louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04573335: Diabetes Outcomes in COVID-19 Pandemic
Official title: Health-related Outcomes and Behaviour Changes in a Cohort of Diabetic Population During COVID-19 Pandemic: Results of a Telephonic Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Covid19
Isolation, Social
Keywords: COVID-19
diabetes mellitus
telesurvey
Lead sponsor: Services Institute of Medical Sciences, Pakistan
Sponsor class: OTHER_GOV
First posted: 2020-10-05
Enrollment: 1282
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetic subjects already registered with and on regular follow-up with DMC and had visited DMC for consultation more than once between 1st August 2019 to 15th March 2020.

Brief summary: Diabetes management and follow-up has become a challenge during the COVID-19 pandemic. Nation-wide lockdowns and social distancing measures adopted in an attempt to break the chain of COVID-19 transmission have significantly disrupted routine care and follow-up of diabetes. In the health sector, especially in low-income countries such as Pakistan, there has been a shift of resources and staff reassignment from stable chronic illnesses to support COVID-19 pandemic. Disruption of routine outpatient health services and travel restrictions increase the risk of worsening diabetes control and diabetes-related health outcomes. Additionally, social isolation amidst an atmosphere of fear and uncertainty contributes to stress further affecting glycaemic control.

Detailed description: An observational cross-sectional study was conducted using telephone interview method in Diabetes Management Centre (DMC), Services hospital, Lahore. The study participants were 1282 diabetic patients selected randomly from electronic medical record (EMR) database of the Centre. A structured questionnaire was used to evaluate parameters which included patients' demographic information; diabetes self-care and general health profile; COVID-related questions and its impact on quality of life (QoL); financial and social support issues.

Eligibility criteria: Inclusion Criteria:

* Type 1 and type 2 diabetic patients registered with Diabetes Management Centre, Services hospital, Lahore, Pakistan.

Exclusion Criteria:

* Patients lacking telephonic contact or with invalid contact numbers.

Primary outcomes:
measure: All-cause mortality
timeFrame: during 3months of lockdown
Secondary outcomes:
measure: COVID-19 illness
timeFrame: During 3months of lockdown
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Hospital
state: Punjab
Study officials:
affiliation: SIMS
name: Saira Burney, MB;FRCP (Edin)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01346735: Multi-center Observational Study to Evaluate Epidemiology and Resistance Patterns of Common ICU-Infections (MOSER)
Official title: Multi-center Observational Study to Evaluate Epidemiology and Resistance Patterns of Common ICU-Infections (MOSER)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nosocomial Infections
Keywords: Ventilator associated pneumonia
Catheter related blood stream infection
Catheter associated urinary tract infection
ICU-related infections (VAP, CAUTI and CRBSI)
India
Lead sponsor: Indian Society of Critical Care Medicine
Sponsor class: OTHER
First posted: 2011-05-03
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult ICU patients

Brief summary: Most literature on ICU infections and the resistant patterns comes from the western literature. This data may not truly reflect the incidence, epidemiology and resistance patterns in developing countries such as India. However, empiric antibiotic therapy is generally initiated using western guidelines. This can potentially lead to inadequate, inappropriate and ineffective empiric antibiotic therapy for ICU infections in the Indian setting. Hence in this multi-center observational study, we seek to:

1. To determine the incidence of ICU-related infections (VAP, CAUTI and CRBSI) in India
2. To explore the microbiology, resistance and treatment patterns of these infections


Eligibility criteria: Inclusion Criteria:

1. ICU stay \>48 hours
2. One of the following infections (VAP, CAUTI or CRBSI)

Exclusion Criteria:

1. Index ICU stay \< 48 hours
2. Re-admissions to the ICU within the same hospitalization
3. Age \>18 years or \<70 years
4. Known HIV serology positivity
5. Burns
6. Solid organ or Bone-marrow transplant
7. No ICU-acquired infections (specifically VAP, CAUTI and CRBSI)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Indian Society of Critical Care Medicine
Study officials:
References:
Clinical trial NCT05955235: A Long-term Safety Follow-up Study of SCM-AGH in Patients Who Completed SCM-APT2001 Study
Official title: A Long-term Safety Follow-up Study of SCM-AGH in Patients Who Completed SCM-APT2001 Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreatitis, Acute
Keywords: Stem Cell Therapy
SCM-AGH
Pancreatitis
Lead sponsor: SCM Lifescience Co., LTD.
Sponsor class: INDUSTRY
First posted: 2023-07-21
Enrollment: 42
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have received at least 1 dose of SCM-AGH in the SCM-APT2001 study (ClinicalTrials.gov ID: NCT04189419)

Brief summary: This is a long-term safety follow-up study of the Phase I/IIa multicenter study of SCM-AGH in subjects with moderate to severe acute pancreatitis. subjects will be followed up for a maximum period of 240 weeks after the first dose of investigational product. Only subjects previously enrolled in protocol SCM-APT2001 (ClinicalTrials.gov ID: NCT04189419) will be eligible for this long-term follow-up protocol.

Detailed description: Subjects who meet all eligibility criteria for Long Term Follow-Up(LTFU) study participation at the SCM-APT2001 End of Treatment(EOT) visit may continue LTFU for a maximum period of up to 240 weeks post first dose of investigational product. No additional dosing will be administered on this LTFU protocol.

Eligibility criteria: Inclusion Criteria:

* Subjects who provide written informed consent
* Subjects who have received at least 1 dose of SCM-AGH in the SCM-APT2001 study

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Long-term safety assessment
timeFrame: Up to 5 Years
measure: Mortality
timeFrame: Up to 5 Years
measure: Ratio of subjects with malignant tumors formed during the long-term safety follow-up period
timeFrame: Up to 5 Years
Secondary outcomes:
measure: Number of occurrences of Abnormal, clinically significant in laboratory results
timeFrame: Up to 5 Years
measure: Number of occurrences of Abnormal, clinically significant in Vital Signs
timeFrame: Up to 5 Years
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Hosptial Bucheon
state: Gyenggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Goyang-si
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Medical School
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
References:
Clinical trial NCT04230135: Cultural Adaptation of Hap-pas-Hapi (Step-by-Step) for Albanian-speaking Immigrants in Switzerland and Germany
Official title: Randomised Controlled Trial to Test to What Extent the Adaptation of a Smartphone-based Self-help Programme to Albanian Immigrants' Cultural Concepts of Distress Enhances Its Acceptability and Efficacy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Psychological Distress
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Freie Universität Berlin
First posted: 2020-01-18
Enrollment: 97
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: We aim to compare two different levels of cultural adaptation of an Internet- and mobile-based intervention for the treatment of depression called Hap-pas-Hapi among Albanian-speaking immigrants in Switzerland and Germany. One arm will include the generic (minimally adapted) version of Hap-pas Hapi. The other arm will include a version of Hap-pas-Hapi that was adapted to the target population's cultural concepts of distress. Both versions include five sessions and the same therapeutic techniques.


Eligibility criteria: Inclusion Criteria:

* Electronic informed consent documented by time-stamped agreement to a set of consent questions
* Albanian-speaking
* Male and female participants aged above 18
* Kessler Psychological Distress Scale (K10), Albanian version score \>15
* Access to Smartphone (iOS or Android) or web-browser

Exclusion Criteria:

* People living outside Germany or Switzerland
* Serious suicidal thoughts or plan (self-assessed with a corresponding question)

Primary outcomes:
measure: Psychological distress
timeFrame: Six weeks
measure: Treatment adherence
timeFrame: Six weeks
Secondary outcomes:
measure: Functional impairment (health and disability)
timeFrame: Six weeks
measure: Well-being
timeFrame: Six weeks
measure: Post-traumatic stress disorder
timeFrame: Six weeks
measure: Self-defined problems
timeFrame: Six weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Freie Universität Berlin
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
References:
Clinical trial NCT01199835: The Effects of Dairy Products on Energy Balance
Official title: The Effects of Dairy Products on Energy Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
metabolic syndrome
fecal fat excretion
fecal calcium
weight loss
appetite regulation
intestinal micro flora
lipid profile
energy balance
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
name: The Danish Dairy Research Foundation, Denmark
First posted: 2010-09-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to investigate the long time effects of high and low intake of dairy products on fecal fat excretion, weight loss, blood pressure, lipid profile, lipid oxidation and appetite regulation in moderately overweight men and women over 24 weeks.


Eligibility criteria: Inclusion Criteria:

* men and women,
* medium overweight (body mass index 28-36 kg/m2),
* 18-60 years old,
* low habitual calcium intake (\<800 mg/d)

Exclusion Criteria:

* milk allergy, infection diseases and diabetes,
* intake of dietary supplements,
* smoking,
* pregnancy and/or breast feeding,
* any medications known to affect the outcome measurements,
* weigh reducing diet,
* gastrointestinal diseases,
* participation in other intervention studies

Primary outcomes:
measure: Fecal fat excretion
timeFrame: 24 weeks
measure: Body weight
timeFrame: 24 weeks
measure: body composition
timeFrame: 24 weeks
Secondary outcomes:
measure: Resting energy expenditure
timeFrame: 24 weeks
measure: Blood pressure
timeFrame: 24 weeks
measure: Appetite regulation
timeFrame: 24 weeks
measure: Lipid profile
timeFrame: 24 weeks
measure: Intestinal micro flora
timeFrame: 24 weeks
measure: Metabolomics in urine, feces and blood
timeFrame: 24 week
measure: calcium excretion
timeFrame: 24 weeks
measure: bone markers
timeFrame: 24 weeks
measure: vitamin D status
timeFrame: 24 weeks
measure: calcium status
timeFrame: 24 weeks
measure: lipid metabolism
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Exercise, Nutrition and Sports, Faculty of Sciences, University of Copenhagen
Study officials:
References:
Clinical trial NCT04588935: Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer
Official title: To Develop and Implement a Method for Medical Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Women With Breast Cancer
Lead sponsor: State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To develop a method of medical prevention of cardiovascular diseases caused by cardiotoxicity against the background of complex treatment of patients with primary resectable breast cancer to reduce the risk of cardiovascular complications

Detailed description: Purpose of the study: to develop a method of medical prevention of cardiovascular diseases caused by cardiotoxicity against the background of complex treatment of patients with primary resectable breast cancer to reduce the risk of cardiovascular complications

Eligibility criteria: Inclusion Criteria:

* women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy.

Exclusion Criteria:

* presence of other oncological diseases

Primary outcomes:
measure: development of cardiovascular diseases and complications
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Scientific and Practice Center of Cardiology
Study officials:
References:
Clinical trial NCT02867735: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema
Official title: A Randomized, Single-masked, Sham-control, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema From Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (AMD), or Retinal Vein Occlusions (RVO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Macular Edema
Diabetic Macular Edema
Neovascular Age-related Macular Degeneration
Retinal Vein Occlusions
Keywords: Macular Edema
Diabetic Macular Edema (DME)
Neovascular age-related Macular Degeneration(AMD)
Retinal Vein Occlusions (RVO)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-08-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and tolerability of LKA651 in patients with macular edema from diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal vein occlusions (RVO)


Eligibility criteria: Inclusion Criteria:

-Patients with macular edema with center involvement in at least one eye, including those with focal or diffuse DME, neovascular AMD, or RVO

The ETDRS letter score in the study eye must be 60 letters or worse (approximate Snellen equivalent of 20/63)

Vital signs as specified within the protocol

Exclusion Criteria:

-Proliferative diabetic retinopathy in the study eye, with the exception of tufts of neovascularization less than one disc area with no vitreous hemorrhage

Patient, with type 1 or type 2 diabetes who have a hemoglobin A1C \> or = 12% at screening

other ocular conditions as specified in the protocol

systemic conditions as specified in the protocol

Primary outcomes:
measure: Number Of participants with Adverse Events as a measure of Safety and Tolerability
timeFrame: Day 1 through study completion
Secondary outcomes:
measure: Pharmacokinetics of Single Dose of LKA651 - Area Under the Curve (AUC)
timeFrame: Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85
measure: Pharmacokinetics of Single Dose of LKA651 - Cmax
timeFrame: Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Novartis Investigative Site
state: California
city: Fort Myers
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Winter Haven
country: United States
facility: Novartis Investigative Site
state: Florida
city: Augusta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Arecibo
country: Puerto Rico
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04975035: A Prospective, Open-ended, Multi-center Study of Schizophrenia Patients Switching to Zolodine
Official title: A Prospective, Open-ended, Multi-center Study of Schizophrenia Patients Switching to Zolodine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Schizophrenia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Through self-controlled studies on metabolic syndrome related indicators, efficacy and other adverse reactions in patients with schizophrenia who developed metabolic syndrome after treatment with other antipsychotics, switched to Zoladine capsules (ziprasidone hydrochloride capsules). To evaluate the clinical application value of switching to Zolodine for schizophrenia patients with metabolic syndrome, and to explore the drug selection strategy for long-term treatment of schizophrenia patients.


Eligibility criteria: Inclusion Criteria:

* Meet the DSM-IV diagnostic criteria for schizophrenia, patients aged 18-40 years old have been treated with other antipsychotics for more than 8 weeks (inclusive) before being included, meet the diagnostic criteria for metabolic syndrome (IDF, 2005), and have not reached diabetes , Patients with diagnostic criteria for hypertension.

Exclusion Criteria:

* Female patients who are pregnant or breastfeeding;
* Serious and unstable physical diseases, including: cardiovascular, respiratory, liver, kidney, gastrointestinal, nerve, endocrine, immune, blood system, narrow-angle glaucoma, history of seizures;
* Patients with refractory schizophrenia;
* Those who meet the DSM-IV standards for dementia or substance dependence (except tobacco);
* Patients with a history of contraindications to ziprasidone or intolerance of ziprasidone;
* Patients who use long-acting antipsychotic injections or oral medications;
* Patients who have recently experienced prolonged QT interval, acute myocardial infarction, and decompensated heart failure;
* Patients have recently taken drugs that can prolong the QT interval, such as dofetilide, sotalol, quinidine, other class Ia and III antiarrhythmic drugs, mesoridazine, thioridazine, Chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadone, dolastron methanesulfonate Acid, probucol or tacrolimus;
* At the same time taking other drugs that can cause obesity, such as oral contraceptives;
* Patients who have met metabolic syndrome before diagnosis and treatment of schizophrenia.

Primary outcomes:
measure: score of PANSS
timeFrame: 2 weeks
measure: score of HAMA
timeFrame: 2 weeks
measure: score of HAMD
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03992235: Importance of Exercise Educational Materials in Chest Physiotherapy
Official title: Importance of Exercise Educational Materials in Chest Physiotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Educational Problems
Physiotherapy
Chest Physiotherapy
Keywords: chest physiotherapy
physiotherapy
education
educational material
thoracotomy
chest
surgery
lung
exercise
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will randomize into 2 group
Primary purpose: TREATMENT

Brief summary: The patients who have undergone thoracotomy operation will include in the study. All patients have chest physiotherapy in the intensive care unit. Patients will be randomized and divided into two groups. One group will be given an exercise form with details and photographs of the exercises. No documents will be given to the other group. The program includes breathing exercises, incentive spirometry study, coughing and graded ambulation. After 1 intensive care session, patients are admitted to the service rooms due to routine procedures. The patients will be served in the afternoon and will be questioned whether they are performing their exercises or not.

Detailed description: * Physiotherapy will be applied to patients undergoing thoracotomy after 24 hours of intensive care hospitalization.
* Patients will be randomized and divided into two groups. Study group will be given exercise form. Control group not.
* Physiotherapy program includes breathing exercises, incentive spirometry study, graded ambulation and both groups will receive this physiotherapy session in the intensive care unit..
* After the patients are admitted to the service rooms, a service visit will be performed, the amount of remembering of the exercises and whether the exercises are performed in a proper form will be questioned.

Eligibility criteria: Inclusion Criteria:

* Between 18-70 years
* Having undergone post-thoracotomy
* Hemodynamically stable,
* To be conscious

Exclusion Criteria:

* Excessive pain
* Neurological complications
* Cardiovascular and musculoskeletal problems that prevent him from exercising
* Not wanting to be involved in the study
* Fever above 38 degrees

Primary outcomes:
measure: The number of exercises remembered
timeFrame: 15 second
measure: The number of exercises done correctly
timeFrame: 15 second
Secondary outcomes:
measure: Demographic features
timeFrame: 5 second
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yedikule Chest Disease Hospital
state: Zeytinburnu
Study officials:
affiliation: SBÜ
name: ESRA PEHLİVAN, PhD
role: PRINCIPAL_INVESTIGATOR
References: