louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00845013: Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension
Official title: Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Pulmonary Hypertension
Endothelial Function
HIV Infections
Keywords: HIV infection
pulmonary hypertension
endothelial function
antiretroviral medication
Treatment Experienced
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-02-16
Enrollment: 365
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: HIV infected individiuals with the clinical diagnosis of pulmonary hypertension or who have mildly elevated pulmonary arterial pressures

Brief summary: The purpose of this study is to describe the epidemiology of pulmonary hypertension in individuals with HIV infection and to investigate its pathogenesis. We propose to conduct a prospective observational cohort study to determine the association between highly active antiretroviral therapy (HAART) and viral suppression in HIV-infected patients who have been identified to have pre-clinical pulmonary hypertension (Aim 1). In addition, we will investigate the mechanistic role of the HIV-1 Nef protein and HHV-8 infection in the development and progression of pulmonary hypertension in individuals with HIV (Aim 2). We will also investigate endothelial function in HIV-infected patients with pulmonary hypertension (Aim 3).


Eligibility criteria: Inclusion Criteria:

1. Infection with HIV greater than 6 months in duration
2. Right heart catheterization showing PASP \> 30mm Hg
3. Ability to provide reliable history of HIV medications or has received the majority of medical care from San Francisco General Hospital with available records of medical treatment.
4. Ability to participate in follow-up for the duration of the study.

Exclusion Criteria:

1. Known significant cardiovascular disease, including clinically significant valvular heart disease, congenital heart disease, current or prior symptomatic coronary disease, or known cardiomyopathy.
2. Any known pulmonary disease that could potentially cause pulmonary hypertension.
3. A pO2 by pulse oximetry below 90% on room air.
4. Obstructive sleep apnea.
5. Known collagen vascular disease.
6. History of anorexigen use

   * 7. Age less than 18 years old.
   * 8. Other co-morbidities for which the investigators, in conjunction with the primary care provider, believe render the participant with an expected survival of 6 months or less.

Primary outcomes:
measure: pulmonary artery pressure
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Priscilla Hsue, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02828813: Neural Mechanisms of Motor and Cognitive Networks
Official title: Neural Mechanisms of Motor and Cognitive Networks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Volunteers
Cognition Disorders
Motor Disorders
Lead sponsor: National Research Center for Rehabilitation Technical Aids
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 120
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers: Advertising recruitment Persons with cognitive impairments: from inpatients and outpatients Persons with motor deficits: from inpatients and outpatients

Brief summary: This study investigates the neural mechanisms of motor and cognitive networks using cognitive assessment, reaction time measurement, high-density EEG and fMRI.


Eligibility criteria: Inclusion Criteria (for healthy people):

* right handed,
* no history of psychological/psychotic problems,
* no history of important diseases.

Exclusion Criteria (for healthy people):

* Being Pregnant or breast feeding
* having any non-MRI compatible conditions

Inclusion Criteria (for patients):

* right handed
* in a stable condition
* ability to follow complex commands

Exclusion Criteria (for patients):

* having any non-MRI compatible conditions
* inability to perform required tasks

Primary outcomes:
measure: cognitive assessment scores
timeFrame: within one week
Secondary outcomes:
Other outcomes:
measure: reaction time measurement
timeFrame: within one week
measure: EEG
timeFrame: within one week
measure: fMRI
timeFrame: within one week
Locations:
city: Beijing
country: China
facility: National Research Center for Rehabilitation Technical Aids
Study officials:
affiliation: National Research Center for Rehabilitation Technical Aids
name: PX Wei, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02202213: Safety and Tolerability Study of Lu AF11167 After Repeated Dosing in Patients With Schizophrenia
Official title: Interventional, Randomised, Double-blind, Placebo Controlled, Multiple-dose Study Investigating the Safety, Tolerability, PK and PD Properties of Lu AF11167 in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2014-07-28
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of Lu AF11167 in patients with schizophrenia following various repeated dosing regimens of Lu AF11167 (alone or as added treatment to risperidone).


Eligibility criteria: Inclusion Criteria:

* Man or woman aged ≥18 years and ≤60 years with a body mass index (BMI) of ≥18.5 and ≤38 m2
* Primary diagnosis of schizophrenia according to DSM-IV-TR™ (codes 295.10, 295.20, 295.30, 295.90)
* Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill) at the Screening Visit and Baseline Visit (Day -1)
* PANSS total score ≤80 at the Screening Visit and the Baseline Visit (Day -1)
* Score of 4 (moderate) of the following PANSS items at the Screening Visit and the Baseline Visit (Day -1): P7 (hostility), G8 (uncooperativeness)
* Minimal level of extrapyramidal signs, defined as a score ≤5 (moderately severe) in any of the four Clinical Global Impression of Severity (CGI-S) items of the ESRS-A; parkinsonism, akathisia, dystonia, and tardive dyskinesia at the Screening Visit and the Baseline Visit
* Willingness to be hospitalised for approximately 3 weeks after the Baseline Visit (Day -1)

Exclusion Criteria:

* The patient experienced an acute exacerbation requiring hospitalization within the last 6 months
* The patient experienced an acute exacerbation requiring increase in antipsychotic medication (with reference to drug or dose) within the last 4 weeks

Other pre-defined inclusion and exclusion criteria may apply

Primary outcomes:
measure: Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs,respiratory rate, weight, body temperature and ECG)
timeFrame: Screnning to day 25
Secondary outcomes:
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Screening to day 25
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Parexel International
state: California
Study officials:
affiliation: LundbeckClinicalTrials.com
name: Email contact via H.Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT06163313: Protocol No. 2016 - Calculosis- Endourology;
Official title: Retrospective and Prospective Study of Patients Suffering From Nephrolithiasis Undergoing Surgery Using a Minimally Invasive Endoscopic Approach.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Calculosis
Keywords: calculosis
calculi
endourologia
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 15000
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: Patients suffering from kidney stones who undergo endoscopic surgery

Brief summary: Retrospective and prospective study on patients suffering from nephrolithiasis who undergo minimally invasive surgery of the upper excretory system; correlation between the phenotypic and genotypic aspects of the patients and the stone pathology treated with an endoscopic surgical approach.

Detailed description: Clinical data will be collected from patients suffering from kidney stones before and after surgery, in order to demonstrate how the endoscopic approach can not only be effective in treating kidney stones but also reduce operative complications.

These data will be collected in a database in order to be able to perform statistical analyzes useful for demonstrating our theory.

Furthermore, data from the surgery will be collected regarding the endoscopic instruments used and the intraoperative findings (site, size, appearance of the stone), degree of calcification of the renal papillae.

All this in order to improve the therapeutic approach to patients suffering from stones and reduce the risk of recurrence over time through the identification of genetic expression patterns that predispose to the expression of the stone phenotype.

Eligibility criteria: Inclusion Criteria:

* subjects suffering from kidney stones or tumors of the upper excretory tract \>= 18 years
* signature of informed consent

Exclusion Criteria:

* subjects \< 18 years
* presence of mental or physical disability that may prevent the patient from answering the questionnaires.

Primary outcomes:
measure: Clinical data
timeFrame: Baseline and after 6 months
measure: Eating habits
timeFrame: Baseline and after 6 months
measure: Prostatic Function
timeFrame: Baseline and after 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Lombardy
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Andrea Salonia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01363713: A Long-term Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis
Official title: A Long-term Open-label Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3 -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-06-01
Enrollment: 130
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Safety and efficacy of DE-114 ophthalmic solution will be evaluated in patients with allergic conjunctivitis, in an open-label, multicenter study.


Eligibility criteria: Inclusion Criteria:

* Provided signed, written informed consent.
* Has a positive result from a Type I allergy test.
* If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
* Presence of any abnormality or significant illness that could be expected to interfere with the study.

Primary outcomes:
measure: Change in Ocular Itching Score by Visit
timeFrame: From baseline to 8-week
Secondary outcomes:
Other outcomes:
measure: Change in Palpebral Hyperemia Score by Visit
timeFrame: From baseline to 8-week
measure: Change in Bulbar Conjunctiva Hyperemia Score by Visit
timeFrame: From baseline to 8-week
Locations:
city: Osaka
country: Japan
facility: Santen study sites
Study officials:
References:
Clinical trial NCT02737813: Cardiac Output Changes During Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Cesarean Section
Official title: Cardiac Output Changes During Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Cesarean Section: An Randomization Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Output
Hypotension
Anesthesia, Spinal
Keywords: isobaric marcaine
hyperbaric marcaine
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spinal block leads to the reduction of systemic vascular resistance (SVR) which may effect the cardiac output. Ngan Kee et al. has showed that spina block with 0.5% hyperbaric bupivacaine for Cesarean section combined with intravenous infusion norepinephrine had higher cardiac output than those who received phenylephrine


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology classification I - II
* Elective or urgency Cesarean section with spinal block e.g. cephalopelvic disproportion, premature rupture of membrane
* Singleton pregnancy
* Body mass index \< 40 kg/m2

Exclusion Criteria:

* Pregnancy \<35 weeks gestational age
* Hypertensive disease e.g. gestational hypertension, chronic hypertension, preeclampsia
* History of allergy to the study drugs

Primary outcomes:
measure: Change of cardiac output (L/min) after spinal block
timeFrame: 5 minutes after spinal block
Secondary outcomes:
measure: Total dose of vasopressor
timeFrame: 2 hours
measure: Number of patients who experience systolic blood pressure < 25% of preoperative measurement
timeFrame: 2 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Sirilak Suksompong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06848413: The Impact of an Arabic Educational Video on Reducing Ageism and Promoting Positive Attitudes Toward Older Adults Among Physical Therapists an Application of the PEACE Model
Official title: The Impact of an Arabic Educational Video on Reducing Ageism and Promoting Positive Attitudes Toward Older Adults Among Physical Therapists an Application of the PEACE Model
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Physiotherapy
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 110
Sex: ALL
Minimum age (years): 23
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Brief Summary The goal of this experimental study is to determine the effectiveness of implementing an Arabic education video intervention based on the Positive Education about Aging and Contact Experiences (PEACE) model in reducing ageism and anxiety, promoting positive attitudes, and increasing knowledge toward older adults and assessing the effect over time among physical therapists.

The main hypothesis:

The investigators hypothesize that an Arabic educational video intervention based on the PEACE model will significantly reduce ageism and anxiety and increase positive attitudes and knowledge about older adults, and the effectiveness will last over time among physical therapists.

Participants will:

* Complete an initial online survey assessing demographic and professional information, as well as measures of ageism, aging knowledge, anxiety about interactions with older adults, and positive and negative age stereotypes (Time-1).
* Watch a 7-minute Arabic video that includes (1) an animated segment addressing ageism and debunking stereotypes and (2) a live-action segment featuring older adults sharing personal stories to promote intergenerational contact (Time-2).
* Complete an attention check followed by the same outcome measures as in Time-1.
* Complete the same set of outcome measures one week later (Time-3) to assess any changes.


Eligibility criteria: Inclusion Criteria:

* Licensed Saudi physical therapists.

Exclusion Criteria:

* Students.
* Intern physical therapists.
* Physical therapy technicians.

Primary outcomes:
measure: Ageism Measure
timeFrame: Baseline in week 1 and after intervention in week 2.
measure: Aging Knowledge
timeFrame: Baseline in week 1 and after intervention in week 2.
measure: Anxiety about interacting with older adult
timeFrame: Baseline in week 1 and after intervention in week 2.
measure: Age stereotypes
timeFrame: Baseline in week 1 and after intervention in week 2.
Secondary outcomes:
Other outcomes:
measure: Attention Checks
timeFrame: After intervention in week 2.
Locations:
Study officials:
References:
Clinical trial NCT00613613: Fenofibrate and Pharmacogenetic Impact in Dyslipidemia
Official title: The Impact of Genetic Determinants of Fenofibrate's Pharmacogenetics on Lipid Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Laval University
First posted: 2008-02-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with dyslipidemia

Brief summary: The purpose of the study is to learn whether genetics plays a role in predicting response to a commonly used and FDA (Food and Drug Administration) approved medication for lowering triglycerides and cholesterol. The hypothesis: The pharmacogenetics of genes which affect drug metabolism (how the body handles the drug) and drug targets (how the drug acts on the body) influences how a person responds to the lipid lowering medication-fenofibrate.

Detailed description: The investigators seek to screen over 200 subjects for select candidate genes to serve as a source of subjects which may participate in a genotype guided investigation as to the predictability of response based on genotype. Response endpoints relate to lipid parameters and other variables of interest to cardiovascular endpoints. Subjects with genotypes of interest would then be enrolled into a short term clinical trial evaluating their response to fenofibrate based on their genetic profile ascertained from the screening phase.

Eligibility criteria: Inclusion Criteria:

* 18-75 year old
* Be willing to participate in the study and attend the scheduled clinic exams
* Consent to taking lipid lowering therapy for 4 weeks and if necessary discontinue lipid lowering agents for a period of 8 weeks

Exclusion Criteria:

* \<18 years of age
* History of liver, kidney, pancreas, pancreatitis, gall bladder disease or malabsorption (Crohn's disease etc.)
* Use of insulin or currently taking warfarin
* Pregnant women or women of childbearing potential not using an acceptable form of contraception
* History of an allergy or hypersensitivity to fenofibrate
* Investigational drug use within 30 days of the study
* A disease that, in the opinion, of the PI, would put the subject at risk during the study

Primary outcomes:
measure: Pharmacokinetics- serum concentration of fenofibric acid AUC (0-24hrs) for high vs low metabolizers
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Robert J. Straka
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05181813: Treatment of Infected Pulp in Primary Teeth With a Mixture of Calcium Hydroxide and Gingerols
Official title: Clinical Evaluation of Calcium Hydroxide Mixed With Gingerols Versus Metapex in Treatment of Primary Teeth With Infected Necrotic Pulp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Teeth
Pulp Necroses
Infected Pulp
Root Canal Treatment
Keywords: Pediatric Dentistry
Pulpectomy
Infected Pulp
Necrotic Pulp
Gingerols
Calcium Hydroxide
Metapex
Ginge-Cal
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Selected children will be divided randomly into 2 groups:

Group 1: Ginge-Cal group: primary molars were filled with a creamy mixture of pulpectomy paste of Gingerols and Calcium Hydroxide.

Group 2: Metapex group: primary molars were filled with a ready-made injectable creamy mixture pulpectomy paste of Metapex.
Primary purpose: TREATMENT

Brief summary: This study was conducted to evaluate Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp

Detailed description: Study compare Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp clinically and radiographically

Eligibility criteria: Inclusion Criteria:

1. The cooperation of the child and parents, during the treatment plan, and the commitment to attend the follow-up appointments.
2. Parents signed the consent to participate in the study.
3. Absence of any systemic disease, which would contraindicate pulp therapy.
4. Child didn't have any history of a sensitive reaction to any component of used materials.
5. Present half to two third of tooth root or more
6. Root with signs or symptoms of infected necrotic pulp or chronic abscess, with or without sinus tract, soft tissue swelling, mobility or tenderness to percussion, and internal or external root resorption or unsuccessful past pulp treatment.

Exclusion Criteria:

All that does not correspond to inclusion criteria.

Primary outcomes:
measure: Percentage of primary teeth with control necrotic pulp by clinical examination
timeFrame: Up to 18 months
measure: Percentage of primary teeth with control necrotic pulp by radiographic examination
timeFrame: Up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry
state: Dakahlia
Study officials:
affiliation: Assistant Professor of Pediatric Dentistry Faculty of Dentistry Thamar University Yemen
name: Fathi A Qasem, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University
name: Salwa M Awad, Prof
role: STUDY_DIRECTOR
affiliation: Lecturer of Pediatric Dentistry Faculty of Dentistry Mansoura University
name: Rizk A ELagamy, PhD
role: STUDY_DIRECTOR
References: