louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01065220: Sex Steroids and the Serotonin Transporter
Official title: The Influence of Sex Steroid Hormones on Serotonin Transporter Binding in the Human Brain Investigated by Positron Emission Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Transsexualism
Keywords: Serotonin Transporter
Hormone therapy
Gender Dysphoria
Transsexualism
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2010-02-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to prove the influence of the sex steroid hormones estrogen, progesterone and testosterone on the serotonin transporter (5-HTT) binding using positron emission tomography (PET) and the selective radioligand \[11C\]DASB. Specifically, the 5-HTT binding will be quantified before and after hormone therapy underwent by 10 male-to-female (MtF) and 10 female-to-male (FtM) transsexuals urging for hormone treatment. The high-level, long-term administration of opsite sex steroid hormones in transsexuals provide the unique opportunity to investigate the influence of sex steroid hormones on the serotonergic system. Since the serotonin transporter serves as a primary target molecule for antidepressant treatment, the results of the study will be of benefit for the assessment of the clinical relevance of estrogen and testosterone as modulatory and neuroactive agents.


Eligibility criteria: Inclusion Criteria:

* somatic health
* no previous sex hormone medication
* willingness to sign the written informed consent

Exclusion Criteria:

* severe diseases
* steroid hormone treatment within 6 months prior inclusion
* treatment with psychotropic agents such as selective serotonin reuptake inhibitors (SSRIs)
* any implant or stainless steel graft
* positive urine pregnancy test in women at the screening visit at each PET day

Primary outcomes:
measure: change in serotonin-transporter binding potential (BP) in predefined brain regions, measured by Positron Emission Tomography
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Psychiatry and Psychotherapy, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Rupert Lanzenberger, MD A/Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kranz GS, Wadsak W, Kaufmann U, Savli M, Baldinger P, Gryglewski G, Haeusler D, Spies M, Mitterhauser M, Kasper S, Lanzenberger R. High-Dose Testosterone Treatment Increases Serotonin Transporter Binding in Transgender People. Biol Psychiatry. 2015 Oct 15;78(8):525-33. doi: 10.1016/j.biopsych.2014.09.010. Epub 2014 Sep 23.
Clinical trial NCT03367520: Helping Veterans With SMI "StayQuit" From Smoking After Inpatient Hospitalization
Official title: Helping Veterans With SMI "StayQuit" From Smoking After Inpatient Hospitalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: StayQuit Intervention
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This project has two phases. Phase 1: Develop StayQuit materials and train the study interventionist. Phase 2: Implement StayQuit with 10-20 Veterans who are hospitalized on the inpatient psychiatric unit at the Baltimore VA Medical Center.
Primary purpose: TREATMENT

Brief summary: Given the high prevalence and great cost of smoking for individuals with serious mental illness, an effective smoking cessation intervention for this group of smokers that begins in the hospital and continues following discharge is needed. The investigators will develop and pilot test StayQuit, a multifaceted smoking cessation intervention for smokers with serious mental illness that begins in the hospital and continues for three months after discharge. StayQuit will provide a personalized and tailored experience for smokers with serious mental illness at different levels of motivation to remain abstinent. In the hospital, StayQuit will include a brief motivational intervention that will help smokers relate sustained smoking cessation to their values and preferences, shore up motivation to stay quit, and gain experience using nicotine replacement therapy. This will be followed by cessation-focused discharge planning to engage Veterans in continued smoking cessation services with StayQuit staff. After discharge, StayQuit will offer 13 weeks (spread out over 3 months) of smoking cessation telephone counseling. The investigators will examine the feasibility of StayQuit by collecting both quantitative data on attendance and qualitative data on participants' experiences.


Eligibility criteria: Inclusion Criteria:

* Currently receiving inpatient care at the Baltimore VAMC inpatient psychiatric unit
* 18 years of age or older
* Self-reported smoking of 5+ cigarettes a day prior to hospitalization

Exclusion Criteria:

* Documented history of severe neurological disorder
* Intellectual developmental disorder indicated by chart review

Primary outcomes:
measure: Attendance at in-person StayQuit sessions
timeFrame: 4 weeks
measure: Attendance at telephone StayQuit sessions
timeFrame: 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center
state: Maryland
Study officials:
References:
Clinical trial NCT04911920: Validation of a German Version of the Patient Rated Tennis Elbow Evaluation
Official title: Validation of a German Version of the Patient Rated Tennis Elbow Evaluation (PRTEE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Elbow Tendinitis
Elbow, Tennis
Keywords: Questionnaire
PRTEE
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The German version of the Patient Rated Tennis Elbow Evaluation (PRTEE) questionnaire is tested for reliability, validity and responsiveness.

Detailed description: In this prospective study, patients with lateral epicondylitis will complete the PRTEE before ACP injection, 6 weeks after treatment and 2-11 days later.

The statistics will include analyses about reliability, validity and responsiveness.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Diagnosed lateral epicondylitis
* Receive a first ACP treatment at the Schulthess Klinik
* Signed informed consent form

Exclusion Criteria:

* Lack of German language skills, which make it impossible to complete the questionnaire
* Diseases or conditions that would prevent accurate evaluation (e.g. central neurological, psychiatric or metabolic diseases)
* Legal incompetence
* Recent operations on the elbow or hand (less than three months ago)

Primary outcomes:
measure: Questionnaire Patient Rated Tennis Elbow Evaluation
timeFrame: Ten Weeks
Secondary outcomes:
measure: Sociodemographic data
timeFrame: Ten Weeks
measure: The Disabilities of Arm Shoulder and Hand (DASH) questionnaire
timeFrame: Ten Weeks
measure: The Patient Rated Elbow Evaluation (PREE)
timeFrame: Ten Weeks
measure: EQ-5D-5L
timeFrame: Ten Weeks
measure: Patient satisfaction Questionnaire
timeFrame: Ten Weeks
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Schulthess Klinik
Study officials:
affiliation: Schulthess Klinik
name: Miriam Marks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04429620: Prospective Assay for SARS-CoV-2 (COVID-19) Antibody Detection Indirectly by Immunofluorescence: SARS-CoV2 IIF Method
Official title: Prospective Assay for SARS-CoV-2 Antibody Detection Indirectly by Immunofluorescence: SARS-CoV2 IIF Method
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sars-CoV2
Lead sponsor: Szeged University
Sponsor class: OTHER
Collaborators: name: Bilogical Research Centre, Szeged
First posted: 2020-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults, Hungarian

Brief summary: Prospective assay for SARS-CoV-2 antibody detection indirectly by immunofluorescence: SARS-CoV2 IIF method

Detailed description: Sample preparation, serum separation by centrifugation

* 100 µl of serum for standard SARS-CoV2 ELISA is used according to the instructions for use.
* 100 µl of serum indirect immunofluorescent (IIF) method is used, the samples thus prepared analysis is performed under an automated microscope

Eligibility criteria: Inclusion Criteria:

* Person over 18 years of age
* Signing a package leaflet and a informal consent
* In the case of a positive group, confirmed by SARS-CoV2 qPCR Patient with COVID-19 or recovered individual.
* In case of negative group by SARS-CoV2 qPCR test 2 negative in COVID-19 suffering individual

Exclusion Criteria:

* Refuses to sign the consent form

Primary outcomes:
measure: Sensitivity of the method by SARS-CoV2 ELISA compared
timeFrame: 8 months
Secondary outcomes:
measure: Detectability of the antibodies IgA type against SARS-CoV2 virus
timeFrame: 8 months
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: University of Szeged, Albert Szent-Györgyi Health Center
Study officials:
affiliation: University of Szeged, Institute of Clinical Microbilogy
name: Katalin Burián, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07007520: A Study to Evaluate the Food Effect on the Pharmacokinetics of DA-5223 in Healthy Adult Subjects
Official title: An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Food Effect on the Pharmacokinetics of DA-5223 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Adult
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-06
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: This study will evaluate the food effect on the pharmacokinetics of DA-5223 in healthy adult subjects


Eligibility criteria: Inclusion Criteria:

* Adult male or female, 19 years to 55 years
* Male weighing 50 kg or more, female weighing 45 kg or more with a body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2
* The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate

Exclusion Criteria:

* The subjects with acute illness
* The subjects with a history of gastrointestinal disease or surgery that may affect the absorption of Investigational Product
* The subjects hypersensitive to any of the Investigational Product components or other drug components
* The subjects who have continuously consumed excessive smoking or alcohol within 6 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization
* The subjects who are pregnant or lactating

Primary outcomes:
measure: AUC-last
timeFrame: 0~12 hours
measure: Cmax
timeFrame: 0~12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Global Clinical Trials Center
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT02291120: MEDCEM PC and MTA in Pulpotomies of Primary Molars
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Evaluate the Effects of MEDCEM PC and MTA in Pulpotomies of Primary Molars.
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate and compare, clinically and radiographically,the effects of MEDCEM PC and MTA when used as pulp dressings following pulpotomy in human primary molars.


Eligibility criteria: Inclusion Criteria:

* healthy children
* molars showing: symptomless exposure of vital pulp by caries no clinical or radiographic evidence of pulp degeneration (excessive bleeding from the root canal, internal root resorption, inter-radicular and/or furcal bone destruction) the possibility of proper restoration of the teeth no physiological resorption of more than one-third of the root

Exclusion Criteria:

* presence of systemic pathology
* history of allergic reaction to latex, local anaesthetics or to the constituents of the test pulp dressing agents

Primary outcomes:
measure: Clinical success
timeFrame: 24 months
measure: Radiographic success
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sant Cugat del Valles
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
References:
Clinical trial NCT02841020: The Effect of Pre-treatment Biopsy for Non-neoplastic Renal Disease vs no Biopsy on Estimated Glomerular Filtration Rate in Patients With Small Renal Mass: a Single-center, Single-blinded, Randomized, Parallel Group Clinical Trial
Official title: The Effect of Pre-treatment Biopsy for Non-neoplastic Renal Disease vs no Biopsy on Estimated Glomerular Filtration Rate in Patients With Small Renal Mass: a Single-center, Single-blinded, Randomized, Parallel Group Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Kidney Neoplasms
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if biopsy for non-neoplastic renal disease for patients with a small renal mass results in greater postoperative renal function than the current standard of care (no additional biopsy).


Eligibility criteria: Inclusion Criteria:

* Age 18 or greater
* Scheduled for renal biopsy as part of clinical care
* Diagnosis of small renal mass (\< 4cm) based on imaging (CT, MRI, Ultrasound, or other)
* Patient must provide written, informed consent for study procedures before randomization
* Renal mass must be primarily solid (as opposed to cystic) in nature

Exclusion Criteria:

* Patients less than 18 years of age
* Patients who are prisoners
* Women who are pregnant-self reported
* Patients with Bosniak 3 or 4 cystic renal masses
* Patients with history of renal transplantation
* Patients with eGFR less than 30-based on review of clinical labs
* Patients on dialysis
* Patients with bleeding disorders

Primary outcomes:
measure: difference in change in glomerular filtration rate (GFR)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03323320: Evaluation of Patient's Knowledge of Their NACO Treatment
Official title: Evaluation of Patient's Knowledge of Their NACO Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulant
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients under AOD treatment in GHPSJ (hospitalization and consultation)

Brief summary: More than one million of patient receive anti vitamine K treatment which is the main cause of hospitalization. About 50 000 patient receive direct oral anticoagulant .

The aim is to evaluate the patient's level of knowledge about their anticoagulant treatment and specially about the side effect


Eligibility criteria: Inclusion Criteria:

* patient with AOD treatment
* capable to answer to questionnaire
* with or without antivitamin K

Exclusion Criteria:

* dementia
* cognitive trouble
* refusing participation

Primary outcomes:
measure: questionnaire score >80%
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: GHPSJ
name: Romain CADOR, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02231320: Postmarketing Surveillance Study to Assess Handling and Patient Satisfaction on Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Pulmonary Disease
Official title: Berodual® Respimat® 20/50 Microgram/Dose Solution for Inhalation: Assessment of Handling and Patient Satisfaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of chronic obstructive pulmonary disease recruited at pneumologists in practice

Brief summary: New perceptions about handling and patient satisfaction of the everyday use of Berodual® Respimat® in patients with chronic obstructive lung disease (COLD). Moreover, further knowledge should be attained about the tolerability of Berodual® Respimat®


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged at least 18 years who were suffering from symptoms of a COLD (naive or pre-treated) could be included in the PMS

Exclusion Criteria:

* Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SmPC) are excluded from the Postmarketing Surveillance (PMS)

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 8 weeks
measure: Number of patients who premature discontinued therapy with Berodual® Respimat®
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Assessment of patient satisfaction with regard to handling of Berodual® Respimat® inhaler
timeFrame: up to 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00727220: Prospective Study of the Impact of Insulin Pump Therapy in Young Children With Type 1 Diabetes
Official title: A Prospective Study of the Impact of CSII Therapy in Young Children With Type 1 DM
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
continuous glucose sensor monitoring
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2008-08-01
Enrollment: 42
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children diagnosed with type 1 diabetes for at least one year at the time of study. In addition, children must be under the age of 5 years

Brief summary: The purpose of the study is to examine glycemic and neuropsychological outcomes in very young children with Type I diabetes who are being started on insulin pumps and to compare their outcomes to children who are not utilizing insulin pumps. We propose to assess 40 children with IDDM under 5 years of age. 10 patients examined will be using multiple daily injections with basal glargine, 10 will be using NPH or Lente and rapid-acting insulin, and 20 will be examined prior to and 12 months after the implementation of insulin pump therapy. These subjects will be recruited and followed because they are currently undergoing treatment for Type 1 diabetes. Children will be recruited based upon the insulin regimen that they and their primary diabetes physician have chosen to utilize clinically. Insulin regimens will not be changed by the study team. Outcome measures will examine: glycemic outcomes (overall control, blood sugar variability), cognitive outcomes, parenting Stress, and changes in diet.


Eligibility criteria: Inclusion Criteria:

1. Children with Type I diabetes:
2. Children must be 5 years of age or less at the time of entry into the study.
3. Children must have had a diagnosis of type I diabetes for at least 1 year at time of entry.
4. Children must be receiving two or more insulin injections daily.

Exclusion Criteria:

1. Children will be excluded if they have additional medical problems requiring treatment with agents known to affect blood glucose such as steroids or L-asparaginase.
2. Children must not have any other chronic illness in addition to diabetes.

Primary outcomes:
measure: Change in HgBA1c
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Linda DeMeglio, MD
role: PRINCIPAL_INVESTIGATOR
References: