louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05633953: Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome
Official title: A Retrospective Observational Study to Evaluate the Safety and Effectiveness of Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome (LINC7)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cushing's Syndrome
Keywords: Endogenous Cushing's Syndrome
Cushing's Syndrome
Osilodrostat
Lead sponsor: RECORDATI GROUP
Sponsor class: INDUSTRY
First posted: 2022-12-01
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients with non-CD CS. Patients meeting eligibility criteria will be retrospectively identified and included in the study by site investigators based on a review of medical records at site. Site policies and local regulations regarding patient consent (NOL) will be followed. All eligible patients identified at a site between April 2019 and study start date and consenting to be part of the study will be included.

Brief summary: This is a multi-centre, observational, non-comparative, retrospective cohort study designed to evaluate the long-term safety and effectiveness of osilodrostat in non-CD CS patients. Patients treated with oral osilodrostat regardless of the duration of their treatment will be followed retrospectively for up to 36 months after initiating osilodrostat.


Eligibility criteria: Inclusion Criteria:

1. Male and female patients ≥18 years old with diagnosis of CS, except for CD (i.e., an aetiology of adrenal adenoma, adrenocortical carcinoma, adrenal hyperplasia, or ectopic adrenocorticotropic hormone secretion). Patients should have a contemporaneously documented diagnosis of CS as per effective guidelines.
2. Patients treated with osilodrostat between April 2019 and study start date as part of ATU programme or commercialisation.

Exclusion Criteria:

1. Patients who participated in a clinical trial anytime during the study period.
2. Patients with Pseudo-Cushing's syndrome, cyclic CS, or iatrogenic CS.

Primary outcomes:
measure: Effectiveness of Osilodrostat
timeFrame: at week 12
Secondary outcomes:
measure: Long-term Effects of Osilodrostat on Mean Urinary Free Cortisol (mUFC)
timeFrame: at weeks 18, 24, 36, 48, 60, and 72
measure: Long Term Effects of Osilodrostat on Morning Serum Cortisol
timeFrame: At baseline and Weeks 4, 8, 12, 18, 24, 36, 48, 60 and 72
measure: Long-term Effects of Osilodrostat on Composite Cortisol Measure
timeFrame: At baseline and Weeks 4, 8, 12, 18, 24, 36, 48, 60 and 72
Other outcomes:
Locations:
city: Pessac
country: France
facility: Hôpital Haut-Lévèque
Study officials:
affiliation: RECORDATI GROUP
name: Mario M MALDONADO, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00446953: Caesarean and Corticotherapy
Official title: Interest in Programming Caesarean Section at 38 Weeks of Pregnancy With Antenatal Betamethasone to Prevent Neonatal Respiratory Distress and to Avoid Emergency Caesarean Section Before Planned Date.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neonatal Distress
Keywords: Caesarean section
Corticosteroids
Betamethasone
Neonatal distress
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2007-03-13
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison of two randomized group :

* caesarean section planned at 38 weeks after 2 antenatal injections of 12 mg of betamethasone 48 h before.
* caesarean section planned at 39 weeks without corticosteroid.

The aim is to demonstrate that programming caesarean section at 38 weeks of pregnancy, after antenatal corticosteroid, allows to avoid caesarean section in emergency (because of a labour before 39 weeks), without increasing the neonatal respiratory distress rate.


Eligibility criteria: Inclusion Criteria:

* woman who needs elective caesarean section

Exclusion Criteria:

* multiple pregnancy
* toxaemia
* rhesus immunization
* fetal infection
* maternal gastro-duodenal ulcer
* mother HIV+
* prior injection of corticosteroid during the pregnancy

Primary outcomes:
measure: Neonatal respiratory distress
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Colmar
country: France
facility: Le Parc Centre pour la Mère et l'Enfant
city: Haguenau
country: France
facility: Centre Hospitalier de Haguenau
city: Mulhouse
country: France
facility: Hôpital de Hasenrain
city: Schiltigheim
country: France
facility: Cmco-Sihcus
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Bruno Langer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00584753: Molecular Imaging of Breast Cancer With Breast PET/CT
Official title: Molecular Imaging of Breast Cancer With Breast PET/CT
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: Breast cancer
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is a feasibility study to determine if a combined breast PET/CT scanner can image malignant functional activity while determining anatomical structure in the same clinical setting for patients with breast cancer. End-points of this study are whether women will accept the imaging position and timing, and whether functional properties of breast cancer can be imaged with this device. The secondary purpose of this study is to explore protocol parameters with a view to optimizing imaging performance whilst minimizing patient discomfort. Imaging results will be compared to histological samples to determine ground truth.

Detailed description: PET is literally a molecular imaging modality. In monitoring the patient's response to a specific chemotherapeutic regime, baseline and subsequent PET/CT scans can be used to quantitatively determine the therapeutic effect of the regime, using the standard uptake value (SUV), a common metric in PET imaging. The breast PET/CT system will facilitate molecular imaging of breast cancer using a number of radiolabeled molecules, available both commercially (18-FDG) and from the research environment.

Eligibility criteria: Inclusion Criteria:

- Normal Adult Volunteers

* Female, at least 18 years of age
* Ability to lie motionless for up to 20 minutes

Patient Volunteers

* Female, at least 18 years of age
* Diagnostic findings from prior mammography highly suggestive of invasive breast carcinoma (BI-RADS category 5)
* Not pregnant or breast-feeding
* Ability to lie motionless for up to 20 minutes

Exclusion Criteria:

* Normal Adult Volunteers

  * Inability to understand the risks and benefits of the study

Patient Volunteers

* Recent breast biopsy
* Diagnostic findings from prior mammography highly suggestive of noninvasive ductal or lobular carcinoma
* Uncontrolled diabetes
* Diabetic and blood sugar level \> 200 mg/dL
* Positive urine pregnancy test or currently breast-feeding
* Inability to understand the risks and benefits of the study

Primary outcomes:
measure: End-points of this study are whether women will accept the imaging position and timing, and whether functional properties of breast cancer can be imaged with this device.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC David Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Ramsey Badawi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06450353: Prospective Evaluation of Disparities in Provision of Allogeneic Transplantation
Official title: Prospective Evaluation of Disparities in Provision of Allogeneic Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Allogeneic Transplantation
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 1200
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: MD Anderson Cancer Center

Brief summary: To look at the effect of a recipient's ancestry and socio-economic status on their choice of bone marrow transplantation donor cells and their chance of receiving genetically similar (allogeneic) bone marrow cells versus cells that are not genetically similar (allograft).

Detailed description: Primary Objectives To prospectively evaluate graft options and choice of donor by patient ancestry and SES for allograft candidates at MDACC.

Secondary Objectives

* To prospectively evaluate time to transplant for allograft candidates at MDACC.
* To evaluate treatment-related mortality for allograft candidates at MDACC.
* To assess overall survival for allograft candidates at MDACC.
* To prospectively evaluate receipt of preferred unrelated donor for allograft recipients at MDACC.
* To evaluate receipt of an optimal graft for allograft recipients at MDACC.

Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years of age.
2. Candidate for allogeneic transplantation

Exclusion Criteria:

1) Allogeneic stem cell transplantation not medically indicated.

Primary outcomes:
measure: Patient Ancestry Questionnaire
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Warren Fingrut, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05423353: Comparative Effects of Paraffin Bath Therapy and ESWT in Patients With De Quervain Tenosynovitis
Official title: Comparative Effects of Paraffin Bath Therapy and Extracorporeal Shock Wave Therapy on Pain and Hand Functions in Patients With De Quervain Tenosynovitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: De Quervain Disease
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 70
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: There is no study in the literature comparing both paraffin bath therapy and Extracorporeal Shock Wave Therapy (ESWT) in the treatment of patients with De Quervain Tenosynovitis. The aim of this study is performing this comparison.


Eligibility criteria: Inclusion Criteria:

* Being 18 years or older
* Meeting De Quervain diagnostic criteria
* Not having applied any physical therapy modality to the hand-wrist in the last 1 month
* Not using pain medication in the last 1 month,
* Not using local anesthetics or steroid injections on the hand-wrist in the last 3 months
* Have received written consent to participate in the study, and have come to the last control at the 6th week.

Exclusion Criteria:

* Neurological diseases (especially neuropathies),
* Malignancy,
* Rheumatological diseases
* Pregnancy
* History of hand/wrist fracture or surgery
* Hand/wrist trauma in the last 1 month
* Coagulation disorder diseases

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: at baseline (before the treatment)
measure: Visual Analogue Scale (VAS)
timeFrame: 2 weeks after baseline (at the end of treatment)
measure: Visual Analogue Scale (VAS)
timeFrame: 6 weeks after baseline (one month after the end of treatment)
measure: Duruöz Hand Index (DHI)
timeFrame: at baseline (before the treatment)
measure: Duruöz Hand Index (DHI)
timeFrame: 2 weeks after baseline (at the end of treatment)
measure: Duruöz Hand Index (DHI)
timeFrame: 6 weeks after baseline (one month after the end of treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University
Study officials:
affiliation: Yüzüncü Yıl Üniversitesi Tıp Fakültesi
name: Volkan Şah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04083053: High-Resolution Anoscopy Perceived Discomfort Study
Official title: High-Resolution Anoscopy Perceived Discomfort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anal Cancer
Keywords: anoscopy
screening
perianal examination
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Study should determine if performing the less uncomfortable part of the exam (the perianal exam) results in less recalled discomfort if performed last vs. if performed first.

Detailed description: Performance of the perianal examination at the end of the high resolution anoscopy (HRA) procedure will lead to patients reporting less discomfort directly following the procedure. The study team hypothesizes at least a 10% decrease in subsequently rated pain scores in the group where the perianal exam is performed last compared to the group where it is performed first.

Eligibility criteria: Inclusion Criteria:

* Present for a previously scheduled high resolution anoscopy procedure
* Able to participate in an English written survey following the HRA procedure

Exclusion Criteria:

* Undergoing ablation during the HRA procedure
* Inability to tolerate or complete the HRA procedure
* Unwillingness or inability to complete the post-procedure survey
* Previous participation in the study

Primary outcomes:
measure: High Resolution Anoscopy (HRA) discomfort scale
timeFrame: following the HRA procedure at day one
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Luis Barroso, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02143453: Comparative Study of High Intensity Interval Training and Endurance Training in Juvenile Obesity
Official title: Comparative Study of High Intensity Interval Training and Endurance Training in Juvenile Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: exercise
overweight
children
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 39
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Exercise is an effective strategy to manage juvenile obesity; however this ideal exercise training mode is still unclear. In this study, the investigators compared the health-related effects of high intensity interval training versus endurance training in obese children.


Eligibility criteria: Inclusion Criteria:

* age between 8 and 12 years
* Body mass index (BMI) = 95th percentile, according to the First National Health and Nutrition Examination Survey
* no pharmacological treatment
* no evidence of metabolic, hormonal, orthopedic, and cardiovascular disease at the time of the study's commencement
* no participation in any regular exercise training program (except physical education classes, two days a week) at least 6 months before the commencement of the study and throughout the protocol.

Exclusion Criteria:

* non-obese participants
* physically active participants
* participants with cardiovascular diseases or any other condition that could preclude the participation in the the exercise training program

Primary outcomes:
measure: body mass index (BMI)
timeFrame: 12 weeks
measure: aerobic conditioning (VO2max)
timeFrame: 12 weeks
measure: insulin sensitivity (HOMA-index)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: General Hospital (School of Medicine, University of Sao Paulo)
Study officials:
affiliation: University of Sao Paulo
name: Bruno Gualano, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05483153: Infant-Directed Singing for At-Risk Mothers and Infants
Official title: Infant-Directed Singing (IDS) for Maternal Sensitivity and Infant Self-Regulation in an At-Risk Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Behavior
Infant Behavior
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: GRAMMY Museum Grant Program
First posted: 2022-08-01
Enrollment: 12
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to figure out if mothers can learn how to use singing to help their babies. Singing can help babies calm down or encourage them to play, both of which are needed for learning.


Eligibility criteria: Inclusion Criteria:

Mothers:

* must have infants enrolled at the Linda Ray Intervention Center (LRIC).
* must be 18 years of age or older
* must be able to read and write in English

Infants:

* must be enrolled at the Linda Ray Intervention Center (LRIC).
* must be at least 3 months and no older than 12 months.

Exclusion Criteria:

- Participants who are not enrolled at the Linda Ray Intervention Center (LRIC).

Primary outcomes:
measure: Change in Maternal Perceived Self-Efficacy as measured by Karitane Parenting Confidence Scale
timeFrame: 1 week prior to intervention, 1 week after intervention
measure: Change in Acoustic Parameters of Mothers' Singing
timeFrame: 1 week prior to intervention, week 2 of intervention, 1 week after intervention
measure: Change in percentage of time Infant displays gaze type
timeFrame: 1 week prior to intervention, week 2 of intervention, 1 week after intervention
measure: Change in percentage of time Infant displays affect type
timeFrame: 1 week prior to intervention, week 2 of intervention, 1 week after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami, Linda Ray Intervention Center
state: Florida
Study officials:
affiliation: University of Miami
name: Shannon K de l'Etoile, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05201053: Acute Pancreatitis and Coagulation Study
Official title: Coagulation Disturbances and Thrombosis in Acute Pancreatitis (Koagulopati Och Trombos Vid Akut Pankreatit-APK Studien)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pancreatitis
Keywords: Acute Pancreatitis
biomarkers
severity prediction
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2022-01-21
Enrollment: 141
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: All patients admitted with Acute Pancreatitis at Skåne University Hospital in Malmö

Brief summary: The study aims to investigate pathophysiological changes in coagulation in relation to inflammation in patients with acute pancreatitis. Serum and plasma is sampled repeated days from admission. Analysis will be done after recruitment. Specific biomarkers accuracy for prediction of moderate and severer acute pancreatitis will be calculated.

Detailed description: Inclusion criteria:

Patients with acute pancreatitis admitted to Skåne University Hospital in Malmö

Acute pancreatitis is defined as minimum 2 out of following: amylase levels \>3 times upper reference limit, clinical signs of acute pancreatitis, imaging findings of acute pancreatitis)

Exclusion criteria:

\<18 years of age

\>72 hours from onset of symptom until first sampling

Patients with immunosuppression or autoimmune diseases are excluded from som parts of the study.

Methods: Serum and plasma is sampled repeatedly during the hospital admission. Pre defined protocols are used for data collections of relevant clinical information.

Specific aspects of inflammation, thrombin generation, platelet function and Microparticles will be analysed in serum or plasma during the first consecutive days of acute pancreatitis.

Biomarkers for severe disease as well as correlation between inflammation and coagulopathy will be investigated.

Eligibility criteria: Inclusion Criteria: Acute Pancreatitis, accept informed consent -

Exclusion Criteria: More than 72h from onset of symptoms until first sample, patient already included once

-

Primary outcomes:
measure: Severe acute pancreatitis
timeFrame: 14 days
Secondary outcomes:
measure: Moderately Severe Acute Pancreatitis
timeFrame: 14 days
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne University Hospital
state: Skåne
Study officials:
affiliation: Region Skåne and Lund University
name: Sara Regnér, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: