louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05416788: Effect of Cervical Manipulation on Mouth Opening
Official title: Effect of Cervical Manipulation on Mouth Opening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bruxism
Face Pain
Lead sponsor: University of Americas
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: To compare the effects of cervical manipulation on the ranges of motion of

mouth opening and painful pressure points in the masseter and temporal muscles after

of cervical manipulation compared to the control group.

Material and methods: Single-blind randomized clinical trial with two arms, one group

intervention and a control group.

Hypothesis: There is a significant difference in mouth opening and painful pressure points

between the intervention group and the control group.

Expected results: The intervention group would significantly increase their mouth opening

maximal and decrease pressure pain in the masseter and temporalis muscles.


Eligibility criteria: Inclusion Criteria:

* Subjects over 18 years of age, men and women
* Students with neck and/or facial pain minimum 3/10 VAS scale
* Kinesiology students who regularly attend face-to-face classes

who have a mobility pass and a health declaration.

· Students who read and sign the informed consent.

Exclusion Criteria:

* Orthognathic surgery
* Head and neck fracture or injury
* Contraindication (red flag) to perform high-speed, low-amplitude cervical manipulation (bone cancer, osteoporosis, vertebral artery injury, etc.)
* Positive cervical safety tests (example: Klein test positive)

Primary outcomes:
measure: normal mouth opening in millimeters
timeFrame: Change from Baseline mouth open at 5 minutes
Secondary outcomes:
measure: masseter muscle pressure points
timeFrame: Change from Baseline pain points at 5 minutes
Other outcomes:
Locations:
city: Santiago de Chile
country: Chile
facility: Universidad de las Americas
state: Santiago
Study officials:
References:
Clinical trial NCT00211588: Galantamine Executive Function in Parkinson's Disease
Official title: Investigator Initiated Study: Galantamine CR Potential Enhancement of Attentional and Executive Function in Non-Demented Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: cognition
Lead sponsor: Memorial Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: Ortho-McNeil Neurologics, Inc.
First posted: 2005-09-21
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to determine whether galantamine stabilizes or improves thinking abilities in individuals with Parkinson's disease. Individuals included in the study have minor complaints about thinking such as problems with concentration or memory but do not have dementia. This medication has been shown to have a positive effect on stabilizing memory in individuals with Alzheimer's disease. It is FDA approved for use in elderly individuals with Alzheimer's disease. It is hypothesized that galantamine will stabilize or improve executive and attentional functions in individuals with Parkinson's.

Detailed description: While several cholinesterase inhibitors have effectiveness in Alzheimer's disease (AD), galantamine is unique since it has a dual mode of action: inhibition of acetylcholinesterase and modulation of nicotinic acetylcholine receptors.As Parkinson's disease (PD) impacts frontal systems, executive cognition rather than memory function (mediated by medial temporal) would be the targeted area for potential improvement. This single center, double blind, placebo controlled study compares a group of PD patients treated with galantamine to a group of PD patients who are not treated with this medication on a series of cognitive tasks that examine attention and executive control.

Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson's Disease

Exclusion Criteria:

* dementia, depression, cardiac disease, gastrointestinal disease

Primary outcomes:
measure: Improvement on cognitive measures
timeFrame: 16 weeks
Secondary outcomes:
measure: No worsening of PD symptoms
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Pawtucket
country: United States
facility: Memorial Hospital of RI
state: Rhode Island
Study officials:
affiliation: NeuroHealth
name: Joseph H Friedman, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Hospital of RI
name: Janet Grace, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Buelow MT, Amick MM, Queller S, Stout JC, Friedman JH, Grace J. Feasibility of use of probabilistic reversal learning and serial reaction time tasks in clinical trials of Parkinson's disease. Parkinsonism Relat Disord. 2015 Aug;21(8):894-8. doi: 10.1016/j.parkreldis.2015.05.019. Epub 2015 May 27.
Clinical trial NCT00366288: Study Evaluating PAZ-417 in Healthy Young/Elderly
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAZ-417 Administered Orally to Healthy Young and Healthy Elderly Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Keywords: Healthy
Safety
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-21
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of a certain town

Brief summary: This study is to evaluate the safety and tolerability of single, ascending doses of PAZ-417 in healthy young and healthy elderly subjects. The effect of a high fat meal on the metabolism of PAZ-417 will also be studied, along with blood levels of PAZ-417 . Changes in cognitive function will be assessed.


Eligibility criteria: Inclusion Criteria:

1. Men or women, aged 18 to 50 years inclusive (healthy young subjects) and \> 65 years inclusive (elderly subjects) on study day 1. Women of nonchildbearing potential may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥1 year (with estradiol ≤25 pg/mL\[92 pmol/L\] and FSH ≥40 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile or post-menopausal must provide documentation of the procedure by an operative report or by ultrasound and have a negative serum pregnancy test result within 48 hours before administration of test article.
2. The elderly subjects must be generally healthy, but may be enrolled with a stable, chronic illness, if it is well-controlled, and does not interfere with the primary objective of the study. Subjects may be included with clinically important deviations from normal limits in medical history, physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results which are associated with stable, chronic, well-controlled, medical conditions.
3. The estimated creatinine clearance must be within the age-appropriate normal range.

Exclusions Criteria:

1. Presence or history of any disorder that may prevent the successful completion of the study.
2. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
3. Exclude subjects with a history of vascular disorders (peripheral, coronary, venous), chronic inflammatory disorders (e.g., rheumatoid arthritis), hematologic disorders, and bleeding disorders (e.g., hemophilia, idiopathic thrombocytopenic purpura, von willebrand's disease).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05056688: Effect of Online Education Given to Young Adults on Testicular Cancer Health Beliefs and Behaviors
Official title: Effect of Online Education Given to Young Adults on Testicular Cancer Health Beliefs and Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Testicular Neoplasms
Keywords: Health Belief Model
Health Behavior
Education, Distance
Testicular Neoplasms
Lead sponsor: Agri Ibrahim Cecen University
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the study, 90 individuals, including 1 experimental and 1 control group, were included in the study.
Primary purpose: PREVENTION

Brief summary: Aim: One of the cheapest, easiest and most effective ways to detect testicular cancer early is to resort to early detection screening methods associated with health beliefs about testicular cancer, and the second is to self-examine the testicles. In the country, there are a limited number of studies on the health beliefs and early diagnosis behaviors of young adult men for testicular cancer. For this reason, the study was conducted to determine the effect of online education given to young adults on testicular cancer health beliefs and behavior.

Material and method: The research was conducted as a randomized controlled experimental study. The study population consisted of 768 individuals who applied to Family Health Centers affiliated to Agri Provincial Health Directorate between April 2021 and June 2022, and the sample of the research consisted of 90 individuals selected from the population using the improbable random sampling method. "Descriptive Feature Form", "Champion's Health Belief Model Scale in Testicular Cancer Screenings" were used to collect data. In the analysis of data; percentile distribution, chi-square, Fisher-Freeman-Halton Exact test, t-test in independent groups, Repeated Measures ANOVA Test, Friedman Test, One Way ANOVA test, Kruskall Wallis test, and post hoc analyzes (Bonferroni, Games Howell, Dunn) were used.


Eligibility criteria: Inclusion Criteria:

* Being 18-35 years old,
* Being literate,
* Computer can be used,
* Being able to access the Internet,
* Not having a testicular diagnosis before,
* Deciding to participate in the research.

Exclusion Criteria:

* Being outside the age range of 18-35,
* To be diagnosed with testicular cancer before

Primary outcomes:
measure: Giving training to the experimental group for 6 weeks with an interval of 2 weeks.
timeFrame: Four monts
measure: Collection of the final test
timeFrame: Three monts
Secondary outcomes:
Other outcomes:
Locations:
city: Agri
country: Turkey
facility: Agri Ibrahim Cecen University
Study officials:
affiliation: Agri Ibrahim Cecen University
name: Mehmet Salih YILDIRIM, Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00162188: An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection: Canada
Official title: Canadian Sustiva Oral Liquid Expanded Access Program: An Open-Label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP266)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: HIV Infection
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-09-13
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: This study is being conducted to assess the safety and tolerability of an oral liquid solution of Sustiva for antiretroviral therapy-naive or therapy-experienced HIV-1 infected children between the ages of 3-16 who are failing or intolerant of their current antiretroviral regimen and who are unable to swallow Sustiva capsules.


Eligibility criteria: Inclusion Criteria:

* Children 3-16 years of age
* Anti-retroviral naive or experienced
* Failing or intolerant to current anti-retroviral (ARV) regimen
* Limited available viable therapeutic options
* Inability to take capsules/tablets

Exclusion Criteria:

* Weighs less than 10 kg
* Failure on or concomitant use of other non-nucleoside reverse transcriptase inhibitors (NNRTIs)
* An active AIDS-defining opportunistic infection or disease
* More than two episodes of moderate to severe diarrhea or vomiting lasting more than four days within the past three months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00497588: the Comparison of Voice Quality in Early Laryngeal Cancer Between Surgery and Radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Voice Quality
Keywords: laryngeal cancer
RADIOTHERAPY
Voice Quality
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-07-06
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: early laryngeal cancer is a well known field with great controversy in treatment. two options are available in treatment of patients the first one is partial laryngectomy and the second one is radiotherapy.one of major concern of patients have been the quality of voice ,so we design this trial to answer the priority of each options.

Detailed description: early laryngeal cancer is a well known field with great controversy in treatment. two options are available in treatment of patients the first one is partial laryngectomy and the second one is radiotherapy.one of major concern of patients have been the quality of voice as part of quality of life ,so we design this clinical randomised trial to answer the priority of each options.

Eligibility criteria: Inclusion Criteria:

* Early laryngeal cancer

Exclusion Criteria:

* No history of radiotherapy and collagen vascular disease

Primary outcomes:
measure: quality of voice
timeFrame: 3 to 6 month after therapy
Secondary outcomes:
measure: quality of life
timeFrame: 6 month later
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Khomainee hospital
Study officials:
affiliation: tehran university of medical science
name: babak saedi, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06341088: Evaluation of Anatomical Results and Sexual Functions After Unilateral and Bilateral Laparoscopic Suture Sacro-hysteropexy Operations
Official title: Evaluation of Anatomical Results and Sexual Functions After Unilateral and Bilateral Laparoscopic Suture Sacro-hysteropexy Operations, a Prospective Randomised Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: suture sacro hysteropexy
Pelvic Organ Prolapse
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was planned as prospective and randomized. For the study, patients will be randomized into two groups as unilateral and bilateral suture sacro-hysteropexy operations.

Detailed description: The study was planned as prospective and randomized. For the study, patients will be randomized into two groups as unilateral and bilateral suture sacro-hysteropexy operations.Computerized random number table will be used as randomization method. Patients who agree to participate in the study and fulfill the inclusion criteria will be evaluated on the effects of prolapse on quality of life and sexual function before and after the surgical procedures and their complaints and satisfaction will be questioned. Surgical success and complications will be evaluated. Changes in the level of prolapse will be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Patients between the ages of 18-60
2. No previous prolapse surgery
3. Not having a chronic disease
4. Having stage 3-4 prolapse

Exclusion Criteria:

1. Outside the age range of 18-60 years
2. Previous prolapse surgery
3. Having early stage (1-2) prolapse
4. History of chronic disease

Primary outcomes:
measure: anatomical success of the operations
timeFrame: changes at 1 and 3 months after surgery
Secondary outcomes:
measure: evaluation of the sexual functions of the patients
timeFrame: changes at 1 and 3 months after surgery
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University
state: Palandöken
Study officials:
affiliation: Ataturk University
name: Gamze Nur Cimilli Senocak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04534088: A Virtual-reality Based Approach to Improve Behavioral Weight Management Outcomes
Official title: A Virtual-reality Based Approach to Improve Behavioral Weight Management Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lead sponsor: California Polytechnic State University-San Luis Obispo
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A pilot randomized trial was done to test the feasibility integrating virtual reality (VR) into standard behavioral weight loss treatment.

Detailed description: Participants with overweight or obesity are randomly assigned to a 4-week Standard Behavioral Weight Loss plus Non-Weight-Related VR app (i.e., Control Group) or Standard Behavioral Weight Loss plus Weight-Related VR app (i.e., Intervention Group). The Intervention's VR tool was designed to enable practice of behavioral skills taught in weekly group meetings, including managing social and home environmental cues for eating and activity.

Eligibility criteria: Inclusion Criteria:

Non-pregnant Adults (age \> 18 years) Overweight or obesity (BMI ≥ 25) Able to speak and read in English. Available on Thursday evenings Have an iPhone 6 or higher

Exclusion Criteria:

Self-reported serious psychological problems or medical problems

Primary outcomes:
measure: Intervention Satisfaction
timeFrame: 4 weeks
Secondary outcomes:
measure: Proportion of participants retained
timeFrame: 4 weeks
Other outcomes:
measure: weight loss
timeFrame: 4 weeks
Locations:
city: San Luis Obispo
country: United States
facility: Cal Poly
state: California
Study officials:
affiliation: Cal Poly Dept. KPH
name: Suzanne Phelan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phelan S, Peruvemba S, Levinson D, Stulberg N, Lacy A, Legato M, Werner JP. Feasibility of a virtual reality-based approach to improve behavioral weight management outcomes. Pilot Feasibility Stud. 2021 Jun 22;7(1):129. doi: 10.1186/s40814-021-00865-5.
Clinical trial NCT04020588: Anti-inflammatories and Adolescent Schizophrenia
Official title: Effect of Anti-inflammatory Treatments on the Symptoms, Cognition, and Functioning of Adolescents With Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Schizophrenia
Keywords: schizophrenia
adolescents
inflammation
anti-inflammatory
Lead sponsor: Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico
Sponsor class: OTHER_GOV
First posted: 2019-07-16
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A double-blind controlled trial assessing the efficacy of anti-inflammatories on symptoms and cognition of adolescents with schizophrenia

Detailed description: Patients will be evaluated to confirm the diagnosis of schizophrenia, duration of the disease and record a history of atopic diseases or recurrent infections throughout life. The PANSS, PSP, and MCCB battery scales will be administered. A blood sample will be taken for the determination of markers of inflammation before the start of pharmacological treatment.

Patients will start the antipsychotic medication assigned by their treating physician. They will also be assigned randomly to the treatment arm. The study drug will be provided by the research team under the presentation of capsules containing Celecoxib 200 mg, Minocycline 100 mg or Placebo, and patients will be instructed to take one capsule every 12 hrs daily.

The patient will be reassessed with PANSS, PSP, and MCCB after completing 6 weeks of pharmacological treatment, type and dose of medication will be recorded and serum markers of inflammation will be determined again.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia or schizophreniform disorder.
* Patients in their first psychotic episode or previously diagnosed
* No specific pharmacological treatment (antipsychotic at therapeutic doses in regular doses) in the previous two weeks.
* Have a responsible parent or guardian.

Exclusion Criteria:

* Active infection

  * Chronic somatic diseases, including autoimmune diseases
  * Comorbidity with anorexia, substance use disorders
  * Pregnancy
  * Use of anti-inflammatory medications or antibiotics

Primary outcomes:
measure: Symptom severity: Positive and Negative Syndrome Scale score
timeFrame: six weeks
measure: Cognition: MATRICS Consensus Cognitive Battery (MCCB) scores
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital Psiquiatrico Infantil
state: Ni Ee.uu. Ni Canadá
Study officials:
References: