louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05219032: Interpreters as Advocates for Hypertensive Patients
Official title: Interpreters as Advocates for Hispanic Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Spanish
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-02-01
Enrollment: 38
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 purpose of the study is to determine if medical interpreters trained to advocate on behalf of their patients deliver improved care compared to standard medical interpreters

Detailed description: Over 21 million Americans have limited English proficiency. About two-thirds of these individuals speak Spanish. Limited English proficiency has major adverse impacts on health and health care. Using trained medical interpreters may help overcome this language barrier. Compared to patients who need but don't get an interpreter, patients who use trained medical interpreters have better satisfaction, quality of care, and health outcomes. However, the outcomes of patients using interpreters is often poorer than that of English-speaking patients. This randomized controlled trial will test the utility of using interpreters as advocates for Spanish-speaking inner city patients with hypertension.

Eligibility criteria: Inclusion Criteria:

* Spanish speaking
* Limited English proficiency
* Uncontrolled hypertension
* Regular visit with primary care provider who is not proficient in Spanish

Exclusion Criteria:

-

Primary outcomes:
measure: Patient reported satisfaction with the clinical encounter with their clinician
timeFrame: 6 months
Secondary outcomes:
measure: Provider reported satisfaction with the clinical encounter with the patient
timeFrame: 6 months
measure: Change in systolic and diastolic blood pressure
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01140932: The Electroretinogram in Healthy and Glucose Intolerant Young Men
Official title: Electroretinographic Changes in Healthy Young Men Before and After Induction of Glucose Intolerance by Glucocorticoids Treatment, Hyperphagia and Lack of Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electroretinography
Keywords: Retina
Electroretinography
Diabetes Mellitus
Glucose Intolerance
Physiology
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2010-06-10
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose is to investigate the electroretinogram (ERG) in young, healthy men in the normoglycaemic and hyperglycaemic state before and after intervention with corticosteroids treatment, high calorie diet and exercise restraint.

Detailed description: The subjects will be fasting from midnight the day before the experiment. Standard procedures (including pupil dilation, dark adaptation, and local anaesthetics) are carried out to allow the ERG to be obtained. After electrophysiology, the subject will be clamped at a plasma glucose level of 10 mM (\~180 mg/dL) and after a stabilisation period the ERG protocol is repeated.

Each subject is examined twice on two different days. The first day the subjects are normoglycaemic in the morning (first examination) and hyperglycaemic (clamped to 10 mM) throughout the second examination. The second day subjects are also normoglycaemic and hyperglycaemic but shows up after 7-12 days of daily intake of prednisolone, high calorie diet, and exercise restraint.

Eligibility criteria: Inclusion Criteria:

* Caucasians without type 2 diabetes mellitus
* Normal OGTT (75 g glucose dissolved in 250 mL water) according to WHO's criteria
* BMI 20-30
* Haemoglobin \> 8,0 mM

Exclusion Criteria:

* Nephropathy (s-creatinin \> 130 µM or albuminuria)
* Relatives (parents or sibling with T2DM)
* Medical treatment which cannot be paused for 12 hours

Primary outcomes:
measure: ERG
timeFrame: 12 days
Secondary outcomes:
measure: Retinal Vessel Caliber
timeFrame: 12 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital at Glostrup
Study officials:
affiliation: Glostrup University Hospital, Copenhagen
name: Michael Larsen, MD, DMsc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05272332: Gastric Ultrasound Prior to Extubation
Official title: Serial Ultrasound Assessment of Gastric Volume in Mechanically Ventilated Patients Fasted Prior to Extubation: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fasting
Keywords: Gastric ultrasound
Gastric emptying
Lead sponsor: Prince of Wales Hospital, Shatin, Hong Kong
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mechanically ventilated patients in the ICU who had been on enteral feeding via nasogastric tube, fasted for extubation

Brief summary: Serial gastric ultrasound assessments to assess the effect of fasting for 4 hours on gastric volume in mechanically ventilated patients in the ICU fasted for extubation.


Eligibility criteria: Inclusion Criteria:

* over 18 years of age,
* mechanically ventilated patients in the ICU,
* intubated with endotracheal
* enteral feeding for over 6 hours before fasting

Exclusion Criteria:

* BMI \> 40, pregnant, fine bore nasogastric tube, mechanical obstruction to gastric emptying, history of upper GI surgeries

Primary outcomes:
measure: Difference in gastric volume before and after 4 hours of fasting
timeFrame: Over 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Prince of Wales Hospital, Shatin, Hong Kong
name: Esther Tang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05801432: A Study to Evaluate Coronary Atherosclerosis in Patients With Diabetes Mellitus
Official title: Diabetes Follow-up Study for REduction of cardiovAscular outcoMes: a Coronary Computed Tomographic Angiography Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 511
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: About 511 consecutive asymptomatic patients with type 2 DM, who had undergone initial CCTA evaluation at the Diabetes Center of the Asan Medical Center between February 2008 and June 2012, will be screened for enrollment in this study. A member of research team should review the patients' medical history for eligibility. If all eligibility criteria are met and written informed consent is provided, the patient may be enrolled in the study

Brief summary: The purpose of this study is to evaluate the natural history of coronary atherosclerosis development and progression over time by CCTA and to identify risk factors attributable to the development of coronary atherosclerosis in a Korean DM population.

Detailed description: Patients with diabetes mellitus, who underwent initial CCTA (coronary computed tomographic angiography) at the Diabetes Center of the Asan Medical Center between February 2008 and June 2012, will be evaluated for inclusion in the study. All DREAM-CCTA study patients will undergo follow-up CCTA based on order from their primary physician. CCTA and demographic data, medical history, cardiovascular risk factors, and laboratory data was collected in case report forms at the time of the initial CCTA and at the time of follow-up CCTA.

Eligibility criteria: Inclusion Criteria:

* Age 19 years or older
* Asymptomatic patients with type 2 DM who had undergone initial CCTA evaluation at the Diabetes Center of the Asan Medical Center between February 2008 and June 2012
* Willing and able to provide informed written consent

Exclusion Criteria:

* Blood test results that the Creatinine level exceeds 1.5 mg/dL
* A person with a history of anaphylaxis or allergic shock associated with a contrast medium
* Pregnant women
* Unable to undergo follow-up CCTA
* Uninterpretable CCTA

Primary outcomes:
measure: The change in coronary atherosclerosis detected by initial and follow-up CCTA
timeFrame: about 10 years after first CCTA
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT00253032: Pain Relief Investigation of NeuroModulation Therapy in Adult Humans
Official title: PRIMA Study: Pain Relief Investigation of NeuroModulation Therapy in an Adult Population: A Double Blind, Randomized, Multicenter, Placebo Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Musculoskeletal Pain
Lead sponsor: Fralex Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: PharmaNet
First posted: 2005-11-15
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The study is being performed to determine the efficacy and safety of Fralex Neuromodulation Therapy (F-NMT), delivered by the Fralex PRIMA device, in reducing chronic musculoskeletal pain.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sepulveda-Sanchez JM, Gil-Gil M, Alonso-Garcia M, Vaz Salgado MA, Vicente E, Mesia Barroso C, Rodriguez Sanchez A, Duran G, De Las Penas R, Munoz-Langa J, Velasco G, Hernandez-Lain A, Hilario A, Navarro Martin M, Benavides M, Oleaga L, Cantero Montenegro D, Ruano Y, Sanchez-Gomez P, Martin-Soberon MC, Morales-Llombart R, Pachon V, Pineda E. Phase II Trial of Palbociclib in Recurrent Retinoblastoma-Positive Anaplastic Oligodendroglioma: A Study from the Spanish Group for Research in Neuro-Oncology (GEINO). Target Oncol. 2020 Oct;15(5):613-622. doi: 10.1007/s11523-020-00754-6.
Clinical trial NCT06500832: Defensive Dentistry Practices and Dentists (DDP)
Official title: An Analysis of Clinicians' Knowledge and Attitudes Regarding Defensive Dentistry Practices: A Survey-based Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Defensive Medicine
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 410
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants are the volunteered dentists registered as a member of Turkish Dental Association

Brief summary: Medical malpractice claims have been on the rise in recent years due to the growing patient rights movement. This term is defined as an injury caused by a healthcare professional's failure to follow standard practice during treatment, a lack of skill, or failure to provide treatment. Defensive dentistry is on the rise as violence and malpractice claims increase. Defensive dental practices (DDP) refer to minimize legal responsibility of the clinician primarily rather than looking out for the patient's benefit. This study aims to evaluate the knowledge, awareness and attitudes of dentists in terms of DDP.


Eligibility criteria: Inclusion Criteria:

* Having worked as a dentist for at least one year;
* Speaking Turkish as their native language;
* Being a member of the Turkish Dental Association;
* Participating in the study voluntarily.

Exclusion Criteria:

-To stop volunteering until the study is completed.

Primary outcomes:
measure: DDPS Score
timeFrame: 1hour
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Aydin University
state: Kucukcekmece
Study officials:
References:
citation: Baungaard N, Skovvang PL, Assing Hvidt E, Gerbild H, Kirstine Andersen M, Lykkegaard J. How defensive medicine is defined in European medical literature: a systematic review. BMJ Open. 2022 Jan 20;12(1):e057169. doi: 10.1136/bmjopen-2021-057169.
citation: Raposo VL. Defensive Medicine and the Imposition of a More Demanding Standard of Care. J Leg Med. 2019 Oct-Dec;39(4):401-416. doi: 10.1080/01947648.2019.1677273.
Clinical trial NCT00944632: Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis
Official title: Double-blind, Randomized, Dose Escalation Study of the Efficacy and Safety of ZK 245186 Ointment in Concentrations of 0.01%, 0.03%, and 0.1% Over 4 Weeks in Patients With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-07-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of three concentrations of ZK 245186 ointment and vehicle on increasing body surface areas for the treatment of atopic dermatitis and to obtain dose-response information for the three concentrations.


Eligibility criteria: Inclusion Criteria:

* diagnosis of atopic dermatitis (Hanifin and Rajka criteria)
* mild to moderate atopic dermatitis at beginning of study
* wash-out periods for systemic and topical treatments for atopic dermatitis
* females must use effective contraception

Exclusion Criteria:

* pregnant or lactating women
* conditions that in the opinion of the investigator may pose a risk or interfere with the evaluation of the study
* wide-spread atopic dermatitis requiring systemic treatment
* diagnosed with immunocompromised status
* skin diseases - other than atopic dermatitis - in the treatment area
* mental handicap or legally incompetent

Primary outcomes:
measure: Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Investigator's Global Assessment of target area
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Bloemfontein
country: South Africa
facility: PAREXEL International (Bloemfontein)
city: George
country: South Africa
facility: PAREXEL International (George)
city: Newton Park
country: South Africa
facility: PAREXEL International (Port Elizabeth)
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05956132: Clinical and Biochemical Features for the Identification of Dominant Calpainopathies
Official title: Retrospective Analysis of Clinical and Biochemical Features for the Identification of Dominant Inheritance of Calpainopathies
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Calpain-3 Deficiency Limb Girdle Muscular Dystrophy Type 2A
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
Collaborators: name: IRCCS Fondazione Stella Maris
name: Istituto Giannina Gaslini
name: Ospedale Policlinico San Martino
name: Universita di Verona
name: Azienda Ospedaliera Universitaria Senese
name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
First posted: 2023-07-21
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Suitable subjects identified in the participating centers.

Brief summary: Mutations in the CAPN3 gene cause muscular dystrophies with dysfunction in calpain-3. Calpainopathies are usually inherited in an autosomal recessive manner but in some families they can occur in a dominant inheritance. The significance of heterozygous variants is difficult to interpret in the absence of family history. In this study, the investigators will review the clinical and laboratory information in a cohort of patients identified in the participating centers, with the aim of improving the diagnostic strategy of dominant calpainopathies.

Detailed description: The investigators will review clinical and biomarker information in a cohort of 50 patients with heterozygous variants in the CAPN3 gene. Patients are referred by participating centers who will provide anonymised information on the clinical phenotype and laboratory test results. Suitable subjects will be contacted to obtain informed consent. Pseudonymised anamnestic data will be collected from the patient's clinical history and medical records.The aim is to identify a set of multidisciplinary data sufficient to define a diagnostic algorithm for the dominant calpainopathies.

Eligibility criteria: Inclusion Criteria:

* Clinical LGMD phenotype, family history with dominant inheritance or sporadic cases, single variant in CAPN3, second variant excluded by MLPA (Multiplex Ligation Probe Amplification) or by analysis of mRNA extracted from muscle.

Exclusion Criteria:

* No variants in CAPN3, two variants in CAPN3

Primary outcomes:
measure: Muscle strenght
timeFrame: through study completion, an average of 1 year
measure: Muscle biopsy
timeFrame: through study completion, an average of 1 year
measure: Creatin Kinase
timeFrame: through study completion, an average of 1 year
measure: Clinical history
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Venice-Lido
country: Italy
facility: San Camillo Irccs
state: VE
city: Venice-Lido
country: Italy
facility: IRCCS San Camillo
Study officials:
affiliation: IRCCS SAN CAMILLO
name: RITA BARRESI, DR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06205732: A Retrospective Study on the Treatment of Intermediate and Advanced Liver Cancer.
Official title: Retrospective Study and Construction of a Prediction Model for Patients With Intermediate and Advanced Liver Cancer Treated With TACE Combined With Immunotherapy and Targeted Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with intermediate and advanced liver cancer who received TACE combined with immunotherapy and targeted therapy.

Brief summary: To evaluate the effectiveness of TACE combined with immunotherapy and targeted therapy versus TACE alone in patients with intermediate and advanced liver cancer.

Detailed description: To evaluate the efficacy and safety of TACE combined with immunotherapy and targeted therapy in patients with intermediate and advanced liver cancer. Explore the factors affecting the prognosis of liver cancer treated with TACE combined with immunotherapy and targeted therapy and establish a specific individualized prognostic score and risk stratification model.

Eligibility criteria: Inclusion Criteria:

* ≥18 years old, both men and women
* primary liver cancer confirmed by liver biopsy or history of hepatitis B, AFP, and typical imaging findings
* patients with liver function Child-Pugh A or B (≤8 points)
* BCLC stage B and stage C
* expected survival time ≥8 weeks
* patients with generally good performance status (ECOG PS score 0 or 1)

Exclusion Criteria:

* The patient's key data is missing
* liver metastatic cancer confirmed by histology or cytology
* patients who interrupt treatment due to intolerance of adverse drug reactions
* combined with primary malignant tumors of other organs within 5 years; combined with other serious diseases, such as severe heart disease, renal insufficiency, severe infection, bleeding, etc.
* combined with systemic infection, autoimmune disease, or other types of tumors; previous allogeneic bone marrow transplantation or solid organ transplantation
* study participants known to have mental illness
* situations such as drug use or substance abuse

Primary outcomes:
measure: Progression-Free-Survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: the Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: the Qianfoshan Hospital
name: Jing Liang, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT00149032: Treatment of Patients With Donor Lymphocytes Sensitized by Antigens Expressed by the Host
Official title: Treatment of Patients With Resistant Cancer/ Post Allogeneic Stem Cell Transplantation With Donor Lymphocytes Sensitized by Antigens Expressed by the Host
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hematological Malignancy
Neoplasm Metastasis
Keywords: Metastatic solid tumor
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-08
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Allogeneic stem cell transplantation is the only effective treatment to patients resistant to conventional chemotherapy. Donor lymphocytes infusion (DLI) serve as a routine treatment of choice for patients relapsing following allogeneic stem cell transplantation. The present proposal is presented for introducing the use of immune rather than naive donor lymphocytes for patients with resistant relapse and resistant to DLI. DLI primed in-vitro against tumor cells of host origin or against host alloantigens presented by parental alloantigens in one way mixed lymphocytes culture can induce much more than potent graft-vs-leukemia and graft-vs-tumor effects, while down-regulating graft-vs-host disease (GVHD).


Eligibility criteria: Inclusion Criteria:

* Patients with hematologic malignancy or metastatic solid tumor relapsing following allogeneic bone marrow or blood stem cell transplantation (alloBMT) or non-myeloablative stem cell transplantation resistant to DLI with no GVHD when taken off anti-GVHD prophylaxis.
* Patients with documented chimerism to confirm induction of host-vs-graft transplantation tolerance.

Exclusion Criteria:

* Patients not consenting to participate in the study, or minors without approved parental consent.
* Patients with other diseases or complications that may limit their life span other than their basic disease.
* Pregnant or lactating women.
* Non-compliant patients or patients with poor performance status with life expectancy, e.g. 6 weeks.

Primary outcomes:
measure: Introducing more effective graft vs leukemia and graft vs tumor effects with immune donor lymphocytes in patients relapsing following allogeneic bone marrow or blood stem cell transplantation
Secondary outcomes:
measure: Upregulating of anti-tumor effects while minimizing anti-host responses
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Shimon Slavin, MD
role: PRINCIPAL_INVESTIGATOR
References: