louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00392743: A Study to Compare Two Different Brain Imaging Techniques in Healthy Volunteers and in Schizophrenic Patients
Official title: An Open-label, Cross-over Study, to Compare the PET and SPECT Measurement of Antipsychotic-induced D2 Receptor Occupancy, in a Group of Healthy Volunteers and in Another Group of Patients With Schizophrenia and Other Psychotic Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Bolus
11C-Raclopride
Schizophrenia
123I-IBZM
SPECT
Receptor Occupancy
PET
MRI
Antipsychotics
Bolus/Infusion
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a methodology study.

Brief summary: A direct comparison of Positron Emission Tomography (PET) (11C-Raclopride) and Single Photon Emission Computed Tomography (SPECT) (123I-IBZM) D2 RO measurements would allow GSK to gain understanding on the SPECT results obtained with SB773812, and to accurately interpret future D2 RO results from either PET or SPECT studies with new compounds.


Eligibility criteria: Inclusion criteria:

* Not pregnant or becoming pregnant during the study.
* No abnormality in clinical examination, clinical laboratory test or ECG.
* Not taking drugs
* Patients with schizophrenia, schizophreniform disorder or schizoaffective disorders.
* Patients with at least 1 month antipsychotic monotherapy with either risperidone, olanzapine or clozapine.
* Healthy volunteers with no neurological or psychiatric illness.

Exclusion criteria:

* Have received other antipsychotic during the last month or neuroleptics during the last year.
* If you have taken part in investigations you should not receive a radiation dose of more than 10 mSv over any 3 year period.
* History of bleeding disorder or are taking medication that affects blood clotting
* History of substance dependence (except nicotine)
* Claustrophobia
* Gross head deformity.
* Unable to lie still in the PET or SPECT camera for 1 hour and a half.
* The presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies.

Primary outcomes:
measure: PET and SPECT striatal binding potential
timeFrame: at day 1
Secondary outcomes:
measure: plasma concentrations at the time of scanning,
timeFrame: at day 1
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Espluges de Llobregat
country: Spain
facility: GSK Investigational Site
city: Sant Boi de Llobregat
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03382743: Endocervical Lidocaine Spray for Pain Control During Office Hysteroscopy
Official title: Endocervical Lidocaine Spray for Pain Control During Office Hysteroscopy - a Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pain Uterus
Keywords: office hysteroscopy
Lidocaine spray
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

Brief summary: lidocaine spray is used endocervical before office hysteroscopy to reduce the pain

Detailed description: 5 sprays of Lidocaine is applied 3 minutes before office hysteroscopy

Eligibility criteria: Inclusion Criteria:

Patients indicated for diagnostic hysteroscopy for infertility or AUB. Postmenstrual between days 7 and 11 of the cycle ( except in irregular bleeding)

Exclusion Criteria:

Contraindication to office hysteroscopy Neurological disorders affecting the evaluation of pain. Previous cervical surgery.

Primary outcomes:
measure: Pain sensation
timeFrame: The VAS will be applied immediately after the procedure ended
measure: Procedure time
timeFrame: immediately after the process
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Ainiy Hospital
city: Cairo
country: Egypt
facility: Kasr Alaini hospital
Study officials:
References:
Clinical trial NCT00296543: T Wave Alternans in Hemodialysis
Official title: Pilot Study of a Noninvasive Predictor of Sudden Cardiac Death in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Coronary Heart Disease
Congestive Heart Failure
Keywords: hemodialysis
sudden cardiac death
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Dialysis Clinic, Inc.
First posted: 2006-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemodialysis patients with heart disease and/or poor cardiac function

Brief summary: The purpose of this study is to determine if the hemodialysis procedure changes the risk for cardiac arrest in patients.

Detailed description: One-third to one-quarter of hemodialysis patients die of sudden cardiac death (SCD). The hemodialysis procedure may theoretically increase the risk of SCD. This study uses T wave alternans, a noninvasive marker of SCD, to objectively determine whether the hemodialysis procedure alters the risk of SCD in hemodialysis patients.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Normal sinus rhythm

Exclusion Criteria:

* Inability to give written informed consent
* Active cardiac ischemia
* Pacemaker
* Inability to perform a brief walking treadmill test

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Allon Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05397743: Quality Of Life After Eye Surgical Removal
Official title: A Prospective Study About Global, Psychological and Visual Quality of Life After an Eye Surgical Removal (Enucleation or Evisceration)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Evisceration; Traumatic, Eye
Keywords: Enucleation
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Studies have shown that health-related quality of life (HRQOL) was worse among patients who underwent surgical eye removal compared to the general population in Denmark.

A third of eye amputated patients suffered from anxiety and depression. Most of the available evidence on the subject is based on retrospective studies that interviewed patients several years after surgery, which can potentially introduce biases.

Moreover, in the literature, there are no data concerning postoperative psychological and visual impact.


Eligibility criteria: Inclusion Criteria:

* Patient who underwent an eye removal surgery: evisceration, enucleation or exenteration

Exclusion Criteria:

* Patient who underwent bilateral eye removal surgery

Primary outcomes:
measure: Score VFQ 25 score up to 3 months after surgery
timeFrame: Month 3
Secondary outcomes:
measure: PSS score up to 3 months after surgery
timeFrame: Month 3
measure: SF-36 score up to 3 months after surgery
timeFrame: Month 3
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
affiliation: CHU de Besançon
name: Lauriana SOLECKI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rasmussen ML, Ekholm O, Prause JU, Toft PB. Quality of life of eye amputated patients. Acta Ophthalmol. 2012 Aug;90(5):435-40. doi: 10.1111/j.1755-3768.2010.02092.x. Epub 2011 Feb 10.
citation: Ahn JM, Lee SY, Yoon JS. Health-related quality of life and emotional status of anophthalmic patients in Korea. Am J Ophthalmol. 2010 Jun;149(6):1005-1011.e1. doi: 10.1016/j.ajo.2009.12.036. Epub 2010 Mar 15.
citation: Damato B. Improving the quality of life of patients undergoing enucleation. Eye (Lond). 2022 Aug;36(8):1711. doi: 10.1038/s41433-021-01783-9. Epub 2021 Oct 13. No abstract available.
Clinical trial NCT04794543: Effects of Using E-Cigarettes on Lungs in People With HIV (HBS Ancillary)
Official title: Effects of E-Cigarettes on the Lung Metabolome in People Living With HIV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hiv
Lung Injury
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2021-03-12
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People living with HIV (PLWH) in the study site areas who are enrolled in the HBS study (main trial).

Brief summary: This is an ancillary study, thus participants will be recruited from participants in the HBS Study. This project acutely assesses the role of the e-cigarettes and vaping on lung health. The proposed work will inform the design of future studies to better understand vaping's health consequences and to test novel interventions to mitigate vaping's contribution to acute and/or chronic lung injury.


Eligibility criteria: This project is an ancillary study to the HBS Study. Inclusion Criteria for that IRB approved study are:

* documented HIV-infection
* in care at an HIV specialty clinic
* age ≥ 18 years.

Exclusion criteria for the HBS Study are:

* a pacemaker or other implanted electronic device
* pregnant women, prisoners, cognitively-impaired subjects.

For this ancillary, the experimental group must actively use at least one of the following: e-cigarettes, e-liquid vapes, burning leaf tobacco cigarettes, or inhaled burning leaf marijuana (cannabis). The control group will have no use of e-cigarettes or vape or active smoking in the past year.

Participants must be willing to archive data and biological samples for future use.

Exclusion from the ancillary are:

* overt respiratory or oral cavity disease
* acute illness in the past 4 weeks
* active cancer
* active weight loss program
* any other medical, psychiatric or behavioral factors that, in the judgment of the PI may interfere with study participation or ability to follow the protocol

Primary outcomes:
measure: Changes in respiratory tract metabolite profiles in PLWH
timeFrame: Baseline only (at Visit 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: New Orleans
country: United States
facility: Lsuhsc-No
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: John Apolzan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03096743: Evaluating Raised Intracranial Pressure Using MR Elastography
Official title: Evaluating Raised Intracranial Pressure Using MR Elastography
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Idiopathic Intracranial Hypertension
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2017-03-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Investigators will compare magnetic resonance (MR) elastography measurements to other forms of noninvasive methods of detecting raised intracranial pressure, including optical coherence tomography (OCT) imaging measurements of the retinal nerve fiber layer (RNFL) and indirect signs of raised intracranial pressure on magnetic resonance imaging (MRI).

Detailed description: The goal of this study is to evaluate the brain elasticity in patients with idiopathic intracranial hypertension (IIH) and other forms of raised intracranial pressure, such as obstructive hydrocephalus. Investigators will evaluate for a correlation between brain stiffness and opening pressure on lumbar puncture. Investigators will also evaluate for changes in brain stiffness after interventions that are aimed at lowering intracranial pressure, including lumbar punctures, medications, and surgical interventions, such as ventriculoperitoneal shunts. Lastly, investigators will compare MR elastography measurements to other forms of noninvasive methods of detecting raised intracranial pressure, including optical coherence tomography (OCT) measurements of the retinal nerve fiber layer (RNFL) and indirect signs of raised intracranial pressure on MRI.

Eligibility criteria: All subjects will have the following inclusion criteria:

* Group 1: Papilledema from idiopathic intracranial hypertension and other forms of elevated intracranial pressure, including obstructive hydrocephalus
* Group 2: Patients without raised intracranial pressure.

All subjects will have the following exclusion criteria:

* Age \<18
* Pregnancy (self-reported)
* Individuals for whom MR is contraindicated

Primary outcomes:
measure: MR elastography measurement of the brain elasticity
timeFrame: 1-2 weeks prior to lumbar puncture
Secondary outcomes:
measure: MRI finding
timeFrame: 1--2 weeks prior to lumbar puncture
measure: Ocular Coherence Tomography (OCT) finding
timeFrame: 1--2 weeks prior to lumbar puncture
measure: Optic Nerve B-scan ultrasound finding
timeFrame: 1--2 weeks prior to lumbar puncture
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: John J Chen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06602843: Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy
Official title: Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: Esophageal Squamous Cell Carcinoma
Locally advanced
Chemoimmunotherapy
Radioimmunotherapy
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2024-09-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study was to explore the efficacy and safety of neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy in patients with locally advanced esophageal squamous cell carcinoma


Eligibility criteria: Inclusion Criteria:

* Ages 18-75;
* Radical operation for esophageal cancer;
* Esophageal squamous cell carcinoma was confirmed by postoperative pathology; . Preoperative imaging (enhanced cervical, thoracoabdominal CT+ bone scan) and postoperative pathological evaluation were performed, and the stage was pIIB-IVA (AJCC eighth edition staging criteria: T≥3 or N+).
* More than or equal to 12 lymph nodes were surgically removed;
* Postoperative ECOG score 0-1, able to tolerate postoperative adjuvant radiotherapy and immunotherapy;
* Informed consent signed by patient or family member.

Exclusion Criteria:

* Less than 18 years old, more than 75 years old;
* did not receive radical resection of esophageal cancer, including palliative resection;
* Postoperative pathology showed non-esophageal squamous cell carcinoma;
* After preoperative imaging (enhanced cervical, thoracoabdominal CT+ bone scan) and postoperative pathological evaluation, the stage was pI, IIA, IVB (AJCC eighth edition staging standard); e. Less than 12 lymph nodes were surgically removed;
* Postoperative ECOG score 2-3 points, unable to tolerate postoperative adjuvant radiotherapy and immunotherapy;
* The patient or family member did not sign the informed consent.

Primary outcomes:
measure: pCR
timeFrame: immediately after the intervention/procedure/surgery
Secondary outcomes:
measure: R0 resection rate
timeFrame: immediately after the intervention/procedure/surgery
Other outcomes:
measure: 1#3-year disease free survival
timeFrame: immediately after the intervention/procedure/surgery
Locations:
city: Hefei
country: China
facility: Anhui provincial hospital
Study officials:
References:
Clinical trial NCT00631943: A Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain
Official title: An Open Label, Non-comparative, Multicentre Study to Evaluate the Efficacy and Tolerability of Pregabalin in Peripheral Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuralgia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-10
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Lyrica in Indian patients with nerve pain


Eligibility criteria: Inclusion criteria:

* Peripheral neuropathic pain
* Score of at least 40 mm on the VAS of the SF-MPQ at screening and baseline
* Completion of at least 4 daily pain diary entries with an average daily pain score of at least 4 over the 7 days prior to baseline

Exclusion criteria:

(none)

Primary outcomes:
measure: Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) visual analog score (VAS)
timeFrame: Weeks 1 and 2 and end of treatment
measure: Change from baseline in weekly mean pain scores
timeFrame: Weeks 1 and 2 and end of treatment
Secondary outcomes:
measure: Change from baseline in Euro Quality of Life Questionnaire (EQ-5D) scores
timeFrame: End of treatment
measure: Adverse events and laboratory value changes
timeFrame: Weeks 1 and 2 and end of treatment
measure: Change from baseline in weekly mean sleep interference score
timeFrame: Weeks 1 and 2 and end of treatment
measure: Change from baseline in sensory, affective, and total components of the pain descriptor score and the Present Pain Intensity (PPI) of the SF-MPQ
timeFrame: Weeks 1 and 2 and end of treatment
measure: Change from baseline in Patient Global Impression of Change (PGIC)
timeFrame: Weeks 1 and 2 and end of treatment
measure: Change from baseline in Clinical Global Impression of Change (CGIC)
timeFrame: Weeks 1 and 2 and end of treatment
measure: Change from baseline in pain interference scores on the Brief Pain Inventory (BPI ) Short-Form
timeFrame: End of treatment
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka / India
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Maharashtra
country: India
facility: Pfizer Investigational Site
state: Mumbai
city: Chennai
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Chennai
country: India
facility: Pfizer Investigational Site
state: Tamil, Nadu
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00949143: Effects of Axle Positions on Wheelchair Skills in Manual Wheelchair Users
Official title: Effects of Axle Positions on Wheelchair Skills in Manual Wheelchair Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Disability
Keywords: wheelchair user
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2009-07-30
Enrollment: 15
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to investigate the effects of altering the wheelchair set-up on mobility and safety by changing the rear-axle position on a manual wheelchair.


Eligibility criteria: Inclusion Criteria:

* manual wheelchair users
* minimum of 17 years of age
* at least one week experience in a manual wheelchair, for at least an hour a day
* alert
* able to answer questions
* able to fit in the testing wheelchairs
* permission to participate from the attending physician

Exclusion Criteria:

* significant visual impairments
* unstable medical conditions (e.g., angina)
* emotional/psychological problems that may make testing unpleasant

Primary outcomes:
measure: Wheelchair skills test
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Rehabilitation Centre
state: Nova Scotia
Study officials:
affiliation: CDHA
name: Lee Kirby, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: