louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04592055: The Effect of COVID-19 on Diabetes Mellitus
Official title: The Effect of COVID-19 on the Glycemic Control in Patients With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Covid19
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All hospitalised diabetic patients with RT-PCR- positive for SARS-COV-2 will be enrolled and evaluated.

Brief summary: The study aimed to evaluate the effect of SARS-COV-2 infection on metabolic status in patients with diabetes mellitus. Patients' HbA1c levels before and after SARS-COV-2 infection will be evaluated.

Detailed description: In this time pediods, all patients with RT-PCR positive for SARS-COV-2 will be analysed for the presence of diabetes mellitus. Previous HbA1c levels will be obtained from hospital records. In these patients, previous A1c levels and A1c levels 3 months after the SARS-COV-2 infection will be compared.

Eligibility criteria: Inclusion Criteria:

- All hospitalised diabetic patients with RT-PCR- positive for SARS-COV-2 will be enrolled.

Exclusion Criteria:

- The absence of diabetes mellitus RT-PCR- negative for SARS-COV-2 Non-hospitalised patients

Primary outcomes:
measure: A1c
timeFrame: 6 months (3 months before and after COVID-19
Secondary outcomes:
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Usak University Training and Research Hospital
Study officials:
affiliation: Uşak University
name: Cevdet Duran, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02034955: Prostatectomy Adaptive Radiation Therapy (ART)
Official title: A Feasibility Study of Post-operative Adaptive Radiation Therapy for Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Adaptive Radiotherapy
Prostatectomy
Patients who had a prostatectomy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will ultimately aim to evaluate the side effects of treatment by asking 20 subjects to receive post-operative radiotherapy for prostate cancer with the treatment plan adapted after the first week of treatment to account for changes in the target shape. These patients will be asked to complete toxicity scores and a quality of life questionnaire at the start and completion of treatment, and at 3 months 1, 2 and 5 years from the start of radiotherapy. These results will be used to determine the feasibility of the proposed approach, and obtain early estimates of improvements in uncertainty margin requirements for this population of patients.


Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis of adenocarcinoma of the prostate after radical prostatectomy AND
* Clinical stage pT3, pT4, or pT2 with positive margin OR
* Any p-Stage with a persistently elevated post-operative PSA \> 0.05 ng/ml OR
* A delayed rise in PSA post-operatively

Exclusion Criteria:

* Inflammatory bowel disease or other contraindications to radiotherapy
* Prior pelvic radiotherapy
* Previous cytotoxic chemotherapy
* Radiological or pathologic evidence of nodal metastases.
* Planned radiotherapy to pelvic lymph nodes
* Evidence of systemic metastases on imaging.
* Prosthetic hip replacement
* No signed informed consent

Primary outcomes:
measure: Change in radiation dose delivered to target volumes and normal tissue
timeFrame: 5 years
Secondary outcomes:
measure: Time for radiotherapy replanning
timeFrame: 5 years
measure: Volumetric modulated arc therapy impact in a clinical adaptive Radiotherapy workflow.
timeFrame: 5 years
measure: Toxicity associated with the adaptive radiotherapy technique.
timeFrame: 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: The Princess Margaret Cancer Foundation
name: Charles N Catton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04498455: Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency
Official title: Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Weight Gain Trajectory
Metabolic Syndrome
Keywords: Fiber
Microbiome
Metabolism
Lead sponsor: Baylor University
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo-controlled trial of a fiber supplement \[Prebiotin\] compared to placebo \[maltodextrin\]
Primary purpose: PREVENTION

Brief summary: A randomized placebo controlled trial to determine if increased dietary fiber will prevent weight gain, inhibit adiposity and reduce perceived stress levels in residents at the Waco Family Health Center as the result of changes in distal gut microbiota composition and function.

Detailed description: This study will utilize a single blind, placebo controlled, parallel design to assess the effect of dietary fiber \[Prebiotin\] on the gut microbiome, perceived stress, anthropometric variables, and clinical biomarkers of metabolism. All participants in this study will be resident physicians at the Family Health Center in Waco, TX. This population was selected based on pilot data indicating they are at a greater risk for weight gain and have higher levels of stress than the average population. The goal is to recruit 40 participants for a 12 week intervention trial.

Eligibility criteria: Inclusion Criteria:

* Currently a resident in training at the Family Health Center in their first year.

Exclusion Criteria:

* Pregnancy
* Currently on prescribed metformin or NSAIDS
* A diagnosed gastro-intestinal disease (i.e. irritable bowel syndrome or Crohn's disease)
* Known allergy to the supplement, placebo, or provided meal replacements
* Antibiotic use within the last 3 months.

Primary outcomes:
measure: Change in body weight
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Waco
country: United States
facility: Baylor University
state: Texas
Study officials:
affiliation: Baylor University
name: LesLee Funderburk, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04355455: Effects of Serotonin Agonist Citalopram on Multimodal Esophageal Stimulation in Healthy Volunteers
Official title: Effects of Serotonin Agonist Citalopram on Multimodal Esophageal Stimulation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To investigate the effect of citalopram, a selective serotonin reuptake inhibitor, on esophageal sensitivity.


Eligibility criteria: Inclusion Criteria:

* HV aged between 18 - 60 years

Exclusion Criteria:

* history of psychiatric disease or a positive first degree psychiatric family history
* pregnancy or lactation
* concomitant administration of any centrally activating medication (anti-depressive medication, hypnotics, sedatives, anxiolytics, ...)
* medication affecting esophageal motility
* significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic)
* prior history of esophageal, gastric surgery or endoscopic anti-reflux procedure
* history of gastrointestinal disease

Primary outcomes:
measure: Change in sensitivity to thermal stimulation
timeFrame: After 1 hour 30 minutes after administration citalopram, we will start with the thermal stimulation
Secondary outcomes:
measure: Change in sensitivity to mechanical stimulation
timeFrame: After 1 hour 45 minutes after administration citalopram, we will start with the mechanical stimulation
measure: Change in sensitivity to electrical stimulation
timeFrame: After 2 hours after administration citalopram, we will start with the electrical stimulation
measure: Change in sensitivity to chemical stimulation
timeFrame: After 2 hours 15 minutes after administration citalopram, we will start with the chemical stimulation
measure: Change in positive and negative affect score
timeFrame: At the beginning of the study and at the end of the multimodal stimulation
measure: Change in state trait and anxiety score
timeFrame: At the beginning of the study and at the end of the multimodal stimulation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04681755: Rehabilitation Required Due to Clinical Disorders After Severe Covid-19 Infection
Official title: Rehabilitation Required Due to Functional Neurological Impairment and Respiratory Disorders After Severe SARS-CoV-2 Infection in ICU Units
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: Rehabilitation
SARS-CoV-2
COVID-19
Neurological function
Respiratory disorder
Intensive care unit
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient with a SARS-CoV-2 infection documented by RT-PCR or with lesions suggestive on chest CT.

Brief summary: Due to the emergence of an epidemic cluster in Mulhouse, a city located 100 km south of Strasbourg, Alsace was one of the first French regions to be affected by the coronavirus (SARS-CoV-2 or COVID-19). As a result, all hospitals in the region, including both Strasbourg University Hospitals, had to deal with the epidemic wave earlier and more intensely than the rest of France. At the time of writing this article, 6 weeks after the start of the epidemic, we have counted 998 hospital deaths in our region, i.e., an intrahospital mortality rate linked to COVID-19 of 5.3 deaths per 10,000 inhabitants (https://dashboard.covid19.data.gouv.fr/).

Currently, our intensive care unit still has a large number of patients hospitalized for COVID-19. Some of these patients have severe damage to one or more organs, and in particular a neurological or respiratory deficit suggesting that they will need post-resuscitation rehabilitation. The primary aim is to assess the neurological disorder after severe SARS-CoV-2 infection and the second is the respiratory impairment evaluation.


Eligibility criteria: Inclusion Criteria:

* Adult patient (≥18 years old)
* Patient hospitalized in surgical intensive care at the New Civil Hospital between February 24 and April 15, 2020.
* Patient with a SARS-CoV-2 infection documented by RT-PCR or with lesions suggestive on chest CT.
* Patient who has given his consent for the use of his data for the purposes of this research

Exclusion Criteria:

* Patient without documentation of SARS-CoV-2 infection (RT-PCR or chest scanner)
* Patient who expressed his opposition to participating in the study
* Subject under safeguard of justice
* Subject under guardianship or guardianship

Primary outcomes:
measure: Retrospective analysis of the neurological disorder after severe SARS-CoV-2 infection
timeFrame: The files analysed retrospectily from February 24, 2020 to April 15, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Strasbourg University Hospitals - Anesthesia and surgical resuscitation service
Study officials:
References:
Clinical trial NCT00139555: Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension
Official title: Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Left Ventricular Hypertrophy
Keywords: Hypertension
Left ventricular hypertrophy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 125
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Left ventricular hypertrophy (LVH) increases the risk of cardiovascular morbidity and mortality in patients with high blood pressure, compared to those without LVH. Reduction of left ventricular mass (LVM) with antihypertensive agents is associated with improved clinical outcome. This study will evaluate the effects of amlodipine/benazepril in reducing LVM in patients with high risk hypertension.


Eligibility criteria: Inclusion Criteria:

* Males or female patients ≥ 55 years of age
* LVH as confirmed by echocardiogram
* Patients with high risk hypertension, currently treated or already taking antihypertensive medication

Exclusion Criteria:

* Renal artery stenosis
* Symptomatic heart failure or known ejection fraction \< 40%
* Myocardial infarction or stroke within 6 months
* Presence of cranial aneurysm clips, coronary artery metal stents and pacemakers
* Pregnant or lactating females
* Cancer within the last 5 years

Primary outcomes:
measure: Change from baseline in left ventricular mass index after 52 weeks
Secondary outcomes:
measure: Change from baseline in left ventricular mass after 52 weeks
measure: Change from baseline in diastolic function after 52 weeks
measure: Change from baseline in aorta function assessed blood pressure measurements after 52 weeks
measure: Change from baseline in markers of fibrosis and increased heart size after 52 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Reichek N, Devereux RB, Rocha RA, Hilkert R, Hall D, Purkayastha D, Pitt B. Magnetic resonance imaging left ventricular mass reduction with fixed-dose angiotensin-converting enzyme inhibitor-based regimens in patients with high-risk hypertension. Hypertension. 2009 Oct;54(4):731-7. doi: 10.1161/HYPERTENSIONAHA.109.130641. Epub 2009 Aug 17.
Clinical trial NCT02740855: Endtidal Ethanol in Sclerotherapy
Official title: Endtidal Ethanol in Sclerotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ethanol Concentration
Keywords: sclerotherapy
ethanol
pulmonal hypertension
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients undergoing ethanol sclerotherapy at the university hospital Berne over the age of 18.

Brief summary: During the ethanol sclerotherapy procedure, the investigators will record doses of and time of ethanol injections and record ethanol concentrations in endtidal breath every 5 minutes. Furthermore after every ethanol injection the concentration will be measured every minute for 5 minutes. To do so, the investigators will attach a breath alcohol testing device to the expiratory carbon dioxide measuring unit. Since this is the new standard of the university hospital Berne all patients undergo the same procedure. There is no study specific intervention. In this study the investigators will only document the breath alcohol levels, doses and timing of ethanol injections. All other data will be obtained from the anesthesia information system. During the two months of the study, the investigators will also record endtidal ethanol concentration after anesthesia in the postoperative care unit discharge from the unit.

The intention is to show the correlation between injected ethanol doses and measured endtidal ethanol concentration over the entire time of the intervention.


Eligibility criteria: Inclusion Criteria:

* undergoing ethanol sclerotherapy at the university hospital Berne

Exclusion Criteria:

* under the age of 18

Primary outcomes:
measure: Endtidal ethanol concentrations in mg/dl over time
timeFrame: 1 year 2 months
Secondary outcomes:
measure: Bloodpressure in mmHg over time
timeFrame: 1 year 2 months
measure: Bloodpressure in mmHg over injected peripheral ethanol volume
timeFrame: 1 year 2 months
measure: Pulse rate in beats er minute over time
timeFrame: 1 year 2 months
measure: Pulse rate in beats er minute over injected peripheral ethanol volume
timeFrame: 1 year 2 months
measure: Endtidal ethanol concentrations in mg/dl over injected ethanol volume
timeFrame: 1 year 2 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Bern University Hospital and University of Bern
Study officials:
References:
Clinical trial NCT00478855: Tazocin Intervention Study
Official title: Association of Antibiotic Utilization Measures and Control of ESBLs Producing Bacteria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacterial Infections
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 1. To determine the value of using piperacillin/tazobactam in reducing the cases of extended spectrum beta lactamases (ESBL) producing E. coli or K. pneumoniae colonization and infection.
2. To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, both pre-and post-intervention in the selected medical centers.


Eligibility criteria: Inclusion Criteria:

* All patients admitted or transferred to the ICU/pulmonary/Infection units
* Patients of either sex, 18 years of age or older Patients who stay in units less than 48 hours will not be enrolled.

Primary outcomes:
measure: The acquisition rate of ESBL producing E. coli or K. pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months; post-intervention)
Secondary outcomes:
measure: The infection rate due to ESBL producing E. coli or K. pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months; post-intervention)
Other outcomes:
Locations:
city: Peking
country: China
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06640855: Academic Education of Midwifes in Germany - Teaching in the Field of Maternal and Infant Oral Health
Official title: Academic Education of Midwifes in Germany - Teaching in the Field of Maternal and Infant Oral Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Education, Medical
Keywords: dental education, midwife, midwifery
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study coordinators of all academic locations for Midwifery B.Sc. in Germany

Brief summary: The goal of this study is to learn about teaching of maternal and infant oral health in the recently implemented degree program Midwifery B.Sc. in Germany. The main questions it aims to answer are:

What contents regarding maternal and infant oral health are taught? How is teaching in the field of maternal and infant oral health organized? Study coordinators of all study locations of Midwifery B.Sc. in Germany are asked to participate in an online survey once.


Eligibility criteria: Inclusion Criteria:

* Returned questionnaire

Exclusion Criteria:

* Questionnaire not returned

Primary outcomes:
measure: Online-Questionnaire
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: Department of Preventive Dentistry, Periodontology and Cariology University Medical Center Goettingen
Study officials:
References:
Clinical trial NCT06293755: Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores
Official title: The Efficacy of Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores Compared to Intradermal Botulinum Toxin
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Enlarged Pores
Lead sponsor: Dhurakij Pundit University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of microneedle patch with botulinum toxin for improving enlarged pores.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old and concerned about enlarged pores
* Have pore size 0.3-0.6 mm
* Have pore parameter in each other side of faces not different more than 5%

Exclusion Criteria:

* Any neuromuscular condition
* Pregnancy or breast feeding
* History of allergy : Botulinum toxin, topical anesthesia
* History of keloid or hypertrophic scar
* History of coagulation or receiving medication that causes coagulation disorder
* Using drugs that have interaction with Botulinum toxin
* Using topical medication that improves enlarged pores in 1 month
* Taking medication that improves enlarged pores in 1 month
* Receiving the laser/treatment/chemical peeling in 6 months

Primary outcomes:
measure: Change from baseline of enlarged pores as measured by VISIA (pores parameter) and using pore score
timeFrame: Post-intervention, week 4 and week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Lak Si
country: Thailand
facility: Dhurakij Pundit University
state: Bangkok
Study officials:
affiliation: Dhurakij Pundit University
name: Chotip Jitudomtham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salem RM, Salah SAE, Ibrahim SE. Microbotox injection versus its topical application following microneedling in the treatment of wide facial pores: A split face comparative study. J Cosmet Dermatol. 2023 Apr;22(4):1249-1255. doi: 10.1111/jocd.15590. Epub 2023 Jan 6.