louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05187806: Motivational Interviewing With Diabetes Patients
Official title: Effects of Motivational Interviewing Intervention on Self- Management and HbA1c in Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
motivational interviewing
HbA1c
self management
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted in a quasi-experimental research design with a pretest-posttest control group to determine the effect of motivational interviewing on self-management and HbA1c in patients with type 2 diabetes. The sample of the study consisted of 25 experimental and 26 controls, who applied to an outpatient clinic in a training and research hospital.

Detailed description: This study was conducted in a quasi-experimental research design with a pretest-posttest control group to determine the effect of motivational interviewing on self-management and HbA1c in patients with type 2 diabetes. The sample of the study consisted of 25 experimental and 26 controls, who applied to an outpatient clinic in a training and research hospital. After the pretest, the experimental group was intervened with a motivational interview (MI) method that consisted of four sessions; the control group received routine treatment.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Having been diagnosed with type 2 diabetes for more than 3 months
* Being in the contemplation
* Preparation, and/or action stages of any section of the Behavioral Change Stage Identification Form of the Trans-Theoretical Model
* Having HbA1c levels above 6
* Agreeing to take part in the study

Exclusion Criteria:

* Having a perception disorder that will prevent communication
* Having been diagnosed with any mental disorder

Primary outcomes:
measure: Comparison of the pretest-posttest Diabetes Self-management Instrument-35 scores
timeFrame: 3 months
Secondary outcomes:
measure: Comparison of the pretest-posttest HbA1c values
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ministry of Health, Gaziosmanpasa Training and Research Hospital
Study officials:
affiliation: Ministry of Health, Gaziosmanpasa Training and Research Hospital
name: Deniz Kaya Meral, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06591806: An Observational Study in Children and Adults With Stargardt Disease
Official title: A Multicenter, Prospective, Longitudinal, Observational Study in Children and Adults With Stargardt Disease Related Atrophy Secondary to Biallelic Mutations in the ABCA4 Gene
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stargardt Disease
Keywords: ABCA4
Lead sponsor: AAVantgarde Bio Srl
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Stargardt disease secondary to mutation in the ABCA4 gene

Brief summary: This multicenter, prospective, longitudinal, observational study in approximately 80 subjects with Stargardt disease secondary to biallelic mutations in the ABCA4 gene (STGD1) aims to evaluate prognostic factors of disease progression, and to further characterize the patient population for future clinical studies.


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects between 8 and 50 years of age at the time of enrolment.
2. Willingness to adhere to the protocol as evidenced by written informed consent if the subject is 18 years or older. If the subject is under 18 years of age, written assent must be obtained from the subject and written informed consent must be obtained from the subject's legally authorized representative (parent or legal guardian).
3. Confirmed mutation in the ABCA4 gene.

Exclusion Criteria:

1. History of uveitis.
2. Any ocular disease in either eye that may confound assessment of the retina morphologically and functionally.
3. Any pathology of the posterior segment other than ABCA4 retinopathy.
4. Presence of any other genetic mutation(s) that have been associated with retinal or macular dystrophy.

Primary outcomes:
measure: To measure the change from baseline in Fundus Autofluorescence
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
Study officials:
References:
Clinical trial NCT00750906: ECT/Succinylcholine: Biochemical, Serum and Cardiovascular Changes
Official title: The Muscle Biochemical, Serum Potassium and Cardiovascular Changes After Succinylcholine in Patients Undergoing Electroconvulsive Therapy.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Depression
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-09-11
Enrollment: 13
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: Patients undergoing electroconvulsive therapy.

Brief summary: This study will be conducted to determine the pharmacodynamics, cardiovascular and biochemical effects of succinylcholine when given during electroconvulsive therapy. (ECT). This is a single center, prospective, study in patients who will be receiving ECT as indicated and prescribed by their psychiatrist. The study will be performed twice on each patient, 48-72 hours apart during consecutively scheduled ECT procedures.

Detailed description: Patients will receive the anesthetic that is traditionally given which includes appropriate doses of succinylcholine. Serum potassium and creatinine phosphokinase (CK) levels will be determined pre and post anesthesia; serum and urine myoglobin will be determined post anesthesia. Vital signs data \[i.e., heart rate (arrhythmias) and arterial blood pressure\] will be compared pre and post anesthesia. In addition patients will be asked about the presence of muscle pain (myalgia) 1 hour before discharge from the recovery room and the following day post ECT.

Eligibility criteria: Inclusion Criteria:

1. A male or non-pregnant female aged 18 years and older
2. American Society of Anesthesiologists physical status 1, 2, 3
3. Scheduled to undergo electroconvulsive therapy under general anesthesia
4. Have given written informed consent

Exclusion Criteria:

1. Pregnant or nursing
2. Any patient in the study investigators opinion who may not be suitable for research.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ronald D Miller, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00136006: The Vancouver-BOLD Study: The Burden of Chronic Obstructive Lung Disease
Official title: The Burden of Chronic Obstructive Lung Disease (BOLD) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Lung Disease
Keywords: Epidemiology
Lung health
lung function
COPD
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-08-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population of Vancouver, BC, Canada

Brief summary: This is a study of the lung health of the population of Vancouver and the extent of, and the risk factors for, chronic obstructive lung disease.


Eligibility criteria: Inclusion Criteria:

* 40 years of age and older
* Both sexes
* Random sample of population

Exclusion Criteria:

* Contraindication for lung function testing and serious life threatening illness.

Primary outcomes:
measure: Lung health
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St.Paul's Hospital/Providence Health Care
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Wen Wang
role: STUDY_DIRECTOR
References:
Clinical trial NCT03803306: Vedic Medical Astrology in Essential Hypertension
Official title: Vedic Medical Astrology in Essential Hypertension: A Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Hypertension
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Warwick Research Services (UK) Ltd
name: Swamigal Trust for Vedic Science, India
First posted: 2019-01-14
Enrollment: 68
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Previous studies have explored the correlation and impact of astrological events in relation of diseases, health concerns and relationship between birth chart and disease risk. Cardiovascular conditions, sleep and fertility were found significantly associated with moon phase. However, to best of our knowledge no study has documented the impact of astrological intervention in disease management.

This is a randomised, multi-center, double blind placebo controlled clinical trial with two parallel arms. This trial aims to evaluate the effectiveness of Vedic medical astrological intervention for patients with mild to moderate hypertension,with respect to decreasing their blood pressure and improving their quality of life.


Eligibility criteria: Inclusion Criteria:

* Patients age between 35 and 60 years old, male and female;
* Patients who meet the diagnostic criteria of essential hypertension (
* Patients taking antihypertensive drugs under the supervision of physicians.
* Patients having understanding of our study and willing to comply with astrological protocol.
* Informed consent

Exclusion Criteria:

* Patients who have been diagnosed as secondary hypertension or malignant hypertension
* Patients with comorbid conditions
* Patients with a chronic disease associated or psychiatric conditions which might not suitable for the study
* Patients who had been treated with any other alternative or complementary medicine during the previous three months

Primary outcomes:
measure: Average systolic and average diastolic blood pressure
timeFrame: change from baseline to 12-weeks
Secondary outcomes:
measure: Changes in patients Quality of life
timeFrame: change from baseline to 12-weeks
Other outcomes:
Locations:
city: Jaipur
country: India
facility: NMP Medical Reserach Institute
state: Rajasthan
Study officials:
affiliation: Warwick Research Services (UK) Ltd
name: Neha Sharma, PhD
role: STUDY_DIRECTOR
affiliation: Warwick Research Services (UK) Ltd
name: Prashanna Chockalingam
role: PRINCIPAL_INVESTIGATOR
affiliation: NMP Medical Research Institute, India
name: Puneet Sharma
role: STUDY_CHAIR
affiliation: Swamigal Trust for Vedic Science, India
name: Ramanathan Ravisankar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00643006: Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia
Official title: Physical Exercise and Its Impact on Signs of Inflammation in Women With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Therapy
Pain
Keywords: Fibromyalgia
Physical activity
Function
Pain
Exercise
Inflammation
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
name: Västra Götalands Forskningsfond
name: Reumatikerförbundet
First posted: 2008-03-25
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation.


Eligibility criteria: Inclusion Criteria:

* Women with Fibromyalgia, interested in exercise twice a week

Exclusion Criteria:

* Other severe diseases

Primary outcomes:
measure: Six-minute Walk Test
timeFrame: 15 weeks
measure: Change of Pain Level From Baseline.
timeFrame: 15 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alingsås
country: Sweden
facility: Alingsås Primary Health Care
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital, Dept of Physical Therapy
city: Uddevalla
country: Sweden
facility: Uddevalla Primary Health Care
Study officials:
affiliation: Göteborg University, Dept of Rheumatology
name: Kaisa E Mannerkorpi, Ass prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjersing JL, Erlandsson M, Bokarewa MI, Mannerkorpi K. Exercise and obesity in fibromyalgia: beneficial roles of IGF-1 and resistin? Arthritis Res Ther. 2013 Feb 27;15(1):R34. doi: 10.1186/ar4187.
citation: Bjersing JL, Dehlin M, Erlandsson M, Bokarewa MI, Mannerkorpi K. Changes in pain and insulin-like growth factor 1 in fibromyalgia during exercise: the involvement of cerebrospinal inflammatory factors and neuropeptides. Arthritis Res Ther. 2012 Jul 9;14(4):R162. doi: 10.1186/ar3902.
citation: Mannerkorpi K, Nordeman L, Cider A, Jonsson G. Does moderate-to-high intensity Nordic walking improve functional capacity and pain in fibromyalgia? A prospective randomized controlled trial. Arthritis Res Ther. 2010;12(5):R189. doi: 10.1186/ar3159. Epub 2010 Oct 13.
Clinical trial NCT00615706: Study to Evaluate the Impact of Obesity on Airway Inflammation and Mechanics in Asthmatics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: asthma, inhaled corticosteroids
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Critical Therapeutics
First posted: 2008-02-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asthmatics and healthy volunteers

Brief summary: In the United States there has been a dramatic increase in the number of people who are obese and in the number of people who have asthma. Both are considered serious public health concerns. Several studies have shown that becoming obese or overweight can increase the risk of developing asthma or can make asthma symptoms more severe and difficult to control. How obesity affects asthma is not fully understood. This research study will examine whether obesity affects the amount of inflammation that is present in the lungs of people with asthma, and will also examine whether obesity leads to narrow and stiff airways.

Participation in this study involves 2 visits in order to complete questionnaires, various pulmonary function tests, as well as the collection of blood, urine, and exhaled breath condensate specimens.

This research study includes optional genetic and bronchoscopy substudies.


Eligibility criteria: Inclusion Criteria:

* Adults 18 to 70 years of age
* If asthmatic, currently taking a short acting beta agonist and an inhaled corticosteroid
* Never smoked or limited smoking history

Exclusion Criteria:

* Current upper respiratory illness (other than asthma)
* Illegal drug use within past month
* Consumption of more than 6 alcoholic drinks per week
* Active, pronounced rhinitis or sinusitis
* Pregnancy
* Currently taking oral steroids or steroid injection over the past month
* Asthma exacerbation over the past month
* Certain medical illnesses

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University, Emory Crawford Long Hospital, Clinical Research Center
state: Georgia
Study officials:
References:
Clinical trial NCT01094106: Infiltration Analgesia After Caesarean Section
Official title: Local Infiltration Analgesia for Postoperative Pain After Caesarean Section. A Prospective, Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Caesarean Section
Keywords: postoperative pain
infiltration analgesia
ropivacaine
Caesarean Section
Lead sponsor: North Karelia Central Hospital
Sponsor class: OTHER
First posted: 2010-03-26
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Infiltration of a local anesthetic into the surgical wound is a simple method to strive to control postoperative pain after surgery. In the investigators institution, this method is used quite often. However, there is a controversy regarding the analgesic efficacy. Moreover, the cost of the single use elastomeric pump used with this procedure is clearly higher than the costs of other routinely used analgesic methods.

According to the investigators observations, infiltration of a local anesthetic into the surgical wound after caesarean section seems to reduce the need for rescue analgesics. However, the scientific evidence of the efficacy of this technique is weak. The investigators decided to conduct a prospective, controlled, randomised, double blind trial on this topic.

The hypothesis is that wound infiltration with local anesthetic will reduce postoperative pain and opioid consumption after caesarean section without major adverse effects.


Eligibility criteria: Inclusion Criteria:

* volunteer
* age over 18 years
* spinal anesthesia
* ASA 1-2
* no allergy to used medications
* no medications which have effect on pain perception

Exclusion Criteria:

* patient's refusal to participate
* marked systemic disease

Primary outcomes:
measure: The Demand of Rescue Analgesics (Oxycodone)
timeFrame: 48 hours
Secondary outcomes:
measure: Strength of Pain on Numerical Rating Scale (NRS)
timeFrame: 48 hours, divided to five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h)
measure: Postoperative Nausea and Vomiting (PONV)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Joensuu
country: Finland
facility: North Karelia Central hospital
Study officials:
affiliation: North Carelia CH, Department of Anesthesia
name: Sakari Syväoja, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03618706: Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer
Official title: A Phase II Trial of Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Ovarian Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 107
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effect of involved-field radiotherapy for recurrent ovarian cancer after primary standard treatment. We will investigate whether the addition of involved-field RT improves 2-year PFS in those patients than that of historical data (only with other standard salvage treatments as systemic chemotherapy ± maximum tumor resection).


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed ovarian carcinoma
* Patients who received "standard treatment" for each stage as a primary treatment
* No. of recurrent lesions:

If, all in lung, or intra-abdominal or pelvis organs - ≤ 5 If, any in liver, bone, or spinal cord - ≤ 2

* Size of recurrent lesions ≤5 cm
* All recurrent lesions are available for involved-field radiotherapy
* Within 60 days before enrollment:
* Absolute neutrophil count ANC ≥ 500 / mm3
* Platelet ≥ 50,000 / mm3
* Hb ≥ 8.0 g / dl
* Good performance status (ECOG 0-1)

Exclusion Criteria:

* Brain metastasis
* Diffuse peritoneal carcinomatosis
* Malignant pleural effusion
* History of previous salvage radiotherapy for recurrent lesions
* History of other malignancy or severe/unstable medical condition

Primary outcomes:
measure: 2-year progression-free survival (PFS)
timeFrame: 2 years after radiotherapy
Secondary outcomes:
measure: Local control of recurred lesions
timeFrame: 2 years after radiotherapy
measure: Any other new recurrence events
timeFrame: 2 years after radiotherapy
measure: Radiotherapy-related complications
timeFrame: 2 years after radiotherapy
measure: Chemotherapy-free interval (The interval to delay the need for a new chemotherapy regimen for disease progression)
timeFrame: 2 years after radiotherapy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Korea
Study officials:
References:
Clinical trial NCT04476706: Canakinumab MAP in COVID-19 Pneumonia With CRS
Official title: Managed Access Program (MAP) to Provide Access to Canakinumab Treatment of Cytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Cytokine Release Syndrome in COVID-19-induced Pneumonia
Keywords: canakinumab
Ilaris
ACZ885
COVID-19
coronavirus
pneumonia
CRS
cytokine release syndrome
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-07-20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is a global Managed Access Program (MAP) to provide access to canakinumab to patients with cytokine release syndrome resulting from COVID-19 pneumonia


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old;
* Clinical diagnosis of SARS-CoV-2 virus by PCR, or by other approved diagnostic methodology, or, with presumptive diagnosis of COVID-19 (other respiratory causes ruled out and COVID-19 test pending);
* Hospitalized with COVID-19-induced pneumonia;
* Elevated CRP or ferritin levels;
* Body weight ≥ 40kg.

Exclusion Criteria:

* Eligible patients must not have a history of hypersensitivity to any drugs or metabolites of similar chemical classes as canakinumab;
* On the day of canakinumab treatment initiation; treatment with biologic immunomodulators or immunosuppressant drugs, including but not limited to TNF inhibitors and anti-IL-17 agents. Immunomodulators (topical or inhaled) for asthma and atopic dermatitis are permitted as are systemic low-dose corticosteroids (e.g. ≤10 mg prednisone per day);
* Use of tocilizumab within 3 weeks prior to dosing with canakinumab;
* Suspected or known active bacterial, fungal, or parasitic infection (besides COVID-19);
* Patients with significant neutropenia (ANC \<1000/mm3);
* Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) prior to canakinumab dose.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: