louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06906380: A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
Official title: A Long-term Follow-up Study of Patients Enrolled in ARD103_ARCE-CL-P-001 Phase 1/2 Study and Treated With ARD103 CAR-T Cell Therapies
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Myeloid Leukemia, in Relapse
Acute Myeloid Leukemia, in Relapsed or Refractory
MDS (Myelodysplastic Syndrome)
Lead sponsor: ARCE Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-02
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will comprise participants with R/R AML or MDS treated with ARD103. All subjects with AML or MDS who are enrolled in a parent study and were received ARD103 CAR-T infusion will be asked to participate in this long-term follow-up (LTFU) study.

Brief summary: This study will evaluate the long-term safety of ARD103 cellular therapies

Detailed description: Participants who receive administration of ARD103 (i.e., a partial dose or a full dose) will roll into the LTFU study upon completion of the 24-month interventional study period (Study: ARD103_ARCE-CL-P-001), or after early discontinuation from the interventional study protocol. The LTFU study is a study intended to characterize long-term safety for 15 years post-ARD103 administration. Participants who complete the full 24-month interventional study period will undergo an additional 13 years of monitoring under the LTFU study. No IP will be administered during the LTFU study. The number and percentage of participants with ARD103 CAR-T cell therapy related AEs, SAEs, and AESIs will be recorded throughout the LTFU Period.

Eligibility criteria: Inclusion Criteria:

* The participant has R/R AML or MDS and has previously received ARD103 CAR-T cell therapies in the parent study.
* The participant is able to understand and comply with protocol-required study procedures and has provided a written informed consent document.

Exclusion Criteria:

* There are no specific exclusion criteria for this study

Primary outcomes:
measure: The incidence and duration of AEs, SAEs, and AESIs related to ARD103 treatment.
timeFrame: 15 years
Secondary outcomes:
measure: The long-term efficacy of ARD103 in participants with R/R AML or MDS
timeFrame: 15 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05837780: Effect of Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients
Official title: Three Dimensional Evaluation of Maxillary Arch Changes After Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients (Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Unilateral Cleft Lip and Palate
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 36
Sex: ALL
Minimum age (years): 7
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study includes Three Dimensional Evaluation of Maxillary Arch Changes After Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients (Randomized Controlled Trial) Null hypothesis: there is no difference between using conventionally constructed nasoalveolar molding device and using digitally constructed nasoalveolar molding device


Eligibility criteria: Inclusion Criteria:

Good general health without any systematic disease, disability or other syndromes Non syndromatic unilateral cleft lip and palate Both genders Age less than one month Parents willing to participate in the study and sign informed consent

Exclusion Criteria:

* Patients exhibiting systemic disease, disability or other syndrome, parents denying participating in the study or not given their informed consent

Primary outcomes:
measure: Alveolar cleft width
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Dentistry ,Minya university
Study officials:
References:
Clinical trial NCT06537180: Gender-based Differences in the Outcome of the Treatment of Persistent Septic Shock With Hydrocortisone
Official title: Gender-based Differences in the Outcome of the Treatment of Persistent Septic Shock With Hydrocortisone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Keywords: Critical Care, Septic Shock, Hydrocortisone, Gender
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 621
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: Adult patients of both sexes with persistent septic shock received hydrocortisone during their intensive care unit (ICU) stay.

Brief summary: The aim of this study is to explore the gender-based differences in the outcomes of treatment with hydrocortisone in critically ill patients with persistent septic shock.

Detailed description: Because of their pleiotropic effects, corticosteroids are widely used as adjunctive therapy in sepsis for their anti-inflammatory, metabolic, and immune-suppressing actions. Moreover, the treatment benefits of corticosteroids in terms of hemodynamics and organ functions for septic shock were established. Hydrocortisone reduces the duration of mechanical ventilation and critical care treatment and reduces the time needed for shock reversal. Hydrocortisone use at a daily dose of ≤400 mg for at least 3 days was associated with survival benefits.

Interestingly, corticosteroid treatment was reported to be more cost-effective in females than in males with septic shock, compared with placebo. This may be explained by the fact that sex hormones modulate the expression and sensitivity of glucocorticoid receptors differently, potentially influencing the body's response to cortisol. To the best of our knowledge, the data available on whether females and males may be more or less likely to acquire a better or worse prognosis of persistent septic shock when treated with hydrocortisone is sparse.

The aim of this study is to explore the gender-based differences in the outcomes of treatment with hydrocortisone in critically ill patients with persistent septic shock.

Eligibility criteria: Inclusion Criteria:

* Adult patients of both sexes with persistent septic shock received hydrocortisone during their intensive care unit (ICU) stay.

Exclusion Criteria:

* Patients with incomplete data sets.

Primary outcomes:
measure: 28-day mortality
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Alexandria University Hospitals
Study officials:
References:
Clinical trial NCT05555680: Effect of Hyperandrogenism on IVF Outcomes in PCOS Patients
Official title: Effect of Hyperandrogenism on IVF Success Rates in PCOS Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Keywords: Hyperandrogenism
Fertility issues
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2022-09-27
Enrollment: 188
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PCOS patients undergoing the first embryo transfer following the first IVF treatment during the study period (or up to two embryo transfers)

Brief summary: Ovulatory dysfunction affects 18 to 25% of infertile women, the most common identifiable condition is polycystic ovarian syndrome (PCOS). The most frequent symptoms of PCOS are oligo-anovulation, hyperandrogenism and polycystic ovary appearance.

Hyperandrogenism is the main contributor that affects oocyte and embryo quality and decreases the success rates in PCOS patients undergoing IVF treatments.

The aim of this study is to determine the effect of hyperandrogenism as an independent factor on IVF success rates and oocyte/embryo quality in PCOS patients undergoing IVF.

Detailed description: Despite that PCOS patients obtain a higher yield of oocytes retrieved in IVF treatments, they often have lower fertilization, cleavage and implantation rates and a higher rate of miscarriage, which can be attributed to a poor quality of retrieved oocytes and the resulting embryos. Multiple studies compared IVF outcomes in PCOS patients to control groups and found that PCOS might negatively affect oocyte maturation rate, fertilization rate in conventional IVF and miscarriage rate. Hence, it seems that PCOS might be associated with poor outcomes in IVF cycles when compared to non-PCOS patients.

Eligibility criteria: Inclusion Criteria:

* Women between ages of 18 - 39 inclusively
* ≥15 oocytes collected on the day of oocyte retrieval and/or anti-mullerian hormone (AMH) ≥ 4.0 ng/ml in the participant's medical chart in the last 24 months

Exclusion Criteria:

* Male factor necessitating testicular sperm aspiration (TESA), testicular sperm extraction (TESE) or micro-TESE
* Fertility preservation
* Recurrent pregnancy losses (RPL) (defined as 2 or more failed clinical pregnancies as documented by ultrasonography or histopathologic examination,or 3 or more failed pregnancies before 14 weeks of gestation)
* Oocyte donation
* Medical diagnosis of non classic congenital adrenal hyperplasia diagnosed based on 17 hydroxyprogesterone level

Primary outcomes:
measure: Evaluate the effect of hyperandrogenism on frozen embryo transfer
timeFrame: 10 days after frozen embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Joanne Benoit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00741780: Long-Term Follow-up Study for Multiple Myeloma Patients Who Received Study Treatment (Plerixafor or Placebo) in the AMD3100-3102 Study (NCT00103662).
Official title: Long-term Observational Follow-up Study of a Multicenter, Randomized, Double-blind, Placebo-controlled, Comparative Trial of AMD3100 (240µg/kg) Plus G-CSF (10µg/kg) Versus G-CSF (10µg/kg) Plus Placebo to Mobilize and Collect ≥ 6X 10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Autologous Transplantation
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 164
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the AMD3100-3102 study (NCT00103662) who received a at least one dose of study treatment (plerixafor or placebo).

Brief summary: This is a long-term observational study of patients that were treated with at least 1 dose of study treatment (plerixafor or placebo) in the AMD3100-3102 protocol (NCT00103662).

Detailed description: This is a long-term observational study of patients who received at least one dose of study treatment (plerixafor or placebo) in a multicenter, randomized, double blind, placebo-controlled study to evaluate AMD3100 plus granulocyte colony stimulating factor (GCSF) versus G-CSF plus placebo to mobilize and transplant Multiple Myeloma (MM) patients (protocol AMD31003102LTF \[NCT00103662\]). The objective of this study is to assess progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) for a period of 5 years following the first dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102 (NCT00103662).

Eligibility criteria: Inclusion Criteria:

* All patients who received a dose of study treatment (plerixafor or placebo) in protocol AMD3100-3102 (NCT00103662)

Exclusion Criteria:

* No Exclusion Criteria

Primary outcomes:
measure: Progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102 (NCT00103662)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Micallef IN, Stiff PJ, Nademanee AP, Maziarz RT, Horwitz ME, Stadtmauer EA, Kaufman JL, McCarty JM, Vargo R, Cheverton PD, Struijs M, Bolwell B, DiPersio JF. Plerixafor Plus Granulocyte Colony-Stimulating Factor for Patients with Non-Hodgkin Lymphoma and Multiple Myeloma: Long-Term Follow-Up Report. Biol Blood Marrow Transplant. 2018 Jun;24(6):1187-1195. doi: 10.1016/j.bbmt.2018.01.039. Epub 2018 Feb 2.
Clinical trial NCT03491280: Diagnostic Research in Patients With Rare Diseases - Solving the Unsolved Rare Diseases
Official title: Diagnostic Research in Patients With Rare Diseases - Solving the Unsolved Rare Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rare Diseases
Genetic Predisposition
Keywords: Rare Diseases
Genetic Predisposition
Omics Technology
Next Generation Sequencing (NGS)
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 5500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study recruit both underage and adult persons (male and female) with unclear genetic syndromes who present themselves for consultation at the UKT and who are suspected of having a genetic cause of the disease.

Brief summary: The DiRiP study will enroll patients (n = 3500) with unclear rare diseases and suspected genetic reasons. In group 1 (n = 500) subjects are clinically characterized in the context of outpatient/ inpatient standard care at the UKT or cooperating location, NGS analyzes and other omics analyzes (transcriptomics, proteomics, metabolomics), functional cell biology studies will be performed. In group 2 diagnostics is already performed.

The DiRiP-study fully integrates with the newly formed European Reference Networks (ERNs) for rare diseases, and in particular the ERN-RND, -EURO-NMD, -ITHACA, and -GENTURIS.

Detailed description: In the DiRiP-RD study (monocentric, prospective, open-label diagnostic study), patients with genetically unexplained diseases will be analyzed or re-analyzed from existing datasets for further omics analysis. These are evaluated with regard to the following questions:

Primary:

* Verification of the genetic causes of unclear genetic diseases

Secondary:

* Improve number of diagnoses of unclear syndromes
* Further characterization of the identified gene defects
* Number of patients receiving appropriate therapy after successful diagnosis. In addition, patient phenotype and genotype data can be collected using a software tool for collecting and analyzing phenotypic information of patients with genetic disorders ( PhenoTips®) software to facilitate data exchange within the UKT, with external collaborators and data transfer to the Solve-RD project.

Eligibility criteria: Inclusion Criteria:

* Unclear diagnosis
* Suspected genetic cause of the disease

Exclusion Criteria:

* Missing informed consent of the patient/ legal guardian

Primary outcomes:
measure: Molecular genetic
timeFrame: Day 1
Secondary outcomes:
measure: Number of diagnoses
timeFrame: Day 1
measure: Characterization of gene defects
timeFrame: Day 1
measure: Number of patients receiving appropriate therapy after successful diagnosis
timeFrame: Day 1
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital
Study officials:
affiliation: Managing Director
name: Holm Graessner, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT06295380: Virtual Reality Rehabilitation to Promote Motor Recovery in Amputees
Official title: Study of Motor Recovery and Biomechanical Adaptation Mechanisms in Amputee Patients Using an Immersive Virtual Reality System (CAREN)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lower Limb Amputation Knee
Injuries
Biomechanical Lesion
Keywords: rehabilitation
virtual reality
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Interventional, non-pharmacological crossover study aimed at identify statistically significant differences in postural stability and spatio-temporal gait cycle parameters in patients with lower limb amputation by means of taskoriented rehabilitation training and multisensory feedback generated by an immersive RV environment, aiming at the enhancement of use-dependent brain plasticity. These changes will be compared between the two groups examined, respectively experimental (Caren virtual training phase plus conventional physiotherapy phase) and control (conventional physiotherapy phase plus Caren virtual training phase).

Detailed description: Primary objectives: Evaluation of biomechanical and spatio-temporal asymmetries in gait in subjects with lower limb amputation by motion capture systems; improvement of postural stability and gait cycle in patients with lower limb amputation by "task-oriented" rehabilitation training and multisensory feedback generated by an immersive virtual reality environment, aiming at the enhancement of use-dependent brain plasticity; improving body weight distribution on both lower limbs, during static and dynamic activities, through more effective control of the body's centre of gravity. Secondary objectives include improving mood, psycho-social wellbeing and quality of life in lower limb amputees.

Eligibility criteria: Inclusion Criteria:

* unilateral lower limb amputation
* ability to walk independently
* age between 18 and 75 years
* absence of severe comorbidities that may interfere with treatment

Exclusion Criteria:

* presence of severe neurological and psychiatric disorders
* walking with aids

Primary outcomes:
measure: Kinematic data
timeFrame: seven months
measure: Kinetic data
timeFrame: seven months
measure: Electromyography
timeFrame: seven months
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi
state: Sicily
Study officials:
affiliation: IRCCS Centro Neurolesi Bonino Pulejo
name: Giuseppe Paladina, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01676480: The Effect of Endurance Training on Body Composition and Insulin Sensitivity in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Official title: The Effect of Endurance Training on Body Composition and Insulin Sensitivity in Prostate Cancer Patients Receiving ADT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
ADT
Endurance training
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
First posted: 2012-08-31
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to investigate if endurance training can be used as a therapeutic action against the adverse metabolic disturbances and unfavourable changes in body composition that accompany the androgen deprivation therapy (ADT) treatment in prostate cancer patients.


Eligibility criteria: Inclusion Criteria:

* Prostate cancer patients receiving ADT for at least 3 months
* Healthy age and BMI matched controls

Exclusion Criteria:

* severe cardiovascular disease
* severe arthritis
* severe neuropathy
* severe hypertension
* therapy with antidiabetic agents
* VO2max \> 30.

Primary outcomes:
measure: Changes in body composition and insulin sensitivity in response to training
timeFrame: Body composition and insulin sensitivity are measured at baseline and after 12 weeks of endurance training
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Centre of Inflammation and Metabolism, Rigshospitalet
Study officials:
affiliation: Centre of Inflammation and Metabolism, Rigshospitalet
name: Bente K Pedersen
role: STUDY_DIRECTOR
References:
Clinical trial NCT01595880: BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone
Official title: A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2012-05-10
Enrollment: 29
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and metformin HCl extended release 500mg in comparison to each component administered alone in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Age between 20 to 45, healthy male subjects(at screening)
* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
* FPG 70-125mg/dL glucose level(at screening)
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
* Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
* Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
* Subject who already participated in other trials in 2months
* Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.
* Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)

Primary outcomes:
measure: AUClast, Cmax
timeFrame: up to 48h post-dose
Secondary outcomes:
measure: AUCinf, Tmax, t1/2, CL/F, metabolic ratio
timeFrame: up to 48h post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul national univ. hospital
name: Kyung-sang Yu, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: