louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03845673: Fiber Regimens for Constipation Symptoms
Official title: Randomized Trial Comparing Two Fiber Regimens for the Reduction of Symptoms of Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: Bowel recipe
Bristol stool form scale
Konsyl
psyllium
wheat bran
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 53
Sex: FEMALE
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 objective of the current study is to compare the effects of bowel recipe with psyllium on symptoms associated with constipation.

Detailed description: Patients presenting to the urogynecology clinics at Parkland Health and Hospital System and UT Southwestern Medical Center at Dallas from July 2003 to July 2005 were screened for symptoms of constipation. Subjects were randomized to a 6-week course of either psyllium (Konsyl, Konsyl Pharmaceuticals, Easton, MD) or a special bowel recipe. The bowel recipe was a modification of that used by Behm and consisted of 1 cup of unprocessed wheat bran, 1 cup of applesauce, and 1/4 cup of prune juice. A validated constipation scoring questionnaire12 was administered to participants at the beginning and at the end of the six-week study period. During the six-week trial patients also kept a bowel diary recording characteristics of each bowel movement.

Eligibility criteria: Inclusion Criteria:

* fluent and literate in either English or Spanish.
* responds affirmatively to at least two symptoms according to Rome II criteria for functional constipation, for at least 12 weeks

Exclusion Criteria:

* pregnant or less than six weeks postpartum
* six weeks post abdominal surgery,
* colostomy
* history of bowel obstruction, inflammatory bowel disease, diagnosis of slow colonic transit time, spinal cord injury, neurogenic disease, myopathic disorders, or cognitive impairment, history of an allergic reaction to psyllium or any of the ingredients contained in the bowel recipe, such as wheat bran, prunes, or apples.

Primary outcomes:
measure: Constipation questionnaire scores
timeFrame: 6 weeks
Secondary outcomes:
measure: frequency of bowel movements
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Clifford Y Wai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00481273: AVIDA The Vidaza® (Azacitidine) Patient Registry
Official title: AVIDA The Vidaza® (Azacitidine) Patient Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndromes
Keywords: MDS
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2007-06-01
Enrollment: 479
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community-based hematology/oncology centers

Brief summary: This registry is a prospective, multi-center, observational study compiling data on the natural history and management of patients receiving Vidaza, and will provide unique insights into the management of myelodysplastic syndromes (MDS) and other hematological disorders and the impact of these disorders on patients.


Eligibility criteria: Inclusion Criteria:

* Patient who is deemed appropriate for treatment with Vidaza® by his or her clinician, but who has not already started receiving Vidaza® treatment.
* Patient who is able to read and speak English.
* Patient who is willing and able to provide informed consent.
* Patient who agrees to complete patient assessment questionnaires.

Exclusion Criteria:

* Patients who are currently being treated with Vidaza®.
* Patients who are concurrently participating in a clinical trial.
* Patients unwilling or unable to complete the baseline and follow-up questionnaires.
* Patients who are deemed inappropriate for treatment with Vidaza®.

Primary outcomes:
measure: Vidaza usage
timeFrame: Approximately 4 years
measure: Concomitant care and treatment
timeFrame: Approximately 4 years
measure: Duration and number of cycles
timeFrame: Approximately 4 years
measure: Publication
timeFrame: Approximately 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: AVIDA Registry Help
state: Missouri
Study officials:
affiliation: Endeavor Health
name: David L. Grinblatt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grinblatt DL, Sekeres MA, Komrokji RS, Swern AS, Sullivan KA, Narang M. Patients with myelodysplastic syndromes treated with azacitidine in clinical practice: the AVIDA registry. Leuk Lymphoma. 2015 Apr;56(4):887-95. doi: 10.3109/10428194.2014.935366. Epub 2014 Aug 20.
Clinical trial NCT03094273: Prospective Study of 2 mm Margins for the Biopsy of Dysplastic Nevi
Official title: Prospective Study of 2 mm Margins for the Biopsy of Dysplastic Nevi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysplastic Nevi
Keywords: Melanocytic neoplasm
Biopsy
Saucerization biopsy
Skin lesion
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NYU Dermatology Faculty Practice

Brief summary: Non-interventional study to evaluate the utility of removing Dysplastic Nevi with a defined 2 mm margin.

Detailed description: This is a prospective, observational study to evaluate the utility of removing Dysplastic Nevi (DN) with a defined 2 mm margin. This is a non-interventional study that will observe the pathology results following a standard of care biopsy. Principal Investigator (PI) hypothesize that the majority of lesions removed with this technique will have margins free of nevus cells on examination of histopathological sections. Hence, pathologists will not suggest that an additional excision be performed to remove any residual nevus. PI also hypothesize that if biopsy sites are followed over time, the rate of nevus recurrence will be low, because investigators would have removed the majority, if not all of the lesion at the time of initial biopsy.

Eligibility criteria: Inclusion Criteria:

* All patents seen in the practices of the study physicians are eligible to participate in the study.
* Patients must be over 18 years of age.
* Patients who are able to provide informed consent.
* Patient must have a lesion in which the differential diagnosis includes a DN and for which the study dermatologist deems it is appropriate to perform a saucerization biopsy.

Exclusion Criteria:

* Patients who are less than 18 years of age.
* Patients who are unable to provide informed consent.
* Lesions for which a saucerization biopsy is impractical in the judgment of the study dermatologist based on certain clinical factors (e.g. patient on anticoagulation therapy, lesion size and/or anatomic location).

Primary outcomes:
measure: Clear margins on the histopathological sections examined after a 2 mm saucerazation biopsy.
timeFrame: Up to 1 year
Secondary outcomes:
measure: Nevus recurrence rate
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Laura & Isaac Perlmutter Cancer Center & NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: David Polsky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Terushkin V, Ng E, Stein JA, Katz S, Cohen DE, Meehan S, Polsky D. A prospective study evaluating the utility of a 2-mm biopsy margin for complete removal of histologically atypical (dysplastic) nevi. J Am Acad Dermatol. 2017 Dec;77(6):1096-1099. doi: 10.1016/j.jaad.2017.07.016. Epub 2017 Oct 2.
Clinical trial NCT01503073: Noninvasive Brain Stimulation for Stroke
Official title: Noninvasive Brain Stimulation for Stroke Improvement
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Stroke
Keywords: stroke
Lead sponsor: University Hospital of Mont-Godinne
Sponsor class: OTHER
First posted: 2012-01-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Noninvasive brain stimulations will be used in acute and chronic stroke patients to improve a variety of functions.

Detailed description: Noninvasive brain stimulations (NIBS) will be used in acute and chronic stroke patients to improve a variety of functions such as motor functions, cognitive functions, ...

NIBS will be applied in a placebo-controlled, double-blind, randomised fashion. Behavioural data will be collected before and after NIBS, as well as brain functional imaging data.

Eligibility criteria: Inclusion Criteria:

* stroke with at least slight deficit

Exclusion Criteria:

* epilepsy
* contraindication to tDCS and/or to fMRI
* presence of metal in the head
* unability to understand / complete behavioural tasks
* chronic intake of alcohol or recreative drugs
* major health condition
* presence of pacemaker
* pregnancy

Primary outcomes:
measure: change in function before/after tDCS
timeFrame: Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months
Secondary outcomes:
measure: change in neuroimaging and neurophysiological before/after tDCS
timeFrame: Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: Department of Neurology, CHU Mont-Godinne
state: Namur
Study officials:
References:
citation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
citation: Lefebvre S, Thonnard JL, Laloux P, Peeters A, Jamart J, Vandermeeren Y. Single session of dual-tDCS transiently improves precision grip and dexterity of the paretic hand after stroke. Neurorehabil Neural Repair. 2014 Feb;28(2):100-10. doi: 10.1177/1545968313478485. Epub 2013 Mar 13.
Clinical trial NCT03312673: Asthma, Smoking, Emotional Deficits
Official title: Asthma, Smoking, Emotional Deficits
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Emotional Disorder
Alexithymia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asthma sufferers treated at the Croix Rousse hospital

Brief summary: The objective of the study is to determine whether poor control of asthma is related to an emotional deficit such as alexithymia. The hypothesis is that there is a correlation between the severity of asthma, its control, and the degree of emotional deficits.


Eligibility criteria: Inclusion Criteria:

* Men and women (\> 18 years).
* Asthma (mild, moderate, severe).
* Beneficiary of social security

Exclusion Criteria:

* Pregnant women
* Patients who oppose their participation in the study
* Multiple drug users (psychoactive substances).
* Patients with severe psychiatric antecedents and comorbidities.
* Patients with cancer
* Patients with cognitive impairment
* Patients with speech, hearing, visual, and praxic disorders.
* Any chronic and especially respiratory pathology other than asthma (COPD, bronchiectasis), which can alter the study.
* Patients not speaking French
* Persons protected by law

Primary outcomes:
measure: Poor control of asthma
timeFrame: During routine visit (one hour and a half)
measure: Emotional deficit such as alexithymia
timeFrame: During routine visit (one hour and a half)
measure: Emotional deficit indicator traces
timeFrame: During routine visit (one hour and a half)
measure: Depression
timeFrame: During routine visit (one hour and a half)
measure: Anxiety
timeFrame: During routine visit (one hour and a half)
measure: Emotional valences
timeFrame: During routine visit (one hour and a half)
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Pneumologie Hôpital de la Croix-Rousse
Study officials:
References:
Clinical trial NCT02267473: Hepatitis B Patients Under Oral Nucleos(t)Ide Treatment With Intermittent Assessment of Kidney Function
Official title: A Multicenter, Prospective, Observational Study of Patients With Chronic Hepatitis B Under Various Oral Nucleos(t)Ide Treatment With Intermittent Assessment of Kidney Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B, Chronic
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic Hepatitis B under oral antiviral treatment with an approved Nucleos(t)ice for a minimal duration of 6 months at study inclusion

Brief summary: Patients with chronic Hepatitis B who are under oral antiviral treatment for at least 6 months at study start will be monitored once yearly for kidney function changes within their routine outpatient visit. Therefore urine samples will be collected and some additional blood test will be done within the routine blood sampling.

Detailed description: This non-interventional, long-term observational cohort study will evaluate demographic, clinical, biochemical and virological parameters of outpatients with chronic Hepatitis B who are under oral antiviral treatment with an approved Nucleos(t)ide for \> 6 months at study inclusion.

During their routine outpatient visits annually an assessment of their kidney function especially for a proximal tubular dysfunction will be performed and their comedication will be explored. Patients included in the study are followed up for 5 years.

Eligibility criteria: Inclusion Criteria:

* chronic Hepatitis B Virus infection
* indication for an antiviral treatment due to the recent german Hepatitis B guidelines and oral intake of an approved Nucleos(t)ide for a minimum of 6 months at inclusion
* ALT \< 2 x UNL (upper normal limit) at study inclusion
* age 18 - 89 years
* signed informed consent form

Exclusion Criteria:

* coinfection with Hepatitis D Virus (HDV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)
* Comorbidities that will hinder the study performance (e.g. malignancies, relevant psychiatric disorder)
* hepatocellular carcinoma or hepatic metastases
* legally incapacitated patients

Primary outcomes:
measure: Change in Kidney Function
timeFrame: 5 Years
Secondary outcomes:
measure: Kidney relevant Comorbidities
timeFrame: 5 Years
measure: Kidney relevant Comedication
timeFrame: 5 Years
measure: HBV-DNS
timeFrame: 5 Years
measure: quantitative HBs Antigen
timeFrame: 5 Years
measure: Mitochondrial Toxicity
timeFrame: 5 Years
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
state: Rheinland-Pfalz
city: Frankfurt
country: Germany
facility: Klinikum der J. W. Goethe-Universität
Study officials:
References:
Clinical trial NCT03246373: the Effects of Cerebral Collateral Circulation on the Outcome of Leukoaraiosis in High-risk Population
Official title: Prospective, Single Center, Observational, Clinical Trial of the Effects of Cerebral Collateral Circulation on the Outcome of Leukoaraiosis in High-risk Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leukoaraiosis
Keywords: cognitive impairment
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 1037
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inpatients of physical exmination department or out-patients of neurology department in Zhongshan hospital Fudan University.

Brief summary: This study observed the relationship between cerebral collateral circulation and the prognosis of leukoaraiosis in high-risk population. Cerebral collateral circulation and leukoaraiosis levels will be evaluated and followed up by magnetic resonance examination. The participants' clinical performance caused by leukoaraiosis will be assessed by a series of scales.

Detailed description: 1. Case collection information is sent daily to clinical trial supervisors.
2. The clinical trial team meets once a week to monitor the quality of clinical trials.
3. The severity of the leukoaraiosis will be evaluated by a scale. The patients whose score is more than 2 will take additional magnetic resonance examination including magnetic resonance angiography (MRA) and arterial spin labeling (ASL). And their cognitive ability will be evaluated by a series of scales including Mini-Mental State Examination (MMSE) and Montreal cognitive assessment (MoCA) and gait by the short physical performance battery (SPPB).

   The blood sample will be taken for biochemical detection and hair and nail samples for trace element detection.
4. Data were analyzed by regression analysis.

Eligibility criteria: Inclusion Criteria:

* Physical Examinees or out-patients
* The MRI scale score ≥ 2

Exclusion Criteria:

* History of stroke
* History of malignant tumor
* History of connective tissue disease
* Pregnant, trying to become pregnant or within 6 weeks after delivery
* serious infections

Primary outcomes:
measure: change in cognitive assessment scale score
timeFrame: baseline and one year
Secondary outcomes:
measure: change in mood assessment Scale score
timeFrame: baseline and one year
measure: change in gait evaluation score
timeFrame: baseline and one year
measure: stroke
timeFrame: baseline and one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: neurology department of Zhongshan hospital, Fudan University
state: Shanghai
Study officials:
affiliation: neurology department of Zhongshan hospital, Fudan University
name: Xin Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03180073: Conduction Abnormalities With Severe Aortic Stenosis Before and After Transcatheter Aortic Valve Replacement
Official title: Prevalence and Significance of Bradycardic Arrhythmias and Conduction Abnormalities Among Patients With Severe Aortic Stenosis Before and After Transcatheter Aortic Valve Replacement Using Extended Heart Rhythm Recording (Brady-TAVR Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients to be scheduled for TAVR without preexisting Cardiac Implantable Electronic Device (CIED) can be screen and enrolled

Brief summary: Most of the conduction abnormalities with TAVR are usually detected during the procedure or during the following days of observation. Little is known about the prevalence and timing of any conduction abnormalities that exist before (other than standard ECG) or after through long term cardiac monitoring.

Detailed description: Each subject who fulfills the inclusion/exclusion criteria will be provided with Zio patch for 2 weeks before TAVR. Immediately after the procedure, patients will be admitted per TAVR protocol and will be on telemetry. Data about their ECGs and any arrhythmias will be collected.

Upon discharge, patients will be provided with another Zio patch for 2 weeks. At the 2-3 months follow up, subjects will be provided with a third Zio patch for 2 weeks

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 and \<90 years old
2. Able to provide informed consent
3. Willing to follow up at Cleveland Clinic (per TAVR protocol)

Exclusion Criteria:

1. Prior CIED (Pacemaker or defibrillator)
2. Unable to provide consent
3. Unable to follow up at Cleveland Clinic per TAVR protocol

Primary outcomes:
measure: Need for Pacemaker post TAVR
timeFrame: 2 months prior to TAVR
Secondary outcomes:
measure: Prevalence of in hospital brady arrhythmia post TAVR
timeFrame: 72 hours post TAVR
measure: Prevalence of brady arrhythmia after discharge from hospital post TAVR
timeFrame: 3 weeks post discharge
measure: Prevalence of delayed brady arrhythmia post TAVR
timeFrame: 2 months post TAVR
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Khaldoun Tarakji, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tarakji KG, Patel D, Krishnaswamy A, Hussein A, Saliba W, Wilkoff BL, Wolski K, Svensson L, Wazni OM, Kapadia SR. Bradyarrhythmias detected by extended rhythm recording in patients undergoing transcatheter aortic valve replacement (Brady-TAVR Study). Heart Rhythm. 2022 Mar;19(3):381-388. doi: 10.1016/j.hrthm.2021.11.020. Epub 2021 Nov 18.