louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02856438: Early Patient Access Treatment Use Protocol CA204-220
Official title: An Expanded Access Program for Elotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma in Japan
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2016-08-04
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT

Brief summary: The objective of this expanded access program is to provide treatment with elotuzumab in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma at Japanese sites where licensed physicians determine clinical need.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria

* Men and women 20 years and older.
* Active, relapsed or refractory multiple myeloma by International Myeloma Working Group (IMWG) criteria as assessed by the treating physician and have received at least 1 prior line of multiple myeloma therapy.
* Progression from a most recent line of therapy.
* Prior lenalidomide exposure is permitted only if they fulfill all of the following:.

  i) Were not refractory to prior lenalidomide, defined as no progression while receiving lenalidomide (induction dose) or within 60 days of last dose of lenalidomide. Patients progressing on lenalidomide maintenance dose are eligible for enrollment.

ii) Patient did not discontinue lenalidomide due to a Grade ≥ 3 related AE.

Exclusion Criteria

* All Adverse Events of any prior chemotherapy, surgery, or radiotherapy not resolved to NCI CTCAE (v. 3.0) Grade ≤ 2.
* Significant cardiac disease as determined by the treating physician including cardiac amyloidosis.
* HIV infection or active hepatitis A, B, or C.
* Any medical conditions that, in the attending physician's opinion, would impose excessive risk to the patient.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Shibukawa-shi
country: Japan
facility: Local Institution
state: Gunma
city: Osaka-shi
country: Japan
facility: Local Institution
state: Osaka
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04907838: Insulin Stimulated Vasodilation in Patients With Type 2 Diabetes
Official title: Insulin Stimulated Vasodilation in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: The University of Texas at Arlington
First posted: 2021-06-01
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the role of endothelin in insulin stimulated vasodilation and glucose uptake. The subjects will complete an hyperinsulinemic euglycemic clamp with and without blockade of the endothelin receptors.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes OR healthy control (no type 2 diabetes)
* BMI\<32

Exclusion Criteria:

* heart disease
* pregnancy or birth within 3 month
* smoking
* Kidney disease
* beta-blockers
* insulin treatment (for type 2 diabetics)

Primary outcomes:
measure: Glucose infusion rate
timeFrame: 3.5 hours
measure: Leg blood flow
timeFrame: 3.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Cardiovascular and Renal Research
Study officials:
affiliation: Professor
name: Stefan Mortensen, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young BE, Padilla J, Finsen SH, Fadel PJ, Mortensen SP. Role of Endothelin-1 Receptors in Limiting Leg Blood Flow and Glucose Uptake During Hyperinsulinemia in Type 2 Diabetes. Endocrinology. 2022 Mar 1;163(3):bqac008. doi: 10.1210/endocr/bqac008.
Clinical trial NCT02855138: Effects of Isotretinoin on The Gonads and Hirsutism
Official title: The Effects of Oral Isotretinoin in Women With Acne and Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adverse Effects of Medical Drugs
Keywords: isotretinoin
PCOS
acne vulgaris
Lead sponsor: Kayseri Education and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Kayseri Erciyes University Faculty of Medicine
First posted: 2016-08-04
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators consider that there are some rising concerns about the use of isotretinoin by women of reproductive age with depleted ovarian reserve, hence it is important to detect the effect of isotretinoin on ovarian reserve.

There has not been a well-designed study evaluating its effects on the human ovarian reserve, hormone levels and menstrual cycles in women with polycystic ovary syndrome (PCOS). For this reasons, this study was administered to determine whether there is an effect of isotretinoin on the gonads and hirsutism in women with acne and PCOS.


Eligibility criteria: Inclusion Criteria:

* consisted of 40 volunteers women with PCOS (aged 18- 40 years, BMI, 18-44kg/m2) who attended our obstetrics and gynecology clinic for the treatment menstrual irregularities and hirsutism

Exclusion Criteria:

* 1)presence of any dermatologic disorder besides acne 2) presence of any systemic disease 3) exposure to any systemic treatment in the last three months that could alter ovarian reserve 4) pregnancy or lactation 5) infection diseases 6) use of antidepressants, steroidal hormone drugs, mood stabilizers, caffeine, alcohol, or tobacco 7) histories of abdominal surgery for endometriosis or ovarian surgery

Primary outcomes:
measure: Adverse Events on the Gonads and Hirsutism That are Related to Treatment
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kayseri Education and Research Hospital
name: GÖKHAN ACMAZ
role: PRINCIPAL_INVESTIGATOR
References:
citation: Acmaz G, Cinar L, Acmaz B, Aksoy H, Kafadar YT, Madendag Y, Ozdemir F, Sahin E, Muderris I. The Effects of Oral Isotretinoin in Women with Acne and Polycystic Ovary Syndrome. Biomed Res Int. 2019 Apr 7;2019:2513067. doi: 10.1155/2019/2513067. eCollection 2019.
Clinical trial NCT03390738: Nivolumab as Treatment for Recurrent/Metastatic Nasopharyngeal Carcinoma After Failing 2 Lines or More Previous Chemotherapy
Official title: Nivolumab as Treatment for Recurrent/Metastatic Nasopharyngeal Carcinoma After Failing 2 Lines or More Previous Chemotherapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 0
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: A phase II, open label, single arm, single agent study using nivolumab in patients who failed 2 or more lines of previous chemotherapy for recurrent/metastatic NPC (At least 1 line should include platinum based chemotherapy)


Eligibility criteria: Inclusion Criteria:

* Recurrent or metastatic NPC incurable by local therapies and failed at least 2 lines of previous chemotherapy with at least 1 line including platinum based chemotherapy
* Measurable disease (RECIST 1.1)
* ECOG 2 or less
* Life expectancy greater than 3 months
* Adequate organ function
* (Provided tissue for PD-L1 biomarker analysis from a core or excisional biopsy Paired biopsy of baseline tissue at first diagnosis and for recurrence if possible) - optional but encouraged

Exclusion Criteria:

* Suitable for local therapy
* Did not have prior platinum chemotherapy
* Immunodeficiency; immunosuppressive treatment
* Anti-cancer monoclonal antibody treatment within 4 weeks prior to Day 1
* Other cancer treatment within 2 weeks prior to Day 1
* Other malignancies (some exceptions)
* CNS metastases; carcinomatous meningitis
* Active temporal lobe necrosis or on steroid treatment
* Autoimmune disease
* Active, non-infectious pneumonitis
* Active infection requiring systemic treatment
* Hepatitis

Primary outcomes:
measure: Overall response rate of patients. Response will be assessed by RECISTS 1.1 criteria
timeFrame: 1 year
Secondary outcomes:
measure: Toxicities as defined by CTCAE criteria
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02662738: The Effect of a Natural Extract on Glucose Fluxes After Consumption of a Wheat Product
Official title: The Effect of a Natural Extract on Glucose Fluxes After Consumption of a Wheat Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Blood glucose
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
First posted: 2016-01-25
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is to quantify the effect of a natural fruit extract added to a wheat product on the time needed to absorb 50% of the apparent total of available exogenous carbohydrate (RaE \* Time). In addition the different glucose fluxes will be quantified (RaE, EGP and GCR)


Eligibility criteria: Inclusion Criteria:

* Healthy Caucasian male.
* Body mass index (BMI) ≥ 18.0 and ≤ 25.0 kg/m2.
* Apparently healthy: no medical conditions which might affect the study measurements including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases.
* Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/liter (i.e. 62- 110 mg/dl) at screening.
* HbA1c ≤ 6.5 % (48 mmol/mol).

Exclusion Criteria:

* Use of antibiotics within 3 months before Day 1; use of any other medication except paracetamol within 14 days before Day 1.

Primary outcomes:
measure: 13C (13 carbon) and D-[6,6-2H2] glucose
timeFrame: 0-6 hours
Secondary outcomes:
measure: Total blood glucose (BG)
timeFrame: 0-2 hours and 0-4 hours
measure: Insulin
timeFrame: 0-2 hours and 0-4 hours
measure: Endogenous glucose production (EGP)
timeFrame: 0-2 hours and 0-4 hours
measure: Glucose clearance rate (GCR)
timeFrame: 0-2 hours and 0-4 hours
measure: 13C Metabolites of glucose (metabolomics)
timeFrame: 0-2 hours and 0-4 hours
measure: 12C Metabolites of glucose (metabolomics)
timeFrame: 0-2 hours and 0-4 hours
measure: Postprandial hormones (Gastric inhibitory polypeptide, glucagon-like peptide-1 and Glucagon)
timeFrame: 0-2 hours and 0-4 hours
measure: Selected anti-oxidants (vitamin E (alpha-tocopherol), lycopene, retinol, alpha-carotene and beta-carotene)
timeFrame: -5, 60, 120, 180, 240 and 300 minutes
measure: Haematocrit
timeFrame: -5, 60, 120, 180, 240 and 300 minutes
measure: Concentration of key active in extract
timeFrame: -5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300 and 360 minutes
measure: 13CO2 in breath
timeFrame: 30, 30, 60, 90,120, 150, 180 and every 30 minutes up to 6 hours
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: QPS
state: Hanzeplein 1
Study officials:
affiliation: QPS Netherlands
name: Tjeerd Mensinga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03268538: Finger Wearable Device to Monitor Heart Rate Variability and Oxygen Saturation
Official title: Evaluation of Finger Wearable Device to Monitor Heart Rate Variability and Oxygen Saturation in Older People
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 277
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 COPD and 200 healthy older people

Brief summary: Introduction: Chronic obstructive airway disease (COPD) is common condition in old age and the perception of hypoxia is often impaired in some COPD patients. Therefor it is need to monitor oxygen saturation in older people with COPD. A finger wearable device has been developed to measure oxygen saturation and heart rate variability. The investigators therefore will perform a cross sectional study to evaluate the clinical application of this finger wearable device in the detection and management of COPD in older people.

Subject and method: 100 COPD subjects and 200 community dwelling older people without diagnosis of COPD will be recruited. Physical functioning and lung function test will be performed. Subjects will wear a finger wearable device to monitor heart rate variability and oxygen saturation and wear another wrist wearable device (Actigraph) to monitor physical activity and sleep for 6 days at the same time.

Statistical analysis: Statistical analysis will be made to examine the potential association between oxygen saturation and physical activity and sleep, and the association between heart rate variability and physical activity and sleep.


Eligibility criteria: Inclusion Criteria:

* Aged 60 years old or more with or without COPD

Exclusion Criteria:

* Current smokers

Primary outcomes:
measure: COPD
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Medicine
Study officials:
References:
Clinical trial NCT04646538: Volume Assessment of the Periapical Healing Following Regenerative Endodontic Procedures Using Cone- Bean Computed Tomography
Official title: 3 D Volume Assessment of the Periapical Healing Following Regenerative Endodontic Procedures Using Cone- Bean Computed Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Necrotic Pulp
Periapical; Infection
Keywords: REPs
CBCT
volume
Mature teeth
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 3D volume assessment was done to evaluate the periapical healing following REPs in mature teeth.

Detailed description: REPs were done for 10 mature maxillary necrotic teeth with periapical lesions confirmed by digital periapical radiographs. Instrumentation was done using Protaper Next till size X3 (size 30). Pre-operative radiographs also included CBCT scans to measure the 3D volume and area of the periapical lesion to be used as baseline data. The postoperative radiographic examination included: a) digital periapical radiographs taken at 3,6,9, and 12 months to monitor the lesion through out the follow-up period. b)CBCT scan to measure quantitatively the volume and area of the periapical lesion after 12 months follow up

Eligibility criteria: Inclusion Criteria:

* Necrotic Mature Maxillary anterior teeth with periapical lesions.

Exclusion Criteria:

* Patients with mobile and fractured teeth

Primary outcomes:
measure: Measurement the volume of periapical lesion preoperatively and comparing it with the new volume after REPs using cone-beam computed tomography.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
References:
citation: Kateb NME, Fata MM. Influence of periapical lesion size on healing outcome following regenerative endodontic procedures: a clinical investigation. Oral Radiol. 2022 Oct;38(4):480-489. doi: 10.1007/s11282-021-00578-8. Epub 2021 Nov 26.
Clinical trial NCT03527238: Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine
Official title: Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Transplant
Kidney Transplant
Keywords: Phenotypic Precision Medicine (PPM)
Tacrolimus
Calcineurin Inhibitors
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-05-17
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Clinical trial applying Phenotypic Precision Medicine (PPM) to tacrolimus dosing in liver and/or kidney transplant recipients to show improvement in maintaining drug trough levels within the target range.

Detailed description: The introduction of calcineurin inhibitors like tacrolimus has greatly reduced the incidence of acute rejection, improving graft and patient survival after transplantation. However, tacrolimus, one of the most widely used immunosuppressants and a mainstay of solid organ transplantation, has a narrow therapeutic index and wide pharmacokinetic variability. As such, there is a clear need for precision medicine to address post-transplant immunosuppression.

The study team has developed a powerful platform \[Phenotypic Precision Medicine (PPM)\] that utilizes patient-specific clinical data which represents each patient's response to drug treatment. This platform can efficiently prescribe precise and optimized drug doses despite the frequent changes to patient treatment regimens following transplantation. This potentially can have a profound effect on drug metabolism.

The aim of this project is to use PPM to uncover valuable and previously unknown information pertaining to patient dose requirements and correlate them with patient clinical and other contextual information. This study is also expected to reveal vital patient subpopulation information; and any future discovery of quantitative biomarkers as measures of immunosuppression will serve as a gateway towards even more effective personalized and relevant drug dosing.

Eligibility criteria: Inclusion Criteria:

* adults undergoing liver and/or kidney transplantation

Exclusion Criteria:

* transplant patients with contraindications to tacrolimus

Primary outcomes:
measure: Tacrolimus Target Trough Level Maintenance
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Gainesville
country: United States
facility: UF Health at the University of Florida
state: Florida
city: Singapore
country: Singapore
facility: National University of Singapore
Study officials:
affiliation: University of Florida
name: Ali Zarrinpar, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00916838: Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes
Official title: Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitis
Keywords: Type 1 Diabetes Mellitis
MRI
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-06-10
Enrollment: 187
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 125 children with Type 1 Diabetes Mellitus (T1DM) between 4 and 16 were recruited from the Diabetes Clinic at St. Louis Children's Hospital. 62 healthy siblings between 4 and 16 also enrolled in the study.

Brief summary: 125 children with Type 1 Diabetes mellitis (T1DM) between 4 and 16 were recruited and 62 healthy siblings also enrolled in the study.

Children with T1DM and sibling controls ages 4 to 16 were assessed on memory and executive control skills at entry to the study (Test 1) and after two years of close monitoring for blood sugar events (Test 2). Diabetic children have their blood sugar tested directly before and after cognitive testing to ensure their blood sugar is within range during the testing. The 2-year follow-up period involves parents/child reporting any severe diabetic episode and periodically providing the results of the diabetic child's usual blood tests from their glucose monitoring device.

Children 7 and older also underwent high resolution MRI scans.


Eligibility criteria: Inclusion Criteria:

* Age 4 - 16 (for MRI, must be 7 or older)

Exclusion Criteria:

* Pregnant or lactating (females 13+)
* Chronic disease other than T1DM, well-controlled asthma, or Hashimoto's thyroiditis. (Exclude for hypothyroidism)
* Other current serious medical illness
* Co-morbid psychiatric illness: such as mania, ADHD, LD, major depression, mental retardation, or psychoactive drug dependence
* Co-morbid neurological illness: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries (i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness
* EXCEPT T1DM-related
* Pre-maturity at birth \>4 wks early (\<36 wk term) w/ sequelae e.g. on respirator at NICU
* Use of psychoactive medications or exposure to neuroleptics (except that exposures of less than 1 month, occurring more than 5 years ago, will be allowed) or pts. w/recent tx w/dopamine depleting agents or stimulants such as Ritalin, Cylert, Adderall
* Contraindication to MRI scan (e.g. claustrophobia, metal implants, foreign bodies) - N/A if \< 4 years old
* Full set (top and bottom) orthodontic braces. (Half set braces, fillings, and retainers are OK)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Washington Univeristy School of Medicine
name: Tamara G Hershey, PhD.
role: PRINCIPAL_INVESTIGATOR
References: