louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02945319: Integrated Molecular and Clinical Profiling to Optimize Outcome Prediction in Splenic Marginal Zone Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Splenic Marginal Zone Lymphoma
Lead sponsor: International Extranodal Lymphoma Study Group (IELSG)
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 373
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 with diagnosis of SMZL on spleen histology.

Brief summary: The study aims at developing and validating an integrated clinico-molecular model for an accurate survival prognostication in newly diagnosed SMZL.

Already existing and coded tumor biological material and health-related personal data will be retrospectively collected. Mutation analysis will be performed by targeted deep next generation sequencing of tumor genomic DNA. Deletion of 7q will be assessed by FISH on nuclei isolated from tumor tissues. Immunoglobulin gene rearrangement and mutation status will be analyzed on tumor genomic DNA by PCR and Sanger sequencing. The methylation status of target genes will be assessed by methylation specific PCR on tumor genomic DNA.

The adjusted association between exposure variables and OS will be estimated by Cox regression. This approach will provide the covariates independently associated with OS that will be utilized in the development of a hierarchical molecular model to predict OS. The hierarchical order of relevance in predicting OS among covariates will be established by recursive partitioning analysis. An amalgamation algorithm will be used to merge terminal nodes showing homogenous OS. The discrimination capacity of the model will be assessed by calculating the c-index. Relative survival analysis will be used to provide a measure of the excess mortality experienced by patient's subgroups stratified according to the developed hierarchical molecular models, irrespective of whether the excess mortality is directly or indirectly attributable to the disease. The model developed in the training set will be tested in the validation sets and the model performance (c-index) in the validation set will be compared with that in the training set.


Eligibility criteria: Inclusion Criteria:

* Male or female adults 18 years or older
* Diagnosis of SMZL on spleen histology before Dec 31st 2010 (to provide the cohort with a minimum follow-up of at least 5 years)
* Availability of tumor material (from spleen, peripheral blood or bone marrow) collected before initiation of medical therapy
* Availability of the baseline and follow-up annotations

Exclusion Criteria:

* Having received any medical therapy including anti CD20 monoclonal antibody, chemotherapy or biological agents before splenectomy

Primary outcomes:
measure: Overall survival (OS)
timeFrame: From date of enrollment to study ending at 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: IOSI
Study officials:
References:
Clinical trial NCT03907319: SIS Evaluation of the MRI Defined Subthalamic Nucleus*
Official title: Retrospective Multi-Site Re-Evaluation of the MRI Defined STN and Its Correlation to Motor Outcomes With Stimulation Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Deep Brain Stimulation
Keywords: STN
Parkinson's Disease
Subthalamic Nucleus
Lead sponsor: Surgical Information Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-08
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have completed bilateral or unilateral high frequency stimulation of the subthalamic nucleus (STN-HFS) for idiopathic PD and have pre and post operative MR and CT imaging, programming data, Unified Parkinson's Disease Rating Scale Part III (UPDRS-III) scores and a 3-6 month follow-up evaluation

Brief summary: Retrospective review of images used to target the STN during DBS procedure and ability of the Surgical Information Sciences ("SIS") system to visualize the STN location.

Detailed description: The purpose of this study is to collect retrospective data to demonstrate the ability of the SIS system to visualize the MRI-defined STN in patients with Parkinson's Disease (PD) who have undergone deep brain stimulation (DBS) procedure targeting the STN.

Eligibility criteria: Key Inclusion Criteria:

* Idiopathic PD
* Bilateral or unilateral STN-HFS for PD
* 40% improvement response to medications preoperatively

Key Exclusion Criteria:

* Missing required MR/CT imaging data

Primary outcomes:
measure: Percent of STN Visualization Success
timeFrame: Day 1
measure: Incidence of DBS Lead Location in Proximity to STN
timeFrame: Day 1
Secondary outcomes:
measure: Rate of Correlation of Predicted Outcome to Monopolar Review Outcome
timeFrame: 1 Month
measure: Rate of Correlation of DBS Lead Location to Long Term Outcomes
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
affiliation: Surgical Information Sciences
name: Noam Harel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00214019: The Effect of Salmeterol on Eosinophil (EOS) Function
Official title: The Effect of Salmeterol on Eosinophil (EOS) Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Asthma
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2005-09-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is designed to test the hypothesis that salmeterol use, and not fluticasone use or the combination treatment with fluticasone and salmeterol, is associated with a greater number of sputum eosinophils following antigen challenge and, under these circumstances, the migrating peripheral blood eosinophils are less adherent.

Detailed description: An antigen challenge is when a participant inhales either cat, ragweed, or dust dander in increasing concentrations until their lung function drops 15 or 20 percent.

Eligibility criteria: Inclusion Criteria:

* 18-55 years of age
* history of asthma symptoms for the previous 6 months
* Forced Expiratory Value (FEV1) \>75% of predicted
* positive prick skin test to cat, house dust mite or ragweed

Exclusion Criteria:

* history of life threatening asthma or anaphylaxis
* current smoker
* pregnant or breast-feeding
* evidence of an upper respiratory infection within 4 weeks of screening

Primary outcomes:
measure: Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge
timeFrame: Eosinophils are measured 24 hours after the subject has an antigen challenge
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: William Busse, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03184519: Comparison of hhCG With hCG+ß in the Early Prediction of Ongoing Pregnancy.
Official title: Comparison of hhCG With hCG+ß in the Early Prediction of Ongoing Pregnancy After In-vitro Fertilization and Embryo Transfer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Test
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All the patients will undergo 3 blood samples for analyses to determine pregnancy.
Primary purpose: DIAGNOSTIC

Brief summary: Proof of concept study for the prediction of ongoing pregnancy in women undergoing In-Vitro Fertilization (IVF), using hyperglycosylated human chorionic gonadotropin (hhCG), early after In-Vitro Fertilization and fresh Embryo Transfer (IVF-ET).


Eligibility criteria: Inclusion criteria:

* Written informed consent
* Patients undergoing their first or second IVF-ET cycle
* Age 18-45 years
* Use of Ovitrelle for final follicular maturation and luteinization
* Fresh or Frozen day-5 blastocysts transrer (Autologus or Egg donation)

Exclusion criteria:

* Gestational surrogacy (patient's eggs used for pregnancy in a surrogate mother)
* Canceled IVF cycles
* GnRH agonist triggering cycles in the case of fresh ET.

Primary outcomes:
measure: Number of Participants With Early Detection of Pregnancy
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
affiliation: IVIRMA VALENCIA
name: Ernesto Bosch, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06122519: Characteristics of Eye Diseases in Children and Adolescents With Autism Spectrum Disorders and the Effect of Corresponding Treatment on the Quality of Life of Children and Adolescents With Autism and Their Caregivers
Official title: Disorders and the Effect of Corresponding Treatment on the Quality of Life of Children and Adolescents With Autism and Their Caregivers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autism Spectrum Disorder
Visual Function
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The plan is to enroll nearly 1,000 children with autism in the study.

Brief summary: This study mainly investigated the incidence of eye diseases in children with autism spectrum disorder(ASD) in Tianjin area, and analyzed related risk factors, so as to raise attention to eye diseases in children with ASD. To evaluate the impact of ophthalmic treatment on the quality of life of children with autism and their primary caregivers.

Detailed description: In recent years, the incidence of autism has increased year by year, which has brought a heavy burden to society and families. For the special group of children with autism spectrum disorder, previous studies focused on the lack of comprehensive and accurate visual function characteristics and defects of this group. In the early stage, it was believed that there was a certain correlation between visual impairment and autism, and some patients with visual impairment were misdiagnosed as autism. Moreover, some studies have shown that the incidence of refractive errors and oblique amblyopia in autistic children is significantly higher than that in normal children. This study mainly includes two parts: On the one hand, investigate the autism children in Tianjin area to understand the incidence of eye diseases. On the other hand, children with eye problems were given relevant interventions, such as optometry, amblyopia training, strabismus surgery, etc., to assess the impact of the corresponding treatment on the quality of life of the children and their primary caregivers.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with ASD but without medical intervention. To cooperate with relevant inspectors.

Exclusion Criteria:

* Brain organic diseases (such as tumors, strokes, epilepsy, etc.) and serious physical diseases (such as heart, liver, kidney and other organ dysfunction, cancer, etc.);Do not cooperate to check.

Primary outcomes:
measure: refractive error
timeFrame: 6 months
measure: strabismus
timeFrame: 6 months
measure: amblyopia
timeFrame: 6 months
Secondary outcomes:
measure: OCTA
timeFrame: 6months
measure: eye tractor
timeFrame: 6months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT03180918: Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment
Official title: Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Cancer
Fertility Disorders
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 100
Sex: MALE
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Background:

Due to the remarkable improvement in treatments these last decades, long term survival can be expected in more than 80% of childhood cancer patients. Unfortunately, cancer treatments can be harmful to the gonads and can affect reproductive and endocrine functions. While loss of fertility is a major concern for most patients, sperm cryopreservation should be offered to all pubertal male patients. For prepubertal boys, only the experimental option of testicular biopsy in order to cryopreserve testicular stem cells can be proposed.

Primary aims

- To cryopreserve testicular tissue of prepubertal patient receiving highly gonadotoxic oncological treatment.

Secondary aims

* To cryopreserve testicular tissue after failure of sperm cryopreservation in pubertal patient with high risk of infertility
* To create a database in order to record clinical and biological follow-up data
* To create a research biobank for future research projects

Multicentric study: HUG, CHUV, UKBB


Eligibility criteria: Inclusion Criteria:

* Prepubertal patients aged 3 months and older
* Peri and pubertal patients after failure of sperm cryopreservation
* Patients presenting high risk of infertility because of gonadotoxic treatments (i.e high dose of alkylating agents, testicular irradiation, total body irradiation).
* Multidisciplinary team consensus in favour of proposition to cryopreserve testicular tissue

Exclusion Criteria:

* Patients under the age of 3 months
* Refusal of the patient and/or his parents
* Treatments that are not highly gonadotoxic

Primary outcomes:
measure: Number of pediatric cancer patient who will undergo testicular tissue cryopreservation for fertility preservation
timeFrame: 0-20 years
Secondary outcomes:
measure: Incidence of complications related to the testicular biopsy (safety)
timeFrame: 0-20 years
measure: Comparison of biochemical markers
timeFrame: 0-20 years
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: UKBB
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
city: Lausanne
country: Switzerland
facility: CHUV
Study officials:
affiliation: University Hospital, Geneva
name: Fabienne Gumy-Pause
role: STUDY_CHAIR
References:
Clinical trial NCT02568319: Safety and Efficacy Study of LIPO-202 for the Reduction of Central Abdominal Bulging in Obese Subjects
Official title: A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging in a Defined Special Population - Obese Subjects (BMI > or Equal to 30 kg/m2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Central Abdominal Bulging
Lead sponsor: Neothetics, Inc
Sponsor class: INDUSTRY
First posted: 2015-10-05
Enrollment: 120
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: This is a multi-center, randomized, placebo-controlled, double-blind study evaluating the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging in obese subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male or non-pregnant female subjects
* Capable of providing written consent
* BMI \> 30 kg/m2 but \< 40 kg/m2
* Stable diet and exercise routine
* At least "Slightly Dissatisfied" with their abdominal bulging on the Abdominal Contour Questionnaire (ACQ)

Exclusion Criteria:

* BMI \> 40 kg/m2
* Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen.
* Plan on starting a weight loss or exercise program during the study
* Known hypersensitivity to study drugs
* Have any medical condition that might complicate study procedures

Primary outcomes:
measure: Safety as measured by physical examination, adverse events, vital signs, and laboratory tests.
timeFrame: 9 weeks
Secondary outcomes:
measure: Change in waist circumference.
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Diagnamics, Inc.
state: California
city: Manhattan Beach
country: United States
facility: Ablon Skin Institute and Research Center
state: California
city: Aventura
country: United States
facility: The Center for Clinical & Cosmetic Research
state: Florida
city: Coral Gables
country: United States
facility: Skin Research Institute
state: Florida
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center
state: Virginia
Study officials:
affiliation: Neothetics, Inc
name: Maria Feldman
role: STUDY_DIRECTOR
References:
Clinical trial NCT03093519: A Repeated Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease
Official title: A Phase 1 Randomized, Double-blind, Placebo-controlled, Repeated Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-03-28
Enrollment: 21
Sex: ALL
Minimum age (years): 55
Maximum age (years): 84
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 evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a repeated dose in Japanese patients with Mild to Moderate Alzheimer's Disease.


Eligibility criteria: Inclusion Criteria:

* Patients with mild to moderate Alzheimer's Disease
* Body weight ≥ 40 kg and \< 100 kg
* Clinical Dementia Rating (CDR) score of 1 or 2
* Mini Mental State Examination (MMSE) score of ≥ 17 amd ≤ 26

Exclusion Criteria:

* Previous active treatment with an Alzheimer's Disease immunotherapy in an investigational study
* Use of another investigational drug within 16 weeks prior to the enrollment
* Subjects who meet National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
* Subjects with a history of presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease
* Subjects with a presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's Alzheimer's Disease
* Subjects who have evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than Alzheimer's Disease

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Up to 197days after first dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Saitama
country: Japan
facility: Closed information
Study officials:
References:
Clinical trial NCT01349218: Relationship Between Potassium Level in Venous Blood Samples Drawn and Heel Sticks In Infants and Newborns
Official title: In Infants and Newborns, is There a Relation Between the Potassium Level in Blood Samples Drawn From a Vein and Those Drawn From a Heel Stick?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperkalemia
Keywords: Potassium
Infants
Heel Stick
Less than or equal to 6 months of age
IV catheter blood samples
perioperatively
elective surgical procedures
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Memorial Hermann Hospital
First posted: 2011-05-06
Enrollment: 31
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to find out whether there is a correlation (link) between the level of potassium in blood samples drawn from a vein and those drawn from a heel stick in infants scheduled for elective surgery.

Detailed description: This is a prospective study which will take place at the Children's Memorial Hermann Hospital Operating Room.

After obtaining written informed consent from parents or guardians, infants and babies scheduled to have elective surgery under routine general anesthesia and are \<6 months of age will be included in the study. After the baby receives routine general anesthesia, a small amount of blood, 0.5 ml, will be drawn from a vein when an I.V. is started for the surgery. The largest possible cannula will be placed whenever possible to decrease hemolysis. If a baby has a central line, the blood sample will be drawn from it. If a baby has an existing peripheral I.V., a blood sample will be drawn from the I.V. cannula only if blood is freely running, to avoid hemolysis.

Blood will be placed into a heparinized, 1 ml syringe for venous blood gas analysis. A second blood sample, 0.3 ml, will be drawn into a capillary pipette from a heel stick for capillary blood gas analysis. The heel will be properly sterilized, and a proper size lancet will be used. The same operator will be performing the heel stick in each case.

Eligibility criteria: Inclusion Criteria:

* Infants and babies, ASA physical Status I-III, less than 6 month of age and scheduled to have elective surgery under routine general anesthesia at Children's Memorial Hermann Hospital will be included.

Exclusion Criteria:

* Babies and infants with documented anemia (\< 8 gm), who are bleeding, ASA Classification \>III, have sickle cell disease or trait, thalassemia, HIV or DIC will be excluded from the study. Babies with organ failure will be excluded.

Primary outcomes:
measure: Potassium Measurements
timeFrame: 0-30 minutes after start of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: Faculty
name: Samia N Khalil, M.D.
role: PRINCIPAL_INVESTIGATOR
References: