method is to label leukocytes in vivo with an anti-murin anti body fragment ( Sulesomab , Leukoscan®). This scintigraphy is regularly used in the investigation of osteomyelitis and has been proposed in infectious endocarditis. To knowledge of investigators, the value of Leukoscan® scintigraphy on prosthetic valve or cardiac device infection had not been studied.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged \> 21 years
* Patients presenting a suspicions of infectious endocarditis on surgical materials
* Written informed consent

Exclusion Criteria:

* Patient with a history of exposure to murine antigens, particularly a patient who has already received a 99mTc-Leukoscan® scintigraphy
* Patients whose clinical condition requires prompt care, not allowing them to wait for the examination
* Pregnant or nursing (including pumping for storage and feeding)
* Patients under adapted antibiotic therapy for more than 15 days
* Deprivation of civil rights (curatorship, guardianship, safeguard of justice)

Primary outcomes:
measure: Presence or not of infectious endocarditis on surgical materials
timeFrame: 3 months (plus or minus 1 month)
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Bastien GREGOIRE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04343456: Salvage Surgery for Patients With Metastatic GIST With Rego
Official title: Analysis of Benefit From Salvage Surgery for Highly Selected Patients With Metastatic Gastrointestinal Stromal Tumors Receiving Regorafenib Facing Local Progression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Stromal Tumors
Metastasis
Disease Progression
Keywords: regorafenib
Gastrointestinal Stromal Tumors
Metastasis
local progression
surgery
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between 2014 and 2019, 41 metastatic GIST patients receiving regorafenib therap at Chang Gung Memorial Hospital, Linkou, Taiwan were enrolled. All the patients were managed by a multidisciplinary GIST team composed of medical oncologists and surgical oncologists.

Brief summary: Some researches have shown surgery may acquire progression-free (PFS) benefit for selected patients with metastatic gastrointestinal stromal tumor (GIST) who received first-line imatinib and second-line sunitinib. However, impact of salvage surgery on pre-treated GIST patients receiving third-line regorafenib facing progression is not yet reported. Investigators retrospectively reviewed patients with regorafenib treatment with salvage surgery.

Detailed description: Between 2014 and 2019, 41 metastatic GIST patients received regorafenib therapy. 35 out of 41 metastatic GIST patients who were on regorafenib therapy facing progression and 15 experienced local progression underwent salvage surgery. Thirty-five of 41 (85.4 %) pre-treated GIST patients receiving regorafenib who experienced disease progression after a median follow-up of 12.4 months of regorafenib use. 15 out of 35 (42.9%) metastatic GIST patients receiving regorafenib facing progression underwent salvage surgery.

Eligibility criteria: Inclusion criteria:

1. Patients who is taking regorafenib after treatment failure by 1st line and 2nd line tyrosine kinase, namely Imatinib and Sunitinib.
2. Patients with aforementioned condition and is facing local progression of disease or stationary disease.

Exclusion criteria

1. Systemic progression of disease
2. ASA classification \> 3

Primary outcomes:
measure: Overall survival
timeFrame: 01/2014~12/2019
measure: Disease free survival
timeFrame: 01/2014~12/2019
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital Linkou Branch
Study officials:
affiliation: Chang Gung Memorial Hospital, Linkuo
name: Chun Nan Yeh, MD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01358656: Anterior Cruciate Ligament Reconstruction Using Single Bundle and Double Bundle Techniques
Official title: Comparison of the Anterior Cruciate Ligament Reconstruction Using Single Bundle and Double Bundle Techniques: Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Lead sponsor: Vita Care
Sponsor class: OTHER
First posted: 2011-05-24
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anterior Cruciate Ligament (ACL) reconstruction surgery has greatly advanced over the last 20 years. However, data in the literature reveal that approximately 15-25% of patients undergoing surgery still do not present optimal outcomes, which suggests that there is room for improvement of the procedure. A possible explanation for this fact is that most ACL reconstructions consider only one of the functional bundles of the ligament. Our hypothesis is that the ACL reconstruction with the double-bundle technique will be effective in reducing the patients' rotation of the knee joint for high-demanding tasks compared to the patients who had ACL reconstruction with the single-bundle technique.

Detailed description: The aim of this study is to compare the ACL reconstruction with only one bundle (one tunnel in the tibia and femur) with the procedure to reconstruct the the ACL with two bundles with 2 tunnels in the tibia and 2 in the femur (considered closest to the normal anatomy of of the ACL), both in terms of objective and subjective results.

Eligibility criteria: Inclusion Criteria:

1. Male or female.
2. Body mass index (BMI), which corresponds to the ratio between weight in kilograms (pounds) and height in m2 (square meters) between 18.5 and 24.99.
3. Anterior instability alone or associated with chondral lesions of up to 1cm or associated with meniscal injuries that do not alter the postoperative rehabilitation.
4. Magnetic resonance imaging (MRI) confirming the ACL injury.
5. Aged between 20 and 45 years.
6. Not having asymmetric varus alignment, greater than or equal to 5 degrees (to eliminate cases with indication for osteotomy of the tibia), using panoramic radiographic comparison of the lower limbs in standing position.
7. Absence of associated ligament instabilities (medial, lateral or posterior).
8. No previous surgery on the affected knee.

Exclusion Criteria:

1. New post-surgical trauma after 12 months.
2. Interruption of treatment / follow-up.
3. Postoperative infection.

Primary outcomes:
measure: Isokinetic testing
timeFrame: 2 years
measure: Subjective and Objective IKDC Scores
timeFrame: 2 years
measure: Kinematic evaluation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Vita
Study officials:
References:
Clinical trial NCT04886856: Mindful Moms Randomized Control Trial
Official title: Mindful Moms Randomized Control Trial Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: pregnancy
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-05-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
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 test whether a program called "Mindful Moms" can be helpful for specific measures of mood and health in pregnant women with depressive symptoms, compared to group-based education workshops.

Detailed description: The Mindful Moms Study is a randomized controlled trial, in which participants will be randomly assigned (like the flip of a coin) to either the "Mindful Moms" group (12 weeks of group-based prenatal yoga) or the "Prenatal Education Circle" group (12 weeks of group-based prenatal education). 200 pregnant women will participate over the course of the study.

Eligibility criteria: Inclusion Criteria:

1. pregnant woman at 12-26 weeks gestation at baseline visit;
2. defined as minority (e.g., Black/ African American, Hispanic/ Latino, Native American, etc) and/or annual household income at qualification level for Women, Infants, \& Children \[WIC\] benefits in Virginia and/or educational attainment ≤high school education;
3. ≥age 18;
4. current depressive symptoms, as defined by a score ≥7 on the Edinburgh Postnatal Depression Scale (EPDS);
5. able to read, write, and understand English;
6. has not been told by a healthcare provider to avoid physical activity;
7. has not engaged in a consistent (once/week or more) yoga-based practice during the current pregnancy.

Exclusion Criteria: Does not meet the inclusion criteria above.

Primary outcomes:
measure: Change in Depressive symptom severity
timeFrame: Baseline to postpartum, about 8 months
Secondary outcomes:
measure: Change in anxiety
timeFrame: Baseline to postpartum, about 8 months
measure: Change in stress
timeFrame: Baseline to postpartum, about 8 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Patricia Kinser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04310956: A RCT for Y-Knot All-suture Anchor in Ankle Ligaments Injury Repair
Official title: A Multi-center, Randomized Controlled Trial to Evaluate the Effectiveness and Safety of Y-Knot All-suture Anchor in Ankle Ligaments Injury Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ligament Injury
Lead sponsor: ConMed Linvatec Beijing
Sponsor class: INDUSTRY
First posted: 2020-03-17
Enrollment: 148
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: Purpose of this study is to evaluate the effectiveness and safety of Y-Knot all-suture anchor by comparing patients' clinical outcome after ankle ligaments repair surgery.


Eligibility criteria: Inclusion Criteria:

* Male or Female, no less than 18 years old;
* Patient was diagnosed as Collateral Ligament injury or Achilles tendon injury based on MRI or X-Ray who need to conduct foot\&ankle repair surgery by investigator;
* Patient willing to sign a written consent form participating in this study；
* Subject is able to understand study, willing to comply the study procedures, and willing to return to hospital for follow-up up to 6 months postoperative；
* Life expectancy is more than 2 years post-operationally;

Exclusion Criteria:

* Conducted surgery at index ankle and possibly influence the outcome evaluation;
* Bilateral ankle surgery;
* Suffering concurrent ankle disease that may leads to a surgery during the study phase;
* known or suspected allergies to implant and/or instrument materials;
* pathological conditions of bone which would adversely affect the anchor fixation; with concurrent severe injury at index leg that may influence the outcome evaluation; Severe obesity;
* With concurrent disease that may influence the index ankle function;
* Patients with active sepsis or infection;
* With concurrent disease that may influence the stability of device and rehabilitation;
* Immune suppression, impairment of immune function, or autoimmune disease;
* Pregnant or lactating women;
* Known noncompliance or lost follow-up risk;
* Participated other drug, biologic, or device clinical trial 12 months before enrollment;
* Alcohol or drug abuser;
* Other inappropriate condition based on investigator determination;

Primary outcomes:
measure: improvement of AOFAS score
timeFrame: From pre-operation to 6 months postoperative
Secondary outcomes:
measure: improvement of AOFAS score
timeFrame: From pre-operation to 3 months postoperative
measure: Improvement of VAS score
timeFrame: From pre-operation to 3 and 6 months postoperative
measure: ligament injury recurrences
timeFrame: up to 6 months postoperative
measure: secondary surgery
timeFrame: up to 6 months postoperative
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hosptial
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Orthopedics Hospital
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
Study officials:
References:
Clinical trial NCT04871009: A Trial of Neurofeedback As an Adjunctive Treatment for Youth in Outpatient Mental Health Settings
Official title: A Trial of Neurofeedback As an Adjunctive Treatment for Youth in Outpatient Mental Health Settings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trauma
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the feasibility and effectiveness of a neurofeedback intervention conducted as an adjunctive behavioral health treatment to reduce trauma and affective symptoms in trauma-exposed youth.


Eligibility criteria: Inclusion Criteria:

(children)

* caregiver-reported exposure to two or more ACE types on the ACE-Q-Child measure.
* ages of 6-12 years old
* receiving or eligible to receive trauma-focused cognitive behavior therapy or another type of trauma-focused therapy, as determined by their primary therapist, designated as the TAU condition
* speaks and reads English

(caregivers)

* own an iPhone, iPad, smartphone, or tablet that is equipped with Bluetooth and uses an Apple or Android operating system that is compatible with the MUSE Calm app and accompanying MUSE wearable neurofeedback device
* speaks and read English

Exclusion Criteria:

Child-caregiver dyads will be excluded if

* the child falls outside of the required age range,
* has a documented history of epilepsy
* is currently considered to be at high risk for suicide attempt
* is currently experiencing psychosis

Primary outcomes:
measure: Mean change in Trauma Symptom Checklist for Young Children (TSCYC)
timeFrame: baseline to 3 months
measure: Mean change in Short Mood and Feelings Questionnaire (SMFQ)
timeFrame: baseline to 3 months
measure: Mean change in Patient Reported Outcomes Measurement Information System Pediatric Item Bank v2.0 - Anxiety - Short Form 8a (PROMIS)
timeFrame: baseline to 3 months
Secondary outcomes:
measure: Number of caregivers reporting childhood trauma
timeFrame: baseline to 3 months
measure: Mean number of sessions per week
timeFrame: 3 months
measure: Mean satisfaction with the intervention
timeFrame: 3 months
measure: mean length of each session
timeFrame: 3 months
measure: Mean change in Beck Depression Inventory II (BDI-II)
timeFrame: baseline to 3 months
measure: post traumatic stress disorder (PTSD) Checklist for DSM-5 (PCL-5)
timeFrame: baseline to 3 months
measure: Parental Stress Scale (PSS)
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: