louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06258421: Burden of Disease and Living Situation in Desmoid Patients
Official title: Burden of Disease and Living Situation in Desmoid Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Desmoid Tumor
Quality of Life
Keywords: Health-related Quality of Life
Unmet needs
Return to normal life
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: SOS Desmoid e.V.
name: Universitätsmedizin Mannheim
First posted: 2024-02-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who have been diagnosed with a desmoid tumorafter the age of 18. Treatment at the Mannheim University Hospital or via SOS Desmoid e.V.

Brief summary: The main aim of the study is to assess the situation and quality of life of desmoid patients. Impaired areas of quality of life and the associated factors are to be identified. The survey is planned as a cross-sectional study (patient survey).

Prevalent and incident desmoid patients will be identified at the University Hospital Mannheim and checked for eligibility. Quality of life and patient-reported data are collected by means of written questionnaires. Medical data is collected from patient files in the clinics. The aim is to include 100 patients. Descriptive analyses of the variables collected and regression models are planned as statistical analysis.


Eligibility criteria: Inclusion Criteria:

* Desmoid diagnosis (primary neoplasia, all stages)
* Age ≥18 years at diagnosis

Exclusion Criteria:

* Inability to complete a structured questionnaire (insufficient language skills; dementia)

Primary outcomes:
measure: Health-related Quality of Life (EORTC C30)
timeFrame: baseline
Secondary outcomes:
measure: The Brief Pain Inventory (BPI)
timeFrame: baseline
measure: Reintegration to Normal Living (RNL) Index
timeFrame: baseline
measure: Supportive Care Needs Survey
timeFrame: baseline
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl-Gustav-Carus Dresden
state: Saxony
Study officials:
affiliation: Universitätsklinikum Carl-Gustav-Carus Dresden
name: Martin Eichler, Dr., M.Sc. / PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05834621: AMNIOmics: A Prenatal Rapid Genome Validation Study
Official title: AMNIOmics: A Prenatal Rapid Genome Validation Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Multiple Anomalies of Fetus
Genetic Predisposition Suspected
Amniocentesis Affecting Fetus or Newborn
Family Members
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be identified internally through provider referrals most commonly through the Mayo Clinic Obstetrical and Maternal Fetal Medicine services.

Brief summary: The purpose of this study is to validate Whole Genome Sequencing (WGS) on amniotic fluid to reduce the time to diagnosis and enhance the care for the fetus/neonate.


Eligibility criteria: Inclusion Criteria

* Fetus with multiple anomalies/suspected genetic disease.
* Pregnant patient already planning on having an amniocentesis for another reason separate from this study.

Exclusion Criteria

* Parents under the age of 18.
* Parents lacking the capacity to consent.
* Institutionalized (i.e., Federal Medical Prison).

Primary outcomes:
measure: Validation of Rapid Whole Genome Sequencing technology on amniotic fluid samples
timeFrame: 5 years
measure: Enrollment of study participants
timeFrame: 5 years
measure: Collection of Biospecimens
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Myra Wick, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06251921: The Chromatic Evaluation of Universal Nano-hybrid Composites
Official title: The Chromatic Evaluation of Universal Nano-hybrid Composites
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Lifestyle
Keywords: resin-based composite
color
pre-heated
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the preheating effect of a group shade resin-based composite. The evaluation will be done on Ryge criteria. The main question it aims to answer is if there is a difference in time between preheated and non-heated resin-based composites in the oral cavity. Participants will be given treatment for cavities class 2 on premolars and molar and will come for recall at 24h, 1 week, 6 weeks, 3 months, 6 months, and 1 year.

Detailed description: The participants in the study will be adult patients (over 18 years old). Each patient will receive 2 restorations on premolars or molars, class 2, and medium cavities. The restorations will be performed under isolation with rubber-dam, and restored with preheated or not-heated resin-based composite. The occlusion will be tested and they will be notified to come for recall in order to make the evaluation of the restorations.

Eligibility criteria: Inclusion Criteria:

* Permanent dentition
* The OHI index = 0
* Non-smoking patient
* The patient has a healthy diet
* The patient has parafunction
* The antagonist tooth is healthy / with direct restorations
* The caries are situated on proximal surfaces on premolars, molars
* The cavities have a medium depth

Exclusion Criteria:

* Temporary dentition
* The OHI index \>= 1
* The patient is smoker
* The patient has an unhealthy diet
* The patient suffers from bruxism, clenching
* The antagonist tooth has an indirect restoration
* The caries are situated on canines or incisors
* The cavities have a deep or shallow depth

Primary outcomes:
measure: Clinical inspection of the restorations
timeFrame: 24 hours
measure: Clinical inspection of the restorations
timeFrame: 1 week
measure: Clinical inspection of the restorations
timeFrame: 6 weeks
measure: Clinical inspection of the restorations
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: GlobalDent
state: Cluj
Study officials:
affiliation: Iuliu Hațeganu University of Medicine and Pharmacy
name: Diana Dudea, DDS
role: STUDY_DIRECTOR
References:
Clinical trial NCT04301921: Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography - Diagnostic Transradial Coronary Angiography Without Systemic Anticoagulatio
Official title: Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography - Diagnostic Transradial Coronary Angiography Without Systemic Anticoagulatio
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients Undergoing Diagnostic Coronary Angiography
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate whether omitting systemic anticoagulation during transradial coronary angiography and/or a distal radial access reduce the risk of postprocedural radial artery occlusion


Eligibility criteria: Inclusion Criteria:

* Clinical indication to perform diagnostic coronary angiography
* Age \> 18 years
* Written informed consent

Exclusion Criteria:

* Preexisting or already administered anticoagulation prior to coronary angiography
* Planned coronary intervention
* Preexisting radial artery occlusion or missing pulse at the potential puncture sites
* Allergy / intolerance to anticoagulants
* Active bleeding or comorbidity with elevated bleeding risk
* Pregnancy
* Inability to sign informed consent
* Participation in another trial

Primary outcomes:
measure: Occurrence of postprocedural RAO
timeFrame: Day 1
measure: Bleeding events
timeFrame: Day 1
Secondary outcomes:
measure: Sonographic characteristics of radial artery occlusion
timeFrame: 3 Month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06335121: Implementation of PrEP Care Among Women in Family Planning Clinics
Official title: Implementation of PrEP Care Among Women in Family Planning Clinics
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PrEP Uptake
HIV
Prevention
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Illinois at Chicago
name: Planned Parenthood of Illinois
First posted: 2024-03-28
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will evaluate implementation strategies to address barriers and increase uptake of PrEP among Black cisgender women in Planned Parenthood of Illinois (PPIL) health centers.


Eligibility criteria: Inclusion Criteria:

* Eligible participants include ciswomen presenting at a PPIL health center with a positive STI test (syphilis, gonorrhea, or chlamydia) and identified in the EHR using STI testing records and new fields for optimizing support of provider PrEP counseling.

Exclusion Criteria:

- Participants will be excluded if they are not PrEP eligible, have a negative STI test, or are not identified in the EHR.

Primary outcomes:
measure: PrEP prescriptions among Black women accessing PPIL services and eligible for PrEP.
timeFrame: 1 month
Secondary outcomes:
measure: Receipt of PrEP refills among Black women accessing FP services at 6 months.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Rush University Medical Center
name: Sadia Haider, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine
name: Amy Johnson, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01380821: DNA Double-strand Breaks After SPECT
Official title: DNA Double-strand Breaks Following Myocardial Scintigraphy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: clinical indication for myocardial SPECT
suspected or known coronary artery disease
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 40
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: Patients clinically indicated to undergo myocardial SPECT.

Brief summary: Ionizing radiation has a number of harmful effects in humans. The most important among these is the induction of cancer. It is assumed that damage to DNA in the nucleus of a single cell can induce cancer. Among the different types of lesions inducted, DNA double-strand breaks (DSBs) are considered to be the most relevant effects that can initiate carcinogenesis.

The investigators are already conducting several other studies to prospectively compare the inducted DSBs by coronary CT-angiography and conventional coronary angiography. Extending these examinations to investigate the induced DSBs by myocardial scintigraphy allows a comparison of all three relevant imaging methods of the heart that incorporate ionizing radiation.

To evaluate this, the investigators are planning to examine patients who are scheduled for a clinically indicated myocardial scintigraphy. These examinations are routinely done by the Department of Nuclear Medicine in either a 1-day or a 2-day protocol according to the diagnostic reference values of the Federal Department for Radiological Protection. Blood samples will be taken from these patients at predefined time steps before and after the examination and DNA double-strand breaks will be determined from these blood samples specifically considering the applied activity of the tracer and the exposition kinetics.


Eligibility criteria: Inclusion Criteria:

* myocardial SPECT clinically indicated

Exclusion Criteria:

* acute leukaemia or lymphoma
* radiation or chemotherapy in the last 6 months
* x-ray or scintigraphy within the last 3 days
* age below 18 years
* eGFR of below 60 ml/min

Primary outcomes:
measure: Radiation-induced DNA double-strand breaks after myocardial scintigraphy.
timeFrame: 48 hours
Secondary outcomes:
measure: Comparison of radiation-induced DSBs with activity used for myocardial scintigraphy.
timeFrame: Activity will be measured 5 min and 1h after injection of the technetium tracer for SPECT.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité
Study officials:
affiliation: Charite University, Berlin, Germany
name: Marc Dewey
role: PRINCIPAL_INVESTIGATOR
References:
citation: Geisel D, Heverhagen JT, Kalinowski M, Wagner HJ. DNA double-strand breaks after percutaneous transluminal angioplasty. Radiology. 2008 Sep;248(3):852-9. doi: 10.1148/radiol.2483071686.
Clinical trial NCT04656821: Erector Spinae Block Versus Thoracic Paravertebral Block for Acute Thoracic Herpes Zoster
Official title: Ultrasound Guided Erector Spinae Block Versus Ultrasound Guided Thoracic Paravertebral Block for Pain Relief in Patients With Acute Thoracic Herpes Zoster
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Thoracic Herpes Zoster
Erector Spinae Plane Block
Thoracic Paravertebral Block
Pain Relief
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 90
Sex: ALL
Minimum age (years): 51
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this research is to study and compare the efficacy and safety of single injection erector spinae plane block and thoracic paravertebral block in prevention of post herpetic neuralgia in patients with acute thoracic herpes zoster.


Eligibility criteria: Inclusion Criteria:

* Over 50 years of age
* Chest wall herpetic eruption of less than one week
* Moderate or severe pain

Exclusion Criteria:

* Patient refusal
* Eruption more than one week duration
* Patients who will not receive appropriate anti-viral therapy
* Patients with mild pain
* Infection at the site of injection
* Patients with a history of renal, hepatic diseases, coagulopathy, steroid therapy, malignancies.
* Patient taking chemotherapy and/or radiotherapy.

Primary outcomes:
measure: The incidence of post herpetic neuralgia (PHN)
timeFrame: 3 months
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 6 months
measure: Total consumption of rescue analgesia
timeFrame: 6 months
measure: The times of complete resolution of pain
timeFrame: 3 months
measure: Adverse effects and complications
timeFrame: 1 day
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
Study officials:
References:
Clinical trial NCT00526721: Real-life EValuation Of High Dose RosUvastatin in High Risk Patients After TitraTION
Official title: An Observational, Non-interventional, Multi-center Study to Evaluate Efficacy and Tolerability of High Dose Rosuvastatin in High Risk Patients After Titration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia
Crestor
LDL target goal
high risk patients
Naturalistic
Observational
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-09-10
Enrollment: 1482
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hypercholesteromia patients with high risk according to NCEP ATP III guideline in Korean tertiary care centers

Brief summary: To evaluate achievement ratio of treatment target goal in hypercholesterolemia patients with high risk after high dose rosuvastatin(20mg/day) titration


Eligibility criteria: Inclusion Criteria:

* High-risk hyperlipidemia patients who are prescribed with rosuvastatin 10mg, based on the physician's clinical decision and fulfill the following criteria

  1. Over 18 years of age
  2. Have history of CHD or CHD risk equivalents, such as peripheral arterial disease, abdominal aortic aneurysm, symptomatic carotid artery disease (TIA or stroke of carotid origin or \>50% obstruction of carotid artery), DM, and 2+ risk factors with 10-year risk CHD\>20%

Exclusion Criteria:

1. Patients already taking other hyperlipidemic agents
2. Patients who do not fulfil the indication criteria for statin therapy
3. Patients who do not have baseline and/or follow-up lipid data to verify the efficacy data

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Jongro-gu
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Kangnam-gu
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Songpa-gu
Study officials:
affiliation: AstraZeneca Korea
name: Hyunah Caroline Choi
role: STUDY_DIRECTOR
References:
Clinical trial NCT01538121: Antiphospholipid Antibodies and Early Severe Preeclampsia.
Official title: Antiphospholipid Antibodies and Early Severe Preeclampsia (< 34 Weeks of Gestation). A Case-Control Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Preeclampsia
Antiphospholipid Syndrome
Keywords: Antibodies, anticardiolipin
Antibodies, B2 Glycoprotein I
Lupus Anticoagulant
Severe Preeclampsia
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 310
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant patients admitted for severe preeclampsia between 24-34 weeks pf gestation (cases) and normal patients in labor at term (controls).

Brief summary: The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed against cell membrane phospholipids (antiphospholipid antibodies) can cause an hypercoagulable state that causes thrombosis and obstetric complications (miscarriages, stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis includes the development of severe preeclampsia before 34 weeks of gestation, but this was done without solid evidence of a relation between the two. Our study will try to add information to this particular point.


Eligibility criteria: Inclusion Criteria:

* Gestational age between 24-34 weeks
* Diagnosis of severe preeclampsia

Exclusion Criteria:

* Known antiphospholipid syndrome.
* Known presence of antiphospholipid antibodies.
* Patients with systemic lupus erythematosus.

Primary outcomes:
measure: Lupus anticoagulant
timeFrame: 15 months
measure: Anticardiolipin antibodies
timeFrame: 15 months
measure: B2 Glycoprotein I
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas Maternity Hospital
Study officials:
affiliation: Saint Thomas Hospital, Panama
name: Osvaldo A Reyes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01909921: Retrospective Medical Record Review of Mind Body Depression Group Participants
Official title: Retrospective Medical Record Review of Mind Body Depression Group Participants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Anxiety
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-07-29
Enrollment: 156
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MGH-Health Center patients who have participated in the Relaxation Response Intervention for Depression groups.

Brief summary: The purpose of this study is to assess the effectiveness of a Relaxation Response Intervention for Depression offered to low income populations at Massachusetts General Hospital (MGH) - Chelsea, Revere and Charlestown health centers.

Detailed description: This is a retrospective review of medical records. The study aims to evaluate the effects of participation in the Relaxation Response Intervention for Depression Clinical groups, on patient measures of: 1) depression, anxiety and perceived stress; 2) work productivity and activity impairment; 3) demand for, and adherence to behavioral medicine; 4) medication use for depression and/or anxiety; and 5) dose-response effects.

Eligibility criteria: Inclusion Criteria:

* Patients receiving care through MGH-Health Centers
* a diagnosis of depression and/or anxiety
* 21 years of age or older

Exclusion Criteria:

-

Primary outcomes:
measure: Change from baseline in Depression scales (CES-D 10) at 8 weeks
timeFrame: Pre- and Post-Intervention (8 weeks)
measure: Change from baseline Anxiety Scales (STAI-20) at 8 weeks
timeFrame: Pre- and Post- Intervention (8 weeks)
measure: Change from baseline in Perceived Stress Scale (PSS-10) at 8 weeks
timeFrame: Pre- and Post-Intervention (8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: