louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00894972: Rehabilitation Following Lumbar Disc Surgery
Official title: Examining the Effectiveness of a Post-operative Rehabilitation Program Emphasizing Restoration of Multifidus Muscle Function for Individuals Undergoing Lumbar Discectomy: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Radiculopathy
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2009-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study will be a randomized clinical trial designed to determine the most effective physical therapy program for individuals who have undergone lumbar discectomy surgery. The study will compare two different post-operative physical therapy programs (general strengthening or general + specific strengthening). Both groups will begin treatment 2 weeks post-surgery. Subjects in both groups will receive weekly treatment sessions for 8 weeks with a treatment program emphasizing exercises shown to activate the large trunk muscles without imposing potentially harmful compression or shear forces. The general + specific strengthening group will also receive exercises shown to isolate activation of the deep trunk muscles, in particular the multifidus, with training augmented by the use of diagnostic ultrasound biofeedback. Patient assessments will be conducted pre- and post-surgery, as well as 10 (post-treatment) and 26 weeks after surgery.


Eligibility criteria: Inclusion Criteria:

* 18-60 years old
* Diagnosis of LDH based on imaging (MRI or CT scan) of the lumbar spine with concurring clinical examination findings (based on the judgment of the attending neurosurgeon)
* Appropriate surgical candidate based on the opinion of the attending spine surgeon, and scheduled for single-level lumbar discectomy (open or micro-discectomy).
* Able to attend weekly treatment sessions.

Exclusion Criteria:

* Prior surgery to the lumbar spine
* Spondylolytic or degenerative spondylolisthesis present on pre-surgical imaging
* Unable to speak and understand English
* Peri- or post-operative complication (infection, nerve injury, dural tear, vascular injury, etc.) that would limit or delay the ability to participate in post-operative rehabilitation.
* Multi-level surgery or the use of instrumentation during surgery (i.e., lumbar fusion)

Primary outcomes:
measure: Modified Oswestry disability index
timeFrame: Preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months
Secondary outcomes:
measure: Lumbar multifidus muscle activation as estimated by diagnostic ultrasound imaging
timeFrame: preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah, Department of Physical Therapy
state: Utah
Study officials:
affiliation: University of Utah
name: Julie Fritz, PT, PhD, ATC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03617068: The Effectiveness of Coconut Oil Cream as a Prevention Treatment for Occupational Hand Dermatitis Among Batik Workers
Official title: The Effectiveness and Dermato-pharmacokinetic of Coconut Oil Cream as a Prevention Treatment for Occupational Hand Dermatitis Among Batik Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hand Dermatoses
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 32
Sex: MALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Batik traditional workers with occupational hand dermatitis using emolient for prevention
Primary purpose: PREVENTION

Brief summary: Empirically, mosturizer is used to prevent and treat many occupational dermatoses that has skin barrier impairment. Evidence based medicine about the effectivity of mosturizer in occupational dermatoses is limited. Coconut oil is one of traditional substance that is used as a skin care. There is study shows that coconut oil is effective for atopic dermatitis treatment in children. Other studies are needed to assess the effectivity coconut oil mosturizer cream to overcome occupational hand dermatitis.

Detailed description: The aim of this study is to measure the effectivenes of coconut oil cream for batik workers who suffer from occupational hand dermatitis. The gloves that used as a protective equipment are made from rubber which have its own limitations. Therefore other interventions are needed to improve barrier skin.

Eligibility criteria: Inclusion Criteria:

* signing the informed consent document before the study start
* adult population include patients between the ages of 18 and 64 years who work in the dyeing and washing process more than 6 months.
* suffering from occupational hand dermatitis that meet Mathias Criteria.
* willing to obey the research protocol
* willing to fill in diary periodically

Exclusion Criteria:

* having history of allergy or irritation caused by coconut oil or other mosturizer
* suffering from symptoms including edema, exudation, crust, fissures, liver problems, and signs of infection
* on corticosteroid treatment ( medium to high potency) or on systemic immunosuppressive therapy

Primary outcomes:
measure: clinical improvement of hand dermatitis measured by Hand Eczema Severity Index (HECSI) after using coconut oil
timeFrame: 14 days
Secondary outcomes:
measure: Transepidermal water loss (TEWL)
timeFrame: 14 days
measure: Skin capacitance
timeFrame: 14 days
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Faculty of Medicine Universitas Indonesia
state: Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Retno W Soebaryo, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03013868: CTCs and Novel Target Bio-marker Analysis for Prediction and Monitoring of Metastasis/Recurrence in Post-surgery Colorectal Cancer Patients Using MiSelect R Rare Cell System
Official title: CTCs and Novel Target Bio-marker Analysis for Prediction and Monitoring of Metastasis/Recurrence in Post-surgery Colorectal Cancer Patients Using MiSelect R Rare Cell System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Circulating Tumor Cells, CTC
Lead sponsor: MiCareo Taiwan Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-01-09
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 200 Colorectal cancer stage II/III patients who will undergo surgical resection

Brief summary: Despite the growing public awareness and recent progress in multimodality therapy to the colorectal cancer (CRC), CRC still ranks high on the list of the most common and deadly cancers in Taiwan. The cause of CRC mortality is due mainly to the occurrence of distant metastasis. Several reports suggested that circulating tumor cells (CTCs) highly associated with metastasis suggesting that targeting CTCs may offer an unprecedented opportunity to prevent the development of metastasis. Early detection and characterization of CTCs is therefore important as a potential strategy to monitor the progression of CRC. The current proposal is focused on detecting CTCs from peripheral blood of CRC patients using Miselect R system. We will monitor the amount of CTCs and correlate with CRC progression and prognosis.


Eligibility criteria: Inclusion Criteria:

1. Over 20 and less than 90 years of age.
2. Colorectal cancer stage II/III patients who will undergo surgical resection.
3. Subject having agreed to participate in the study and follow the study procedures by providing written informed consent prior entering the study.

Exclusion Criteria:

1. Have other cancer history.
2. Subject being identified with any blood borne infectious disease

Primary outcomes:
measure: Disease Free Survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References:
Clinical trial NCT06076668: Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium
Official title: Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Unit (ICU) Delirium; A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dexmedetomidine
Melatonin
Delirium
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to compare the effect of dexmedetomidine infusion and oral melatonin on preventing delirium in intensive care unit (ICU) patients.

Detailed description: Delirium is experienced in 20% to 40% of the critically ill and up to 80% of mechanically ventilated (MV) medical or surgical patients . It is a confessional state that has been described as a transient global disorder of cognition, awareness, and attention and as such is not only challenging for the treating medical team, but also has a considerable impact on affected patients. It is associated with prolonged hospital length of stay and time on MV, deterioration in cognition, and increased morbidity and mortality causing additional health-care expenses.

Eligibility criteria: Inclusion Criteria:

* Patients aged 21 years or older.
* Either gender.
* Healthy gastrointestinal function (patients tolerated oral medications by gavage or mouth).
* Richmond Agitation Sedation Scale (RASS) \>-1.
* No basic delirium or mood changes before admission to intensive care unit(ICU).

Exclusion Criteria:

* Patient refusal.
* History of irreversible brain disease consistent with severe dementia.
* Patient admitted with a primary neurologic condition or injury (e.g., intracranial hemorrhage).
* Heart rate (HR) less than 50 beats/ min or second- third degree heart block in the absence of a pacemaker.
* Acute alcohol withdrawal requiring benzodiazepine administration.
* History of hepatic encephalopathy or end-stage liver disease (Child-Pugh class B or C).
* The expected duration of intensive care unit (ICU) stay less than 5 days.
* Inability to obtain informed consent.
* Pregnancy.
* Allergy to dexmedetomidine or melatonin.

Primary outcomes:
measure: The incidence of delirium
timeFrame: 14 days from admission to intensive care unit
Secondary outcomes:
measure: The onset of delirium. • Duration of delirium. • Frequency of delirium. • Length of ICU stay. • Total dose of Haloperidol per day.
timeFrame: 14 days from admission to intensive care unit
measure: Duration of delirium
timeFrame: 14 days from admission to intensive care unit
measure: Frequency of delirium
timeFrame: 14 days from admission to intensive care unit
measure: Total dose of Haloperidol per day
timeFrame: 14 days from admission to intensive care unit
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT04753268: Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors
Official title: Preliminary Examination of a Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Behavior, Health
Lead sponsor: Noom Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, single-arm pilot study evaluating preliminary efficacy and acceptability of a Noom breast cancer survivor weight loss program.

The intervention consists of a curriculum, provided through daily articles that users are encouraged to read; logging features for weight, meals, and physical activity; in-app groups; and a virtual coach, who will communicate with participants via in-app messaging. During the first week of the study, participants will be introduced to the program, the Noom app, and their coach.

Coaches will use a secure dashboard to monitor patient progress, which is used to increase engagement and motivation. Participants are encouraged to log their weight, physical activity, and meals daily.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the preliminary efficacy of a Noom Breast Cancer Weight Loss Program on weight loss outcomes, quality of life, and physical activity. Also, to qualitatively determine acceptability of this novel program among breast cancer survivors with overweight or obesity.


Eligibility criteria: Inclusion Criteria:

* Able to understand and provide informed consent
* 18 years and older
* Overweight or obesity (BMI ≥ 27.5)
* Not 6 months postpartum
* Not planning to become pregnant in the next 7 months
* Have a smartphone that is compatible with Noom's mobile app
* Breast cancer survivor with stage I, II, or III
* Completed active treatment (e.g, surgery, chemo, radiation, etc.) \> 6 months ago

Exclusion Criteria:

* Inability or unwillingness of a participant to give written informed consent
* Currently pregnant or \< 6 months postpartum
* Plans to become pregnant within the next 7 months
* Stage IV, metastatic cancer or DCIS
* Currently taking insulin
* Uncontrolled hypertension

Primary outcomes:
measure: Weight
timeFrame: baseline to 6 months
measure: Program engagement
timeFrame: weeks 1-26
measure: Program retention
timeFrame: weeks 1-26
measure: Program satisfaction
timeFrame: week 1 - 26 week
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Noom, Inc
state: New York
Study officials:
References:
Clinical trial NCT01027468: Long-term Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration
Official title: Functional, Morphological And Safety Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration - 3 Years Of Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neovascular Age-related Macular Degeneration
Keywords: bevacizumab, choroidal neovascularization
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-12-08
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 200 eyes with each subtype of neovascular age-related macular degeneration will be included in this study and 3 years after the initial intravitreal bevacizumab, best-corrected visual acuity (BCVA) will be measured using Snellen charts at 6m. Central retinal thickness (CRT) will be measured using Stratus OCT and Cirrus SD-OCT (Zeiss). Data of treatment-naive eyes (group 1) were compared to the data of eyes that had undergone prior treatment with photodynamic therapy with verteporfin and intravitreal triamcinolone acetonide (group 2).

Detailed description: In this interventional clinical study, 181 eyes of 160 consecutive patients with active neovascular related macular degeneration meeting recommended criteria for inclusion and protocol criteria for anti-vascular endothelial growth factor therapy undergoing intravitreal bevacizumab monotherapy were evaluated. Data of treatment-naive eyes (Group 1, n = 114) were analyzed separately from eyes that had undergone previous photodynamic therapy plus intravitreal triamcinolone (Group 2, n = 67). Re-treatment criteria were based on clinical outcome following the official European label regimen. After 1 year of continuous service at an academic referral center, follow-up was performed in private practices in collaboration with the referral center. Main outcome parameters were best-corrected visual acuity and central retinal thickness.

Eligibility criteria: Inclusion Criteria:

* any subtype of neovascular age-related macular degeneration
* age of 50 years or older
* initial treatment with intravitreal bevacizumab between August 2005 and June 2006

Exclusion Criteria:

* previous vitrectomy
* presence of cystoid macular edema without choroidal neovascularization
* Uncontrolled systemic disease

Primary outcomes:
measure: Vision
timeFrame: 3 years after first intravitreal bevacizumab treatment
measure: CRT (Central Retinal Thickness)
timeFrame: 3 years after initial intravitreal bevacizumab treatment
Secondary outcomes:
measure: Systemic Complications After Treatment
timeFrame: 3 years after initial bevacizumab treatment
Other outcomes:
Locations:
Study officials:
affiliation: Department of Ophthalmology, Medical University of Vienna, Austria
name: Stefan Sacu, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05498168: Computational Prediction and Experimental Validation of Esophageal Cancer Associated Neoantigens
Official title: Computational Prediction and Experimental Validation of Esophageal Cancer Associated Neoantigens
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Cancer
Neoantigen
Lead sponsor: University Medical Center Ho Chi Minh City (UMC)
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients who were diagnosed with adavanced esophageal cancer and underwent surgical resection

Brief summary: This study is to develop computational pipelines and experimental validation assays for improving the identification of neoantigens from patients with esophageal cancer.

Detailed description: Esophageal cancer (EC) is the common malignant tumor with poor survival. The long-term surival rate of patients with advanced EC stages has not been improved with multidisciplinary treatments including surgery and chemotherapy and radiation. Recently, immunotherapy approaches using checkpoint inhibitors (CPI), cancer vaccine, and adoptive T cell therapy have improved survival outcomes of EC patients. The clinical outcomes are associated with expression levels as well as the immunogenicity of neoantigens which arise from soma mutations. Therefore, the identification of immunogenic neoantigens is essential for achieving effective therapies. Recent data published by the Tumor Neoantigen Selection Alliance (TESLA) show that the majority (98%) of predicted neoantigens are lack of immunogenicity and ineffective in activating antitumor immune responses. In our study, we aim to develop a pipeline with both computational prediction tools and experimental validation assays to enhance the accuracy of neoantigen identification.

Eligibility criteria: Inclusion Criteria:

1. Male or Female patients aged 18 years and older
2. Diagnosed with advanced esophageal cancer
3. Treatment-Naive
4. Not known for other concomitant cancers
5. Provide written informed consent

Exclusion Criteria:

1. Insufficient tumor tissues (less than 1 cm3 )
2. Unable to sign informed consent
3. Underwent treatment

Primary outcomes:
measure: The neoantigen landscape of patients with esophageal cancer
timeFrame: 3 months from the begining of study
measure: The ratio of predicted neoantigens being presented by HLA-I
timeFrame: 6 months from the begining of study
measure: The ratio of predicted neoantigens being immunogenic
timeFrame: 12 months from the begining of study
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center Ho Chi Minh City
Study officials:
References:
Clinical trial NCT03653468: Exercise for Preventing the Metabolic Syndrome in Latinoamerican Amerindians
Official title: Similar Improvements in Cardiometabolic Risk Factors for Preventing the Metabolic Syndrome in Latinoamerican Amerindians After 12-weeks of Concurrent Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cardiovascular Risk Factor
Physical Activity
Lead sponsor: Universidad Santo Tomas
Sponsor class: OTHER
Collaborators: name: Universidad del Rosario
name: Universidad Pública de Navarra
name: Healthcare Center Tomas Rojas
name: Universidad de Los Lagos
First posted: 2018-08-31
Enrollment: 28
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioral
Primary purpose: PREVENTION

Brief summary: Despite exercise training decrease blood fasting glicaemy in 'average' terms, there is a wide inter-individual variability after exercise training explored mainly in adults but not in adults with prediabetes comorbidities. Thus, is yet unknown the effects and influence of the concurrent training (CT) eliciting responders (R) and non-responders (NR) cases (i.e., percentage of subjects who experienced a non-change/worsened response after training in some metabolic outcomes).


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Interested in improving health and fitness

Exclusion Criteria:

* Cardiovascular contraindications to exercise
* History of stroke, asthma or chronic obstructive pulmonary disease, muscle-skeletal disorders
* Smoking
* A compliance rate to the exercise program ≥ 70% was required for the participants in the intervention group to be included in the statistical analyses.

Primary outcomes:
measure: Fasting glucose
timeFrame: Baseline and 20-weeks immediately after the interventions ends
measure: Total cholesterol
timeFrame: Baseline and 20-weeks immediately after the interventions ends
measure: Blood pressure
timeFrame: Baseline and 20-weeks immediately after the interventions ends
Secondary outcomes:
measure: Body mass
timeFrame: Baseline and 20-weeks immediately after the interventions ends
measure: Waist circumference
timeFrame: Baseline and 20-weeks immediately after the interventions ends
measure: Fat mass
timeFrame: Baseline and 20-weeks immediately after the interventions ends
measure: Lean mass
timeFrame: Baseline and 20-weeks immediately after the interventions ends
measure: Heart rate at rest
timeFrame: Baseline and 20-weeks immediately after the interventions ends
measure: Six minutes walking test
timeFrame: Baseline and 20-weeks immediately after the interventions ends
Other outcomes:
Locations:
city: Los Lagos
country: Chile
facility: Cristian Alvarez
state: Osorno
Study officials:
affiliation: Universidad de Los Lagos
name: Cristian Alvarez, PhD
role: PRINCIPAL_INVESTIGATOR
References: