louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004423: Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
Keywords: Crohn's disease
gastrointestinal disorders
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's disease of the small bowel.

Detailed description: PROTOCOL OUTLINE: This is a randomized, placebo controlled, multicenter study. Patients are randomized to receive either oral 4-aminosalicylic acid (4-ASA) or placebo twice a day for 12 weeks. After 12 weeks patients who improved with 4-ASA and those who received placebo are given the option of receiving 4-ASA for an additional year.

Patients who were randomized to receive 4-ASA and continue treatment after 12 weeks are followed every 3 months for 1 year. Patients who were randomized to receive placebo and begin 4-ASA therapy after 12 weeks are followed monthly for 3 months, then every 3 months for 1 year.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Active small bowel Crohn's disease established by clinical evaluation and prior radiologic study, endoscopy, surgical findings and/or histopathology
* Crohn's Disease Activity Index (CDAI) must be between 150 and 450
* No ulcerative or infectious colitis or severe perianal disease

--Prior/Concurrent Therapy--

* Biologic therapy: Not specified
* Chemotherapy: Stable dose of no greater than 20 mg per day of prednisone allowed
* Endocrine therapy: No immunosuppressive drugs within the past 3 months No concurrent immunosuppressive drugs
* Radiotherapy: Not specified
* Surgery: No impending surgery No prior ileostomy or colostomy
* Other: No 5-aminosalicylates within the past 2 weeks No concurrent 5-aminosalicylates No concurrent metronidazol or ciprofloxacin

--Patient Characteristics--

* Age: 18 to 80
* Performance status: Ambulatory
* Hematopoietic: Not specified
* Hepatic: No hepatic disease
* Renal: No renal disease
* Other: Not pregnant (negative pregnancy test required) Fertile patients must use effective contraception No documented salicylate allergy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Vermont
name: James A. Vecchio
role: STUDY_CHAIR
References:
Clinical trial NCT05050123: Smartphone-based Virtual Reality Exposure and Standard Relaxation Training for Anxiety on an Inpatient Psychiatric Unit
Official title: Comparing a Smartphone-based Virtual Reality Exposure With Standard Relaxation Training for Anxiety on an Inpatient Psychiatric Unit
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety
Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare a smartphone-based virtual reality exposure with standard relaxation training for anxiety and associated symptoms (including pain) on an inpatient psychiatric unit, and whether patients find it usable and beneficial.

Detailed description: The study is open only to inpatients on a specific Mayo Clinic Rochester psychiatric hospital unit, the Mood Disorders Unit. Two different techniques for reducing anxiety will be tried. The first time patients report anxiety, they will be asked to listen to a 15 minute audio CD guiding them through relaxation strategies. The second time patients are anxious, they will be given a cardboard VR goggle set and will view 15 minutes of unguided VR. Before and after each session, they will fill out a short survey of anxiety and related symptoms (including pain ratings) and their reaction to each technique. They will be asked to try each technique at least once during your hospital stay.

Eligibility criteria: Inclusion Criteria:

- Hospitalized on inpatient Mayo Clinic Mood Disorders psychiatric unit (Generose 3W).

Exclusion Criteria:

* Inability to understand English.
* Patients with primary substance use disorders, primary psychotic disorders, major neurocognitive disorders and active self-harm behaviors and seizure disorders

Primary outcomes:
measure: Change in anxiety
timeFrame: Baseline, approximately 90 minutes
Secondary outcomes:
measure: Change in associated emotions rating
timeFrame: Baseline, approximately 90 minutes
measure: Change in pain
timeFrame: Baseline, approximately 90 minutes
measure: Change in blood pressure
timeFrame: Baseline, approximately 90 minutes
measure: Change in heart rate
timeFrame: Baseline, approximately 90 minutes
measure: Change in respiratory rate
timeFrame: Baseline, approximately 90 minutes
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Simon Kung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05905523: Testing of Online Version of QAPS
Official title: Testing of Online Version of QAPS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Child Development
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between 3 to 7 years old

Brief summary: Early evaluation of prewriting skills is important, as prewriting skills set the stage for later learning of the fine motor and visual motor skills needed for writing. Evaluation of prewriting skills allows for the identification of those children who struggle with these tasks so that early intervention might address these foundational skills before academic demands become more challenging. However, current prewriting skill assessments are limited to pencil-and-paper assessments that require an evaluator to score the drawn shapes. Manual scoring is time consuming, can be subjective, and limit the ability to capture subtle changes in performance.

We have developed an assessment on a tablet to assess prewriting skills in children. The preliminary testing of the assessment is published in a paper (https://pubmed.ncbi.nlm.nih.gov/35417278/). We are now working on developing an online version of the assessment that will allow offsite data collection and will automate the analysis on the website so that the results can be automatically generated for the clinician or educator who wants to use this with the children they work with.


Eligibility criteria: Inclusion Criteria:

* Children between 3 to 7 years old

Exclusion Criteria:

* Children unable to follow directions to attempt copying shapes.

Primary outcomes:
measure: Online QAPS
timeFrame: 5-10 minutes
measure: Beery VMI
timeFrame: 5-10 minutes
measure: Functional hand tasks
timeFrame: 5-10 minutes
measure: Demographics survey
timeFrame: 5 minutes
measure: Emotionality Assessment
timeFrame: 5 minutes
measure: Strengths & difficulties Questionnaire Inattention/Hyperactivity subscale
timeFrame: 5 minutes
measure: Ego Resiliency Scale
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonweath University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Virginia Chu, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03208023: RESIPI for Reducing Perioperative Major Adverse Cardiac Events
Official title: RESIPI for Reducing Perioperative Major Adverse Cardiac Events: A Phase II Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inotropy
Fluid Management
Cardiac Event
Perioperative Cardiac Risk
Vascular Resistance
Hemodynamic Monitoring
Hemodynamic Management
Fluid Responsiveness
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Cheetah Medical Inc.
First posted: 2017-07-05
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of a novel hemodynamic management and monitoring strategy for reducing cardiac bio marker elevations and major adverse cardiac events.

Detailed description: Modest elevations in cardiac biomarkers in the immediate postoperative period are associated with significantly increased risk of morbidity and mortality. The RESIPI model of hemodynamic monitoring and management in the perioperative period takes into account the dynamic interplay of vascular resistance, inotropy, and fluid management. This study aims to evaluate the effect of a novel hemodynamic management and monitoring strategy for reducing cardiac bio marker elevations and major adverse cardiac events.

Eligibility criteria: Inclusion Criteria:

* Revised Cardiac Risk Index greater than or equal to 1, history of diastolic dysfunction, or age greater than 55 years.
* Surgery type: Major Abdominal Oncologic Surgery
* Planned surgery length greater than or equal to 90 minutes with planned in-patient stay of at least 2 days

Exclusion Criteria:

* Patients who are unstable by current American Heart Association/American College of Cardiology Clinical Practice Guidelines
* Patients with Chronic Kidney Disease Stage IV or V
* Urgent/emergent surgical interventions (e.g. Level 1 or 2 by VUMC VOR definitions)
* No signs of ischemia, congestive heart failure, or volume overload: Creatinine Clearance greater than 30

Primary outcomes:
measure: B-typer Natriuretic Peptide (BNP)
timeFrame: Post Op day 1
measure: Troponin
timeFrame: Post Op day 1
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30 days post op
measure: Major cardiac events
timeFrame: 30 days post op
measure: Hospital length of stay
timeFrame: Approximately 3-5 days
measure: Readmission rate (Emergency room or hospital)
timeFrame: 30 days post operative
measure: Return to operating room
timeFrame: 30 days post operative
measure: Total hospital cost
timeFrame: 30 days post operative
measure: Occurrence of significant medical events
timeFrame: 30 days post operative
measure: Days at home in first 30 days
timeFrame: 30 days post operative
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Matthew D McEvoy, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03444623: Survivin as Predictive Biomarker for RA
Official title: Survivin as Predictive Biomarker for Development of Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Arthralgia
Joint Pain
Keywords: predictive factor
prognostic factor
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2018-02-23
Enrollment: 6000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seeking treatment at the primary health care for problems with their joints (pain, stiffness).

Brief summary: Purpose: to examine the possibility of using the onco-protein survivin as a predictive biomarker for identifying individuals at risk of developing rheumatoid arthritis within a cohort of patients seeking treatment for joint pain/stiffness. Secondly, to study survivin as a prognostic marker for joint destruction, refractory and highly active disease in patients with established RA.

Detailed description: The study will analyse survivin levels in a non-selected material within a cohort of patients seeking help at their primary health care for joint pain, stiffness, swelling etc. Patients presenting with such symptoms (not explained by injury or other factors) are suspected to have an arthritic condition such as RA, and are routinely tested for presence of autoantibodies RF and ACPA. In this observational study we add measurement for survivin to the blood analyses of these patients. Information about patients expressing high levels of survivin will be reported to the referring doctor at the primary health care, and for patients not previously having been examined by a rheumatologist this will be offered.

The study will be performed at Sahlgrenska university hospital Gothenburg and Umeå university hospital.

Eligibility criteria: Inclusion Criteria:

* Patients seeking treatment at the primary health care for problems with their joints (pain, stiffness).

Exclusion Criteria:

* Patients diagnosed with RA

Primary outcomes:
measure: Survivin positive
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept of Rheumatology and Inflammation research
Study officials:
References:
Clinical trial NCT03704623: Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic
Official title: Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic Due to Ureteric Calculi: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Renal Colic
Ureteric Stone
Keywords: Acute renal colic
Ureteric stone
Selective COX2 inhibitor
Parecoxib
Paracetamol
Lead sponsor: Mansoura University
Sponsor class: OTHER
Collaborators: name: Amiri Hospital
First posted: 2018-10-15
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomized to one of the two treatment groups.
Primary purpose: TREATMENT

Brief summary: This study will be conducted to compare the efficacy and safety of Parecoxib versus Paracetamol for treatment of acute renal colic due to ureteric stones.

Detailed description: Eligible patients will be randomized to one of the two treatment groups. Group 1 patients will receive IV 1 g of Paracetamol while group 2 patients will receive 40 mg of Parecoxib IV.

The Visual Analogue Scale (VAS) will be calculated on presentation and at 30 minutes after analgesia administration. Patients who do not respond to an initial dose of the analgesia will receive rescue analgesia in the form of Morphine, 01.mg/kg, IV.

Eligibility criteria: Inclusion Criteria:

* Clinical signs and symptoms consistent with acute renal colic

Exclusion Criteria:

* Hypersensitivity to either Paracetamol or Parecoxib.
* History of peptic ulcer.
* Pregnant or breastfeeding females.
* Patients with hepatic impairment (Child-Pugh score \>10).
* Patients with chronic kidney disease (CKD) Stage 4 or 5 (eGFR \<30mls/min).
* History of coronary ischemia, peripheral vascular or cerebrovascular disease.

Primary outcomes:
measure: The need for rescue analgesia (Morphine)
timeFrame: 30 minutes
Secondary outcomes:
measure: The incidence of adverse effects due to medication used
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Al-Amiri Hospital
Study officials:
affiliation: Amiri Hospital
name: Abdullatif AL-Terki, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04411823: Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction
Official title: Prediction of Post-laparoscopic Sleeve Gastrectomy Gastroesophageal Reflux Disease With an Endolumenal Functional Lumen Imaging Probe (EndoFLIP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastroesophageal Reflux
Sleeve Gastrectomy
Bariatric Surgery Complication
Keywords: Gastroesophageal Reflux
Sleeve gastrectomy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Researchers are trying to identify predictors for gastroesophageal reflux disease after sleeve gastrectomy.

Detailed description: Subjects will undergo an upper endoscopy with EndoFLIP before sleeve gastrectomy to measure parameters from endoscopy and EndoFLIP device to develop a prediction model for post-operative gastroesophageal reflux disease. Subjects will undergo a repeat upper endoscopy with EndoFLIP at 6 months if an upper endoscopy is clinically indicated after surgery and complete questionnaires during follow-ups up to 5 years.

Eligibility criteria: Inclusion Criteria:

* Adult patients \> 18 years
* BMI 30 or greater kg/m2
* Participants can give a consent to the procedure
* Participants have no contraindications to LSG (gastric ulceration)

Exclusion Criteria:

* Participants who have LA grade C or D esophagitis, Barrett mucosa or peptic stricture.
* Patients who have evidence of a major motility abnormality defined by the Chicago classification version 3.0 (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis)
* Patients with hiatal hernia \> 3 cm
* Patients with previous esophageal or stomach surgery

Primary outcomes:
measure: Worsening or new-onset gastroesophageal reflux disease
timeFrame: Baseline, 6 months, and 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Omar Ghanem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02392923: Quality of Life in a Representative Swedish Population
Official title: Quality of Life and Body Functions in a Representative Swedish Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Keywords: health related quality of life
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2015-03-19
Enrollment: 3000
Sex: ALL
Minimum age (years): 30
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: Swedish cohort aged 30-89, representatvie for entire Swedish population age 30 -89

Brief summary: Cohort descriptive study of quality of life and body functions in a reference population of Swedish inhabitants from age 30 to age 89. The population was selected to be representative for the general Swedish population and 500 in each 10 year group, 250 men and 250 women.

The population is contacted and asked for informed consent, whereafter a questionnaire of about 200 questions, used in a number of studies in clinical studies and trials, are sent out.

The results will be used as reference values to our patient cohorts

Detailed description: Individuals contacted by letter with information about the study and it's aim. The next step is a telephone contact from the study secretariate where the person can ask for more detailed information and put questions to the reserach nurse. The call leads up to a question to the person, if the questionnaire can be sent. If yes, the questionnaire is posted includeing the consent form and an pre-paid return envelope. After two weeks a thank you/reminder letter is sent out, and if no reply one more phone call is made two weeks further on.

Eligibility criteria: Inclusion Criteria:

* list generated by the equivalent to inland revenue ("Skatteverket", Sweden)

Exclusion Criteria:

* unable to read and understand Swedish
* no informed consent

Primary outcomes:
measure: quality of life
timeFrame: 12 months
Secondary outcomes:
measure: sexual health
timeFrame: 12 months
measure: gastrointestinal function
timeFrame: 12 months
measure: urinary function
timeFrame: 12 months
measure: other body functions
timeFrame: 12 months
measure: mental health
timeFrame: 12 months
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Göteborg University, Sahlgrenska Academy, Inst Clinical Sciences, Dept Surgery,
Study officials:
affiliation: Department of Surgery, Institure for Clinical Sciences, Sahlgernska Academy at Göteborg University
name: Eva Haglind
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bock D, Angenete E, Gonzales E, Heath J, Haglind E. Assessing health, quality of life and urogenital function in a sample of the Swedish general population: a cross-sectional study. BMJ Open. 2018 May 5;8(5):e021974. doi: 10.1136/bmjopen-2018-021974.
Clinical trial NCT05312723: Sleep Disturbance in Chronic Rhinitis
Official title: Sleep Disturbance in Chronic Rhinitis: Evaluation of Nasal Symptoms, Sleep Disorder Questionnaires, and Sleep Architecture in Allergic & Non-Allergic Rhinitis in Dr. Cipto Mangunkusumo Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disturbance
Keywords: allergic
nasal congestion
daytime sleepiness
polysomnography
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Allergic and non-allergic rhinitis patients

Brief summary: The aim of this study is to evaluate the characteristic of sleep disturbance in allergic and non-allergic rhinitis in Dr. Cipto Mangunkusumo Hospital, Jakarta. A cross sectional analytic descriptive study with consecutive sampling was performed. A total of 22 chronic rhinitis patients, consisted of 11 allergic and 11 non-allergic rhinitis were evaluated of their sleep disturbance's characteristics.

Detailed description: At first, all recruited subjects were evaluated for total nasal symptom scores (TNSS) and nasal obstruction symptoms evaluation scores (NOSE). Sleep disorder was assessed using Epworth Sleepiness Scale (ESS), Pittsburg Sleep Quality Index (PSQI) questionnaires, and polysomnography (PSG). Both the allergic and non-allergic rhinitis groups will be compared in terms of their sleep disturbance characteristics (from comparing ESS, PSQI, and PSG results).

Eligibility criteria: Inclusion Criteria:

* All male and female between 18-60 years old with chronic rhinitis symptoms and sleep disorder
* Did not receive intranasal steroid within the last one month
* Have psychiatric disorder

Exclusion Criteria:

* Polyp
* Nasal or sinonasal tumor
* Septum deviation
* Chronic rhinosinusitis
* Adenoid hypertrophy
* Tonsil hypertrophy
* Macroglossia
* Oropharyngeal tumor

Primary outcomes:
measure: Mean value of TNSS based on VAS symptoms
timeFrame: Evaluation is done at Day 1(cross-sectional)
measure: Nasal obstruction symtpms evaluation (NOSE) score
timeFrame: Evaluation is done at Day 1 (cross-sectional)
measure: Sleep quality from Epworth sleepiness scale (ESS)
timeFrame: Evaluation is done at Day 1 (cross-sectional)
measure: Sleep quality from Pittsburg Sleep Quality Index (PSQI)
timeFrame: Evaluation is done at Day 1 (cross-sectional)
measure: Objective sleep measurement using polysomnography (PSG)
timeFrame: Evaluation is done at Day 1 (cross-sectional)
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RSUPN Dr. Cipto Mangunkusumo
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Nina Irawati
role: PRINCIPAL_INVESTIGATOR
References: