louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01382563: Registry for Eosinophilic Gastrointestinal Disorders (REGID)
Official title: Registry for Eosinophilic Gastrointestinal Disorders (REGID)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eosinophilic Gastrointestinal Disorders (EGID)
Eosinophilic Esophagitis
Eosinophilic Disorder
Keywords: Eosinophilic Gastrointestinal Disorders
EGID
Eosinophilic Esophagitis
Registry
Eosinophils
Eosinophilia
Eosinophilic enteropathy
Eosinophilic enteritis
Eosinophilic gastritis
Eosinophilic gastroenteritis
Eosinophilic gastroenteropathy
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-06-27
Enrollment: 34
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eosinophilic Gastrointestinal Disorders

Brief summary: Develop Registry tool

Detailed description: The purpose of this research study is to develop a registry tool used for the management and care of patients with eosinophilic disorders, and create a research resource that will provide further insights into these disorders.

Eligibility criteria: Inclusion Criteria:

* Eosinophilic Gastrointestinal Disorder diagnosis

Primary outcomes:
measure: Registry Aim
timeFrame: Open-ended
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Aurora
country: United States
facility: The Children's Hospital
state: Colorado
city: Chicago
country: United States
facility: Northwestern University School of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Riley Children's Hospital
state: Indiana
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Mason
country: United States
facility: Kara Kliewer
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Marc E. Rothenberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06683963: AI-Assisted TelerehabiLitAtion System (ATLAS) for Post-discharge Continuation of Rehabilitative Care
Official title: AI-Assisted TelerehabiLitAtion System (ATLAS) for Post-discharge Continuation of Rehabilitative Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rehabilitation
Deconditioning
Lead sponsor: SingHealth Community Hospitals
Sponsor class: OTHER
Collaborators: name: Rebee Health
name: Jurong Community Hospital
First posted: 2024-11-12
Enrollment: 450
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study team proposes ATLAS (AI-Assisted TelerehabiLitAtion System) a two-part solution. The first-Rebee AI-assisted telerehabilitation device-assists in inpatient rehabilitation, and allows patients to continue with their physical rehabilitation when discharged and waiting for Day Rehabilitation Centre (DRC). The second-a structured programme to train and familiarise patients and caregivers to Rebee over patients' Community Hospital (CH) inpatient rehabilitation stay-adopts an evidence-based approach to increase uptake and adherence to Rebee.


Eligibility criteria: Inclusion Criteria:

1. Rehabilitation Diagnostic Group (RDG): Total Knee Replacement / Deconditioning
2. Age 60 and above
3. Speak English/Mandarin
4. Able to follow instructions, no cognitive impairment
5. No MDRO (MultiDrug Resistant Organism)
6. Suitable and able to wear motion sensor on upper and lower limbs
7. Suitable and able to engage in Rebee exercises

Exclusion Criteria:

1. Not under RDG: Total Knee Replacement / Deconditioning
2. Below 60 years old
3. Unable to speak English/Mandarin
4. Cognitive impaired, unable to follow instructions
5. Has MDRO
6. Not suitable to wear motion sensor on upper and lower limbs
7. Refusal to participate / give informed consent

Primary outcomes:
measure: Change in Modified Barthel Index scores from baseline to 4, 8, and 12 weeks
timeFrame: from recruitment (week 0) till end of study at 12 weeks
Secondary outcomes:
measure: Change in Quality of Life scores from baseline to 4, 8, and 12 weeks
timeFrame: from recruitment (week 0) till end of study at 12 weeks
measure: Change in Patient Activation Level from baseline to 4, 8, and 12 weeks
timeFrame: from recruitment (week 0) till end of study at 12 weeks
measure: Readmission rates to hospital within 30 days of discharge
timeFrame: within 30 days from discharge date
measure: Change in Joint range of motion from baseline to 4, 8, and 12 weeks
timeFrame: from recruitment (week 0) till end of study at 12 weeks
measure: Length of Stay in Community Hospital reported in days
timeFrame: From recruitment (week 0) till end of study at 12 weeks
measure: Change in STS (sit to stand) score from baseline to 4, 8, and 12 weeks
timeFrame: from recruitment (week 0) till end of study at 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03292263: ASCT With Nivolumab in Patients With Multiple Myeloma
Official title: Autologous Stem Cell Transplantation With Nivolumab in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Nivolumab
Melphalan
Autologous hematopoietic stem cell transplantation
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, single center trial of Autologous Stem Cell Transplantation (ASCT) with nivolumab in multiple myeloma patients to determine the efficacy and safety of ASCT and PD1 inhibitor combination.

For this purpose, 30 multiple myeloma patients, who have received induction therapy and have achieved a partial response (PR), stable disease (SD) or progression, and thus have unfavorable prognosis, will be treated with nivolumab administered iv at a dose of 100 mg on days 3 before and 17 after high-dose melphalan with autologous stem cell transplantation.


Eligibility criteria: Inclusion Criteria:

* Subjects with MM (Multiple Myeloma)
* Partial response, stable disease or progression after induction therapy (including ASCT)
* Measurable disease
* Successful peripheral blood stem cell collection with G-CSF
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
* Signed informed consent
* Patients after first-line induction therapy

Exclusion Criteria:

* Another malignancy requiring treatment at the time of inclusion
* History of interstitial lung disease or pneumonitis
* Patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure NYHA Class III or IV, myocardial infarction within 6 months, and poorly controlled hypertension) which, in the opinion of the investigator could compromise participation in the study
* Uncontrolled bacterial or fungal infection at the time of enrollment
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent
* Active or prior documented autoimmune disease requiring systemic treatment
* Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA4 therapy

Primary outcomes:
measure: Overall response
timeFrame: 3 months
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 12 months
measure: Overall Survival (OS)
timeFrame: 24 months
measure: Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Boris V Afanasyev, MD, Prof.
Study officials:
References:
Clinical trial NCT05643963: The COOKER-BLADDER Trial
Official title: modifiCatiOn of fOod intaKe to Influence the Equilibrium of the uRinary BLADDER
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diet, Healthy
Urinary Bladder Diseases
Oncogenesis
Lead sponsor: Hospital Centre Biel/Bienne
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The goal of this interventional study is to test the influence of food intake with characteristics of the urinary bladder. The main questions it aims to answer are:

* How does food intake modify the characteristics of urothelial cells?
* Does change of specific diet regimes influence biomarker characteristics in urine? Participants will follow specific diet regime for a given time period. After completion of this period biomarker assessment is performed. Thereafter the participants follow an opposite diet regime for the same time period with identical biomarker assessment at the end.

Biomarkers within the participants and between the diet regimes will be compared to investigate the influence of food intake on the urinary bladder.


Eligibility criteria: Inclusion Criteria:

* no daily medication
* no ongoing medical treatment

Exclusion Criteria:

* Chronic disease
* Regular medication
* Not willing to follow diet instructions

Primary outcomes:
measure: Change in molecular profile of urothelial cells
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in multiplex cytokine levels in voided urine
timeFrame: 12 weeks
measure: DNA sequences in urinary microbiome
timeFrame: 12 weeks
measure: Change of BMI
timeFrame: 12 weeks
measure: Change of heart rate
timeFrame: 12 weeks
measure: Change of blood pressure
timeFrame: 12 weeks
measure: Change of health status
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Biel/Bienne
country: Switzerland
facility: Department of Urology, Spitalzentrum Biel
state: BE
city: Biel
country: Switzerland
facility: Roland Seiler
Study officials:
References:
Clinical trial NCT01686763: Endothelin-1 and Methabolites Concentrations in Mycrodialysis and Cerebrospinal Fluid in Subarachnoid Hemorrhage Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 35
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: Patients with subarachnoid hemorrhage at high risk for vasospasm according to Fisher scale admitted to the ICU were consecutively studied.

Brief summary: Endothelin-1 (ET-1) seems to be involved in the pathogenesis of cerebral vasospasm after subarachnoid hemorrhage. However measurements of cerebrospinal fluid concentrations (CSF) of ET-1 are not sensitive enough to predict the development of vasospasm representing the average value throughout the entire cerebral circulation. Cerebral microdialysis (MD) is a technique able to detect molecule concentrations in a small perivascular area. The investigators performed a prospective observational clinical study to test the hypothesis that MD ET-1 concentrations should be a sensitive predictor for vasospasm.

Patients with subarachnoid hemorrhage at high risk for vasospasm according to Fisher scale admitted to the ICU were consecutively studied. All patients received surgery within 48 hours from the bleeding; MD probe was placed in the area at risk for vasospasm after surgery and samples were hourly collected and analysed to measure lactate, piruvate and glutamate levels; ET-1 levels in CSF and MD fluids were measured from admission until day 7. At admission and after 7 days two angiographies were performed to detect the degree and extent of vasospasm, Transcranial Doppler and neurological evaluation were daily performed. Patients were then classified according to the presence of vasospasm in 3 groups: absence of vasospasm (NV), presence of vasospasm (CV), acute neurological deterioration (AND).


Eligibility criteria: Inclusion Criteria:

* diagnosys of subarachnoid hemorrhage
* angiographic proof of aneurysm
* admission within 24 hours from the subarachnoid hemorrhage
* presence of an intraventricular catheter and a microdialysis catheter placed either after admission or at the time of the surgery

Exclusion Criteria:

* moribund
* GCS=3
* denied consent

Primary outcomes:
measure: cerebral vasospasm incidence
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Turin, Italy
name: Luciana Mascia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00930163: A Study of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Adult Asthma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-30
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled study to evaluate the effects of lebrikizumab in patients with asthma who remain inadequately controlled while on chronic therapy with inhaled corticosteroids (ICS).


Eligibility criteria: Inclusion Criteria:

* Body weight 40 kg--150 kg
* Chest radiograph with no evidence of clinically significant abnormality
* Uncontrolled asthma

Exclusion Criteria:

* Asthma exacerbation during screening
* Known malignancy
* Known immunodeficiency
* Pre-existing lung disease other than asthma
* Uncontrolled clinically significant medical disease
* Current smoker
* History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator
* Prior allergic reaction to a monoclonal antibody
* Patients (men and women) of reproductive potential who are not willing to use contraception
* Pregnancy

Primary outcomes:
measure: Change in forced expiratory volume in 1 second (FEV1)
timeFrame: From baseline to Week 12
Secondary outcomes:
measure: Change in pre-bronchodilator FEV1
timeFrame: From baseline to Week 24
measure: Change in quality of life and symptom scores
timeFrame: From baseline to Week 12
measure: Change in peak flow
timeFrame: From baseline to Week 1
measure: Rate of asthma exacerbations
timeFrame: During the 24 week treatment period
measure: Change in rescue medication use
timeFrame: From baseline to Week 1
measure: Frequency and severity of adverse events
timeFrame: Through study completion or early study discontinuation
measure: Incidence of human anti-therapeutic antibodies (ATA)
timeFrame: At the end of the follow-up period
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Michelle Freemer, M.D.
role: STUDY_DIRECTOR
References:
citation: Corren J, Lemanske RF, Hanania NA, Korenblat PE, Parsey MV, Arron JR, Harris JM, Scheerens H, Wu LC, Su Z, Mosesova S, Eisner MD, Bohen SP, Matthews JG. Lebrikizumab treatment in adults with asthma. N Engl J Med. 2011 Sep 22;365(12):1088-98. doi: 10.1056/NEJMoa1106469. Epub 2011 Aug 3.
Clinical trial NCT05434663: Safety Study of Repeat Doses of SUSTOL in Adults
Official title: A Phase 4, Open-Label Safety Study of Repeat Doses of SUSTOL in Adult Subjects Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Chemotherapy-Induced Nausea and Vomiting (CINV)
Keywords: HTX-100
APF530
Lead sponsor: Heron Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-06-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a repeat-dose, single-arm, open-label study that will evaluate the potential impact of subject-reported injection-site reactions (ISRs) on activities of daily living (ADL) in adult subjects with cancer receiving SUSTOL® (granisetron) extended-release injection, for subcutaneous use for prevention of chemotherapy induced nausea and vomiting (CINV) for up to 4 sequential cycles of chemotherapy (Moderately Emetogenic Chemotherapy \[MEC\] or Anthracycline and Cyclophosphamide \[AC\] combination regimen).


Eligibility criteria: Inclusion Criteria:

1. Has cancer and is scheduled to receive MEC or AC regimen for at least 4 cycles of chemotherapy, and is prescribed SUSTOL for CINV prevention.
2. Has an Eastern Cooperative Oncology Group performance status of 0 or 1.
3. Has life expectancy of greater than 6 months.
4. Able to receive standardized doses of dexamethasone for the prevention of emesis.
5. Females are eligible only if not pregnant, not lactating, not planning to become pregnant during the study.

Exclusion Criteria:

1. Has hypersensitivity to granisetron, any component of SUSTOL, or any other 5-HT3 Receptor Antagonists.
2. Severe renal impairment (creatinine clearance \[CLcr\] \<30 mL/min).
3. Symptomatic primary or metastatic central nervous system (CNS) disease.
4. Has participated in an interventional clinical study within 30 days of Cycle 1 Day 1.
5. Investigator assessment that subject would not be a good fit for the trial.

Primary outcomes:
measure: Number of subjects with potential impact of subject-reported ISRs on ADL in adult subjects with cancer administered SUSTOL.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology/Oncology
state: Mississippi
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
Study officials:
References:
Clinical trial NCT02149563: Oxygen Therapy in Depression
Official title: Oxygen Therapy in Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression, Normobaric Hyperoxia.
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The major objective of the present study is to examine the influence of normobaric hyperoxia treatment on the symptoms of patients diagnosed with depression members of Clalit Health Services. The investigators hypothesize that normobaric hyperoxia treatment will improve the symptoms of patients with depression.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 18-65 years diagnosed with mild to moderate depression.

Exclusion Criteria:

* Patients with oxygen saturation below 95%;
* An unstable mental (psychiatric) condition
* A psychiatric condition that requires a change in pharmacotherapy (importantly - medications will not be changed in patients who will be enrolled to the study)
* Acute or chronic respiratory disease
* Any severe physical illness
* Suicidal thoughts or attempts
* Drug abuse
* Obesity (BMI over 30)
* Inability to cease smoking during night hours while participants are supposed to be using the oxygen/air supplementing machine.

Primary outcomes:
measure: Hamilton Rating Scale for Depression (HRSD)-changes in patients' depression.
timeFrame: Baseline (time zero), 2 weeks and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-sheva
country: Israel
facility: Clalit Health Services in the Southern region
Study officials:
References:
citation: Bloch Y, Belmaker RH, Shvartzman P, Romem P, Bolotin A, Bersudsky Y, Azab AN. Normobaric oxygen treatment for mild-to-moderate depression: a randomized, double-blind, proof-of-concept trial. Sci Rep. 2021 Sep 23;11(1):18911. doi: 10.1038/s41598-021-98245-9.
Clinical trial NCT06306963: Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias
Official title: Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Antral Vascular Ectasia
Cirrhosis
Chronic Kidney Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Cairn Diagnostics
First posted: 2024-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have undergone an endoscopy and found to have GAVE will be included. Patients with underlying cirrhosis or chronic kidney disease and GAVE in comparison to control patients with cirrhosis or chronic kidney disease and no GAVE.

Brief summary: The researchers are trying to find out more about Gastric Antral Vascular Ectasia (GAVE). This is a condition that affects the blood vessels in the stomach, leading to their enlargement and possible bleeding. It can also cause symptoms such as abdominal pain and nausea. By participating in this study, you will help us learn how often these symptoms occur and how they relate to stomach functioning.


Eligibility criteria: Inclusion Criteria:

* Patients \>18 years of age with endoscopic evidence of Gastric Antral Vascular Ectasia.
* Willingness to participate in the study
* Capacity to provide informed consent.
* No evidence of organic, systemic, or metabolic disease (e.g. diabetes mellitus) to explain the symptoms on routine investigations

Exclusion Criteria:

* Patients with transfusion dependent blood loss.
* Patients with severe decompensated liver disease.
* Patients with end stage renal disease.
* Presence of other diseases (structural or metabolic) which could interfere with interpretation of the study results.
* Pregnant or lactating women.
* Patients who have not had a CBC and differential blood draw completed within the last six months.
* Current heavy alcohol use.

Primary outcomes:
measure: Nepean Dyspepsia Index
timeFrame: baseline
measure: Abridged Bowel Disease Questionnaire
timeFrame: baseline
measure: Leuven Postprandial Distress Scale
timeFrame: baseline
Secondary outcomes:
measure: GEBT Breath Test
timeFrame: 6 Hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Xiao Jing Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szarka LA, Camilleri M, Vella A, Burton D, Baxter K, Simonson J, Zinsmeister AR. A stable isotope breath test with a standard meal for abnormal gastric emptying of solids in the clinic and in research. Clin Gastroenterol Hepatol. 2008 Jun;6(6):635-643.e1. doi: 10.1016/j.cgh.2008.01.009. Epub 2008 Apr 14.