louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01401751: Feasibility Study Assessing The Ability Of An Insulin Pump-Controlling Algorithm To Minimize Hypoglycemia And Hyperglycemia In Patients With Type 1 Diabetes In A Clinical Research Setting
Official title: Feasibility Study Assessing The Ability Of An Insulin Pump-Controlling Algorithm To Minimize Hypoglycemia And Hyperglycemia In Patients With Type 1 Diabetes In A Clinical Research Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes Mellitus
Artificial Pancreas
Lead sponsor: Animas Corporation
Sponsor class: INDUSTRY
First posted: 2011-07-25
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to evaluate the performance of an insulin pump controlling algorithm while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.

Detailed description: This study is a non-randomized, uncontrolled feasibility study that looks to enroll people with type 1 diabetes who are currently using an insulin pump. During the subject's participation, the study staff will closely monitor the study subject in a clinical research center environment for approximately 24 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.

Total subject participation approximately 1 week for screening to completion. This includes approximately 24 hours usage of the investigation device in the clinical research center under close medical supervision.

Eligibility criteria: Summary of Key inclusion/exclusion criteria:

Inclusion Criteria:

* Age 21-65 years
* Type 1 diabetes mellitus for at least one year
* Using an insulin infusion pump for at least the past 6 months

Exclusion Criteria:

* Pregnancy
* History of diabetic ketoacidosis (DKA) in the past six months
* History of severe hypoglycemia (seizure, unconsciousness) in the past 6 months

Other Inclusion/Exclusion criteria apply.

Please contact clinical study site for complete details.

Primary outcomes:
measure: To evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
timeFrame: End of Study - in approximately 5 months from first subject enrolled
Secondary outcomes:
measure: Safety Evaluation
timeFrame: End of Study - in approximately 5 months from first subject enrolled
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
Study officials:
affiliation: Sansum Diabetes Research Institute
name: Howard Zisser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03470051: Case Collection Study in the Evaluation of Doubling Time Rates in Non-Suspicious Breast Masses Using QT Ultrasound Technology
Official title: A Prospective Multi-center Case Collection Study of Breast Imaging Examinations From Women With Non-suspicious Breast Masses to Correlate the Calculated Mass Doubling Time Using Quantitative Transmission Ultrasound (QT Ultrasound) With Mass Histology.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Fibroadenoma
Lead sponsor: QT Ultrasound LLC
Sponsor class: INDUSTRY
First posted: 2018-03-19
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a non-suspicious breast mass will be recruited.

Brief summary: This is a prospective case collection study to collect cases for subsequent statistical studies and future reader studies.


Eligibility criteria: Inclusion Criteria:

1. Female
2. Age 18 or older
3. Willing to receive QT Ultrasound Breast Scans
4. Willing to undergo an ultrasound-guided needle breast biopsy if performed after enrollment in the study
5. Willing and able to provide Informed Consent prior to any research-related procedure(s)
6. Have an identified solid non-suspicious breast mass

Exclusion Criteria:

1. Pregnancy
2. Currently breastfeeding
3. Magnetic material in the chest which in the judgement of the Principal Investigator would interfere or be impacted by the magnets utilized with the study device.
4. Not willing to provide information for primary care physician
5. History of breast cancer
6. History of treated or untreated cancer of a non-breast origin which in the judgment of the Principal Investigator would be a concern for metastatic disease to the breast
7. Physical inability to tolerate the QT scan, i.e. inability to lie prone and still for up to 30 minutes at a time
8. Open wounds, sores or skin rash present on the breast(s) or nipple discharge from the scanned breast(s)
9. Breasts too large for scanner, i.e. bra size larger than DDD or inability to successfully "fit" breast after the subject is placed on scanner
10. Body weight greater than 400 lbs. (180 kg)
11. Concurrent disease or condition which in the judgment of the Principal Investigator disqualifies the subject from participating in the study

Primary outcomes:
measure: Breast mass doubling time change
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Memorial Care Long Beach
state: California
city: Novato
country: United States
facility: Marin Breast Health Trial Center
state: California
Study officials:
References:
Clinical trial NCT02072551: Future of Beta Cells in Adults With Genetic Abnormality Behind Neonatal Diabetes
Official title: Devenir au Long Cours de la Cellule bêta Chez Les Adultes Porteurs d'Anomalies génétiques à l'Origine du Diabète Néonatal
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diabetic people

Brief summary: The main objective of this study is to evaluate Beta cells in patients with a neonotal diabetes linked to a genetic abnormality Metabolic caracteristics will described using a transversal cohort study.


Eligibility criteria: Inclusion Criteria:

* Age : 18 à 65 year
* diabetic patient with a neonatal diabetis (before 1 year old) and need for insuline or patient with a relative having neonatal diabetis

Exclusion Criteria:

Diabète induit (médicaments - ex corticoïdes) ou syndromique

* infection
* cancer
* pegnancy

Primary outcomes:
measure: Mean insulin secretion output
timeFrame: Week after inclusion
Secondary outcomes:
measure: insulin secretion outout after arginine perfusion
timeFrame: during hospitalisation (3 days)
measure: sensitivity to insulin
timeFrame: during hospitalisation (3 days)
measure: glucago secretion output
timeFrame: during hospitalisation (3 days)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Siant-louis
Study officials:
References:
citation: Le Bourgeois F, Beltrand J, Baz B, Julla JB, Riveline JP, Simon A, Flechtner I, Ait Djoudi M, Fauret-Amsellem AL, Vial Y, Scharfmann R, Sommet J, Boudou P, Cave H, Polak M, Gautier JF, Busiah K; TNDM Long-Term Follow-Up Study Group. Long-term Metabolic and Socioeducational Outcomes of Transient Neonatal Diabetes: A Longitudinal and Cross-sectional Study. Diabetes Care. 2020 Jun;43(6):1191-1199. doi: 10.2337/dc19-0324. Epub 2020 Apr 9.
Clinical trial NCT06977451: Personalized Antisense Oligonucleotide for a Single Participant With CHCHD10 ALS
Official title: An Open-Label Single Center, Single Participant Study of an Experimental Antisense Oligonucleotide Treatment for Amyotrophic Lateral Sclerosis (ALS) Due to an Arg15Leu Pathogenic Variant in CHCHD10
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: n-Lorem Foundation
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2025-05-18
Enrollment: 1
Sex: ALL
Minimum age (years): 63
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for a single participant with amyotrophic lateral sclerosis (ALS) due to a pathogenic variant in CHCHD10


Eligibility criteria: Inclusion Criteria:

* Informed consent/assent provided by the participant (when appropriate), and/or participant's parent(s) or legally authorized representative(s).
* Ability to travel to the study stie and adhere to study-related follow-up examinations and/or procedures and provide access to participant's medical records.
* Genetically confirmed neurological disorder.

Exclusion Criteria:

* Participant has any condition that in the opinion of the Site Investigator, would ultimately prevent the completion of study procedures.
* Use of an investigational medication within less than 5 half-lives of the drug at enrollment

Primary outcomes:
measure: Clinical Functioning
timeFrame: Baseline to 12 months
measure: Motor Functioning
timeFrame: Baseline to 12 months
measure: Motor Functioning
timeFrame: Baseline to 12 months
measure: Clinical Functioning
timeFrame: Baseline to 12 months
measure: Clinical Functioning
timeFrame: Baseline to 12 months
measure: Clinical Functioning
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Disease Biomarkers
timeFrame: Baseline to 12 months
measure: Safety and Tolerability
timeFrame: Baseline to 12 months
measure: Safety and Tolerability
timeFrame: Baseline to 12 months
measure: Safety and Efficacy
timeFrame: Baseline to 12 months
measure: Safety and Efficacy
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University, Irving Medical Center
state: New York
Study officials:
References:
Clinical trial NCT02067351: Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy
Official title: Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 6
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: There is evidence that mindfulness-based interventions (MBIs) such as meditation, mindfulness-based stress reduction (MBSR) and yoga might improve Quality of Life (QOL) and reduce stress in breast cancer survivors. These interventions are becoming increasingly popular in cancer survivors. However, little is known about the feasibility and effect of MBIs administered during the interval of time of chemotherapy, on QOL and stress. The investigators are planning a MBI intervention study developed specifically for breast cancer survivors receiving chemotherapy (usually 4-5 months) at the investigators institution, for at least 8 sessions combined with at least 8 weeks of home-practice, in 25 women receiving chemotherapy for breast cancer.


Eligibility criteria: inclusion criteria:

* Women 20-75 years old
* Diagnosed with breast cancer
* Scheduled to begin chemotherapy at Mayo Clinic Rochester

Exclusion criteria

* Pregnant
* Practicing mindfulness

Primary outcomes:
measure: Feasibility - percentage of patients recruited from those approached, percentage of patients who dropped off, percentage of patients who are compliant (attending more than 75% of recommended sessions)
timeFrame: While receiving chemotherapy (usually 4-5 months)
Secondary outcomes:
measure: Stress - measured by the Perceived Stress Scale - statistically and clinically significant reductions in stress
timeFrame: 7-8 months
Other outcomes:
measure: Fatigue - Multidimensional Fatigue Symptom Inventory -Short Form statistically and clinically significant reductions in fatigue score
timeFrame: 7-8 months
measure: Quality of life measured by the Functional Assessment of Cancer Therapy - Breast - statistically and clinically significant improvement in quality of life
timeFrame: 7-8 months
measure: Sleep measured by the Pittsburgh Sleep Quality Index -statistically and clinically significant improvements in sleep
timeFrame: 7-8 months
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Daniela Stan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06934551: Patient Satisfaction & Abutment Teeth Health in Maxillectomy Patients
Official title: Patient Satisfaction & Abutment Teeth Health in Maxillectomy Patients Rehabilitated With Laser CAD CAM & Conventionally Constructed Obturators
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maxillary Diseases
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: randomized controlled trial in maxillectomy patients with two types of obturators with different manufacturing techniques

Detailed description: randomized controlled trial measuring patient satisfaction and abutment teeth health in maxillectomy patients rehabilitated with laser polished CAD CAM obturators versus conventionally constructed obturators

Eligibility criteria: Inclusion Criteria

* Patients with hemi maxillectomy
* Sufficient number of natural teeth not less than 5 teeth
* Age between 30 and 60 years
* Intact soft palate

Exclusion Criteria

* Cognitive impairment
* Heavy smokers
* Patients exposed to radiotherapy

Primary outcomes:
measure: patient satisfaction
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT06846151: Retinal Investigation Using Optos OCT Device
Official title: Clinical Investigation of Optos OCT in Patients with Retinal Pathologies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: AMD - Age-Related Macular Degeneration
Retinitis Pigmentosa (RP)
Diabetic Retinopathy
Control Patients
Lead sponsor: Optos, PLC
Sponsor class: INDUSTRY
First posted: 2025-02-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all participants receive a single intervention at a single point in time
Primary purpose: OTHER

Brief summary: Retinal investigation using OCT with control and diseased eyes


Eligibility criteria: Inclusion Criteria:

1. Male or female participants 18 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed.
2. Participants who understand the study and patient information sheet and can follow the instructions.
3. Participants who agree to participate in the study.
4. Control group where no retinal abnormalities were detected as part of the standard basic ophthalmic examination.
5. Participants with retinal disease in at least one eye including: Early dry age-related macular degeneration, late stage dry age-related macular degeneration specifically geographic atrophy, Wet age-related macular degeneration, Retinitis pigmentosa, Diabetic retinopathy and other macular atrophic diseases

Exclusion Criteria:

1. Inability to understand written and verbal English sufficiently to comprehend the study and provide informed consent
2. Ophthalmic disease other than condition under investigation.
3. Participants unable to tolerate ophthalmic imaging.
4. Cataract (unless deemed mild in the opinion of the investigator)
5. Participants with significant ocular media not sufficiently clear to obtain acceptable OCT images.
6. Diabetes (unless part of the diabetic eye disease group)
7. Binocular visual acuity worse than 6/18
8. Strabismus (squint)
9. Age related macular degeneration groups: polypoidal choroidal vasculopathy
10. Participants with photo sensitivity epilepsy, experience of seizures, or sensitivity to flickering light (based on self-report)
11. Pregnant

Primary outcomes:
measure: OCT physical response data
timeFrame: 6 months from recruitment start
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03007251: Immediate Effects of Eurythmy Therapy on Psychophysiological Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eurythmy Therapy
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
First posted: 2017-01-02
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate different effects of Eurythmy Therapy on psychological and physiological parameters of circulation and thermoregulation


Eligibility criteria: Inclusion Criteria:

* Healthy adults 18-55 Years old, signed informed consent available

Exclusion Criteria:

* Any known diseases of the cardiovascular system, allergic reactions to electrode patches in the past, coffee, alcohol or smoking less than 3 hours prior to the study, insufficient knowledge of the German language

Primary outcomes:
measure: Pulse Wave Velocity
timeFrame: 10 minutes after the movement exercises
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01991951: Short Term Warfarin Therapy for Radiofrequency Catheter Ablation of Atrial Fibrillation
Official title: Prospective Randomized Study of Incidence of Thromboembolic and Bleeding Events According to the Period of Warfarin Use Before and After Catheter Ablation of Paroxysmal Atrial Fibrillation in Low Risk Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 520
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We hypothesized that in patients with low CHADS-VASc score (2 or \< 2), there is no difference in thromboembolic or bleeding events between patients with short term warfarin therapy (2 weeks after catheter ablation) and conventional therapy (3 weeks before and 8 weeks after procedure).


Eligibility criteria: Inclusion Criteria:

* Patients with paroxysmal atrial fibrillation who underwent radiofrequency catheter ablation
* Patients with CHADS-VASc score 2 or less than 2

Exclusion Criteria:

* Patients who do not consent to the study
* Permanent or persistent atrial fibrillation
* Patients who have underwent prior catheter ablation for atrial fibrillation
* CHADS-VASc score more than 2
* History of stroke
* LVEF \<40%
* Significant liver or kidney dysfunction
* History of major bleeding during warfarin therapy

Primary outcomes:
measure: Incidence of thromboembolic and bleeding events during 2 months
timeFrame: 2 months after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References:
Clinical trial NCT06733051: Phase II Study of Golidocitinib and Benmelstobart in Patients with R/R ENKTL (JACKPOT50)
Official title: A Single-arm, Open-label, Phase II Study of Golidocitinib and Benmelstobart Combination Treatment in Patients with Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma (ENKTL) (JACKPOT50)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Natural Killer T-cell Lymphoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of golidocitinib and benmelstobart combination treatment in patients with relapsed or refractory extranodal natural killer/T cell lymphoma.


Eligibility criteria: Inclusion Criteria:

1. Subjects fully understand and voluntarily participate in this study and sign informed consent.
2. Pathologically confirmed extranodal natural killer/T cell lymphoma (ENKTL).
3. Age ≥18, no gender limitation.
4. Treatment failure to at least one line of asparaginase-based therapy.
5. Eastern Cooperative Oncology Group performance status of 0-2
6. Expected survival ≥ 3 months.
7. At least one measurable lesion that meets Lugano 2014 criteria.
8. Sufficient organ function.

Exclusion Criteria:

1. Invasive NK-cell leukemia or NKTCL that has progressed to leukemia.
2. Accompanied by hemophagocytic lymphohistiocytosis.
3. NKTCL with central nervous system invasion.
4. Previously treated with JAK inhibitors.
5. The patients have contraindications to any drug in the combined treatment.
6. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
7. Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
8. Pregnant and lactating women and subjects of childbearing age who do not want to use contraception.
9. Mentally ill persons or persons unable to obtain informed consent. The investigators think that the patient is not suitable for the study.

Primary outcomes:
measure: Objective response rate(ORR)
timeFrame: 2 years
Secondary outcomes:
measure: Complete Response(CR)
timeFrame: 2 years
measure: Duration of Response(DOR)
timeFrame: Up to 4 years
measure: Progression-free survival(PFS)
timeFrame: Up to 4 years
measure: Overall survival(OS)
timeFrame: Up to 4 years
measure: Incidence and severity of adverse events (AE) , Serious adverse event (SAE) and immune-related adverse event (irAE)
timeFrame: Through study completion, up tp 2 years.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: