louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01812096: Study of Subcutaneous Versus Intravenous Administration of Bortezomib in Patients With Multiple Myeloma in China
Official title: Prospective Comparison the Pharmacokinetics of Subcutaneous Versus Intravenous Administration of Bortezomib in Newly Diagnosed Patients of Multiple Myeloma in China.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma Proved by Laboratory Tests
Keywords: multiple myeloma
bortezomib
Subcutaneous
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2013-03-15
Enrollment: 20
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: Intravenous injection is the standard administration route of bortezomib; however, subcutaneous administration is an important alternative. We want to compared the pharmacokinetic of subcutaneous versus intravenous bortezomib at the approved 1•3 mg/m2 dose and twice per week,on days1, 4, 8 and 11 of 21-day cycles, schedule in newly diagnosed patients of multiple myeloma.

Detailed description: The new diagnosed multiple myeloma patients are randomized to receive bortezomib by standard intravenous bolus (n=10) or subcutaneous injection (n=10) at the recommended dose and schedule (1.3 mg/m2), days 1, 4, 8, 11;eight 21-day cycles).

Patients discontinued treatment due to progressive disease, insufficient efficacy, unacceptable toxicity, or serious protocol violation. Dose modifications are specified for unexpected pharmacokinetic observations or toxicity. Bortezomib-related neuropathic pain and/or peripheral sensory neuropathy were managed using established dose-modification guidelines.

Blood samples for pharmacokinetic/pharmacodynamic analysis are collected on days 1 and 11, cycle 1:before bortezomib administration, and at 2, 5, 15, 30, and 60 min, and 2, 4, 6, 10, 24, 32, 48, and 72 hours post-dosing. Pharmacodynamic analyses were performed using a whole-blood 20S proteasome specific activity inhibition assay.

Eligibility criteria: Inclusion Criteria:

* Must be Multiple Myeloma Proved by Laboratory Tests
* Must have the ability to observe the efficacy and events
* Patient must have the ability to understand and willingness to provide written informed consent in the study and any related procedures being performed

Exclusion Criteria:

* If have uncontrolled intercurrent illness including ongoing or active infection,heart failure,unstable angina pectoris,or psychiatric illness/social situations that study requirements
* If have severe side-effects on bortezomib

Primary outcomes:
measure: pharmacokinetic
timeFrame: 6 months
Secondary outcomes:
measure: curative effect
timeFrame: two years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: First Affiliated Hospital,Soochow University
name: Fu chengcheng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04278196: Computer Assisted Quality-monitoring for Magnet-controlled Capsule Endoscopy: a Prospective Case-control Study.
Official title: Computer Assisted Quality-monitoring for Magnet-controlled Capsule Endoscopy: a Prospective Case-control Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnet Controlled Capsule Endoscopy
Keywords: Artificial intelligence
Magnet controlled capsule endoscopy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who acccept the magnet controlled capsule endoscopy with the help of "AI-box"will be enrolled.

Brief summary: During the past several years，MCE（magnet controlled endoscopy）has made great process in detecting lesions of gastric as well as screening. Compared with conventional endoscopy, magnetically controlled capsule endoscopy can be further optimized in gastric examination. So we make an AI for operators to help improve the quality of MCE and record the mucosa visibilty of gastirc.

Detailed description: We developed a new artificial intelligence for quality improving during the operation of magnet controlled endoscopy. The AI can help operators screen every part of gastric and then evaluate the visibilty of gastic. Also, It can be record time of the opration. Other than that ,we compared the performancce of AI with experts.

Eligibility criteria: Inclusion Criteria:

* patients between 18 and75
* patients who can sign informed consent

Exclusion Criteria:

* patients who are unsuitable to accept the check

Primary outcomes:
measure: The integrity of the magnet controlled capsule endoscopy
timeFrame: 2 months
measure: The visibilty of the gastric
timeFrame: 2 months
measure: The time of operation in gastric
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT00463996: MRI in Staging Ovarian Cancer Using MRI Contrast Agent
Official title: Værdien af MRI Til Staging af c.Ovarii-et Prospektivt Studie
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Keywords: Ovarian cancer
MRI
Contrast agent
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: Can MRI be used to stage ovarian cancer?

Detailed description: Staging of ovarian cancer can best be performed with CT or MRI compared to ultrasound. Studies have shown an increase in pos. predictive value by adding contrast i.v. to the MR-examination protocol. We compare staging of ovarian cancer by 1.MRI without contrast (standard method) to 2.MRI with contrast agent i.v. (new method)in the same patient. Golden standard are findings at operation.

Eligibility criteria: Inclusion Criteria:

* suspicion of ovarian cancer

Exclusion Criteria:

* recurrence of disease
* contraindication to MRI, contrast agent
* inoperable patients for other reasons

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Aarhus University Hospital, BDA, Skejby
name: Liselotte Ibsen, doc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03300596: Brief New Treatment for Suicide Attempts
Official title: Suicidal Adults With Alcohol or Drug Use Problems: A New Hospital-based Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide, Attempted
Drug Use
Alcohol; Use, Problem
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2017-10-03
Enrollment: 34
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: Individuals with alcohol or drug use problems who are hospitalized for suicide attempt are at high risk for reattempt. This treatment development study adapts a promising outpatient intervention to prevent suicide reattempt in order to administer it during hospitalization to individuals with alcohol and drug use problems, and to test the adapted intervention in a pilot randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* suicide attempt within one week of hospitalization with acknowledgment of some intent to die using a standard item
* problematic alcohol or drug use as determined by score \>8 on Alcohol Use Disorders Identification Test, AUDIT or \>3 on the 10-item version of the Drug Abuse Screening Test, DAST-10
* admission to hospital
* residence within 40 miles of Strong Memorial Hospital

Exclusion Criteria:

* under age 18
* treated in ED, CPEP, or observation unit only
* unable to communicate with the researcher in English
* unable to comprehend the nature of the study
* participation untenable from a medical (e.g., intubated), psychiatric (e.g., florid psychosis), or behavioral (e.g., refusing to speak with staff) standpoint
* short hospital length of stay, ruling out administering three sessions of the therapy prior to discharge

Primary outcomes:
measure: suicide reattempt
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
citation: Conner KR, Kearns JC, Esposito EC, Pizzarello E, Wiegand TJ, Britton PC, Michel K, Gysin-Maillart AC, Goldston DB. Pilot RCT of the Attempted Suicide Short Intervention Program (ASSIP) adapted for rapid delivery during hospitalization to adult suicide attempt patients with substance use problems. Gen Hosp Psychiatry. 2021 Sep-Oct;72:66-72. doi: 10.1016/j.genhosppsych.2021.07.002. Epub 2021 Jul 19.
citation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Clinical trial NCT04106596: HLA Analysis in Autoimmune Encephalitis and Related Disorders
Official title: Immunogenetic Characteristics in Autoimmune Encephalitis and Related Disorders: HLA Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autoimmune Encephalitis
Imbic Encephalitis
Autoimmune Cerebellar Ataxia
Stiff-person Syndrome
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with autoimmune encephalitis or related disorders whose samples were sent for analysis at Centre de Référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Lyon, for anti-neural antibody study and then stored at the biobank Neurobiotec

Brief summary: Autoimmune encephalitis (AE) are characterized by subacute onset of memory deficits, altered mental status or psychiatric symptoms, frequently associated with seizures, inflammatory cerebrospinal fluid and in cases with prominent limbic involvement, typical magnetic resonance imaging. Several autoantibodies (Ab) may be detected in AE, although its detection is not mandatory to establish a diagnosis. These Ab mainly recognize different synaptic and cell-surface proteins in the central nervous system, and are thought to be pathogenic as they alter the normal location or function of its antigens.

The primary trigger of the immune response is unknown for most of AE. In addition to acquired susceptibility, genetic predisposition may also be important in the pathogenesis of AE. Human leukocyte antigen (HLA) is the genetic factor most frequently associated with autoimmune diseases, due to its genetic complexity and key role in the adaptive immune response. The aim of the study is to describe HLA profile in three groups of autoimmune encephalitis and related disorders: anti-LGI1, anti-CASPR2 and anti-GAD neurological diseases.


Eligibility criteria: Inclusion Criteria:

1. Presence of anti-LGI1, anti-CASPR2 or anti-GAD antibodies in serum or cerebrospinal fluid;
2. Clinical picture compatible with the detected antibody (limbic encephalitis in anti-LGI1; limbic encephalitis, neuromyotonia or Morvan's syndrome in anti-CASPR2; limbic encephalitis, cerebellar ataxia or stiff-person syndrome in anti-GAD

Exclusion Criteria:

- Absence of complete clinicobiological data.

Primary outcomes:
measure: HLA in autoimmune encephalitis and related disorders
timeFrame: 12 Months
measure: Clinical relevance of HLA in autoimmune encephalitis and related disorders
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes
Study officials:
affiliation: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes
name: Jerome HONNORAT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00873496: Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients
Official title: Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients: a Prospective Sample Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sjögren's Syndrome
Xerostomia
Keywords: Sjögren's Syndrome
hyposalivation
mouth dryness
complications
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2009-04-01
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study group consisted of 30 female patients recently diagnosed as Sjögren's syndrome.

Brief summary: Chronic inflammation that comprises the exocrine glands' function leads to xerophthalmia and xerostomia in Sjögren's syndrome. The oral consequences range widely and they are related to decreased salivary output. Hydroxychloroquine may inhibit cholinesterase activity in salivary glands via interference with antigen processing mechanism, and thus, the investigators' hypothesis was that salivary gland function may be improved if treated with hydroxychloroquine. The effects of hydroxychloroquine on the salivary flow rate, subjective and objective parameters of the patients were also assessed.


Eligibility criteria: Inclusion Criteria:

* Patients who were recently diagnosed with primary SS according to American-European criteria and who were scheduled for HCQ treatment in Ege University Faculty of Medicine, Department of Rheumatology

Exclusion Criteria:

* Sjögren patients consuming alcohol or tobacco

Primary outcomes:
measure: Salivary flow rate, objective and subjective clinical oral complaints
timeFrame: 2005 Jan-2009 Jan
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University School of Dentistry
state: Bornova
Study officials:
affiliation: Ege University School of Dentistry
name: Esin Alpoz
role: STUDY_DIRECTOR
References:
citation: Alpoz E, Guneri P, Onder G, Cankaya H, Kabasakal Y, Kose T. The efficacy of Xialine in patients with Sjogren's syndrome: a single-blind, cross-over study. Clin Oral Investig. 2008 Jun;12(2):165-72. doi: 10.1007/s00784-007-0159-3. Epub 2007 Nov 14.
citation: Kruize AA, Hene RJ, Kallenberg CG, van Bijsterveld OP, van der Heide A, Kater L, Bijlsma JW. Hydroxychloroquine treatment for primary Sjogren's syndrome: a two year double blind crossover trial. Ann Rheum Dis. 1993 May;52(5):360-4. doi: 10.1136/ard.52.5.360.
citation: Dawson LJ, Caulfield VL, Stanbury JB, Field AE, Christmas SE, Smith PM. Hydroxychloroquine therapy in patients with primary Sjogren's syndrome may improve salivary gland hypofunction by inhibition of glandular cholinesterase. Rheumatology (Oxford). 2005 Apr;44(4):449-55. doi: 10.1093/rheumatology/keh506. Epub 2004 Dec 8.
Clinical trial NCT03843996: Comparison of a Novel Wound Dressing Stratamed Versus Current Clinical Practice After Follicular Unit Extraction Hair Transplantation
Official title: Comparison of a Novel Wound Dressing Stratamed Versus Current Clinical Practice After Follicular Unit Extraction Hair Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds and Injuries
Keywords: Stratamed
wound healing
follicular unit extraction hair transplantation
Lead sponsor: Stratpharma AG
Sponsor class: INDUSTRY
First posted: 2019-02-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This Phase IV, post-marketing, single center study will be a single-blind, within subject split scalp efficacy comparison of Stratamed® and standard clinical practice, Bacitracin, post FUE. Twenty subjects desiring to undergo FUE for hair restoration will apply Stratamed® on one half of the donor area on the back of the scalp and Bacitracin on the other side at least twice a day for a week post procedure. The side of the scalp receiving each product will be randomized, and the evaluating physician will be blinded. Subjects will be evaluated, photographed, and will fill out subject reported questionnaires live at days 1 (+1) and 7 (±1) post procedure. Subjects will also fill out the subject reported questionnaires at home in between live study visits (days 2, 3, 4, 5, and 6).
Primary purpose: TREATMENT

Brief summary: Follicular donor sites on the scalp for hair transplantation will be treated with studied products post harvest.

A randomized side of the scalp will be treated with Stratamed, the other side with standard clinical practice.

Subjects will be assessed live immediately post treatment and in 2 sessions during the healing phase post harvest. Subjects will also complete subject reported outcome questionnaires at home between study visits.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Able to provide informed consent
* Planning to undergo follicular unit extraction hair restoration

Exclusion Criteria:

* Significant medical or surgical conditions
* Unable to give informed consent
* Patient unable to apply topical device
* Allergy or intolerance to ingredients or excipients of the formulation of studied products
* Pregnancy

Primary outcomes:
measure: Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1)
timeFrame: duration of the studybe evaluated and rated on days 1 (+1) and 7 (±1) post procedure for both the investigational and standard treatment products
Secondary outcomes:
Other outcomes:
Locations:
city: Montclair
country: United States
facility: New Jersey Plastic Surgery, Montclair, NJ USA
state: New Jersey
Study officials:
References:
Clinical trial NCT04115696: Biodegradable Stent Implantation in Biliary Benign Strictures.
Official title: Biodegradable Stent Implantation in Biliary Benign Strictures. Spanish Register.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Tract
Biliary Tract Diseases
Stenosis
Follow-Up Studies
Stents
Lead sponsor: Group of Research in Minimally Invasive Techniques
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 120- 150 patients

Brief summary: Spanish registry of resorbable stent implantation in biliary benign strictures.

This registry is sponsored by the Spanish Society of Vascular and Interventional Radiology (SERVEI) and conducted by the Research Group GITMI (Group of Research in Minimally Invasive Techniques) of the University of Zaragoza (Spain).

A software tool hosted on the official website of SERVEI and the journal Intervencionismo will be used for data collection a(https://estudios.watsoncme.com).

Detailed description: This is an prospective observational study of patients that have been implanted a biodegradable stent in the biliary tree.

Patients are recruited when the stent is implanted, and the investigators perfom a patients follow-up during 1, 3, 6, 12, 24, 36, 48 and 52 months.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years-old
* Informed consent
* Non-lithiasic chronic bening single or multiple stenosis
* Possibility of follow-up plus 1 year

Exclusion Criteria:

* Under 18 years old
* Unsigned consent
* Non treatable coagulopathy
* Acute signs of infection
* Diagnosis of neoplasia

Primary outcomes:
measure: Biliary duct patency: bilirubin alterations (> 2.2)
timeFrame: 24 months
measure: Stent reabsorption: radiographic persistence of stent radiopaque marks
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Lozano Blesa Universitary Hospital
state: Aragon
city: Sabadell
country: Spain
facility: Hospital Parc Tauli
state: Barcelona
Study officials:
References:
Clinical trial NCT03525496: Interest of Challenge Tests for Diagnosis of Immediate Hypersensitivity Against Iodinated Contrast Agents
Official title: Interest of Challenge Tests for Diagnosis of Immediate Hypersensitivity Against Iodinated Contrast Agents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Reaction
Keywords: Iodinated contrast agents
Immediate hypersensitivity reactions
Reintroduction tests
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major patient who had an iodinated contrast agents reintroduction test

Brief summary: Iodinated contrast agents (ICA) are widely used in medical imaging. They provide however a risk of immediate hypersensitivity reactions (IHS). The risk of anaphylactic shock is estimated at 1/100 000 injections. Nevertheless, for safety reasons and to limit undesirable effects, the reintroduction tests are not conducted along similar lines to throughout scan or arteriography. Moreover, reintroduction protocols are actually not standardized, in terms of injected volume and doses progression. It should be evaluated the relevance of the reintroduction tests with injection of a low volume and ensure the absence of reaction during the ICA injections Under real conditions.

The investigators are assuming that the realization of a provocation test by intravenous reintroduction with a reduced dose of ICA improves the predictive value of IHS in comparison with only cutaneous tests.

Detailed description: The main objective of this study will be to estimate the negative predictive value of the combination of cutaneous tests and provocation test by intravenous reintroduction in the IHS to iodinated contrast agents.

Eligibility criteria: Inclusion Criteria:

* Major patient
* Having suffered single-blind reintroduction
* Having benefited from cutaneous tests and ICA reintroduction test in the framework of IHS

Exclusion Criteria:

* Patient with delayed hypersensitivity
* Opposed to use data

Primary outcomes:
measure: Percentage of immediate hypersensitivity reactions
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville
state: Moselle
Study officials:
References: