louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01651793: Effect of Phytochemicals From Theobroma Cacao on Mental Energy
Official title: Effect of Phytochemicals From Theobroma Cacao on Mental Energy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Fatigue
Keywords: cacao
theobromine
flavanols
caffeine
sustained attention
vigilance
vigor
vitality
energy
fatigue
Lead sponsor: University of Georgia
Sponsor class: OTHER
Collaborators: name: The Hershey Company
First posted: 2012-07-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine which substances in cocoa produces changes in mental energy. This is a double blind study. The primary outcome measures are performance on tasks of sustained attention (serial subtract, continuous performance test and Bakan task) at pre and 90, 120 and 160 minutes post intervention, energy and fatigue symptoms (profile of mood state), and ratings of motivation to perform cognitive tasks. The assigned interventions are the following:

Detailed description: Only one prior study has examined the acute influence of cocoa on mental energy. The purpose of this research is to replicate the previous observations and extend research in four ways: 1) start to determine which substance in cocoa responsible for the effect by including several comparison groups, 2) focus on individuals with average or below average symptoms of mental energy and who are not high consumers of fruits, vegetables and other products containing high amounts of flavonoids in order to learn whether people with low energy accrue a greater benefit, and 3) include additional measures of mental energy plausibly influenced by cocoa to better understand the health consequences of cocoa.

Eligibility criteria: Inclusion Criteria:

* Women and men ages 18-34
* Lower than average feelings of energy (score of \< 13 on Profile of Mood States Vigor scale)

Exclusion Criteria:

* Pregnant
* GI tract disorder
* Psychoactive medication use
* Daily consumption of \> 200 mg caffeine
* Body mass index \> 30
* Cigarette smoker
* Allergy to cocoa, chocolate or caffeine
* Frequent consumption of cocoa, chocolate-based products or fruits and vegetable containing flavonoids

Primary outcomes:
measure: Correct Responses on Serial 7 Subtraction Task
timeFrame: Pre and 30, 60 and 120 minutes post intervention
measure: Performance on Bakan Task
timeFrame: baseline, post 60, post 90, post 120
Secondary outcomes:
measure: Vigor Symptoms (Profile of Mood State)
timeFrame: Pre and 90, 120 and 160 minutes post intervention
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia
state: Georgia
Study officials:
affiliation: University of Georgia
name: Patrick O'Connor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01798693: Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology
Official title: Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Rotator Cuff/Shoulder Structure and Function
Keywords: Shoulder
Supplement
Amino Acids
Collagen
Standard of Care
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 5
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: Rotator Injury:

* Strength/range of Motion
* ASES, VAS

Detailed description: The addition of a nutritional therapy to a standardized physical therapy program, may expedite recovery from shoulder injury. An attractive feature of this approach is the development of an efficacious adjunct therapy that is economically superior to traditional therapy modalities and logistically feasible.

Eligibility criteria: Inclusion Criteria:

* Between 18-65 years old
* Diagnosed with rotator cuff injury that will not be treated surgically

Exclusion Criteria:

* Have received a previous injection therapy (platelet-rich plasma or corticosteroid injection) within previous 6 months
* Have used the following supplements in the previous 2 weeks: Vitamin C or D, or protein supplements
* Have poorly controlled type I or type II diabetes (HgB A1C \> 9.5%) or renal insufficiency (GFR \< 60 ml/min).
* Have an inability to participate in rehabilitation exercises.
* Are diagnosed with arthritis, rheumatoid arthritis, or any other autoimmune or rheumatologic disease
* Have musculoskeletal pathology in a neighboring joint or structure
* Have an allergy to any component of the nutritional supplement
* Are consuming warfarin

Primary outcomes:
measure: Change in shoulder function, pain, strength and range of motion
timeFrame: Change from baseline to four, six, and twelve weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Orthopedics and Exercise and Sport Medicine
state: North Carolina
Study officials:
References:
Clinical trial NCT01974193: Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer
Official title: Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gynecologic Cancer
Lead sponsor: Ewha Womans University Mokdong Hospital
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2013-11-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Pelvic lymph node dissection (PLND) is an important step in the surgical staging and treatment of gynecologic malignancies.

Sometimes, complicated lymphoceles after PLND often delay adjuvant treatment including chemotherapy and radiation therapy, which potentially affects the success of cancer treatment.

A number of surgical techniques have developed, but failed to reduce the incidence of pelvic lymphoceles after PLND.

The investigators hypothesized that floseal can prevent lymphoceles in patients with gynecologic cancer who has undergone PLND.

The investigators designed prospective randomized controlled study as a pilot study.

The investigators will randomly apply floseal to one side of pelvis after bilateral PLND, and observe the occurence of pelvic lymphoceles after 6 months later.


Eligibility criteria: Inclusion Criteria:

* Gynecologic cancer patients who need laparotomic bilateral PLND

Exclusion Criteria:

* Incomplete PLND which can influence the occurrence of lymphocele (surgeon's decision)

Primary outcomes:
measure: Frequency of pelvic lymphocele
timeFrame: 6 month
Secondary outcomes:
measure: Post-operative drainage
timeFrame: post-operative 3 days
measure: lymphedema
timeFrame: post-operative 3 and 6 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
References:
Clinical trial NCT01941771: Phase II Trial With Metronomic, Capecitabine Plus Oral Vinorelbine for Metastatic Breast Cancer
Official title: Randomized Phase II Trial of Capecitabine Plus Oral Vinorelbine Day 1 and 8 vs Metronomic Capecitabine Plus Oral Vinorelbine as Treatment of Metastatic Breast Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast cancer
Metronomic chemotherapy
Vinorelbine
Navelbine
Capecitabine
Xeloda
Antineoplastic Agents
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Pierre Fabre Laboratories
First posted: 2013-09-13
Enrollment: 110
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 study hypothesis is that metronomic treatment is more efficient than standard treatment.

Detailed description: Purpose: In an open-label randomized phase II trial, patients with metastatic Human Epidermal Growth Factor Receptor 2-negative breast cancer with normal organ function sant WHO performance status \< 3 are randomized to receive either capecitabine (day 1-14) plus vinorelbine oral (day 1 and 8) or capecitabine (day 1-14) plus vinorelbine oral metronomic (3 days a week).

Eligibility criteria: Inclusion Criteria:

* Locally advanced or metastatic Human Epidermal Growth Factor Receptor2-Negative breast cancer
* WHO performance status \< 3

Exclusion Criteria:

* Former treatment with Capecitabine or Vinorelbine
* Patients who have received more than one line of chemotherapy for metastatic disease
* Brain metastases
* Malabsorption syndrome
* Abnormal organ function
* pregnant or lactating women

Primary outcomes:
measure: Primary endpoint is overall response rate i both arms.
timeFrame: up to 60 month
Secondary outcomes:
measure: Time to progression.
timeFrame: up to 60 month
measure: Overall survival.
timeFrame: up to 60 month
Other outcomes:
measure: Toxicity
timeFrame: Side effects of treatment
Locations:
city: Aarhus
country: Denmark
facility: Department of Oncology, Aarhus University Hospital
state: Aarhus C
Study officials:
affiliation: University hospital of Aarhus
name: Sven Tyge Langkjer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03664271: Educational Eczema Video Intervention
Official title: Randomized Controlled Trial of an Educational Eczema Video
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Eczema
Keywords: atopic dermatitis
eczema
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to increase families' understanding of eczema and improve eczema management in the primary care setting. The investigators plan to create an educational video for families providing general information about eczema as well as instructions about good skincare management and common treatments. The investigators will conduct a randomized controlled trial of the plan in the primary care clinic at Boston Children's Hospital. Specifically, the investigators aim to (1) decrease eczema severity (2) improve patient and family quality of life (QOL) and (3) increase parental knowledge about eczema and eczema management.


Eligibility criteria: Inclusion Criteria:Eligibility criteria include the following:

* accompanying adult speaks English
* patient has a history of eczema
* patient is between the ages of 1 month and 16 years
* accompanying adult is a primary caregiver
* child is not in foster care
* accompanying adult is 18 years old or older.

Exclusion Criteria:

* accompanying adult does not speak English
* accompanying adult is not the primary caregiver
* accompanying adult is not 18 years old or older
* patient is in foster care

Primary outcomes:
measure: change in eczema severity
timeFrame: 3 month follow-up
Secondary outcomes:
measure: change in infant quality of life
timeFrame: 3 month follow-up
measure: change in family quality of life
timeFrame: 3 month follow-up
measure: change in caregiver knowledge
timeFrame: 3 month follow-up
measure: change in child quality of life
timeFrame: 3 month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Boston Children's Hospital
name: Corinna Rea, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05441293: Determinants of the Success of Flap Reconstruction: Outcome Analysis of 484 Surgeries for Pressure Injury
Official title: b Division of Plastic Surgery, Department of Surgery, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Injury
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 484
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients who received debridement or flap reconstruction surgery for Pressure injury in Wan Fang Hospital from January 2016 to December 2021

Brief summary: Background: Pressure injury (PI) mainly occurs in bedridden older adults or those with physical limitations. PI treatment is typically long-term, requiring coordination between health-care workers and the patient's caregiver. Here, we aimed to determine the appropriate timing to conduct flap reconstruction in patients with PIs and identify factors affecting surgical outcomes.

Materials and Methods: We retrospectively reviewed the data of all patients who received debridement or flap reconstruction surgery for PIs in our hospital from January 2016 to December 2021. The extracted data included patient demographics, surgical records, blood test results, vital signs, and flap outcomes. Next, these characteristics including the flap outcomes of our patients with PIs were analyzed, along with the risk factors for poor wound healing and complications.


Eligibility criteria: Inclusion Criteria:

all patients who received debridement or flap reconstruction surgery for Pressure injury in Wan Fang Hospital from January 2016 to December 2021

Exclusion Criteria:

the patients who did not received debridement or flap reconstruction surgery for Pressure injury

Primary outcomes:
measure: Complete wound healing
timeFrame: from January 2016 to December 2021
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01876693: A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy
Official title: A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy in Medical Practice
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Carcinoma, Squamous Cell of Head and Neck
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether prophylactic gastrostomy leads to less treatment interruption and provide better quality of life in head and neck cancer patients receiving chemoradiotherapy.

Detailed description: Nutritional status is one of the essential factor to determine outcome of chemoradiotherapy in head and neck cancer patients. Almost all these patients develop mucositis during the treatment, which usually leads to treatment interruptions and affects the efficacy of the treatment. Prophylactic gastrostomy has been accepted for these patients with improvement of quality of life. However, there is no prospective study confirming superiority of such treatment.

The investigators enrolled head and neck cancer patients who had the plan of chemoradiotherapy. The patients will be informed about both treatment arms and will decide the arm that they preferred. The treatment interruptions, body weight and nutritional status will be assessed every 2 weeks during treatment period.

Eligibility criteria: Inclusion Criteria:

* pathologically confirmed of head and neck cancer
* plan to have chemoradiotherapy session
* Performance status of 0-2

Exclusion Criteria:

* contraindications for percutaneous gastrostomy, eg coagulopathy, obstructed tumor
* Body mass index less than 16 kg/m2

Primary outcomes:
measure: treatment interruption due to toxicity
timeFrame: during period of chemoradiatherapy, an expected average of 6 weeks
Secondary outcomes:
measure: quality of life
timeFrame: during period of chemoradiation, an expected avearage of 6 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of medical oncology, department of medicine Siriraj Hospital
Study officials:
affiliation: Siriraj Hospital
name: Suthinee Ithimakin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pramyothin P, Manyanont S, Trakarnsanga A, Petsuksiri J, Ithimakin S. A prospective study comparing prophylactic gastrostomy to nutritional counselling with a therapeutic feeding tube if required in head and neck cancer patients undergoing chemoradiotherapy in Thai real-world practice. J Hum Nutr Diet. 2016 Dec;29(6):768-776. doi: 10.1111/jhn.12377. Epub 2016 Mar 29.
Clinical trial NCT04461171: Enhanced Recovery After Surgery in Extremity Sarcoma
Official title: Enhanced Recovery After Surgery in Extremity Sarcoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcoma
Keywords: Enhanced Recovery After Surgery
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Two-group, prospective, consecutively enrolled, comparative non-randomized trial (N = 120) is to determine the feasibility and efficacy of implementing an enhanced recovery after surgery (ERAS) pain management pathway to patients undergoing surgical treatment for an extremity sarcoma.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the efficacy of implementing the enhanced recovery after surgery (ERAS) pathway in a prospective manner to patients undergoing surgical treatment for extremity sarcoma.

Detailed description: Specifically, the focus of this study will be regarding the administration of a perioperative non-narcotic, multimodal pain management pathway. Primary endpoints collected with be short-term patient reported outcomes (pain scores \[PROMIS\] and \[QoR-15\]), limb function scores \[MSTS\], and key clinical outcomes (hospital length of stay, opioid requirements/prescribing data and perioperative complications).

Eligibility criteria: Inclusion Criteria:

* Any patient at Vanderbilt University Medical Center treated with surgical excision of a suspected extremity sarcoma
* Adult patients \>17 years of age
* Patients of all preoperative opioid status (naïve or dependent)

Exclusion Criteria:

* Patients treated non-operatively
* Non-English speaking patients

Primary outcomes:
measure: Pain scores
timeFrame: 3 months
measure: Pain scores
timeFrame: 3 months
measure: Limb function
timeFrame: 3 months
measure: Clinical outcomes - length of hospital stay
timeFrame: 3 months
measure: Clinical outcomes - opioid requirements
timeFrame: 3 months
measure: Clinical outcomes - perioperative complications (e.g. wound complications and 30-day readmission)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt Medical Center
name: Joshua Lawrenz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03886571: U01-Biomarkers for Noninvasive and Early Detection of Pancreatic Cancer
Official title: U01-Biomarkers for Noninvasive and Early Detection of Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Lead sponsor: Hoag Memorial Hospital Presbyterian
Sponsor class: OTHER
Collaborators: name: Baylor Research Institute
First posted: 2019-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an upcoming standard of care clinical and/or surgical event who meet criteria for study participation are identified by the treating physician and will be asked to participate in the study.

Brief summary: This is an observational, biospecimen collection protocol to develop a bank of pancreatic cancer tissue and normal tissue.

Detailed description: This is an observational, biospecimen collection protocol to develop a bank of pancreatic cancer tissue, normal tissue. Biospecimens collected through this protocol will be shared with collaborators in the Pancreatic Cancer Detection Consortium to support projects funded through an NIH U01 grant. Participants will be enrolled when they present for clinically indicated surgical procedures for their possible tumor or pancreas resection or cyst resection, or at a clinically indicated follow-up appointment after their procedure.

This protocol supports this effort by providing investigators with access to a wide variety of pancreatic tissues and biospecimens for translational studies in pancreatic cancer. This protocol covers the collection of clinical data and biospecimens (blood; malignant, benign, or precancerous pancreatic tumor; and adjacent normal tissues) from patients with, or suspected to have, pancreatic cancer. Additionally, saliva and cyst fluid, may be collected in the future from patients with pancreatic cysts. These will be shared with the Pancreatic Cancer Detection Consortium for further analysis.

Eligibility criteria: Inclusion Criteria:

* Males or Females ≥ 18 years of age who have been diagnosed with Pancreatic Cancer (PDAC), Pancreatic Neoplasms (PNs - IPMMs, PanINs and MCNs), pancreatitis and diabetes or no disease/healthy.
* Individuals undergoing or have previously undergone a diagnostic procedure (i.e. EUS or ERCP) evaluation or surgery.
* Willingness and ability to donate biospecimens for the purpose of research.
* Subjects must have had diagnostic procedure or surgery after September 1, 2017.

Exclusion Criteria:

* Individuals under 18 years of age.
* Inability to donate biospecimens.
* Females pregnant or lactating.

Primary outcomes:
measure: Measuring cell-free and exosomal-miRNA biomarkers using small RNA-Seq in matched tissue and plasma from patients with PDAC, PNs, pancreatitis and normal pancreas for early detection.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
Study officials:
References: