louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02671526: Cognitive Remediation for HIV-associated Neurocognitive Dysfunction
Official title: Plasticity-based Adaptive Cognitive Remediation (PACR) for HIV-associated Neurocognitive Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-associated Neurocognitive Dysfunction
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
First posted: 2016-02-02
Enrollment: 19
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a validation study to document the acceptability of the revised Plasticity-based Adaptive Cognitive Remediation (PACR) program to patients with HIV-associated Neurocognitive Dysfunction (HAND). The primary objective of this study is to evaluate the effects of the revised PACR program on the cognitive abilities (e.g., attention, executive function), functional status and quality of life of individuals diagnosed with HAND. The secondary objective of the study is to collect relevant data to support a pre-investigational device exemption (IDE) submission to the FDA required before the pivotal randomized, controlled trial planned for Phase II.


Eligibility criteria: 1. Participant is between 25-60 years of age
2. Participant is HIV positive
3. Participant has diagnosis of HIV-associated neurocognitive disorder (HAND), Mild Neurocognitive Disorder (MND) and HIV associated dementia (HAD)
4. Participant is fluent in English
5. Participant is able to use an iPad and have access to wireless internet connection
6. Participant does not have a history of other conditions (other that from HAND), including mental illness, cancer, or other neurological conditions (multiple sclerosis, seizure disorder)
7. Participant is not enrolled in another research study
8. Participant does not have current or significant past history of substance abuse
9. Participant does not have severe depression or other chronic psychiatric disorder (eg. Schizophrenia or Bipolar Disorder)

Primary outcomes:
measure: Computerized Exercise-based Assessment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Posit Science Corporation
state: California
Study officials:
affiliation: Posit Science Corporation
name: Thomas Van Vleet, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03516526: Towards Personalized Dosing of Natalizumab in Multiple Sclerosis
Official title: Towards Personalized Dosing of Natalizumab in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: natalizumab
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Prothya Biosolutions
name: Erasmus Medical Center
name: St. Antonius Hospital
name: OLVG
name: Rijnstate Hospital
First posted: 2018-05-04
Enrollment: 61
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 prospective clinical trial with the aim of maintaining drug efficacy of natalizumab while extending dose intervals guided by drug concentrations in patients with relapsing remitting multiple sclerosis.

Detailed description: Our main objective is to prove that extending dose intervals guided by natalizumab serum concentrations, will not result in radiological or clinical disease activity in completely stable RRMS patients treated with natalizumab. Adult patients with RRMS with no evident disease activity during the last 12 months of natalizumab infusions with a minimum treatment of 12 months wil be included. Before subsequent natalizumab infusions, serum concentrations will be evaluated. If the concentration exceeds 15μg/ml the dose interval will be extended with a week to a maximum of eight weeks. Patients will get regular brain MRI scans and clinical follow-up.

Eligibility criteria: Inclusion Criteria:

* Relapsing-remitting multiple sclerosis (RRMS) according to the McDonald criteria, revised by Polman 2010
* Natalizumab treatment for 12 months or longer at inclusion.
* An expanded disability status scale (EDSS) score of 0.0-6.0 at baseline.
* Natalizumab level of ≥15 μg/ml
* Written informed consent.

Exclusion Criteria:

* Any MS disease activity (radiologically or clinically) during the last 12 months of natalizumab treatment.
* Unable to undergo frequent MRI.
* The use of other immunomodulatory medication other than natalizumab.

Primary outcomes:
measure: Gadolinium enhancing T1 lesions on brain MRI
timeFrame: 12 months
Secondary outcomes:
measure: New T2 lesions on brain MRI
timeFrame: 12 months
measure: Relapses
timeFrame: 12 months
measure: EDSS
timeFrame: 12 months
measure: MSFC
timeFrame: baseline and 12 months
measure: patient perspective measured with the SF-36
timeFrame: baseline and 12 months
measure: patient perspective measured with the MSIS-29
timeFrame: baseline and 12 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: OLVG
city: Amsterdam
country: Netherlands
facility: VU medical center
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus medical center
city: Utrecht
country: Netherlands
facility: St. Antonius Hospital
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Joep Killestein, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02922426: An Insulin Sensitivity Study in Healthy Subjects
Official title: A Randomized, Double-Blind, Parallel-Group Study in Healthy Subjects to Characterize Insulin Sensitivity and Lipid Metabolism in Response to Treatment With ALKS 3831 and Olanzapine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: ALKS 3831
Samidorphan
Olanzapine
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will characterize insulin sensitivity in response to treatment with ALKS 3831, olanzapine, and placebo.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) between 18.0 and \< 25.0 kg/m\^2 at screening and randomization
* No prior history of regular smoking or nicotine use
* Women of child-bearing potential should be on stable regimens of oral contraceptives for at least 2 months prior to screening
* Subjects must be willing to avoid a regular exercise regimen from screening through the end of the treatment period
* Additional criteria may apply

Exclusion Criteria:

* Has current evidence or history of any clinically significant medical or psychiatric condition or observed abnormality
* Is currently pregnant or breastfeeding, or is planning to become pregnant during the study
* Has a lifetime history of diabetes
* Has a known risk of narrow-angle glaucoma
* Has a clinically significant illness within 30 days prior to screening or admission to the clinic
* Has a history of dependence on any substance other than caffeine
* Has a current or anticipated need for prescribed opioid medication (eg, planned surgery) during the study period
* Has a positive urine drug screen for drugs of abuse at screening or admission to the study site
* Has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to screening or admission to the clinic
* Has had any vaccinations in the 4 weeks prior to screening or admission to the clinic
* Chronic use of non-steroid anti-inflammatory drugs (NSAIDs) and acetaminophen, except for low-dose Aspirin is not allowed
* Use of new prescription and non-prescription drugs, as well as dietary/nutritional supplements within 3 weeks preceding the first dosing of study drugs, unless approved by Investigator
* Has prior use of any antipsychotic medication, including on and off label uses
* Additional criteria may apply

Primary outcomes:
measure: Changes in blood glucose concentrations
timeFrame: 21 days
Secondary outcomes:
measure: Changes in insulin concentrations
timeFrame: 21 days
measure: Incidence of treatment-emergent adverse events (AEs)
timeFrame: 24 days
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Alkermes Investigational Site
state: California
Study officials:
affiliation: Alkermes, Inc.
name: David McDonnell, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03048526: Influence of Perfluorohexyloctane (NovaTears) on Tear Film Thickness in Patients With Mild to Moderate Dry Eye Disease
Official title: Influence of Perfluorohexyloctane (NovaTears) on Tear Film Thickness in Patients With Mild to Moderate Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease
Lead sponsor: Novaliq GmbH
Sponsor class: INDUSTRY
First posted: 2017-02-09
Enrollment: 48
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: Patients with mild to moderate dry eye disease will be randomized to receive either NovaTears® or Hydrabak® eye drops as control.


Eligibility criteria: Inclusion Criteria:

* Men and women aged over 18 years
* History of dry eye disease for at least 3 months before the screening visit
* Be able and willing to follow instructions, including participation in all study assessments and visits
* Signed and dated written informed consent

Exclusion Criteria:

* Have any clinically significant slit-lamp findings at the screening visit that may include trauma, Steven Johnson syndrome, and/or in the opinion of the investigator may interfere with study parameters
* Participation in a clinical trial in the 4 weeks preceding the before the screening visit
* Active ocular allergies or ocular allergies that are expected to be active during the study period
* Pregnancy, planned pregnancy or lactating
* Known hypersensitivity to any component of the study medication
* Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease

Primary outcomes:
measure: Tear film thickness as measured with high resolution optical coherence tomography
timeFrame: 4 weeks
Secondary outcomes:
measure: Lipid layer thickness
timeFrame: 4 weeks
measure: Non-invasive tear break up time
timeFrame: 4 weeks
measure: Dynamic Meibomian Gland Imaging
timeFrame: 4 weeks
measure: Blink frequency
timeFrame: 4 weeks
measure: Symptom VAS
timeFrame: 4 weeks
measure: Corneal fluorescein staining
timeFrame: 4 weeks
measure: Conjunctival lissamine green staining
timeFrame: 4 weeks
measure: Schirmer I test
timeFrame: 4 weeks
measure: Tear film break up time
timeFrame: 4 weeks
measure: Ocular surface disease index
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Clinical Pharmacology
Study officials:
affiliation: Novaliq GmbH
name: Gerhard Garhoefer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02841826: Evaluation of a Novel and Simplified Technique for Intrauterine Contraceptive Devices Insertion: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraception
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The intrauterine devices (IUDs) are a safe, reliable, long-acting and reversible contraceptive method. It is also sound safe and cheap contraceptive methods available and is nearly maintenance free for up to 10 years.

The fear and the pain associated with IUDs insertion consider barriers to using this contraception method, this is because that the mucosal lining of female genital tract is highly sensitive to touch and pain. However; most of small procedures done in this sensitive area are performed without analgesia.

The pain during IUDs insertion is due to application of the tenaculum , traction of the cervical canal, passing the uterine sound, insertion of the IUDs through the cervix, and irritation of the endometrial lining by the IUDs.


Eligibility criteria: Inclusion Criteria:

* Women requesting intrauterine contraceptive device as a contraction
* Women accepted participation in the study

Exclusion Criteria:

* Uterine abnormalities
* Endometrial lesions as polyp
* Adenomyosis
* Fibroids distorting the cavity
* Intrauterine adhesions.
* Chronic pelvic pain
* Dysmenorrhea
* History of cervical surgery

Primary outcomes:
measure: The degree of pain perception measured visual analogue score
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT02467426: Isolated Thoracic Perfusion (ITP-F) for MPM
Official title: Isolated Thoracic Perfusion With Hemofiltration (ITP-F) for Pretreated and Progressive Malignant Pleural Mesothelioma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mesothelioma
Keywords: Mesothelioma, malignant
Chemotherapy
Lead sponsor: Medias Klinikum for Surgical Oncology
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with progressive malignant mesothelioma after failure of convetional multimodal therapy including resection

Brief summary: This is an observational study of isolated thoracic perfusion with subsequent hemofiltration to lower the concentration of the cytotoxic drugs as a locoregional therapeutic strategy in malignant pleural mesothelioma.

Detailed description: Treatment of patients with progressive malignant pleural mesothelioma (MPM) after multimodal therapy is a therapeutic challenge. Survival of the patients is low and the treatment options are sparse. This is an observational study of isolated thoracic perfusion with subsequent hemofiltration as a locoregional therapeutic strategy in this situation.

23 pts. with epithelioid MPM were included in this phase II study after informed consent. All patients had progressive disease after multiple therapies and were recommended BSC of a MDT. Following insertion of a venous and arterial 21 ch. stop flow catheter via a femoral access, the inferior vena cava was blocked beneath the right atrium, the arterial catheter was blocked in the aorta at the diaphragm. The upper arms were blocked by pneumatic cuffs. Chemotherapy was given via the arterial catheter. Chemotherapy consisted of 60mg/m2 cisplatinum and 15mg/m2 mitoxantrone q for 3 weeks until progress. After administration of chemotherapy, thoracic perfusion with blocked stop-flow catheters was maintained for 15 minutes. After de-blocking of the catheters, hemofiltration was performed for 45 min. with 5l filtrate. The endpoint of the study was overall survival.Secondary endpoint was toxicity.

Eligibility criteria: Inclusion Criteria:

* History of pre-treated Malignant Pleural Mesothelioma, Progress after Staging

Exclusion Criteria:

* Drug abuse, distant metastases, no bone marrow function

Primary outcomes:
measure: Survival
timeFrame: one year survival
Secondary outcomes:
measure: Toxicity
timeFrame: 4 weeks after therapy
Other outcomes:
Locations:
Study officials:
affiliation: Medias Klinikum Burghausen
name: Karl R. Aigner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01515826: VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery
Official title: Evaluation of the Safety and Efficacy of VIGADEXA Ophthalmic Gel Compared to VIGADEXA Ophthalmic Solution in Preventing Inflammation and Infection Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Cataracts
Keywords: Cataract surgery
Topical therapy
Prevention of inflammation
Inflammation of infection
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 0
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: The purpose of this study is to compare VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.075%) ophthalmic gel to VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.1%) ophthalmic solution in the prevention of postoperative inflammation and infection.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older.
* Diagnosis of cataract with intention to undergo routine, uncomplicated cataract surgery.
* Able to understand and sign an informed consent form.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Glaucoma or ocular hypertension.
* Use of topical or systemic non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to surgery or planned use during the study. Low-dose acetylsalicylic acid (up to 100 mg/day) is allowed.
* Use of anti-bacterial, anti-viral, or anti-fungal agents or ocular medications within 30 days prior to enrollment in the study or during study, as specified by protocol.
* Secondary implantation or replacement of the intra-ocular lens (IOL) in the study eye.
* Planned use of contact lenses in the study eye during the study period.
* Cataract surgery in the contralateral eye within 30 days prior to the Screening Visit, or planned for the 3 weeks after the cataract surgery in the study eye.
* History of clinically significant trauma to the study eye within the past 12 months.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber
timeFrame: Day 15 post-operative
measure: Percentage of patients with no clinically evidenced bacterial infection
timeFrame: Day 15 post-operative
Secondary outcomes:
measure: Cells in the anterior chamber (study eye)
timeFrame: Day 15 post-operative
measure: Ocular pain (study eye)
timeFrame: Day 15 post-operative
measure: Inflammatory reaction (study eye)
timeFrame: Day 15 post-operative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00965926: A Study to Investigate the Food Effect on the Pharmacokinetics of YM178 in Healthy, Non-elderly Volunteers
Official title: A Pharmacokinetic Study in Healthy Non-elderly Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of YM178
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Pharmacokinetics of YM178
Keywords: Overactive Bladder
Urinary incontinence
YM178
mirabegron
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-08-26
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the study is to evaluate the effect of food intake on the pharmacokinetics of YM178 in healthy, non-elderly adult subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests
* Body weight (at screening); female ≥40.0 kg, \<70.0 kg, male ≥50.0 kg, \<80.0 kg
* BMI (at screening): ≥17.6, \<26.4
* Written informed consent has been obtained

Exclusion Criteria:

* Received any investigational drugs within 120 days before the screening test
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening test
* Received medication within 7 days before hospital admission or is scheduled to receive medication
* Females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period
* History of drug allergies
* Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before hospital admission

Primary outcomes:
measure: Plasma concentration of unchanged YM178
timeFrame: Up to 96 hours post dose
Secondary outcomes:
measure: Urinary concentration of unchanged YM178
timeFrame: Up to 96 hours post dose
Other outcomes:
Locations:
city: Kantou
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT01848626: Study With Advanced Vaginal Tactile Imager
Official title: Study With Advanced Vaginal Tactile Imager
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Investigative Techniques
Lead sponsor: Artann Laboratories
Sponsor class: INDUSTRY
First posted: 2013-05-07
Enrollment: 22
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult females, presenting to the urogynecological office for a vaginal examination with normal pelvic floor organs, referred to gynecologic examination due to pelvic organ prolapse concern or earlier diagnosed with pelvic organ prolapse, will be considered eligible as volunteers to be enrolled in the clinical studies.

Brief summary: The objectives of this study are:

1. To collect data necessary for assessing the performance of advanced Vaginal Tactile Imager (VTI) and evaluating the probe ergonomic design, safety and patient tolerance;
2. To assess the clinical suitability of the interface software to facilitate the data collection process and to get in vivo examination data for validation of visualization and analysis routines;
3. To test the data collection technique and establish a reliable examination procedure.


Eligibility criteria: Inclusion Criteria:

Adult women (over the age of 21) falling within one of the following groups:

1. No evidence of pelvic floor disorder and no prior pelvic surgery;
2. Stage 1 or 2 pelvic organ prolapse affecting one or more vaginal compartment.

Exclusion Criteria:

1. Active skin infection or ulceration within the vagina
2. Presence of a vaginal septum;
3. Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
4. Ongoing radiation therapy for pelvic cancer;
5. Impacted stool;
6. Recent (less than three months) pelvic surgery;
7. Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvodynia;
8. Severe hemorrhoids;
9. Surgically absent rectum or bladder;
10. Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician.

Primary outcomes:
measure: Imaging performance
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Princeton Urogynecology
state: New Jersey
Study officials:
affiliation: Artann Laboratories
name: Vladimir Egorov, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Raalte H, Egorov V. Characterizing female pelvic floor conditions by tactile imaging. Int Urogynecol J. 2015 Apr;26(4):607-9. doi: 10.1007/s00192-014-2549-9. Epub 2014 Oct 25.