louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05428098: The Effect of the Educatıon and Counselıng of Prostatectomy Patıents
Official title: The Effect of educatıon and counselıng gıven to patıents patıent wıth Prostatectomy on qualıty of lıfe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Surgery
Nursing Caries
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The research was planned as a randomized controlled experimental study. This study is planned to be conducted in the Urology clinic of a university hospital located in the south of Turkey. The population of the research will be the patients admitted to the urology clinic for prostatectomy. The sample of the study will consist of patients who meet the criteria for participation in the study and volunteer to participate in the study. Evaluation of the research data will be done with the SPSS package program.


Eligibility criteria: Inclusion Criteria:

* Being 18 years or older,
* Being literate,
* Being able to understand and speak Turkish and not have a hearing impairment,
* Agreeing to participate in the research.

Exclusion Criteria:

* Development of any complications during the surgical intervention,
* Having any psychiatric disorder that will reduce the ability to comprehend and understand,
* Having other concomitant cancer,
* Having metastases.

Primary outcomes:
measure: Effect of traınıng and counselıng gıven after prostatectomy on qualıty of lıfe
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
References:
Clinical trial NCT06988098: The Effect of Different Deproteinising Agents on the Clinical Success of Fissure Sealants in Permanent Teeth
Official title: Evaluation of the Effect of Different Deproteinizing Agents on the Clinical Success of Fissure Sealants in Permanent Teeth: Splint Mouth Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fissure Sealant
Keywords: Deproteinization Agents
Sodium Hypochlorite
Hypochlorous Acid
fissure sealent
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigation of the effect of deproteinization agents on the clinical success of non-invasive fissure sealant application, which is a non-invasive method used to prevent caries formation or to stop the progression of initial caries lesions limited to enamel on tooth surfaces thought to be at high risk of caries.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 6-9 who do not have any systemic problems
* Have a score of 3 and 4 on the Frankl Behavior Scale
* Do not have a habit of clenching and/or grinding their teeth
* Have newly erupted permanent lower first molars without caries
* Have an indication for fissure sealant application

Exclusion Criteria:

* Teeth with fissure sealants
* Teeth with developmental defects such as hypoplasia
* Teeth with approximal or incipient caries lesions on one or both mandibular first permanent molars
* Children who are not systemically healthy
* Uncooperative children with scores of 1 and 2 on the Frankl Behavior Scale
* Children and parents who refuse to attend follow-up appointments
* Children with parafunctional habits such as teeth grinding

Primary outcomes:
measure: Modified Simonsen Criteria
timeFrame: Following the sealant application, controls will be made at 6, 12, 24 and 36 months.
Secondary outcomes:
measure: Edge Integrity Evaluation Criteria
timeFrame: Following the sealant application, controls will be made at 6, 12, 24 and 36 months.
Other outcomes:
measure: Marginal Coloration Evaluation Criteria
timeFrame: Following the sealant application, checks will be made at 6, 12, 24 and 36 months
measure: Anatomical Form Evaluation Criteria
timeFrame: Following the sealant application, checks will be made at 6, 12, 24 and 36 months
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpaşa University
Study officials:
References:
citation: Feigal RJ, Musherure P, Gillespie B, Levy-Polack M, Quelhas I, Hebling J. Improved sealant retention with bonding agents: a clinical study of two-bottle and single-bottle systems. J Dent Res. 2000 Nov;79(11):1850-6. doi: 10.1177/00220345000790110601.
citation: Simonsen RJ. Retention and effectiveness of dental sealant after 15 years. J Am Dent Assoc. 1991 Oct;122(10):34-42. doi: 10.14219/jada.archive.1991.0289.
Clinical trial NCT01115998: Effect of Power Wheelchairs on the Development and Function of Young Children With Severe Physical Disabilities
Official title: Learning Early Travel Skills: Effects of Power Mobility on the Development of Young Children With Severe Motor Impairments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Palsy
Child, Preschool
Keywords: cerebral palsy
wheelchair
disabled children
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2010-05-04
Enrollment: 34
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Self-produced locomotion often is limited in children with cerebral palsy and other conditions that cause severe motor impairments. As a result, these children may be at risk for secondary impairments in spatial cognition, communication, social development, and other domains influenced by independent mobility. To compensate, power mobility has increasingly been advocated for young children with severe motor impairments. The study hypotheses were:

1. Children with severe disabilities that prevent independent locomotion who learn to use power mobility devices when they are 14- to 30-months-of-age will have greater communication, social, and cognitive development over a 12-month period, and will demonstrate more competent coping skills than children with the same characteristics who do not use power mobility.
2. Parents of children who use power mobility will view it as a positive influence on their children's lives, and will perceive their children's development to be more mature than the parents of children who do not use power mobility will perceive their children's development.

Detailed description: More extensive description is not desired.

Eligibility criteria: Inclusion Criteria:

* Age 14 to 30 months
* Motor impairment that prevents functional independent mobility
* Vision and hearing adequate to use a power mobility device safely.
* Cognitive abilities assessed to be at least equivalent to a 12-month level or alertness and interest in the environment that suggests a trial of power mobility is warranted.

Primary outcomes:
measure: Pediatric Evaluation of Disability Inventory
timeFrame: Baseline and 12 months
measure: Battelle Developmental Inventory (BDI)
timeFrame: Baseline and 12 months
measure: Early Coping Inventory
timeFrame: Baseline and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Irene R McEwen, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mockler SR, McEwen IR, Jones MA. Retrospective Analysis of Predictors of Proficient Power Mobility in Young Children With Severe Motor Impairments. Arch Phys Med Rehabil. 2017 Oct;98(10):2034-2041. doi: 10.1016/j.apmr.2017.05.028. Epub 2017 Jul 5.
Clinical trial NCT04512898: Helicobacter Pylori Eradication and Irritable Bowel Syndrome: A Prospective Study
Official title: Effect of Helicobacter Pylori Eradication on Symptoms and Quality of Life of Irritable Bowel Syndrome: A Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with IBS and have H. pylori
Primary purpose: TREATMENT

Brief summary: H. Pylori is frequently observed in patients with irritable bowel syndrome(IBS). However, the effect of H. pylori eradication on IBS is not clear.

Detailed description: Patients with IBS symptoms using Rome IV criteria will be included. Testing for H. pylori will be done. Patients with H. pylori will receive triple therapy and followed after two weeks for eradication and assessment of IBS symptoms.

Eligibility criteria: Inclusion Criteria:

* Patients newly diagnosed with IBS and H.pylori

Exclusion Criteria:

* Patients received previous treatment of H.pylori
* Patients receiving treatment for IBS.

Primary outcomes:
measure: Questionnaire for Rome IV criteria
timeFrame: 2 weeks
Secondary outcomes:
measure: Quality of life questionnaire
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03176498: Human Umbilical Cord Mesenchymal Stem Cell Therapy (19#iSCLife®-CI) for Cerebral Infarction Patients in Convalescent Period.
Official title: The Effects of Human Umbilical Cord Mesenchymal Stem Cell Therapy on Neurological Function for Cerebral Infarction Patients in Convalescent Period.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Cerebral Infarction
Keywords: cerebral Infarction
umbilical cord mesenchymal stem cells
Lead sponsor: Sclnow Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-05
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind study. Human umbilical cord mesenchymal stem cells (hUC-MSC) will be treated on cerebral infarction patients, and evaluates their neurological function of convalescent period.

Detailed description: 40 participants will be selected based on eligibility criteria and collected information, then, randomly separated into two groups. All participants will sign informed consent form, monitor vital signs, laboratory examination (CT/MRI, blood routine examination, urine routine examination, liver function, renal function, etc.), NIHSS, Fugl-Meyer analysis (FMA) 0-3 days before treatment. All of them will receive basic treatment with Aspirin Enteric-coated Tablets and Atorvastatin Calcium. And experimental group will treat with hUC-MSC, control group with placebo (normal saline) on the 7th and 14th day. After the treatment, investigator will follow-up, monitor vital signs, laboratory examination, NIHSS, FMA analysis on 2 weeks, 1 month, and 6 months after the treatment.

Eligibility criteria: Inclusion Criteria:

* proved cerebral infarction by CT or MRI.
* no cerebrovascular disease before
* signed informed consent form

Exclusion Criteria:

* serious body and intracranial lesions (tumor, infection, etc.)
* patients repeated cerebral infarction attacks
* multi-foci of cerebral infarction
* history of drug dependence and mental disease
* disturbance of consciousness and non-compliance patients
* subjects who are HIV positive
* pregnant or lactation
* donor: HIV infected, Active hepatitis B/C infected, Syphilis antibody positive
* subjects/ donor: alcoholism, drug addicts or mental disease

Primary outcomes:
measure: Motor function analysis
timeFrame: 6 months
Secondary outcomes:
measure: Neurological deficits analysis
timeFrame: 6 months
measure: Limb motor function analysis
timeFrame: 6 months
measure: Barthel Index analysis
timeFrame: 6 months
Other outcomes:
Locations:
city: Hohhot
country: China
facility: Inner Mongolia International Mongolian Hospital
state: Inner Mongolia
Study officials:
affiliation: Inner Mongolia International Mongolian Hospital
name: Wulan
role: STUDY_DIRECTOR
affiliation: China-Japan Union Hospital, Jilin University
name: Lei Guo, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT01342198: An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release Tablet
Official title: A Phase 1, Open-Label, Randomized, Cross-Over Study to Evaluate the Effects of Multiple Doses of Erythromycin on the Pharmacokinetics of a Single Dose of Pregabalin Controlled Release in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pregabalin
pharmacokinetics
bioavailability
bioequivalence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-04-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet with and without coadministration of erythromycin and 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet with and without coadministration of erythromycin.

Detailed description: Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet with and without erythromycin

Eligibility criteria: Inclusion Criteria:

* Healthy male or females
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Illicit drug use
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Primary outcomes:
measure: Area under the curve from 0 to infinity (AUCinf)
timeFrame: 3 days
measure: Peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) alone and CR with erythromycin
timeFrame: 3 days
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 3 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05732298: Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant Treatment
Official title: Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled trial in which 72 patients with depressive disorder were treated in two study arms using the non-invasive brain stimulation method of intermittent thetaburst intermittent theta burst stimulation (iTBS).

This is a wait-list control study, and the arms differ in the start of the four-week treatment (either promptly i.e., at the beginning of the next week of work) or delayed (start of treatment in four weeks).

The patients to be treated are those who refuse treatment with antidepressant medications.

The effectiveness of the four-week iTBS treatment is to be evaluated in comparison to a "watchful waiting" after 4 weeks.

A interim analysis is planned after 36 patients.


Eligibility criteria: Inclusion Criteria:

* uni- or bipolar depression according to ICD-10
* present episode at least four weeks
* 18-70 years old
* no intake and rejection of anti-depressant medication and
* no adequate anti-depressant medication in the present episode
* no or stable non-drug anti-depressant treatment (e.g. psychotherapy)
* residency in Germany, German speaking

Exclusion Criteria:

* contraindications for transcranial magnetic stimulation (electric devices or metal parts in the body such as pacemaker
* relevant neurological or internistic diseases according to study investigator
* participation in other trials during treatment
* pregnancy or breatfeeding
* legal care and placement in a psychiatric hospital
* active suicidality

Primary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: 20 weeks
measure: Major Depression Inventory
timeFrame: 20 weeks
measure: World Health Organisation quality of life bref
timeFrame: 20 weeks
measure: State Trait Anxiety Inventory
timeFrame: 20 weeks
measure: clinical global impression
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Department of Psychiatry and Psychotherapy
Study officials:
affiliation: University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum
name: Berthold Langguth, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01723098: Effect of Regular Exercise on Maternal Cardiovascular System During Pregnancy
Official title: Effect of Supervised Exercise Program on Cardiovascular Function and Structure in Pregnant Women. Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Keywords: Pregnancy, cardiovascular system, physical exercise
Lead sponsor: Technical University of Madrid
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main aim of this study was to analysed the security of a supervised exercise program on maternal cardiovascular system and assess the positive effects of this program on maternal cardiovascular function and structure

Detailed description: During pregnancy, the effectiveness of cardiovascular system is necessary to the growth and development of the baby, however many changes in it occur during this period.

Physical exercise has shown to have a positive effect on cardiovascular structure and function in the general population.

Eligibility criteria: Inclusion Criteria:

* Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
* Being able to communicate in spanish
* Giving birth at Hospital Universitario de Fuenlabrada and Hospital Universitario Severo Ochoa (Madrid).

Exclusion Criteria:

* Multiparity
* Obstetrician complications
* Being interested in the study after 18 weeks
* Not being regular in physical exercise program
* Younger than 18 years old

Primary outcomes:
measure: Change from cardiovascular function at the end of pregnancy: Stroke volume
timeFrame: Weeks 20 and 34
measure: Change from cardiovascular structure at the end of the pregnancy
timeFrame: Weeks 20 and 34
Secondary outcomes:
measure: Maternal and fetal pregnancy outcomes
timeFrame: During pregnancy. At the moment of delivery.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Politecnica de Madrid
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Ruben Barakat, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06588998: Xengenic Cortical Membranes Versus Connective Tissue Graft With Coronally Advanced Flap for the Treatment of Peri-implant Soft Tissue Dehiscences: A Randomized, Controlled Clinical Trial
Official title: Xengenic Cortical Membranes Versus Connective Tissue Graft With Coronally Advanced Flap for the Treatment of Peri-implant Soft Tissue Dehiscences: A Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Immediate Implant
Connective Tissue Graft
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Peri-implant soft tissue dehiscences represent a common complication in implant dentistry, often leading to esthetic and functional challenges. Current treatment options, including Xengenic cortical membranes and connective tissue graft with coronally advanced flap, aim to promote soft tissue regeneration and improve clinical outcomes. However, there is a need for comparative studies to determine the optimal treatment modality for peri-implant soft tissue dehiscences.

Detailed description: Aim: Comparing the effectiveness and patient outcomes of Xengenic cortical membranes versus connective tissue graft with coronally advanced flap for the treatment of peri-implant soft tissue dehiscences.

Eligibility criteria: Inclusion Criteria:

* Adults (20-50) years old. •peri-implant soft tissue dehiscence . •Thin gingival phenotype. •Optimal compliance as evidenced by no missing treatment appointments and positive attitude towards oral hygiene.

Exclusion Criteria:

* •Medically compromised patients and systemic conditions precluding implant and periodontal surgery. •Smokers, diabetics, pregnant or lactating women. •History of chemotherapy, radiotherapy in head and/or neck region. •Bisphosphonate therapy.

Primary outcomes:
measure: peri implant soft tissue thickness
timeFrame: six months
Secondary outcomes:
measure: pink esthetic score
timeFrame: six months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: TantaU
state: Gharbia
Study officials:
References: