louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02567669: Muscle Loss and Fatigue as a Consequence of Radiotherapy
Official title: Muscle Loss and Fatigue as a Consequence of Radiotherapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Fatigue
Sarcopenia
Keywords: radiotherapy
Lead sponsor: Essentia Health
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with nonmetastatic breast cancer with indications for postoperative radiotherapy

Brief summary: This study examines the extent of systemic muscle loss and the degree of fatigue experienced by breast cancer patients undergoing radiotherapy. This study seeks to identify whether muscle loss occurs outside the radiation fields and if muscle loss is correlated with the degree of fatigue.

Detailed description: This study uses a patient reported survey to assess fatigue prior to radiotherapy for breast cancer. Fatigue is measured again at the completion of radiation treatments and at one and three months following completion of radiation.

Muscle measurements are made outside the treatment area using ct scans prior to radiation treatment, at the completion of radiation treatment and at one and three months after radiation treatment. The degree of fatigue and changes in muscle will be assessed. Changes will be correlated to determine if muscle loss contributes to fatigue.

Eligibility criteria: Inclusion Criteria:

1. Women Age ≥ 18 years
2. Non-metastatic breast cancer for which post-operative radiation treatment has been recommended as standard of care
3. Able to provide informed consent
4. Able to complete the Brief Fatigue Inventory questionnaire -

Exclusion Criteria:

1. Pregnant
2. Inability to meet eligibility requirements -

Primary outcomes:
measure: Changes in self-reported fatigue using the validated questionnaire "Brief Fatigue Inventory"
timeFrame: 5 months
measure: Changes in muscle area outside the radiation treatment area determined on cross sectional anatomy from CT scan images
timeFrame: 5 months
measure: Correlation between muscle area and fatigue
timeFrame: 5 months
Secondary outcomes:
measure: Changes in cross-sectional muscle area within the radiation treatment area measured on ct scans
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
affiliation: Essentia Health
name: Ken Dornfeld, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04473469: Previously Implanted Pudendal Nerve Stimulation
Official title: Previously Implanted Pudendal Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Retention
Underactive Bladder
Keywords: Pudendal nerve mapping
Nerve stimulation
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-07-16
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study seeks to examine the response of the bladder to different pudendal nerve stimulation frequencies, by studying patients who have been previously-implanted with pudendal nerve neurostimulators.

Detailed description: The pudendal nerve goes to the urethra, anus, and other areas of the pelvic floor. Electrical stimulation of this nerve can help with bladder, bowel, and sexual problems, and pelvic pain. Researchers do not fully understand how the nerve helps with these functions or how the anatomy is different between people. Successful stimulation of the pudendal nerve may help improve medical care for future patients with bladder problems, pelvic pain, bowel problems, and/or sexual problems.

Eligibility criteria: Inclusion Criteria:

* Previously received an implanted neurostimulator at the pudendal nerve
* Adult (18 or older), capable of providing own informed consent and communicating clearly with the research team
* Capable of speaking, reading, and understanding English, as all study questionnaires are standardized assessments only available in English.
* Capable of attending the experimental session

Exclusion Criteria:

* Pregnant or planning to become pregnant during study. If a woman of child- bearing potential wishes to participate in this study, they will be pre-screened with a test to detect pregnancy
* Currently has a urinary tract infection (UTI)
* Currently has or tested positive in the last 14 days for COVID-19, or is symptomatic for COVID-19
* Unwilling to allow de-identified data to be stored for future use or shared with other researchers

Primary outcomes:
measure: Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During Cystometrogram
timeFrame: Visit 1, approximately 1 week after consent
Secondary outcomes:
measure: Selective Stimulation of Pudendal Nerve Branches
timeFrame: 2 hours
measure: Measurement of Effect of Selective Pudendal Nerve Stimulation (PNS) on Urethral Leak Point Pressure (ULPP)
timeFrame: 2 hours
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Tim Bruns, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Priyanka Gupta, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00956969: Stress Management for Chronic Headaches
Official title: Emotional Awareness and Expression Training and Relaxation Training for People With Chronic Headaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headaches
Keywords: headaches
stress management
assertiveness training
relaxation training
emotional expression
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 147
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: This interventional, randomized controlled study seeks to test the effects of a novel emotional awareness and expression intervention against relaxation training or no intervention for college students with chronic headaches. These two interventions are conceptually quite distinct, as the former seeks to activate and process anger, whereas the latter, more commonly used technique, seeks to suppress or avoid it.


Eligibility criteria: Inclusion Criteria:

* Undergraduate students at Wayne State University who have chronic headaches

Exclusion Criteria:

* Insufficiently frequent headaches
* Uninterested in engaging in a stress management intervention
* Headaches appear due to substance use or head trauma

Primary outcomes:
measure: Headache frequency and severity
timeFrame: baseline, 6-weeks, 6-months
Secondary outcomes:
measure: Headache disability
timeFrame: baseline, 6-weeks, 6-months
measure: Mood, self-efficacy, stress symptoms
timeFrame: baseline and 6-weeks
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: Wayne State University
name: Mark A. Lumley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02796469: Meta-Analysis of Drug Therapy in Patients With Severe Alcoholic Hepatitis
Official title: Statistical Analysis Plan for an Individual Patient Data Meta-analysis of Ten Clinical Trials Comparing Drug Therapy in Patients With Severe Alcoholic Hepatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholic Hepatitis
Alcoholic Liver Disease
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 1974
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe alcoholic hepatitis assessed by Discriminant Function (DF) ≥32.

Brief summary: In the specific setting of the evaluation of corticosteroids, pentoxifylline of their combination in severe alcoholic hepatitis, only meta-analysis combining individual data is able to provide detailed information from each individual with severe alcoholic hepatitis assessed by a DF ≥ 32. The need for such an approach is confirmed by the fact that in both univariate and multivariate analyses, truth survival is lower for conclusions from meta-analysis of the literature than for conclusions derived from non-meta-analyses.

The present study is a meta-analysis of individual data from RCTs restricted to patients with a DF ≥ 32. The primary endpoint will be to compare 28-day survival of patients receiving either corticosteroids, or pentoxifylline or their combination to those of patients not receiving them adjusted on the independent prognostic factors at baseline.

The secondary endpoints will be: a) assessment of response to the assigned treatment using the Lille model; b) analysis of 6-month survival according to allocated therapy.


Eligibility criteria: Inclusion Criteria:

* patients included in 10 randomized controlled trials testing either corticosteroids alone, or pentoxifylline alone or their combination have been published.

Exclusion Criteria:

-

Primary outcomes:
measure: Overall survival
timeFrame: at 28 days, after the first administration of treatment
Secondary outcomes:
measure: Lille Model Score
timeFrame: at day 7, after the first administration of treatment
measure: Biological measure : Bilirubin
timeFrame: at day 7, at day 28
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Philippe Mathurin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02402569: Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease
Official title: Implantation Feasibility Study of a Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease (Smart in Vivo 2)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Parkinson Disease
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to demonstrate innocuity and feasibility of deep brain stimulation with a multi-electrodes set.

Detailed description: Bilateral stimulation in subthalamic nucleus with the multi-electrodes set will be compared with single electrode.

Eligibility criteria: Inclusion Criteria:

* more or equal than 18 years old and less than 70 years
* patient affiliated to social security or similarly regime
* informed consent form signed
* parkinson disease (UPDRS III20 score up than 30/108 except for severe tremors)
* motor and non motor dysfunctions
* pre-operative cerebral MRI without lesion
* without chirurgical contraindications
* without psychiatric disease

Exclusion Criteria:

* Pregnant women and lactating mothers
* Ward of court or under guardianship
* Adult unable to express their consent
* Person deprived of freedom by judicial or administrative decision
* Person hospitalized without their consent
* Person under legal protection
* Person with carcinological antecedent during precedent 5 years
* Chirurgical or MRI contraindications

Primary outcomes:
measure: Safety, as measured by Number of Participants with Adverse Events
timeFrame: 3 months
Secondary outcomes:
measure: Neurologic evaluation
timeFrame: 3 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CLINATEC
Study officials:
References:
Clinical trial NCT01668069: Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy
Official title: Is Zofran Superior to Pyridoxine at Reducing Nausea and Vomiting in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vomiting of Pregnancy
Keywords: nausea
vomiting
pregnancy
ondansetron
doxylamine
vitamin B6
pyridoxine
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2012-08-17
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our purpose is to determine whether ondansetron, a commonly used antiemetic, is equivalent in efficacy to the combination of pyridoxine and doxylamine, the currently recommended first line therapy for nausea and vomiting in pregnancy by the American Congress of Obstetricians and Gynecologists (ACOG). Since both treatments are safe in pregnancy, many physicians are using ondansetron as first line in practice. Despite this practice and the recommendations from ACOG, there is not data to suggest that ether practice is superior. This will be the first prospective, randomized, double blind, controlled trial comparing the two treatments. We hypothesize that ondansetron will be equally efficacious in reducing nausea and episodes of emesis. By alleviating nausea and vomiting associated with pregnancy, patients will likely benefit from less Emergency Department visits, urgent clinic visits, and admissions for progression to hyperemesis gravidarum.


Eligibility criteria: Inclusion Criteria:

* Women who are less than 16 weeks pregnant by last menstrual period or ultrasound
* Greater than 18 years of age
* English speaking
* No significant visual or hearing impairment
* Requesting treatment for nausea associated with pregnancy

Exclusion Criteria:

* If nausea or vomiting preexisted the pregnancy
* Requires hospitalization at the time of initial enrollment
* Already taking anti-emetics to include metoclopramide, ondansetron, doxylamine, pyridoxine, or promethazine
* The patient has an allergy to either study regimen
* If they are unable to return for a follow up visit in 1 week

Primary outcomes:
measure: Reduction of nausea on the VAS (Visual Analog Scale)
timeFrame: 5 days
Secondary outcomes:
measure: Reduction in vomiting on the VAS
timeFrame: 5 days
measure: Any adverse effects caused by the study medications.
timeFrame: 5 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center, San Diego
state: California
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: Lauren G Oliveira, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oliveira LG, Capp SM, You WB, Riffenburgh RH, Carstairs SD. Ondansetron compared with doxylamine and pyridoxine for treatment of nausea in pregnancy: a randomized controlled trial. Obstet Gynecol. 2014 Oct;124(4):735-742. doi: 10.1097/AOG.0000000000000479.
Clinical trial NCT01431469: Efficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Infection
Diarrheal Disease
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
Collaborators: name: Federal University of Bahia
First posted: 2011-09-09
Enrollment: 250
Sex: ALL
Minimum age (years): 12
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.


Eligibility criteria: Inclusion Criteria:

* Child 12-48 months of age
* Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization
* Signed informed consent

Exclusion Criteria:

* Child who is receiving predominantly breast-milk
* Child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization
* Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child
* Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization
* Child's z-score of weight for length/height \< -3 according to World Health Organization criteria

Primary outcomes:
measure: Episodes of acute respiratory infections and diarrheal disease
timeFrame: 28 weeks
Secondary outcomes:
measure: Occurrence of allergic manifestations
timeFrame: 28 weeks
measure: Systemic antibiotic use
timeFrame: 28 weeks
measure: Duration of acute respiratory infection and diarrheal disease
timeFrame: 28 weeks
measure: Changes in stool patterns
timeFrame: 28 weeks
measure: Fecal and serum immune markers
timeFrame: 28 weeks
measure: Serum Ferritin and Zinc status
timeFrame: 28 weeks
measure: Incidence of stool parasites
timeFrame: 28 weeks
measure: Growth
timeFrame: 28 weeks
measure: Incidence of adverse events
timeFrame: 28 weeks
measure: Acceptance of study product
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Universidade Federal da Bahia, Hospital Universitário Prof. Edgard Santos Complexo HUPES, Centro Pediátrico Professor Hossanah Oliveira, Centro da Pesquisas Fima Lifshitz, Rua Augusto Viana s/n Canela
state: Bahia
Study officials:
References:
citation: Pontes MV, Ribeiro TC, Ribeiro H, de Mattos AP, Almeida IR, Leal VM, Cabral GN, Stolz S, Zhuang W, Scalabrin DM. Cow's milk-based beverage consumption in 1- to 4-year-olds and allergic manifestations: an RCT. Nutr J. 2016 Feb 27;15:19. doi: 10.1186/s12937-016-0138-0.
Clinical trial NCT00789269: Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From a Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pneumonia
Acute Stroke
Keywords: lung infection after ischemic Stroke
prevention of pneumonia
rhubarb
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2008-11-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will determine if rhubarb will reduced the incidence of pneumonia and improved recovery from an acute stroke. The study is designed to look at both infection rate and overall recovery and recovery of motor function, for example muscle strength and coordination.


Eligibility criteria: Inclusion Criteria:

* Occurrence of an acute ischemic stroke (between 9 and 72 h after onset) with a score of at least 6 on the National Institute of Health Stroke Scale (NIHSS), and patient age of at least 18 years.
* Have no pneumonia according to modified criteria of the U.S. Centers for Disease Control and Prevention (CDC)
* Consistent with the Constipation of Phlegm-Heat Accumulation type by Traditional Chinese Medicine (TCM) standard
* Patients or their representatives voluntarily take part in this study and signed the informed consent

Exclusion Criteria:

* Cerebral hemorrhage, subarachnoid hemorrhage
* Transient ischemic attack(TIA)
* Proven cerebral embolism caused by tumor, Brain Trauma, cerebral parasitic disease, dysbolismus, fibrillation atrial resulted from rheumatic heart disease, coronary heart disease, and other heart diseases
* Clinical signs of infection on admission
* Pregnant or breast-feeding
* Allergic to rhubarb
* Preceding or ongoing antibiotic therapy within the last 24 h
* Participation in another interventional trial
* Immunosuppressant treatment within the last 30 days
* Combining severe clinical conditions such as liver, kidney, Hematopoietic System, endocrine system or psychological diseases

Primary outcomes:
measure: The lung infection rate within 14 days after stroke onset
timeFrame: 14 days
Secondary outcomes:
measure: Global disability on modified Rankin scale
timeFrame: 90 days
measure: NIH stroke scale
timeFrame: 90 days
measure: Barthel Index
timeFrame: 90 days
measure: Death rate
timeFrame: 90 days
measure: Syndrome score by Traditional Chinese Medicine (TCM) standard
timeFrame: 90 days
measure: Changes in laboratory indexes as safety assessment, including red blood cell(RBC), white blood cell(WBC), platelet(PLT), alanine transaminase (ALT), aspartate transaminase (AST), blood urea nitrogen (BUN), creatinine(Cr) in blood samples, etc.
timeFrame: 90 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Integrative Medicine, Zhongshan hospital, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT01274468: Tumor Markers in Lung Cancer
Official title: Tumor Markers in Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 10
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ten patients with an expected age \>45 years

Brief summary: The aim of this study is to determine if DCAMLK1 can be measured in the endobronchial biopsy specimens and bronchial washings from patients with lung cancer.

Detailed description: DCAMLK1 is a Ca2+ - ca/modulin (CaM) - dependent protein kinase that is a marker of stem cells in colonic crypts. Mutations within the stem cell population are thought to be responsible for the development of most colorectal carcinomas and studies have shown that DCAMLK1 is highly expressed in these tumors. Since the lung is an embryological development of the foregut, we speculate that DCAMLK1 will also be upregulated in lung cancers. The aim of this pilot study is to determine if DCAMLK1 can be measured in the endobronchial biopsy specimens and bronchial washings from patients with lung cancer.

This is a prospective study in 10 patients with lung masses suspected to be malignant who are scheduled for diagnostic bronchoscopy.

Patients with lung masses scheduled for diagnostic bronchoscopy will be included if they can give informed consent to participate and the diagnostic portion of the bronchoscopy has been uncomplicated. Patients considered to be at high risk during bronchoscopy because of either abnormal blood gases (Pco2 \> 50 mmHg or PaO2 \< 70 mmHg on oxygen) or coagulopathy (platelets \<100,000 or INR \> 1.5) will be excluded.

If the preliminary results indicate this is feasible, we will then propose a larger study to examine DCAMLK1 distribution in normal and cancerous tissue as well as the predictive value of this biomarker.

Eligibility criteria: Inclusion Criteria:

* abnormality on chest x-ray that requires diagnosis and physically capable of undergoing bronchoscopy

Exclusion Criteria:

* \<45 years
* Patients with severe abnormalities in blood gases and/or a coagulopathy will be excluded.

Primary outcomes:
measure: Identification of DCAMLK1 in BAL and lung biopsy specimens.
timeFrame: After collection and analysis of specimens.
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Veterans Affairs Medical Center
state: Oklahoma
Study officials:
affiliation: OU Health Sciences Center
name: Gary T Kinasewitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Humphries A, Wright NA. Colonic crypt organization and tumorigenesis. Nat Rev Cancer. 2008 Jun;8(6):415-24. doi: 10.1038/nrc2392. Epub 2008 May 15.