louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05890417: Evolution of Sexual Life Quality of Women With POI Before and After Introduction of Hormone Replacement Therapy
Official title: Evolution of Sexual Life Quality of Women With POI Before and After Introduction of Hormone Replacement Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Ovarian Failure
Keywords: premature ovarian insufficiency
sexuality
quality of life
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate the evolution of quality of sex life of women with POI after introduction hormone replacement therapy through the FSFI scale

Detailed description: Premature ovarian failure (POI) is a pathology that affects about 1-2% of women before the age of 40. The resulting estrogen deficiency is the cause of multiple repercussions. Clinically, sexual disorders may appear in the short term, such as a decrease in libido, vaginal dryness, an increase in dyspareunia, resulting in less frequent sexual intercourse and less satisfaction with sexual life. The quality of life of these patients also appears to be reduced compared to women with normal ovarian reserve. A 2008 study showed that the sexual function of patients with POI treated with hormone replacement therapy (HRT) was normal but remained significantly lower than that of patients with normal ovarian function. However, no study has attempted to assess the evolution of the symptomatology of these patients before and after the introduction of HRT. Evidence of improvement in sexual disorders under treatment could be an additional argument to improve patient adherence and treatment compliance; as well as information for health professionals

Eligibility criteria: Inclusion Criteria:

* positive diagnosis of POI (amenorrhea \> 4 months or spaniomenorrhea \> 4 months and FSH \> 25 IU/L checked twice, more than 4 weeks apart)
* absence of hormonal treatment,
* patient's oral consent,
* affiliated or beneficiary of health insurance

Exclusion Criteria:

* contraindication to hormonal treatment (history of hormone-dependent cancer, history of ischemic arterial stroke),
* inability of the patient to understand the nature or risks or significance and implications of the clinical investigation,
* patient under legal protection

Primary outcomes:
measure: FSFI questionnaire score
timeFrame: Month 6
Secondary outcomes:
measure: FSFI score according to the aetiology and to the mode of administration of hormonal treatment
timeFrame: Baseline, Month 6
measure: WHOQOL-BREF score
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References:
Clinical trial NCT01177917: Evaluation of Mineral Absorption in Infants Fed Infant Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mineral Absorption in the Urine
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2010-08-09
Sex: ALL
Minimum age (years): 56
Maximum age (years): 70
Standard ages: CHILD
Accepts healthy volunteers: yes

Brief summary: This clinical trial will help determine if prebiotics can increase mineral absorption in babies


Eligibility criteria: Inclusion Criteria:

* Singleton
* Term infant
* Birth weight of 2500 g or more
* 56-70 days of age
* Signed informed consent
* Consuming a cow's milk-based infant formula for at least 24 hours.

Exclusion Criteria:

* History of underlying disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development or the evaluation of the mineral absorption of the participant
* Use of multiple vitamin and mineral supplements prior to enrollment.
* Evidence of formula intolerance or poor intake at time of randomization

Primary outcomes:
measure: To evaluate the amount of minerals in the urine
Secondary outcomes:
measure: Compare the amount of vitamins and minerals in the blood
Other outcomes:
Locations:
city: Coralville
country: United States
facility: Children's Hospital of Iowa
state: Iowa
city: Louisville
country: United States
facility: Pediatric Clinical Trials Unit
state: Kentucky
city: Omaha
country: United States
facility: The Center for Human Nutrition
state: Nebraska
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center Clinical Trials Office
state: Ohio
city: Houston
country: United States
facility: Children's Research and Nutrition Center
state: Texas
Study officials:
References:
Clinical trial NCT04235517: RSA Study on the Behaviour of the Growth Plate During and After Temporary Hemi-epiphysiodesis and Epiphysiodesis
Official title: Behaviour of the Growth Plate in Patients Operated With Either Permanent or Temporary Hemi-epiphysiodesis or Epiphysiodesis Through by the Use of Radiostereometric Analysis (RSA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anisomelia
Deformity of Limb
Keywords: LLD, guided growth
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with growth remaining and limb length discrepancy or axial deviations in the lower extremity

Brief summary: By using radiostereometric analysis (RSA) we will be able to study growth during and after temporary epiphysiodesis and with great accuracy be able to detect asymmetric growth following this procedure.

By using the same method we also want to analyse patients with axial deviations operated with guided growth (tension band plating) to study the growth during and after the procedure and be able to set the correct timing for removal of the implant.

Detailed description: The RSA method consists of implantation of small tantalum beads on either side of the physis during surgery on the the physis. Later analysis of the RSA Pictures with the RSA-method will give us an microscopically accurate measure of the growth in three planes.

Eligibility criteria: Inclusion Criteria:

* Children with idiopathic axial deviations in the lower extremities
* Children with limb length discrepancys where timing of epiphysiodesis is difficult because of a big discrepancy in skeletal age and chronological age

Exclusion Criteria:

* Children with axial deviations and pathological physis

Primary outcomes:
measure: Behaviour of the growth plate during and after temporary hemi-epiphysiodesis and epiphysiodesis
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: The Ortopedic dep at Oslo Unversity Hospital, Rikshospitalet
Study officials:
affiliation: Oslo Unversity Hospital
name: Joachim Horn, MD,PHD
role: STUDY_CHAIR
References:
Clinical trial NCT04980417: Concomitant Versus Delayed Cholecystectomy for Management of Obesity With Gallstone
Official title: Concomitant Cholecystectomy With Bariatric Surgery Versus Delayed Post Bariatric Cholecystectomy for Obesity With Gallstone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Gallstone
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: in this study we compare the results of concomitant cholecystectomy with bariatric surgery versus delayed cholecystectomy for management of gallstone in obese patients

Detailed description: in this study we compare the results of concomitant cholecystectomy with bariatric surgery versus delayed cholecystectomy for management of gallstone in obese patients. patients will be divided into 2 group: group1, will be operated by the bariatric surgery and cholecystectomy in the same session. group 2 will be operated by cholecystectomy at least 6 months after bariatric surgery or whenever develop complications

Eligibility criteria: Inclusion Criteria:

* BMI \> 35
* presence of gallstone
* fit for laparoscopic surgery

Exclusion Criteria:

* BMI \< 35
* unfit for surgery
* refuse to share in the study

Primary outcomes:
measure: the incidence of complications
timeFrame: one year
Secondary outcomes:
measure: operative time of cholecystectomy
timeFrame: 30-90 minutes
measure: %EWL
timeFrame: one year
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of medicine
Study officials:
References:
Clinical trial NCT00264017: Palladium-103 Seed Implant and Single Daily Dosing of Uroxatral Vs. Twice Daily Dosing of Flomax- A 3 Month Retrospective Efficacy Analysis
Official title: Palladium-103 Seed Implant and Single Daily Dosing of Uroxatral Vs Twice Daily Dosing of Flomax-A 3 Month Retrospective Efficacy Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer Patients Undergoing External Radiation and Seed Implantation
Lead sponsor: Dattoli Cancer Center and Brachytherapy Research Institute
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2005-12-12
Enrollment: 60
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: In the past ten years, newer drugs with more selective affinity for the alpha-receptor have been introduced. Alfuzosin (Uroxatral) and Tamulosin(Flomax are two second generation alpha-blockers. In the course of our clinical proctice, both drugs have been used routinely. This retrospective comparison is intended to be a priliminary comparison of their effectiveness and side effects.


Eligibility criteria: Inclusion Criteria:

* Males age 45-80 years
* Diagnosis of prostate cancer
* Status post IMRT and Palladium-103 seed implantation and initiated alpha blocker therapy with alfuzosin10mg daily or tamulosin 0.4mg bid at time of seed implantation
* Baseline AUA score\< or =12
* May be on antiandrogenand/or alpha reductase therapy
* Patients receiving IMRT followed by Palladium-103 Brachytherapy implantation as the primary therapy for prostate cancer with curatives intent -

Exclusion Criteria:

* History of insulin-dependent diabetes
* Uncontrolled hypertention
* History of symptomtic hypotension (including syncope and dizziness)
* Pre-existing obstructive uropathy based on history of BPH and or Acute Urinary Retention
* Pre-existing prostatitis either continuous or intermittent
* Concurrent use of any other anticholinergics
* previous or concurrent usage of LHRH agonist

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Dattoli Cancer Center and Brachytherapy Research Institute
state: Florida
Study officials:
affiliation: Dattoli Cancer Center and Brachytherapy Research Institute
name: Michael J Dattoli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04296617: Brain Imaging Changes Following Proton Therapy for Pediatric Primary Central Nervous System and Base of Skull Tumors
Official title: Assessment of Predicted LET and Dosimetry in Relation to White Matter Changes in Pediatric Patients Following Proton Therapy for Primary Central Nervous System and Base of Skull Malignancies: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Central Nervous System Neoplasm
Malignant Skull Base Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 36
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are diagnosed with central nervous system or base of skull malignancies, undergoing proton beam therapy

Brief summary: This trial gathers information from patients with primary central nervous system or base of skull tumors that receive proton beam therapy and see if certain imaging techniques can help detect radiation-related changes over time. This study may help providers learn more about proton beam radiotherapy and how to improve the way it is delivered.

Detailed description: PRIMARY OBJECTIVE:

I. To establish linear energy transfer (LET)-based models as early predictors for white matter changes on magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI) sequences in pediatric patients following proton beam therapy for primary central nervous system (CNS) and base of skull tumors.

OUTLINE:

Patients' medical charts are reviewed.

Eligibility criteria: Inclusion Criteria:

* Patients must have histologically confirmed central nervous system of skull base tumors
* Patient is going to undergo central nervous system (CNS) or base of skull proton beam therapy

Exclusion Criteria:

* Patients who have received prior therapeutic radiotherapy to the primary brain tumor site
* Patients who are unable to maintain follow-up through the Phoenix Children's Hospital and Mayo Clinic Arizona

Primary outcomes:
measure: White matter changes within the central nervous system (CNS) following proton beam therapy using magnetic resonance imaging (MRI) sequences
timeFrame: At 18 months
measure: White matter changes within the CNS following proton beam therapy using diffusion tensor imaging (DTI) sequences
timeFrame: At 18 months
measure: Relative biological effectiveness (RBE) predictions
timeFrame: Up to 18 months
Secondary outcomes:
measure: White matter changes within the CNS following proton beam therapy using DTI and MRI
timeFrame: Up to 18 months
measure: Dose-volume effect and predicted LET distribution
timeFrame: Up to 18 months
measure: White matter changes identified on imaging, and predict concordance
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Tamara Z. Vern-Gross, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00048217: A Rollover Study to Provide Chronic T-1249 to Patients Who Completed Study T1249-102
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Keywords: Treatment Experienced
Lead sponsor: Trimeris
Sponsor class: INDUSTRY
First posted: 2002-10-30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Patients who complete study T1249-102 (must be currently failing a T-20 containing regimen to participate in this study) will receive T-1249 at a dose of 200mg daily in combination with a background antiretroviral regimen for 96 weeks. Only patients that participated in study T1249-102 can participate in study T1249-105.


Eligibility criteria: Inclusion Criteria:

* Completion T1249-102;
* Currently failing a T-20 containing regimen

Exclusion Criteria:

* Non-completion of T1249-102.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Trimeris
state: North Carolina
Study officials:
References:
Clinical trial NCT00132717: A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808)
Official title: An Open-Label, Multicenter Study to Assess the Efficacy of Switching to a Combination Tablet Ezetimibe/Simvastatin 10mg/40mg, Compared to Doubling the Dose of Statin in Patients Hospitalized With a Coronary Event
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-08-22
Enrollment: 450
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 this study is to investigate the effect of an investigational cholesterol-lowering drug in patients who are currently taking an approved medication for hypercholesterolemia (high cholesterol levels) and have been hospitalized for a heart problem.


Eligibility criteria: Inclusion Criteria:

* Patients greater than 18 years old, who were admitted to a hospital for an investigation of a heart problem and are currently receiving an approved medication to lower cholesterol

Exclusion Criteria:

* Patients who have congestive heart failure (CHF), uncontrolled high blood pressure, poorly controlled blood sugar, impaired kidney function, or HIV.

Primary outcomes:
measure: Evaluate the effectiveness of MK0653A compared to doubling the statin dose as shown by the low-density lipoprotein cholesterol (LDL-C) values achieved after 12 weeks of treatment
timeFrame: After 12 weeks of treatment
Secondary outcomes:
measure: To determine the effect of MK0653A compared to doubling the statin dose on total cholesterol (TC) after 12 weeks
timeFrame: After 12 weeks of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Reckless JP, Henry P, Pomykaj T, Lim ST, Massaad R, Vandormael K, Johnson-Levonas AO, Lis K, Brudi P, Allen C. Lipid-altering efficacy of ezetimibe/simvastatin 10/40 mg compared with doubling the statin dose in patients admitted to the hospital for a recent coronary event: the INFORCE study. Int J Clin Pract. 2008 Apr;62(4):539-54. doi: 10.1111/j.1742-1241.2008.01697.x. Epub 2008 Feb 11.
citation: Brudi P, Reckless JP, Henry DP, Pomykaj T, Lim ST, Massaad R, Vandormael K, Johnson-Levonas AO. Efficacy of ezetimibe/simvastatin 10/40 mg compared to doubling the dose of low-, medium- and high-potency statin monotherapy in patients with a recent coronary event. Cardiology. 2009;113(2):89-97. doi: 10.1159/000172795. Epub 2008 Nov 15.
Clinical trial NCT06818617: Analysis of Changes in Blood Glucose Spinal Epidural Nerve Block with Steroids in Patients with Low Back Pain
Official title: Analysis of Changes in Blood Glucose Using a Continuous Blood Glucose Monitoring After Spinal Epidural Nerve Block with Steroids in Patients with Low Back Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Glucose Level Change
Keywords: continous glucose monitering
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effect of different doses of dexamethasone used in epidural nerve block procedures on blood sugar levels. Patients with spinal conditions such as stenosis or disc herniation will be enrolled. Blood glucose and HbA1c levels will be measured before the procedure, and participants will use continuous glucose monitoring devices for 2-3 days before the procedure. They will be randomly assigned to one of three groups: no dexamethasone, 5mg dexamethasone, or 7.5mg dexamethasone. Blood glucose will be monitored for one week after the procedure, and follow-up will be done two weeks later to assess pain and blood sugar data. This study will help determine how steroid doses affect blood sugar, especially in elderly patients, and provide more accurate information than previous studies.


Eligibility criteria: Inclusion Criteria:

* patients need to epidural steroid injection for treating back pain
* patients diagnosed with diabetes or prediabetes.

Exclusion Criteria:

* Patients with poorly controlled blood sugar.(HbA1c\>8.5)

Primary outcomes:
measure: Glucose change
timeFrame: glucose change between befor intervention and after for 7days.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06665217: G-Pola-ZLP in Diffuse Large B-Cell Lymphoma
Official title: Glofitamab, Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Prednisone in Previously Untreated Diffuse Large B-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Diffuse Large B-Cell Lymphoma
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 80
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this phase 2 trial is to test the safety and efficacy of G-Pola-ZLP as induction therapy in patients with DLBCL.

Detailed description: The investigators will evaluate safety and efficacy of G-Pola-ZLP as induction therapy in Previously Untreated Diffuse Large B-Cell Lymphoma. ORR(Overall response rate, progression-free survival (PFS), Overall survival (OS), Adverse events (AEs) will be assessed.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed Diffuse Large B Cell Lymphoma according World Health Organization (WHO) classification;
* Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
* Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
* Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
* Patient has not received chemotherapy previously.
* Anticipated life expectancy at least 3 months

Exclusion Criteria:

* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
* Pregnant or lactating women

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 1 year
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: through study completion, an average of 2 years
measure: Progression Free Survival (PFS)
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Navy General Hospital, Beijing
name: Liren Qian, PhD
role: PRINCIPAL_INVESTIGATOR
References: