louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00534222: Unraveling the Relation of Patient's Profile and Therapeutical Effects of Atypicals, Including Quetiapine Effect
Official title: Unraveling the Relation of Patient's Profile and Therapeutical Effects of Atypicals, Including Quetiapine Effect
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mania
Schizophrenia
Keywords: Patients with a manic episode
Patients diagnosed w/schizophrenia, who start a treatment with an atypical antipsychotic & who are at least scored as moderately ill on the CGI at baseline
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-09-24
Enrollment: 387
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: Psychiatrist' patients

Brief summary: With this observational study we want to examine if the intensity of agitation, the intensity of psychotic symptoms and the presence of sleeping disorder predict the success of the treatment with a atypical antipsychotic after 12 weeks of treatment with patients with a psychotic and/or manic episode. In this study it will be examined what the percentage of patients with a 2-point improvement at the CGI-scale is. Of these group, the responders, retrospective the profile of the responders will be analysed (key-factors and confounders).

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility criteria: Inclusion Criteria:

* Patients with a manic episode or patients diagnosed with schizophrenia (psychotic episode)
* Patients who start a treatment with an atypical antipsychotic : quetiapine, olanzapine or risperidone
* Patients who are prepared to consent to make the coded data available to AstraZeneca
* Patients with a CGI ≥ 4

Exclusion Criteria:

* Patients with a serious underlying disease (including renal or hepatic insufficiency, cancer, cardiovascular diseases and suchlike).
* Contra-indications for quetiapine, olanzapine or risperidone according to the SmPC for these products
* Patients unable to give informed consent according to the attending physician

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Research Site
city: Almelo
country: Netherlands
facility: Research Site
city: Alphen aan de Rigjn
country: Netherlands
facility: Research Site
city: Amersfoort
country: Netherlands
facility: Research Site
city: Amstelveen
country: Netherlands
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04010422: Ocular Function in Autism Spectrum Disorder
Official title: Evaluating the Ocular Function of Adults With Autism Spectrum Disorder: Interrelationship Between Blinking Reflex and Cornea Innervation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism
Ocular Surface Disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is an observation study. We will recruit 50 adults with autism spectrum disorder aging over 20 years old from the Psychiatry Department, National Taiwan University Hospital. We will also recruit 50 adults without autism spectrum disorder aging over 20 years old from the Ophthalmology Department, National Taiwan University Hospital.

Brief summary: This study will investigate the visual function in individuals with ASD, with a particular focus on the ocular surface condition and visual function assessment.

Detailed description: Anomalies in visual information processing can have a major effect on the life quality of individuals with autism spectrum disorders (ASD), including eye gaze abnormality, higher frequency of refractive errors (e.g., astigmatism, hypermetropia, and anisometropia), strabismus, abnormal blinking rate, disturbed eye movements that may be associated with or aggravated social communication deficits of ASD. However, little is known about the ocular surface conditions. This study will investigate the visual function in individuals with ASD, with a particular focus on the ocular surface condition. We plan to recruit 50 adults with ASD and 50 age-/sex-matched typically developing controls in this project, and perform visual function assessment.

Eligibility criteria: ASD group:

Inclusion Criteria:

1. Having a clinical diagnosis of autism spectrum disorder
2. Aged over 20 years; able to read and sign an informed consent form.
3. Clear conscious and can follow the instruction of opening eyes and movement toward all direction.

Exclusion Criteria:

1. Unable to cooperate with the examinations.
2. Younger than 20 years old.

TD group:

Inclusion Criteria:

1. Aged over 20 years; able to read and sign an informed consent form.
2. Clear conscious and can follow the instruction of opening eyes and movement toward all direction.

Exclusion Criteria:

1. Unable to cooperate with the examinations.
2. Younger than 20 years old.
3. Having a clinical diagnosis of autism spectrum disorder

Primary outcomes:
measure: cornea innervation
timeFrame: 30 min
measure: Blinking reflex
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yi Ling Chien
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00800722: A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.
Official title: Phase I Combined Use of Pulsed Dye Laser and Rapamycin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Port Wine Stain
Keywords: hypervascular anomalies
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Beckman Laser Institute University of California Irvine
First posted: 2008-12-02
Enrollment: 21
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: The purpose of this study is to improve port wine stain therapeutic outcome in response to laser therapy. The researchers want to determine whether the combined use of pulsed dye laser therapy and rapamycin will improve PWS therapeutic outcome.

Detailed description: The researchers want to combined use of pulsed dye laser to induce port wine stain blood vessel injury, and rapamycin directly inhibits the proliferation of vascular endothelial cells driven by vascular endothelial growth factor which preventing port wine stain angiogenesis and recanalization, to improve port wine stain lesion blanching.

Eligibility criteria: Inclusion Criteria:

* port wine stain birthmarks suitable for comparison testing.

Exclusion Criteria:

* Pregnancy.
* Abnormal blood hematology or chemistry blood tests or urine analysis.
* History of cancer, History of high cholesterol, lipids or liver disease
* Allergy to macrolide drugs (e.g., erythromycin).
* Any therapy within the previous two months to the proposed PWS treatment sites.
* Concurrent use of known photosensitizing drugs,immunosuppressive drugs or systemic steroids,antifungals, antiepileptics, HIV protease inhibitors, cimetidine, cisapride, clarithromycin, dannzol, diltiazem, erythromycin, metoclopramide, rifabutin, rifampin, rifapentine, troleandomycin, or verapamil.

Primary outcomes:
measure: improve port wine stain (PWS) therapeutic outcome
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical clinic
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: John S Nelson, M.D,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03139422: Treatment of Copper Intra Uterine Device Associated Heavy Menstrual Blood Loss
Official title: Tranexamic Acid Versus Calcium Dobesilate for the Treatment of Copper Intra Uterine Contraceptive Device Associated Heavy Menstrual Blood Loss : A Randomized , Open-labelled , Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Menorrhagia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 140
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intrauterine contraceptive device is the most commonly reversible method used among women of reproductive age worldwide. Almost one in five married contraceptive users is currently using Intrauterine contraceptive device. The Egyptian demographic and health survey results indicate that 30% of currently married women interviewed in the Egyptian demographic and health survey were using Intrauterine contraceptive device. Main reasons for discontinuation of Intrauterine contraceptive device as cited by women were excessive bleeding per vagina 39.68%, abdominal pain 38.62%, low backache35.97%.


Eligibility criteria: Inclusion Criteria:

1. Women usingsopperT380A and reporting heavy menstrual blood loss during use.
2. Menorrhagia , will be defined as a Pictorial blood loss assessment chart-Score greater than 100.
3. No contraindication to drugs used in treatment.
4. No other cause for heavy menstrual blood loss

Exclusion Criteria:

1. Refusing to participate.
2. Irregular menstrual cycle.
3. Misplaced Intrauterine device.

Primary outcomes:
measure: Percent of women requesting treatment for heavy menstrual blood loss.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT06268522: Adjunctive Mindfulness During Opioid Tapering for patientS With Chronic Pain (The AMOS Study)
Official title: Adjunctive Mindfulness During Opioid Tapering for Patients With Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioral
Primary purpose: TREATMENT

Brief summary: This study is a Randomized Controlled Trial exploring the effects of a Mindfulness interventions in reducing pain interference and opioid dose in patients with Chronic Low Back Pain. A total of 200 opioid-using patients with chronic pain, male and female participants will be enrolled, with a need for 160 completers. Patient will be randomly assigned into the Mindfulness-Oriented Recovery Enhancement or the Psychoeducation comparison control group.


Eligibility criteria: Inclusion criteria:

* age\>18yo
* Chronic Low Back Pain as seen on medical history as well as score of \>3 on pain visual analog scale (VAS) at the start of experimental sessions.
* receiving prescription opioids for three or more months and planning to start tapering their opioids with their provider.
* willing to be randomized to one of the two behavioral treatment. Patients referred or self-referred to the study from an outside clinic will also be able to participate (we will be in contact with their prescribing provider)
* able and willing to perform/tolerate pain procedures (e.g., QST)
* able to communicate fluently in English
* able to use a smartphone or laptop for the virtual therapy program

Exclusion criteria:

* Current illicit substance use (e.g marijuana use will be exempted) at screening or during trial as verified by urine toxicology screen and/or self-report for all participants;
* Medical condition known to influence QST or participation in the MORE intervention; serious psychiatric condition;
* regular meditation practice
* cognitive impairment
* pregnancy
* lack of English fluency
* severe OUD
* inability to provide informed consent.

Primary outcomes:
measure: Pain Interference
timeFrame: Baseline, 8 weeks, 3 month and 6 month follow up
measure: Opioid Dose
timeFrame: Baseline, 8 weeks, 3 month and 6 month follow up
Secondary outcomes:
measure: Pain Intensity
timeFrame: Baseline, 8 weeks, 3 month and 6 month follow up
measure: Opioid Misuse
timeFrame: Baseline, 8 weeks, 3 month and 6 month follow up
measure: Opioid Withdrawal
timeFrame: Baseline, 8 weeks, 3 month and 6 month follow up
measure: Opioid Craving
timeFrame: Baseline,8 weeks, 3 month and 6 month follow up
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT06572722: Perioperative Immunotherapy for NSCLC (ECTOP-1030)
Official title: Perioperative Immunotherapy for Early-stage Non-small-cell Lung Cancer: a Randomised, Multicentre, Open-label, Phase 2 Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is a randomized, multicenter, open label phase II clinical study. The main objective is to evaluate the efficacy of three perioperative immunotherapy modalities (atezolizumab adjuvant therapy, nivolumab neoadjuvant therapy, pembrolizumab neoadjuvant+adjuvant therapy) in early-stage resectable NSCLC patients. The enrolled patients are randomly assigned in a 1:1:1 ratio to receive relevant treatment in the three perioperative immunotherapy groups mentioned above, and undergoing short-term pathological efficacy evaluation and long-term prognosis follow-up after surgery.


Eligibility criteria: Inclusion Criteria:

1. Patients who sign the informed consent form and are willing to complete the study according to the plan;
2. Aged from 18 to 80 years old;
3. ECOG equals 0 or 1;
4. Not receiving lung cancer surgery before;
5. Resectable cIB-IIIA tumors;
6. Not receiving chemotherapy or radiotherapy before.

Exclusion Criteria:

1. Not cIB-IIIA tumors;
2. Nodules not suitable for resection;
3. Not lung adenocarcinoma diagnosed cytologically or pathologically;
4. Receiving lung cancer surgery before;
5. Receiving radiotherapy or chemotherapy.

Primary outcomes:
measure: Disease-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Major pathological response
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University
name: Haiquan Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01410422: Metabolomic Analysis of Exhaled Breath Condensates in Patients With COPD and Bronchiectasis
Official title: Exhaled Breath Analysis in Patients With COPD and Bronchiectasis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Bronchiectasis
Keywords: COPD
Bronchiectasis
Metabolomics
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-08-05
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COPD and bronchiectasis

Brief summary: Metabolomics is a large-scale approach to monitoring the compounds involved in cellular processes. It may reflect changes in biological function. Collection of exhaled breath is a newly developed, noninvasive method that may allow clinicians and researchers to assess biochemical profiles in the airway. This study is conducted for the metabolomic analysis of the exhaled gas in patients with Chronic Obstructive Pulmonary Disease (COPD) and bronchiectasis.

Detailed description: Metabolomics is a large-scale approach to monitoring as many as possible of the compounds involved in cellular processes in a single assay to derive metabolic profiles. Compared with genomics or proteomics, metabolomics reflects changes in phenotype and therefore function. Collection of exhaled breath condensate (EBC) is a newly developed, noninvasive method that may allow clinicians and researchers to assess biochemical profiles in the alveolar lining fluid. The aims of this study are: (1)Collecting and metabolomic profiling of the EBCs from patients with COPD/bronchiectasis; (2) Comparing the profiles of these patients obtained during stable and acute exacerbation periods; (3) Comparing the profiles of these patients with and without Pseudomonas colonization/infection; (4) Correlation of EBC metabolomic profiles with clinical phenotypes, severity and outcomes of these patients.

Eligibility criteria: Inclusion Criteria:

* patients with COPD or bronchiectasis

Exclusion Criteria:

* not willing to sign ICF

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ping-Hung Kuo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03463122: Head Mount Display-based Virtual Reality Rehabilitation of Hemispatial Neglect
Official title: Virtual Reality Based Visual Perception Evaluation and Rehabilitation-pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Neglect, Hemispatial
Keywords: stroke
neglect
virtual reality
head mount display
rehabilitation
Lead sponsor: National Rehabilitation Center, Seoul, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Hanyang University
First posted: 2018-03-13
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Head-mounted display based virtual reality rehabilitation for hemispatial neglect.

Detailed description: The investigators examine about the efficacy of field-of-regard-focused visual exploration therapy implemented using a head-mounted display virtual reality system for hemispatial neglect rehabilitation following stroke.

Eligibility criteria: Inclusion Criteria:

* presence of left hemispatial neglect as demonstrated by a score above the cut-off on the line bisection test or star cancellation test of the Behavioral Inattention Test, or mild-to-moderate neglect-related functional impairment defined by a score of 1-20 points on the Catherine Bergego Scale
* age 19 to 65 years
* first-time right hemispheric ischemic or haemorrhagic stroke as evidenced by brain imaging and medical records
* a score \>25 on the Mini-Mental State Examination

Exclusion Criteria:

* presence of oculomotor palsies or visual defects as assessed via standard neurological examination
* orthopaedic disorders affecting neck movement
* inability to maintain a seated position.

Primary outcomes:
measure: Change in Field of regard-response time
timeFrame: Baseline, 4 weeks from baseline, 8 weeks from baseline
measure: Change in Field of regard-success rate
timeFrame: Baseline, 4 weeks from baseline, 8 weeks from baseline
measure: Change in Field of regard-head movement
timeFrame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Secondary outcomes:
measure: Field of view-response time
timeFrame: Baseline, 4 weeks from baseline, 8 weeks from baseline
measure: Field of view-success rate
timeFrame: Baseline, 4 weeks from baseline, 8 weeks from baseline
measure: Line bisection test
timeFrame: Baseline, 4 weeks from baseline, 8 weeks from baseline
measure: Star cancellation test
timeFrame: Baseline, 4 weeks from baseline, 8 weeks from baseline
measure: Catherine Bergego Scale
timeFrame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: National Rehabilitation Center
Study officials:
affiliation: National Rehabilitation Center of Korea
name: Joon-Ho Shin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim TL, Kim K, Choi C, Lee JY, Shin JH. FOPR test: a virtual reality-based technique to assess field of perception and field of regard in hemispatial neglect. J Neuroeng Rehabil. 2021 Feb 18;18(1):39. doi: 10.1186/s12984-021-00835-1.
Clinical trial NCT02388022: A Retrospective Study Using CALIBER® TLIF Expandable Spacer in the Treatment of DDD: 2 Year Follow-up.
Official title: A Retrospective Study Using CALIBER® TLIF Expandable Spacer in the Treatment of DDD: 2 Year Follow-up.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Lead sponsor: Globus Medical Inc
Sponsor class: INDUSTRY
First posted: 2015-03-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both male and female between the ages of 18 and 80 with objective evidence of degenerative disc disease between L2 and S1 at 1-2 contiguous levels.

Brief summary: The purpose of the study is to gather clinical and radiographic outcome data from patients who have undergone treatment with an expandable interbody spacer.

Detailed description: This is a multi center retrospective study with 200 patients. Sites will screen their patient records for patients who have had a TLIF utilizing the CALIBER® expandable interbody spacer in conjunction with the REVOLVE® or REVERE® posterior stabilization systems and subsequent follow-up visits.

The study aims to collect both pre-operative and post-operative data at the 6, 12 and 24 month time points according to existing standard of care and the surgeon's custom and practice.

Eligibility criteria: Inclusion Criteria:

* Objective evidence of degenerative disc disease at 1 or 2 level(s) between L2 and S1 resulting from degeneration of disc confirmed by history and radiographic studies.
* At least 18 years of age and maximum 80 years of age

Exclusion Criteria:

* • Presence of systemic or localized infection at the site of surgery

  * More than 2 levels to be instrumented
  * Previous fusion attempt at the involved level(s)
  * Spondylolisthesis unable to be reduced to Grade 1
  * Previous documentation of osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
  * Diagnosis of a condition or on postoperative medication(s), which may interfere with bony/soft tissue healing
  * Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
  * History of substance abuse (drugs or alcohol)
  * Mentally incompetent or prisoner

Primary outcomes:
measure: radiographic evaluation
timeFrame: Pre-Op to 2 years post-operative
Secondary outcomes:
measure: Clinical outcomes
timeFrame: pre-op to 2 years post-operative
Other outcomes:
Locations:
Study officials:
affiliation: Spine Institute of San Diego
name: Choll Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: