louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03850418: Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant
Official title: Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Myeloid Malignancy
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Previous studies provide a rationale for administration of AZA after allo SCT for decreasing chimerism. The investigators hypothesize that azacitidine can be well tolerated after SCT and help decrease rate of decreasing donor chimerism and hence decrease relapse without increasing GVHD


Eligibility criteria: Inclusion Criteria:

1. Patients with AML/MDS/MPN, CMML post Allogeneic SCT who experience any drop in total or myeloid chimerism any time after day 30, or their day 30 or day100 myeloid donor chimerism is below 98% without concurrent hematologic relapse (that is, patients with \<5% bone marrow blasts as obtained at that time point) will be offered treatment with azacitidine
2. \>=30 -180 days post SCT and patients must have ANC\> 1000, PLT \> 50,000
3. Age 18-75 years old
4. Performance score of at least 70% by Karnofsky
5. Adequate kidney and liver function as demonstrated by:

   1. Creatinine clearance should be \>60 ml/min
   2. Total Bilirubin \<1.5, ALT/AST/Alk Phos \< 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.
6. Negative Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.
7. Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
8. Patients must be off any prior chemotherapy, radiotherapy, or other investigational therapy within 2 weeks prior to start treatment

Exclusion Criteria:

1. Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause
2. Active or prior CNS leukemia, unless in complete remission for at least 2 months.
3. History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs.
4. Uncontrolled infection
5. Grade III, IV graft versus host disease (GVHD

Primary outcomes:
measure: The rate of increase or stable donor chimerism
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry ford hospital
state: Michigan
Study officials:
References:
Clinical trial NCT00419718: Effect of Exercise on the Absorption of Inhaled Human Insulin in Subjects With Type 1 Diabetes
Official title: Effect of Exercise on the Pharmacokinetics and Pharmacodynamics of Inhaled Human Insulin in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-01-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The trial is conducted in Europe. This clinical pharmacology trial investigates the effect of exercise on the pharmacokinetics and pharmacodynamics of inhaled insulin in subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes more than or equal to 12 months
* Baseline HbA1c less than or equal to 11%
* Body mass index (BMI) less than or equal to 29 kg/m2
* Normal lung volumes
* Treatment with intensified insulin therapy for at least 3 months

Exclusion Criteria:

* Any present or history of pulmonary disease
* Any findings from the cardiopulmonary exercise test compromising safety of moderate exercise
* Impaired hepatic or renal function
* Cardiac problems
* Uncontrolled hypertension
* Current proliferative retinopathy or maculopathy
* Treatment with drugs, which may interfere with insulin action, glucose metabolism or recovery from hypoglycaemia (judged by investigator)
* Current smoking or smoking within the last 6 months
* Blood donation (more than 500 mL) within the last nine weeks

Primary outcomes:
measure: Area under the plasma insulin profile in the interval
timeFrame: From 30-150 min after trial product administration
Secondary outcomes:
measure: Area under the plasma insulin profile in the interval from 120-240 min after trial product administration
measure: Area under the plasma insulin profile in the interval from 240-360 min after trial product administration
measure: Area under the plasma insulin profile in the interval 0-600 min after trial product administration
measure: Maximum plasma insulin concentration
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Petersen AH, Kohler G, Korsatko S, Wutte A, Wonisch M, Jeppesen OK, Sparre T, Clauson P, Laursen T, Wollmer P, Pieber TR. The effect of exercise on the absorption of inhaled human insulin via the AERx insulin diabetes management system in people with type 1 diabetes. Diabetes Care. 2007 Oct;30(10):2571-6. doi: 10.2337/dc06-2589. Epub 2007 Jul 9.
Clinical trial NCT05760118: Awareness of Osteoporosis in Diabetes Mellitus Patients
Official title: Awareness of Osteoporosis in Diabetes Mellitus Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Osteoporosis
Osteoporosis Risk
Lead sponsor: Uskudar State Hospital
Sponsor class: OTHER_GOV
First posted: 2023-03-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 to 90 years with a diagnosis of diabetes mellitus who gave consent to participate in the study

Brief summary: Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Diabetes mellitus patients are at increased risk for developing osteoporosis. Identifying whether multiple sclerosis patients have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in diabetes mellitus patients.

Detailed description: Osteoporosis is a common disease of bone loss. The reduced bone strength predisposes an increased risk for fractures in older individuals. It can affect people from different ethnicity. Many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin D, immobility, and chronic inflammation. Patients with multiple sclerosis are at high risk of developing osteoporosis due to chronic inflammation and their medications. Patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. This study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with diabetes mellitus.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of diabetes mellitus
* Must be between the ages of 18 and 99
* Must give consent to participate in the study

Exclusion Criteria:

• Not giving consent

Primary outcomes:
measure: Revised Osteoporosis Knowledge Test
timeFrame: 1 day
Secondary outcomes:
measure: Osteoporosis Self-Efficacy Scale
timeFrame: 1 day
measure: Osteoporosis Health Belief Scale
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Uskudar State Hospital
name: Mustafa H Temel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06857318: Colostrum From MERS-CoV Seropositive Camels for SARS-CoV-2 Infection - a Placebo-controlled Randomized Trial.
Official title: Colostrum From MERS-CoV Seropositive Camels for SARS-CoV-2 Infection - From Lab to Human- a Placebo Controlled Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COVID 19
Keywords: infectivity
viral load
MERS-Cov
SARS-CoV-2
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 43
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: The study aims to study the efficacy of colostrum from MERS-CoV-positive camels applied as a nasal spray to COVID-19 patients for treatment and prevention of SARS-CoV-2 infection. This study will compare the usage of colostrum to placebo.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years.
* Laboratory-proven infection with COVID-19 using PCR or another approved kit
* Hospitalized / community setting-at low-moderate clinical risk according to the NEWS-2 scale with a score of 0-10.
* Onset of symptoms up to 7 days before inclusion
* Can sign informed consent
* Willingness and ability to participate in research

Exclusion Criteria:

* Pregnant women or lactating
* Lack of judgment (psychiatric disorder or dementia)
* Immunosuppressed - HIV with CD4 below 500, chemotherapy, steroids - more than 5 mg per day, solid organ transplants, bone marrow transplants, active hematological or oncological malignancies, biological therapy
* Neutropenia (less than 2000 neutrophils per cubic meter) or thrombocytopenia (platelet count less than 50000 per cubic meter).
* Acute or chronic sinusitis.
* Nasal polyps or any pathology in the nasal cavity
* Cystic fibrosis
* Significant disturbance in liver functions (AST/ALT more than 5 times the ULN)
* Significant renal dysfunction (GFR lower than 30 ml per minute)
* Known allergy to colostrum or cow\&#39;s milk
* Use of another study drug

Primary outcomes:
measure: Viral Load and Infectivity
timeFrame: 24 hours
Secondary outcomes:
measure: Undetectable Viral Load and Non-infectious Virus
timeFrame: 72 hours
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University
Study officials:
References:
Clinical trial NCT01593618: Empowering Cancer Survivors Through Information Technology
Official title: Empowering Cancer Survivors Through Information Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivor
Keywords: cancer survivor
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 53
Sex: ALL
Minimum age (years): 15
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized controlled trial of a web-based informational intervention (UMFollowUp) for adolescent and young adult survivors of childhood cancer to improve cancer knowledge and psychosocial functioning.

Detailed description: Individuals randomly assigned to the control group will receive standard of care for the duration of their participation. This means they will continue to receive information regarding their diagnosis, treatments and ongoing health needs from their provider (no access to website).

Individuals randomly assigned to the treatment group will receive access to UMFollowUp, a secure, HIPAA-compliant website.

All participants will be asked to complete paper-and-pencil surveys at baseline and 9 months later to determine the impact of the web-based intervention.

Eligibility criteria: Inclusion Criteria:

* History of diagnosis of hematologic malignancy or malignant neoplasm, and in disease free remission at time of recruitment.
* Must be English-speaking and have access to a computer with internet access, and must have completed treatment at University of Minnesota Medical Center-Fairview for cancer.

Exclusion Criteria:

* Individual with significant visual impairments and neurologic/cognitive difficulties which limit their ability to see and under our outcome questionnaires or website content will be excluded from participation.

Primary outcomes:
measure: Cancer Knowledge Survey
timeFrame: Time of Enrollment and 9 Months Later
Secondary outcomes:
measure: SF-36 Questionnaire
timeFrame: Time of Enrollment and 9 Months Later
measure: Cancer Rehabilitation Evaluation System
timeFrame: Time of Enrollment and 9 Months Later
measure: Herth Hope Index
timeFrame: Time of Enrollment and 9 Months Later
measure: Multidimensional Scale of Perceived Social Support
timeFrame: Time of Enrollment and 9 Months Later
measure: Health Locus of Control Scale
timeFrame: Time of Enrollment and 9 Months Later
measure: State Trait Anxiety Inventory
timeFrame: Time of Enrollment and 9 Months Later
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Alicia Kunin-Batson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00743418: Tracking Technologies for the Analysis of Mobility in Alzheimer's Disease
Official title: The Use of Advanced Tracking Technologies for the Analysis of Mobility in Alzheimer's Disease and Related Cognitive Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Dementia
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-08-28
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The research is aimed at exploring the application of novel tracking technique for the study of spatial activity among dementia patients and its implication on their families. The study sample will be composed of three groups of volunteers, each including100 participants aged over 60 years. The first group will include MCI (Mild Cognitive Impairment) patients. The second group will include patients that suffer from mild dementia. The third group will include age matched healthy participants. The tracking equipment will be a GPS apparatus of 450 gms that will be carried by the participants for 24 hours along 2-4 weeks. The GPS data will be transferred via the cellular network to operator center at the Hebrew university at Jerusalem, and will be documented in assigned data files. This monitoring procedure will be held every year and along a period of five years. The impact of the patient behavior on the care giver will be studied by means of five interviews along the tracking period.


Eligibility criteria: Inclusion Criteria:

* Patients with MCI, Alzheimer's disease, or mixed type dementia; OR
* Healthy control subjects who meet the following criteria:

  * Mini Mental State (MMSE) of at least 21
  * Age 60 years or older
  * Patients with history of stroke which is not followed by cognitive decline may be included
  * Fluent language skills

Exclusion Criteria:

* Other dementias (e.g. vascular, frontotemporal, metabolic etc);
* Other major psychiatric disorders (e.g. major depression, schizophrenia);
* Substance abuse;
* MMSE 20 or less;
* Severe motor disturbances;
* Sensory deficits potentially affecting mobility; OR
* Severe physical disorders (e.g. cancer, major operation)

Primary outcomes:
measure: Evaluation tools include: Geriatric Depression Scale, functional health questionnaire (SF-36), Emotional well-being questionnaire (Positive and Negative Affect Schedule; PANAS), single Life Satisfaction question and the Zarit Burden Interview
timeFrame: Before and after interventions
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Psychogeriatric clinic, Sourasky Medical Center
Study officials:
References:
citation: Shoval N, Auslander GK, Freytag T, Landau R, Oswald F, Seidl U, Wahl HW, Werner S, Heinik J. The use of advanced tracking technologies for the analysis of mobility in Alzheimer's disease and related cognitive diseases. BMC Geriatr. 2008 Mar 26;8:7. doi: 10.1186/1471-2318-8-7.
Clinical trial NCT03392818: An Innovative Approach for Uniblocker Intubation
Official title: An Innovative Approach for Accurately Predicting the Optimal Insertion Depth of Uniblocker Without Fiberoptic Bronchoscope Assistance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Therapeutic Procedural Complication
Lead sponsor: The First Hospital of Qinhuangdao
Sponsor class: OTHER_GOV
First posted: 2018-01-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: To measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina was calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB.

Detailed description: In previous study, the investigators found Chest computed tomography (CT) image can accurately predicting the optimal insertion depth of Uniblocker,however in some hospital the CT scan performed for the preoperative surgical evaluation without the vocal cords slices. If a more extensive CT scan was needed for obtaining a more reliable image of the vocal cords,the additional exposure dose would be a major disadvantage of the method.So the investigators measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB.

Eligibility criteria: Inclusion Criteria:

1. Adult patients undergoing left side thoracic surgery
2. The thoracic surgery requiring a Uniblocker for one-lung ventilation

Exclusion Criteria:

1. Age\>70 or \<18 years
2. ASA classifications \>III
3. BMI \>35kg/m2
4. Modified Mallampati classification ≥III
5. Thoracic surgery within the last one month
6. Severe cardiopulmonary disease

Primary outcomes:
measure: The intubation time
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Qinhuangdao
country: China
facility: The first hospital of Qinhuangdao
state: Hebei
Study officials:
affiliation: The First Hospital of Qinhuangdao
name: Ximing Qi
role: STUDY_DIRECTOR
References:
Clinical trial NCT02098018: Comparison of Stress Reduction Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Connecticut
First posted: 2014-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are many ways to reduce stress. This study will compare 2 different programs for reducing stress. In addition to looking at how well the programs reduce stress, we will also ask questions about how these programs may be working.


Eligibility criteria: Inclusion Criteria:

* 25-50 years of age
* Able to engage in moderate physical activity
* Interested in being treated for stress

Exclusion Criteria:

* Use of psychotropic medications within 6 months prior to study.
* History of extreme physical or psychological trauma.
* Medical conditions that would interfere with study procedures or confound results, such as diabetes, pregnancy, or paralysis.
* Axis I psychiatric diagnosis; e.g., history of substance use disorder, psychotic disorder, bipolar disorder, or eating disorder.

Primary outcomes:
measure: Change in Perceived Stress
timeFrame: baseline to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut- Storrs
state: Connecticut
city: Boston
country: United States
facility: Massachusettts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sara Lazar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Braun TD, Riley KE, Kunicki ZJ, Finkelstein-Fox L, Conboy LA, Park CL, Schifano E, Abrantes AM, Lazar SW. Internalized weight stigma and intuitive eating among stressed adults during a mindful yoga intervention: associations with changes in mindfulness and self-compassion. Health Psychol Behav Med. 2021 Nov 19;9(1):933-950. doi: 10.1080/21642850.2021.1992282. eCollection 2021.
Clinical trial NCT03784118: Complications Associated with Arterial Line Placement in Children
Official title: Study on Complications After Arterial Line Placement and the Risk Factors in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications After Arterial Catheterization
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 82
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to find the risk factors for complications following arterial line catheterization. Ultrasonography is used to evaluate the size of artery which is cannulated, before and after catheterization. The complications include ischemia, bleeding, thrombosis and so on.

Detailed description: artery observation with ultrasound

Eligibility criteria: Inclusion Criteria:

* Pediatric patients under 5 years of age who require invasive arterial pressure monitoring

Exclusion Criteria:

* Patients who do not need invasive arterial pressure monitoring

Primary outcomes:
measure: Incidence of complications associated with arterial catheterization
timeFrame: within 5 days after arterial catheterization
Secondary outcomes:
measure: Time-dependent changes in perfusion index
timeFrame: from arterial catheterization to the end of surgery
measure: Age as a risk factor
timeFrame: within 5 days after arterial catheterization
measure: Number of attempts as a risk factor
timeFrame: within 5 days after arterial catheterization
measure: Duration of catheterization as a risk factor
timeFrame: within 5 days after arterial catheterization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Soo Kim Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References: