louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00347815: Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers
Official title: Pharmacokinetics and Pharmacodynamics of Buprenorphine After Intravenous Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Danish University of Pharmaceutical Sciences
Sponsor class: OTHER
First posted: 2006-07-04
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the amount of buprenorphine and its metabolites in blood and urine after administration of 0.6 mg buprenorphine in healthy volunteers. Furthermore the purpose is to correlate the amount of buprenorphine in the blood with the effect on the ability to concentrate and coordinate.


Eligibility criteria: Inclusion Criteria:

healthy 18-40 years able to follow the protocol able to provide informed consent

Exclusion Criteria:

* Allergy to buprenorphine
* Mental illness
* Alcohol or drug abuse
* Chronic pain
* Daily use of analgesics
* Chronic medicinal treatment
* Treatment with corticosteroids
* Any use of medicine 48 hours before day of trial
* Smoker
* Blood donation within 3 months before day of trial
* Dementia
* Abnormal ECG
* Abnormal blood values:

Serum creatinine \> 100 umol/l Serum haemoglobin \< 8 mmol/L LDH \< 105 U/L or \> 255 U/L ASAT \> 45 U/L ALAT \> 70 U/L PP \< 0.9 INR or \> 1.1 INR Alkaline phosphatase \< 35 U/L or \> 275 U/L K+ \< 3,5 mmol/L or \> 5,0 mmol/L Na + \< 136 mmol/L or \> 146 mmol/

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte University Hospital
Study officials:
affiliation: Multidisciplinary Pain Centre, Herlev Hospital
name: Niels-Henrik Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01595815: Successful Pregnancy and Delivery After AOA
Official title: Successful Pregnancy and Delivery After AOA in Couples With Repeated Complete Fertilization Failure or Low Fertilization Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Fertilization failure, calcium ionophore, SrCl2
Lead sponsor: Maria Fertility Hospital
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Artificial oocyte activation with strontium chloride or calcium ionophore improves fertilization, embryo quality, pregnancy and delivery rate in women who showed complete fertilization failure or low fertilization rates


Eligibility criteria: Inclusion Criteria:

* Fertilization rate was less than 30% after conventional ICSI.
* Fertilization rate was less than 50% after ICSI with calcium ionophore.
* Repeated complete fertilization failure or low fertilization rates following ICSI in previous cycles

Exclusion Criteria:

* Fertilization rate was more than 30% after conventional ICSI
* Fertilization rate was more than 50% after ICSI with calcium ionophore.
* Successful pregnancy and delivery after ICSI in previous cycles

Primary outcomes:
measure: Fertilization rate
timeFrame: 18 hours
Secondary outcomes:
measure: Embryo quality
timeFrame: 3 Days
measure: Pregnancy and Implantation rates
timeFrame: 2 months
measure: Assessment of Infant health care
timeFrame: birth and at 3, 6, 12, 24, 36, 60, and 72 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Maria Fertility Hospital
Study officials:
References:
citation: Kim JW, Yang SH, Yoon SH, Kim SD, Jung JH, Lim JH. Successful pregnancy and delivery after ICSI with artificial oocyte activation by calcium ionophore in in-vitro matured oocytes: a case report. Reprod Biomed Online. 2015 Apr;30(4):373-7. doi: 10.1016/j.rbmo.2014.11.014. Epub 2014 Dec 11.
Clinical trial NCT01597115: ENhancing Maturation of Autogenous Arteriovenous Hemodialysis Access by Aggressive surveillaNCe With Duplex and Endovascular Treatment
Official title: ENhancing Maturation of Autogenous Arteriovenous Hemodialysis Access by Aggressive surveillaNCe With Duplex and Endovascular Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: duplex study
hemodialysis access
maturation rate
endovascular intervention
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-05-11
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate whether Aggressive duplex surveillance after vascular access surgery with native vein for hemodialysis can increase the maturation rate of arteriovenous fistula. This study will be conducted as a single center, prospective, 1:1 randomized study. Enrolled patients will be randomized as a control group (Physical exam at 2 and 4 weeks after surgery) and duplex group (duplex study and physical exam at 2 and 4 weeks after surgery). Maturation of arteriovenous fistula will be evaluated at 8 weeks after surgery by duplex in all patients.


Eligibility criteria: Inclusion Criteria:

* end stage renal disease
* newly formed hemodialysis access with native vein
* 20\~70 years

Exclusion Criteria:

* hemodialysis access surgery with ePTFE graft
* hemodialysis access surgery with basilic vein transposition
* hemodialysis access surgery with brachial vein transposition
* cephalic vein \< 2.5mm in diameter
* radial artery diameter \<2.0mm in radiocephalic arteriovenous fistula

Primary outcomes:
measure: hemodialysis access maturation rate
timeFrame: 8 weeks after surgery
Secondary outcomes:
measure: factors predicting maturation failure
timeFrame: 8 weeks after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sang-Il Min, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02871115: Pilot Study of a Pharmacy Intervention for Older Adults With Cancer
Official title: Pilot Study of a Pharmacy Intervention for Older Adults With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lung Cancer
GI Cancer
Keywords: Cancer Care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 62
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to address the challenge of medication management for older patients undergoing treatment for cancer. The sponsor of this protocol is the Massachusetts General Hospital Cancer Center who is providing funding for this research study.

Detailed description: The goals of the proposed study are: (1) to demonstrate the feasibility and acceptability of delivering PRIME (Pharmacist Reconciliation to Improve Medication Management in the Elderly) to older patients with breast, gastrointestinal, and lung cancers; and (2) to estimate the effect size (i.e. the magnitude of the difference between groups) of PRIME for improving medication management (e.g. accurate medication list, less polypharmacy, fewer potentially inappropriate medications) and achieving up-to-date vaccinations.

Eligibility criteria: Inclusion Criteria:

* Age 65 or older
* Diagnosed with any stage breast, GI or lung cancer
* Panning to receive first-line chemotherapy at MGH
* Verbal fluency in English

Exclusion Criteria:

* Unwilling or unable to participate in the study
* Significant psychiatric, cognitive or other comorbid disease which the treating clinician believes prohibits informed consent or participation in the study

Primary outcomes:
measure: Rates of study enrollment
timeFrame: 2 years
Secondary outcomes:
measure: Rates of Study Completion
timeFrame: 2 years
measure: Rates of study satisfaction
timeFrame: 2 years
measure: Rates of Medication List Accuracy
timeFrame: Baseline to 4 weeks
measure: Change In The Number Of Medications
timeFrame: Baseline to 4 weeks
measure: Number Of Medications
timeFrame: Baseline to 4 weeks
measure: Rates of Polypharmacy
timeFrame: Baseline to 4 weeks
measure: Change In The Number Of Potentially Inappropriate Medications
timeFrame: Baseline to 4 weeks
measure: Number Of Potentially Inappropriate Medications
timeFrame: Baseline to 4 weeks
measure: Rates Of Appropriate Pneumococcal Vaccinations
timeFrame: Baseline to 4 weeks
measure: Rates Of Appropriate Pneumococcal Vaccinations
timeFrame: Baseline to 8 weeks
measure: Rates Of Appropriate Influenza Vaccinations
timeFrame: Baseline to 4 weeks
measure: Rates Of Appropriate Influenza Vaccinations
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts general Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ryan Nipp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02843815: Combination of Cryosurgery and NK Immunotherapy for Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-small Cell Lung Cancer Metastatic
Keywords: Non-small cell lung cancer
Cryosurgery
NK Immunotherapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2016-07-26
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced NSCLC.

Detailed description: By enrolling patients with NSCLC adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and nature killer (NK) cells for NSCLC.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients withgrade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Institute in Fuda cancer hospital
state: Guangdong
Study officials:
References:
citation: Lin M, Liang SZ, Wang XH, Liang YQ, Zhang MJ, Niu LZ, Chen JB, Li HB, Xu KC. Clinical efficacy of percutaneous cryoablation combined with allogenic NK cell immunotherapy for advanced non-small cell lung cancer. Immunol Res. 2017 Aug;65(4):880-887. doi: 10.1007/s12026-017-8927-x.
Clinical trial NCT03645915: GLUT1: A Novel Tool re fl Ecting Proliferative Activity of Lung Neuroendocrine Tumors
Official title: GLUT1: A Novel Tool Reflecting Proliferative Activity of Lung Neuroendocrine Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Tumor
Keywords: glut1
biomarkers
diagnosis
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Between 2009 and 2014, 36 consecutive patients underwent a surgical resection or biopsy of pulmonary neuroendocrine tumor at University Hospital of Amiens: 5 cases of atypical carcinoid tumor; 13 cases of typical carcinoid tumor; 8 cases of small cell neuroendocrine carcinoma; and 10 cases of large cell neuroendocrine carcinoma. Clinical data were obtained from retrospective review of medical records: population characteristics (age, gender) and tumor size

Brief summary: Lung neuroendocrine tumor (LNT) represents approximately 20% of all lung cancers. The classification of LNT relies upon morphology. Recently, in the World Health Organization (WHO) classification, Ki-67 rate has been proposed for classi fication. It is, however, known that Ki-67 count has a poor interlaboratory reproducibly. For that reason, our team has looked for a new biomarker.

GLUT1 protein a facilitative glucose transporter protein which has ubiquitous expression in mammalian. GLUT1 is overexpressed in many human cancers. But, no study has evaluated the GLUT1 staining as an aid diagnosis in LNT.

The team have assessed the GLUT1 immunohistochemical staining in 36 LNT and to assess its diagnostic value.

Detailed description: The (LNT) Lung neuroendocrine tumor represents approximately 20% of all lung cancers. The classification of LNT relies upon morphology. Recently, in the World Health Organization (WHO) classification, Ki-67 rate has been proposed for classi fication. It is, however, known that Ki-67 count has a poor interlaboratory reproducibly. For that reason, our team has looked for a new biomarker.

GLUT1 protein a facilitative glucose transporter protein which has ubiquitous expression in mammalian. GLUT1 is overexpressed in many human cancers. But, no study has evaluated the GLUT1 staining as an aid diagnosis in LNT.

Eligibility criteria: Inclusion Criteria:

* Patients with neuroendocrine tumors

Exclusion Criteria:

* Patients without neuroendocrine tumors

Primary outcomes:
measure: Assess the GLUT1
timeFrame: 5years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU AMIENS
name: henri sevestre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05259215: Predicting Independent Walking Ability Using the Simplified Stroke Rehabilitation Assessment of Movement, Berg Balance Scale, Barthel Index for Activities of Daily Living in Individuals Post Stroke
Official title: Predicting Independent Walking Ability Using the Simplified Stroke Rehabilitation Assessment of Movement, Berg Balance Scale, Barthel Index for Activities of Daily Living in Individuals Post Stroke: an Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Ukrainian Association of Physical Therapy
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 29
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with stroke

Brief summary: Cohort observational retrospective pilot study by design. The purpose of this study was to determine a cut scores to predict independent ambulation for the Simplified Stroke Rehabilitation Assessment of Movement, Berg Balance Scale, Barthel Index for Activities of Daily Living.


Eligibility criteria: Inclusion Criteria:

* Male or female patients with stroke after the age of 17 confirmed stroke by neuroimaging, understanding instructions, time after stroke up to 1 year.

Exclusion Criteria:

* Subjects were excluded if they have: the presence of aphasia that would have interfered with the participant's ability to understand and comply with study procedures or complete stroke assessments, dementia, ataxia, localization of stroke in the cerebellum or vertebrobasilar insufficiency, orthopedic problems that affected the ability to walk before the stroke and time after stroke more than 1 year.

Primary outcomes:
measure: Functional Ambulation Category
timeFrame: 1-5 minutes
Secondary outcomes:
measure: Simplified Stroke Rehabilitation Assessment of Movement (S-STREAM)
timeFrame: 15-20 minutes
measure: Berg Balance Scale (BBS)
timeFrame: 15-20 minutes
measure: Barthel Index for Activities of Daily Living (BI)
timeFrame: 15-20 minutes
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: communal non-commercial enterprise "Kyiv Regional Clinical Hospital", Department of Rehabilitation of Patients with Consequences of Diseases and Injuries of the Nervous System
Study officials:
References:
Clinical trial NCT02213315: A Double-blind, Placebo-controlled, Single-dose Study to Evaluate the PK, IM, and Safety in Japanese Subjects
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Pharmacokinetics, Immunogenicity, and Safety of Mavrilimumab in Healthy Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers, Rheumatoid Arthritis, mavrilimumab
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2014-08-11
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: A phase 1 randomized, double blind single-dose study to evaluate the PK and immunogenicity of single SC 100 and 150 mg doses of mavrilimumab in healthy adult Japanese subjects.

Detailed description: This is a Phase 1, randomized, double-blind, placebo-controlled, parallel group, single-dose study to evaluate the PK, immunogenicity, and safety of mavrilimumab at doses of 100 and 150 mg in healthy adult Japanese subjects. The study will be conducted at one site in Europe and subjects will be randomized in a 5:5:2 ratio to 100, 150mg mavrilimumab and placebo.

Eligibility criteria: Inclusion Criteria:

* Subject is of Japanese ethnicity
* No evidence of clinically significant respiratory disease

Exclusion Criteria:

* Any condition that, would interfere with the evaluation of the study drug or safety of subjects.
* Subject has a known hypersensitivity to any components of the investigational product.
* History of infection requiring hospitalization or treatment with IV antibiotics within 12 weeks before screening, or evidence of clinically significant active infection.
* Subject has a history or present condition of malignancy.
* Subject has a history or presence of drug addiction (urine test) or has alcohol consumption (breath test) of more than 21 (males) or 14 (females) units of alcohol per week.
* Any blood donation or significant loss of blood within 56 days of study initiation,
* Receipt of live (attenuated) vaccine within the 4 weeks before screening or during the study.

Primary outcomes:
measure: PK profile of mavrilimumab
timeFrame: from dosing to day 85
Secondary outcomes:
measure: To evaluate the safety of mavrilimumab
timeFrame: from dosing to day 85
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Hammersmith Medicines Research
name: malcolm Boyce, BSc MB ChB FRCP FFPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01780415: Genomic DNA in Human Blastocoele Fluid
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chromosomal Aneuploidies
Single Gene Desease
Keywords: Blastocoele fluid
Human DNA
molecular diagnosis
Lead sponsor: Cervesi Hospital, Cattolica, Italy
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IVF patient with supernumerary embryos to vitrify at blastocyst stage

Brief summary: The objective will focus on the characterization of DNA fragments present in Blastocoele fluid, and the evaluation of these fragments as potential target for Preimplantation Genetic Diagnosis. To reach this goal, real-time PCR, Whole Genome Amplification techniques and -subsequently- Next Generation Sequencing and aCGH approaches will be used.


Eligibility criteria: Inclusion Criteria:

* IVF patient with supernumerary embryos to vitrify at blastocyst stage

Exclusion Criteria:

* IVF patient without blastocyst formation

Primary outcomes:
measure: Number of samples with DNA in blastocoele Fluid
timeFrame: 6 month
Secondary outcomes:
measure: Number of euploid samples
timeFrame: 8 months
Other outcomes:
Locations:
city: Cattolica
country: Italy
facility: Cervesi Hospital IVF Unit
state: Rimini
Study officials:
References: