louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04937114: Unidirectional Barbed Sutures in Mucogingival Procedures
Official title: Efficacy of Unidirectional Barbed Sutures on Various Outcomes in Mucogingival Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Heal
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the efficacy of barbed suture with conventional suture in muco-gingival surgeries.

Detailed description: Experimental: Main treatment group, flap will be approximated using conventional, simple continuous suturing with barbed sutures.

Comparator: In patients allocated to control group, flap will be approximated using conventional, simple continuous suturing with conventional sutures.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy individuals within an age group of 20-50yrs with presence of attached gingiva, shallow vestibule and frenum interfering with the marginal gingiva.

Exclusion Criteria:

* Medically compromised patients.
* Subjects who underwent radiotherapy or chemotherapy in the past 12 months.
* Smokers

Primary outcomes:
measure: To assess primary wound closure
timeFrame: Baseline to 21days
Secondary outcomes:
measure: To assess pain
timeFrame: Baseline to 21days
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: SVS Institute of Dental Sciences, Mahabubnagar
state: Telangana
Study officials:
References:
Clinical trial NCT02373514: IV Paracetamol Versus IV Dexketoprofen in Dysmenorrhea
Official title: Intravenous Paracetamol Versus Intravenous Dexketoprofen in Patients Presented With Dysmenorrhea in Emergency Department
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dysmenorrhea
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 100
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: Patients presented with dysmenorrhea composed the study population. One gram paracetamol and 50 mg dexketoprofen in 100 ml saline with a rapid infusion were compared in ceasing dysmenorrhea in emergency department.

Detailed description: Patients over 18 years old who presented with dysmenorrhea composed the study population. Patients received pain killer within the last six hours, physical findings consistent with peritoneal irritation, allergy to the study drugs, renal or liver failure, drug addiction, pregnancy or woman with lactation and denied to give inform consent were the exclusion criteria. The pain of the study patients are measured with visual analogue scale at baseline, 15th and 30th minutes. At the end of the 30 minutes, rescue drug need is also recorded.

Eligibility criteria: Inclusion Criteria:

* Patients with dysmenorrhea
* Patients over 18 years old

Exclusion Criteria:

* denied to give inform consent
* Renal or liver failure
* Allergy to the study drugs
* Receiving pain killer within the last 6 hours.
* Physical examination findings consistent with peritoneal irritation
* Pregnancy or patients with lactation
* Drug addiction

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 15 minutes
measure: Visual Analogue Scale
timeFrame: 30 minutes
Secondary outcomes:
measure: Rescue drug need
timeFrame: 30 minutes
measure: Adverse effects
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Mustafa Serinken, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00625014: Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Haloperidol in Healthy Humans
Official title: Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Haloperidol in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Dyslipidemia
Keywords: Insulin resistance
Dyslipidemia
Haloperidol
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Diabetes Research Foundation
First posted: 2008-02-28
Enrollment: 8
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: We hypothesized that short-term treatment with haloperidol induces insulin resistance through a mechanistic route that is independent of weight gain. We therefore treated healthy non-obese men with haloperidol for 8 days, and studied the impact of these intervention on glucose and lipid metabolism by hyperinsulinemic euglycemic clamp, isotope dilution technology and indirect calorimetry.


Eligibility criteria: Inclusion Criteria:

* Healthy men
* 20 kg/m2 \< BMI \< 26 kg/m2
* Age 20-40 years
* FPG \< 6 mmol/L

Exclusion Criteria:

* FPG \> 6 mmol/L
* BMI \> 26 kg/m2
* Psychiatric disorders and/or use of antipsychotic or antidepressants drugs at present or in the past.
* A positive family history of schizophrenia
* Any significant chronic disease
* Renal, hepatic or endocrine disease
* Use of medication known to influence lipolysis and/or glucose metabolism
* Total cholesterol \> 7mmol/L and/or triglycerides \> 2 mmol/L
* Recent weight changes or attempts to loose weight (\> 3 kg weight gain or loss, within the last 3 months)
* Difficulties to insert an intravenous catheter
* Smoking (current)
* Severe claustrophobia (ventilated hood)
* Recent blood donation (within the last 2 months)
* Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
* Extensive sporting activities (more than 10 hours of exercise per week)

Primary outcomes:
measure: To determine the effect of subchronic haloperidol treatment on HGO, whole body peripheral glucose disposal, fatty acid flux and fuel oxidation.
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
References:
Clinical trial NCT00004814: Phase III Randomized, Double-Blind, Placebo-Controlled Study of Copolymer 1 for Relapsing-Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Maryland
First posted: 2000-02-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Compare tolerance to and therapeutic impact of copolymer 1, a mixture of synthetic polypeptides, with placebo in patients with relapsing-remitting multiple sclerosis.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.

One group receives copolymer 1, a mixture of synthetic polypeptides composed of 4 amino acids, subcutaneously each day for 2 years.

The other group receives an injection of placebo daily for 2 years.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Clinically or laboratory-supported definite multiple sclerosis
* Neurologically stable for at least 30 days prior to entry Expanded Disability Status Scale score no greater than 5
* At least 2 documented relapses within 2 years prior to entry Onset of first relapse at least 1 year prior to randomization

--Prior/Concurrent Therapy--

* Biologic therapy: No prior copolymer 1
* Immunosuppressive therapy: No prior cytotoxic immunosuppressives, i.e.: Azathioprine Cyclophosphamide Cyclosporine At least 30 days since corticosteroids
* Radiotherapy: No prior lymphoid irradiation

--Patient Characteristics--

* Not HIV or HTLV-I seropositive No insulin-dependent diabetes mellitus No Lyme disease No requirement for aspirin or chronic nonsteroidal anti-inflammatory drugs No pregnant or nursing women Adequate contraception required of fertile women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Maryland
name: Kenneth P. Johnson
role: STUDY_CHAIR
References:
Clinical trial NCT05724914: Call to Door Timing in Out-of-hospital Cardiac Arrest
Official title: Clinical Impact in Patients With Delayed Hospitalization in Patients With Out-of-hospital Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Morality
Keywords: Cardiac arrest
Mortality
Timing
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 182508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac arrest with cardiopulmonary resuscitation

Brief summary: The investigators aimed to investigate the effect of delayed hospitalization on the basis of the call time on the clinical outcomes of patients with OHCA patients using a nationwide OHCA registry.

Detailed description: According to "2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care", immediate call for the local emergency response number takes a key role in the OHCA as the CPR in community does not provide quality of in-hospital CPR. The strong recommendation of speedy transportation, however, does not provide time limitation, and evident data supporting benefit within certain minutes to transfer is lack through our best of search. Therefore, The investigators aimed to investigate the effect of delayed hospitalization on the basis of the call time on the clinical outcomes of patients with OHCA patients using a nationwide OHCA registry.

Eligibility criteria: Inclusion Criteria:

* Out-of-hospital cardiac arrest event

Exclusion Criteria:

* Arrest of non-cardiac origin
* Age \< 18 years
* No any CPR
* Missing data on call time

Primary outcomes:
measure: Death from any cause at hospital discharge
timeFrame: up to 30 days
Secondary outcomes:
measure: Poor neurological outcomesat hospital discharge
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital
state: Giheung-gu
Study officials:
affiliation: Severance Hospital, Yonsei University College of Medicine
name: Yongcheol Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05807295: The Effect of Relaxation Program on Coping With Stress and Anxiety Levels of Caregivers of Children With Cancer.
Official title: The Effect of Relaxation Program on Coping With Stress and Anxiety Levels of Caregivers of Children With Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caregivers With a Child Followed up With a Cancer Diagnosis
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research will be carried out to determine the effect of the relaxation program applied to the caregivers of children followed by the diagnosis of cancer on the levels of caregivers' anxiety and coping with stress. The research will be conducted in a single-blind parallel-group randomized controlled trial design. A relaxation program including progressive muscle relaxation exercises will be applied to caregivers. The application will be carried out by sending muscle relaxation videos and videos for relaxation to mothers. The relaxation program is planned to last approximately 6 weeks

Detailed description: In this study, a relaxation program will be applied to mothers who have a child followed up with a cancer diagnosis. The relaxation program will include progressive muscle relaxation exercises and videos for relaxation. Initial applications will be implemented with caregivers. The relaxation program is planned to last 6 weeks. The program is planned to last 8 weeks in total, with pre-test and post-test applications. Caregivers will then be asked to perform the treatments each week. Coping with Stress and State-Trait Anxiety Scale will be used at the beginning and end of the program.

Eligibility criteria: Inclusion criteria

* The child has received cancer treatment for at least two months,
* Those who have internet access on their smartphone or computer
* Those who can continue the work for six weeks (doing progressive relaxation exercises at least 2 times a week)

Exclusion Criteria:

* Those whose children/caregivers are in the terminal period,
* Those whose child/caregiver has not received chemotherapy treatment,
* Those who take medication for anxiety or use one of the complementary medicine approaches.

Primary outcomes:
measure: coping with stress
timeFrame: Change from Baseline level of Coping with stress to 8 weeks (change is being assessed)
measure: Anxiety
timeFrame: Change from Baseline level of Spielberger State-Trait Anxiety to 8 weeks (change is being assessed)
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References:
Clinical trial NCT02269995: Post-marketing Surveillance of DC Bead in Patients With Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular
Carcinoma
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-21
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Hepatocellular carcinoma

Brief summary: This surveillance's objectives are:

1. Unknown adverse reactions
2. Incidences of adverse drug reaction
3. Factors considered to have effect to safety and effectiveness


Eligibility criteria: Inclusion criteria:

Patients with Hepatocellular carcinoma

Exclusion criteria:

None

Primary outcomes:
measure: Safety and Tolerability as measured by Adverse Events
timeFrame: Up to 30 days
Secondary outcomes:
measure: Efficacy of DC bead as assessed by embolic performance
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
References:
citation: Jpn J Intervent Radiol. 2017;32:136-141.
Clinical trial NCT02824614: Effect of the Natural Sweeteners Erythritol and Xylitol on Gut Microbiota and Glucose Metabolism in Obese Volunteers
Official title: Effect of the Natural Sweeteners Erythritol and Xylitol on Gut Microbiota and Glucose Metabolism in Obese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Sugar alcohols such as xylitol and erythritol are increasingly popular as sugar substitutes in the food industry and are also recommended to diabetic patients. Both substances are already in use in the food industry and are freely available. Since the 1970s, beneficial effects on oral health could be demonstrated as oral bacteria were influenced positively. Animal studies showed an increase in gut Clostridium perfringens after xylitol intake; certainly a non-desirable effect. However, studies on effects of erythritol and xylitol on the human gut microbiota are lacking so far. In this trial, investigators aim to examine whether gut microbiota and glucose tolerance can be influenced by polyol intake in a non-diabetic but obese cohort.


Eligibility criteria: Inclusion Criteria:

* Obese volunteers (BMI \> 30kg/m2)
* Aged 18- max. 55 years
* Otherwise healthy.

Exclusion Criteria:

* Known cardiovascular disease
* Diabetes mellitus
* Arterial Hypertension with medication
* Dyslipidaemia with medication
* Known chronic hepatic disease (NASH, hepatitis).
* Known renal disease: kidney failure
* Pregnancy
* Intake of proton pump inhibitors (PPIs) on a regular basis
* Intake of antibiotics within the last 3 months before inclusion
* Intake of pro or prebiotics
* Chronical diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract
* Substance abuse, alcohol abuse.
* Inability to follow procedures due to psychological disorders, dementia or insufficient knowledge of project language (German).

Primary outcomes:
measure: Glucose tolerance measured with oral glucose tolerance test
timeFrame: change from baseline to 8 weeks after polyol intake
Secondary outcomes:
measure: Human gut microbiota composition measured with metagenomic shotgun sequencing
timeFrame: change from baseline to 8 weeks after polyol intake
measure: Gut microbial-related metabolites in feces
timeFrame: change from baseline to 8 weeks after polyol intake
measure: Gastrointestinal tolerance assessed by questionnaire
timeFrame: change from baseline to 8 weeks after polyol intake
measure: Gut microbial-related metabolites in urine
timeFrame: change from baseline to 8 weeks after polyol intake
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: St Claraspital
Study officials:
affiliation: St. Claraspital klinische Forschungsabteilung
name: Christoph Beglinger, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01021514: Association Between Arterial Wall Uptake of Fluorodeoxyglucose on PET Imaging and sRAGE
Official title: Association Between Arterial Wall Uptake of Fluorodeoxyglucose on PET Imaging and sRAGE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: sRAGE Level
SUV and TBR Levels in FDG PET
Keywords: sRAGE
SUV
TBR
FDG PET CT
Type 2 DM
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2009-11-30
Enrollment: 82
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: type 2 DM diagnoed according to critereia of American Diabetes Asociation.

Brief summary: Arteriosclerosis is a dynamic inflammatory disorder. Recently, FDG-PET CT is emerging diagnostic tool of non-invasive technique to detect vulnerable atherosclerotic plaque. And there are arising evidence that sRAGE(soluble Receptor for Advanced glycation End Product) is correlated with metabolic risk. So the investigators will investigate association between sRAGE and FDG-PET uptake in large artery in healthy patient.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis od type 2 DM

Exclusion Criteria:

* Type 1 DM
* Gestational Diabetes
* Severe Liver or Renal disease
* Diagnosis of cancer
* Trauma
* Acute infection or inflammatory disease
* Acute vasculitis or history of vasculitis
* Pregnant or Lactating women
* Dyslipidemia(active state)
* Cardiovascular disease or history of CVD
* Chronic obstructive pulmonary disease
* Any patient by judge of investigator

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Korea University Guro Hospital
name: Kyoungmook Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang SJ, Kim S, Hwang SY, Kim TN, Choi HY, Yoo HJ, Seo JA, Kim SG, Kim NH, Baik SH, Choi DS, Choi KM. Association between sRAGE, esRAGE levels and vascular inflammation: analysis with (18)F-fluorodeoxyglucose positron emission tomography. Atherosclerosis. 2012 Feb;220(2):402-6. doi: 10.1016/j.atherosclerosis.2011.11.008. Epub 2011 Nov 16.
Clinical trial NCT06035614: Efficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children
Official title: Efficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitiligo
Pediatric ALL
Dermatologic Disease
Autoimmune Diseases
Keywords: vitiligo
excimer
308nm
Lead sponsor: Clarteis
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitiligo is a auto immune that impact 2% of the global population, regardless from the phototype. Even though it affects patients in a physical way through loss of pigmentation, it is also impacting them on a mental/emotional way.11-12 Current treatments offer a symptomatic solution to patients, however the response rate can be low and results can be slow.

Pediatric patients in vitiligo deserves special care as frequently (50%), the disease onset is before 20 years of age and, in 25% of the cases, it starts before the age of 10 years.13 Also, the current treatments for children are limited since it can involve pain and claustrophobia. The combination therapy of the study could offer a painless and easy treatment to follow.

If the combination of those two therapies can fasten and improve the response rate, this could be a good option to treat this condition not only in children, but also for adults patients.


Eligibility criteria: Inclusion Criteria:

* vitiligo and surface area involved of less than10% who are being followed in the outpatient dermatology clinics of King Abdullah University Hospital (KAUH)
* 6 weeks wash out period from previous treatments will be employed to eliminate any effect from such treatments

Exclusion Criteria:

* Skin dermatoses with Kobner phenomenon
* Lupus erythematous
* Pacemakers
* Hyper-photosensitivity
* Melanoma and non-melanoma skin cancers
* Drugs with photosensitizer side effect
* Radiotherapy
* Pregnancy (by principle, nno study available)
* Diseases that are contagious by contact

Primary outcomes:
measure: repigmentation rate
timeFrame: 1,2,3 and 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ar Ramthā
country: Jordan
facility: King Abdullah University Hospital
Study officials:
References:
Clinical trial NCT00843895: Multicenter Prospective Evaluation of the Incidence and Serotyes of Invasive Pneumoccocal Disease (IPD) Among Children Below 5 Years
Official title: Serotyping of Pneumococci
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pneumococcal Disease
Keywords: Laboratory based study
antibiotic susceptibilty
invasive strains
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2009-02-13
Enrollment: 400
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to identify the S. pneumoniae serotypes strains and to determine antibiotic susceptibility.


Eligibility criteria: Inclusion Criteria:

* age less than 5 years

Exclusion Criteria:

* none

Primary outcomes:
measure: Incidence and serotypes of invasive pneumococcal dis.
timeFrame: 6-8 months
Secondary outcomes:
measure: Antibiotic susceptibility
timeFrame: 6-8 months
Other outcomes:
Locations:
Study officials:
References: