louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00147576: Study To Examine Effect Of CP-866,087 On Consumption And Craving Of Alcohol In Alcohol Dependent Subjects.
Official title: Randomized, Placebo-Controlled Parallel Group Study Comparing Effect Of Three Doses Of CP-866,087 And Naltrexone On Acute Alcohol Consumption And Craving After Seven Days Of Treatment In Alcohol Dependent (DSM IV) Subjects Who Are Not Currently Seeking Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 88
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Test the hypothesis that increasing doses of CP-866,087 will decrease the total number of drinks consumed during a 2 hour acute alcohol consumption assessment and to determine the safety and tolerability of multiple doses of CP-866,087 in alcohol dependent subjects compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Subject meets the DSM-IV criterion for current alcohol dependence.
* Subject is currently not engaged in, and does not want, treatment for alcohol related problems.

Exclusion Criteria:

* Subject meets criteria for current DSM-IV diagnosis for any other psychoactive substance abuse or dependence disorder, excluding nicotine and caffeine.
* Specialized inpatient or outpatient alcoholism or other addiction treatment (except nicotine) within the past 12 months.

Primary outcomes:
measure: The amount of alcohol consumed will be based on the total number of standardized drinks consumed during a two-hour laboratory-based self-administration procedure following 7 days of treatment with study medication.
Secondary outcomes:
Other outcomes:
Locations:
city: Cerritos
country: United States
facility: Pfizer Investigational Site
state: California
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Melbourne
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lenexa
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04653376: Relationship of Endoplasmic Reticulum Stress and Tonsillar Tissue Diseases
Official title: Possible Relationship Between Apoptosis and Endoplasmic Reticulum Stress in the Etiopathogenesis of Chronic Tonsillitis and Tonsillar Hypertrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tonsillitis
Tonsillar Hypertrophy
Immune System Diseases
Keywords: Endoplasmic Reticulum
Apoptosis
İmmune system
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 46
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent tonsillectomy surgery aged between 2 and 16 years and who were clinically diagnosed with chronic tonsillitis and tonsil hypertrophy by the ENT clinician.

Brief summary: Tonsillar tissue is a significant organ for the performing of immune systems in children. The Endoplasmic Reticulum (ER), is an organelle needed for the care of a stable function of the cells. The purpose of the study was to explore the correlation among ER stress and tonsillar tissue disorders and to explain the structure of diseases related to the immune system.

Detailed description: A prospective study was conducted on 46 children aged who underwent tonsillectomy for chronic tonsillitis or tonsil hypertrophy. Tonsil tissues were evaluated in terms of ER stress markers and apoptosis markers by Real-time PCR and Western blot methods.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent tonsillectomy surgery with the clinical diagnosis of chronic tonsillitis and tonsillar hypertrophy.

Exclusion Criteria:

* Systemic diseases
* Other otolaryngological disorders

Primary outcomes:
measure: Relationship of Endoplasmic Reticulum stress and apoptosis with chronic tonsillitis and tonsillar hypertrophy
timeFrame: 2018-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
Study officials:
References:
citation: So JS. Roles of Endoplasmic Reticulum Stress in Immune Responses. Mol Cells. 2018 Aug 31;41(8):705-716. doi: 10.14348/molcells.2018.0241. Epub 2018 Jul 30.
citation: Onal M, Yilmaz T, Bilgic E, Muftuoglu SF, Kuscu O, Gunaydin RO. Apoptosis in chronic tonsillitis and tonsillar hypertrophy. Int J Pediatr Otorhinolaryngol. 2015 Feb;79(2):191-5. doi: 10.1016/j.ijporl.2014.12.005. Epub 2014 Dec 15.
citation: Onal M, Kocak N, Duymus F, Bozkurt MK, Elsurer C, Erdur O, Onal O. Relationship of endoplasmic reticulum stress with the etiopathogenesis of chronic tonsillitis and tonsillar hypertrophy in pediatric patients: a prospective, parallel-group study. Mol Biol Rep. 2021 Jul;48(7):5579-5586. doi: 10.1007/s11033-021-06579-4. Epub 2021 Jul 22.
Clinical trial NCT05651776: Golf, Physical Rehabilitation, and Movement Disorders
Official title: An Outpatient Physical Therapy and Golf Program Designed for Individuals With Movement Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease, Movement Disorders
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The importance of physical activity for individuals with movement disorders, including Parkinson disease and Essential tremor, has been established. Barriers including patient engagement continue to limit effectiveness. Golf requires skills found challenging to individuals with movement disorders. This study seeks to assess the feasibility and effectiveness of an outpatient-based rehabilitation program incorporating golf skills and activities on functional measures and quality of life.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of either PD, Parkinsonism, or ET. Subjects must also demonstrate functional deficits in at least one of the three categories (gait, transfers, balance) to be further assessed by the evaluating PT

Exclusion Criteria:

* Subjects will be excluded if they are unable to maintain standing balance with an assistive device, if they are non-ambulatory even with a device, if pain does not allow for subject participation, and if they are unable to follow instructions due to an underlying attentional or cognitive deficit.

Primary outcomes:
measure: Change in functional gait assessment
timeFrame: Scale completed at baseline and at 6 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: UF Health Neurology
name: Joseph Legacy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00748176: The Relationship of Abdominal Circumference and Trunk Length With the Level of Spinal Anesthesia in Obstetric Patients
Official title: The Relationship of Abdominal Circumference and Trunk Length With the Level of Spinal Anesthesia in Obstetric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetrics for C/S
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-09-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obstetric patients for C/S

Brief summary: The body shape might have influence on the spinal level. In this research we plan to investigate the relationship of abdominal circumference, trunk length and the level of spinal anesthesia in obstetric patients during Cesarean section.

Detailed description: The level of spinal anesthesia in obstetric patients had been investigated in several studies. Increased cephalad spread of local anesthetics had been demonstrated with increased intra-abdominal pressure, changes in anteroposterior spinal curves and lumbar lordosis. Theoretically the body shape might have contribution to the above factors and might have influence on the spinal level. In this research we plan to investigate the relationship of abdominal circumference, trunk length and the level of spinal anesthesia in obstetric patients during Cesarean section. Only those C/S patients indicated and scheduled for spinal anesthesia will be observed. The spinal anesthesia will be performed as routine practice. This study will not change the clinical plan in any aspect. We will only passively record the abdominal circumference, trunk length and the level of spinal anesthesia and calculate the correlation between them.

Eligibility criteria: Inclusion Criteria:

* Obstetric patients for C/S

Exclusion Criteria:

* With major systemic diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of anesthesiology, National Taiwan University Hospital
name: Hui-Hsun Huang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03973476: Effectiveness of Midwife Phone Support With the to Reduce the Early Abandonment of Breastfeeding
Official title: Effectiveness of Midwife Phone Support With the to Reduce the Early Abandonment of Breastfeeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: phone support; midwife; early abandonment of breastfeeding
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objective: To evaluate the effectiveness of telephone support of the reference midwife, in relation to the abandonment of breastfeeding of primiparous mothers and to identify, both the risk factors and the protective factors for the early abandonment of breastfeeding.

Material and Method Randomized parallel controlled clinical trial.

Detailed description: Sample: 220 primiparous mothers with access, during the 8 weeks postpartum, to a mobile phone to contact the midwife randomization of 110 mothers to the experimental group and 110 to the control group. The mothers of the experimental group will be offered the mobile phone number to contact their midwife after delivery. The mothers of the control group will receive the usual attention of the portfolio of services that includes the spontaneous visit in the center, the telephone call in the center, the home visit and the health education groups.

Eligibility criteria: Inclusion Criteria:

* Primiparians who carry out the follow-up of pregnancy for the midwife
* The pregnant woman is of low risk
* Possibility of the mother to make calls to the mobile phone.
* The pregnant woman wishes to participate in the study.

Exclusion Criteria

* Maternal or fetal pathology that can condition maternal breastfeeding.
* idiomatic barrier.
* Prematurity.
* Baby with weight \<2,500 gr. at birth
* Home delivery during the puerperium

Primary outcomes:
measure: Percentage of participants who breast-feed at 3 months of intervention
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04007276: The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
Official title: The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients Using Brimonidine 0.2%, 0.15%, or 0.1%
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Glaucoma
Glaucoma, Open-Angle
Glaucoma; Drugs
Droopy Eyelid
Ptosis
Glaucoma, Primary Open Angle
Lead sponsor: Tulane University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each patient will be randomized to receive the study medication in one eye and placebo in the other eye.
Primary purpose: TREATMENT

Brief summary: Glaucoma represents a group of conditions that cause damage to the optic nerve and can lead to irreversible vision loss. Current treatments are aimed at lowering intraocular pressure while minimizing medication side effects. Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) is an FDA-approved medication for alleviating eye redness, a common side effect of glaucoma medications. The purpose of this study is to evaluate the effect of Lumify™ on eye redness, intraocular pressure, and eyelid position in patients with glaucoma who are already using the Brimonidine 0.1%, 0.15% or 0.2% eye drops.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Diagnosis of primary open angle glaucoma
* Willing and able to give informed consent
* Current and greater than 6 weeks of brimonidine 0.2%, 0.15% or 0.1% use

Exclusion Criteria:

* Pregnancy
* Prisoners
* Known allergy or sensitivities to brimonidine
* No surgery within the past 6 months
* No history of lid surgery or botox
* Any other significant ophthalmologic disorder or condition with relevant effect on ocular redness, IOP, or eyelid position as evaluated by principal investigator
* Inability to sit comfortably for 30 minutes
* Prior use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines, or phenylephrine dilating drops within 1 week of study

Primary outcomes:
measure: Ocular redness
timeFrame: 5 minutes after application of eye drop
measure: Ocular redness
timeFrame: 15 minutes after application of eye drop
measure: Ocular redness
timeFrame: 30 minutes after application of eye drop
measure: Ocular redness
timeFrame: 60 minutes after application of eye drop
measure: Intraocular pressure
timeFrame: 60 minutes after application of eye drop
Secondary outcomes:
measure: Palpebral fissure height
timeFrame: 60 minutes after application of eye drop
measure: Eye discomfort
timeFrame: 60 minutes after application of eye drop
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
Study officials:
affiliation: Tulane University
name: Ze Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000276: Dopamine Reuptake Inhibitors of Cocaine Abuse - 1
Official title: Dopamine Reuptake Inhibitors of Cocaine Abuse
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Keywords: Cocaine-Related Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: VA Connecticut Healthcare System
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate dopamine reuptake inhibitors for cocaine abuse.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
measure: Side effects
measure: Cocaine effects
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Thomas R Kosten, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01793376: Development of Niv Score of Capsule Endoscopy in Patients With Crohn's (CECDAIic)
Official title: Development of Niv Score of Capsule Endoscopy in Patients With Crohn's (CECDAIic)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: videos of colon Crohn's disease subjects who have undergone the Colon 2 CE procedure will be included.

Brief summary: Hypothesis This study is designed as an integral part of the development of a new CE score for Crohn's disease.

The SB (small bowel) CD (Crohn's Disease)Niv score (CECDAI) is an established and validated CD score for SB involvement. In order to expand this score to the colon, this study will aim to develop the colonic score and later on will be combined with the already established SB score in order to achieve a full CE gut score for Crohn's disease Proposed Design This is a retrospective study in which up to 30 videos of colon Crohn's disease subjects who have undergone the Colon 2 CE procedure will be evaluated.

These cases will have evidence of large and / or small bowel Crohn's disease The chosen videos will be marked for CD lesions by the site The de-identified marked videos will be scored by 4 independent experienced endoscopists, blinded to the results of the standard workup procedures, according to the colonic and CECDAIic new scores


Eligibility criteria: Inclusion Criteria:

* videos of colon Crohn's disease subjects who have undergone the Colon 2 CE procedure will be included.

Exclusion Criteria:

-

Primary outcomes:
measure: The inter-observer variability of the new CD Colonic Score, between four reviewers in Crohn's Disease patients with large bowel involvement
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rabin MC
name: Yaron Niv, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06388876: The Effect of Exercise on Post-traumatic Stress Disorder and Sleep Quality in Individuals Affected by the 2023 Kahramanmaraş Earthquakes
Official title: The Effect of Exercise Interventions on Post-traumatic Stress Disorder and Sleep Quality in Young Individuals Directly Affected by the 2023 Kahramanmaraş Earthquakes in Türkiye: A Randomized Controlled Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Earthquake
Stress Disorders, Post-Traumatic
Keywords: natural disaster
earthquake
exercise
post-traumatic stress disorder
sleep quality
physiotherapy and rehabilitation
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-04-29
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: there are 2 groups; exercise and control
Primary purpose: TREATMENT

Brief summary: Natural disasters can have adverse impacts on both physical and mental health. Post-traumatic stress disorder (PTSD) and sleep disorders are among the most common problems seen after natural disasters. Exercise may represent a safe, cost-effective, accessible, non-pharmacological method for treating PTSD and sleep problems. The aim of this study was to investigate the effect of exercise interventions on PTSD and sleep quality in young individuals affected by the 2023 Kahramanmaraş earthquakes in Türkiye.


Eligibility criteria: Inclusion Criteria:

* age 18-30
* being directly affected by the earthquake in Mardin
* providing voluntary consent to participating in the study

Exclusion Criteria:

* involvement in an existing active regular exercise program
* the presence a physical problem capable of preventing exercise
* the presence of severe psychiatric disorders or cognitive and/or perceptual problems
* regular use of sedative or neuropsychiatric drugs
* active alcohol or drug addiction
* missing assessment parameters
* failure to participate in the intervention programs, or not continuing wıth the study

Primary outcomes:
measure: Post-traumatic Stress Disorder Short Scale
timeFrame: 6 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazıt University
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: bahar külünkoğlu, assoc. prof.
role: PRINCIPAL_INVESTIGATOR
References: