louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02784145: Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease
Official title: Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators will investigate the effects of an 8-week resistant starch (RS) supplementation (5 g twice a day) in patients with Parkinson Disease and matched controls on:

1. symptoms of constipation (assessed by clinical scores);
2. fecal short chain fatty acid concentrations (measured by chromatography);
3. gut microbiota composition.


Eligibility criteria: Main Inclusion Criteria:

* Written informed to participate
* For patients: diagnosis of Parkinson Disease

Main Exclusion Criteria:

* Use of antibiotics, steroids or probiotic supplements
* Chronic or acute disorders of the gastrointestinal tract
* History of gastrointestinal surgery (other than appendectomy)
* For healthy controls: Family history of neurodegenerative disorders

Primary outcomes:
measure: Bowel habits
timeFrame: 8 weeks
measure: Fecal short chain fatty acid (SCFA) concentrations
timeFrame: 8 weeks
measure: Analysis of fecal microbiota composition
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Homburg / Saar
country: Germany
facility: Saarland University
state: Saarland
Study officials:
affiliation: Saarladnd University, Department of Neurology
name: Marcus M Unger, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00718445: Pennsylvania Consortium: Clinical Database
Official title: Pennsylvania Consortium: Clinical Database
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Amyotrophic Lateral Sclerosis
Neurodegenerative Disease
Motor Neuron Disease
Keywords: Amyotrophic Lateral Sclerosis
Cerebrospinal Fluid
Neurodegenerative Disease
Motor Neuron Disease
Autonomic Nervous System
Neurodegenerative Diseases
Movement Disorders
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: MDA/ALS Center of Hope
First posted: 2008-07-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen in the MDA/ALS Center of Hope at Drexel University College of Medicine Patients seen in the Department of Neurology at Drexel University College of Medicine

Brief summary: In order to streamline disease research in ALS and other motor neuron diseases, we have joined a consortium of clinical centers (Hershey and University of Pittsburgh) who will collaborate on clinical and basic research projects. As part of this collaboration, de-identified clinical data from subjects at each institution will be entered into a joint database kindly provided and maintained by the ALS Hope Foundation. This database is password protected and contains only de-identified information. In addition to clinical data, any research specimens that are available through IRB approved tissue collections will be linked to the subject so that the collaborating investigators can share samples and have the maximum information. This will enhance the usefulness of each specimen.

Once established, the database will provide a resource in which clinical data on a large number of patients along with tissue (blood, urine, muscle, csf, and autopsy) samples will be readily available. This will expedite research by circumventing the delays in collecting specimens prospectively and increase the number of specimens available by allowing the collaborating researchers access to each others specimens. In each case there will be a formal request placed to use specimens that are at the other institutions. These specimens will be used for research in the ALS Center of Hope at the Drexel University College of Medicine and shared with outside investigators with valid IRB approved protocols.


Eligibility criteria: Inclusion Criteria:

* Clinical data on patients with motor neuron diseases (ALS, PLS, Bulbar Palsy) and related disorders

Exclusion Criteria:

* Any patient without a motor neuron disease or related disorder

Primary outcomes:
measure: None Specified
timeFrame: None Specified
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: MDA/ALS Center of Hope
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03898245: Effectiveness of Transcranial Direct Current Stimulation for TKR
Official title: Effectiveness of Transcranial Direct Current Stimulation for Postoperative Pain in Total Knee Replacement Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transcranial Direct Current Stimulation
Post Operative Pain
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Transcranial direct current stimulation (tDCS) is a technique of noninvasive cortical stimulation allowing significant modification of brain function used. Clinical application of this technique could be helpful for pain, Parkinson's disease, dystonia, cerebral palsy and dementia etc. And tDCS is safe with only mild, transient adverse effects. But there is few studies focused to postoperative states.

The aim of this project is to reveal the effect of tDCS for postoperative pain after total knee replacement surgery,


Eligibility criteria: Inclusion Criteria:

* Subjects who have scheduled elective spine surgery.

Exclusion Criteria:

* Who has Cognitive dysfunction before surgery.
* Who already has delirium before surgery.
* Who has pain disorder ( like CRPS)
* Who cannot reveal the one's pain.

Primary outcomes:
measure: VAS score
timeFrame: 1hour, 6hours, 24 hours, 48 hours
Secondary outcomes:
measure: Incidence of Delirium
timeFrame: postop day 1,3,6
measure: Consumption of PCA
timeFrame: 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
affiliation: Seoul Metropolitan Government Seoup National University Boramae Medical Center
name: Jin-Young Hwang, MD,phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lefaucheur JP. A comprehensive database of published tDCS clinical trials (2005-2016). Neurophysiol Clin. 2016 Dec;46(6):319-398. doi: 10.1016/j.neucli.2016.10.002. Epub 2016 Nov 17.
citation: Borckardt JJ, Romagnuolo J, Reeves ST, Madan A, Frohman H, Beam W, George MS. Feasibility, safety, and effectiveness of transcranial direct current stimulation for decreasing post-ERCP pain: a randomized, sham-controlled, pilot study. Gastrointest Endosc. 2011 Jun;73(6):1158-64. doi: 10.1016/j.gie.2011.01.050. Epub 2011 Apr 5.
citation: Borckardt JJ, Reeves ST, Robinson SM, May JT, Epperson TI, Gunselman RJ, Schutte HD, Demos HA, Madan A, Fredrich S, George MS. Transcranial direct current stimulation (tDCS) reduces postsurgical opioid consumption in total knee arthroplasty (TKA). Clin J Pain. 2013 Nov;29(11):925-8. doi: 10.1097/AJP.0b013e31827e32be.
Clinical trial NCT00003445: Docetaxel in Treating Patients With Advanced Cancer of the Cervix
Official title: Neoadjuvant Chemotherapy With Docetaxel in Advanced Cervical Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: stage III cervical cancer
stage IIB cervical cancer
stage IVA cervical cancer
cervical squamous cell carcinoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-04-23
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with advanced cancer of the cervix.

Detailed description: OBJECTIVES: I. Assess the antitumor activity of docetaxel as neoadjuvant chemotherapy in patients with locally advanced squamous cell carcinoma of the cervix. II. Assess the tumor response, toxic effect, and survival rate of this regimen in these patients.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Treatment is repeated every 3 weeks for 3 courses. Patients are followed every 3 months posttreatment.

PROJECTED ACCRUAL: A total of 16-35 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically proven stage IIB, IIIA, IIIB, and IVA squamous cell carcinoma of the cervix Bidimensionally measurable disease No bilateral hydronefrosis

PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 10 g/dL Leukocytes at least 4,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin less than 1.25 times upper limit of normal (ULN) AST less than 1.25 times ULN Renal: BUN less than 30 mg/dL AND Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No prior or other concurrent malignancies, other than properly treated basal cell skin cancer

PRIOR CONCURRENT THERAPY: Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Neuquen
country: Argentina
facility: Unidad Oncologica Del Comahue
Study officials:
affiliation: Grupo Oncologico Cooperativo del Sur
name: Carlos Teodoro Vallejo, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00208845: Hypernet- Hypertension Screening
Official title: Hypernet- Hypertension ED Surveillance
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Asymptomatic Hypertension
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2005-09-21
Enrollment: 100
Sex: ALL
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: adult ED patients

Brief summary: Identify untreated, asymptomatic hypertension in ER patients

Detailed description: this was a prospective study done with no intervention- the study has since been completed

Eligibility criteria: Inclusion Criteria:

* asymptomatic hypertension

Exclusion Criteria:

* cardiac symptoms

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Emory University
name: Katherine Heilpern, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05697445: Combined Effect Of Cranial And Cervical Mobilization In Patients With CGH
Official title: Combined Effect Of Cranial And Cervical Mobilization In Patients With Cervicogenic Headache
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervicogenic Headache
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * The purposes of this study are:
* To investigate the combined effect of cranial and cervical mobilization in patient with cervicogenic headache and there effect on :

  1. Perceptive neck pain intensity
  2. Perceptive headache intensity
  3. pain by pressure
  4. frequency of headache episodes
  5. duration of headache episodes
  6. Medications uptakes


Eligibility criteria: Inclusion Criteria:

* pain originating at the neck and radiating to oculo-frontal-temporal regions.
* symptom unilaterally.
* symptom provocation through cervical movement and/or awkward cervical postural.
* symptom provocation through external pressure application through palpation to associated posterior cervical spine segments with resultant symptom reproduction.
* possible ipsilateral shoulder and/or arm pain of vague reference.
* 15 or more headache episodes per month
* No history of cervical operation or any disease that result in headache as colities -All patients will sign the informed consent before joining the study.

Exclusion Criteria:

* Headache not of cervical origin
* Headache with autonomic involvement, dizziness, or visual disturbance
* Congenital conditions of the cervical spine
* It is of primary concern to exclude serious or life-threatening pathology such as :
* cranial tumors.
* Meningitis.
* sub-arachnoid hemorrhage.
* carotid artery,vertebral artery dissection.
* History of cervical operation or any disease that result in headache as colitis
* Age less than 18 or more than 40 years
* chronic maxillary sinusitis

Primary outcomes:
measure: Assis Headache Perceptive intensity
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05234645: Short Term Effects of Probiotics in the Human Micro-vascular Physiology
Official title: Short Term Effects of Probiotics in the Human Micro-vascular Physiology - Comparison Between Older and Younger Healthy, Sedentary Adults: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microcirculation
Endothelial Dysfunction
Lead sponsor: Sheffield Hallam University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: While the beneficial properties of kefir consumption have been thoroughly studied for many years, very little research has been conducted to explore the potential protective properties of kefir consumption to the endothelium in humans. Therefore, the aim of the current study is to explore the short-term efficacy of kefir consumption in improving endothelial function in older and younger healthy, sedentary adults.


Eligibility criteria: Inclusion Criteria:

All recruited participants were either 18-35 yrs. or 55-75 yrs.

Exclusion Criteria:

Pregnancy; chronic diseases with the potential to influence vascular function; smoking status; sedentary (defined via the completion of the international physical activity questionnaire; IPAQ); regular consumption of probiotic-containing products; any overt chronic diseases.

Primary outcomes:
measure: Microcirculatory function
timeFrame: Baseline.
measure: Microcirculatory function
timeFrame: 8 weeks.
Secondary outcomes:
measure: Anthropometry - 1
timeFrame: Baseline.
measure: Anthropometry - 1
timeFrame: 8 weeks.
measure: Anthropometry - 2
timeFrame: Baseline.
measure: Anthropometry - 2
timeFrame: 8 weeks.
measure: SF-IPAQ
timeFrame: Baseline.
measure: A discontinuous, sub-maximal test, coupled with transcutaneous oxygen pressure (TcPO2).
timeFrame: Baseline
measure: A discontinuous, sub-maximal test, coupled with transcutaneous oxygen pressure (TcPO2).
timeFrame: 8 weeks.
measure: Blood pressure
timeFrame: Baseline.
measure: Blood pressure
timeFrame: 8 weeks.
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Hallam University
state: Yorkshire
Study officials:
affiliation: Reader (Clinical Physiology)
name: Markos Klonizakis, D.Phil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04141345: Comorbid Chronic Lung Disease on Heart Failure
Official title: Influence of Comorbid Chronic Lung Disease on Heart Failure Long-Term Outcomes: Relevance of Ventilatory Inefficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Comorbid Chronic Lung Disease on Heart Failure
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A cohort of 169 HF outpatients with exercise intolerance took the CPET at a tertiary referral center between May 2007 and July 2010. Patients were recruited consecutively based on clinical assessment of risk factors for HF and echocardiographic evidence of systolic dysfunction or diastolic dysfunction. In patients with normal LVEF (\>=50), the diagnosis of diastolic dysfunction was based on echocardiographic parameters. Chronic lung disease (CLD) was defined as spirometry with obstructive lung disease or restrictive lung disease with accompanying clinical symptoms and signs included in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.

Brief summary: Comorbid chronic lung disease (CLD) increases mortality in heart failure (HF) patients. Understanding the predictors and pathophysiology of HF can improve the efficacy of HF treatment. This study evaluated the cardiopulmonary exercise test (CPET) results to identify significant predictors on long-term outcomes in HF patients with CLD.

Detailed description: The CPET was administered in a cohort of 169 HF outpatients with exercise intolerance at a tertiary referral center between May 2007 and July 2010. A CLD was defined as abnormal spirometry accompanied by clinical symptoms and signs included in the Global Initiative for Chronic Obstructive Lung Disease criteria. The primary endpoint was defined as CV mortality or the first HF hospitalization. Totally 49 events occurred before the end of follow up in January 2018.

Eligibility criteria: Inclusion Criteria:

* outpatients ≥ 18 years of age, male or female.
* Patients with a diagnosis of heart failure with clinical symptoms and echocardiography evidence
* Patients received cardiopulmonary exercise test exams

Exclusion Criteria:

* Cannot tolerance exercise test due to muscular-skeletal disorder
* Cannot co-operate all functional studies
* Family reject to participate in this project

Primary outcomes:
measure: Number of Participants That Had Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or First Heart Failure (HF) Hospitalization
timeFrame: May, 2007 ~ January, 2018
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02434445: Use of Novel Plasma and Urinary Biomarkers to Predict the Development of Hepatorenal Syndrome in Cirrhotic Patients
Official title: Use of Novel Plasma and Urinary Biomarkers to Predict the Development of Hepatorenal Syndrome in Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatorenal Syndrome
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Society of Nephrology
First posted: 2015-05-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
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: Patients with advanced cirrhosis (Child's B or C) referred for liver transplantation

Brief summary: This study investigated the use of novel plasma and urinary biomarkers to predicte the development of hepatorenal syndrome in patients with advanced cirrhosis. The biomarkers investigated include plasma cystatin C, plasma NGAL, plasma NAG, plasma IL-18, plasma ADMA, plasma BTP, urinary KIM-1 and urinary LFABP. These biomarkers will be checked in advanced cirrhotic patients who have or have not developed hepatorenal syndrome and compared between the two groups. These biomarkers will also be correlated with the occurence of hepatorenal syndrome.

Detailed description: This study investigated the use of novel plasma and urinary biomarkers to predicte the development of hepatorenal syndrome in patients with advanced cirrhosis. The biomarkers tested include plasma cystatin C, plasma NGAL, plasma NAG, plasma IL-18, plasma ADMA, plasma BTP, urinary KIM-1 and urinary LFABP. These biomarkers will be checked in advanced cirrhotic patients who have or have not developed hepatorenal syndrome and compared between the two groups. These biomarkers will also be correlated with the occurence of hepatorenal syndrome.

Eligibility criteria: Inclusion Criteria:

* Patients with advanced cirrhosis (Child's B or C) referred for liver transplantation
* Willing to give informed consent

Exclusion Criteria:

* Patients with co-existing renal diseases

Primary outcomes:
measure: Hepatorenal syndrome
timeFrame: 12 weeks
Secondary outcomes:
measure: Mortality
timeFrame: 6 months
measure: Chronic renal impairment
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Desmond Yap, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05133245: PHACE - Prospective Genetic Investigation
Official title: PHACE - Prospective Genetic Investigation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: PHACE Syndrome
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All age groups, genders, and ethnicities who qualify with the PHACE syndrome diagnosis and consent to undergo an examination and genetic testing.

Brief summary: Investigation for potential PHACE syndrome gene.

Detailed description: Subjects with PHACE syndrome diagnosis will undergo a brief physical examination with possible external photographs. Cheek swabs will be sent for genetic analysis. Subjects will be notified of the results.

Eligibility criteria: Inclusion Criteria:

* PHACE syndrome diagnosis
* Must be willing to have an eye examination
* Must be willing to undergo genetic testing

Exclusion Criteria:

* No PHACE syndrome diagnosis

Primary outcomes:
measure: Potential PHACE Gene Identification
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Eye Institute
state: Tennessee
Study officials:
affiliation: Vanderbilt Eye Institute
name: Karen Joos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: